Form 10-KSB Nutra Pharma Corp.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-KSB
(Mark One)
[X] ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
For the fiscal year ended December 31, 2004
[ ] TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
For the transition period from _________ to ________
Commission file number 000-32141
NUTRA PHARMA CORP.
(Name of registrant as specified in its charter)
California 91-2021600
(State or Other Jurisdiction (IRS Employer
of Incorporation or organization) Identification Number)
1829 Corporate Drive, Boynton Beach, FL 33426
(Address of principal executive offices)
(954) 509-0911
Issuer's telephone number
Securities registered pursuant to Section 12(b) of the Exchange Act: None
Securities registered pursuant to Section 12(g) of the Exchange Act:
Common Stock, $0.001 par value
Check whether the issuer (1) filed all reports required to be filed by Section
13 or 15(d) of the Securities Exchange Act of 1934 during the past 12 months (or
for such shorter period that the registrant was required to file such reports),
and (2) has been subject to such filing requirements for the past 90 days.
Yes [X] No [ ]
Check if there is no disclosure of delinquent filers pursuant to Item 405 of
Regulation S-B is not 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. [ ]
The registrant's revenues for the fiscal year ended December 31, 2004 were $-0-.
The aggregate market value of the voting and non-voting common equity held by
non-affiliates computed by reference to the price at which the common equity was
sold, or the average bid and asked price of such common equity, as of April 21,
2005 is $20,143,903.
As of April 21, 2005, there were 60,854,682 shares of common stock issued and
outstanding.
Transitional Small Business Disclosure Format (Check one): Yes [ ]; No [X]
INDEX
Part I
Item 1. Description of Business ..........................................1
Item 2. Description of Property ..........................................9
Item 3. Legal Proceedings ................................................9
Item 4. Submission of Matters to a Vote of Security Holders ..............9
Part II
Item 5. Market for Common Equity and Related Stockholder Matters ........10
Item 6. Management's Discussion and Analysis or Plan of Operation .......15
Item 7. Financial Statements ............................................18
Item 8. Changes in and Disagreements with Accountants and
Financial Disclosure ............................................18
Item 8A. Controls and Procedures .........................................18
Item 8B. Other Information ...............................................19
Part III
Item 9. Directors, Executive Officers, Promoters and Control
Persons; Compliance with Section 16(a) of the Exchange Act ......19
Item 10. Executive Compensation ..........................................21
Item 11. Security Ownership of Certain Beneficial Owners and
Management and Related Stockholder Matters ......................22
Item 12. Certain Relationships and Related Transactions ..................24
Item 13. Exhibits ........................................................24
Item 14. Principal Accountant Fees and Services ..........................26
Forward-Looking Statements
This Annual Report on Form 10-KSB, including our "Plan of Operations" on page
15, contains forward-looking statements that involve risks and uncertainties,
as well as assumptions that, if they never materialize or prove incorrect, could
cause the results of Nutra Pharma Corp. (hereafter referred to as "we", "our" or
"us")to differ materially from those expressed or implied by such
forward-looking statements. The words or phrases "would be," "will allow,"
"intends to," "will likely result," "are expected to," "will continue," "is
anticipated," "estimate," "project," or similar expressions are intended to
identify "forward-looking statements." All statements other than statements of
historical fact, are statements that could be deemed forward-looking statements,
including any projections of revenue, gross margin, expenses, earnings or losses
from operations, synergies or other financial items; any statements of the
plans, strategies and objectives of management for future operations and; any
statement concerning developments, plans, or performance. Unless otherwise
required by applicable law, we do not undertake and we specifically disclaim any
obligation to update any forward-looking statements to reflect occurrences,
developments, unanticipated events or circumstances after the date of such
statement.
PART I
Item 1. Description of Business
HOW WE ARE ORGANIZED
We were incorporated in California on February 1, 2000. We have been conducting
our operations under the name, Nutra Pharma Corp. since October 31, 2001. We are
a development stage company and have never been the subject of a bankruptcy,
receivership, material reclassification, merger, consolidation, or purchase or
sale of a significant amount of assets not in the ordinary course of business,
or similar such proceeding or event. As of December 31, 2004, we had 54,059,682
shares of our common stock outstanding. As of April 21, 2005, we had 60,854,682
shares of our common stock outstanding.
BUSINESS OVERVIEW
We are a biopharmaceutical company specializing in the acquisition, licensing
and commercialization of pharmaceutical products and technologies for the
management of neurological disorders, cancer, autoimmune and infectious
diseases. Entities or we with which we are affiliated conduct basic drug
discovery research and clinical development in connection with the following
disorders and diseases:
o Multiple Sclerosis;
o HIV;
o Myasthenia Gravis (Autoimmune Disease); and
o AMN.
We currently have the following holdings, licenses, or investment:
o ReceptoPharm, Inc. - We agreed to acquire a 49.5% interest in
ReceptoPharm, a privately held biopharmaceutical company located in
Fort Lauderdale, in return for $2,000,000 in cash; as of April 18,
2005, we have invested $1,585,000 in ReceptoPharm, a development stage
company which is developing technologies for the development of drugs
for Multiple Sclerosis ("MS") and HIV.
o Infectech, Inc. - We hold approximately 13% of Infectech, Inc.,
("Infectech"), which is engaged in the research and development of
diagnostic test kits designed to be used for the rapid identification
of infectious human diseases such as Tuberculosis (TB) and
Mycobacterium avium-intracellulare (MAI).
o XenaCare - We have agreed with XenaCare, LLC, a healthcare management
company, to invest $250,000 in 15 Site of Care physicians' offices,
$75,000 of which we have already invested. XenaCare is engaged in the
business of manufacturing and distributing non-prescription
pharmaceuticals to physicians' offices.
We will continue to attempt to develop therapeutic approaches to diseases that
lack therapeutic options in the current market.
STRATEGY
Long term goal - Our long term goal is to continue research efforts based on our
drug discovery platform and to license the resulting drugs in the field of
neurological diseases, infectious diseases and autoimmune disorders. This goal
will require us to establish strategic partners or alliances with pharmaceutical
companies, academic institutions, biotechnology companies, and clinical
diagnostic laboratories, to complement our research and development efforts and
to develop licensing based revenue streams. We will also seek such partners or
alliances to reduce the risks associated with the drug development process. We
will continue our efforts to identify and acquire intellectual property and
companies in the biotechnology arena.
Mid term goal - Our mid term strategy is to license our AMN, MS and HIV
technologies with the intent to bring them to market within the next five years.
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OUR REVENUE MODEL
We will attempt to develop licensing agreements with pharmaceutical companies
from which we will receive licensing fees.
MARKETING
We currently do not have a marketing program. If and when we have US Food and
Drug Administration approved drug treatments, we intend to market such
treatments through pharmaceutical companies, other biotechnology companies, and
diagnostic laboratories. Our marketing program will be directed by our Chief
Executive Officer, Rik Deitsch, who will market the treatments to licensing and
development officers of those companies. We will also attempt to secure
consulting agreements with marketing consultants who will actively market our
products to such companies and/or provide our Chief Executive Officer with
guidance in the marketing area.
EMPLOYEES
As of March 30, 2004, we had 2 full time employees, our President, Rik Deitsch,
and Nina Goldstein, our Executive Administrative Assistant. We have a consulting
agreement with our Director, Mr. Tanvir Khandaker, which is described at page
8. We utilize the services of other consultants on an as-needed basis.
LICENSED TECHNOLOGIES
ReceptoPharm, Inc.
ReceptoPharm is developing potential drugs for the treatment of MS and HIV,
which is based in part on our licensed technology. ReceptoPharm has three
patents pending for the protection of its own proprietary technologies in these
areas. Additionally, ReceptoPharm is engaged in the research and development of
potential drugs for other viral, auto-immune and neuro-degenerative diseases,
which are being developed based on novel, modified proteins that have been
studied as treatments for several clinical disorders. As part of our agreement
with ReceptoPharm, it may use our licensed technology, which involves a specific
chemical process for the modification of cobratoxin, which is ozonolysis that
eliminates its poisonous effect. As a result of this process, the modified
cobratoxin retains some of the affinities of the native toxin, but to a
diminished degree. These drugs have successfully completed Phase I safety
studies in the United States and Europe. ReceptoPharm is now focusing its near
term drug development efforts on initiating a Phase II human clinical trial for
its HIV drug. Phase II is meant to show preliminary efficacy in a human
population and is usually a smaller trial in one or two locations. Phase III is
the last step before potential regulatory approval and usually consists of a
large, multi-center, multi-national trial and would provide data for proper
dosage, potential side effects and potential contraindications. With HIV, the
Phase II trial would most likely involve fewer than 50 patients and last fewer
than 10 weeks. The trial would only need to show a reduction in viral load.
ReceptoPharm's Multiple Sclerosis (MS) Applications
Background Information Pertaining to MS
MS is a neurological disorder affecting approximately 2.0 million people
globally and is believed to be an autoimmune disease in which the body's immune
system damages primarily the central nervous system. People with MS may
experience diverse signs and symptoms. MS symptoms may include pain, fatigue,
cognitive impairment, tremors, loss of coordination and muscle control, loss of
touch sensation, slurred speech and vision impairment. The course of the disease
is unpredictable and for most MS patients, the disease initially manifests a
"relapsing-remitting" pattern. Periods of apparent stability are punctuated by
acute exacerbations which are sudden unpredictable episodes that might involve
impaired vision, diminished ability to control a limb, loss of bladder control,
or a great variety of other possible neurologic deficits. In relapsing-remitting
MS, some or all of the lost function returns, however, the patient sustains an
unceasing, often insidious, accumulation of neuronal damage. As the burden of
neural damage grows, new lesions are more likely to produce irreversible
impairment of function. Typically, about eight to fifteen years after onset, MS
patients enter the secondary-progressive phase. Eventually, progressive MS
sufferers become wheelchair-bound, and may become blind and even incapable of
speech. There is currently no approved drug that reverses the course of the
progressive form of MS.
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ReceptoPharm's Proposed Drug for Treatment of MS
ReceptoPharm's proposed drug for the treatment of MS is derived from
alpha-cobratoxin. This compound binds strongly to the acetylcholine receptors on
the post-synaptic nerve. Normally, this action stops the progression of a signal
through the nerve and this has the effect of slowing or paralyzing muscles -
including muscles responsible for heart and lung function. The process used to
chemically modify the alpha-cobratoxin weakens its binding potential.
ReceptoPharm's researchers believe that by binding weakly to these receptors,
the drug controls nerve function by regulating the charges distributed down the
nerve pathway (much like a resistor on an electrical circuit). Early in-vitro
studies conducted by ReceptoPharm's researchers have shown that conduction in
demyelinated nerves is stabilized in the presence of the drug. In pre-clinical
studies, the drug has been found to significantly affect the disease process of
MS. It had a significant affect on the genes in the cytokine pathway as well as
the myelination pathway. The cytokine pathway genes play a role in marshaling
the attack on the nervous system by immune cells. Since this is one of the
principle pathways that lead to the forward progression of MS, it is notable
that if these results are replicated in the patient population it may greatly
reduce the severity of the disease. Additionally, genes responsible for repair
and maintenance of the myelin sheathes of neurons were upregulated. MS patients
have a loss of myelin, the insulating material that surrounds the nerve fibers
in the brain, spinal cord, and optic nerves. This damage or loss of myelin can
prevent nerve signals from being conducted, or can cause those signals to be
conducted too slowly. The data from this study suggests that the drug may aid
the patient in reversing some of the damage caused to the myelin by their
disease.
ReceptoPharm's HIV/AIDS Applications
Background Information Pertaining to HIV/AIDS
More than forty million people are infected with HIV, the virus that causes
AIDS. Globally, an estimated 5 million people were newly infected and 3 million
people died of AIDS in 2003. Three-quarters of those who have the disease live
in Africa, where AIDS is now the leading cause of death. According to a recently
published report by the financial services firm Griffin Securities, the market
for HIV therapies is expected to triple in size by 2007, growing from $5 billion
dollars in sales to over $13 billion in sales by 2007. Growth in the HIV therapy
market will continue to be driven by the rapidly growing HIV and AIDS
population. In the absence of therapeutic intervention, the vast majority of
individuals infected with HIV will ultimately develop AIDS, on average in about
10 years, which has a mortality rate approaching 100%. Experts say that the
drugs currently available only extend life on average 1.8 years.
To cause infection, HIV needs to gain entry into cells through the attachment to
receptors on the cell membrane. These receptors are called chemokine receptors.
There are two principal types, CCR5 and CXCR4. Different HIV strains use one of
these types. A single drug that would block all of the chemokine receptors
("tropism-independent") could be more useful, for several reasons, than a
mixture of molecules that would have to be used to do the same.
New drugs and adjunct therapies with novel mechanisms of action or unique
resistance profiles are needed in the fight against HIV. Constant innovation, in
terms of efficacy, side effect profile and dosing are occurring. Current
research and development for HIV is focused on adjunctive therapy, which when
combined with existing HAART (Highly Active Anti-Retroviral Therapy) regimens
reduce side effects, enhance the efficacy of existing treatments and delay the
progression of the HIV virus.
ReceptoPharm's Treatments of HIV
Results from completed assays have indicated that ReceptoPharm's drug inhibited
by over 90%, the infection rate of two strains of HIV, one specific to the CCR5
receptor and the other specific for the CXCR4 receptor. Based on these results,
ReceptoPharm intends to initiate a Phase II human trial in HIV. The early work
in HIV will continue with further in-vitro assays to provide definitive data on
the efficacy of the drug as an inhibitor of HIV fusion. These assays should also
yield information on the drug's potential to cause viral mutations.
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Bio-Therapeutics, Inc.
We have a non-exclusive license to certain intellectual property of Bio
Therapeutics, Inc, which consists of the following two distinct technology
platforms:
o Alteration of Proteins and Peptides - We have patented methods for
altering the 3-Dimensional structure of certain proteins and peptides.
The natural peptides bind to receptors in the body with toxic effects.
This technology allows us to alter the structure of these peptides,
preserving their receptor-binding characteristics, while making them
non-toxic and therapeutic. Different receptors have various functions
in many disease states. By the peptides binding to these receptors in
a controlled fashion certain symptoms of diseases may be treated. In
connection with MS, binding to the acetylcholine receptor on the
nerves allows for more efficient nerve conduction. With HIV, binding
to chemokine receptors may prevent the virus from entering and
infecting new cells;
o Innovative aerosolized drug delivery system - Many therapeutic agents
cannot be effectively delivered by aerosol formulation due to their
large size and/or irregular shapes. Since these therapeutic agents
cannot be ingested orally without being degraded by the digestive
system, patients have no alternative but to inject these drugs
directly. We have a non-exclusive license to a proprietary aerosol
formulation, for which a patent is now pending, which greatly enhances
the permeability of the mucous membranes found on the roof of the
mouth and the back of the throat. This allows for the easy and
efficient systemic delivery into the bloodstream of a much wider
variety of proteins and peptides. This non-exclusive license for
"Buccal Delivery System" (patent-pending) includes claims that
identify the active mucosal enhancer, its combination with therapeutic
agents and the mode of delivery through aerosol. This may allow for
the effective and pain-free delivery of peptide and protein
therapeutics for the treatment of HIV and MS.
During April 2005, Bio Therapeutics filed a Motion to Enforce a Settlement
Agreement against us in the Circuit Court of Broward County Florida alleging
breaches of a license agreement we have with Bio Therapeutics. This litigation
is described on page 9 of this Form 10-KSB.
Infectech
Our other approximately 13% holding, Infectech, owns 29 issued patents related
to the rapid isolation, growth, identification and antibiotic sensitivity of
disease causing pathogens such as Tuberculosis ("TB") and Mycobacterium
avium-intracellulare ("MAI"). Infectech also owns 1 issued patent related to a
method of inducing apoptosis in cancer cells and 1 patent related to methods
used in bioremediation of contaminated air, soil and water. Infectech's primary
patented technologies are related to a technique known as "paraffin baiting".
Infectech's researchers discovered that certain grades of paraffin wax, when
used in conjunction with a microscope slide, and combined with a nutrient broth,
provides for the rapid isolation, growth and identification of various disease
causing pathogens. Infectech is in the process of developing a diagnostic test
kit based on this technology. Infectech initially plans to market its product
through licensing and distribution arrangements with large, well-established
medical diagnostic companies. Infectech's markets will potentially include
hospitals, clinical laboratories, medical research institutions, medical
schools, physician's offices, and even pharmaceutical companies, as the
antibiotic sensitivity testing methodology may be useful in creating new drugs
to treat paraffinophilic microorganisms. Infectech is currently working with
third-party researchers in academia to provide a current validation of their
technology for submission to the FDA.
GOVERNMENT REGULATION
The production and marketing of potential drug products as well as research and
development activities generally are subject to regulation by numerous
governmental authorities in the United States and other countries. In the United
States, vaccines, drugs and certain diagnostic products are subject to Food and
Drug Administration ("FDA") review of safety and efficacy. The Federal Food,
Drug and Cosmetic Act, the Public Health Service Act and other federal statutes
and regulations govern or influence the testing, manufacture, safety, labeling,
storage, record keeping, approval, advertising and promotion of such products.
Noncompliance with applicable requirements can result in criminal prosecution
and fines, recall or seizure of products, total or partial suspension of
production, or refusal of the government to approve Biological License
Applications ("BLAs"), Product License Applications ("PLAs"), New Drug
Applications ("NDAs") or refusal to allow a company to enter into supply
contracts. The FDA also has the authority to revoke product licenses and
establishment licenses previously granted.
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In order to obtain FDA approval to market a new biological or pharmaceutical
product, proof of product safety, purity, potency and efficacy, and reliable
manufacturing capability must be submitted. This requires companies to conduct
extensive laboratory, preclinical and clinical tests. This testing, as well as
preparation and processing of necessary applications, is expensive,
time-consuming and often takes several years to complete. There is no assurance
that the FDA will act favorably in making such reviews. Our partners or we may
encounter significant difficulties or costs in their efforts to obtain FDA
approvals, which could delay or preclude from marketing any products that may be
developed. The FDA may also require post-marketing testing and surveillance to
monitor the effects of marketed products or place conditions on any approvals
that could restrict the commercial applications of such products. Product
approvals may be withdrawn if problems occur following initial marketing, such
as, compliance with regulatory standards is not maintained. Delays imposed by
governmental marketing approval processes may materially reduce the period
during which a company will have the exclusive right to exploit patented
products or technologies. Refusals or delays in the regulatory process in one
country may make it more difficult and time consuming to obtain marketing
approvals in other countries.
The FDA approval process for a new biological or pharmaceutical drug involves
completion of preclinical studies and the submission of the results of these
studies to the FDA in an Initial New Drug application, which must be approved
before human clinical trials may be conducted. The results of preclinical and
clinical studies on biological or pharmaceutical drugs are submitted to the FDA
in the form of a BLA, PLA or NDA for product approval to commence commercial
sales. In responding to a BLA, PLA or NDA, the FDA may require additional
testing or information, or may deny the application. In addition to obtaining
FDA approval for each biological or chemical product, an Establishment License
Application ("ELA") must be filed and the FDA must inspect and license the
manufacturing facilities for each product. Product sales may commence only when
both BLA/ PLA/ NDA and ELA are approved. In certain instances in which a
treatment for a rare disease or condition is concerned, the manufacturer may
request the FDA to grant the drug product Orphan Drug status for a particular
use. "Orphan" status refers to serious ailments affecting less than 250,000
individuals. In this event, the developer of the drug may request grants from
the government to defray the costs of certain expenses related to the clinical
testing of such drug and be entitled to marketing exclusivity and certain tax
credits.
In order to gain broad acceptance in the marketplace of a medical device, our
partners or we will need to receive approval from the FDA and other equivalent
regulatory bodies outside of the United States. This approval will be based upon
clinical testing programs at major medical centers. Data obtained from these
institutions will enable us or our partners to apply to the FDA for acceptance
of its technology as a "device" through a 510(k) application or exemption
process. Once the data has been fully gleaned, it is expected that this process
would take less than ninety days.
According to the FDA, a "device" is: "an instrument, apparatus, implement,
machine, contrivance, implant, in vitro reagent, or other similar or related
article, including a component part, or accessory which is recognized in the
official National Formulary, or the United States Pharmacopoeia, or any
supplement to them, intended for use in the diagnosis of disease or other
conditions, or in the cure, mitigation, treatment, or prevention of disease, in
man or other animals, or intended to affect the structure or any function of the
body of man or other animals, and which does not achieve any of it's primary
intended purposes through chemical action within or on the body of man or other
animals and which is not dependent upon being metabolized for the achievement of
any of its primary intended purposes."
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The FDA classifies devices as either Class I/II-exempt, Class II, or Class III.
Class III: Pre-Marketing Approval, or PMA: A Pre-Marketing Approval or PMA is
the most stringent type of device marketing application required by FDA. A PMA
is an application submitted to FDA to request clearance to market, or to
continue marketing of a Class III medical device. A PMA is usually required for
products with which FDA has little previous experience and in such cases where
the safety and efficacy must be fully demonstrated on the product. The level of
documentation is more extensive than for a 510(k) application and the review
timeline is usually longer. Under this level of FDA approval, the manufacturing
facility will be inspected as well as the clinical sites where the clinical
trials are being or have been conducted. All the appropriate documents have to
be compiled and available on demand by the FDA. The manufacturing facility is
registered with the FDA and the product or device is registered with the FDA.
Class II: 510(k). This is one level down from the PMA and it is applied to
devices with which the FDA has had previous experience. A 510(k) is a
pre-marketing submission made to FDA to demonstrate that the device to be
marketed is as safe and effective, that is, substantially equivalent, to a
legally marketed device that is not subject to pre-market approval. Applicants
must compare their 510(k) device to one or more similar devices currently on the
U.S. market and make and support their substantial equivalency claims. The
legally marketed device to which equivalence is drawn is known as the
"predicate" device. Applicants must submit descriptive data and, when necessary,
performance data to establish that their device is SE to a predicate device.
Again, the data in a 510(k) is to show comparability, that is, substantial
equivalency (SE) of a new device to a predicate device. Under this level of
approval, the manufacturing facility is registered with the FDA and the product
or device is registered with the FDA. Inspections under this classification are
possible. All the appropriate cGMP and clinical data backing the claims made
must be on file and available on demand by the FDA.
Class I/II Exemption: This is the lowest level of scrutiny. Most Class I devices
and a few Class II devices are exempt from the pre-marketing notification
requirements subject to the limitations on exemptions. However, these devices
are not exempt from other general controls. All medical devices must be
manufactured under a quality assurance program, be suitable for the intended
use, be adequately packaged and properly labeled, and have establishment
registration and device listing forms on file with the FDA. However, as
described above, all the appropriate documentation including cGMP and clinical
data supporting the claims being made has to be on hand and available on demand
by the FDA. The data must be available to support all the product claims.
Sales of biological and pharmaceutical products and medical devices outside the
United States are subject to foreign regulatory requirements that vary widely
from country to country. Whether or not FDA approval has been obtained, approval
of a product or a device by a comparable regulatory authority of a foreign
country must generally be obtained prior to the commencement of marketing in
that country.
Infectech is also subject to regulation by the Occupational Safety and Health
Administration ("OSHA") and the Environmental Protection Agency ("EPA") and to
regulation under the Toxic Substances Control Act, the Resource Conservation and
Recovery Act and other regulatory statutes, and may in the future be subject to
other federal, state or local regulations. Infectech believes that they are in
compliance with regulations regarding the disposal of its biological,
radioactive and chemical waste. Infectech voluntarily complies with NIH
guidelines regarding research involving recombinant DNA molecules. Such
guidelines, among other things, restrict or prohibit certain recombinant DNA
experiments and establish levels of biological and physical containment that
must be met for various types of research.
PRODUCT LIABILITY
The design, development, and manufacture of drug products or diagnostic tests
involve an inherent risk of product liability claims and damage to our brand
name reputation. Such claims may involve allegations of product failure or harm
caused by the drug product. ReceptoPharm has product liability insurance for
purpose of manufacturing the drugs currently under clinical trials. Apart from
that, we do not currently manufacture any drugs and currently do not maintain
product liability insurance; however, we plan to obtain product liability
insurance in the future should we bring any products and services to market.
Product liability claims may result in significant legal costs related to our
defense of such actions. In addition, should we become liable for any product
liability claims, the amount of damages may exceed our product liability
insurance coverage.
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RESEARCH AND DEVELOPMENT
During 2003, we spent $0 on our research and development. During 2004, we spent
$1,104,968 on our research and development.
COSTS ASSOCIATED WITH ENVIRONMENTAL COMPLIANCE
We have no present or anticipated direct future costs associated with
environmental compliance, since we are not and will not be directly involved in
manufacturing drug products as result of our research and development.
ReceptoPharm produces a drug that has limited waste issues and related costs.
ReceptoPharm handles these environmentally related matters through the FDA's
Good Manufacturing Practices, which are the guidelines mandated by the FDA for
the production of drugs in the United States.
SOURCES AND AVAILABILITY OF RAW MATERIALS
ReceptoPharm uses the raw material, cobra venum, which is the main ingredient
for the drugs being studied by ReceptoPharm. Apart from that, we do not
currently use raw materials in our business.
CUSTOMER DEPENDENCY
Our potential customers consist of men and women using the drugs that are
developed through relationships with pharmaceutical and other companies; as
such, we do not plan on being dependent upon one single customer or just a few
customers.
PATENTS AND INTELLECTUAL PROPERTY
We seek patent and other intellectual property rights to protect and preserve
our proprietary technology and our right to capitalize on the results of our
research and development activities. We also rely on trade secrets, know-how,
continuing technological innovations and licensing opportunities to develop new
products.
Bio Therapeutics Patents
We hold a license to certain intellectual property from Bio Therapeutics, which
it intends to utilize in conjunction with ReceptoPharm's research and
development of modified venom and peptides thereof in applications for the
treatment of HIV and MS. These patents include:
- U.S. Patent No. 5,989,857, which was granted in November 1999 with 10 claims.
- U.S. Patent No. 6,670,148, which was granted in December 2003, with 9 claims.
The patent further describes the method for preparing a bioactive peptide
(protein) found in cobra venom, in a stable, inactivated form, by treating the
peptide with ozone.
- Buccal Delivery System, on which a patent is pending. This application
describes a throat spray that permits efficient delivery of the modified
peptide drugs to the body through oral mucosa.
- Technology contained in one pending U.S. patent application for the further
development of bioactive peptides in cobra venom for use in the treatment of
HIV and MS.
- Technology contained in two pending U.S. patent applications for Immunokine
Composition and Method, which describes a method for developing modified
peptides from alpha-cobratoxin.
- Technology contained in two patents pending for the topical delivery of our
proprietary wound healing treatment, which was developed in conjunction with
Bio Therapeutics. One of these products is in the form of an ointment style
skin protectant and the other a foaming aerosol.
Infectech Patents
We own approximately 13% of Infectech, which holds 31 U.S. patents covering
technologies related to growing, detecting, identifying, defining antibiotic
sensitivity and designing apparatus for the detection of 32 different
paraffin-eating microorganisms.
Our business is dependent upon our ability to protect our proprietary
technologies and processes. Despite our efforts to protect our proprietary
rights, unauthorized parties may attempt to obtain and use information that we
regard as proprietary. We will rely on patent and trade secret law and
nondisclosure and other contractual arrangements to protect such proprietary
information. We will file patent applications for our proprietary methods and
devices for patient treatments. There can be no assurance that others will not
independently develop substantially equivalent proprietary information and
techniques or otherwise gain access to our proprietary information that such
information will not be disclosed or that we can effectively protect our rights
to unpatented trade secrets or other proprietary information.
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COMPETITION
The biotechnology research and development field is extremely competitive and is
characterized by rapid change. Our competitors have substantially greater
financial, scientific, and human resources, and as a result greater research and
product development capabilities. Our competitors have competitive advantages
with greater potential to develop revenue streams.
Our competitors are located in the United States as well as around the world and
include:
ReceptoPharm and Infectech will compete with many new and emerging companies as
well as established pharmaceutical companies, all of which have superior
financial resources than Nutra Pharma.
Currently, there are 19 AIDS drugs on the market, falling into four general
classes: Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Protease
Inhibitors (PIs), Entry Inhibitors (EIs); and Non-Nucleoside Reverse
Transcriptase Inhibitors (nNRTIs). These drugs are usually used in combinations
of three or more to create an effective antiviral therapy. In addition, almost
100 investigational new drug applications (INDs) have been submitted to the U.S.
Food and Drug Administration to conduct clinical trials on HIV candidates.
Leadership in entry inhibitors include: Roche/Trimeris' fusion inhibitor T-20,
Progenics Pharmaceuticals' CD4 receptor blocker, PRO-542, and Aethlon Medical's
extracorporeal entry inhibitor, the HIV-Hemopurifier. These products will be
used in addition to, rather than instead of existing regimens, and should serve
to expand the overall market.
The only current competitive agent to ReceptoPharm's proposed HIV drug is
Trimeris' drug, T-20 (Fuzeon). This is an entry inhibitor that has recently been
approved by the FDA. The cost of Fuzeon to the patient is roughly $20,000 per
year. Because of production constraints, the drug will be available to no more
than 15,000 persons worldwide during the next 12 months. Fuzeon must be
administered by subcutaneous injection twice daily. Fuzeon is also known to
naturally select for viral mutations, leading patients to grow resistant to the
drug.
The pharmaceutical market for MS therapy is currently dominated by
interferon-based drugs - Avonex(R)from Biogen, Betaseron(R)from Berlex
Laboratories and Schering, and Rebif(R)from Serono and Pfizer. The only other
major market brand is Copaxone(R)(glatiramer acetate) from Teva and Aventis. The
global MS market achieved sales of $2.9 billion in 2002 and is forecast to grow
to $4.7 billion by 2006. It is estimated that nearly 80 percent of MS patients
choose to go without medication, choosing to suffer the symptoms of their
disease rather than face the negative side effects of the prescription drugs.
This places the potential global market for an effective therapy at over $14
billion annually.
The only competing products to Infectech's test kits are the conventional solid
media, such as Lowenstein Jensen, and Middlebrook Media. These media are not
capable of distinguishing between TB and Non-TB media, have a short shelf life
and require extensive pre-preparation. In addition, these media require
refrigeration.
MATERIAL AGREEMENTS
Consulting Agreement with Tanvir Khandaker
On February 14, 2005, we completed a Consulting Agreement with Dr. Tanvir
Khandaker, to work full time as our consultant in the areas of business
development, mergers and acquisitions, partnering and licensing during our
Fiscal Year 2005. In return for Dr. Khandaker's services, we provide a monthly
retainer of $10,000 to him. Dr. Khandaker is also one of our Directors.
-8-
REPORTS TO SECURITY HOLDERS
We are subject to the informational requirements of the Securities Exchange Act
of 1934. Accordingly, we file annual, quarterly and other reports and
information with the Securities and Exchange Commission. You may read and copy
these reports in Washington, D.C. Our filings are also available to the public
from commercial document retrieval services and the Internet world wide website
maintained by the Securities and Exchange Commission at www.sec.gov.
Item 2. Description of Property
In accordance with the terms of a March 2004 verbal agreement between Stan
Cherelstein, on behalf of Waiora, Inc. as Waiora's President, and Rik Deitsch,
our President, on our behalf, we use 800 square feet of office space located at
1829 Corporate Drive, Boynton Beach, Florida that is leased by Waiora, Inc. We
make no cash payment for the use of this space. The verbal agreement between
Waiora and us provides that we are permitted to use such space in return for our
President, Rik Deitsch, serving as Chairman of Waiora's Scientific Advisory
Board. There is no expiration date to this agreement, and Waiora, Inc may
terminate our use of this space at any time. Waiora's's lease term expires April
2007. The 800 square feet of office space is allotted specifically to Nutra
Pharma Corp. As part of the agreement, Waiora also provides us with access to a
conference room, office equipment, and a T-1 Internet connection. Stan
Cherelstein serves as one of our Directors and is Chair of our Audit and
Compensation Committees. Our offices are in good condition and are sufficient to
conduct our operations.
Item 3. Legal Proceedings
Subsequent to our year-end, on April 4, 2005, a Motion to Enforce Settlement
Agreement was filed against us in the Circuit Court of Broward County Florida by
Bio Therapeutics, Inc. f/k/a Phylomed Corp. in Nutra Pharma Corp. v. Bio
Therapeutics, Inc. (17th Judicial Circuit, Case No. 03-008928 (03)). This
proceeding results from our alleged breach of a settlement agreement that was
entered into between Bio Therapeutics and us in resolution of a previous lawsuit
between us and Bio Therapeutics that was resolved by entering into a Settlement
Agreement. We also entered into a related License Agreement and Amendment to the
License Agreement ("License Agreement") with Bio Therapeutics.
In the April 4, 2005 motion, Bio Therapeutics alleges that we breached certain
provisions of the License Agreement and requests that the Court grant its motion
to enforce the Settlement Agreement by declaring the License Agreement
terminated, enjoining us from further use of license products that was granted
to us by the License Agreement, and awarding attorneys fees and costs to Bio
Therapeutics. This matter is set for a hearing on April 28, 2005 to hear a
motion to set a motion for an evidential hearing.
We intend to defend against this action. We do not believe that this action will
have a material effect upon our operations; however, a negative judgment against
us could have a materially adverse effect on our operations and financial
condition.
Item 4. Submission of Matters to a Vote of Security Holders
There were no matters submitted to a vote of security holders.
-9-
PART II
Item 5. Market for Common Equity and Related Stockholder Matters
The Company's common stock is quoted on the over-the-counter bulletin board
under the trading symbol "NPHC." The following table sets forth the high and low
bid prices for each quarter within the last two fiscal years.
2004 2003
High Bid Low Bid High Bid Low Bid
---------- --------- ---------- ---------
First Quarter 0.76 0.45 0.85 0.34
Second Quarter 0.77 0.36 0.40 0.12
Third Quarter 0.43 0.22 1.02 0.13
Fourth Quarter 0.60 0.21 0.95 0.41
The above quotations reflect inter-dealer prices, without retail mark-up,
mark-down or commission and may not represent actual transactions.
PENNY STOCK CONSIDERATIONS.
Our Shares are "penny stocks" as that term is generally defined in the
Securities Exchange Act of 1934 as equity securities with a price of less than
$5.00. Our shares are subject to rules that impose sales practice and disclosure
requirements on broker-dealers who engage in certain transactions involving a
penny stock.
Under the penny stock regulations, a broker-dealer selling a penny stock to
anyone other than an established customer or "accredited investor" must make a
special suitability determination regarding the purchaser and must receive the
purchaser's written consent to the transaction prior to the sale, unless the
broker-dealer is otherwise exempt. Generally, an individual with a net worth in
excess of $1,000,000 or annual income exceeding $200,000 individually or
$300,000 together with his or her spouse is considered an accredited investor.
In addition, under the penny stock regulations the broker-dealer is required to:
o Deliver, prior to any transaction involving a penny stock, a
disclosure schedule prepared by the Securities and Exchange Commission
relating to the penny stock market, unless the broker-dealer or the
transaction is otherwise exempt;
o Disclose commission payable to the broker-dealer and its registered
representatives and current bid and offer quotations for the
securities;
o Send monthly statements disclosing recent price information pertaining
to the penny stock held in a customer's account, the account's value
and information regarding the limited market in penny stocks; and
o Make a special written determination that the penny stock is a
suitable investment for the purchaser and receive the purchaser's
written agreement to the transaction, prior to conducting any penny
stock transaction in the customer's account.
Because of these regulations, broker-dealers may encounter difficulties in their
attempt to sell shares of our common stock, which may affect the ability of
shareholders to sell their shares in the secondary market and have the effect of
reducing the level of trading activity in the secondary market. These additional
sales practice and disclosure requirements could impede the sale of our
securities. In addition, the liquidity for our securities may be adversely
affected, with a corresponding decrease in the price of our securities. Our
shares are subject to such penny stock rules and our shareholders will, in all
likelihood, find it difficult to sell their securities.
HOLDERS
At March 31, 2004, based upon records obtained from our transfer agent, there
were 222 holders of record of our common stock. Our transfer agent records do
not account for other holders of our common stock that are held in street name
or by broker dealers as custodian for individual holders of our stock. We have
one class of common stock outstanding.
-10-
DIVIDENDS
We have not declared any cash dividends on our common stock since our inception
and do not anticipate paying such dividends in the foreseeable future. We plan
to retain any future earnings for use in our business. Any decisions as to
future payment of dividends will depend on our earnings and financial position
and such other factors as the Board of Directors deems relevant.
SECURITIES AUTHORIZED FOR ISSUANCE UNDER EQUITY COMPENSATION PLANS
Equity Compensation Plan Information
On December 3, 2003, our Board of Directors approved the Employee/Consultant
Stock Compensation Plan (the "Plan"). The Plan was not submitted to our
shareholders for approval. The purpose of the Plan is to further our growth by
allowing us to compensate employees and consultants who have provided bona fide
services to us through the award of our common stock. The maximum number of
shares of common stock that may be issued under the Plan is 2,500,000.
Our board of directors is responsible for the administration of the Plan and has
full authority to grant awards under the Plan. Awards may take the form of stock
grants, options or warrants to purchase common stock. Our Board of Directors has
the authority to determine; (a) the employees and consultants that will receive
awards under the Plan, (b) the number of shares, options or warrants to be
granted to each employee or consultant, (c) the exercise price, term and vesting
periods, if any, in connection with an option grant, and (d) the purchase price
and vesting period, if any, in connection with the granting of a warrant to
purchase shares of our common stock.
On December 9, 2003, we filed a Registration Statement on Form S-8 with the
Securities and Exchange Commission which covered the issuance of up to
2,500,000 shares of common stock under the Plan. As of December 31, 2003, we
had issued a total of 15,000 shares under the Plan. These shares were issued to
a consultant for services rendered during 2003. During 2004, we issued an
additional 2,480,000 shares to consultants for services rendered.
The following table summarizes our equity compensation plan information as of
December 31, 2004.
Number of securities
to be issued upon Weighted average Number of securities
exercise of exercise price of remaining available
outstanding options, outstanding options, for
Plan Category warrants and rights (1) warrants and rights future issuance
---------------------------- ---------------------- -------------------- --------------------
Equity compensation plans N/A N/A N/A
approved by security holders
Equity compensation plans not -0- N/A 5,000
approved by security holders ---------------------- -------------------- --------------------
Total -0- N/A 5,000
====================== ==================== ====================
(1) As of December 31, 2004, there were no outstanding options or warrants to
purchase our common stock.
RECENT SALES OF UNREGISTERED SECURITIES
The following reflects issuances of our restricted common stock during the
fourth quarter of 2004, or corrections to issuances made during our third
quarter for the period ending September 30, 2004. All other issuances of our
restricted common stock during our Fiscal Year 2004 were reported in our Forms
10-QSB for Fiscal Year 2004.
-11-
Subsequent to our year end at December 31, 2004, on January 26, 2005, we issued
500,000 shares of our restricted common stock to our Director, Tanvir Khandaker
in return for his services as our Director. The restricted shares were valued at
$0.40 per share or an aggregate of $200,000. We relied upon Section 4(2) of the
Act. We believed Section 4(2) was available because the offer and sale did not
involve a public offering. We had a pre-existing relationship with Tanvir
Khandaker as our Director.
On November 5, 2004, we issued 500,000 shares of our restricted common stock to
our Director, Rik J. Deitsch in return for his services as our Chairman of the
Board. The restricted shares were valued at $0.40 per share or an aggregate of
$200,000. We relied upon Section 4(2) of the Act. We believed Section 4(2) was
available because the offer and sale did not involve a public offering. We had a
pre-existing relationship with Rik J. Deitsch as our Chairman of the Board.
On November 5, 2004, we issued 500,000 shares of our restricted common stock to
our Director, Michael D. Flax in return for his services as our Director. The
restricted shares were valued at $0.40 per share or an aggregate of $200,000. We
relied upon Section 4(2) of the Act. We believed Section 4(2) was available
because the offer and sale did not involve a public offering. We had a
pre-existing relationship with Michael D. Flax as our Director.
On November 5, 2004, we issued 500,000 shares of our restricted common stock to
our Director, Stanley J. Cherelstein in return for his services as our Director.
The restricted shares were valued at $0.40 per share or an aggregate of
$200,000. We relied upon Section 4(2) of the Act. We believed Section 4(2) was
available because the offer and sale did not involve a public offering. We had a
pre-existing relationship with Stanley J. Cherelstein as our Director.
On November 5, 2004, we issued 500,000 shares of our restricted common stock to
our Director, Stewart Lonky in return for his services as our Director. The
restricted shares were valued at $0.40 per share or an aggregate of $200,000. We
relied upon Section 4(2) of the Act. We believed Section 4(2) was available
because the offer and sale did not involve a public offering. We had a
pre-existing relationship with Stewart Lonky as our Director.
On November 5, 2004, we issued 100,000 shares of our restricted common stock to
Kevin Leigh in return for consulting services rendered by Mr. Leigh in
connection with an investor relation's agreement we have with Investor-Gate.com.
The restricted shares were valued at $0.24 per share or an aggregate of $24,000.
These shares were previously valued in error at $0.40 per share or an aggregate
of $40,000, which we previously reported in our Form 10-QSB for the period
ending September 30, 2004. We believed Section 4(2) was available because the
offer and sale did not involve a public offering. We had a pre-existing
relationship with Mr. Leigh in connection with our agreement with
Investor-Gate.com.
On October 18, 2004, we issued 424,200 shares of our common stock to Structured
Management, a Nevada corporation owned and controlled by Shon Conine, in return
for consulting services pertaining to business operations and due diligence for
potential acquisitions that Structured Management rendered to us. The restricted
shares were valued at $0.38 per share or an aggregate of $161,196. These shares
were previously valued in error at $0.36 per share or an aggregate of $152,712,
which we previously reported in our Form 10-QSB for the period ending September
30, 2004. We believed Section 4(2) was available because the offer and sale did
not involve a public offering. We had a pre-existing relationship with Shon
Conine who rendered consulting services to us on behalf of Structured
Management.
On October 18, 2004, we issued 15,000 shares of our common stock to David M.
Isserman in return for consulting services pertaining to website design that Mr.
Isserman rendered to us. The restricted shares were valued at $0.38 per share or
an aggregate of $5,700. These shares were previously valued in error at $0.36
per share or an aggregate of $5,400, which we previously reported in our Form
10-QSB for the period ending September 30, 2004. We believed Section 4(2) was
available because the offer and sale did not involve a public offering. We had a
pre-existing relationship with Mr.Isserman as our consultant.
-12-
On November 12, 2004, we sold 50,000 shares of our common stock at $0.17 per
share or an aggregate of $8,500 to CM31, a trust based in Naples Florida that is
managed by Charles Marcom for the benefit of his children. We relied upon
Section 4(2) of the Securities Act of 1933, as amended ("the Act") for the
issuances of these shares. We believed Section 4(2) was available because:
o We are not and were not a blank check company at the time of the offer
or sale;
o The investor had business experience and was an accredited investors
as defined by Rule 501 of Regulation D of the Act;
o All offers and sales of the investment were made privately and no
party engaged in any general solicitation or advertising of the
proposed investment;
o Each investor had a preexisting social, personal or business
relationship with us and members of our management;
o The investor was provided with all information sufficient to allow him
to make an informed investment decision;
o The investor had the opportunity to inspect our books and records and
to verify statements made to induce them to invest;
o The investor representing the investment were issued with a
restrictive legend indicating the securities represented by the
certificate have not been registered; and
o No party received any transaction based compensation such as
commissions in regard to locating any investor for the venture.
On November 12, 2004, we sold 100,000 shares of our restricted common stock at
$0.17 per share or an aggregate of $17,000 to Robert Sarka. We relied upon
Section 4(2) of the Securities Act of 1933, as amended ("the Act") for the
issuances of these shares. We believed Section 4(2) was available because:
o We are not and were not a blank check company at the time of the offer
or sale;
o The investor had business experience and was an accredited investors
as defined by Rule 501 of Regulation D of the Act;
o All offers and sales of the investment were made privately and no
party engaged in any general solicitation or advertising of the
proposed investment;
o The investor had a preexisting social, personal or business
relationship with us and members of our management;
o The investor was provided with all information sufficient to allow him
to make an informed investment decision;
o The investor had the opportunity to inspect our books and records and
to verify statements made to induce them to invest;
o The Certificate representing the investment was issued with a
restrictive legend indicating the securities represented by the
certificate have not been registered; and
o No party received any transaction based compensation such as
commissions in regard to locating any investor for the venture.
On November 24, 2004, we sold 145,000 shares of our restricted common stock at
$0.17 per share or an aggregate of $24,650 to Jenny Bryan. We relied upon
Section 4(2) of the Securities Act of 1933, as amended ("the Act") for the
issuances of these shares. We believed Section 4(2) was available because:
o We are not and were not a blank check company at the time of the offer
or sale;
o The investor had business experience and was an accredited investors
as defined by Rule 501 of Regulation D of the Act;
o All offers and sales of the investment were made privately and no
party engaged in any general solicitation or advertising of the
proposed investment;
o The investor had a preexisting social, personal or business
relationship with us and members of our management;
o The investor was provided with all information sufficient to allow her
to make an informed investment decision;
o The investor had the opportunity to inspect our books and records and
to verify statements made to induce her to invest;
o The Certificate representing the investment was issued with a
restrictive legend indicating the securities represented by the
certificate have not been registered; and
o No party received any transaction based compensation such as
commissions in regard to locating any investor for the venture.
-13-
On December 16, 2004, we sold 88,235 shares of our restricted common stock at
$0.17 per share or an aggregate of $15,000 to Anglim Prevention Healthcare, a
private corporation incorporated in Arizona located in Scottsdale, Arizona.
Patrick Anglim is the President of Anglim Prevention Healthcare. We relied upon
Section 4(2) of the Securities Act of 1933, as amended ("the Act") for the
issuances of these shares. We believed Section 4(2) was available because:
o We are not and were not a blank check company at the time of the offer
or sale;
o The investor had business experience and was an accredited investors
as defined by Rule 501 of Regulation D of the Act;
o All offers and sales of the investment were made privately and no
party engaged in any general solicitation or advertising of the
proposed investment;
o The investor had a preexisting social, personal or business
relationship with us and members of our management;
o The investor was provided with all information sufficient to allow him
to make an informed investment decision;
o The investor had the opportunity to inspect our books and records and
to verify statements made to induce them to invest;
o The Certificate representing the investment was issued with a
restrictive legend indicating the securities represented by the
certificate have not been registered; and
o No party received any transaction based compensation such as
commissions in regard to locating any investor for the venture.
On December 16, 2004, we sold 600,000 shares of our restricted common stock at
$0.17 per share or an aggregate of $102,000 to Martin Kusmirek. We relied upon
Section 4(2) of the Securities Act of 1933, as amended ("the Act") for the
issuances of these shares. We believed Section 4(2) was available because:
o We are not and were not a blank check company at the time of the offer
or sale;
o The investor had business experience and was an accredited investors
as defined by Rule 501 of Regulation D of the Act;
o All offers and sales of the investment were made privately and no
party engaged in any general solicitation or advertising of the
proposed investment;
o The investor had a preexisting social, personal or business
relationship with us and members of our management;
o The investor was provided with all information sufficient to allow him
to make an informed investment decision;
o The investor had the opportunity to inspect our books and records and
to verify statements made to induce them to invest;
o The Certificate representing the investment was issued with a
restrictive legend indicating the securities represented by the
certificate have not been registered; and
o No party received any transaction based compensation such as
commissions in regard to locating any investor for the venture.
On December 29, 2004, we sold 3,061,765 shares of our restricted common stock at
$0.17 per share or an aggregate of $520,500 to Rajni Kassett. We relied upon
Section 4(2) of the Securities Act of 1933, as amended ("the Act") for the
issuances of these shares. We believed Section 4(2) was available because:
o We are not and were not a blank check company at the time of the offer
or sale;
o The investor had business experience and was an accredited investors
as defined by Rule 501 of Regulation D of the Act;
o All offers and sales of the investment were made privately and no
party engaged in any general solicitation or advertising of the
proposed investment;
o The investor had a preexisting social, personal or business
relationship with us and members of our management;
o The investor was provided with all information sufficient to allow him
to make an informed investment decision;
o The investor had the opportunity to inspect our books and records and
to verify statements made to induce them to invest;
o The Certificate representing the investment was issued with a
restrictive legend indicating the securities represented by the
certificate have not been registered; and
o No party received any transaction based compensation such as
commissions in regard to locating any investor for the venture.
-14-
On December 31, 2004, we sold 60,000 shares of our restricted common stock at
$0.17 per share or an aggregate of $10,200 to David Gasser. We relied upon
Section 4(2) of the Securities Act of 1933, as amended ("the Act") for the
issuances of these shares. We believed Section 4(2) was available because:
o We are not and were not a blank check company at the time of the offer
or sale;
o The investor had business experience and was an accredited investors
as defined by Rule 501 of Regulation D of the Act;
o All offers and sales of the investment were made privately and no
party engaged in any general solicitation or advertising of the
proposed investment;
o The investor had a preexisting social, personal or business
relationship with us and members of our management;
o The investor was provided with all information sufficient to allow him
to make an informed investment decision;
o The investor had the opportunity to inspect our books and records and
to verify statements made to induce them to invest;
o The Certificate representing the investment was issued with a
restrictive legend indicating the securities represented by the
certificate have not been registered; and
o No party received any transaction based compensation such as
commissions in regard to locating any investor for the venture.
Item 6. Management's Discussion and Analysis of Plan of Operations
PLAN OF OPERATIONS
We anticipate that our total estimated cash requirements of $1,030,000 for the
next 12 months, pending adequate financing, will include: (a) $490,000
pertaining directly to our own operations; (b) funding of $415,000 for
ReceptoPharm; and (c) $125,000 pertaining to our investment in Xenacare.
Specifically, our planned expenditures pertaining to (a) and (b) are:
OUR DIRECT EXPENDITURES
Type Expenditure Total Expenditure Monthly Expenditure
--------------------- ----------------- -------------------
Salaries* $ 165,000 $ 13,750
--------------------- ----------------- -------------------
Travel related
expenses for our
Chief Executive
Officer pertaining
to research and due
diligence $ 40,000 $ 3,333
--------------------- ----------------- -------------------
Consulting Fees for $ 120,000 $ 10,000
Director Tanvir Khandaker
Pertaining to acquisition
Of licenses
Professional
Fees -Legal
and Accounting $ 165,000 $ 13,750
--------------------- ----------------- -------------------
Total $ 490,000 $ 40,833
* Salaries include the following: (a) Chief Executive Officer - $130,000;
and (b) Administrative Assistant - $35,000
-15-
FUNDING OF RECEPTOPHARM, INC.
Type Expenditure Total Expenditure Monthly Expenditure
--------------------- ----------------- -------------------
Operating Expenses
(Rent, supplies,
utilities) $ 50,000 $ 4,166
--------------------- ----------------- -------------------
Salaries
(CEO, President,
Chief Science
Officer, and
Administrative
Assistant) $ 80,000 $ 6,667
--------------------- ----------------- -------------------
Pre-Clinical
Related Consulting $ 15,000 $ 1,250
--------------------- ----------------- -------------------
Clinical Studies
(HIV, MS, AMN) $ 270,000 $ 22,500
--------------------- ----------------- -------------------
Total: $ 415,000 $ 34,583
FUNDING OF XENACARE
Type Expenditure Total Expenditure Monthly Expenditure
--------------------- ----------------- -------------------
Funding of Site of
Cares $ 125,000 $ 10,417
OUR TWELVE-MONTH PLAN OF OPERATIONS PENDING ADEQUATE FINANCING
We intend to accomplish the following regarding our Plan of Operations over the
next twelve months.
ReceptoPharm
Pre-Clinical Related Consulting
Throughout our Plan of Operations, we plan to conduct pre-clinical consulting
with various companies that we have agreements with pertaining to ReceptoPharm's
Multiple Sclerosis (MS) and HIV drugs, which will consist of the following:
o MS Drug under Development - Microarray analysis is the study of the
gene expression of cells. Histoculture is the study of the entire
cellular environment. We plan to conduct microarray and histoculture
studies and related analysis of the cells of Multiple Sclerosis
patients' to ascertain the how certain drugs affect the cells of these
patients. We plan to conduct these studies through our agreement with
Eno Research and Development, a clinical research organization; and
o HIV Drug under Development - Viral isolates are common mutations of
HIV. We plan to conduct these studies through our agreement with
ReceptoPharm. ReceptoPharm, has an agreement with the University of
California, San Diego, to study the effect of ReceptoPharm's drug
under development on different viral isolates to determine the drug's
efficacy in mutated forms of the HIV virus.
-16-
Clinical Studies
Adrenomyeloneuropathy (AMN)
Adrenomyeloneuropathy (AMN) is a genetic disorder that affects the central
nervous system. The disease causes neurological disability that is slowly
progressive over several decades. Throughout our twelve month Plan of Operations
and for 3 months thereafter, ReceptoPharm plans to conduct clinical studies of
its Adrenomyeloneuropathy (AMN) drug, which is currently under development. We
have an agreement with the Charles Dent Metabolic Unit located in London,
England to conduct a clinical study that consists of:
o Recruitment of 20 patients with AMN;
o Administering the ReceptoPharm's AMN drug under development; and
o Monitoring patients throughout a 15-month protocol.
The clinical study is classified as a Phase III study and is the final step
required for regulatory approval of the drug.
HIV and MS
ReceptoPharm also plans to conduct clinical studies of its HIV and MS drugs
under development. These "Phase II" studies will either prove or disprove the
preliminary efficacy of ReceptoPharms's HIV/MS drugs under development.
ReceptoPharm will seek to secure agreements with third parties to conduct such
clinical studies.
Liquidity and Capital Resources
Our independent registered public accounting firm has issued a going concern
opinion on our audited financial statements for the fiscal year ended December
31, 2004 since we have experienced recurring net losses and at December 31,
2004, a working capital deficiency. Further, as stated in Note 12 to our
consolidated financial statements included herein, we have experienced recurring
net losses, and at December 31, 2004 we have a working capital deficiency that
raises substantial doubt about our ability to continue as a going concern.
We have estimated expenses of $1,030,000 pertaining to our twelve month Plan of
Operations or $85,833 of monthly expenditures. Based upon our current cash
position at December 31, 2004 as well as our current outstanding obligations, we
have insufficient funds to conduct our operations for even one month.
We intend to satisfy our estimated cash requirements of $1,030,000 for our
twelve month Plan of Operations pending adequate financing through divestiture
of assets, a private placement of our equity securities or, if necessary,
possibly through shareholder loans or traditional bank financing or a debt
offering; however, because we are a development stage company with a limited
operating history and a poor financial condition, we may be unsuccessful in
obtaining shareholder loans, conducting a private placement of equity or debt
securities, or in obtaining bank financing. In addition, if we only have nominal
funds by which to conduct our operations, we may have to curtail our research
and development activities, which will negatively impact development of our
possible products. We have no alternative Plan of Operations. In the event that
we do not obtain adequate financing to complete our Plan of Operations or if we
do not adequately implement an alternative plan of operations that enables us to
conduct operations without having received adequate financing, we may have to
liquidate our business and undertake any or all of the following actions:
o Sell or dispose of our assets, if any;
o Pay our liabilities in order of priority, if we have available cash to
pay such liabilities;
o If any cash remains after we satisfy amounts due to our creditors,
distribute any remaining cash to our shareholders in an amount equal
to the net market value of our net assets;
o File a Certificate of Dissolution with the State of California to
dissolve our corporation and close our business;
o Make the appropriate filings with the Securities and Exchange
Commission so that we will no longer be required to file periodic and
other required reports with the Securities and Exchange Commission,
if, in fact, we are a reporting company at that time; and
o Make the appropriate filings with the National Association of Security
Dealers to effect a delisting of our common stock, if, in fact, our
common stock is trading on the Over-the-Counter Bulletin Board at that
time.
-17-
Based upon our current assets, however, we will not have the ability to
distribute any cash to our shareholders. If we have any liabilities that we are
unable to satisfy and we qualify for protection under the U.S. Bankruptcy Code,
we may voluntarily file for reorganization under Chapter 11 or liquidation under
Chapter 7. Our creditors may also file a Chapter 7 or Chapter 11 bankruptcy
action against us. If our creditors or we file for Chapter 7 or Chapter 11
bankruptcy, our creditors will take priority over our shareholders. If we fail
to file for bankruptcy under Chapter 7 or Chapter 11 and we have creditors, such
creditors may institute proceedings against us seeking forfeiture of our assets,
if any.
We do not know and cannot determine which, if any, of these actions we will be
forced to take. If any of these foregoing events occur, you could lose your
entire investment in our shares.
Item 7. Financial Statements
The Financial Statements appear in a separate section of this report following
Part III.
Item 8. Changes in and Disagreements with Accountants on Accounting and
Financial Disclosure
On February 24, 2005, we changed accountants from Eisner LLP to Stark Winter
Schenkein & Co., LLP. On February 24, 2005, we decided to dismiss Eisner LLP as
our independent accountants. Eisner LLP's report on the financial statements for
the years ended December 31, 2002 and 2003, and the period from February 1, 2000
inception) to December 31, 2003, as contained in our Forms 10-K and 10-K/A,
which were filed on April 20, 2004 and May 7, 2004, respectively, were not
subject to an adverse or qualified opinion or a disclaimer of opinion and were
not modified as to uncertainty, audit scope or accounting principles for the
period from February 1, 2000 inception) to December 31, 2003 or for either of
the past two years, except that Eisner LLP's report on the financial statements
as of and for the year ended December 31, 2003 contained explanatory language
that substantial doubt existed about our ability to continue as a going concern
due to our recurring net losses and our working capital deficiency at December
31, 2003. The decision to change accountants was approved by our Board of
Directors. During the period from our engagement of Eisner LLP on March 11,2004
to the date we dismissed Eisner LLP on February 24, 2005, there were no
disagreements with Eisner LLP related to accounting principles or practices,
financial statement disclosure, or auditing scope or procedure, which
disagreements if not resolved to the satisfaction of Eisner LLP, would have
caused Eisner LLP to make reference to the subject matter of the disagreement in
connection with its report. On February 24, 2005, we engaged Stark Winter
Schenkein & Co., LLP as our independent accountants. We did not consult with
Stark Winter Schenkein & Co., LLP,our new independent accountants, regarding any
matter prior to our engagement of that firm.
Item 8A. Controls and Procedures
As required by Rule 13a-15 under the Exchange Act, as of December 31, 2004, the
end of the period covered by this Annual Report on Form 10-KSB, we carried out
an evaluation of the effectiveness of the design and operation of our disclosure
controls and procedures. This evaluation was carried out by our sole executive
officer Rik Deitsch, who is our Chief Executive Officer and Principal Financial
Officer, and a member of our board of directors. Based upon his evaluation, Mr.
Deitsch concluded that our disclosure controls and procedures are effective to
ensure that information required to be disclosed by us in reports that we file
or submit under the Exchange Act is recorded, processed, summarized and reported
within the time periods specified in Securities and Exchange Commission rules
and forms. However, Mr. Deitsch did recommend to the board of directors that the
Company should seek to hire an experienced chief financial officer, which would
improve the review process of our controls and procedures.
-18-
Changes in internal controls over financial reporting.
There have been no changes in our system of internal control over financial
reporting in connection with the evaluation by our Chief Executive Officer and
Principal Financial Officer during our fiscal quarter ended December 31, 2004
that have materially affected, or are reasonably likely to materially affect,
our internal control over financial reporting.
ITEM 8B. Other Information
None.
PART III
Item 9. Directors, Executive Officers, Promoters and Control Persons; Compliance
With Section 16(a) of the Exchange Act
Directors and Executive Officers
Our Board of Directors elects our executive officers annually. Our Directors are
elected at annual meetings of shareholders. Directors are elected to hold office
until the next annual meeting. A majority vote of the directors who are in
office is required to fill vacancies of our Board of Directors not caused by
removal. Each director, including a Director elected to fill a vacancy, will
hold office until the expiration of the term for which the Director was elected
and until a successor has been elected. Our bylaws provide that the authorized
number of directors will be 3. Our directors and executive officers are as
follows:
Listed below are the current executive officers and directors of Nutra Pharma
Corp.
Name Age Position With the Company
----------------------- ------- ----------------------------------------------
Rik J. Deitsch 37 Chairman, President, Chief Executive Officer,
and Chief Financial Officer
Michael D. Flax, D.D.S. 50 Director
Stanley J Cherelstein 46 Director
Stewart Lonky, M.D. 58 Director
Tanvir Khandaker, M.D. 35 Director
Rik J. Deitsch has been our President, Chief Executive Officer and a Director
since November 7, 2002 and our Chairman of the Board since December 15, 2003.
From February 1998 through November 2002, Mr. Deitsch served as the President of
NDA Consulting Inc., a biotechnology research group that provided consulting
services to the pharmaceutical industry. NDA Consulting specializes in the
research of peptides derived from Cone Snail venom and Cobra venom. In October
1999, Mr. Deitsch founded Wellness Industries, a private corporation that
provides formulations, research and education in the dietary supplement
industry. Research conducted by Rik J Deitsch provided some of the beginning
fundamentals for the development of drugs being studied for the treatment of
cancer and intractable pain. Mr. Deitsch has several papers and posters on
rational drug design using computer simulations. Mr. Deitsch received a B.S. in
Chemistry and an M.S. in Biochemistry from Florida Atlantic University in June
1997 and December 1999, respectively. Throughout 1999 and 2000, he conducted
research for the Duke University Medical School Comprehensive Cancer Center. Mr.
Deitsch is an adjunct professor and teaches several courses for Florida Atlantic
University's College of Business and Continuing Education Department. Mr.
Deitsch also teaches physician CME courses internationally, lecturing on
lifestyle choices in the prevention and treatment of chronic disease states. He
is also the co-author of Are You Age-Wise, a book that reviews current research
in healthy aging as it relates to lifestyle choices and supplementation. Mr.
Deitsch has been the Chairman of Waiora's Scientific Advisory Board since April
2004. Waiora develops and markets natural, science-based dietary supplements and
personal care products that provide healthy aging solutions.
-19-
Michael D. Flax, D.D.S. has been our Director since November 26, 2001. From
November 26, 2001 until November 7, 2002, Dr. Flax was our President and Chief
Executive Officer. From 1986 to the present, Dr. Flax has been self employed in
the practice of Endodontics in Coral Springs, Florida. Dr. Flax is a Diplomat of
the American Board of Endodontics, a member of the American Association of
Endodontists, and a Fellow of the American College of Dentists. Dr. Flax is an
Associate Professor, Graduate Endodontics Department at Nova Southeastern
University School of Dental Medicine. He holds a certificate in Endodontics from
the University of Pennsylvania, School of Dental Medicine, 1986, a D.D.S. from
Georgetown University Dental School, 1981, an M.S. in chemistry from St. John's
University, 1977, and a B.A. major in chemistry, minor in engineering from Miami
University in Oxford, Ohio.
Stanley J. Cherelstein has been our Director since September 28, 2004. Since
December 2003, Mr. Chereslstein has been the Chief Executive Officer and
President of Waiora, Inc., which develops and distributes Healthy Aging
products. From August 2002 to July 2003, Mr. Cherelstein was the President and
Chief Operating Officer of Unicity, Inc., a $300 million nutritional supplement
company with offices in thirteen countries in North America, Asia and Europe.
From July 2001 to August 2002, Mr. Cherelstein was the Chief Operating Officer
of Unicity where he was responsible for global operations including supply
chain, distribution, information technology, customer service, human resources
and finance. From July 1999 to July 2001, Mr. Cherelstein served as the Senior
Vice President of Finance and Operations at Rexall Showcase International (RSI),
a division of Rexall Sundown. RSI was a $180 million nutritional supplement
company that operated in the USA, Japan, Korea, Taiwan and Hong Kong. From July
1997 to July 1999, Mr. Cherelstein served as Vice President of Finance at RSI.
Mr. Cherelstein began his career in public accounting at the firm of Cooper's
and Lybrand where he worked for a total of five years from 1983 to 1988,
including three years in auditing and two years in management consulting. In
April 1983, Mr. Cherelstein received a B.S. Degree in Business and Accounting.
Dr. Stewart Lonky has been our director since November 5, 2004. Dr. Lonky is a
co-founder of the Trylon Corporation, a medical test kit firm located in
Torrance, California and has served as its Chief Medical Officer since 1990.
Trylon Corporation has developed diagnostic products for the early diagnosis of
cervical and oral cancer, and in connection with that Dr. Lonky's
responsibilities have included product development, the direction of clinical
research and interacting with regulatory agencies, including the U.S. Food and
Drug Administration (FDA). In these roles he has been instrumental in
successfully bringing a number of products to the medical marketplace. He has
continued to be engaged in both clinical and biochemical research, and has
published research articles in the peer-reviewed literature in the areas of
cervical cancer and cellular pathophysiology. Dr. Lonky has been a practicing
physician in the Los Angeles Area since 1982. He is Board Certified in Internal
Medicine, Pulmonary Medicine, and Critical Care Medicine. Prior to entering
practice, Dr. Lonky served as a full-time faculty member at the University of
California, San Diego in the Department of Medicine, Pulmonary Division, where
he was engaged in research in the biochemistry of lung injury. He was a National
Institutes of Health (NIH) Postdoctoral Fellow from 1974-77. He has published
over twenty articles and abstracts in the peer-reviewed literature during that
time, and authored two book chapters.
Dr. Tanvir Khandaker has been our director since January 24, 2005. Since
November 2001, he has been the President and a Director of Khandaker Partners,
an independent research firm located in New York, New York, which specializes in
fundamental analysis of public companies. From January 1999 to December 2001,
Dr. Khandaker was a Research Associate at the Brigham and Women's Hospital of
the Harvard Medical School and from January 1998 to December 1999, Dr. Khandaker
was a Research Associate at the Massachusetts General Hospital of the Harvard
Medical School. In December 1995, Dr. Khandaker received a medical degree from
the Robert Mitford Medical College located in Dhaka, Bangladesh, and from
January 1996 to April 1997, he was a Resident in Internal Medicine and Surgery
at Robert Mitford Medical College.
-20-
FAMILY RELATIONSHIPS
None
LEGAL PROCEEDINGS
Our directors, executive officers and control persons have not been involved in
any of the following events during the past five years:
1. any bankruptcy petition filed by or against any business of which such
person was a general partner or executive officer either at the time of the
bankruptcy or within two years prior to that time;
2. any conviction in a criminal proceeding or being subject to a pending
criminal proceeding (excluding traffic violations and other minor offenses);
3. being subject to any order, judgment, or decree, not subsequently
reversed, suspended or vacated, of any court of competent jurisdiction,
permanently or temporarily enjoining, barring, suspending or otherwise limiting
his involvement in any type of business, securities or banking activities; or
4. being found by a court of competent jurisdiction (in a civil action),the
Commission or the Commodity Futures Trading Commission to have violated a
federal or state securities or commodities law, and the judgment has not been
reversed, suspended, or vacated.
Section 16(a) Compliance of Officers and Directors
Based upon our review of Forms 3, 4, and 5 furnished to us during the last
fiscal year, all of our officers, directors and persons holding more than ten
percent of our equity securities have filed the reports required of them to be
filed pursuant to Section 16(a) of the Exchange Act, except that Rik Deitsch,
Stanley Cherelstein, Dr. Stewart Lonky, and Dr. Michael Flax each filed their
reports on Form 3 and Form 4 late.
Audit Committee/Compensation Committee
On November 5, 2004, our Board of Directors established an Audit Committee and a
Compensation Committee and appointed the following Board members to both
committees: Stan Cherelstein, Stewart Lonky, and Michael Flax. Stan Cherelstein
was appointed the Chair of both the Audit Committee and the Compensation
Committee. Stan Cherelstein is also the Audit Committee Financial Expert.
Code of Ethics
We have a code of ethics that applies to all of our employees including its
principal executive officer, principal financial officer and principal
accounting officer. A copy of this code is filed as an exhibit to this annual
report on Form 10-KSB and is also available on our website at
www.nutrapharma.com. We will provide any person without charge, a copy of our
code of ethics upon the receipt of a written request sent to our headquarters at
1829 Corporate Drive, Boynton Beach, Florida, 33426. We intend to disclose any
changes in or waivers from its code of ethics by posting such information on our
website or by filing a Form 8-K.
Item 10. Executive Compensation
The following table summarizes compensation information for the last three
fiscal years for (i) the Company's Chief Executive Officer and (ii) the four
most highly compensated executive officers other than the Chief Executive
Officer who were serving as executive officers of the Company at the end of the
fiscal year (collectively, the "Named Executive Officers").
SUMMARY COMPENSATION TABLE
Long Term Compensation
Securities
Annual Compensation Restricted Underlying
Fiscal Salary Bonus Stock Awards Options
Name and Principal Position Year ($) ($) ($)(1) (#)
--------------------------- ------ -------- ----- ------------ ----------
Rik J. Deitsch 2004 $132,500 -- $200,000 --
President, Chief Executive 2003 $ 29,500 -- $275,000 --
Officer and Chief Financial 2002 -- -- -- --
Officer
(1) Mr. Deitsch received 500,000 shares of restricted stock valued at $200,000
based on the $0.40 closing price of our common stock on November 5, 2004, which
was the date of the grant.
-21-
Stock Option Grants in Last Fiscal Year
There were no options granted to the named Executive Officers during fiscal year
2004. Since its inception, we have not granted any stock options.
Board Compensation
On January 26, 2005, we issued 500,000 shares of our restricted common stock to
our Director, Tanvir Khandaker in return for his services as our Director. The
restricted shares were valued at $0.40 per share or an aggregate of $200,000.
On November 5, 2004, we issued 500,000 shares of our restricted common stock to
our Director, Michael D. Flax in return for his services as our Director. The
restricted shares were valued at $0.40 per share or an aggregate of $200,000.
On November 5, 2004, we issued 500,000 shares of our restricted common stock to
our Director, Stanley J. Cherelstein in return for his services as our Director.
The restricted shares were valued at $0.40 per share or an aggregate of
$200,000.
On November 5, 2004, we issued 500,000 shares of our restricted common stock to
our Director, Stewart Lonky in return for his services as our Director. The
restricted shares were valued at $0.40 per share or an aggregate of $200,000.
On February 14, 2005, we completed a Consulting Agreement with Dr. Tanvir
Khandaker, to work full time as our consultant in the areas of business
development, mergers and acquisitions, partnering and licensing during our
Fiscal Year 2005. In return for Dr. Khandaker's services, we provide a monthly
retainer of $10,000 to him. Dr. Khandaker is also one of our Directors.
There are no standard arrangements pursuant to which directors are compensated
for services provided to us.
Item 11. Security Ownership of Certain Beneficial Owners and Management and
Related Stockholder Matters
The following tables sets forth, as of March 31, 2005, certain information with
respect to the beneficial ownership of our common stock by each stockholder
known by us to be the beneficial owner of more than 5% of our common stock and
by each of our current directors and executive officers. Each person has sole
voting and investment power with respect to the shares of common stock, except
as otherwise indicated. Information relating to beneficial ownership of common
stock by our principal stockholders and management is based upon information
furnished by each person using "beneficial ownership" concepts under the rules
of the Securities and Exchange Commission. Under these rules, a person is deemed
to be a beneficial owner of a security if that person has or shares voting
power, which includes the power to vote or direct the voting of the security, or
investment power, which includes the power to vote or direct the voting of the
security. The person is also deemed to be a beneficial owner of any security of
which that person has a right to acquire beneficial ownership within 60 days.
Under the Securities and Exchange Commission rules, more than one person may be
deemed to be a beneficial owner of the same securities, and a person may be
deemed to be a beneficial owner of securities as to which he or she may not have
any pecuniary beneficial interest. We are unaware of any contract or arrangement
that could result in a change in control of our company.
The following table assumes, based on our stock records, that there are
60,854,682 shares issued and outstanding as of March 31, 2005.
The following tables set forth the ownership of our Common Stock as of March 31,
2005:
o Each shareholder known by us to own beneficially more than 5% of our
common stock;
o Each executive officer;
o Each director or nominee to become a director; and
o All directors and executive officers as a group.
-22-
Security Ownership of Beneficial Owners
Shares of Percent of
Common Stock Common Stock
Name and Address of Beneficial Owner Beneficially Owned Outstanding
------------------------------------ ------------------ -------------
Opus International* 11,692,556 19.2%
19 Hillsyde Court
Cockeysville, Maryland 21030
------------------------------------ ------------------ -------------
Dr. Michael D. Flax 3,411,700 5.6%
2499 Banyan Road
Boca Raton, Florida 33432
------------------------------------ ------------------ -------------
Total 15,104,256 24.8%
------------------------------------ ------------------ -------------
*On April 13, 2005, Opus International filed an amendment to Schedule 13D
reporting that its 11,692,556 shares were pledged as collateral for a $2.5
million loan from Clarisco Stiftung. We have attempted to ascertain from Opus
International's other information we consider material to Opus International's
reporting obligations; however, Opus International has failed to respond to our
informing it of these reporting requirements or our request for information.
Security Ownership of Management
Shares of Percent of
Name and Address of Common Stock Common Stock
Director or Executive Officer Beneficially Owned Outstanding
----------------------------------- ------------------ -------------
Rik J. Deitsch 1,500,000 2.5%
1829 Corporate Drive
Boynton Beach, Florida 33426
Dr. Michael D. Flax 3,411,700 5.6%
2499 Banyan Road
Boca Raton, Florida 33432
Stanley J Cherelstein 500,000 0.8%
1829 Corporate Drive
Boynton Beach, Florida 33426
Dr. Stewart Lonky 500,000 0.8%
1158 Chautaqua Boulevard
Pacific Palisades, California 90272
Dr. Tanvir Khandaker 500,000 0.8%
181 Ogden Avenue
Jersey City, New Jersey 07307
----------------------------------- ------------------ -------------
All executive officers and directors
as a group (5) persons 6,411,700 10.5%
----------------------------------- ------------------ -------------
-23-
Item 12. Certain Relationships and Related Transactions
Consulting Agreement with Dr. Tanvir Khandaker
On February 14, 2005, we completed a Consulting Agreement with Dr. Tanvir
Khandaker, to work full time as our consultant in the areas of business
development, mergers and acquisitions, partnering and licensing during our
Fiscal Year 2005. In return for Dr. Khandaker's services, we provide a monthly
retainer of $10,000 to him. Dr. Khandaker is also one of our Directors.
From our inception to May 2004, we funded our ongoing operational costs through
unsecured, non-interest bearing, demand loans from certain of our shareholders,
which included loans from our former Chairman of the Board, Mr. Zirk
Engelbrecht. At June 30, 2004, the balance on the loan due to Mr. Engelbrecht
was $1,384,931. On August 1, 2004, Mr. Engelbrecht assigned the loan to Opus
International, LLC, a company that Mr. Engelbrecht claims is controlled by his
wife, Marcy Engelbrecht. On or about August 9, 2004, a Managing Member of Opus
International, LLC made a formal demand for repayment of the loan in the amount
of $1,384,931. On September 28, 2004, we entered into a settlement agreement
with Opus International, which provided for the following terms: (i) the
transfer of 6,000,000 shares of Infectech common stock we owned to Opus
International, in full and fair settlement of the outstanding debt owed to Opus
International; (ii) upon the transfer of the Infectech shares to Opus
International, any and all outstanding debt that we owed to Opus International
was deemed discharged and we would be released from any and all liability
regarding the debt; and (iii) we accepted the resignation of Mitchell Felder and
David C. McClelland as our directors.
Item 13. Exhibits
Exhibits and Reports on Form 8-K
(a) The following Financial Statements are filed as part of this report under
Item 7.
Report of Independent Auditor
Consolidated Balance Sheet
Consolidated Statements of Operations
Consolidated Statements of Cash Flows
Consolidated Statement of Changes in Stockholders' Equity (Capital Deficit)
Notes to Consolidated Financial Statements
-24-
(b) The following exhibits are filed herewith or are incorporated by reference
to exhibits previously filed with the SEC:
Exhibit Number/Description
3.1 Certificate of Incorporation dated February 1, 2000. (i)
3.2 Certificate of Amendment to Articles of Incorporation dated July 5,
2000. (i)
3.3 Certificate of Amendment to Articles of Incorporation dated October 31,
2001.
3.4 Bylaws of the Company. (i)
4.1 Form of Stock Certificate (i)
5.1 Opinion of Kenneth Eade, Attorney at Law on SB-2 Registration (i)
5.2 Opinion of Kenneth Eade, Attorney at Law on issuance of stock under plan
and consent dated December 4, 2003 (vi)
6 Specimen of Stock Certificate (i)
10.1 Acquisition Agreement between Cyber Vitamin.com and Desert Corporate
Services dated November 26, 2001 (ii)
10.2 Share Exchange Agreement between Nutra Pharma Corp. and Nutra Pharma,
Inc. dated November 26, 2001 (ii)
10.3 Joint Venture Agreement between Nutra Pharma Corp. and Terra Bio Pharma
dated January 29, 2002 (iii)
10.4 Definitive Agreement for Exchange of Common Stock dated August 20, 2002
by and among Nutra Pharma Corp. and Bio Therapeutics, Inc. (iii)
10.5 Closing Agreement for the Exchange of Common Stock dated August 20, 2002
by and between Nutra Pharma Corp. and Bio Therapeutics, Inc. (iv)
10.6 Amendment to Closing Agreement for the Exchange of Common Stock dated
September 27, 2002 (v)
10.7 Acquisition Agreement dated September 19, 2003 between Nutra Pharma Corp.
and Infectech, Inc. (vi)
10.8 Acquisition Agreement between Nutra Pharma Corp. and ReceptoPharm, Inc.
dated February 20, 2004 (vii)
10.9 Settlement Agreement dated September 28, 2004 between Opus International,
LLC (xi)
10.10 Agreement with XenaCare (xi)
10.11 Agreement with Eno Research and Development, Inc. (xi)
10.12 Agreement with Investor-Gate.com (xi)
10.13 Agreement with Tanvir Khandaker
14.1 Code of Ethics of the Company (x)
20.1 Rescission, Settlement and Release Agreement between George Minto and
Zirk Engelbrecht (viii)
20.2 Offer to Purchase for Cash up to 2,000,000 shares of Nutra Pharma Corp.
for $.80 cash per share (viii)
20.3 License Agreement dated October 3, 2003 between Biotherapeutics, Inc.
and Nutra Pharma Corp. (ix)
20.4 Addendum to license Agreement dated October 3, 2003 between
Biotherapeutics, Inc. and Nutra Pharma Corp. (ix)
31.1 Certification of Chief Executive Officer and Chief Financial Officer
pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1 Certification of Chief Executive Officer and Chief Financial Officer
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906
of the Sarbanes-Oxley Act of 2002
-------------------
(i) Incorporated by reference to the Company's Registration Statement on Form
SB-2/A (Registration No. 33-44398) filed on April 6, 2001 (the
"Registration Statement").
(ii) Incorporated by reference to the Company's Current Report on Form 8K, filed
December 26, 2001
(iii)Incorporated by reference to the Company's Current Report on Form 8K,
filed February 28, 2002
(iv) Incorporated by reference to the Company's Current Report on Form 8K, filed
September 9, 2002
(v) Incorporated by reference to the Company's Current Report on Form 8K, filed
October 31, 2002
(vi) Incorporated by reference to the Company's Current Report on Form 8K, filed
October 20, 2003
(vii)Incorporated by reference to the Company's Current Report on Form 8K,
filed March 8, 2004
(viii)Incorporated by reference to the Company's Current Report on Form 8K,
filed November 5, 2002
(ix) Incorporated by reference to the Company's Report on Form 10-KSB, filed
April 20, 2004
(x) Incorporated by reference to the Company's Report on Form 10-KSB/A, filed
May 7, 2004
(xi) Incorporated by reference to the Company's Report on Form 10-QSB, filed
December 21, 2004
-25-
Item 14. Principal Accountant Fees and Services
On March 11, 2004, we engaged the firm of Eisner, LLP, as our new principal
independent accountant to audit our financial statements. Eisner billed us
$85,000 for the audit of our financial statements for the period from our
inception on February 1, 2000 through December 31, 2003. Eisner, LLP did not
perform any quarterly reviews of our financial statements in the fiscal year
ended December 31, 2003 as they were not our principal independent accountant at
the time. Eisner did perform quarterly reviews of our financial statements in
the fiscal year ended December 31, 2004, for which they were paid $47,707.
On February 24, 2005, we engaged the firm of Stark Winter Schenkein & Co., as
our new principal independent accountant to audit our financial statements.
Stark Winter Schenkein & Co. billed us $30,500 for the period from January 1,
2004 through December 31, 2004.
AUDIT RELATED FEES
No such fees were paid to Eisner, LLP or Stark Winter Schenkein & Co. at any
time.
TAX FEES
No such fees were paid to Eisner, LLP or Stark Winter Schenkein & Co. at any
time.
ALL OTHER FEES
No such fees were paid to Eisner, LLP or Stark Winter Schenkein & Co. at any
time.
-26-
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
NUTRA PHARMA CORP.
/s/Rik J. Deitsch
Rik J. Deitsch, Chairman, President, Chief Executive Officer and Chief
Financial Officer
Dated: May 2, 2005
Pursuant to the requirements of the Securities Exchange Act of 1934, this
report has been signed below by the following persons on behalf of the
Registrant and in the capacities indicated.
Signature Title Date
-------------------------------------------------------------------------------
/s/Rik J.Deitsch Chairman of the Board, President, May 2, 2005
Rik J. Deitsch Chief Executive Officer and
Chief Financial Officer
/s/Michael D. Flax Director May 2, 2005
Michael D. Flax
/s/Stanley Cherelstein Director May 2, 2005
Stanley Cherelstein
/s/Stewart Lonky Director May 2, 2005
Stewart Lonky
/s/Tanvir Khandaker Director May 2, 2005
Tanvir Khandaker
-27-
NUTRA PHARMA CORP.
FINANCIAL STATEMENTS
DECEMBER 31, 2004
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Stockholders and Board of Directors
Nutra Pharma Corp.
We have audited the accompanying consolidated balance sheet of Nutra Pharma
Corp. (a Development Stage Company) as of December 31, 2004, and the related
consolidated statements of operations, stockholders' equity and cash flows for
the year ended December 31, 2004. 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 audit.
We conducted our audit in accordance with auditing 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. An audit includes
examining, on a test basis, evidence supporting the amounts and disclosures in
the financial statements. An audit also includes assessing the accounting
principles used and significant estimates by management, as well as evaluating
the overall financial statement presentation. We believe that our audit provides
a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in
all material respects, the financial position of Nutra Pharma Corp. (a
Development Stage Company) as of December 31, 2004, and results of its
operations and its cash flows for the year ended December 31, 2004, in
conformity with accounting principles generally accepted in the United States of
America.
The accompanying financial statements have been prepared assuming that the
Company will continue as a going concern. As discussed in Note 1 to the
financial statements, the Company has incurred significant losses from
operations and has a working capital deficit and no revenue generating
operations. These factors raise substantial doubt about the Company's ability to
continue as a going concern. Management's plans in regard to this matter are
also discussed in Note 1. The financial statements do not include any
adjustments that might result from the outcome of this uncertainty.
Stark Winter Schenkein & Co., LLP
/s/Stark Winter Schenkein & Co., LLP
Denver, Colorado
April 18, 2004
-28-
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders of
Nutra Pharma Corp.
We have audited the accompanying consolidated statements of operations, changes
in stockholders' equity (capital deficit) and cash flows of Nutra Pharma Corp.
and its subsidiary (the "Company"), a development stage company, for the year
ended December 31, 2003. We have also audited the Company's consolidated
statement of operations for the period from February 1, 2000 (inception) through
December 31, 2003 (not separately presented herein), consolidated statement of
stockholders' equity (capital deficit) for the period from February 1, 2000
(inception) through December 31, 2003 and the consolidated statement of cash
flows for the period from February 1, 2000 (inception) through December 31, 2003
(not separately presented herein). 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 audit.
We conducted our audit in accordance with the standards of the Public Company
Accounting Oversight Board (United States). These standards require that we plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audit provides a
reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in
all material respects, the consolidated results of operations and consolidated
cash flows for the year ended December 31, 2003 and for the period from February
1, 2000 through December 31, 2003 of Nutra Pharma Corp. and its subsidiary, in
conformity with accounting principles generally accepted in the United States of
America.
The accompanying financial statements have been prepared assuming the Company
will continue as a going concern. As discussed in Note 1 to the financial
statements, the Company has experienced recurring net losses and has a working
capital deficiency at December 31, 2003 that raise substantial doubt about the
Company's ability to continue as a going concern. Management's plans with regard
to these matters are described in Note 1. The consolidated financial statements
do not include any adjustments that might result from outcome of this
uncertainty.
/s/Eisner LLP
Eisner LLP
New York, New York
April 3, 2004
-29-
NUTRA PHARMA CORP.
(A Development Stage Company)
Consolidated Balance Sheet
December 31, 2004
ASSETS
Current assets:
Cash $ 409,432
-------------
Property and equipment, net
59,375
-------------
Other assets
Investments at cost
105,000
Other 20,011
-------------
125,011
-------------
$ 593,818
=============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 144,108
Accrued expenses 196,057
Convertible loans 206,750
-------------
Total current liabilities 546,915
-------------
Stockholders' equity:
Common stock, $0.001 par value, 2.0
billion shares authorized,
54,059,682 shares outstanding 54,060
Additional paid-in capital 12,353,644
Deficit accumulated during the
development stage (12,360,801)
-------------
46,903
-------------
$ 593,818
=============
See the accompanying notes to the consolidated financial statements.
-30-
NUTRA PHARMA CORP.
(A Development Stage Company)
Consolidated Statements of Operations
For the
Period From
February 1,
2000
(Inception)
Through
Years Ended December 31, December 31,
2003 2004 2004
------------ ------------ ------------
Revenue $ - $ - $ -
------------ ------------ ------------
Costs and expenses:
General and administrative 1,710,301 989,317 3,422,560
Research and development - 1,104,968 1,104,968
Stock based compensation
- 2,865,996 2,865,996
Write-off of advances to - - 629,000
potential acquiree
Finance costs 786,000 - 786,000
Interest expense
- 4,706 4,706
Amortization of license agreement - - 155,210
Amortization of intangibles 107,133 549,599 656,732
Losses on settlements 252,875 955,069 1,261,284
Write-down of investment in
Infectech, Inc. - 620,805 620,805
Equity in loss of unconsolidated - 853,540 853,540
subsidiary ------------ ------------ ------------
Total costs and expenses 2,856,309 7,944,000 12,360,801
------------ ------------ ------------
Loss before provision (benefit) for
income taxes (2,856,309) (7,944,000) (12,360,801)
Provision (benefit) for income taxes (42,853) 42,853 -
------------ ------------ ------------
Net loss $ (2,813,456) $ (7,986,853) $(12,360,801)
============ ============ ============
Per share information - basic
and diluted
Loss per common share $ (0.07) $ (0.16)
======= =======
Weighted average common shares
outstanding 38,669,108 50,927,076
============ ============
--------------------------------------------------------------------------------
See the accompanying notes to the consolidated financial statements.
-31-
NUTRA PHARMA CORP.
(A Development Stage Company)
Consolidated Statements of Changes in Stockholders' Equity
Period From Inception (February 1, 2000) to December 31, 2004
Deficit
Accumulated
Additional During the
Common Stock Paid-in Development
Shares Par Value Capital Stage Total
=========== ========= ========== ============ ===========
Common stock issued to founders 39,000,000 $ 39,000 $ (37,050) $ - $ 1,950
Net loss - - - (1,950) (1,950)
----------- --------- ---------- ------------ -----------
Balance - December 31, 2000 39,000,000 39,000 (37,050) (1,950) -
Proceeds from sale of common
stock ($.025 per share) 1,000,000 1,000 24,000 - 25,000
Common stock issued in
connection with acquisition
($.025 per share) 4,500,000 4,500 108,000 - 112,500
Net loss - - - (67,504) (67,504)
----------- --------- ---------- ------------ -----------
Balance - December 31, 2001 44,500,000 44,500 94,950 (69,454) 69,996
Issuance of common stock in
exchange for services ($.30
to $1.50 per share) 656,000 656 670,874 - 671,530
Return of common stock by
principal stockholder (10,394,000) (10,394) 10,394 - -
Rescission of common stock
issued in acquisition ($.025
per share) - - (112,500) - (112,500)
Cancellation of common stock
issued in connection with
rescission of acquisition (2,037,500) (2,038) 2,038 - -
Net loss - - - (1,491,038) (1,491,038)
----------- --------- ---------- ------------ -----------
Balance - December 31, 2002 32,724,500 32,724 665,756 (1,560,492) (862,012)
Issuance of common stock in
exchange for services ($.38
to $.76 per share) 2,196,828 2,197 1,358,070 - 1,360,267
Cancellation of common stock
issued in connection with
rescission of acquisition (2,055,000) (2,055) 2,055 - -
Value of common stock issued by
stockholder to third party in
connection with settlement
($.51 per share) 229,500 - 229,500
Conversion of stockholder loan
into common stock ($.08 per
share) 10,300,000 10,300 1,637,712 - 1,648,012
Value of common stock issued by
stockholder to employee for
services rendered ($.15 per
share) 75,000 - 75,000
Issuance of common stock in
connection with acquisition
($.85 per share) 4,502,549 4,503 3,822,664 - 3,827,167
Common stock deemed
irretrievable in connection
with rescission of
acquisition ($.11 per share) 23,375 - 23,375
Net loss - - - (2,813,456) (2,813,456)
----------- --------- ---------- ------------ -----------
Balance - December 31, 2003 47,668,877 47,669 7,814,132 (4,373,948) 3,487,853
Cancellation of common stock
issued in connection with
rescission of acquisition (199,000) (199) 199 - -
Cancellation of common stock
issued in connection with
settlement with third parties (120,000) (120) 120 - -
Issuance of common stock in
connection with acquisition
($.85 per share) 775,538 776 658,431 - 659,207
Issuance of common stock in
exchange for services ($.24
to $.66 per share) 4,054,200 4,054 2,061,942 - 2,065,996
Issuance of common stock for
cash ($.17 to $.25) per share 1,285,000 1,285 223,565 - 224,850
Conversion of convertible loans
into common stock ($.16 per
share) 595,067 595 97,405 - 98,000
Common shares subscribed for
services - (2,000,000 shares)
($.40 per share) - - 800,000 - 800,000
Common shares subscribed for
cash (4,105,000 shares)($.17
per share) - - 697,850 - 697,850
Net loss - - - (7,986,853) (7,986,853)
----------- --------- ---------- ------------ -----------
Balance - December 31, 2004 54,059,682 $ 54,060 $12,353,644 $(12,360,801) $ 46,903
=========== ========= ========== ============ ===========
----------------------------------------------------------------------------------------------
See the accompanying notes to the consolidated financial statements.
-32-
NUTRA PHARMA CORP.
(A Development Stage Company)
Consolidated Statements of Cash Flows
For the
Period From
February 1,
2000
(Inception)
Years Ended
December 31, Through
------------------------- December 31,
2003 2004 2004
----------- ----------- -----------
Cash flows from operating activities:
Net loss $(2,813,456) $(7,986,853) $(12,360,801)
Adjustments to reconcile net loss to net
cash used in operating activities:
Deferred taxes (42,853) 42,853 -
Amortization of intangibles 107,133 549,599 656,732
Amortization of license agreement - - 155,210
Depreciation - 4,867 4,867
Write-off of advances to potential
acquiree - - 629,000
Stock-based compensation 1,435,267 2,865,996 4,974,743
Finance costs in connection with
conversion of stockholder loan into
common stock 786,000 - 786,000
Expenses paid by stockholder 94,678 355,000 474,140
Losses on settlements 252,875 955,069 1,261,284
Write-down of investment in
Infectech, Inc. - 620,805 620,805
Equity in loss of unconsolidated
subsidiary - 853,540 853,540
Changes in operating assets and
liabilities:
(Increase) decrease in other assets - (20,011) (20,011)
Increase (decrease) in accounts payable 25,645 126,602 152,247
Increase (decrease) in accrued expenses 75,838 120,219 196,057
----------- ----------- -----------
Net cash (used in) operating activities (78,873) (1,512,314) (1,616,187)
----------- ----------- -----------
Cash flows from investing activities:
Cash reduction due to deconsolidation
of Infectech - (2,997) (2,997)
Cash acquired in acquisition of Infectech 3,004 - 3,004
Acquisition of property and equipment - (57,091) (57,091)
Investments carried at cost - (105,000) (105,000)
----------- ----------- -----------
Net cash (used in) provided by
investing activities 3,004 (165,088) (162,084)
----------- ------------ -----------
Cash flows from financing activities:
Common stock issued for cash - 922,700 947,700
Proceeds from convertible loans - 304,750 304,750
Loans from stockholders 123,000 812,253 935,253
----------- ----------- -----------
Net cash provided by financing
activities 123,000 2,039,703 2,187,703
----------- ----------- -----------
Net increase in cash 47,131 362,301 409,432
Cash - beginning of period - 47,131 -
----------- ----------- -----------
Cash - end of period $ 47,131 $ 409,432 409,432
=========== =========== ===========
Supplemental Cash Flow Information:
Cash paid for interest $ - $ - $ -
Cash paid for income taxes $ - $ - $ -
Non-cash investing and financing activities:
Assumption of obligation under license
agreement $ 1,750,000
Value of shares issued as consideration in
acquisition of Nutra Pharma, Inc. $ 112,500
Payments of license fee obligation by
stockholder $ 208,550
Conversion of stockholder loan to common
stock $ 862,012 $ 862,012
Loan advances to Bio Therapeutics, Inc.
by stockholder $ 629,000
Value of common stock issued as
consideration in acquisition of
Infectech, Inc. $ 3,827,167 $ 659,207 $ 4,486,375
Liabilities assumed in acquisition of
Infectech, Inc. $ 115,586 $ 115,586
Cancellation of common stock $ 2,055 $ 319 $ 14,806
Value of common stock issued by
stockholder to third party in connection
with settlement $ 229,500 $ 229,500
Value of common stock issued by
stockholder to employee for services
rendered $ 75,000 $ 75,000
Net deferred taxes recorded in connection
with Acquisition $ 559,833 $ 407,753 $ 967,586
Notes payable settled with common stock $ 98,000 $ 98,000
Settlement of stockholder loan in exchange
for common stock of subsidiary $ 1,384,931 $ 1,384,931
-------------------------------------------------------------------------------------
See the accompanying notes to the consolidated financial statements.
-33-
NUTRA PHARMA CORP.
(A Development Stage Company)
Notes to Consolidated Financial Statements
December 31, 2004
1. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Organization
Nutra Pharma Corp., a development stage company ("Nutra Pharma" or "the Parent")
is a holding company that owns intellectual property and operations in the
biotechnology industry. Nutra Pharma incorporated under the laws of the state of
California on February 1, 2000 under the original name of Exotic-Bird.com.
Basis of Presentation
The Company's financial statements are presented on a going concern basis, which
contemplates the realization of assets and satisfaction of liabilities in the
normal course of business.
The Company has experienced a significant loss from operations aggregating
$2,813,456, $7,986,853, and $12,360,801 for the years ended December 31, 2003and
2004, and the period from inception to December 31, 2004. In addition, the
Company has a working capital deficit at December 31, 2004 and December 31, 2003
of $137,483 and $387,616 respectively and has no revenue generating operations.
The Company's ability to continue as a going concern is contingent upon its
ability to secure additional financing, increase ownership equity and attain
profitable operations. In addition, the Company's ability to continue as a going
concern must be considered in light of the problems, expenses and complications
frequently encountered in established markets and the competitive environment in
which the Company operates.
The Company is pursuing financing for its operations and seeking additional
investments. In addition, the Company is seeking to establish a revenue base.
Failure to secure such financing or to raise additional equity capital and to
establish a revenue base may result in the Company depleting its available funds
and not being able pay its obligations.
The financial statements do not include any adjustments to reflect the possible
future effects on the recoverability and classification of assets or the amounts
and classification of liabilities that may result from the possible inability of
the Company to continue as a going concern.
Principals of Consolidation
The consolidated financial statements presented herein include the accounts of
Nutra Pharma and its subsidiary Receptopharm, Inc. (collectively, the
"Company"). In addition, the Company consolidated Infectech, Inc. during the
period from October 31, 2003, through September 28, 2004 (see Note 3). All
intercompany transactions and balances have been eliminated in consolidation.
Use of Estimates
The accompanying financial statements are prepared in accordance with accounting
principles generally accepted in the United States of America which require
management to make estimates and assumptions. These estimates and assumptions
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 revenue and expense. Actual results may differ from
these estimates.
Revenue Recognition
In general, the Company will record revenue when persuasive evidence of an
arrangement exists, services have been rendered or product delivery has
occurred, the sales price to the customer is fixed or determinable, and
collectability is reasonably assured. The following policies reflect specific
criteria for the various revenues streams of the Company:
-34-
Revenue will be recognized at the time the product is delivered. Provision for
sales returns will be estimated based on the Company's historical return
experience. Revenue will be presented net of returns.
Cash and Cash Equivalents
The Company considers all highly liquid investments with an original maturity of
three months or less to be cash equivalents. At December 31, 2004, the Company's
cash balance of $409,432 was on deposit at a single financial institution and
the balance exceeded insured limits.
Fair Value of Financial Instruments
Fair value estimates discussed herein are based upon certain market assumptions
and pertinent information available to management as of December 31, 2004. The
respective carrying value of certain on-balance-sheet financial instruments
approximated their fair values. These financial instruments include cash,
accounts payable, accrued expenses and convertible loans. Fair values were
assumed to approximate carrying values for these financial instruments because
they are short term in nature and their carrying amounts approximate fair values
or they are receivable or payable on demand.
Property and Equipment
Property and equipment is recorded at cost. Expenditures for major improvements
and additions are added to the property and equipment accounts while
replacements, maintenance and repairs, which do not extend the life of the
assets, are expensed.
Depreciation and amortization are computed by using the straight-line method
over the estimated useful lives of the assets. The estimated useful lives are
summarized as follows:
Furniture and equipment 5 to 7 years
Automotive equipment 5 years
Leasehold improvements 3 years
Property and equipment consists of the following:
Automotive equipment $ 7,500
Furniture and equipment 27,483
Leasehold improvements 32,849
---------
67,832
Less: accumulated depreciation (8,457)
---------
$ 59,375
=========
Depreciation charged to operations aggregated $4,867 and $0 during 2004 and
2003.
Long Lived Assets
The carrying value of long-lived assets is reviewed on a regular basis for the
existence of facts and circumstances that suggest impairment. Should there be an
impairment, the Company measures the amount of the impairment based on the
amount that the carrying value of the impaired asset exceeds the discounted cash
flows expected to result from the use and eventual disposal of the from the
impaired assets.
During the year ended December 31, 2004, the Company recorded an impairment
related to its investment in Infectech, Inc. in the amount of $620,805 (see Note
3).
-35-
Research and Development
Research and development is charged to operations as incurred.
Income Taxes
The Company follows SFAS 109 "Accounting for Income Taxes" for recording the
provision for income taxes. Deferred tax assets and liabilities are computed
based upon the difference between the financial statement and income tax basis
of assets and liabilities using the enacted marginal tax rate applicable when
the related asset or liability is expected to be realized or settled. Deferred
income tax expenses or benefits are based on the changes in the asset or
liability each period. If available evidence suggests that it is more likely
than not that some portion or all of the deferred tax assets will not be
realized, a valuation allowance is required to reduce the deferred tax assets to
the amount that is more likely than not to be realized. Future changes in such
valuation allowance are included in the provision for deferred income taxes in
the period of change.
Loss per Share
The Company calculates net income (loss) per share as required by Statement of
Financial Accounting Standards (SFAS) 128, "Earnings per Share." Basic earnings
(loss) per share is calculated by dividing net income (loss) by the weighted
average number of common shares outstanding for the period. Diluted earnings
(loss) per share is calculated by dividing net income (loss) by the weighted
average number of common shares and dilutive common stock equivalents
outstanding. During periods in which the Company incurs losses common stock
equivalents, if any, are not considered, as their effect would be anti dilutive.
Stock-Based Compensation
The Company accounts for equity instruments issued to employees for services
based on the fair value of the equity instruments issued and accounts for equity
instruments issued to other than employees based on the fair value of the
consideration received or the fair value of the equity instruments, whichever is
more reliably measurable.
The Company accounts for stock based compensation in accordance with SFAS 123,
"Accounting for Stock-Based Compensation." The provisions of SFAS 123 allow
companies to either expense the estimated fair value of stock options or to
continue to follow the intrinsic value method set forth in APB Opinion 25,
"Accounting for Stock Issued to Employees" (APB 25) but disclose the pro forma
effects on net income (loss) had the fair value of the options been expensed.
The Company has elected to continue to apply APB 25 in accounting for its stock
option plans.
Equity Method
Investments in entities in which the Company has a 20% to 50% interest are
carried at cost, adjusted for the Company's proportionate share of the
undistributed income (loss) (see Note 3).
Recent Accounting Pronouncements
In December 2003, the Financial Accounting Standards Board issued FASB
Interpretation Number 46-R "Consolidation of Variable Interest Entities." FIN
46-R, which modifies certain provisions and effective dates of FIN 46, sets for
the criteria to be used in determining whether an investment is a variable
interest entity should be consolidated. These provisions are based on the
general premise that if a company controls another entity through interests
other than voting interests, that company should consolidate the controlled
entity. The Company currently consolidates an entity under the provisions of FIN
46-R (see Note 4).
-36-
In November 2004, the FASB issued SFAS 151, "Inventory Costs." SFAS 151 amends
the accounting for abnormal amounts of idle facility expense, freight, handling
costs, and wasted material (spoilage) under the guidance in ARB 43, Chapter 4,
"Inventory Pricing." Paragraph 5 of ARB 43, Chapter 4, previously stated that
"...under some circumstances, items such as idle facility expense, excessive
spoilage, double freight, and rehandling costs may be so abnormal as to require
treatment as current period charges...." This Statement requires that those
items be recognized as current-period charges regardless of whether they meet
the criterion of "so abnormal." In addition, this Statement requires that
allocation of fixed production overheads to the costs of conversion be based on
the normal capacity of the production facilities. This statement is effective
for inventory costs incurred during fiscal years beginning after June 15, 2005.
Management does not expect adoption of SFAS 151 to have a material impact on the
Company's financial statements.
In December 2004, the FASB issued SFAS 153, "Exchanges of Nonmonetary Assets,"
an amendment to Opinion No. 29, "Accounting for Nonmonetary Transactions."
Statement 153 eliminates certain differences in the guidance in Opinion No. 29
as compared to the guidance contained in standards issued by the International
Accounting Standards Board. The amendment to Opinion No. 29 eliminates the fair
value exception for nonmonetary exchanges of similar productive assets and
replaces it with a general exception for exchanges of nonmonetary assets that do
not have commercial substance. Such an exchange has commercial substance if the
future cash flows of the entity are expected to change significantly as a result
of the exchange. SFAS 153 is effective for nonmonetary asset exchanges occurring
in periods beginning after June 15, 2005. Earlier application is permitted for
nonmonetary asset exchanges occurring in periods beginning after December 16,
2004. Management does not expect adoption of SFAS 153 to have a material impact
on the Company's financial statements.
In December 2004, the FASB issued SFAS 123(R), "Share-Based Payment." SFAS
123(R) amends SFAS 123, "Accounting for Stock-Based Compensation," and APB
Opinion 25, "Accounting for Stock Issued to Employees." SFAS 123(R) requires
that the cost of share-based payment transactions (including those with
employees and non-employees) be recognized in the financial statements. SFAS
123(R) applies to all share-based payment transactions in which an entity
acquires goods or services by issuing (or offering to issue) its shares, share
options, or other equity instruments (except for those held by an ESOP) or by
incurring liabilities (1) in amounts based (even in part) on the price of the
entity's shares or other equity instruments, or (2) that require (or may
require) settlement by the issuance of an entity's shares or other equity
instruments. This statement is effective (1) for public companies qualifying as
SEC small business issuers, as of the first fiscal year beginning after December
15, 2005, or (2) for all other public companies, as of the first fiscal year or
interim period beginning after June 15, 2005, or (3) for all nonpublic entities,
as of the first fiscal year beginning after December 15, 2005. Management is
currently assessing the effect of SFAS No. 123(R) on the Company's financial
statements.
2. ACQUISITIONS, JOINT VENTURE AND RESCISSIONS
Acquisition of Nutra Pharma, Inc.
On November 23, 2001, the Company acquired 100% of the issued and outstanding
common stock of Nutra Pharma, Inc. ("NPI"), a privately held company, from its
sole stockholder, pursuant to an agreement and plan for exchange of common
stock. NPI was formed on May 3, 2001 under the laws of the State of Nevada and
at the time of this acquisition, its only asset was an exclusive worldwide
license agreement (the "License Agreement") to distribute a medicinal compound.
The principal products that were intended to be developed from this medicinal
compound were products designed to treat and heal open wounds and other skin
disorders such as acne and psoriasis. NPI was a development stage company, as it
had not realized any revenue from the date of its inception on May 3, 2001
through the date that it was acquired by the Company.
-37-
The Company issued 4,500,000 shares of its restricted common stock to NPI's sole
stockholder, in exchange for the outstanding common stock of NPI. At the time of
the acquisition, NPI owed $1,750,000 to Terra BioPharma, S.A. ("TBPH"), a
Panamanian company, as the licensor under the License Agreement. The term of the
License Agreement was for a period of five (5) years commencing in May 2001.
Payments to TBPH under the License Agreement were to be made in installments
through May 2003.
This acquisition was accounted for as the purchase of a license. The Company
valued the shares issued in this transaction at $0.025 per share, the price at
which the Company sold shares of its common stock in a self-underwritten public
offering in May 2001, for a total value of $112,500. The Company recorded the
cost of the license at $1,862,500, which was equal to the $1,750,000 owed to
TBPH plus the $112,500 value of the 4,500,000 shares issued.
Joint Venture with Terra BioPharma
On January 30, 2002, the Company entered into a Joint Venture Agreement (the "JV
Agreement") with TBPH, whereby it acquired a 50% ownership interest in a newly
formed Panamanian company called Terra Nutra, S.A. ("Terra Nutra"). This JV
Agreement superseded the License Agreement between TBPH and NPI. The purpose of
the joint venture was to patent the raw material composition, manufacturing
process and various uses of the medicinal compound that was the subject of the
License Agreement between TBPH and NPI. Pursuant to the JV Agreement, the
parties agreed that the patent for the raw material composition and the patent
for the manufacturing process would be owned by TBPH. Terra Nutra would own all
future patents for all subsequent uses and products.
As part of the JV Agreement, the Company agreed to pay $1,740,000 to TBPH to
secure the exclusive, worldwide distribution rights to all products derived from
the medicinal compound. This sum was to be paid in monthly installments of
varying amounts over a sixteen (16) month period beginning in July 2002. The
Company also agreed to pay all costs associated with purchasing and developing
the land that was to be used for growing the raw material that was required to
produce the medicinal compound, the costs associated with the construction of a
manufacturing plant used to process the raw material and the costs associated
with clinical trials and patent applications. The JV Agreement acknowledged that
amounts paid toward these costs would be deducted from the amounts owing under
the License Agreement. The Company also agreed to pay a 3% royalty to TBPH on
gross sales from any product ultimately derived from the medicinal compound.
Rescission of Acquisition of Nutra Pharma Inc., and Joint Venture with Terra
BioPharma
On May 14, 2002, the Company notified TBPH of its intent to rescind the JV
Agreement. The Company also notified NPI's sole stockholder of its intent to
rescind the NPI Agreement to recover the 4,500,000 shares that were issued to
NPI's sole stockholder in connection with the November 23, 2001 NPI Agreement.
The Company also notified certain other stockholders holding a portion of the
4,500,000 shares of common stock (the "Individual Stockholders") that had
received shares through a transfer from NPI's sole stockholder. The
notifications specified that the Company had rescinded the NPI Agreement and had
instructed its transfer agent to place a stop transfer on all stock certificates
that represented the 4,500,000 shares issued in connection with the NPI
Agreement.
On October 23, 2002, the Company received a total of 2,037,500 shares of its
common stock from a group that included NPI's sole stockholder and other
Individual Stockholders. These shares were cancelled and returned to the
Company's Treasury.
-38-
On December 23, 2002, the Company, and NPI's sole stockholder agreed to rescind
the NPI Agreement dated November 23, 2001. Pursuant to a Rescission, Settlement
and Release Agreement, NPI's sole stockholder agreed to facilitate the return of
2,092,500 of the 4,500,000 shares of common stock that were issued by the
Company in connection with the NPI Agreement. Of the 2,092,500 shares, 2,037,500
were previously returned on October 23, 2002. As part of this Rescission
Agreement, upon the receipt by the Company of the additional 55,000 shares,
NPI's sole stockholder would receive 450,000 shares of common stock directly
from an existing stockholder who was also an Officer and Director of the
Company.
On January 17, 2003, the Company received a total of 55,000 shares of its common
stock from three Individual Stockholders. These shares were cancelled and
returned to the Company's Treasury.
On February 10, 2003, the Company received 1,000,000 shares of its common stock
from an Individual Stockholder. These shares were cancelled and returned to
Treasury.
On June 19, 2003, the Company received 1,000,000 shares of its common stock from
an Individual Stockholder. These shares were cancelled and returned to Treasury.
On January 21, 2004, the Company received 150,000 shares of its common stock
from an Individual Stockholder. These shares were cancelled and returned to
Treasury.
On February 23, 2004, the Company received 30,000 shares of its common stock
from an Individual Stockholder. These shares were cancelled and returned to
Treasury.
At March 31, 2004, the Company had an agreement in place to recover an
additional 15,000 shares from an Individual Stockholder. Upon the return of
those shares in August 2004, a total of 4,287,500 of the 4,500,000 shares
originally issued to NPI's sole stockholder have been returned. The remaining
212,500 shares were deemed by the Company to be irretrievable, and accordingly,
the Company recorded a charge to operations of $23,375 in 2003 for these shares.
On May 19, 2004, the Company received 4,000 shares of its common stock from an
Individual Stockholder. These shares were cancelled and returned to Treasury.
The Company had previously included these 4,000 shares as part of the 212,500
shares that it deemed to irretrievable.
In connection with these transactions, the Company recorded a loss on settlement
of $53,340, representing the write-off of the carrying value of the unamortized
license agreement of $1,707,290, the cancellation of the remaining obligation to
TBPH of $1,541,450 and the reduction to additional paid-in capital for the value
of the common shares issued to NPI's sole stockholder of $112,500. Common shares
received subsequent thereto have been cancelled and reflected as a reduction in
the par value of common stock and a corresponding increase in additional paid-in
capital. In addition, the 450,000 common shares transferred to NPI's sole
stockholder by a stockholder of the Company was valued at market value of
$229,500 on the date of transfer and has been recorded as a charge to operations
in 2003 with a corresponding increase to additional paid-in capital.
-39-
Failed Acquisition of Bio Therapeutics, Inc.:
On May 30, 2002, the Company entered into a definitive agreement (the "Share
Exchange Agreement") to acquire 100% of the issued and outstanding common stock
of Bio Therapeutics, Inc. ("Bio Therapeutics"), a privately held Florida
corporation. Pursuant to this Share Exchange Agreement, the Company was
obligated to issue 11,137,139 shares of common stock in exchange for an equal
number of shares of Bio Therapeutics, which represented 100% of the issued and
outstanding common stock of Bio Therapeutics. The Share Exchange Agreement also
contained a provision that in the event the Company's common stock was trading
below $2.40 on the closing date, the Company would be obligated to issue
additional shares of its common stock to the stockholders of Bio Therapeutics in
order to ascribe a final value of $2.40 for each share of Bio Therapeutics
stock. In addition, as part of this Share Exchange Agreement, the Company agreed
to loan Bio Therapeutics up to $500,000 for working capital purposes. The
closing of this transaction was contingent upon the Company raising a minimum of
$1,500,000 through a private placement of its common stock. The Share Exchange
Agreement also provided that the shares of the Company and the shares Bio
Therapeutics that are being exchanged would be held by an escrow agent, who
would hold all of the subject shares, and release them to the respective
parties, only upon receiving written proof that the Company had successfully
raised a minimum of $1,500,000.
On August 12, 2002, the Company entered into a Closing Agreement for the
Exchange of Common Stock (the "Closing Agreement"), which amended the Share
Exchange Agreement between the parties. The Closing Agreement stipulated that:
(i) the Company had satisfied its obligation to loan up to $500,000 to Bio
Therapeutics, and (ii) the closing shall take place in two phases. In connection
with the First Closing, the Company was obligated to issue 11,130,889 shares of
its common stock in exchange for an equal amount of Bio Therapeutics common
stock, which represented 100% of the issued and outstanding common stock of Bio
Therapeutics. All share certificates to be issued by each party would be issued
to a Trustee who would hold the shares until the Final Closing. The Final
Closing was contingent upon the Company raising a minimum of $1,500,000 through
a private placement of its common stock.
On September 27, 2002, the parties further amended the Closing Agreement as
follows: (i) the number of shares to be issued by the Company in exchange for
100% of the issued and outstanding shares of Bio Therapeutics is now 11,790,889,
and (ii) in the event that the Company's common stock was trading below $1.20 on
the closing date, the Company would be obligated to issue additional shares of
its common stock to the shareholders of Bio Therapeutics in order to ascribe a
final value of $1.20 for each share of Bio Therapeutics stock.
As of December 31, 2002, the Company had written off its loan receivable balance
of $629,000, due to uncertainty about the extent and timing of collection.
On April 23, 2003, Bio Therapeutics withdrew from and terminated the Share
Exchange Agreement due to the fact that the Company had been unsuccessful in
raising the minimum amount of $1,500,000 through a private placement of its
common stock. Upon the termination of the Share Exchange Agreement, the Trustee
returned certificates representing a total of 9,156,961 shares of the Company's
common stock to the Company for cancellation. The Trustee returned an equal
amount of Bio Therapeutics stock to Bio Therapeutics's legal counsel. The number
of shares returned by the Trustee to the Company and Bio Therapeutics in
connection with the termination of the Share Exchange Agreement represented 100%
of the shares issued by each party.
-40-
On May 21, 2003, the Company commenced legal proceedings against Bio
Therapeutics in order to collect amounts owing under the loan that the Company
made to Bio Therapeutics in connection with the Share Exchange Agreement.
On November 14, 2003, the Company entered into a final Settlement Agreement (the
"Settlement") with Bio Therapeutics. The Settlement provided for the dismissal
of the lawsuit that the Company initiated against Bio Therapeutics. The
Settlement also provided the Company with a non-exclusive license to certain
intellectual property of Bio Therapeutics, including patents and patents pending
for the development of therapies for Multiple Sclerosis and HIV. Also as part of
the Settlement, the Company agreed to extinguish the entire amount of the loan
receivable from Bio Therapeutics. With respect to the license received in
connection with the Settlement, the Company deemed it to have a nominal value as
its fair market value was not readily ascertainable.
3. ACQUISITION OF INFECTECH, INC.
On September 19, 2003, the Company entered into an agreement ("Acquisition
Agreement") to acquire up to 100% of the issued and outstanding common stock of
Infectech, Inc., a Delaware corporation ("Infectech"). Infectech is a
development stage company based in Sharon, Pennsylvania, which is engaged in the
development of diagnostic test kits used for the rapid identification of
infectious human and animal diseases. Infectech owns patented technologies,
which allow for the rapid detection of disease causing pathogens. Infectech also
owns a patented technology designed for use in the bioremediation of
contaminated soil and water.
The Acquisition Agreement provided for the acquisition by the Company of up to
100% of the issued and outstanding common stock of Infectech, through an
exchange of one (1) share of the Company's common stock for every two (2) shares
of Infectech common stock. The Company recorded the acquisition of Infectech as
the purchase of assets, principally patents and other intangibles. The value of
the Company's common shares issued in connection with this transaction is $0.85,
which was the market value of the Company's common stock on September 22, 2003,
the date the terms of the acquisition were agreed to and announced.
Through December 31, 2003, the Company issued an aggregate of 4,502,549 shares
of its common stock in exchange for 9,005,098 shares of Infectech. This initial
exchange resulted in the Company owning approximately 58% of the issued and
outstanding common stock of Infectech. In January 2004, the Company issued an
additional 426,275 shares of its common stock, in exchange for 852,550 shares of
Infectech. In September 2004, the Company issued an additional 293,288 shares of
its common stock in exchange for 586,576 shares of Infectech. These exchanges
increased the Company's ownership interest in Infectech from 58% to 67%.
On September 28, 2004, the Company transferred 6,000,000 shares of Infectech,
Inc. common stock that it owned to a shareholder of Nutra Pharma, to discharge a
$1,384,931 demand loan to such shareholder. This transaction is more fully
described in Note 5. After giving effect to this transfer, the Company owned a
total of 4,444,224 shares or approximately 29% of the issued and outstanding
common stock of Infectech which was 15,537,050.
In connection with the settlement, the Company recorded a loss of $955,069,
representing the difference between the Company's carrying value per share of
the Infectech common stock and the value of the Infectech common stock ascribed
in the settlement which was $0.23 per share. In addition, the Company wrote down
the carrying value of its remaining investment in Infectech to reflect the value
ascribed in the settlement of $.23 per share which resulted in an additional
charge to operations of $620,805.
-41-
During the fourth quarter of 2004, the Company issued an additional 55,975
shares of its common stock in exchange for 111,950 shares of Infectech. At
December 31, 2004, the Company owned a total of 4,556,174 shares or
approximately 25% of the issued and outstanding common stock of Infectech which
was 18,327,030 at December 31, 2004. During the first quarter of 2005 Infectech
issued additional shares of its common stock increasing its outstanding shares
to 34,427,030 shares at February 28, 2005, which reduced the Company's ownership
to approximately 13% at that date.
Subsequent to September 28, 2004, the Company owned a minority interest in
Infectech an accordingly, applies the equity method of accounting to its
investment in Infectech. The Company's share of Infectech's earnings or losses
is included in its statement of operations as a single amount. During the year
ended December 31, 2004, Infectech incurred a loss of $6,658,838. The Company's
portion of the loss using the equity method of accounting of $1,664,710 exceeded
the carrying value of the Company's investment which was $853,540 at December
31, 2004, and as such, the $853,540 was charged to operations at December 31,
2004.
A summary of financial position and results of operations of Infectech is as
follows:
2003 2004
----------- -----------
Current assets $ 2,858 $ 48,474
===========
Current liabilities $ 103,382 $ 151,357
Stockholders' deficit (100,524) (102,883)
----------- -----------
$ 2,858 $ 48,474
=========== ===========
Sales $ - $ -
=========== ===========
Net loss $ (950,539) $(6,658,838)
=========== ===========
The Company's share of the loss for Infectech for the period from October 1,
2003 to December 31, 2003, was nominal.
The aggregate market value of the Company's 4,556,174 shares of Infectech common
stock based on the trading price of Infectech common stock as quoted on the pink
sheets of $.58 per share at December 31, 2004, was $2,642,580.
4. ACQUISITION OF RECEPTOPHARM, INC.
On December 12, 2003, the Company entered into an acquisition agreement (the
"Agreement"), whereby it agreed to acquire a 49.5% interest in Receptopharm,
Inc. ("Receptopharm"), a privately held biopharmaceutical company based in Ft.
Lauderdale, Florida. Receptopharm is a development stage company engaged in the
research and development of proprietary therapeutic proteins for the treatment
of several chronic viral, autoimmune and neuro-degenerative diseases.
The closing of this transaction was subject to the approval of Receptopharm's
board of directors, which was obtained on February 20, 2004. Pursuant to the
Agreement, the Company is acquiring 49.5% of Receptopharm's common equity for
$2,000,000 in cash. Receptopharm intends to use such funds to further research
and development, which could significantly impact future results of operations.
-42-
The Company is purchasing its 49.5% ownership interest in a series of
installments. At December 31, 2004, the Company had funded an aggregate of
$1,250,000 to Receptopharm under the Agreement. Subsequent to December 31, 2004
and through April 13, 2005, the Company funded an additional $285,000 to
Receptopharm, which increased the Company's ownership of Receptopharm to
approximately 37%.
Under the terms of the Agreement, the Company was required to complete the
entire $2,000,000 funding on October 1, 2004. The Company is currently in
discussions with Receptopharm regarding a modification to the Agreement to
provide for a new payment schedule for the remaining $465,000 that the Company
is required to pay to Receptopharm.
For accounting purposes, the Company is treating its capital investment in
Receptopharm as a vehicle for research and development. Because the Company is
solely providing financial support to further the research and development of
Receptopharm, such amounts are being charged to expense as incurred by
Receptopharm since Receptopharm presently has no ability to fund these
activities and is dependent on the Company to fund its operations. In these
circumstances, Receptopharm is considered a variable interest entity and has
been consolidated. The creditors of Receptopharm do not have recourse to the
general credit of the Company.
A summary of financial position and results of operations of Receptopharm is as
follows:
2004
-----------
Current assets $ 71,903
Property and equipment 59,375
Other assets 20,011
-----------
$ 151,289
===========
Current liabilities $ 224,003
Stockholders' deficit (72,714)
-----------
$ 151,289
===========
Sales $ -
===========
Net loss $ (944,282)
===========
5. SETTLEMENT OF DEMAND LOAN - STOCKHOLDER
From inception to May 2004, the Company funded its ongoing operational costs
through unsecured, non-interest bearing, demand loans from certain of its
shareholders, which included loans from the Company's former Chairman of the
Board, Zirk Engelbrecht. At June 30, 2004, the balance on the loan due to Mr.
Engelbrecht was $1,384,931. On August 1, 2004, Mr. Engelbrecht assigned the loan
to Opus International, LLC, a company that Mr. Engelbrecht claims is controlled
by his wife, Marcy Engelbrecht. On or about August 9, 2004, a Managing Member of
Opus International, LLC made a formal demand for repayment of the loan in the
amount of $1,384,931.
-43-
On September 28, 2004, the Company entered into a settlement agreement with Opus
International, which provided for the following terms:
o The transfer of 6,000,000 shares of Infectech common stock owned by the
Company to Opus International, in full and fair settlement of the
outstanding debt owed to Opus International.
o Upon the transfer of the Infectech shares to Opus International, any and
all outstanding debt that the Company owed to Opus International was deemed
discharged and the Company was released from any and all liability
regarding the debt.
o The Company accepted the resignation of Mitchell Felder and David C.
McClelland as directors.
In connection with the settlement, the Company recorded a loss of $955,069,
representing the difference between the Company's carrying value per share of
the Infectech common stock and the value of the Infectech common stock ascribed
in the settlement which was $0.23 per share.
6. CONVERTIBLE LOANS
In June and July 2004, the Company received total proceeds of $98,000 from seven
(7) investors. At the expiration of 90 days, each of the seven investors had the
option of: (a) being repaid the amount of their investment together with 15%
interest; (b) converting their investment into shares of the Company's common
stock at the price of $0.20 per share, or (c) converting their investment into
shares of common stock of Infectech, Inc at the price $0.10 per share. Upon the
expiration of the 90-day term, each investor opted to convert their investment
into Infectech shares. The Company arranged for a former Infectech
officer/director, Robert Ollar, to deliver his own shares of Infectech common
stock to the seven investors in full satisfaction of the $98,000 that the
investors had lent to the Company. These shares did not have a restrictive
legend on the certificates. In exchange for Robert Ollar using his 1,590,133
shares of Infectech, the Company issued him 595,067 shares of its common stock
on November 18, 2004. Because there may not have been an available exemption
from the registration requirements of Section 5 of the Securities Act of 1933,
as amended, in connection with the Company's offer and sale of the purportedly
unrestricted Infectech shares to these persons, the Company may have violated
the registration provisions of the federal securities laws; accordingly, each
investor may be entitled to rescission of their investment and the Company may
be subject to regulatory actions regarding the offers and sales.
In November 2004, in accordance with the terms of completed Subscription
Agreements, the Company received total proceeds of $206,750 from four (4)
investors. These agreements provide that upon the expiration of a 6 month term
from the date of execution, each of the four investors has the option of: (a)
being repaid the amount of their investment together with 15% interest per
annum; (b) converting their investment into shares of the Company's common stock
at a conversion price of $0.17 per share up to an aggregate of 1,216,176, if all
four investors convert; or (c) converting their investment into a number of
shares of common stock of the Company equal to the sum of the principal and
accrued interest on the note, divided by the conversion price equal to a price
which is 35% below (i) the average of the last reported sales prices for the
shares of Common Stock on the NASDAQ National Market, the American Stock
Exchange, the NASDAQ Small Cap Market or the Over-the-Counter Bulletin Board for
the 5 trading days immediately prior to such date or (ii) if there has been no
sales on any such market on any applicable day, the average of the highest bid
and lowest ask prices on such market at the end of any applicable day, or (iii)
if the market value cannot be calculated as of such date on any of the foregoing
bases, the Market Price will be at the fair market value as reasonably
determined in good faith by our Board of Directors.
-44-
Each investor has piggyback registration rights that require the Company to
register any shares held by them if the Company voluntarily files a registration
statement. Additionally, should an investor decide to convert their investment
into shares of common stock, the Company is required to file a registration
statement with the Securities and Exchange Commission to register the investor's
common stock. Should the Company fail to file the registration statement
immediately upon the investor's conversion, the Company is required to issue to
each investor, penalty shares of 5,000 shares of common stock per week for every
week the registration statement is not filed.
7. STOCKHOLDERS' EQUITY
On October 31, 2001, Nutra Pharma amended its articles of incorporation to
increase the number of authorized shares of common stock from 100,000,000 to 2
billion.
On November 7, 2001, Nutra Pharma affected a 20-for-1 forward stock split which
increased the total issued and outstanding shares of common stock from 2,000,000
shares to 40,000,000 shares. All share and per share amounts have been
retroactively adjusted for all periods presented to reflect the stock split.
In May 2001, the Company raised $25,000 through the sale of 1,000,000 shares of
its common stock at a price of $0.025 per share in a self-underwritten initial
public offering.
In November 23, 2001, the Company issued 4,500,000 shares in connection with the
acquisition of Nutra Pharma, Inc. (see Note 2 - Acquisitions, Joint Venture and
Rescissions). The Company valued the 4,500,000 shares issued in this transaction
at a price of $0.025 per share, for a total value of $112,500. The value of
$0.025 per share was based on the price at which the Company sold shares of its
common stock in an initial public offering in May 2001, the most recent cash
transaction of its common stock.
On April 23, 2002, the Company issued 1,000,000 shares of restricted common
stock to a lender as collateral for a loan. The loan was never funded and the
Company placed a stop transfer order on the stock certificate. The lender is
currently in Chapter 11 Bankruptcy. These shares have not been reflected as
issued and outstanding.
On May 23, 2002, a stockholder of the Company returned a total of 10,394,000
shares of common stock to the Company for cancellation. The Company did not pay
any consideration to the stockholder. Accordingly, the Company adjusted
stockholders' equity for the treasury shares with no cost.
In 2002, the Company issued a total of 656,000 shares of restricted common stock
to various individuals and companies in exchange for services rendered. These
issuances were made at various times throughout the year. The Company recorded
stock-based compensation expense of $671,530 to reflect the fair market value of
the common stock issued. Fair market value was based on the closing price of the
Company's common stock on the date of each grant.
On December 23, 2002, the Company rescinded the NPI Agreement dated November 23,
2001, pursuant to a Rescission, Settlement and Release Agreement. NPI's sole
stockholder agreed to facilitate the return of 2,092,500 of the 4,500,000 shares
of common stock to the Company for cancellation. Subsequently, through December
31, 2004, an additional 2,199,000 shares were returned to the Company by
Individual Stockholders that received shares of common stock of the Company
directly from NPI's sole stockholder. As part of this Rescission Agreement,
NPI's sole stockholder received 450,000 shares of common stock directly from an
existing stockholder who was also an Officer and Director of the Company. The
Company recorded a charge to operations of $229,500 to reflect the value of the
settlement for the benefit of the Company.
-45-
In June 2003, a stockholder of the Company transferred 500,000 shares of his
common stock to the Company's President/Chief Executive Officer. Such shares
were valued at $75,000, the fair market value on the date of the transfer, and
the accompanying financial statements have been revised to reflect a charge to
operations as compensation with a corresponding increase in additional
paid-in-capital.
In 2003, the Company issued a total of 2,196,828 shares of restricted common
stock, including 15,000 shares issued pursuant to the Company's Equity
Compensation Plan to various individuals and companies in exchange for services
rendered. Of this total, 1,500,000 shares were issued to officers and directors
of the Company. These issuances were made at various times throughout the year.
The Company recorded stock-based compensation expense of $1,360,267 to reflect
the fair market value of the common stock issued. Fair market value was based on
the closing price of the Company's common stock on the date of each grant.
In 2003, the Company issued a total of 4,502,549 shares of common stock in
connection with its acquisition of Infectech, Inc., which was valued at
$3,827,167.
During the year ended December 31, 2004, the Company sold 5,390,000 shares of
restricted common stock at $.17 per share and received proceeds of $922,700. Of
the shares sold 1,285,000 were issued at December 31, 2004, and 4,105,000 shares
were recorded as a subscription.
During the year ended December 31, 2004, the Company issued a total of 4,054,200
shares of restricted common stock to various individuals and companies and
accepted subscriptions for 2,000,000 shares of common stock from officers and
directors in exchange for services rendered. These issuances were made at
various times throughout the year. The Company recorded stock-based compensation
expense of $2,865,996 to reflect the fair market value of the common stock
issued. Fair market value was based on the closing price of the Company's common
stock on the date of each grant, which ranged from $0.24 to $0.66 per share.
During the year ended December 31, 2004, the Company issued a total of 775,538
shares of restricted common stock in connection with its acquisition of
Infectech, Inc., which was valued at $0.85 per share for a total of $659,207.
This issuance was made in connection with the September 19, 2003, Acquisition
Agreement between the Company and Infectech, Inc.
In June and July 2004, the Company received total proceeds of $98,000 from seven
(7) investors. At the expiration of 90 days, each of the seven investors had the
option of: (a) being repaid the amount of their investment together with 15%
interest; (b) converting their investment into shares of the Company's common
stock at the price of $0.20 per share, or (c) converting their investment into
shares of common stock of Infectech, Inc at the price $0.10 per share. Upon the
expiration of the 90-day term, each investor opted to convert their investment
into Infectech shares. The Company arranged for a former Infectech
officer/director, Robert Ollar, to deliver his own shares of Infectech common
stock to the seven investors in full satisfaction of the $98,000 that the
investors had lent to the Company. These shares did not have a restrictive
legend on the certificates. In exchange for Robert Ollar using his 1,590,133
shares of Infectech, the Company issued him 595,067 shares of its common stock
on November 18, 2004.
During 2004 certain third parties returned an aggregate of 120,000 shares of
common stock for cancellation.
-46-
8. INCOME TAXES
The Company accounts for income taxes under SFAS 109, which requires use of the
liability method. SFAS 109 provides that deferred tax assets and liabilities are
recorded based on the differences between the tax bases of assets and
liabilities and their carrying amounts for financial reporting purposes,
referred to as temporary differences. Deferred tax assets and liabilities at the
end of each period are determined using the currently enacted tax rates applied
to taxable income in the periods in which the deferred tax assets and
liabilities are expected to be settled or realized.
The provision for income taxes differs from the amount computed by applying the
statutory federal income tax rate to income before provision for income taxes
for the years ended December 31, 2004 and 2003. The sources and tax effects of
the differences are as follows:
Income tax provision at the federal statutory rate 34%
Effect of operating losses (34)%
-----
0%
=====
As of December 31, 2004, the Company has a net operating loss carry forward of
approximately $3,100,000. This loss will be available to offset future taxable
income. If not used, this carry forward will expire through 2024. The deferred
tax asset of approximately 1,100,000 relating to the operating loss carry
forward has been fully reserved at December 31, 2004. The increase in the
valuation allowance related to the deferred tax asset was approximately $600,000
during 2004. The principal difference between the accumulated deficit for income
tax purposes and for financial reporting purposes results from Stock based
compensation of approximately $5,000,000, non-cash finance charges of
approximately $800,000, non-cash losses on settlements of approximately
$960,000, non-cash losses related to Infectech of approximately $1,700,000 and
the amortization on intangibles of approximately $800,000.
9. INVESTMENTS
Letter of Intent to Acquire Portage BioMed LLC
On October 28, 2004, the Company entered into a non-binding letter of intent to
acquire 100% of the issued and outstanding common stock of Portage BioMed LLC, a
biotechnology research company. The proposed terms reflected in the non-binding
letter of intent are: (i) beginning on November 1, 2004, the Company will pay
$40,000 per month to Portage BioMed for working capital, until such time that
Portage BioMed generates sufficient cash flow to sustain its operations; (ii)
the Company will issue an aggregate of 1,000,000 shares of its restricted common
stock to Portage BioMed's four members in exchange for their shares of Portage
BioMed; (iii) the Company will also issue an aggregate of 550,000 shares of its
restricted common stock to Portage BioMed's four members for four consecutive
quarters commencing six months from the closing date of the transaction and upon
the completion of certain agreed upon quarterly milestones; and (iv) Rik J.
Deitsch, the Company's Chief Executive Officer, will be appointed to Portage
BioMed's Board of Directors and one current Portage BioMed Director will be
appointed as a Director of the Company.
As of December 31, 2004 the Company has made payments totaling $30,000 to
Portage BioMed in connection with the letter of intent. As of March 31, 2005,
the Company has not entered into a definitive agreement with Portage BioMed.
This investment is included in other assets in the accompanying financial
statements.
-47-
Investment in XenaCare LLC
On November 1, 2004, the Company completed an agreement with XenaCare LLC, a
healthcare management company engaged in the business of manufacturing and
distributing non-prescription pharmaceuticals to physician's offices. This
agreement provides that the Company make an investment of up to $250,000 in 15
Site of Cares physician locations to be managed by XenaCare.
As of December 31, 2004, the Company has made payments totaling $75,000 to
XenaCare in connection with this agreement.
10. EQUITY COMPENSATION PLANS
On December 3, 2003, the Board of Directors of the Company approved the
Employee/Consultant Stock Compensation Plan (the "Plan"). The purpose of the
Plan is to further the growth of Nutra Pharma by allowing the Company to
compensate employees and consultants who have provided bona fide services to the
Company, through the award of common stock of the Company. The maximum number of
shares of common stock that may be issued under the Plan is 2,500,000.
The Board of Directors is responsible for the administration of the Plan and has
full authority to grant awards under the Plan. Awards may take the form of stock
grants, options or warrants to purchase common stock. The Board of Directors has
the authority to determine: (a) the employees and consultants that will receive
awards under the Plan, (b) the number of shares, options or warrants to be
granted to each employee or consultant, (c) the exercise price, term and vesting
periods, if any, in connection with an option grant, and (d) the purchase price
and vesting period, if any, in connection with the granting of a warrant to
purchase shares of common stock of the Company.
As of December 31, 2004, the Company had issued a total of 2,495,000 shares
under the Plan. These shares were issued to various consultants for services
rendered to the Company during 2003 and 2004 as described in Note 7.
11. RELATED PARTY TRANSACTIONS
From inception to May 2004, the Company funded its ongoing operational costs
through unsecured, non-interest bearing, demand loans from certain of its
shareholders, which included loans from the Company's former Chairman of the
Board, Mr. Zirk Engelbrecht. At June 30, 2004, the balance on the loan due to
Mr. Engelbrecht was $1,384,931. On August 1, 2004, Mr. Engelbrecht assigned the
loan to Opus International, LLC, a company that Mr. Engelbrecht claims is
controlled by his wife, Marcy Engelbrecht. On or about August 9, 2004, a
Managing Member of Opus International, LLC made a formal demand for repayment of
the loan in the amount of $1,384,931.
On September 28, 2004, the Company entered into a settlement agreement with Opus
International, which provided for the following terms: (i) the transfer of
6,000,000 shares of Infectech common stock owned by the Company to Opus
International, in full and fair settlement of the outstanding debt owed to Opus
International; (ii) upon the transfer of the Infectech shares to Opus
International, any and all outstanding debt that the Company owed to Opus
International was deemed discharged and the Company was released from any and
all liability regarding the debt; and (iii) the Company accepted the resignation
of Mitchell Felder and David C. McClelland as directors.
-48-
12. SUBSEQUENT EVENTS
In the first quarter of fiscal 2005, the Company sold 90,000 shares of
restricted common stock at $0.17 per share and received proceeds of $15,300.
In the first quarter of fiscal 2005, the Company issued 100,000 shares of
restricted common stock to a consultant and 500,000 shares of restricted common
stock to a Director.
In the first quarter of fiscal 2005 the Company issued the 6,105,000 common
shares subscribed for at December 31, 2004.
On February 14, 2005, the Company completed a Consulting Agreement with Dr.
Tanvir Khandaker, to work full time as our consultant in the areas of business
development, mergers and acquisitions, partnering and licensing during our
Fiscal Year 2005. In return for Dr. Khandaker's services, the Company provides a
monthly retainer of $10,000 to him. Dr. Khandaker is a Director.
Subsequent to year-end, on April 4, 2005, a Motion to Enforce Settlement
Agreement was filed against the Company in the Circuit Court of Broward County
Florida by Bio Therapeutics, Inc. f/k/a Phylomed Corp. in Nutra Pharma Corp. v.
Bio Therapeutics, Inc. (17th Judicial Circuit, Case No. 03-008928 (03)). This
proceeding results from the Company's alleged breach of a settlement agreement
that was entered into between Bio Therapeutics and the Company in resolution of
a previous lawsuit between the Company and Bio Therapeutics that was resolved by
entering into a Settlement Agreement. The Company also entered into a related
License Agreement and Amendment to the License Agreement ("License Agreement")
with Bio Therapeutics.
In the April 4, 2005 motion, Bio Therapeutics alleges that the Company breached
certain provisions of the License Agreement and requests that the Court grant
its motion to enforce the Settlement Agreement by declaring the License
Agreement terminated, enjoining the Company from further use of license products
that was granted to the Company by the License Agreement, and awarding attorneys
fees and costs to Bio Therapeutics. This matter is set for a hearing to hear a
motion to set a motion for an evidential hearing.
The Company intends to defend against this action. The Company does not believe
that this action will have a material effect upon its operations; however, a
negative judgment against the Company could have a materially adverse effect on
its operations and financial condition.
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