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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
(i) FORM 10-K
(Mark One)
[ X ] ANNUAL REPORT PURSUANT TO SECTION 13
(ii) OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended July 31, 1999
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[ ] TRANSITION REPORT PURSUANT TO SECTION
(iii) 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
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Commission file number 000-25169
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GENEREX BIOTECHNOLOGY CORPORATION
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(Exact name of registrant as specified in its charter)
Delaware 82-049021
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(State or other jurisdiction (IRS Employer Identification No.)
of incorporation or organization)
33 Harbour Square, Suite 202, Toronto, Canada M5J 2G2
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: 416/364-2551
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Securities registered pursuant to Section 12(b) of the Act:
None
Securities registered pursuant to section 12(g) of the Act:
Common Stock, par value $.001 per share
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(Title of Class)
Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the registrant was
required to file such report(s), and (2) has been subject to such filing
requirements for the past 90 days.
Yes X No
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Indicate by check mark if disclosure of delinquent fliers pursuant to Item 405
of Regulation S-K is not contained herein, and will not 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-K or any amendment to this
Form 10-K. [ ]
The aggregate market value of the voting and non-voting common equity held by
non-affiliates of the registrant at ___________________, 1999, was $________.
At October 25, 1999, the registrant had 14,743,183 shares of Common Stock
outstanding.
Documents incorporated by reference: None
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FORWARD-LOOKING STATEMENTS
We have made statements under the captions "Management's Discussion and Analysis
of Financial Condition and Results of Operations," "Business" and elsewhere in
this Report that are forward-looking statements. You can identify these
statements by forward-looking words such as "may", "will", "expect",
"anticipate", "believe," "estimate," and similar terminology. Forward-looking
statements address, among other things:
o implementing our clinical programs and other aspects of our business
plans;
o financing goals and plans; and
o our expectations of when regulatory approvals will be received or
other actions will be taken by parties other than us.
There may be events in the future that we are not able to accurately predict or
which we do not fully control that will cause actual results to differ
materially from those expressed or implied by our forward-looking statements.
Although we believe that our expectations reflected in the forward-looking
statements are reasonable, we cannot guarantee future results, levels of
activity, performance, or achievements. Our forward looking statements are made
as of the date of this Report, and we assume we are under no duty to update them
or to explain why actual results may differ.
PART I
Item 1. Business.
Generex Biotechnology Corporation is engaged in the research and development of
proprietary drug delivery technology. Our activities to date have been focused
on formulations to administer large molecule drugs by mouth. Large molecule
drugs ordinarily are not effective unless they are administered by injection.
The initial product based upon our large molecule drug delivery technology is a
liquid insulin formulation that can be administered by a spray to the oral
cavity. We believe that the drug delivery technology upon which this product is
based also can be used for other large molecule drugs.
Oral Insulin Formulation.
Background - Insulin Therapy for Diabetes: The term diabetes refers to a group
of disorders that are characterized by abnormally high levels of glucose in the
blood. The disorders that characterize diabetes involve defects in the
relationship between glucose, a type of sugar, and insulin secretion. When
glucose is abundant, it is converted into fat and stored for use when food is
not available. When glucose is not available from food, these fats are broken
down into free fatty acids that stimulate glucose production by the liver.
Insulin, which is secreted by the pancreas, plays an important role in
regulating the level of glucose in the blood stream by stimulating the use of
glucose as fuel and by inhibiting the production of glucose in the liver. In a
healthy individual, a balance is maintained between insulin secretion and
glucose metabolism.
There are two types of diabetes. In Type 1 diabetes (juvenile onset diabetes or
insulin dependent diabetes), the pancreas produces no insulin, and patients
typically inject insulin three to five times per day to regulate blood glucose
levels. In Type 2 diabetes (adult onset or non-insulin dependent diabetes
mellitus), the body is resistant to the effect of insulin and the insulin
produced by the body is insufficient to properly regulate glucose levels in the
blood. In addition to insulin therapy, Type 2 diabetics take oral drugs that
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stimulate the production of insulin by the pancreas or enable the body to more
effectively use insulin.
Complications of diabetes include damage to the walls of blood vessels,
blindness, loss of circulation in arms and legs, coronary artery disease and
kidney failure. In addition, many diabetics are obese and this obesity leads to
cardiovascular disease and stroke.
There is no known cure for diabetes. The World Health Organization has
identified diabetes as the second largest cause of death by disease in North
America. In North America, total diabetes treatment costs in 1998 exceeded $130
billion, of which 50% represented direct costs such as medication, supplies and
medical care, with the balance being indirect costs such as lost wages.
Oral Insulin Research & Development. Insulin taken by mouth is usually not
absorbed because the insulin molecule is too large. As a result, substantially
all insulin used today in the treatment of diabetes is injected. Our research
and development effort has focused on finding an insulin formulation that will
be absorbed when administered by mouth.
We began with studies involving rats and dogs which showed favorable results.
Beginning in January 1998, we conducted a number of studies in Ecuador with
human subjects. Each of these studies involved a selection of between 8 and 10
patients. The principal purpose of these studies was to evaluate the
effectiveness of our oral insulin formulation in humans compared with injected
insulin and placebos. The studies were conducted over periods of from 4 to 5
days. In these studies, oral formulations containing 30, 40 and 50 units of
insulin provided glucose lowering results similar to 10 units of injected
insulin. The oral insulin formulations also provided average insulin absorption
equivalent to the injected insulin.
Concurrently with these studies, we also experimented with a number of devices
and techniques to orally "administer" our formulation. In our earliest studies
in Ecuador, the formulation was administered using a calibrated dropper. The
formulation was "swished" in the mouth and either spit out or swallowed. We
eventually decided to use a hand held aerosol sprayer to administer the
formulations.
On the basis of the test results in Ecuador and other pre-clinical data, we made
an Investigatory New Drug submission to the Health Protection Branch in Canada
(Canada's equivalent to the United States' Food and Drug Administration) in July
1998, and received permission from the Canadian regulators to proceed with
clinical trials in September 1998. We started these trials in November 1998, and
they are now in process.
We filed an Investigative New Drug Submission with the Food and Drug
Administration in October, 1998. In November 1998 we received FDA approval to
proceed with human trials. We began clinical trials in the United States in
February 1999, and they are now in process.
We expect to complete Phase II clinical trials of our oral insulin formulation
in 1999, and to begin Phase III clinical trials of the formulation in 2000. We
also expect to enter into one or more licensing or other collaborations with a
major pharmaceutical or biotechnology company before commencing Phase III
trials. The distinctions between Phase II and Phase III trials are described in
"Government Regulation" below.
Other Large Molecule Drug Projects.
We believe that the large molecule drug delivery system used in our insulin
product is appropriate for a variety of other drugs. We have had numerous and
extensive discussions of possible research collaborations with pharmaceutical
companies concerning the use of our large molecule drug delivery technology with
the prospective partner's products. These products include monoclonal
antibodies, human growth hormone, fertility hormone, and others. We have not
aggressively pursued these relationships,
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however, because we believed it was more advantageous to concentrate our
resources on developing our oral insulin formulation. We have, however, engaged
in preclinical trials of two non-insulin applications.
Government Regulation
United States: All aspects of our research, development and foreseeable
commercial activities are subject to extensive regulation by the FDA and other
regulatory authorities in the United States. United States federal and state
statutes and regulations govern, among other things, the testing, manufacture,
safety, efficacy, labeling, storage, record keeping, approval, advertising and
promotion of pharmaceutical products. Preclinical studies and clinical trials,
and the regulatory approval process usually take several years and require the
expenditure of substantial resources. If regulatory approval of a product is
granted, the approval may include significant limitations on the uses for which
the product may be marketed.
The steps required before a pharmaceutical product may be marketed in the United
States include:
o preclinical tests;
o the submission to FDA of an Investigational New Drug application,
which must become effective before human clinical trials commence;
o human clinical trials to establish the safety and efficacy of the
drug;
o the submission of a New Drug Application to FDA;
o FDA approval of the New Drug Application, including approval of all
product labeling and advertising.
Preclinical tests include laboratory evaluation of product chemistry,
formulation and stability, as well as animal studies to asses the potential
safety and efficacy of each product. The results of the preclinical tests are
submitted to FDA as part of the Investigational New Drug Application and are
reviewed by FDA before the commencement of human clinical trials. Unless FDA
objects to the Investigatory New Application Drug, the Investigational New Drug
Application becomes effective 30 days following its receipt by FDA. The
Investigational New Drug Application for our oral insulin formulation became
effective in November 1998.
Clinical trials involve the administration of the new drug to humans under the
supervision of a qualified investigator. The protocols for the trials must be
submitted to FDA as part of the Investigational New Drug Application. Also, each
clinical trial must be approved and conducted under the auspices of an
Institutional Review Board, which considers, among other things, ethical
factors, the safety of human subjects, and the possible liability of the
institution conducting the clinical trials.
Clinical trials are typically conducted in three sequential phases (Phase I,
Phase II, and Phase III), but the phases may overlap. Phase I clinical trials
test the drug on healthy human subjects for safety and other aspects, but not
effectiveness. Phase II clinical trials are conducted in a limited patient
population to gather evidence about the efficacy of the drug for specific
purposes to determine dosage tolerance and optimal dosages, and to identify
possible adverse effects and safety risks. We began Phase II clinical tests of
our oral insulin formulation in the United States in February 1999, and these
tests are now in progress.
When a compound has shown evidence of efficacy and acceptable safety in Phase II
evaluations, Phase III clinical trials are undertaken to evaluate clinical
efficacy and to test for safety in an expanded patient population at clinical
trial sites in different geographical locations. FDA and other regulatory
authorities require that the safety and efficacy of therapeutic product
candidates be supported through at least two adequate and well-controlled Phase
III clinical trials. The conduct of clinical trials in general and the
performance of the Phase III clinical trial protocols in particular are complex
and difficult.
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In the United States, the results of preclinical studies and clinical trials, if
successful, are submitted to FDA in a New Drug Application to seek approval to
market and commercialize the drug product for a specified use. FDA may deny a
New Drug Application if it believes that applicable regulatory criteria are not
satisfied. FDA also may require additional testing for safety and efficacy of
the drug.
We cannot be sure that any of our proposed products will receive required
regulatory approvals. Even if we receive regulatory approval, our products and
the facilities used to manufacture our products will remain subject to continual
review and periodic inspection by FDA.
To supply drug products for use in the United States, foreign and domestic
manufacturing facilities must comply with FDA's Good Manufacturing Practices.
Domestic facilities are subject to periodic inspection by FDA. Products
manufactured outside the United States are inspected by regulatory authorities
in those countries under agreements with FDA. To comply with Good Manufacturing
Practices, manufacturers must expend substantial funds, time and effort in the
area of production and quality control. FDA stringently applies its regulatory
standards for manufacturing. Discovery of previously unknown problems with
respect to a product, manufacturer or facility may result in consequences with
commercial significance. These include restrictions on the product, manufacturer
or facility, suspensions of regulatory approvals, operating restrictions, delays
in obtaining new product approvals, withdrawals of the product from the market,
product recalls, fines, injunctions and criminal prosecution.
Foreign Countries: Before we are permitted to market any of our products outside
of the United States, those products will be subject to regulatory approval by
foreign government agencies similar to FDA. These requirements vary widely from
country to country. Generally, however, no action can be taken to market any
drug product in a country until an appropriate application has been approved by
the regulatory authorities in that country. FDA approval does not assure
approval by other regulatory authorities. The current approval process varies
from country to country, and the time spent in gaining approval varies from that
required for FDA approval. In Canada, we obtained regulatory approval from the
Health Protection Branch, the Canadian equivalent of the FDA, in September 1998,
and began clinical tests in Canada in November 1998. In Ecuador, we conducted
early clinical and other studies in 1997 and the first half of 1998. Regulatory
authorities in Ecuador approved the limited non-commercial distribution of our
oral insulin formulation in September 1998.
Marketing
We have several options for marketing our products. These include selling our
drug delivery technology outright (for all applications or certain applications
only), licensing one or more companies to market products based on our
technology, or marketing directly through a sales force comprised of our own
staff and independent distributors. Our present intent is to establish joint
ventures or licensing arrangements for marketing our products. We have discussed
licensing and other terms with several potential marketing and distribution
partners for our oral insulin formulation, but have not yet reached any formal
commitments or agreements.
We plan to market oral insulin formulation in the United States under the name
Oralgen(TM), and in Canada and elsewhere under the name Oralin(TM). We expect
that the convenient size of our applicator, the stability of our oral insulin
formulation at room temperature, and the ease and pain-free nature of
self-administration of the product by patients will be the principal strengths
for marketing our formulation to patients who require insulin therapy, if and
when we obtain the necessary approvals to market the product. We also expect
that these same factors will improve patients' compliance with their prescribed
therapy, and that this improvement in patient compliance would be a significant
factor in motivating physicians to prescribe our product for insulin therapy.
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Manufacturing.
We plan to manufacture our oral insulin formulation in company-owned or
controlled facilities. Initially, we produced the formulation needed for our
clinical studies in a laboratory setting. We now have equipped a company-owned
pilot facility in Toronto, that is capable of preparing enough formulation for
approximately 500 applicators daily, and filling and shipping that number of
applicators. We believe that our pilot facility, with the addition of a second
production line, will be able to produce sufficient product for our clinical
program in the United States, Canada and South America. The cost to duplicate
the initial production line will be less than the cost for the initial line
since we will not have new design costs and the same testing and quality
assurance equipment will be used by both lines.
We also plan to equip and start up full scale manufacturing facilities in
Brampton, Ontario, and Mississauga, Ontario, both of which are company-owned and
within 25 miles from downtown Toronto. We believe that these facilities can be
placed into production in calendar year 2000. We do not foresee a need to place
these facilities into production before then.
Our present business plan is to establish a manufacturing capability in South
America to serve that market, and eventually to add additional manufacturing
capacity as and where required. We have acquired a building site in a "duty
free" zone in Ecuador for a South American manufacturing facility, but have
taken no other steps to establish any manufacturing capability outside Canada.
Our manufacturing facilities must comply with regulatory requirements of the
country in which they are located and of countries to which product produced at
the facility is exported. We believe that our pilot facility will be in
compliance with Good Manufacturing Practices before the end of calendar 1999,
and we expect to seek approval of the facility from Canada's Health Protection
Branch at that time.
Raw Material Supplies
All materials other than synthetic insulin which are required to make our oral
insulin formulation can be easily obtained. The excipients used in our
formulation are available from numerous sources. We expect to obtain the aerosol
spray applicator used to administer the product from a third party contractor
that presently is developing the device in cooperation with us. We expect that
this contractor will be a sole source of supply. We intend, however, to obtain
all necessary licenses and technical information to establish alternative
sources of supply if this proves necessary. The propellant used in our aerosol
spray applicator is a proprietary product, but is available from several
suppliers. We do not anticipate any supply difficulties in obtaining the
propellant.
There are limited sources of supply of the synthetic insulin we need. We believe
that Eli Lilly & Company and Novo Nordisk A/S together produce approximately 90%
to 95% of the world's synthetic insulin supply, and are the only sources of the
type of insulin we need that is approved for sale in the United States. The only
other company which has a significant share of the world market for synthetic
insulin is Hoescht Marion Roussel, which has a substantial share of the German
market, and limited sales elsewhere, but presently does not have an insulin
product approved for sale in the United States.
At the present time, we are using insulin obtained from retail supply sources in
our clinical trials. We have also received limited quantities of insulin from
certain insulin producers for use in clinical studies and for other
non-commercial purposes. In order to obtain wide distribution of our oral
insulin product, we will be required to secure a direct supply of insulin in
commercial quantities. We have discussed insulin supply with the leading
suppliers and certain pharmaceutical companies which do not now have a
significant share of the world insulin market or an insulin product that is
approved for sale in the United States. We do not now have a supply agreement
for commercial quantities of insulin.
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Intellectual Property
Our large molecule drug delivery technology is covered by one or more of eleven
US patent applications pending as of June 30, 1999. Two of these patents have
been allowed but have not yet issued. We have three other patent applications
pending, two of which are pending only in Canada, which cover other drug
delivery technology. At the present time, however, we are not devoting
significant resources to develop these other technologies.
Our technology is the result of original research and discoveries by Pankaj
Modi, our Vice President, Research and Development. Under an October 1996
Consulting Agreement, Dr. Modi assigned to us his entire interest in all
inventions, ideas, designs and discoveries made by him during the term of the
Agreement which relate to our actual or demonstrably anticipated business, work,
undertakings or research and development. At that time, Dr. Modi also entered
into an Assignment and Assumption Agreement with us under which he assigned to
us his interests in specific drug delivery systems and technology patents
invented/discovered/conceived by him prior to the execution of the Agreement.
This included all of his interests in three patents which he previously had
assigned to Centrum Biotechnologies, Inc., a Canadian company which was then 50%
owned by Dr. Modi. Generex Pharmaceuticals has since acquired Dr. Modi's
interest in Centrum Biotechnologies for no additional consideration.
Since joining us, Dr. Modi has developed formulations and procedures, including
our oral insulin formulation, that we believe are outside the scope of the
patents and other rights previously assigned to us and to Centrum by Dr. Modi.
At this time, however, we have not obtained any formal legal opinions that Dr.
Modi's inventions and discoveries after joining us do not infringe his earlier
patents or other patents owned by third parties.
Competition
Any product that we may develop will compete directly with products developed
and marketed by other companies. In addition, other institutions, including
pharmaceutical companies, universities, government agencies and public and
private research organizations attempt to develop and patent products which
could compete with our products. These companies and institutions also compete
with us in recruiting and retaining qualified scientific personnel. Many of our
competitors and potential competitors have substantially greater scientific
research and product development capabilities, as well as financial, marketing
and human resources, than we do.
Many pharmaceutical and biotechnology companies are engaged in various stages of
research, development and testing of alternatives to insulin therapy for the
treatment of diabetes, as well as new means of administering insulin The
potential competitive technologies include the following:
o Inhale Therapeutics has developed a technology utilizing a fine powder
form of insulin that is administered using a proprietary inhalation
device and absorbed in the deep lungs. Inhale has announced successful
results using its inhalation techniques in Phase II clinical trials,
and is now engaged in Phase III trials.
o In November 1998, Pfizer, Inc., which has a collaboration agreement
with Inhale, announced that it had entered into worldwide agreements
to co-develop and co-promote the use of inhaled insulin with Hoechst
Marion Roussel, a leading pharmaceutical-company which has been making
insulin for approximately 75 years.
o Cortecs International announced in late 1997 the results of two
insulin studies with its proprietary product in an oral insulin
capsule form and with a liquid version administered with a tube into
the stomach. Cortecs claimed that these studies showed a significant
lowering of glucose levels in Type 2 diabetic patients, and announced
its intention to conduct multiple dose studies in the future.
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o Aradigm Corporation has announced a joint development agreement with
Novo Nordisk A/S to jointly develop a pulmonary delivery system to
administer insulin by inhalation. Aradigm began Phase II testing in
the second half of 1998. Novo Nordisk is one of the two leading
manufacturers of insulin in the world, the other being Eli Lilly &
Company.
o Dura Pharmaceuticals and Eli Lilly & Company announced in September
1998 that they are collaborating to develop pulmonary delivery
technology for insulin products based upon proprietary technology of
Spiros Development Corporation.
o Endorex Corporation has announced receipt of a patent for a technology
for the oral administration of vaccines which it licenses from the
Massachusetts Institute of Technology. According to that announcement,
the patent covers a vaccine delivery system which Endorex is
developing through a joint venture with Elan Pharmaceutical
Technologies, a company which specializes in drug delivery
technologies and systems.
In addition to other delivery systems for insulin, there are numerous
products which have been approved for use in the treatment of Type 2
diabetics in place of or in addition to insulin therapy. These
products include the following:
o Glucophage(R) is a proprietary product of Bristol-Myers Squibb Company
that is used to improve diabetic patients' ability to control glucose
without increasing serum insulin levels. It is believed to work, at
least in part, by reducing glucose output from the liver.
o Arcabose(R) is a proprietary product sold in the United States by
Bayer Corporation. The product is sold in Europe under the tradename
Glucobay(TM). Acarbose(R) reduces blood glucose levels primarily after
meals by slowing down the digestion of carbohydrates and lengthening
the time it takes for carbohydrates to convert to glucose.
o Rezulin(R) is a proprietary product sold by Warner Lambert for use as
the sole therapy or part of a combination therapy for Type 2 diabetes.
The product is believed to work in part by increasing the body's
sensitivity to insulin.
o Prandin(TM) is a proprietary product sold by Novo Nordisk and
Schering-Plough Corporation which has been approved by the FDA for
certain diabetic patients. The product is believed to act via calcium
channels to stimulate insulin secretion.
Virtually all of our competitors and potential competitors have greater research
and development capabilities, experience, manufacturing, marketing, sales,
financial and managerial resources than we now have. Our competitors may develop
competing technologies, and obtain regulatory approval for products more rapidly
than we do. This may allow them to obtain greater market acceptance of their
products. Developments by others may render some or all of our proposed products
or technologies uncompetitive or obsolete.
We expect that competition among products approved for sale to treat diabetes
will be based, among other things, on product safety, efficacy, ease of use,
availability, price, marketing and distribution. We believe that the principal
advantage of our oral insulin formulation will be ease of use which will result
in greater patient compliance. Our product, however, may be more expensive and
more difficult to obtain than other diabetes treatments.
Environmental Compliance
Our manufacturing, research and development activities involve the controlled
use of hazardous materials and chemicals. We believe that our procedures for
handling and disposing of these materials comply with
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all applicable government regulations. However, we cannot eliminate the risk of
accidental contamination or injury from these materials. If an accident
occurred, we could be held liable for damages, and these damages could severely
impact our financial condition. We are also subject to many environmental,
health and workplace safety laws and regulations, particularly those governing
laboratory procedures, exposure to blood-borne pathogens, and the handling of
hazardous biological materials. Violations and the cost of compliance with these
laws and regulations could adversely affect us. However, we do not believe that
compliance with the United States, Canadian or other environmental laws will
have a material effect on us in the foreseeable future.
Research and Development Expenditures
A substantial portion of our activities to date have been in research and
development. In the period from inception to July 31, 1999, our expenditures on
research and development were $3,689,818. These included $1,853,108 in the year
ended July 31, 1999, $876,404 in the year ended July 31, 1998, and $727,479 in
the year ended July 31, 1997.
Employees
On September 30, 1999, We had 22 full-time employees, including our executive
officers and other individuals who work for us full time but are employed by
management companies that provide their services. Eleven of these employees are
executive and administrative, six are scientific and technical personnel who
engage primarily in development activities and in preparing formulations for
testing and clinical trials. Five of our employees are engaged in corporate and
product promotion, public relations and investor relations. We believe our
employee relations are good. None of our employees is covered by a collective
bargaining agreement.
Item 2. Properties.
Our executive and principal administrative officers occupy approximately 5,000
square feet of office space in the Business Centre at 33 Harbour Square in
downtown Toronto, Ontario, Canada. We own the Business Centre, which comprises
approximately 9100 square feet of usable space. The space in the Centre that is
not used by us is leased to third parties. Under the terms of our purchase of
this space, however, net rental income from third parties' leases was retained
by the seller through January 31, 1999.
We also have commenced limited production of our oral insulin formulation for
clinical purposes at a pilot manufacturing facility in Toronto. This facility,
which we own, consists of approximately 3600 square feet of laboratory,
manufacturing and storage space. At this time, we are using approximately
two-thirds of the usable space. On a single shift, we believe the facility has
the capacity to prepare the oral insulin formulation for approximately 500
applicators per day, and to fill and ship those applications. We are not
producing at those levels at this time, however, because there is no need to do
so. We also believe that we can increase production at this facility to
approximately 1000 applicators per day by outfitting and equipping the remaining
space at this facility, and installing a second production line, at a cost of
approximately $300,000.
We have a purchase money mortgage on our executive facility in Toronto. The
amount of this mortgage is $800,000 CAD (approximately $550,000 US) and is
payable in full in March 2000. We have a mortgage of $125,000 CAD (approximately
$86,000 US) on our pilot manufacturing facility which is due in September 2000.
Both of these mortgages require only the payment of interest prior to their due
date.
We also own an 11,625 square foot building in Brampton, Ontario, which is
approximately 25 miles outside Toronto; a 13,500 square foot building in
Mississauga, Ontario, which is about 20 miles from downtown Toronto; and a
commercial building site in Ecuador. We have begun the preliminary work to equip
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and start-up the Brampton and Mississauga facilities to produce our oral insulin
formulation. We believe that we can place these facilities in operation by the
end of calendar year 2000. At this time, we do not expect to need manufacturing
capabilities beyond our pilot facility before the end of the year 2000.
Item 3. Legal Proceedings.
Sands Brothers & Co. Ltd., a New York City-based investment banking and
brokerage firm, initiated an arbitration against us under New York Stock
Exchange rules on October 2, 1998. Sands alleged that it had the right to
receive, for nominal consideration, approximately 1.6 to 2.5 million shares of
our common stock. This claim was based upon an October 1997 letter agreement
which purported to confirm an agreement appointing Sands Brothers as the
exclusive financial advisor to Generex Pharmaceuticals, Inc., our subsidiary. In
exchange for agreeing to act in that capacity, the letter agreement purports to
grant Sands the right to acquire 17% of Generex Pharmaceuticals common stock for
nominal consideration. Following our acquisition of Generex Pharmaceuticals,
Sands claimed right to receive shares of Generex Pharmaceuticals common stock
applies to our common stock since outstanding shares of Generex Pharmaceuticals
were converted into our shares in the acquisition. Sands' claims also included
additional shares as a fee related to that acquisition, and $144,000 in monthly
fees due under the terms of the purported agreement.
On October 1, 1999, we were informed that the arbitration panel that heard this
case had awarded Sands $14,070 and issued a declaratory judgment to the effect
that we are required to issue to Sands a warrant to purchase 1,530,020 shares of
our common stock pursuant to and in accordance with the terms of the October 9,
1997 letter agreement. While we plan to take action in court to set the award
aside, the grounds upon which courts will overturn an arbitration award are
limited, and our ultimate legal and financial liability, including a range of
possible losses with respect to the award, cannot be estimated at this time.
We are also involved in the following proceedings:
o In February 1997, a claim of wrongful dismissal by a former employee
seeking damages of $450,000 (CAD) was brought in Ontario Court in
Toronto, Ontario (Lorne Sparks v. Generex Pharmaceuticals, Inc.). This
case was tried without a jury in October 1999, and a decision is
expected in calendar 1999.
o In June 1996, "Generex Inc." was named as an additional defendant in a
pending action in The Court of Queen's Bench of Alberta, in Calgary,
Alberta (Elbourne, et al. v. Acepharm, Inc., et al.). In this action
the plaintiffs seek injunctive relief relating to the ownership and
control of Acepharm, damages for an alleged reduction in the value of
their shares in Acepharm, Inc. (approximately $680,000 U.S.), and
punitive damages (approximately $3.4 million U.S.). In one paragraph,
plaintiff's amended Statement of Claim identifies Generex
Pharmaceuticals and mis-identifies it as a subsidiary of another
corporation. Except for this paragraph, there is no reference to us in
the amended Statement of Claim. The specific acts alleged in the
amended Statement of Claim to have violated plaintiffs' interests and
caused it injury are ascribed to other defendants, and occurred prior
to Generex Pharmaceuticals' incorporation in November 1995. We believe
that we were made a party to this case because Generex Pharmaceuticals
had expressed interest in acquiring certain assets of Acepharm, and
the plaintiffs wished to prevent the sale. Because of the dispute over
management, ownership and control of Acepharm, Inc., and because
Acepharm's assets are unrelated to its business plans and goals,
Generex Pharmaceuticals has long since abandoned any interest in
purchasing such assets.
We deny any wrongdoing relative to any of the matters upon which
plaintiff's claims in this action are based. We failed, however, to
file a Statement of Defense to those claims on a timely basis, and
plaintiffs caused a notice of default to be entered against us. We
intend to apply to the court to have
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the notice of default set aside, and to permit us to file a Statement
of Defense. Certain discovery proceedings required by the court prior
to our filing this application are expected to be completed this
month. Our application will be filed promptly thereafter. We may not
succeed in setting aside the notice of default, however, in which case
we would be precluded from contesting liability, but would be
permitted to contest the amount of damages, if any, which plaintiffs
incurred as a result of our actions or of actions for which we are
legally responsible. We believe that plaintiffs have suffered no loss
or injury based on any action of ours or for which we were
responsible, and have made no provision in our financial statements
for any loss which might be incurred in this litigation.
o In February 1999, MQS, Inc., a former consultant, commenced a civil
action against us in the United States District Court for the District
of New Jersey claiming that 242,168 shares of our Common Stock and
$243,065.50 are due to it for services which it rendered through
December 22, 1998. MQS also claims that we have used proprietary
technology of MQS in developing our aerosol applicator and in
formulating our oral insulin product for aerosol application. We filed
our answer to MQS's claims in May 1998, in which we deny that MQS is
entitled to the relief that it seeks, or that MQS supplied any
proprietary technology to us in the course of its engagement or
otherwise. We also have filed a counterclaim against MQS for breach of
contract. We are unable to predict the outcome of this litigation at
this time.
We maintain product liability coverage for claims arising from the use of our
products in clinical trials, etc., but do not have any insurance which covers
our potential liability in any of the legal proceedings described above.
Item 4. Submission of Matters to a Vote of Security Holders.
We did not submit any matters to a vote of stockholders in the last quarter of
the year ended July 31, 1999.
10
PART II
Item 5. Market for Registrant's Common Equity and Related Stockholder Matters.
"Bid" and "asked" prices for our common stock have been quoted on the Nasdaq OTC
Electronic Bulletin Board since February, 1998. The OTC Bulletin Board also
publishes prices at which shares are actually sold, as reported to it by
brokerage firms. Prior to February 1998, there was no public market for the
common stock. The table below sets forth the high and low inter-dealer bid
quotations for our common stock for certain periods, as furnished by the NASDAQ
OTC Bulletin Board from the beginning of trading on February 5, 1998. The high
and low bid price quotations for our common stock on October 19, 1999, were
$5.25 and $4.9375, respectively, and the "closing" bid price was $5.00. These
are "inter-dealer" quotations, without retail mark-up, mark-down or commissions,
and may not represent actual transactions.
High Low
---- ---
1998
----
First quarter $ 6.375 $5.75
Second quarter $ 9.00 $6.00
Third quarter $ 8.125 $5.75
Fourth quarter $18.875 $7.375
1999
----
First Quarter $13.75 $7.00
Second Quarter $ 9.375 $6.5625
Third Quarter $8,0625 $5.50
Fourth Quarter (through
October 19, 1999) $5,8125 $4.75
At October 19, 1999, there were 1,048 holders of record of our common stock.
Outstanding Warrants and Options
Placement Warrants to purchase 256,364 shares were issued as compensation to two
broker dealers, Coleman & Company Securities, Inc. and GIA Securities, Inc., and
certain of their employees in connection with our entering into an investment
banking relationship with Coleman Securities and a private placement of common
stock managed by Coleman Securities in April and May 1999. The Placement
Warrants are exercisable at prices ranging from $5.50 to $7.50 per share. The
weighted average exercise price is $6.18 per share. The Placement Warrants
expire in February and April 2004.
We have other outstanding warrants and options which are exercisable for the
number of shares and prices indicated below:
o 7,937 shares at a price of $21.82 per share expiring September 6,
2002.
o 500,000 shares at a price of $2.50 per share expiring March 31, 2003.
o 50,000 shares at a price of $8.00 per share expiring November 13,
2003.
o 150,000 shares at a price of $10.00 per share expiring November 17,
2003.
11
Shares Saleable Under Rule 144
At October 21, 1999, we had outstanding 12,015,844 shares that were "restricted
securities" as defined in SEC Rule 144. Of these shares, 636,364 shares have
been registered for sale in this offering. Of the remaining restricted shares, a
substantial majority currently are saleable under Rule 144 upon the seller's
compliance with the manner of sale and other conditions and limitations of that
Rule. Rule 144 also requires that specified information concerning Generex must
be available at the time any such sale is made. Restricted shares that are not
currently saleable generally will become so one year after the date we issued
the shares. Generex is subject to the reporting requirements of the Securities
Exchange Act of 1934 and, so long as it complies with those reporting
requirements, it satisfies Rule 144 "public information" requirements.
Recent Sales of Unregistered Securities
Sales of unregistered securities in the past fiscal year which occurred on or
prior to February 12, 1999, are set forth in Item 10 of our Registration
Statement on Form 10, as amended on February 24, 1999. The information
pertaining to such sales that is set forth in Item 10 of the Form 10, as amended
February 24, 1999, is incorporated herein by reference.
In the period from February 13, 1999 until June 21, 1999, the Company has
offered and sold Common Stock and other securities in the transactions described
below in reliance upon exemptions from the registration requirements of the
Securities Act pursuant to Section 4(2) thereof, and Rule 506, Regulation D
thereunder. No "public solicitation", as that term is defined in Rule 502(c),
was employed by or in connection with the sale of securities in reliance upon
Section 4(2) and Rule 506. All purchasers were, to the Company's reasonable
belief, accredited investors who purchased for investment. All disclosures
required under Rule 502(d) were made by us, and all other conditions to the
availability of the Rule 506 exemption were, to our knowledge and belief,
complied with by us.
In order to assure that resale restrictions applicable to restricted securities
are complied with, we have placed a legend evidencing the restrictions on all
certificates representing the shares, and has issued "stop transfer"
instructions to our transfer agent to prevent unapproved transfers.
The transactions were as follows:
(a) On February 15, 1999 and March 6, 1999, we issued an aggregate of 22,000
shares of common stock to three purchasers. These were additional sales in the
Rule 506, Regulation D offering described in Paragraph (h) of Item 10 of our
Registration Statement on Form 10. The purchasers of these shares were:
Paul Busch -- 6,000 shares at $5.00 per share cash;
Partners of the Toronto law firm of Brans Lehun Baldwin -- 5,000 shares
issued for services rendered by the law firm and valued at $6.00 per share;
Joseph Chicco -- 11,000 shares at $6.00 per share cash.
(b) Between April 27, 1999 and May 24, 1999, we offered and sold a total of
636,365 shares at a price of $5.50 per share. Coleman Securities and GIA
Securities acted as our agents in the placement of the shares, and received
commissions of 10% and warrants to purchase common stock as described below. The
investors in this private placement were as follows:
12
Investor Number of Shares
- -------- ----------------
Cranshire Capital, L.P. 177,274
Keyway Investments Ltd. 154,545
ICN Capital Ltd. 59,092
Gilford Partners, L.P. 18,182
Howard Horberg 22,727
Steve Levy 22,727
Headwaters Capital 90,909
Aries Domestic Fund, L.P. 27,000
Aries Domestic Fund II, L.P. 272
Aries Master Fund 63,637
(c) In connection with entering into an investment banking relationship with
Coleman & Company Securities, Inc. and as compensation to Coleman Securities and
GIA Securities, Inc. in connection with the private placement of common stock
described in paragraph (b) above, we issued the following warrants to purchase
common stock to these broker dealers and their employees:
o 50,000 Warrants at $6.00 per share expiring 02/16/04
o 100,000 Warrants at $6.00 per share expiring 04/06/04
o 50,000 Warrants at $7.50 per share expiring 04/06/04
o 56,364 Warrants at $5.50 per share expiring 04/26/04
We also issued warrants to purchase 7,274 shares at $5.50 per share to two
finders who introduced the Company to one of the investors in the private
placement.
(d) Between May 11, 1999 and June 4, 1999, we sold a total of 1,002,672 shares
to holders of previously outstanding Series A Redeemable Common Stock Purchase
Warrants (27 holders) at $5.00 per share upon the exercise of such warrants. The
warrants had been issued in the "units" offering described in Item 10, Paragraph
(c) of our Registration Statement on Form 10, and the holders exercising these
warrants were purchasers in the "units" offering. The purchase price of these
shares was paid in cash, in previously owned shares of our common stock valued
for this purpose at $7.8125 per share, by cancellation of indebtedness or by
promissory note, as follows: 388,375 shares were issued for cash ($1,941,875);
506,125 shares were paid for by the surrender of 323,920 previously owned shares
($2,580,625); 98,172 shares were sold partially in consideration of cancellation
of indebtedness ($66,978.30) and partially through the issuance of a two-year
promissory note ($423,701.70); and 10,000 shares were sold in consideration of a
short term promissory note ($50,000).
(e) In June 1999, the Company issued 45,000 shares of Common Stock to Monetary
Advancement, Inc. as compensation for consulting services, and 6,300 shares to
Thompson Kernaghan & Company for services in connection with the warrant
redemption described in paragraph (d) above. These shares were valued at $5.50
per share for these purposes.
13
Item 6. Selected Financial Data.
SELECTED FINANCIAL DATA
The following selected financial data is derived from and should be read in
conjunction with our financial statements and related notes which appear
elsewhere in this prospectus. Our financial statements as of and for the fiscal
years ended July 31, 1999 and 1998, have been audited by Withum, Smith & Brown,
independent auditors. The financial statements as of and for the fiscal year
ended July 31, 1997, have been audited jointly by Withum, Smith & Brown and
Mintz & Partners, independent auditors.
Cumulative
From
November 2,
1995
Years (Date of
Ended July 31 Inception)
------------------------------------- to July 31,
1999 1998 1997 1999
------ ------ ------ ---------
STATEMENT OF
OPERATIONS DATA (In
thousands, except per share
data):
Revenues $ -- $ -- $ -- $ --
Net Loss $(6,240) $(4,664) $(1,379) $(12,976)
Basic and diluted net loss
per common share $ (.47) $(.46) $(.25) --
Weighted average number of
common shares outstanding 13,260 10,079 5,513 --
Cash dividends per share -- -- -- --
July 31,
--------------------
1999 1998
----- ------
BALANCE SHEET DATA (In thousands):
Working capital $5,188 $ 873
Total assets $8,890 $5,456
Total long-term debt (less
current maturities) $ 445 $ 913
Total stockholders' equity $7,310 $2,642
14
Item 7. Management's Discussion and Analysis of Financial Condition and Results
of Operation.
General
Generex Biotechnology Corporation was incorporated in 1983 as Green Mt. P.S.,
Inc. In January 1998, we acquired all of the outstanding capital stock of
Generex Pharmaceuticals, Inc. ("Generex Pharmaceuticals"), a Canadian
corporation formed in November 1995 to engage in pharmaceutical and
biotechnological research and other activities, and changed our corporate name
to Generex Biotechnology Corporation. The acquisition of Generex Pharmaceuticals
was effected by the merger of a recently formed Delaware corporation ("Generex
Delaware"), which had acquired all of the outstanding capital stock of Generex
Pharmaceuticals in October 1997, with a wholly-owned subsidiary which we formed
for this transaction (the "Reverse Acquisition"). As a result of the Reverse
Acquisition, the former shareholders of Generex Delaware acquired a majority of
our outstanding capital stock and, for accounting purposes, Generex Delaware was
treated as the acquiring corporation. Thus, the historical financial statements
of Generex Delaware, which essentially represent the historical financial
statements of Generex Pharmaceuticals, are deemed to be the historical financial
statements of Generex Biotechnology Corporation.
On April 30, 1999, we completed a reorganization in which we merged into Generex
Delaware to change our state of incorporation from Idaho to Delaware. This
reorganization did not result in any material change in our historical financial
statements or current financial reporting. As part of the reorganization,
Generex Delaware changed its corporate name to "Generex Biotechnology
Corporation".
We are engaged in developing drug delivery systems. Our principal business focus
has been to develop a technology to administer large molecule drugs (i.e., drugs
composed of molecules above a specified molecular weight) by the oral route.
Historically, large molecule drugs have been administered only by injection
because their size inhibits or precludes absorption if administered by oral,
transdermal, transnasal or other means.
The first product based on our large molecule drug delivery technology is a
liquid insulin formulation that is administered using a hand-held aerosol spray
applicator. The formulation, which includes insulin and various excipients
(i.e., non-active pharmaceutical ingredients) to facilitate the absorption of
insulin molecules through the mucous membranes in the mouth and upper
gastro-intestinal tract, is sprayed into the mouth and back of the throat, where
absorption occurs. This product is presently undergoing clinical trials in the
United States and Canada.
We do not expect to receive significant revenue from product sales in the
current fiscal year or in the next fiscal year. We do expect, however, to
receive licensing income, or income in the nature of licensing income (e.g.,
"signing bonuses" or "advance royalties"), next year in connection with our
entering into marketing and distribution agreements. Income from such sources,
if received, is likely to be material relative to our total cash needs. We do
not have any commitments to receive such payments at the present time.
Results of Operations
1999 Compared With 1998
We had a net loss of $6,239,602 in the year ended July 31, 1999, compared to a
loss of $4,663,604 in the preceding fiscal year. The increase in our net loss
resulted from increases in research and development expenses (to $1,853,108 from
$876,404) and in general and administrative expenses (to $4,374,523 from
$3,723,909).
15
The principal reasons for the increase in our research and development expense
in the year ended July 31, 1999, were:
o commencement of clinical trials of our oral insulin formulation in
Canada and the United States during the second and third quarters;
o preparations for our clinical program during the first quarter,
including preparation of our IND application to FDA;
o development work associated with our oral insulin applicator; and
o costs associated with starting up our pilot manufacturing facility in
Toronto which supports our clinical programs.
The principal reason for the increase in our general and administrative expense
in the year ended July 31, 1999, was an increase of $455,152 in legal and
accounting fees and expenses ($836,382 in the year ended July 31, 1999, compared
to $381,230 in the prior year). This increase was related principally to legal
and accounting services in connection with the registration of our common stock
under the Securities Exchange Act of 1934, compliance with the reporting
requirements of that Act, legal services related to patents, litigation defense
costs and increased legal activity necessitated by increased business activity.
A significant portion of our increase in general and administrative expenses
($165,611) in the past fiscal year was the result of increased travel and other
costs associated with attendance at and, in one case co-sponsorship of, industry
seminars and exhibitions.
In both of the last two fiscal years, we incurred substantial expenses for
financial advisory and other financing services that were not related to a
specific financing and, therefore, were accounted for as general and
administrative expenses. These expenses were paid primarily through the issuance
of shares of common stock and/or warrants to purchase common stock ($1,573,604
in the year ended July 31, 1999, and $1,758,166 in the prior year). We expect a
significant reduction in such expenses in the current fiscal year.
Results of Operations - Years Ended July 31, 1998, 1997 and 1996
Through July 31, 1998, we have accumulated a substantial operating deficit as a
result of research, development and general and administrative expenses incurred
at a time when we have had no revenues from operations. These expenses have
increased year to year, and increased substantially in the fiscal year ended
July 31, 1998, primarily because of large increases in general and
administrative expenses ($3,723,909 in the year ended July 31, 1998, versus
$651,545 in the prior year).
The increase in our general and administrative expenses in the fiscal year ended
July 31, 1998, was attributable primarily to:
o increase in salaries ($570,230 in the year ended July 31, 1998, versus
$77,806 in the prior fiscal year);
o professional fees ($527,941 versus $98,078);
o consulting services paid for through the issuance of securities valued
at $110,000, versus zero in the prior year; and
o settlement of a liquidated damage claim by a former lender ($738,000)
based upon our failure to become a "public company" prior to December
7, 1997.
16
Liquidity and Capital Resources
To date we have financed our development stage activities primarily through
private placements of common stock. In the year ended July 31, 1999, we issued
shares of common stock, and options and warrants to purchase common stock, as
follows:
o we sold 2,179,189 shares for gross cash proceeds of $9,740,917;
o we issued 147,884 shares valued for this purpose at $679,113, and
options and warrants valued for this purpose at $1,146,874, as
compensation for services, including financial advisory and other
financing services;
o we issued 180,000 shares to settle an accrued liability of $738,000
incurred in a financing transaction;
o we issued 506,125 shares in exchange for 323,920 previously
outstanding shares in a "cashless exercise" of outstanding warrants;
and
o we issued 94,776 shares in consideration of promissory notes in the
aggregate amount of $473,882.
As a result of our sales of common stock for cash during the year, our
stockholders' equity had increased to approximately $7.31 million at July 31,
1999, versus approximately $2.64 million at July 31, 1998, notwithstanding our
net loss during the year.
Implementing our business plan will require the availability of sufficient funds
to complete development of our oral insulin formulation and to carry on other
research and development activities. While we have been able to raise capital
for our development activities in the past, we do not have any commitments for
future financing. Thus, we face the risk that unforeseen problems with our
clinical program or materially negative developments in general economic
conditions could interfere with our ability to raise the capital we need, or
materially adversely affect the terms upon which such capital is available. If
we were unable to raise additional capital as needed, we could be required to
"scale back" or otherwise revise our business plan. Any significant scale back
of operations or modification of our business plan due to a lack of funding
could be expected to materially and adversely affect our prospects.
At July 31, 1999, we had cash on hand of approximately $5.66 million versus
$2.09 million as of the end of the preceding fiscal year. We believe that our
cash on hand is sufficient to complete the Phase II clinical programs for our
oral insulin formulation in the United States and Canada, and to fund general
and administrative expenses at current levels through the end of the current
fiscal year. Additional funds will be required, however, to carry out a Phase
III clinical program. The differences between Phase II and Phase III clinical
programs are described in Item 1 of this Report.
We expect that a substantial portion of our Phase III clinical program costs
will be obtained through licensing income and future marketing partners'
contributions to clinical program costs and/or equity investments. We do not,
however, have any licensing agreements or contractual arrangements for other
funding at the present time.
Transactions with Affiliates
Prior to January 1, 1999, a portion of our general and administrative expenses
resulted from transactions with affiliated persons, and a number of capital
transactions also involved affiliated persons. Although these transactions were
not the result of "arms-length" negotiations, we do not believe that this fact
had a material impact on our results of operations or financial position. Prior
to the current fiscal year, our classified payments to its executive officers as
compensation and expense reimbursements as "Research
17
and development-related party" because its executive officers received such
payments through personal services corporations rather than directly. For this
fiscal year and in the future, these payments have been and will be accounted
for as though the payments were made directly to the officers, and not as a
related party transaction. We do not foresee a need for, and therefore do not
anticipate, any related party transactions in the current fiscal year.
Year 2000 Issues
Many computer systems experience problems handling dates beyond the year 1999.
Therefore, some computer hardware and software will need to be modified prior to
the year 2000 in order to remain functional. We have completed our assessment of
year 2000 issues and believe that the consequences of such issues will not have
a material effect on our business, results of operations or financial condition,
without taking into account any efforts by us to avoid such consequences.
New Accounting Pronouncements
In June 1997, the Financial Accounting Standards Board (FASB) issued Statement
of Financial Accounting Standards No. 130, "Reporting Comprehensive Income"
("SFAS No. 130"). SFAS No. 130 establishes standards for the reporting and
display of comprehensive income and its components (revenues, expenses, gains
and losses) in a full set of general purpose financial statements. SFAS No. 130
is effective for fiscal years beginning after December 15, 1997. We began the
adoption of SFAS No. 130 in our first fiscal quarter ending October 31, 1998.
In June 1997, the FASB issued Statement of Financial Accounting Standards No.
131, "Disclosure about Segments of an Enterprise and Related Information" ("SFAS
No. 131"). SFAS No. 131 establishes standards for public business enterprises to
report information about operating segments in annual financial statements and
selected information in the notes thereto. SFAS No. 131 is effective for
financial statements for periods beginning after December 15, 1997. In the
initial year of application, comparative information for earlier years is to be
restated. SFAS No. 131 need not be applied to interim financial statements in
the year of adoption, but comparative information is required in the second year
of application. We do not believe that the adoption of SFAS No. 131 has had a
material impact on our financial reporting.
In 1998, the FASB issued Statement of Financial Accounting Statement No. 133,
"Accounting for Derivative Instruments and Hedging Activities" ("SFAS No. 133").
SFAS No. 133 modifies the accounting for derivative and hedging activities and
is effective for fiscal years beginning after December 15, 1999. We believe that
the adoption of SFAS No. 133 will not have a material impact on our financial
reporting.
In 1998, the AICPA issued Statement of Position (SOP) 98-1, "Accounting for
Costs of Computer Software Developed or Obtained for Internal Use". We believe
that the adoption of SOP 98-1 will not have a material impact on our financial
reporting.
Item 7A. Quantitative and Qualitative Disclosures About Market Price
We have neither issued nor own any long term debt instruments, or any other
financial instruments as to which we would be subject to material risks,
including market risks, related to interest rate movements.
At the present time, we maintain our cash in short term government or government
guaranteed instruments, short term commercial paper, interest bearing bank
deposits or demand bank deposits which do not earn interest. A substantial
majority of these instruments and deposits are denominated in US dollars, with
the exception of funds denominated in Canadian dollars on deposit in Canadian
banks to meet short term operating needs in Canada. At the present time, with
the exception of costs associated with the conduct of clinical trials in the
United States and professional fees, substantially all of our operating expense
obligations are denominated in Canadian dollars. We do not presently employ any
18
hedging or similar strategy intended to mitigate against losses that could be
incurred as a result of fluctuations in the exchange rates between US and
Canadian currencies.
Item 8. Financial Statements and Supplementary Data
INDEPENDENT AUDITORS' REPORT
To the Board of Directors and Stockholders,
Generex Biotechnology Company:
We have audited the accompanying consolidated balance sheets of Generex
Biotechnology Company and Subsidiaries (a development stage company) as of July
31, 1999 and 1998, and the related consolidated statements of operations,
changes in stockholders' equity and cash flows for the years then ended and the
cumulative amounts of operations and cash flows for the period November 2, 1995
(date of inception) to July 31, 1999. These financial statements are the
responsibility of the Company's management. Our responsibility is to express an
opinion on these financial statements based on our audits.
We conducted our audits in accordance with generally accepted auditing
standards. 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 made by
management, as well as evaluating the overall financial statement presentation.
We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in
all material respects, the consolidated financial position of Generex
Biotechnology Company and Subsidiaries as of July 31, 1999 and 1998 and the
consolidated results of their operations and their cash flows for the years then
ended and the cumulative amounts of operations and cash flows for the period
November 2, 1995 (date of inception) to July 31, 1999 in conformity with
generally accepted accounting principles (United States).
The accompanying financial statements have been prepared assuming that the
Company will continue as a going concern. As discussed in Note 2 to the
financial statements, the Company is a development stage enterprise and has
suffered recurring losses and net cash outflows from operations since inception
that raise substantial doubt about its ability to continue as a going concern.
As such, the Company is dependent upon future capital infusions from existing
and/or new investors to fund operations. Management's plans with regard to these
matters are also described in Note 2. The accompanying financial statements do
not include any adjustments that might result from the outcome of this
uncertainty.
Withum, Smith & Brown
New Brunswick, New Jersey
September 17, 1999, except for Note 7,
"Pending Litigation," paragraph 4, which
is dated October 20, 1999
19
INDEPENDENT AUDITORS' REPORTS
To the Board of Directors and Stockholders,
Generex Biotechnology Company:
We have audited the accompanying consolidated statements of operations, changes
in stockholders' equity and cash flows of Generex Biotechnology Company and
Subsidiaries (a development stage company) for the year ended July 31, 1997.
These financial statements are the responsibility of the Company's management.
Our responsibility is to express an opinion on these financial statements based
on our audits.
We conducted our audits in accordance with generally accepted auditing
standards. 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 made by
management, as well as evaluating the overall financial statement presentation.
We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present
fairly, in all material respects, the consolidated results of operations and
cash flows of Generex Biotechnology Company and Subsidiaries for the year ended
July 31, 1997 in conformity with generally accepted accounting principles
(United States).
Withum, Smith & Brown Mintz & Partners
New Brunswick, New Jersey Toronto, Ontario
October 15, 1998 October 3, 1997
20
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED BALANCE SHEETS
July 31,
----------------------------
1999 1998
------------ ------------
ASSETS
Current Assets:
Cash and cash equivalents $ 5,633,201 $ 2,090,827
Restricted cash -- 106,527
Short-term investments 232,345 --
Miscellaneous receivables 182,413 209,090
Other current assets 119,010 131,340
------------ -----------
Total Current Assets 6,166,969 2,537,784
Property and Equipment, Net 1,879,547 1,634,447
Deposits 66,159 82,509
Due From Related Parties 776,991 1,200,968
------------ -----------
TOTAL ASSETS $ 8,889,666 $ 5,455,708
============ ===========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Accounts payable and accrued expenses $ 428,874 $ 1,253,003
Current maturities of long-term debt 550,589 411,565
------------ -----------
Total Current Liabilities 979,463 1,664,568
Long-Term Debt, Less Current Maturities 444,971 912,817
Due to Related Parties 155,383 236,024
Commitments and Contingencies
Stockholders' Equity:
Preferred stock, $.001 par value; authorized 1,000,000 shares,
issued and outstanding 1,000 shares at July 31, 1999 and 1998 1 1
Common stock, $.001 par value; authorized 50,000,000 shares,
issued and outstanding 14,740,683 and 11,971,272 shares
at July 31, 1999 and 1998, respectively 14,741 11,971
Additional paid-in capital 20,903,728 9,565,836
Notes receivable - common stock (434,903) --
Deficit accumulated during the development stage (12,975,678) (6,736,076)
Accumulated other comprehensive income (loss) (198,040) (199,433)
------------ -----------
Total Stockholders' Equity 7,309,849 2,642,299
------------ -----------
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 8,889,666 $ 5,455,708
============ ===========
The Notes to Consolidated Financial Statements are an
integral part of these statements.
21
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENTS OF OPERATIONS
Cumulative
For the Years Ended November 2,
July 31, 1995 (Date of
------------------------------------------------- Inception) to
1999 1998 1997 July 31, 1999
------------ ----------- ----------- --------------
Revenues $ -- $ -- $ -- $ --
Operating Expenses:
Research and development 1,853,108 707,520 676,145 3,469,600
Research and development - related party -- 168,884 51,334 220,218
General and administrative 4,374,523 3,409,581 651,545 8,896,270
General and administrative - related party -- 314,328 -- 314,328
------------ ----------- ----------- ------------
Total Operating Expenses 6,227,631 4,600,313 1,379,024 12,900,416
------------ ----------- ----------- ------------
Operating Loss (6,227,631) (4,600,313) (1,379,024) (12,900,416)
Other Income (Expense):
Interest income 55,190 -- -- 55,190
Interest expense (67,161) (63,291) -- (130,452)
------------ ----------- ----------- ------------
Net Loss $ (6,239,602) $(4,663,604) $(1,379,024) $(12,975,678)
============ =========== =========== ============
Basic and Diluted Net Loss Per Common
Share $ (.47) $ (.46) $ (.25)
============ =========== ===========
Weighted Average Number of Shares of
Common Stock Outstanding 13,260,260 10,078,875 5,512,840
============ =========== ===========
The Notes to Consolidated Financial Statements are an
integral part of these statements.
22
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY
FOR THE PERIOD NOVEMBER 2, 1995 (DATE OF INCEPTION) TO JULY 31, 1999
Preferred Notes
Common Stock Stock Additional Receivable
----------------------- ----------------- Paid-In - Common
Shares Amount Shares Amount Capital Stock
--------- ------- ------- ------ ---------- ---------
Balance - November 2, 1995 (Inception) -- $ -- -- $ -- $ -- $ --
Issuance of common stock for cash,
February 1996, $.0254 321,429 321 -- -- 7,838 --
Issuance of common stock for cash,
February 1996, $.0510 35,142 35 -- -- 1,757 --
Issuance of common stock for cash,
February 1996, $.5099 216,428 216 -- -- 110,142 --
Issuance of common stock for cash,
March 1996, $10.2428 2,500 3 -- -- 25,604 --
Issuance of common stock for cash,
April 1996, $.0516 489,850 490 -- -- 24,773 --
Issuance of common stock for cash,
May 1996, $.0512 115,571 116 -- -- 5,796 --
Issuance of common stock for cash,
May 1996, $.5115 428,072 428 -- -- 218,534 --
Issuance of common stock for cash,
May 1996, $10.2302 129,818 130 -- -- 1,327,934 --
Issuance of common stock for cash
July 1996, $.0051 2,606,528 2,606 -- -- 10,777 --
Issuance of common stock for cash,
July 1996, $.0255 142,857 143 -- -- 3,494 --
Issuance of common stock for cash,
July 1996, $.0513 35,714 36 -- -- 1,797 --
Issuance of common stock for cash,
July 1996, $10.1847 63,855 64 -- -- 650,282 --
Costs related to issuance of common stock -- -- -- -- (10,252) --
Founders shares transferred for services
rendered -- -- -- -- 330,025 --
Comprehensive Income (Loss):
Net loss -- -- -- -- -- --
Other comprehensive income:
Currency translation adjustment -- -- -- -- -- --
Total Comprehensive Income (Loss)
--------- ------- ----- ---- ---------- -----
Balance -July 31, 1996 4,587,764 $ 4,588 -- $ -- $2,708,501 $ --
========= ======= ===== ==== ========== =====
Deficit
Accumulated Accumlated
Other During the Total
Comprehensive Development Stockholders'
Income (Loss) Stage Equity
------------ ----------- ------------
Balance - November 2, 1995 (Inception) $ -- $ -- $ --
Issuance of common stock for cash,
February 1996, $.0254 -- -- 8,159
Issuance of common stock for cash,
February 1996, $.0510 -- -- 1,792
Issuance of common stock for cash,
February 1996, $.5099 -- -- 110,358
Issuance of common stock for cash,
March 1996, $10.2428 -- -- 25,607
Issuance of common stock for cash,
April 1996, $.0516 -- -- 25,263
Issuance of common stock for cash,
May 1996, $.0512 -- -- 5,912
Issuance of common stock for cash,
May 1996, $.5115 -- -- 218,962
Issuance of common stock for cash,
May 1996, $10.2302 -- -- 1,328,064
Issuance of common stock for cash
July 1996, $.0051 -- -- 13,383
Issuance of common stock for cash,
July 1996, $.0255 -- -- 3,637
Issuance of common stock for cash,
July 1996, $.0513 -- -- 1,833
Issuance of common stock for cash,
July 1996, $10.1847 -- -- 650,346
Costs related to issuance of common stock -- -- (10,252)
Founders shares transferred for services
rendered -- -- 330,025
Comprehensive Income (Loss):
Net loss -- (693,448) (693,448)
Other comprehensive income:
Currency translation adjustment (4,017) -- (4,017)
-----------
Total Comprehensive Income (Loss) (697,465)
------- --------- -----------
Balance -July 31, 1996 $(4,017) $(693,448) $2,015,624
======= ========= ==========
The Notes to Consolidated Financial Statements are an
integral part of these statements.
23
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY
FOR THE PERIOD NOVEMBER 2, 1995 (DATE OF INCEPTION) TO JULY 31, 1999
Preferred Notes
Common Stock Stock Additional Receivable
---------------------- ---------------- Paid-In - Common
Shares Amount Shares Amount Capital Stock
--------- ------ ------ ------ ---------- ---------
Balance - August 1, 1996 4,587,764 $4,588 -- $ -- $2,708,501 $ --
Issuance of common stock for cash,
September 1996, $.0509 2,143 2 -- -- 107 --
Issuance of common stock for cash,
December 1996, $10.2421 1,429 1 -- -- 14,635 --
Issuance of common stock for cash,
January 1997, $.0518 1,466 1 -- -- 75 --
Issuance of common stock for cash,
March 1997, $10.0833 12 -- -- -- 121 --
Issuance of common stock for cash,
May 1997, $.0513 4,233 4 -- -- 213 --
Issuance of common stock for cash,
May 1997, $.5060 4,285,714 4,286 -- -- 2,164,127 --
Costs related to issuance of common
stock, May 1997 -- -- -- -- (108,421) --
Issuance of common stock for cash,
May 1997, $10.1194 18,214 18 -- -- 184,297 --
Issuance of common stock for cash,
June 1997, $.0504 10,714 11 -- -- 529 --
Issuance of common stock for cash,
June 1997, $.5047 32,143 32 -- -- 16,190 --
Issuance of common stock for cash,
June 1997, $8.9810 29,579 30 -- -- 265,618 --
Issuance of common stock for cash,
June 1997, $10.0980 714 1 -- -- 7,209 --
Issuance of common stock for cash,
July 1997, $10.1214 25,993 26 -- -- 263,060 --
Costs related to issuance of common stock -- -- -- -- (26,960) --
Founders shares transferred for services
rendered -- -- -- -- 23,481 --
Comprehensive Income (Loss):
Net loss -- -- -- -- -- --
Other comprehensive income:
Currency translation adjustment -- -- -- -- -- --
Total Comprehensive Income (Loss)
--------- ------ ---- ------ ---------- -----
Balance - July 31, 1997 9,000,118 $9,000 -- $ -- $5,512,782 $ --
========= ====== ==== ====== ========== =====
Deficit
Accumulated Accumulated
Other During the Total
Comprehensive Development Stockholders'
Income (Loss) Stage Equity
------------- ----------- -------------
Balance - August 1, 1996 $(4,017) $ (693,448) $2,015,624
Issuance of common stock for cash,
September 1996, $.0509 -- -- 109
Issuance of common stock for cash,
December 1996, $10.2421 -- -- 14,636
Issuance of common stock for cash,
January 1997, $.0518 -- -- 76
Issuance of common stock for cash,
March 1997, $10.0833 -- -- 121
Issuance of common stock for cash,
May 1997, $.0513 -- -- 217
Issuance of common stock for cash,
May 1997, $.5060 -- -- 2,168,413
Costs related to issuance of common
stock, May 1997 -- -- (108,421)
Issuance of common stock for cash,
May 1997, $10.1194 -- -- 184,315
Issuance of common stock for cash,
June 1997, $.0504 -- -- 540
Issuance of common stock for cash,
June 1997, $.5047 -- -- 16,222
Issuance of common stock for cash,
June 1997, $8.9810 -- -- 265,648
Issuance of common stock for cash,
June 1997, $10.0980 -- -- 7,210
Issuance of common stock for cash,
July 1997, $10.1214 -- -- 263,086
Costs related to issuance of common stock -- -- (26,960)
Founders shares transferred for services
rendered -- -- 23,481
Comprehensive Income (Loss):
Net loss -- (1,379,024) (1,379,024)
Other comprehensive income:
Currency translation adjustment 3,543 -- 3,543
----------
Total Comprehensive Income (Loss) (1,375,481)
------- ----------- ----------
Balance - July 31, 1997 $ (474) $(2,072,472) $3,448,836
======= =========== ==========
The Notes to Consolidated Financial Statements are an
integral part of these statements.
24
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY
FOR THE PERIOD NOVEMBER 2, 1995 (DATE OF INCEPTION) TO JULY 31, 1999
Preferred Notes
Common Stock Stock Additional Receivable
------------------- ---------------- Paid-In - Common
Shares Amount Shares Amount Capital Stock
--------- ------- ------- ------ ---------- -------
Balance - August 1, 1997 9,000,118 $ 9,000 -- $ -- $5,512,782 $ --
Issuance of warrants in exchange for
services rendered, October 1997, $.50 -- -- -- -- 234,000 --
Exercise of warrants for cash, December
1997, $0.0467 234,000 234 -- -- 10,698 --
Shares issued pursuant to the January 9, 1998
reverse merger between GBC-Delaware, Inc.
and Generex Biotechnology Corporation 1,105,000 1,105 -- -- (1,105) --
Issuance of preferred stock for
services rendered, January 1998, $.001 -- -- 1,000 1 99 --
Issuance of common stock for cash,
March 1998, $2.50 70,753 71 -- -- 176,812 --
Issuance of common stock for cash,
April 1998, $2.50 60,000 60 -- -- 149,940 --
Issuance of common stock in exchange
for services rendered, April 1998, $2.50 38,172 38 -- -- 95,392 --
Issuance of common stock for cash
May 1998, $2.50 756,500 757 -- -- 1,890,493 --
Issuance of warrants in exchange for
services rendered, May 1998, $.60 -- -- -- -- 300,000 --
Issuance of common stock in exchange
for services rendered, May 1998, $2.50 162,000 162 -- -- 404,838 --
Issuance of common stock for cash,
June 1998, $2.50 286,000 286 -- -- 714,714 --
Exercise of warrants for cash, June 1998,
$.0667 234,000 234 -- -- 15,374 --
Issuance of common stock in exchange
for services rendered, June 1998, $2.50 24,729 24 -- -- 61,799 --
Comprehensive Income (Loss):
Net loss -- -- -- -- -- --
Other comprehensive income:
Currency translation adjustment -- -- -- -- -- --
Total Comprehensive Income (Loss)
---------- --------- ----- ----- ---------- -----
Balance - July 31, 1998 11,971,272 $11,971 1,000 $ 1 $9,565,836 $ --
========== ======= ===== ===== ========== =====
Deficit
Accumulated Accumulated
Other During the Total
Comprehensive Development Stockholders'
Income (Loss) Stage Equity
------------- ----------- ----------
Balance - August 1, 1997 $ (474) $(2,072,472) $3,448,836
Issuance of warrants in exchange for
services rendered, October 1997, $.50 -- -- 234,000
Exercise of warrants for cash, December
1997, $0.0467 -- -- 10,932
Shares issued pursuant to the January 9, 1998
reverse merger between GBC-Delaware,Inc.
and Generex Biotechnology Corporation -- -- --
Issuance of preferred stock for
services rendered, January 1998, $.001 -- -- 100
Issuance of common stock for cash,
March 1998, $2.50 -- -- 176,883
Issuance of common stock for cash,
April 1998, $2.50 -- -- 150,000
Issuance of common stock in exchange
for services rendered, April 1998, $2.50 -- -- 95,430
Issuance of common stock for cash
May 1998, $2.50 -- -- 1,891,250
Issuance of warrants in exchange for
services rendered, May 1998, $.60 -- -- 300,000
Issuance of common stock in exchange
for services rendered, May 1998, $2.50 -- -- 405,000
Issuance of common stock for cash,
June 1998, $2.50 -- -- 715,000
Exercise of warrants for cash, June 1998,
$.0667 -- -- 15,608
Issuance of common stock in exchange
for services rendered, June 1998, $2.50 -- -- 61,823
Comprehensive Income (Loss):
Net loss -- (4,663,604) (4,663,604)
Other comprehensive income:
Currency translation adjustment (198,959) -- (198,959)
----------
Total Comprehensive Income (Loss) (4,862,563)
--------- ----------- ----------
Balance - July 31, 1998 $(199,433) $(6,736,076) $2,642,299
========= =========== ==========
The Notes to Consolidated Financial Statements are an
integral part of these statements.
25
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY
FOR THE PERIOD NOVEMBER 2, 1995 (DATE OF INCEPTION) TO JULY 31, 1999
Preferred Notes
Common Stock Stock Additional Receivable
---------------------- ----------------- Paid - Common
Shares Amount Shares Amount Capital Stock
---------- ------- ------ ------ ----------- --------
Balance - August 1, 1998 11,971,272 $11,971 1,000 $ 1 $ 9,565,836 $ --
Issuance of common stock for cash,
August 1998, $3.00 100,000 100 -- -- 299,900 --
Issuance of common stock for cash,
August 1998, $3.50 19,482 19 -- -- 68,168 --
Redemption of common stock for cash,
September 1998, $7.75 (15,357) (15) -- -- (119,051) --
Issuance of common stock for cash,
September - October 1998, $3.00 220,297 220 -- -- 660,671 --
Issuance of common stock for cash,
August - October 1998, $4.10 210,818 211 -- -- 864,142 --
Issuance of common stock in exchange
for services rendered, August -
October 1998, $2.50 21,439 21 -- -- 53,577 --
Issuance of common stock in exchange
for services rendered, August -
October 1998, $4.10 18,065 18 -- -- 74,048 --
Issuance of common stock to satisfy
accrued liability, September 1998, $4.10 180,000 180 -- -- 737,820 --
Issuance of warrants in exchange for
services rendered, October 1998, $.26 -- -- -- -- 2,064 --
Issuance of stock options in exchange for
services rendered, November 1998, $1.85 -- -- -- -- 92,500 --
Issuance of warrants in exchange for
services rendered, November 1998, $1.64 -- -- -- -- 246,000 --
Issuance of common stock for cash,
November 1998 - January 1999, $3.50 180,000 180 -- -- 629,820 --
Issuance of common stock for cash,
November 1998 - January 1999, $4.00 275,000 275 -- -- 1,099,725 --
Issuance of common stock for cash,
November 1998 - January 1999, $4.10 96,852 97 -- -- 397,003 --
Issuance of common stock in exchange for
services rendered, November 1998 -
January 1999, $4.10 28,718 29 -- -- 117,715 --
Issuance of common stock for cash,
November 1998 - January 1999, $5.00 20,000 20 -- -- 99,980 --
Issuance of common stock for cash,
November 1998 - January 1999, $5.50 15,000 15 -- -- 82,485 --
Deficit
Accumulated Accumulatec
Other During Total
Comprehensive Development Stockholders'
Income (Loss) Stage Equity
------------- ------------ ------------
Balance - August 1, 1998 $(199,433) $ (6,736,076) $2,642,299
Issuance of common stock for cash,
August 1998, $3.00 -- -- 300,000
Issuance of common stock for cash,
August 1998, $3.50 -- -- 68,187
Redemption of common stock for cash,
September 1998, $7.75 -- -- (119,066)
Issuance of common stock for cash,
September - October 1998, $3.00 -- -- 660,891
Issuance of common stock for cash,
August - October 1998, $4.10 -- -- 864,353
Issuance of common stock in exchange
for services rendered, August -
October 1998, $2.50 -- -- 53,598
Issuance of common stock in exchange
for services rendered, August -
October 1998, $4.10 -- -- 74,066
Issuance of common stock to satisfy
accrued liability, September 1998, $4.10 -- -- 738,000
Issuance of warrants in exchange for
services rendered, October 1998, $.26 -- -- 2,064
Issuance of stock options in exchange for
services rendered, November 1998, $1.85 -- -- 92,500
Issuance of warrants in exchange for
services rendered, November 1998, $1.64 -- -- 246,000
Issuance of common stock for cash,
November 1998 - January 1999, $3.50 -- -- 630,000
Issuance of common stock for cash,
November 1998 - January 1999, $4.00 -- -- 1,100,000
Issuance of common stock for cash,
November 1998 - January 1999, $4.10 -- -- 397,100
Issuance of common stock in exchange for
services rendered, November 1998 -
January 1999, $4.10 -- -- 117,744
Issuance of common stock for cash,
November 1998 - January 1999, $5.00 -- -- 100,000
Issuance of common stock for cash,
November 1998 - January 1999, $5.50 -- -- 82,500
The Notes to Consolidated Financial Statements are an
integral part of these statements.
26
Issuance of common stock in exchange for
services rendered, January 1999, $5.00 392 -- -- -- 1,960 --
Issuance of common stock for cash,
February 1999, $5.00 6,000 6 -- -- 29,994 --
Issuance of common stock in exchange
for services rendered, February 1999,
$6.00 5,000 5 -- -- 29,995 --
Issuance of common stock for cash,
March 1999, $6.00 11,000 11 -- -- 65,989 --
Issuance of common stock for cash,
April 1999, $5.50 363,637 364 -- -- 1,999,640 --
Issuance of warrants in exchange for
services rendered, April 1999, $3.21 -- -- -- -- 160,500 --
Issuance of warrants in exchange for
services rendered, April 1999, $3.17 -- -- -- -- 317,000 --
Issuance of warrants in exchange for
services rendered, April 1999, $2.89 -- -- -- -- 144,500 --
Issuance of warrants in exchange for
services rendered, April 1999, $3.27 -- -- -- -- 184,310 --
Stock adjustment 714 1 -- -- (1) --
Issuance of common stock for cash,
May 1999, $5.50 272,728 273 -- -- 1,499,731 --
Issuance of common stock in exchange for
services rendered, May - June 1999, $5.50 60,874 61 -- -- 334,746 --
Exercise of warrants for cash, June 1999,
$5.00 388,375 389 -- -- 1,941,484 --
Exercise of warrants in exchange for note
receivable, June 1999, $5.00 94,776 95 -- -- 473,787 (473,882)
Exercise of warrants in exchange for services
rendered, June 1999, $5.00 13,396 13 -- -- 66,967 --
Reduction of note receivable in exchange for
services rendered -- -- -- -- -- 38,979
Shares tendered in conjunction with warrant
exercise, June 1999, $7.8125 (323,920) (324) -- -- (2,530,301) --
Exercise of warrants for shares tendered,
June 1999, $5.00 506,125 506 -- -- 2,530,119 --
Cost of warrants redeemed for cash -- -- -- -- (3,769) --
Cost related to warrant redemption, June 1999 -- -- -- -- (135,431) --
Cost related to issuance of common stock -- -- -- -- (1,179,895) --
Comprehensive Income (Loss):
Net loss -- -- -- -- -- --
Other comprehensive income:
Currency translation adjustment -- -- -- -- -- --
Total Comprehensive Income (Loss)
---------- ------- ----- ---- ----------- ---------
Balance - July 31, 1999 14,740,683 $14,741 1,000 $ 1 $20,903,728 $(434,903)
========== ======= ===== ==== =========== =========
Issuance of common stock in exchange for
services rendered, January 1999, $5.00 -- -- 1,960
Issuance of common stock for cash,
February 1999, $5.00 -- -- 30,000
Issuance of common stock in exchange
for services rendered, February 1999,
$6.00 -- -- 30,000
Issuance of common stock for cash,
March 1999, $6.00 -- -- 66,000
Issuance of common stock for cash,
April 1999, $5.50 -- -- 2,000,004
Issuance of warrants in exchange for
services rendered, April 1999, $3.21 -- -- 160,500
Issuance of warrants in exchange for
services rendered, April 1999, $3.17 -- -- 317,000
Issuance of warrants in exchange for
services rendered, April 1999, $2.89 -- -- 144,500
Issuance of warrants in exchange for
services rendered, April 1999, $3.27 -- -- 184,310
Stock adjustment -- -- --
Issuance of common stock for cash,
May 1999, $5.50 -- -- 1,500,004
Issuance of common stock in exchange for
services rendered, May - June 1999, $5.50 -- -- 334,807
Exercise of warrants for cash, June 1999,
$5.00 -- -- 1,941,873
Exercise of warrants in exchange for note
receivable, June 1999, $5.00 -- -- --
Exercise of warrants in exchange for services
rendered, June 1999, $5.00 -- -- 66,980
Reduction of note receivable in exchange for
services rendered -- -- 38,979
Shares tendered in conjunction with warrant
exercise, June 1999, $7.8125 -- -- (2,530,625)
Exercise of warrants for shares tendered,
June 1999, $5.00 -- -- 2,530,625
Cost of warrants redeemed for cash -- -- (3,769)
Cost related to warrant redemption, June 1999 -- -- (135,431)
Cost related to issuance of common stock -- -- (1,179,895)
Comprehensive Income (Loss):
Net loss -- (6,239,602) (6,239,602)
Other comprehensive income:
Currency translation adjustment 1,393 -- 1,393
----------
Total Comprehensive Income (Loss) (6,238,209)
--------- ------------ ----------
Balance - July 31, 1999 $(198,040) $(12,975,678) $7,309,849
========= ============ ==========
The Notes to Consolidated Financial Statements are an
integral part of these statements.
27
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENTS OF CASH FLOWS
Cumulative
For the Years Ended November 2,
July 31, 1995 (Date of
--------------------------------------------- Inception) to
1999 1998 1997 July 31, 1999
----------- ----------- ------------ --------------
Cash Flows From Operating Activities:
Net loss $(6,239,602) $(4,663,604) $(1,379,024) $(12,975,678)
Adjustments to reconcile net loss to net
cash used in operating activities:
Depreciation 79,784 31,096 10,411 123,869
Reduction of notes receivable - common stock
in exchange for services rendered 38,979 -- -- 38,979
Common stock issued for services rendered 612,175 562,253 -- 1,174,428
Stock options and warrants issued for services
rendered 1,146,874 534,000 -- 1,680,874
Preferred stock issued for services rendered 100 -- 100
Founders' shares transferred for services rendered -- -- 23,481 353,506
Changes in operating assets and liabilities:
Miscellaneous receivables 27,571 -- (119,967) (142,608)
Other current assets 12,610 (89,268) (37,020) (123,967)
Accounts payable and accrued liabilities (87,134) 1,099,815 226,131 1,238,812
Other, net -- 110,317 -- 110,317
----------- ----------- ----------- ------------
Net Cash Used in Operating Activities (4,408,743) (2,415,291) (1,275,988) (8,521,368)
Cash Flows From Investing Activities:
Purchase of property and equipment (217,018) (16,287) (41,987) (292,791)
Change in restricted cash 105,655 (111,250) -- (5,595)
Purchase of short-term investments (232,345) -- -- (232,345)
Change in deposits -- (17,601) -- (17,601)
Change in notes receivable -- 104,153 (104,153) --
Collection of subscriptions receivable -- -- 1,527,606 --
Change in due from related parties 428,216 154,945 (2,740,260) (2,546,170)
Other, net -- 89,683 -- 89,683
----------- ----------- ----------- ------------
Net Cash Provided By (Used in)
Investing Activities 84,508 203,643 (1,358,794) (3,004,819)
Cash Flows From Financing Activities:
Proceeds from issuance of long-term debt -- 993,149 -- 993,149
Repayment of long-term debt (416,649) (63,389) -- (480,038)
Change in due to related parties (81,483) 236,024 -- 154,541
Proceeds from issuance of common stock, net 8,488,798 2,959,672 2,785,212 16,616,746
Purchase and retirement of common stock (119,066) -- -- (119,066)
----------- ----------- ----------- ------------
Net Cash Provided By Financing Activities 7,871,600 4,125,456 2,785,212 17,165,332
Effect of Exchange Rates on Cash (4,991) (18,985) 17,251 (5,944)
----------- ----------- ----------- ------------
Net Increase in Cash and Cash
Equivalents 3,542,374 1,894,823 167,681 5,633,201
Cash and Cash Equivalents, Beginning of Period 2,090,827 196,004 28,323 --
Cash and Cash Equivalents, End of Period $ 5,633,201 $ 2,090,827 $ 196,004 $ 5,633,201
=========== =========== =========== ============
The Notes to Consolidated Financial Statements are an
integral part of these statements.
28
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 1 - Organization and Business:
Generex Biotechnology Corporation (the Company) was incorporated in
the State of Delaware on April 30, 1999. Previously, the Company was
incorporated in Idaho in 1983 as Green Mt. P.S., Inc. Since 1983 and
prior to January 16, 1998, the Company had essentially been inactive.
In January 1998, the Company, with a wholly-owned subsidiary which had
been recently formed, acquired all of the outstanding capital stock of
GBC - Delaware, Inc., an entity whose only asset consisted of the
stock of Generex Pharmaceuticals, Inc. ("Generex Pharmaceuticals"), a
Canadian corporation formed in November 1995 to engage in
pharmaceutical and biotechnological research and other activities. The
shareholders of GBC - Delaware, Inc. were the same shareholders of
Generex Pharmaceuticals. As a result of this acquisition, the former
shareholders of GBC - Delaware, Inc. acquired approximately 90 percent
of the Company's outstanding capital stock. GBC - Delaware, Inc. was
treated as the acquirer in this transaction for accounting purposes,
and accordingly, the historical financial statements of GBC -
Delaware, Inc., prior to the acquisition date, are deemed to be the
historical financial statements of the Company.
The Company is engaged in the research and development of drug
delivery systems and technology. Since its inception, the Company has
devoted its efforts and resources to the development of a platform
technology for the oral administration of large molecule drugs,
including proteins, peptides, monoclonal antibodies, hormones and
vaccines, which historically have been administered by injection,
either subcutaneously or intravenously.
The Company is a development stage company, which has a very limited
history of operations and has not generated any revenues from
operations. The Company has no products approved for commercial sale
at the present time. There can be no assurance that the Company will
be successful in obtaining regulatory clearance for the sale of
existing or any future products or that any of the Company's products
will be commercially viable.
Note 2 - Basis of Preparation:
Since inception, the Company has suffered recurring losses and net
cash outflows from operations. The Company expects to continue to
incur substantial losses to complete the development and testing of
its drug candidates, and does not expect to complete the development
stage and begin commercialization of its products in the foreseeable
future. Management is actively pursuing various options, which include
entering into strategic partnerships with large pharmaceutical
companies. Since its inception, the Company has funded operations
through debt and common stock issuances in order to meet its strategic
objectives. Management believes that sufficient funding will be
available to meet its planned business objectives including
anticipated cash needs for working capital, for a reasonable period of
time. However, there can be no assurance that the Company will be able
to obtain sufficient funds to continue the development of, and if
successful, to commence the manufacture and sale of its drug
candidates, if and when approved by the applicable regulatory
agencies. As a result of the foregoing, there exists substantial doubt
about the Company's ability to continue as a going concern. These
financial statements do not include any adjustments relating to the
recoverability of the carrying amounts of recorded assets or the
amount of liabilities that might result from the outcome of this
uncertainty.
29
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 3 - Summary of Significant Accounting Policies:
Principles of Consolidation
The accompanying consolidated financial statements include the
accounts of the Company and its wholly owned subsidiaries. All
significant intercompany transactions and balances have been
eliminated.
Development Stage Company
The accompanying consolidated financial statements have been prepared
in accordance with the provisions of Statement of Financial Accounting
Standard No. 7, "Accounting and Reporting by Development Stage
Enterprises."
Cash and Cash Equivalents
The Company considers all highly liquid investments purchased with a
maturity of three months or less to be cash equivalents.
Short-Term Investments
At July 31, 1999, short-term investments consisted of Ontario Savings
Bonds bearing interest at 5 percent per annum and maturing on December
21, 1999. At July 31, 1999, the cost of the investments approximated
market value.
Property and Equipment, Net
Property and equipment are recorded at cost less accumulated
depreciation. Depreciation is provided on the straight-line method
over the estimated useful lives of the assets, which range from three
to thirty years. Gains and losses on depreciable assets retired or
sold are recognized in the statement of operations in the year of
disposal. Repairs and maintenance expenditures are expensed as
incurred.
Research and Development Costs
Expenditures for research and development are expensed as incurred and
include, among other costs, those related to the production of
experimental drugs, including payroll costs, and amounts incurred for
conducting clinical trials. Amounts expected to be received from local
governments under research and development tax credit arrangements are
offset against the related expenses. Included in miscellaneous
receivables is $178,763 and $153,597 of such a receivable due from the
Canadian government at July 31, 1999 and 1998, respectively.
Income Taxes
Income taxes are accounted for under the asset and liability method
prescribed by Statement of Financial Accounting Standards No. 109,
"Accounting for Income Taxes." Deferred income taxes are recorded for
temporary differences between financial statement carrying amounts and
the tax basis of assets and liabilities. Deferred tax assets and
liabilities reflect the tax rates expected to be in effect for the
years in which the differences are expected to reverse. A valuation
allowance is provided if it is more likely than not that some or all
of the deferred tax asset will not be realized.
30
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 3 - Summary of Significant Accounting Policies (Continued):
Stock-Based Compensation
As permitted by the provisions of Statement of Financial Accounting
Standards No. 123, "Accounting for Stock-Based Compensation: (SFAS
123), the Company follows Accounting Principles Board Opinion No. 25,
"Accounting for Stock Issued to Employees" (APB 25) and related
interpretations in accounting for its employee stock option plans.
Under APB 25, if the exercise price of the Company's employee stock
options equals or exceeds the fair market value of the underlying
stock on the date of grant, no compensation expense is recognized.
Stock options and warrants issued to non employees are accounted for
based on the fair value of the consideration received or the fair
value of the equity instruments issued, whichever is more reliably
measurable.
Net Loss Per Common Share
The Company has adopted Statement of Financial Accounting Standards
No. 128, "Earnings per Share" (SFAS 128), which requires presentation
of basic earnings per share (Basic EPS) and diluted earnings per share
("Diluted EPS") by all entities that have publicly traded common stock
or potential common stock (options, warrants, convertible securities
or contingent stock arrangements). SFAS 128 also requires presentation
of earnings per share by an entity that has made a filing or is in the
process of filing with a regulatory agency in preparation for the sale
of securities in a public market.
Basic EPS is computed by dividing income (loss) available to common
stockholders by the weighted average number of common shares
outstanding during the period. Diluted EPS gives effect to all
dilutive potential common shares outstanding during the period. The
computation of Diluted EPS does not assume conversion, exercise or
contingent exercise of securities that would have an antidilutive
effect on earnings. Refer to Note 12 for methodology for determining
net loss per share.
Comprehensive Loss
The Company has adopted Statement of Financial Accounting Standards
No. 130, "Reporting Comprehensive Income." Other comprehensive income
(loss), which includes only foreign currency translation adjustments,
is shown in the Statement of Stockholders' Equity.
New Accounting Standards
In March 1998, the American Institute of Certified Public Accountants
issued Statement of Position (SOP) 98-1, "Accounting for the Costs of
Computer Software Developed for or Obtained for Internal Use." The SOP
is effective for the Company beginning in fiscal 2000. After the date
of adoption, the SOP will require the capitalization of certain costs
to develop or obtain software for internal use that the Company
currently expenses as incurred and will require expensing certain
costs that the Company now capitalizes. The Company does not
anticipate that the adoption of this SOP will have a material impact
on the Company's consolidated financial statements.
31
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 3 - Summary of Significant Accounting Policies (Continued):
New Accounting Standards (Continued)
In June 1998, the Financial Accounting Standards Board issued
Statement of Financial Accounting Standards No. 133, "Accounting for
Derivative Instruments and Hedging Activities" (SFAS 133). This
statement establishes accounting and reporting guidelines for
derivatives and requires an establishment to record all derivatives as
assets or liabilities on the balance sheet at fair value.
Additionally, this statement establishes accounting treatment for
three types of hedges: hedges of changes in the fair value of assets;
liabilities or firm commitments; hedges of the variable cash flows of
forecasted transactions; and hedges of foreign currency exposures of
net investments in foreign operations. Any derivative that qualifies
as a hedge, depending upon the nature of that hedge, will either be
offset through earnings against the change in fair value of the hedged
assets, liabilities or firm commitments or recognized in other
comprehensive income until the hedged item is recognized in earnings.
SFAS 133 has been amended by Statement of Financial Accounting
Standards No. 137, "Accounting for Derivative Instruments and Hedging
Activities - Deferral of Effective Date of FASB Statement No. 133 - An
Amendment of FASB Statement No. 133," which has delayed the effective
date to all fiscal quarters of all fiscal years beginning after June
15, 2000. The Company is analyzing the implementation requirements and
does not anticipate that the adoption of these statements will have a
material impact on the Company's consolidated financial statements.
Concentration of Credit Risk
The Company maintains cash balances, at times, with financial
institutions in excess of amounts insured by the Canada Deposit
Insurance Corporation. Management monitors the soundness of these
institutions and considers the Company's risk negligible. The Company
also maintains cash balances with Canadian legal counsel. Management
believes the Company's credit risk on these balances to be minimal.
Use of Estimates
The preparation of financial statements in conformity with generally
accepted accounting principles requires management to make estimates
and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the
dates of the financial statements and the reported amounts of revenues
and expenses during the reporting periods. Actual results could differ
from those estimates.
Foreign Currency Translation
Foreign denominated assets and liabilities of the Company are
translated into US dollars at the prevailing exchange rates in effect
at the end of the reporting period. Income statement accounts are
translated at a weighted average of exchange rates which were in
effect during the period. Translation adjustments that arise from
translating the foreign subsidiary's financial statements from local
currency to US currency are recorded in the cumulative translation
adjustment component of stockholders' equity.
Financial Instruments
The carrying values of accounts payable and accrued expenses
approximate their fair values. The fair value of the Company's
long-term debt is assumed to approximate its book value.
32
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 4 - Property and Equipment:
The costs and accumulated depreciation of property and equipment are
summarized as follows:
July 31,
----------------------------
1999 1998
---------- ----------
Land $ 258,560 $ 239,810
Buildings and Improvements 1,555,162 1,366,956
Furniture and Fixtures 8,036 7,998
Office Equipment 61,137 60,850
Lab Equipment 113,550 --
Construction in Progress 4,513 --
---------- ----------
Total Property and Equipment 2,000,958 1,675,614
Less: Accumulated Depreciation 121,411 41,167
---------- ----------
Property and Equipment, Net $1,879,547 $1,634,447
========== ==========
Depreciation expense amounted to $79,784, $31,096 and $10,411 for the
years ended 1999, 1998 and 1997, respectively.
Note 5 - Income Taxes:
The Company has incurred losses since inception which have generated
net operating loss carryforwards on a consolidated basis of
approximately $7,900,000 at July 31, 1999 which are available to
offset future taxable income. The net operating loss carryforwards
arise from both United States and Canadian sources. The net operating
loss carryforwards will expire in 2005 through 2019. These loss
carryforwards are subject to limitation in future years should certain
ownership changes occur.
For the years ended July 31, 1999, 1998 and 1997, the Company's
effective tax rate differs from the federal statutory rate principally
due to net operating losses and other temporary differences for which
no benefit was recorded.
Deferred tax assets consist of the following:
July 31,
-----------------------------
1999 1998
----------- -----------
Net operating loss carryforwards $ 3,404,374 $ 2,008,795
Research and development tax credits 69,119 75,705
Depreciation and amortization 169,417 204,755
Accrued liabilities -- 118,914
----------- -----------
Total deferred tax assets 3,642,910 2,408,169
Valuation allowance (3,642,910) (2,408,169)
----------- -----------
Net deferred tax assets $ -- $ --
=========== ===========
33
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 6 - Accounts Payable and Accrued Expense:
Accounts payable and accrued expenses consist of the following:
July 31,
-------------------------
1999 1998
-------- ----------
Accounts Payable $366,927 $ 336,633
Penalty Arising from Violation of
Financing Agreement (A) -- 738,000
Consulting Accruals 61,947 151,945
Building Purchase Liability -- 26,425
-------- ----------
Total $428,874 $1,253,003
======== ==========
(A) See Note 9 for further discussion of underlying debt and penalty
amount.
Note 7 - Commitments and Contingent Liabilities:
Consulting Services
In October 1996, the Company entered into a Consulting Agreement with
its Vice President of Research and Development (the V.P.) pursuant to
which, among other things, the V.P. assigned to the Company his entire
right, title and interest in and to all inventions, ideas, designs and
discoveries made by him during the term of such agreements which
relate in any manner to the actual or demonstratably anticipated
business, work, undertaking or research and development of the
Company. Concurrently with execution of this Consulting Agreement, the
V.P. and the Company entered into an Assignment and Assumption
Agreement pursuant to which the V.P. assigned to the Company his
interests in and to specific drug delivery systems, controlled release
drug delivery systems, and technology patents invented/discovered/
conceived by the V.P. prior to the execution of the Agreement,
including three existing patents covering insulin delivery systems,
applicable to peptides and proteins; drug vaccines and hormones
delivery; and controlled release of drugs and hormones (the "Existing
Patents"). In addition to the Existing Patents, the V.P. assigned to
the Company his interest in four US and/or Canadian patent
applications and certain abstracts covering, among other things,
liposomes drug delivery for vaccines, drugs, hormones, peptides and
cosmetic delivery; transdermal drug delivery for proteins, peptides,
hormones and small molecules; controlled release drug delivery systems
for capsules, caplets, and liquid suspensions; and DNA technology
relating to insulin preparation (collectively, "Other Existing
Technology"). At the time of this assignment, the Existing Patents
were owned of record by a Canadian corporation which was 50 percent
owned by the V.P. The Company subsequently acquired the V.P.'s
interest in this corporation for no additional consideration.
Under the terms of the agreement, which expires December 31, 2004, a
fee of $93,204 for each year during the term of this agreement,
including expense reimbursement. In addition, the Company agreed to
reimburse the V.P. for $99,095 of expense incurred in research
activities prior to his association with the Company.
34
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 7 - Commitments and Contingent Liabilities:
Consulting Services (Continued)
In November 1998, the Company entered into a consulting agreement with
an individual to assist the Company in testing and evaluating the use
of the Company's oral insulin formulation to reduce fibroid tissue and
serve on the Company's Scientific Advisory Board. As part of the
consultant's compensation, the Company granted the consultant options
to purchase 50,000 shares of the Company's common stock at an exercise
price of $8.00 per share. The agreement shall terminate on December
31, 2000.
In February 1999, the Company entered into an agreement, which was
amended and replaced by an April 1999 agreement, with an investment
banker. Under the terms of the amended agreement, the investment
banker will act as the Company's exclusive investment advisor,
exclusive private placement agent and exclusive investment banker for
a period of five months. In conjunction with the February agreement,
the investment banker received warrants to purchase 100,000 shares of
the Company's common stock at an exercise price of $6.00 per share
during a five-year period. Under the April 1999 agreement, the
investment banker received warrants to purchase 50,000 shares of the
Company's common stock at an exercise price of $6.00 per share during
a five-year period. The amended agreement also provided for the grant
of an additional warrant to purchase 50,000 shares of the Company's
common stock at an exercise price of $7.50 per share during a
five-year period for assisting in obtaining financing in an agreed
upon and stated amount. The warrant was earned in the quarter ended
April 30, 1999. In the event of a private placement of the Company's
securities, the investment banker is entitled to (i) a transaction
fee, (ii) expense allowance and (iii) placement agent warrants equal
to 10 percent of the ownership given to any equity raised. Finally in
the event that the Company enters into a merger, acquisition, or sale
transaction with a party introduced by the investment banker, cash
compensation will be paid based on an agreed upon formula.
Leases
The Company has entered into various lease agreements for the use of
vehicles and office equipment.
Aggregate minimum annual lease commitments of the Company as of July
31, 1999 are as follows:
Year Amount
---- -------
2000 $20,489
2001 10,725
2002 5,062
Thereafter 254
-------
Total Minimum Lease Payments $36,530
=======
Lease expense amounted to $19,240, $50,757 and $9,206 for the years
ended July 31, 1999, 1998 and 1997, respectively.
The preceding data reflects existing leases and does not include
replacements upon their expiration. In the normal course of business,
operating leases are generally renewed or replaced by other leases.
35
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 7 - Commitments and Contingent Liabilities (Continued):
Rental Operations
The Company leases a portion of the floor that it owns in an office
building located in Toronto, Canada, as well as two commercial
buildings. The following represents the approximate amount of sublease
income to be received in years ending after July 31, 1999:
Year Amount
---- --------
2000 $104,281
2001 19,570
2002 --
--------
Total $123,851
========
Pending Litigation
Sands Brothers & Co., Ltd. (Sands), a New York City-based investment
banking and brokerage firm, initiated arbitration against the Company
under New York Stock Exchange rules in September 1998. This claim is
based upon a claim that Sands has the right to purchase, for nominal
consideration, approximately 1.5 million shares of the Company's
common stock. This claim is based upon an October 1997 letter
agreement which purportedly confirmed the terms of an agreement
appointing Sands as the exclusive financial advisor to Generex
Pharmaceuticals, Inc. (GPI) and granting Sands the right to receive
shares representing 17 percent of the outstanding capital stock of GPI
on a fully diluted basis. Following the acquisition of GPI by GBC -
Delaware, Inc., Sands' claimed a right to receive shares of GPI common
stock that would, allegedly, now apply to the Company's common stock.
Sands also claims that it is entitled to additional shares of the
Company as a result of the GBC - Delaware, Inc.'s acquisition of GPI
(approximately 460,000 shares), and $144,000 in fees under the terms
of the purported Agreement.
Sands has never performed any services for the Company, and the
Company and GPI have denied that the individual who is alleged to have
entered into the purported agreement between Sands and GPI, had the
authority to act on GPI's behalf, and accordingly, is defending
against Sands' claim primarily on the basis that no agreement has ever
existed between GPI and Sands.
During a series of hearings before a NYSE arbitration panel commencing
June 8, 1999, Sands amended its claim to include, in the alternative,
an entitlement in the form of an order of specific performance with
regard to the issuance of the warrant as discussed in the October 1997
letter.
By an award dated September 24, 1999, the panel awarded Sands $12,000
plus $2,070 in interest, a declaratory judgment that the Company is
required to issue Sands a warrant for 1,530,020 shares in accordance
with the October 1997 letter, and denied all other relief and split
the $22,800 in forum fees equally between Sands and the Company. The
award must be confirmed by a court of appropriate jurisdiction. The
Company intends to seek relief from the award by requesting, among
other things, a New York State court to vacate the award on various
legal grounds. However, the ultimate legal and financial liability of
the Company, including a range of possible losses with respect to the
award, cannot be estimated at this time. Therefore, no provision has
been recorded in the accompanying financial statements. Furthermore,
it is management's belief that the final outcome is not reasonably
likely to have a material adverse effect on the Company's consolidated
financial position.
36
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 7 - Commitments and Contingent Liabilities (Continued):
Pending Litigation (Continued)
GPI is also contesting a claim for wrongful dismissal in the amount of
approximately $300,000 plus special damages, interest and costs. The
Company believes that the plaintiff was never employed by the Company
or any of its subsidiaries and that the case is without merit.
An action was also commenced against GPI and other companies and
individuals seeking approximately $3,965,000 for allegedly causing
certain adverse consequences of a plaintiff's investment in a
particular company. GPI's only involvement was that at one time there
was interest on its part in buying certain assets from this company.
GPI failed to file a Statement of Defense to the Statement of Claim
and GPI was noted in default on October 1, 1996. On December 9, 1999
an application was filed to set aside the notice of default and permit
the Company to enter a statement of defense. The Company expects
certain discovery proceedings required by the court to be completed in
October 1999, and to proceed with its application to set aside the
notice of default promptly thereafter. The Company cannot now predict
whether it will succeed in setting aside the notice of default.
Failure to do so would preclude the Company from contesting the issue
of liability. The Company, however, would be permitted to contest the
amount of damages, if any, the plaintiff as a result of the Company's
actions or the actions for which the Company is legally responsible.
In February 1999, MQS, Inc., a former consultant to the Company,
commenced a civil action against the Company in the United States
District Court for the District of New Jersey claiming that 242,168
shares of the Company's Common Stock, and $243,066 are due to it for
services which it rendered through December 22, 1998. MQS also claims
compensation on a quantum merit basis for the value of its services,
and for punitive damages. On May 11, 1999, the Company responded to
the complaint in this action, however, discovery has not begun. The
Company has also filed a counterclaim against MQS, Inc. for breach of
contract. The Company is unable to predict the outcome of this
litigation at this time. However, does not expect that the ultimate
resolution of this matter will have a material effect on its results
of operations and financial condition.
With respect to all litigation, as additional information concerning
the estimates used by the Company become known, the Company reassesses
its position both with respect to accrued liabilities and other
potential exposures. Estimates that are particularly sensitive to
future change relate to legal matters, which are subject to change as
events evolve and as additional information becomes available during
the administration and litigation process.
Pending Property Acquisition
Under an agreement entered into in July 1998, the Company has
committed to purchase commercial property in South America for
$418,000 upon the completion of construction. As of July 31, 1999 and
1998, the Company has a $66,159 deposit outstanding on the property.
37
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 8 - Related Party Transactions:
The amounts due from (to) related parties at July 31 are as follows:
Golden
The Angara Angara Ching Bull
Great Tao Equities Investments, Chew An Estates,
Inc. Inc. Inc. Breweries Inc. EBI, Inc.
--------- -------- ------------ --------- --------- ----------
Beginning Balance,
August 1, 1996 $ 54,557 $330,495 $ -- $ -- $ -- $ --
Cash advance -- -- -- -- -- 2,182,294
Company expenses
paid by related parties -- (9,206) -- -- -- --
Related party expenses
paid by the Company 73,067 500,867 -- -- -- --
Other (996) (6,513) -- -- -- (11,527)
--------- -------- -------- -------- --------- ----------
Ending Balance,
July 31, 1997 126,628 815,643 -- -- -- 2,170,767
Purchase of properties -- -- -- -- -- (1,204,640)
Cash collection -- (403,639) -- -- -- (441,548)
Company expenses
paid by related parties (352,384) (22,171) (277,962) (29,481) (209,637) --
Related party expenses
paid by the Company 122,338 293,976 136,644 29,381 468,851 --
Other 1,263 (63,928) 7,543 6 (13,837) (188,869)
--------- -------- -------- -------- --------- ----------
Ending Balance,
July 31, 1998 (102,155) 619,881 (133,775) (94) 245,377 335,710
Cash advance -- (83,016) -- -- -- --
Company expenses
paid by related parties -- (264,091) (60,810) -- (81,265) --
Related party expenses
paid by the Company -- 155 142,294 -- -- --
Other (483) 1,771 (360) -- 886 1,583
--------- -------- -------- -------- --------- ----------
Ending Balance,
July 31, 1999 $(102,638) $274,700 $(52,651) $ (94) $ 164,998 $ 337,293
========= ======== ======== ======== ========= ==========
38
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 8 - Related Party Transactions (Continued):
The above information is summarized and included in the consolidated
balance sheets as follows:
Due From Due to
Related Related
Parties Parties
--------- ---------
July 31, 1999
-------------
The Great Tao, Inc. $ -- $ 102,638
Angara Equities, Inc. 274,700 --
Angara Investments, Inc. -- 52,651
Ching Chew An Breweries -- 94
Golden Bull Estates, Inc. 164,998 --
EBI, Inc. 337,293 --
---------- ---------
Total $ 776,991 $ 155,383
========== =========
July 31, 1998
-------------
The Great Tao, Inc. $ -- $ 102,155
Angara Equities, Inc. 619,881 --
Angara Investments, Inc. -- 133,775
Ching Chew An Breweries -- 94
Golden Bull Estates, Inc. 245,377 --
EBI, Inc. 335,710 --
---------- ---------
Total $1,200,968 $ 236,024
========== =========
These amounts are non-interest bearing. There are no fixed terms of
repayment.
Each of the above related parties is owned in whole or in part by the
Company's Chairman of the Board. In addition, EBI, Inc. and Golden
Bull Estates, Inc. are shareholders of the Company.
Management feels that all related party expenses provided by such
parties were transacted at terms and amounts that would have been
obtained had the transactions been consummated with unrelated third
parties. The exception to this is rent expense in 1997 and the
non-recording of interest income and expense on the balances due
to/from related parties. The Company estimates the following
additional amounts would have been recorded if such transactions were
consummated under arms length agreements:
For the Years Ended July 31,
-----------------------------------------
1999 1998 1997
------- -------- -------
Rental Expense $ -- $ -- $36,826
Interest Income $79,118 $273,429 $75,488
Interest Expense $18,117 $113,064 $ 339
39
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 8 - Related Party Transactions (Continued):
The interest income/expense amounts were computed at estimated
prevailing rates based on the average receivable/payable balance
outstanding during the periods reflected. The average receivable
amount was $988,980 and $3,621,422 during the years ended 1999 and
1998, respectively. The average amount payable was $190,704 and
$1,043,413 during the years ended 1999 and 1998, respectively.
As of July 31, 1999, the Company's three senior officers, who are also
shareholders of the Company were compensated indirectly by the Company
through a management services contract between the Company and a
management firm of which they were equal owners. The amounts paid to
this management firm amounted to $388,420, $280,000 and $-0- for the
years ended July 31, 1999, 1998 and 1997, respectively.
Prior to December 17, 1997, the Company occupied its executive offices
at Harbour Square Business Center under an Occupancy Agreement between
Generex Pharmaceuticals, Inc. (GPI), Angara Equities, Inc. and 1097346
Ontario, Inc. (the Angara/1097346 lease) pursuant to which GPI paid
Angara a monthly occupancy fee of approximately $4,200 CAD, which
represents the rental and other charges allocable to it space under
Angara's lease for space, which included the Company's offices,
1097346 Ontario, Inc., the owner of the space. Angara Equities, Inc.
is owned by the Company's Chairman of the Board. On December 17, 1997,
GPI terminated the Angara/1097346 lease.
See Note 7 for discussion of consulting agreement with the Vice
President of Research and Development.
During fiscal year 1998, the Company purchased two buildings from the
father of the Company's Chairman of the Board. The total purchase
price was $984,343.
40
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 9 - Long-Term Debt:
Long-term debt consists of the following:
July 31,
------------------------
1999 1998
-------- ----------
Mortgage payable - interest at 10.5 percent per annum, monthly
payments of interest only, principal due on March 20, 2000, secured
by real property located at 33 Harbour Square, Toronto, Canada, Suite
3501, which is owned personally by the Company's Chairman of the
Board, and Suite 202 $530,997 $ 528,506
Mortgage payable - interest at 9.25 percent per annum, final payment
due February 1, 2001, secured by real property located at 98 Stafford
Drive, Brampton, Canada and 1740 Sismet Road, Mississauga, Canada 381,595 402,126
Note payable - inclusive of interest, balance originally was to be
paid in full June 1998 (A) -- 393,750
Mortgage payable - interest at 12 percent per annum, monthly payments
of interest only, principal originally due on September 9, 1999, due
date extended until September 9, 2000, secured by real property
located at 17 Carlaw Avenue, Toronto, Canada 82,968 --
-------- ----------
Total Debt 995,560 1,324,382
Less Current Maturities 550,589 411,565
-------- ----------
Long-Term Debt, Less Current Maturities $444,971 $ 912,817
======== ==========
(A) Pursuant to an agreement, the Company originally agreed that in
the event that the common stock, or their equivalent, were not
listed or quoted for trading on a public market in North America
within ninety (90) days of the agreement, the Company shall pay
the sum of $300,000 as damages within five (5) days of the end
of such 90 day period. This milestone was not achieved by the
Company. However, upon mutual agreement, the Company issued
shares of its common stock subsequent to year-end. The value of
this settlement is included in accounts payable and accrued
expenses at July 31, 1998 (see Note 6).
Aggregate maturities of long-term debt of the Company due within the
next five years ending July 31, are as follows:
Year Amount
---- --------
2000 $550,589
2001 444,971
2002 --
2003 --
2004 --
--------
Total $995,560
========
41
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 10 - Stockholders' Equity:
Reverse Merger
On January 9, 1998, the Company issued 9,234,118 of common stock to
acquire GBC - Delaware, Inc. (see Note 1). For accounting purposes,
the acquisition of GBC - Delaware, Inc. by the Company has been
treated as a reverse merger. Accordingly, the 9,234,118 shares issued
to acquire GBC - Delaware, Inc. have been treated as outstanding from
November 2, 1995 (as adjusted for historical issuances of GBC -
Delaware, Inc. and Generex Pharmaceuticals, Inc. during the period
from November 2, 1995 to January 8, 1998) and the previously
outstanding 1,105,000 shares have been treated as issued on the
acquisition date. Since the assets and liabilities acquired on this
date were immaterial, no amounts have been assigned to common stock as
a result of this transaction.
Warrants
As of July 31, 1999, the Company has the following warrants to
purchase common stock outstanding:
Number of Shares Warrant Exercise Warrant
To be Purchased Price Per Share Expiration Date
---------------- ----------------- -----------------
500,000 $ 2.50 March 31, 2003
56,364 $ 5.50 April 26, 2004
50,000 $ 6.00 February 16,2004
100,000 $ 6.00 April 6, 2004
50,000 $ 7.50 April 6, 2004
150,000 $10.00 November 17, 2003
7,937 $21.82 September 6, 2002
Notes Receivable - Common Stock
In conjunction with the redemption of Series A Redeemable Common Stock
Purchase Warrants, the Company accepted two separate promissory notes
for $50,000 and $423,702. These notes bear interest at 7.0 percent per
annum. The payment of principal and accrued interest are due on
December 1, 1999 and June 4, 2001, respectively. As of July 31, 1999,
the notes receivable amounted to $50,000 and $384,903.
Stock Redemption
Under the terms of a settlement, determined in an Ontario, Canada
Court, the Company agreed to purchase 15,357 shares from a
shareholder. The total purchase price of $140,873 included $119,066,
which was charged against additional paid in capital for the stock
redemption and $21,807, which was recorded as litigation settlement
expense which represents the excess paid over the fair value of the
Company's common stock at the time of settlement. The settlement was
concluded in September 1998.
Preferred Stock
The Company has authorized 1,000,000 shares with a par value of
one-tenth of a cent ($.001) per share of preferred stock. The
preferred stock may be issued in various series and shall have
preference as to dividends and to liquidation of the Company. The
Company's Board of Directors is authorized to establish the specific
rights, preferences, voting privileges and restrictions of such
preferred stock, or any series thereof. Other than the Special Voting
Rights Preferred Stock, described below, there are no shares of
preferred stock currently issued and outstanding.
42
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 10 - Stockholders' Equity (Continued):
Special Voting Rights Preferred Stock
The Company has issued 1,000 shares of Special Voting Rights Preferred
Stock (SVR) with a par value of $.001. The Company has the right at
any time after December 31, 2000, upon written notice to all holders
of preferred shares, to redeem SVR Shares at $.10 per share. Holders
of SVR Shares are not entitled to vote, except as specifically
required by Idaho law or in the event of change in control, as
defined. In addition, holders of SVR Shares are entitled to receive a
dividend per share equal to the dividend declared and paid on shares
of the Company's common stock as and when dividends are declared and
paid on the Company's common stock.
Founders' Shares Issued for Services
During the year ended July 31, 1997 and for the period November 2,
1995 (date of inception) to July 31, 1996, the Company recorded
additional compensation expense of $23,481 and $330,025, respectively.
These amounts were recorded to reflect the fair value of services
rendered to the Company by various individuals to whom shares of the
Company's common stock were transferred from the Company's founders.
For the above transactions, management utilized the value of the
Company's stock consistent with other stock transactions in which the
value of the Company's stock was clearly ascertainable. Management
feels that this methodology resulted in a reasonable valuation of
these services being provided to the Company.
Note 11 - Stock Based Compensation:
1998 Stock Option Plan
On January 22, 1998, the Company's Board of Directors approved the
1998 Stock Option Plan (the 1998 Plan), subject to shareholder
approval of the 1998 Plan, and reserved 1,000,000 shares of common
stock for issuance upon options granted under the 1998 Plan.
The 1998 Plan was not submitted for shareholder approval and
terminated on February 1, 1999. A new plan, the 1999 Stock Option
Plan, (the Plan) substantially identical to the 1998 Plan, has been
adopted. In addition, the number of shares of common stock reserved
for issuance upon options granted was increased from 1,000,000 to
1,500,000. All options granted under the 1998 Plan are not affected by
the termination.
The Plan presently is administered by the Board of Directors, but the
Board may establish a Stock Option Committee (the Committee), which
consists of at least three directors, to administer the Plan.
References to the Committee herein include the Board of Directors so
long as it continues to administer the Plan directly.
The Committee is authorized to select from among eligible employees,
directors, advisors and consultants those individuals to whom options
are to be granted and to determine the number of shares to be subject
to, and the terms and conditions of, the options. The Committee also
is authorized to prescribe, amend and rescind terms relating to
options granted under the Plan and the interpretation of options.
Generally, the interpretation and construction of any provision of the
Plan or any options granted thereunder is within the discretion of the
Committee.
43
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 11 - Stock Based Compensation (Continued):
The Plan provides that options may or may not be Incentive Stock
Options (ISOs) within the meaning of Section 422 of the Internal
Revenue Code. Only employees of the Company are eligible to receive
ISOs, while employees and non-employee directors, advisors and
consultants are eligible to receive options which are not ISOs, i.e.
"Non-Qualified Options." The options granted by the Board in
connection with its adoption of the Plan are Non-Qualified Options.
The following is a summary of the common stock options granted,
canceled or exercised under the Plan:
Exercise Price Per
Shares Share
------- -----------------
Outstanding - August 1, 1998 -- --
Granted 50,000 $8.00
Canceled -- --
Exercised -- --
------ -----
Outstanding - July 31, 1999 50,000 $8.00
====== =====
The following table summarizes information on stock options
outstanding at July 31, 1999:
Options Outstanding Options Exercisable
--------------------------------------------- ---------------------------
Weighted
Number Average Weighted Number Weighted
Outstanding Contractual Average Exercisable Average
Range of at Life Exercise at Exercise
Exercise Price July 31, 1999 (Years) Price July 31, 1999 Price
-------------- ------------ ----------- --------- ------------- ---------
$8.00 50,000 4.25 $8.00 50,000 $8.00
There is no proforma disclosure of the loss that would have resulted
from the use of SFAS 123 because the only options issued in the plan
to date have been to non-employees, and as required under SFAS 123,
these stock options have been recorded at fair value.
Note 12 - Net Loss Per Share:
Basic EPS and Diluted EPS for the years ended July 31, 1999, 1998 and
1997 have been computed by dividing the net loss for each respective
period by the weighted average shares outstanding during that period.
All outstanding warrants have been excluded from the computation of
Diluted EPS as they are antidilutive.
44
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 13 - Supplemental Disclosure of Cash Flow Information:
For the Years Ended July 31,
-----------------------------------
1999 1998 1997
------- ------- ------
Cash paid during the year for:
Interest $67,161 $63,291 $ --
Income taxes $ -- $ -- $ --
Disclosure of non-cash investing and financing activities:
Year Ended July 31, 1999
------------------------
Long-term debt was assumed in conjunction with acquisition
of property $ 82,968
Settlement of liability arising from the violation of financing
agreement with issuance of common stock $ 738,000
Deposit was utilized to acquire property and equipment $ 16,740
Notes receivable were accepted in conjunction with issuance
of common stock $ 473,881
Year Ended July 31, 1998
------------------------
Miscellaneous receivable acquired with long-term debt $ 58,516
Long-term debt was assumed in conjunction with acquisition
of property and equipment $ 402,126
Acquisition of property and equipment with collection of
related party receivables $1,204,640
Acquisition of a deposit on property and equipment with
collection of related party receivables $ 68,000
Note 14 - Segment Information:
Effective August 1, 1998, the Company became subject to Statement of
Financial Accounting Standards No. 131, "Disclosures about Segments of
an Enterprise and Related Information: (SFAS 131). SFAS 131 superseded
Statement of Financial Accounting Standards No. 14, "Financial
Reporting for Segments of a Business Enterprise." SFAS 131 establishes
standards for the way that public business enterprises report
information about operating segments in annual financial statements
and requires that those enterprises report selected information about
operating segments in interim financial reports. SFAS 131 also
establishes standards for related disclosures about products and
services, geographic areas, and major customers.
The Company has two reportable operating segments, United States and
Canada, which are organized, managed and analyzed geographically and
operate in one industry segment: the development of proprietary drug
delivery technology focused on formulations to administer large
molecule drugs by mouth. The Company evaluates operating segment
performance based primarily certain operating expenses.
45
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 14 - Segment Information (Continued):
The regions to which the Company had identifiable assets and operating
losses are presented in the following table. Identifiable assets are
those that can be directly associated with a geographic area.
Corporate assets include cash, restricted cash, other current assets,
and due from related parties. Operating loss by geographic segment
does not include an allocation of general corporate expenses.
Identifiable Operating
Assets Loss
------------ ----------
1999
----
United States $ -- $ --
Canada 2,128,611 2,846,662
General Corporate 6,761,055 3,380,969
---------- ----------
Total $8,889,666 $6,227,631
========== ==========
1998
----
United States $ -- $ --
Canada 1,926,046 3,565,378
General Corporate 3,529,662 1,034,935
---------- ----------
Total $5,455,708 $4,600,313
========== ==========
1997
----
United States $ -- $ --
Canada 316,943 1,379,024
General Corporate 3,355,832 --
---------- ---------
Total $3,672,775 $1,379,024
========== ==========
Note 15 - Subsequent Events (Unaudited):
Subsequent events occurring after July 31, 1999 consist of the
following:
On August 30, 1999, the Company settled the outstanding mortgages
securing 98 Stafford Drive, Brampton, Canada and 1740 Sismet Road,
Mississauga, Canada for a total payout figure of approximately
$408,165.
46
Item 9. Changes in and Disagreements with Accountants on Accounting and
Financial Disclosure.
Prior to our "reverse acquisition " of Generex Pharmaceuticals, Inc. in January
1998, our financial statements were audited by Jack F. Burke, Jr. Because, under
"reverse acquisition" accounting rules, our financial statements reflect the
historical financial statements of Generex Pharmaceuticals, Inc. ("GPI"), we
dismissed Mr. Burke and engaged new auditors, Withum, Smith & Brown, to perform
the audit on our financial statements as of and for the year ended July 31,
1998. We also engaged Withum, Smith & Brown and Mintz & Partners to perform a
joint audit on our financial statements as of July 31, 1997 and for the year
then ended and for the period November 2, 1995 (date of inception) to July 31,
1996. Mintz & Partners had been the auditors for GPI prior to our acquisition of
GPI. Mintz & Partners was not engaged to audit our financial statements as of
and for the year ended July 31, 1998, and its engagement as our auditor is
deemed to have terminated on September 23, 1998, which was the effective date of
Withum, Smith & Brown's engagement.
Mr. Burke's and Mintz & Partners' reports on our financial statements for the
fiscal years ending prior to July 31, 1998, did not contain an adverse opinion,
a disclaimer of opinion, or any qualification or modification as to uncertainty,
audit scope or accounting principles, nor are we aware of any disagreements with
Mr. Burke or Mintz & Partners about any accounting or audit issues in the two
fiscal years and interim periods prior to their dismissal or termination as
auditors.
The change in auditors was recommended and approved by our Board of Directors.
Prior to our engagement of Withum, Smith & Brown and Mintz & Partners (the
latter through July 31, 1997 only) as auditors, we had no consultations with
such auditors, and is unaware of any such consultation by anyone on its behalf,
concerning any specific accounting matter or transaction other than the need to
prepare the historical financial statements at GPI in accordance with US GAAP,
and that such financial statements would be required to be prepared in
accordance with and conform to Regulation S-X requirements.
47
PART III
Item 10. Directors and Executive Officers of the Registrant.
Executive Officers and Directors
The current executive officers and directors of are as follows:
Name Age Position
- ---- --- --------
E. Mark Perri 37 Chairman, Chief Financial Officer
and a Director
Anna E. Gluskin 48 President, Chief Executive Officer
and a Director
Pankaj Modi, Ph.D. 45 Vice President of Research & Development
and a Director
Rose C. Perri 32 Chief Operating Officer, Secretary,
Treasurer and a Director
Mark Perri and Rose Perri are siblings. There are no other family relationships
among our officers and directors.
E. Mark Perri - Mr. Perri has served as the our Chairman and Chief Financial
Officer since the acquisition of Generex Pharmaceuticals in January 1998. He has
held comparable positions with Generex Pharmaceuticals since its organization in
1995. Mr. Perri devotes approximately 90% of his time to his duties as Chairman.
The remainder of his time is devoted to private business interests that are
majority owned by Mr. Perri, his sister Rose, who also is our officer and
director, other members of the Perri family and, in some cases, Anna Gluskin,
who also is our officer and director. These interests include Golden Bull
Estates, Ltd. and Perri Rentals, which own, lease and/or operate commercial and
residential real estate in the Toronto area. They also include Angara
Investments, Inc., Angara Equities, Inc. and Ching Chew An Breweries, Inc. which
are engaged in the distribution of chemicals, generic prescription and
non-prescription drugs, beer, vodka and other products in Central America, South
America, China and republics of the former Soviet Union. Mr. Perri's interests
also include Perri International, Inc., which holds interest in biotechnological
companies in Europe. Mr. Perri also has minority interests in a number of
private companies which do not require a significant investment of his time.
Between February 1994 and the organization of Generex Pharmaceuticals in
November 1995, Mr. Perri devoted one hundred percent (100%) of his time to the
investments and business interests described in this paragraph, as well as to
pre-incorporation activities on behalf of Generex Pharmaceuticals.
Mr. Perri holds a Bachelor of Arts degree from the University of Waterloo and a
University of Toronto Masters (MLS) designation.
Anna E. Gluskin - Ms. Gluskin has served as our President and Chief Executive
Officer since the acquisition of Generex Pharmaceuticals. Prior to that time,
she held comparable positions with Generex Pharmaceuticals. Prior to her
association with Generex Pharmaceuticals, Ms. Gluskin was engaged in the real
estate business in the Toronto area as an independent real estate broker, and in
pre-incorporation activities on behalf of Generex Pharmaceuticals. Ms. Gluskin
has, since August 1997, served as Chairman and Chief Executive Officer of
Interlock Consolidated, Inc., an inactive, non-trading Canadian public company
that previously had engaged in the sale of prefabricated housing. Ms. Gluskin is
also a minority
48
shareholder of Golden Bull Estates, Ltd., Angara Investments, Inc., Angara
Equities, Inc. and Ching Chew An Breweries, Inc., private companies that are
majority-owned by Mark and Rose Perri.
Ms. Gluskin holds a Masters degree in Microbiology and Genetics from Moscow
State University.
Pankaj Modi, Ph.D. - Dr. Modi served as our Vice President, Research and
Development, since December 1997. Prior that time, Dr. Modi was Director of
Insulin Research for Generex Pharmaceuticals, a position he assumed in October
1996. Prior to joining Generex Pharmaceuticals, Dr. Modi was engaged in
independent research and was employed as a senior research assistant at McMaster
University from February 1994 through October 1996. Dr. Modi is our chief
scientific officer and substantially all of the Company's intellectual property
is based upon discoveries and other work product by Dr. Modi.
Dr. Modi was educated at the University of Bombay, India and received his
Bachelor of Science degree in Biology, Physics and Chemistry in 1975. His
post-graduate education is extensive and includes a Master of Science degree in
Chemical Engineering (Brooklyn Polytechnic University, 1976); a Master of
Science degree in Polymeric Materials/Biomedical Sciences (Brooklyn Polytechnic
University, 1976); a Master of Business Administration degree (University of
Dallas, U.S.A., 1978) and a Doctorate in Biomedical Sciences/Biopolymeric
Materials (University of Toronto, 1992).
Rose C. Perri - Ms. Perri has served as our Secretary and Treasurer since
January, 1998, and as our Chief Operating Officer since August, 1998. She was
secretary of Generex Pharmaceutical since its inception. Ms. Perri devotes less
than ten percent (10%) of her time to business interests controlled by the Perri
family, principally Perri Rentals, Inc. Between February, 1994 and the
organization of Generex Pharmaceuticals in November, 1995, Ms. Perri devoted one
hundred percent (100%) of her time to business interests controlled by the Perri
family as well as pre-incorporation activities on behalf of Generex
Pharmaceuticals.
Ms. Perri graduated from the University of Toronto in 1990 with a Bachelor of
Arts degree and completed the Business Administration Studies program at York
University in 1993.
Other Key Employees and Consultants
Slava Jarnitskii is our Financial Controller. He began his employment with
Generex Pharmaceuticals in September, 1996. Before his employment with Generex
Pharmaceuticals, Mr. Jarnitskii was a graduate student at York University. He
received an MBA degree from York University in September, 1996.
Item 11. Executive Compensation.
Compensation of Executive Officers
We compensate Mark Perri, Rose Perri, and Anna Gluskin indirectly through a
Management Services Agreement with The Great Tao, Inc. The Great Tao, Inc., is a
management firm of which Mr. Perri, Ms. Perri and Ms. Gluskin are equal owners.
The Agreement does not have a definite term. Their current combined yearly
compensation through this Agreement is $450,000 CAD (approximately $299,000 US).
The following table sets forth compensation to Anna Gluskin, Mark Perri and Rose
Perri in the last two fiscal years. Except as set forth in the table, none of
our officers received salaries and bonus exceeding $100,000 in those years. Mark
Perri, Rose Perri and Anna Gluskin also have received substantial benefits from
us through non-interest bearing loans. These are discussed in Item 13 of this
Report.
49
Summary Compensation Table
Annual Compensation Long-Term Compensation
------------------------------ -------------------------------------------------
Awards Payouts
------------------------ -------
Other Securities
Annual Restricted Underlying All Other
Year Compen- Stock Options/ LTIP Compen-
Name and Prin- Ended Salary Bonus sation Award(s) SARs Payouts sation
cipal Position July 31 ($) ($) ($) ($) (#) ($) ($)
-------------- ------- ------ ----- ------- ---------- ---------- ------- ---------
(a) (b) (c) (d) (e) (f) (g) (h) (i)
Anna E. Gluskin, 1999 136,483 -0- * -0- -0- -0- -0-
Chief Executive 1998 92,488 -0- * -0- -0- -0- -0-
Officer
E. Mark Perri, 1999 120,777 -0- * -0- -0- -0- -0-
Chief Financial 1998 92,488 -0- * -0- -0- -0- -0-
Officer
Rose C. Perri, 1999 120,777 -0- * -0- -0- -0- -0-
Chief Operating 1998 92,488 -0- * -0- -0- -0- -0-
Officer
- ------------
* Less than $50,000
Salaries are stated in the table in U.S. dollars and are based on the
Canadian/U.S. dollar exchange rate on July 31, 1999 and 1998, respectively. This
amount represents compensation which Ms. Gluskin received through The Great Tao,
Inc., as discussed above.
Directors' Compensation, Other Compensation
None of our directors received compensation in the past fiscal year for their
services as directors.
None of our officers or directors received any options or stock appreciation
rights during the year, or owned any options or stock appreciation rights at
year end.
We have no long term incentive plans or defined benefit or actuarial pension
plans.
Corporate Governance Standards
We have applied to have our Common Stock approved for quotation on The Nasdaq
Stock Market, Inc. National Market System under the symbol "GNBT". Companies
that are quoted on Nasdaq NMS must have at least two independent directors, and
an audit committee of which a majority of the members are independent directors.
We do not now have any independent directors, but expect to add a minimum of two
independent directors to our Board of Directors in connection with the listing
of our shares on Nasdaq.
50
Limitation of Directors' Liability
Our Certificate of Incorporation provides that no director of Generex will be
personally liable to us or any of our stockholders for monetary damages arising
from the director's breach of fiduciary duty as a director. This limitation does
not apply to:
o Liability from a director's breach of his duty of loyalty;
o Liability from a director's acts or failures to act which were not
done in good faith or involved intentional misconduct or knowing
violation of law;
o Liability for unlawful dividends or distributions;
o Liability in the event of a transaction in which the director derived
an improper personal benefit.
We believe that these provisions will assist us in attracting and retaining
qualified individuals to serve as directors.
51
Item 12. Security Ownership of Certain Beneficial Owners and Management.
The table on the following page sets forth information regarding the beneficial
ownership of our common stock by:
o Our executive officers and directors;
o All directors and executive officers as a group; and
o Each person known to us to beneficially own more than five percent
(5%) of our outstanding shares of common stock.
The information contained in this table is as of October 22, 1999. At that date,
we had 14,743,183 shares outstanding.
In addition to our common stock, we have outstanding 1,000 shares of our Special
Voting Rights Preferred Stock. All of these shares are owned by Dr. Pankaj Modi.
A person is deemed to be a beneficial owner of shares if he has the power to
vote or dispose of the shares. This power can be exclusive or shared, direct or
indirect. In addition, a person is considered by SEC rules to beneficially own
shares underlying options or warrants that are presently exercisable or that
will become exercisable within sixty (60) days. None of the persons listed in
the following table owns any options or warrants.
In computing the percentage ownership of shares after this offering, we have
assumed that all Placement Warrants will be exercised. None of the persons named
below owns any Placement Warrants. Accordingly, the number of shares owned by
such persons is the same before and after the offering, and only their
percentage ownership will change.
52
Name and Address of
Beneficial Owner Beneficial Ownership
------------------- -----------------------------------------------
Number of
Shares Percent of Class
--------- ----------------
(i) Directors and Executive Officers
E. Mark Perri
33 Harbour Square, Ste. 3502
Toronto, Ontario 4,247,842(1) 28.8%
M5J 2G2
Anna E. Gluskin
33 Harbour Square, Ste. 2409 1,188,127(2) 8.1%
Toronto, Ontario
M5J 2G2
Rose C. Perri
33 Harbour Square, Ste. 2409
Toronto, Ontario 1,188,026(2) 8.1%
M5J 2G2
Pankaj Modi, Ph.D.
519 Golf Links Road
Ancaster, Ontario 1,100,200(3) 7.5%
L9G 4X6
Officers and directors as a group 7,724,105 52.4%
(4 persons)
(ii) Other Beneficial Owners
EBI, Inc. In Trust
c/o Miller & Simons
First Floor, Butterfield Square
P.O. Box 260 1,441,496(4) 9.8%
Providencials
Turks and Calcos Islands
British West Indies
GHI, Inc. In Trust
c/o Miller & Simons
First Floor, Butterfield Square
P.O. Box 260 2,500,050(5) 16.9%
Providencials
Turks and Calcos Islands
British West Indies
(1) Includes 45,974 shares owned of record by Mr. Perri, and a total of
1,529,382 shares beneficially owned by Mr. Perri but owned of record by
EBI, Inc. (1,100,000 shares), GHI, Inc. (124,050 shares) and First Marathon
Securities Corp (305,332 shares). Also includes 2,376,000 shares owned of
record by GHI, Inc. and 341,496 shares owned of record by EBI, Inc., which
Mr. Perri
53
may be deemed to beneficially own because of his power to vote the shares,
but which are beneficially owned by other shareholders because they are
entitled to the economic benefits of the shares.
(2) Includes 1,188,000 shares owned of record by GHI, Inc.
(3) Dr. Modi also owns all the outstanding shares of our Special Voting Rights
Preferred Stock. This stock is not convertible into common stock.
(4) These shares also are deemed to be beneficially owned by Mark Perri because
he has the sole power to vote the shares. Mr. Perri also has investment
power and otherwise is entitled to the economic benefits of ownership of
1,100,000 of the shares owned of record by EBI, Inc.
(5) These shares also are deemed to be beneficially owned by Mark Perri because
he has the sole power to vote the shares. Mr. Perri also has investment
power and is otherwise entitled to the economic benefits of ownership of
124,050 of the shares owned of record by GHI, Inc. Anna Gluskin and Rose
Perri each own beneficially 1, 188,000 of the shares owned of record by
GHI, Inc. by reason of their ownership of investment power and other
economic benefits of the ownership of such shares.
Item 13. Certain Relationships and Related Transactions.
We were incorporated in 1983 as Green MT. P.S., Inc., but we were inactive for a
number of years prior to January 1998, when we acquired Generex Pharmaceuticals,
Inc. When we acquired Generex Pharmaceuticals, Inc., we changed our corporate
name to "Generex Biotechnology Corporation". In that transaction, the former
shareholders of Generex Pharmaceutical acquired approximately 89% of our common
stock, and our pre-transaction shareholders retained approximately 11% of our
common stock. Prior to our acquisition of Generex Pharmaceuticals in January
1998, Generex Pharmaceuticals was a private company.
Unless otherwise indicated, the transactions described below occurred prior to
our acquisition of Generex Pharmaceuticals or pursuant to contractual
arrangements entered into prior to that time. We presently have a policy
requiring approval by stockholders or by a majority of disinterested directors
to approve transactions in which one of our directors has a material interest
apart from such director's interest in Generex.
Real Estate Financing Transactions: In May 1997, EBI, Inc., a company controlled
by Mark Perri, acquired shares of common stock of Generex Pharmaceuticals for $3
million (CAD) which, based on the exchange rate then in effect, represented
approximately $2.1 million (US). Generex Pharmaceutical's use of those funds was
restricted to acquiring an insulin research facility. Subsequently this
restriction was eased to permit use of the funds to acquire properties used for
manufacturing our oral insulin product and other proprietary drug delivery
products, and related testing, laboratory and administrative services. Under the
terms of the investment, Generex Pharmaceuticals was required to lend these
funds back to EBI, Inc. until they were needed for the purposes specified. The
entire amount was loaned back to EBI and was outstanding at July 31, 1997.
During the fiscal year ended July 31, 1998, a total of $2,491,835 CAD was repaid
by EBI. No further repayments were made in the year ended July 31, 1999.
Accordingly, the a balance due from EBI at July 31, 1999, was $508,165 CAD
(approximately $337,293 US based on the exchange rate then in effect). These
funds are due on demand by Generex Pharmaceuticals, provided they are used for
the purchase and/or construction or equipping of oral insulin manufacturing and
testing facilities. The amounts repaid by EBI were used primarily to purchase
and improve the Generex-owned real estate and buildings described in this
prospectus.
54
Loans To and From Stockholders: Between November 1995 and July 31, 1998,
companies owned and controlled by Mark Perri, Rose Perri and Anna Gluskin
incurred a net indebtedness of $629,224 to Generex Pharmaceuticals, excluding
the indebtedness of EBI described in the preceding paragraph. This indebtedness
arose from cash advances and the payment by Generex Pharmaceuticals of expenses
incurred by these companies, net of repayments and payment of expenses on behalf
of Generex Pharmaceuticals. In the current fiscal year, transactions between
Generex Pharmaceuticals and these companies resulted in a $166,099 decrease in
these companies' net indebtedness to Generex Pharmaceuticals, exclusive of the
EBI indebtedness described above, to $466,225.
The transactions between Generex Pharmaceuticals and entities owned and
controlled by Mark Perri, Rose Perri and Anna Gluskin were not negotiated at
arms-length, and were not on normal commercial terms. No interest was charged on
any of the advances, and the transactions were of far greater financial benefit
and convenience to the Mark Perri, Rose Perri and Anna Gluskin than to Generex
Pharmaceuticals. These transactions and financing arrangements were mostly
initiated prior to the transaction in which we acquired Generex Pharmaceuticals,
and no transactions have taken place since January 1, 1999. We have adopted a
policy requiring the approval of shareholders of the Board of Directors,
including a majority of disinterested directors and independent directors, if
any, for any future transactions.
PART IV
Item 14. Exhibits, Financial Statement Schedules and Reports on Form 8-K
Exhibit No. Description
- ----------- -----------
3.1 Restated Certificate of Incorporation of Generex Biotechnology Corporation*
3.2 Bylaws of the Company***
4.1 Form of Common Stock Certificate***
4.2 Form of Special Voting Rights Preferred Stock Certificate***
4.3 1998 Incentive Stock Option Plan***
4.3.1 1999 Incentive Stock Option Plan of predecessor Idaho corporation**
4.4.1 Forms of Coleman Securities Series A, B, C and D Warrants***
4.4.2 Form of GCR Warrant (issued by predecessor Idaho corporation)**
4.4.3 Form of Berckeley Warrant (issued by predecessor Idaho corporation)**
4.4.4 Form of Meyerson Warrant (issued by predecessor Idaho corporation)**
4.5.1 Form of Subscription/Voting/Put Agreement with Dr. William Steinbrink**
4.5.2 Form of Subscription/Voting Agreement executed by purchasers of 337,670
shares of Common Stock**
55
4.6 Registration Rights Agreement between the Company and certain purchasers of Common Stock.***
5 Opinion of Eckert Seamans Cherin & Mellot, LLC regarding the legality of
securities being registered***
10.1.1 Consulting Agreement with Pankaj Modi**
10.1.2 Assignment and Assumption Agreement with Pankaj Modi**
16.1.1 Letter from former accountant Jack F. Burke, Jr.**
16.1.2 Letter from former accountant Mintz & Partners**
21 Subsidiaries of the Registrant***
27. Financial Data Schedules
* Exhibit 3.1 to our Quarterly Report on Form 10-Q for the quarter ended
April 30, 1999, is incorporated by reference.
** Incorporated by reference to the identical numbered exhibits contained in
our Registration Statement on Form 10 filed with the Commission on
December 14, 1998, as amended February 24, 1999.
*** Incorporated by reference to the identical numbered exhibits contained
in our Registration Statement on Form S-1 filed with the Commission on
July 12, 1999 (File no. 333-82667).
56
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) 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 this 27th day of October
1999.
GENEREX BIOTECHNOLOGY CORPORATION
By: /s/ Anna E. Gluskin
--------------------------
Anna E. Gluskin, President
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 and on the dates indicated.
Capacity in Which
Name Signed Date
---- ----------------- ----
/s/ Anna E. Gluskin President and Chief October 27, 1999
- ----------------------- Executive Officer
/s/ E. Mark Perri Chairman and Chief October 27, 1999
- ----------------------- Financial Officer
/s/ Rose C. Perri Director October 27, 1999
- -----------------------
/s/ Pankaj Modi Director October 27, 1999
- -----------------------
57