AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON JULY __, 1999
REGISTRATION NO. ____________
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
-------------------------
FORM S-1
Registration Statement Under The Securities Act of 1933
-------------------------
GENEREX BIOTECHNOLOGY CORPORATION
(Name of Issuer in Its Charter)
Delaware 2834 82-0490211
(State or jurisdiction of (Primary Standard Industrial (I.R.S. Employer
incorporation or organization) Classification Code Number) Identification No.)
33 Harbour Square, Suite 202
Toronto, Ontario
CANADA M5J 2G2
Telephone: 416/364-2551
Facsimile: 416/364-9363
Anna E. Gluskin, CEO and President
33 Harbour Square, Suite 202
Toronto, Ontario
CANADA M5J 2G2
Telephone: 416/364-2551
Facsimile: 416/364-9363
(Name, address and telephone number of agent for service)
-------------------------
Copies to:
Joseph Chicco, Esquire
Eckert Seamans Cherin & Mellott, LLC
1515 Market Street - 9th Floor
Philadelphia, PA 19102
Telephone: 215/851-8410
Facsimile: 215/851-8383
-------------------------
Approximate date of commencement of proposed sale to the public: As soon as
practicable after the effective date of this Registration Statement.
If any of the securities being registered on this Form are to be offered on a
delayed or continuous basis pursuant to Rule 415 under the Securities Act of
1933, other than securities offered only in connection with dividend or interest
reinvestment plans, check the box. [x]
If this Form is filed to register additional securities for an offering pursuant
to Rule 462(b) under the Securities Act, please check the following box and list
the Securities Act registration statement number of the earlier effective
registration statement for the same offering [ ]
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under
the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. [ ]
If delivery of the prospectus is expected to be made pursuant to Rule 434,
please check the following box. [ ]
---------------------------
CALCULATION OF REGISTRATION FEE
========================================================================================================================
Title of Each
Class of Amount to be Proposed Maximum Proposed Maximum Amount of
Securities to Registered Offering Price Aggregate Offer Registration
be Registered Per Share ing Price Fee
- ------------------------------------------------------------------------------------------------------------------------
Common Stock, 150,000 shares $ 6.00 900,000 $ 250.
$.001 par value (1) 50,000 shares 7.50 375,000 104.
63,638 shares 5.50 350,009 97.
- ------------------------------------------------------------------------------------------------------------------------
Common Stock, 636,365 shares $7.875(3) $5,011,374(3) $1,393(3)
$.001 par value (2)
- ------------------------------------------------------------------------------------------------------------------------
900,003 shares $5.50 to $6,636,374 $1,845
Total $7.875
========================================================================================================================
- ---------------------
(1) These shares are issuable upon the exercise of outstanding Common Stock
Purchase Warrants issued in connection with a private placement and
pursuant to an investment banking agreement ("Warrants"), as follows:
50,000 warrants expiring February 16, 2004, exercisable at $6.00
100,000 warrants expiring April 6, 2004, exercisable at $6.00
50,000 warrants expiring April 6, 2004, exercisable at $7.50
63,638 warrants expiring April 26, 2004, exercisable at $5.50
(2) These shares are being offered by certain shareholders of the Company.
(3) Estimated solely for the purpose of calculating the registration fee in
accordance with Rule 457. Pursuant to Rule 457(c), the proposed maximum
offering price per share and registration fee are based on the average
of the bid ($7-11/16) and the asked ($8-1/16) prices of the
registrant's common stock on July 9, 1999 as reported on the NASDAQ
OTC Bulletin Board.
THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR DATES
AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTILE THE REGISTRANT SHALL FILE
A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION STATEMENT
SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(a) OF THE
SECURITIES ACT OF 1933 OR UNTIL THIS REGISTRATION STATEMENT SHALL BECOME
EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SAID SECTION 8(a),
MAY DETERMINE.
CROSS REFERENCE SHEET
Pursuant to Item 501(b)(4) of Regulation S-K
Item Number and Heading Caption in Prospectus
----------------------- ---------------------
1. Forepart of Registration Statement and Outside Front
Cover of Prospectus.................................................... Outside Front Cover of Prospectus
2. Inside Front and Outside Back Cover Pages of
Prospectus............................................................. Inside Front and Outside Back
Cover Pages of Prospectus
3. Summary Information and Risk Factors................................... Prospectus Summary; Risk Factors
4. Use of Proceeds........................................................ Use of Proceeds
5. Determination of Offering Price........................................ Selling Shareholders; Plan of
Distribution
6. Dilution............................................................... Dilution
7. Selling Security Holders............................................... Selling Shareholders
8. Plan of Distribution................................................... Plan of Distribution
9. Disclosure of Commission Position on Indemnification................... Description of Securities
10. Interests of Named Experts and Counsel................................. Not Applicable
11. Information with Respect to the Registrant............................. Outside Front Cover of Prospectus;
Prospectus Summary; Risk Factors;
Capitalization; Selected Financial
Data; Management's Discussion and
Analysis of Financial Condition and
Results of Operations; Business;
Management; Principal Shareholders;
Certain Transactions; Available
Information; Financial Statements
12. Disclosure of Commission Position on Indemnification
For Securities Act of 1933, As amended, Liabilities.................... Disclosure of Commission Position
on Indemnification for Securities
Act Liabilities
The information in this prospectus is not complete and may be changed. These
securities may not be sold until the registration statement filed with the
Securities and Exchange Commission is effective. This prospectus is not an offer
to sell these securities and it is not soliciting an offer to buy these
securities in any state where the offer or sale is not permitted.
PROSPECTUS - SUBJECT TO COMPLETION, DATED JULY __, 1998
GENEREX BIOTECHNOLOGY CORPORATION
Common Stock
900,003 Shares
Generex is a development stage company and has not received any revenues
from operations to date. This prospectus relates to an offering of 900,003
shares of Generex common stock, as follows:
o We are offering 263,638 shares for sale at prices ranging from $5.50 to
$7.50 per share to holders of certain of our outstanding warrants upon exercise
of the warrants.
o Certain of our existing shareholders are offering a total of 636,365
outstanding shares for sale for their own accounts. Generex will not receive any
proceeds from shares sold by the selling shareholders.
Neither we nor the selling shareholders have engaged any underwriter or
selling agent to assist us in the sale of the shares covered by this prospectus.
Inter-dealer "bid" and "asked" price for Generex common stock are quoted on
the NASDAQ OTC Electronic Bulletin Board under the symbol GNBT. The OTC
Electronic Bulletin Board also reports prices at which shares are sold, and
daily sales volume. The closing inter-dealer "bid" and "asked" prices reported
for our common stock on July __, 1999, were $______ and $______.
Investing in our common stock involves a high degree of risk. See "Risk
Factors" beginning on page 2 of this prospectus.
Neither the Securities and Exchange Commission nor any state securities
commission has approved or disapproved of these securities, or determined
whether this prospectus is truthful or complete. Any representation to the
contrary is a criminal offense.
The date of this Prospectus is ________________, 1999.
TABLE OF CONTENTS
SUMMARY.................................................................... 1
FORWARD LOOKING STATEMENTS................................................. 2
RISK FACTORS............................................................... 2
CAPITALIZATION............................................................. 7
DILUTION................................................................... 8
USE OF PROCEEDS............................................................ 8
SELECTED FINANCIAL DATA.................................................... 9
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS................................................ 10
OUR BUSINESS............................................................... 14
MANAGEMENT................................................................. 23
PRINCIPAL SHAREHOLDERS..................................................... 28
SELLING SHAREHOLDERS....................................................... 32
PLAN OF DISTRIBUTION....................................................... 35
MARKET INFORMATION......................................................... 35
CERTAIN TRANSACTIONS....................................................... 37
DESCRIPTION OF SECURITIES.................................................. 39
DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION....................... 43
LEGAL MATTERS.............................................................. 43
EXPERTS.................................................................... 43
ADDITIONAL INFORMATION..................................................... 44
FINANCIAL STATEMENTS.............................................. F-1 to F-29
We are offering to sell, and seeking offers to buy, shares of common stock
only in jurisdictions where offers and sales are permitted.
In making a decision whether or not to buy any shares offered by this
prospectus, you should rely only on the information contained in the prospectus.
We have not authorized anyone to provide you with information different from
that which is contained in the prospectus. The information contained in the
prospectus is accurate only as of the date of the prospectus, regardless of the
time the prospectus is delivered or any shares are sold.
In this prospectus, unless the context indicates otherwise, the terms
"Generex", "we", "us" and "our" refer to Generex Biotechnology Corporation.
For investors outside the United States: Neither we nor, to our knowledge,
any other person has done anything that would permit this offering or possession
or distribution of this prospectus in any jurisdiction where action for that
purpose is required, other than in the United States. You are required to inform
yourselves about and to observe any restrictions relating to this offering and
the distribution of this prospectus.
UNTIL 1999 (__ DAYS AFTER COMMENCEMENT OF THIS OFFERING), ALL DEALERS THAT
BUY, SELL OR TRADE OUR COMMON STOCK, WHETHER OR NOT PARTICIPATING IN THIS
OFFERING, MAY BE REQUIRED TO DELIVER A PROSPECTUS. THIS IS IN ADDITION TO THE
DEALERS' OBLIGATION TO DELIVER A PROSPECTUS WHEN ACTING AS UNDERWRITERS AND WITH
RESPECT TO THEIR UNSOLD ALLOTMENTS OR SUBSCRIPTIONS.
ii
PROSPECTUS SUMMARY
The following is only a summary of detailed information appearing elsewhere
in this prospectus.
Generex and its Products
Generex is a Delaware corporation engaged in the research and development
of drug delivery systems and technology. Our executive offices are located at 33
Harbour Square, Suite 202, Toronto, Canada M5J 2G2, and our telephone number is
416/364-2551.
We have devoted a substantial majority of our efforts and resources to date
to developing a technology to orally administer "large molecule" drugs,
including proteins, hormones, peptides, vaccines and other pharmaceutical
products. Large molecule drugs, such as synthetic insulin, are now administered
almost exclusively by injection because their molecular size makes it difficult
or impossible for the body to absorb them if they are administered by other
means.
Oral Insulin Formulation: The initial application of our large molecule
drug delivery technology is an oral insulin formulation for use in the treatment
of diabetes. The formulation is sprayed into the mouth using a hand-held aerosol
applicator. Absorption occurs through the mucous membranes in the mouth and
upper gastro-intestinal tract.
We presently are conducting clinical trials of our oral insulin formulation
in the United States and Canada. We have not received regulatory approval to
market the product in any country, and do not expect to receive such clearance
in the United States or Canada until the fourth quarter of 2000 at the earliest.
There are numerous risks and uncertainties that we must overcome before we will
be able to market this or any other product.
We expect to market our oral insulin product through distribution and other
agreements with pharmaceutical and/or biotechnology companies. We have not yet
entered into any such agreements.
Other Large Molecule Pharmaceuticals: We believe that the technology upon
which our oral insulin formulation is based can be used successfully with other
large molecule pharmaceuticals. We have engaged in pre-clinical research and
development work on two other applications.
The Offering
Shares offered by Generex...................................... 263,638 shares
Outstanding shares offered by selling shareholders............. 636,365 shares
Total........................................ 900,003 shares
The shares offered by Generex are being offered only to the holders of
certain of our outstanding warrants. We will refer to these warrants as the
"Placement Warrants" to distinguish them from other warrants that we have
issued. We will refer to the shares which would be issued upon exercise of the
Placement Warrants as the "Placement Warrant Shares."
We will refer to the Generex shareholders who are selling shares covered by
this prospectus for their own accounts as the "Selling Shareholders".
Common stock outstanding before the offering.................. 14,746,074 shares
Common stock to be outstanding after the offering............. 15,006,712 shares
The number of shares of common stock to be outstanding after the offering
is based on shares outstanding on June 30, 1999, plus the Placement Warrant
Shares. The holders of the Placement Warrants are not committed to exercise the
Placement Warrants, however, and we may not sell all or any Placement Warrant
Shares.
FORWARD-LOOKING STATEMENTS
We have made statements under the captions "Risk Factors", Use of
Proceeds", "Management's Discussion and Analysis of Financial Condition and
Results of Operations,", "Business" and elsewhere in this prospectus 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.
We believe it is important to communicate our expectations to our
investors. However, 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. These include the factors listed under "Risk
Factors" and elsewhere in this prospectus.
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 prospectus, and we assume we are under no duty to update
them or to explain why actual results may differ.
RISK FACTORS
You should carefully consider the following risks and other information in
this prospectus before deciding to purchase our common stock. The market price
of our common stock could decline due to any of these risks, and you could lose
all or part of your investment. This statement of risks is not intended to be
exhaustive, i.e., these are not the only risks relating to our common stock,
this offering or our business.
We Have Not Yet Sold Any Products Or Received Regulatory Approval To Sell
Our Products.
We are a development stage company. We have engaged primarily in research
and development activities since our inception, and have not received any
revenues from operations. We have no products approved for commercial sale by
drug regulatory authorities and only one product, our oral insulin formulation,
for which we have begun the regulatory approval process.
2
We May Not Achieve Commercial Success Even If Our Products Are Approved
for Sale.
Even if we obtain the required regulatory approvals to market our oral
insulin product, there are many factors which may prevent us from ever
successfully selling the product in commercial quantities. Some factors are
beyond our control, such as:
o acceptance of the formulation by health care professionals and diabetic
patients; and
o the availability, effectiveness and relative cost of alternative
diabetes treatments which may be developed by competitors.
We Have No Arrangements To Obtain Insulin In Commercial Quantities.
We will need to obtain synthetic insulin to produce our oral insulin
formulation. There are a limited number of suppliers of synthetic insulin, with
two companies controlling a substantial majority of the world's supply. At the
present time, we have no agreement or other understanding with any company to
supply insulin to us.
We Cannot Succeed Unless We Obtain Additional Capital.
We have incurred substantial losses from operations from our inception, and
expect to continue to incur substantial losses for at least another 12 to 18
months. During this 12 to 18 month period, we do not expect to obtain
significant revenues from operations but will need substantial funds, primarily
for the following purposes:
o to conduct clinical trials of our oral insulin product and otherwise
pursue regulatory approvals for this product;
o to begin to develop new products based on our oral delivery technology,
and to conduct the clinical tests necessary to develop and refine new
products; and
o to establish and expand our manufacturing capabilities.
To finance our operations to date, we have relied almost entirely on
private offerings of common stock at prices below the current market price of
our common stock. The terms on which we obtain additional financing may dilute
the investment of existing shareholders, or otherwise adversely affect their
position. It is also possible that we will be unable to obtain the additional
funding we need as and when we need it. If we were unable to obtain additional
funding as and when needed it, we could be forced to delay the progress of our
development efforts. These delays would delay our ability to bring a product to
market and obtain revenues, and could result in competitors developing products
ahead of us, and/or in our being forced to relinquish rights to technologies,
products or potential products. Because of the uncertainties in our ability to
satisfy our future financing needs, our auditors' report on our financial
statements for the year ended July 31, 1998 contains an explanatory paragraph
regarding our ability to continue as a going concern.
We Will Depend Upon Others For Marketing And Distributing Our Products.
Since we currently lack marketing and sales experience and personnel,
distribution channels and other infrastructure needed to successfully
commercialize a product, we intend to rely on collaborative arrangements with
one or more other companies which possess strong marketing and distribution
3
resources. We do not, however, have any agreements with other companies for
marketing or distributing our products. We may be forced to enter into contracts
for the marketing and distribution of our products which substantially limit the
potential benefits to us from commercializing our products. In addition, we will
not have the same control over marketing and distribution that we would have if
we conducted those functions ourselves.
We Have No Experience In Manufacturing and Insufficient Capacity to Produce
Product In Large Quantities.
To date, we have produced our oral insulin formulation only under
laboratory conditions on a small scale. We have established a pilot
manufacturing facility that we believe is capable of producing the product at
levels necessary to supply our needs for late stage human clinical trials of the
product, and for initial commercial sales outside the United States. However, we
have not yet actually produced product at those levels. In any event, we will
need to significantly increase our manufacturing capability to manufacture our
product in commercial quantities. We have no experience in resolving the
staffing, manufacturing, regulatory and quality control problems that are likely
to come up in developing and running a large scale manufacturing operation. Our
failure to solve problems of this nature could delay or prevent our ability to
bring the product to market, and inhibit sales after the product comes to
market.
We Are Dependent On Our Executive Management And Other Personnel.
We believe that the continuing availability and dedication of our limited
scientific and management staff is very important. Our business could be
materially harmed if one or more members of our executive management team were
unable or unwilling to continue their association with us. We do not have fixed
term agreements with any of our principal officers, other than Dr. Pankaj Modi.
The fact that we have a fixed term contract with Dr. Modi, however, does not
guarantee his continued availability.
We depend upon non-employee consultants to assist us in formulating
research and development strategy, in preparing regulatory submissions, in
developing protocols for clinical trials, and in designing, equipping and
staffing our manufacturing facilities. These consultants and advisors usually
have the right to terminate their relationship with us on short notice. Loss of
some of these key advisors could interrupt or delay our business plan.
We will continue to need qualified scientific personnel and personnel with
experience in clinical testing, government regulation and manufacturing. We may
have difficulty in obtaining qualified scientific and technical personnel as
there is strong competition for these people from other pharmaceutical and
biotechnology companies as well as universities and research institutions.
Our Reliance On Patents And Other Proprietary Technologies Exposes Us
To Significant Risks.
Our long-term success will substantially depend upon protecting our
technology from infringement, misappropriation, duplication and discovery. We
own two U.S. patent applications that cover our basic drug delivery technology.
One of these has been allowed although not formally issued by the U.S. patent
office. We also own an indirect interest in three patents held by another
company which is fifty (50%) percent owned by us, and we have five other patent
applications pending, two of which are pending only in Canada. We cannot be sure
that any of our pending patent applications will be granted.
Our patent position may not fully protect our competitive position. Our
patent rights, and the patent rights of biotechnology and pharmaceutical
companies in general, are highly uncertain and include complex legal and factual
issues. We believe that our existing technology and the patents which we hold or
have applied for do not infringe any one else's patent rights, and that they
4
will provide meaningful protection against others duplicating our proprietary
technologies. We cannot be sure of this because of the complexity of the legal
and scientific issues that could rise in litigation over these issues. Since
patent applications in the United States are maintained in secrecy until the
patents are approved, we cannot be sure that any technology we are currently
developing is not covered by any pending patent applications.
We also rely on trade secrets and other unpatented proprietary information.
We seek to protect this information, in part, by confidentiality agreements with
our employees, consultants, advisors and collaborators. These agreements may be
breached, however, in which case we may not have adequate remedies for any
breach. Our trade secrets may become known or independently developed by
competitors. Trade secrets do not protect against a competitor's independent
development of the same technology.
Our Ability To Respond To Business Opportunities And Introduce New Products
Is Subject To Extensive Government Regulation Of Our Business.
Our research and development activities, and the eventual manufacture and
marketing of our products, are subject to extensive regulation by the Food and
Drug Administration in the United States, and comparable regulatory authorities
in other countries. Among other things, extensive regulation puts a burden on
our ability to bring products to market. These regulations apply to all
competitors in our industry. However, many of our competitors have extensive
experience in dealing with FDA and other regulators, while we do not. Also,
other companies in our industry do not depend completely on products which still
need to be approved by government regulators, as we do. If we do not obtain
regulatory approvals for our products, or fail to comply with these government
regulations in the future, our business will be substantially harmed.
We May Not Be Able to Compete with Other Diabetes Treatments Marketed By Other
Companies.
Our oral insulin product will compete with existing and new therapies for
treating diabetes, including administration of insulin by injection. We are
aware of a number of companies currently seeking to develop alternative means of
delivering of insulin, as well as new drugs intended to replace insulin therapy,
at least in part. Most of our potential competitors are established firms that
have substantially greater financial resources than we do. In addition, several
competitors that are not themselves major companies have arrangements with major
pharmaceutical companies for financial, technical and marketing assistance. Our
product may not be technically competitive with other products. Even if our
product is technically superior, we may be unable to successfully compete due to
our limited resources.
Pending Litigation Could Result In Dilution To Stockholders.
Sands Brothers and Co. Ltd., a New York City based investment banking and
brokerage firm, initiated an arbitration against us claiming that it has the
right to purchase, for nominal consideration, approximately 1.6 million shares
of our common stock. If Sands should win the arbitration and receive shares of
our common stock for little or no consideration our existing shareholders'
investment would be proportionately diluted.
We Have Substantial Exposure To Product Liability.
The use of our products in clinical trials and the commercial sale of our
products exposes us to liability claims by consumers and pharmaceutical
companies. We have obtained limited product liability insurance of two million
dollar per occurrence and total coverage. We cannot be sure that this would be
sufficient coverage in the case of any substantial liability claim.
5
The Price Of Our Shares May Be Volatile.
There may be wide fluctuation in the price of our shares. Because of this
potential volatility, our shares may be an unsuitable investment for investors
who might be required to sell the shares at a time when the market price of the
shares is depressed. These fluctuations may be caused by several factors
including:
o announcements of research activities and technology innovations or new
products by us or our competitors;
o changes in market valuation of companies in our industry generally;
o variations in operating results;
o changes in governmental regulations;
o results of clinical trials of our products or our competitors' products;
and
o regulatory action or inaction on our products or our competitors'
products.
Our Outstanding Special Voting Rights Preferred Stock And Provisions of Our
Certificate of Incorporation Could Delay Or Prevent The Acquisition Or Sale Of
Generex.
Holders of our Special Voting Rights Preferred Stock have the ability to
prevent any change of control of Generex. Our Vice President of Research and
Development, Dr. Pankaj Modi, owns all of our Special Voting Rights Preferred
Stock. In addition, our Certificate of Incorporation permits our Board of
Directors to designate new series of preferred stock and issue those shares
without any vote or action by the shareholders. Such newly authorized and issued
shares of preferred stock could contain terms which grant special voting rights
to the holders of such shares which make it more difficult to obtain shareholder
approval for an acquisition of Generex or increase the cost of any such
acquisition.
Future Sales Of Shares By Current Shareholders May Adversely Affect The Price Of
Our Stock.
The market price of our common stock could decline as a result of sales of
a large number of shares in the market by Selling Shareholders or other existing
shareholders, as well as Placement Warrant holders after this offering. The
shares being sold by Selling Shareholders could not be sold prior to this
offering because they had not been registered with the SEC, and did not qualify
for an exemption from registration requirements. No Placement Warrant Shares
have been issued prior to this offering.
We Have Engaged In Numerous Transactions With Our Affiliates.
We have engaged in numerous transactions with our affiliates which are not
the result of arms-length negotiations. For that reason, institutional investors
and other potential purchasers of our shares may be less willing to do so due to
a belief that the terms of these transactions may not be as favorable to Generex
as could have been obtained through arms-length negotiations with nonaffiliated
parties.
6
CAPITALIZATION
The following table sets forth our capitalization as of April 30, 1999
under the caption "Actual". The "Pro Forma" information reflects the following
post-April 30, 1999, events:
o sale of 273,002 shares of common stock at a price of $5.50 per share in
May 1999;
o exercise of 1,002,672 Series A Common Stock Purchase Warrants and
redemption of 323,920 Series A Warrants in May and June 1999; and
o payment of expenses of approximately $300,000 in connection with
these transactions, including the issuance of 6,300 shares valued
for this purpose at $5.50 per share.
The "Pro Forma As Adjusted" information reflects all pro forma adjustments
described above, plus the sale for cash of the Placement Warrant Shares offered
by this prospectus and payment of estimated expenses of $100,000 related to this
offering. As set forth under the caption "Use of Proceeds", Placement Warrants
may also be exercised using a "cashless" method, in which case the number of
Placement Warrants Shares issued and our capital will be reduced.
As of April 30, 1999
--------------------------------------------------------
Pro Forma
Actual Pro Forma As Adjusted
--------- --------- ------------
(In thousands except share and per share information)
Notes receivable, less current $ -0- $424 $424
portion...............................
Long-term obligations, less current portion....... $635 $635 $635
Common stock, $.001 par value; 50,000,000 shares
authorized; 13,727,937 shares issued and
outstanding, actual; 14,685,991 shares issued
and outstanding, pro forma; 14,949,629 shares
issued and outstanding, pro forma as adjusted..... $16,338 $20,106 $21,631
Preferred Stock, $.001 par value, 1,000
shares issued and outstanding actual, pro
forma and pro forma as adjusted................... -- -- --
Accumulated deficit............................... $10,679 $10,679 $10,679
Total stockholders' equity........................ $ 5,533 $ 9,251 $10,776
Total capitalization.............................. $ 6,294 $10,062 $11,587
======= ======= =======
Outstanding share information excludes 857,937 shares of common stock
issuable upon exercise of outstanding options and warrants other than the
Placement Warrants as of April 30, 1999, at an average exercise price of $5.62
per share. It also excludes all other transactions after April 30, 1999, except
as expressly stated above. Common Stock, "Pro Forma" and "pro forma" As Adjusted
includes Notes Receivable of $473,701 received in partial payment of shares
issued on the exercise of Series A Warrants.
7
DILUTION
On April 30, 1999, our net tangible book value was approximately
$5,532,772, or $.40 per share of common stock. Our pro forma net tangible book
value per share at that date, which is determined by taking our actual net
tangible book value on April 30, 1999, adding to it the proceeds from sale of
the Placement Warrant Shares (less estimated expenses of this offering of
$100,000), then dividing by the number of shares outstanding at April 30, 1999,
plus Placement Warrants Shares. Assuming all Placement Warrants are exercised,
the holders of Placement Warrants will incur dilution in their investment that
is approximately equal to the difference between the price which they pay for
Placement Warrant Shares ($5.50 to $7.50) and the pro forma net tangible book
value of our common stock.
Purchasers of shares from the Selling Shareholders will incur dilution in
the net tangible book value of their investment equal to the difference between
the price paid for the shares and the net tangible book value of our common
stock. For example, if such shares are purchased at the "asked" price quoted for
our common stock on , 1999, which was $___________, the purchaser's investment
would be diluted by approximately $___________ per share, assuming no change in
the net tangible book value of our shares after April 30, 1999.
USE OF PROCEEDS
We will not receive any proceeds from the sale of shares by the Selling
Shareholders. The net proceeds from the sale of Placement Warrant Shares, if all
such Shares are sold for cash, will be approximately $1,525,000, after deducting
expenses of this offering which we estimate will be approximately $100,000.
Placement Warrant holders also may exercise their Warrants using a "cashless"
exercise method. Under this method, a holder may use the "equity value" of his
Placement Warrants to exercise other Warrants without paying additional money.
The equity value of a Placement Warrant for this purpose is the difference
between the market value of our common stock and the exercise price of the
Placement Warrant. To illustrate this method, if the market price of our common
stock were $7.50 and the exercise price of a Placement Warrant is $6.00, the
equity value of the Warrant would be $1.50. In such a case, a holder of such
Placement Warrants could use four Warrants to pay the exercise price of a fifth
Warrant, i.e., the holder would deliver five Warrants to us for cancellation,
and we would issue one fully paid share of common stock to the holder. Thus, to
the extent that holders of Placement Warrants use the cashless exercise method
to exercise their Warrants, cash proceeds and the number of Placement Warrant
Shares issued upon exercise of the Placement Warrants would be reduced.
Proceeds from any sales of the Placement Warrant Shares will be added to
the funds that we now have on hand, and used primarily to continue the clinical
trials of our oral insulin formulation, in the research and development of other
products, and for general and administrative expenses. The proceeds from the
sale of the Placement Warrant Shares will not materially change our needs for
additional financing even if all Placement Warrants are exercised.
8
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
year ended July 31, 1998, have been audited by Withum, Smith & Brown,
independent auditors. The financial statements as of and for the fiscal year
ended July 31, 1997, and for the period November 2, 1995 (date of inception) to
July 31, 1996, have been audited jointly by Withum, Smith & Brown and Mintz &
Partners, independent auditors. The interim financial statements as of and for
the nine month periods ended April 30, 1998 and 1999 have not been audited. In
the opinion of management, the interim financial statements have been prepared
on the same basis as the audited financial statements and include all
adjustments, consisting only of normal recurring adjustments, necessary for the
fair presentation of the results of these periods.
The "As Adjusted" balance sheet data at April 30, 1999, gives effect to the
proposed sale of 263,638 Placement Warrant Shares, and the payment of expenses
of this offering estimated at $100,000.
For the Cumulative
Period From
November 2, November 2,
1995 1995
Years (Date of (Date of Nine Months
Ended July 31 Inception) Inception) Ended April 30
------------------------ to July 31, to July 31, ---------------------
1998 1997 1996 1998 1999 1998
------ ------ ----------- ----------- ------ -------
STATEMENT OF
OPERATIONS DATA (In
thousands, except per share
data):
Revenues $ -- $ -- $ $ -- $ $ --
Net Loss $(4,614) $(1,356) $(363) $(6,333) $(4,347) $(2,026)
Basic and diluted net loss
per common share $(.46) $(.25) $(.40) -- $ (.34) $(.21)
Weighted average number of
common shares outstanding 10,079 5,513 904 -- 12,891 9,583
Cash dividends per share -- -- -- -- -- --
July 31, April 30, 1999
------------------------ ------------------------------
1998 1997 Actual As Adjusted
------ ------ ------ -----------
BALANCE SHEET DATA (In thousands):
Working capital $ 873 $ 290 $3,213 $4,938
Total assets $5,456 $3,673 $7,267 $7,267
Total long-term debt (less
current maturities) $ 913 -- $ 635 $ 635
Total stockholders' equity $2,642 $3,449 $5,533 $7,357
9
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
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 - Nine months ended April 30, 1999 and 1998
We had a net loss of $4,346,886 for the nine months ended April 30, 1999,
compared to a loss of $2,025,698 in the corresponding period of the preceding
fiscal year. The principal reasons for the increase in our net loss in the nine
month period ended April 30, 1999, were an increase in research and development
expenses (to $1,787,203 from $500,756) and an increase in general and
administrative expenses (to $2,532,692 from $1,524,942).
10
The principal reasons for the increase in our research and development
expense in the nine months ended April 30, 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 personnel costs associated with starting up our pilot manufacturing
facility in Toronto which supports our clinical programs.
The principal reasons for the increase in our general and administrative
expense in the nine months ended April 30, 1999, were:
o the addition of new administrative personnel;
o increased legal and accounting expenses related in part to our
registration of common stock under Section 12(g) of the Securities
Exchange Act and compliance with the reporting requirements of that
Act;
o participation in industry seminars and exhibitions;
o increases in executive compensation; and
o a one time expense associated with the severance of a former executive.
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 ($3,673,909 in the year ended July 31, 1998, versus
$628,064 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.
11
Certain of these expenses were nonrecurring expenses related to our becoming a
public company and to financing transactions. We expect the potential decrease
in general and administrative expenses in the current fiscal year, however, to
be offset by increases in personnel expenses, legal and accounting expenses, and
increases in expenses related to promotional activities, primarily industry
seminars and exhibitions.
Liquidity and Capital Resources
To date we have financed our development stage activities primarily through
private placements of common stock. In the nine months ended April 30, 1999, we
received cash proceeds of approximately $5.5 million in additional equity
capital, net of expenses relating to the issuance of such shares and $140,873 to
redeem certain outstanding shares. As a result, at April 30, 1999, our
stockholders' equity had increased to approximately $5.53 million versus
approximately $2.64 million at July 31, 1998, notwithstanding our net loss
during the nine months ended April 30, 1999.
At April 30, 1999, we had cash on hand of approximately $3.86 million.
Based on our projections of our cash needs at that time, cash on hand was
sufficient to fund development activities over the remainder of the current
fiscal year at the levels then planned. In the current fiscal quarter, which
began May 1, we have received approximately $3.7 in additional equity capital
from an institutional private placement completed in May 1999, and from the
exercise of outstanding warrants in May and June 1999.
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.
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. 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 below under the caption "Business - Government
Regulation".
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
A portion of our research and development and administrative expenses in
the current year and in prior periods have resulted from transactions with
affiliated persons. "Research and development - related party" and "General and
administrative - related party" expenses as reported in our financial statements
represent compensation and expense reimbursements paid to management or
consulting companies owned by officers and directors of Generex and through
which such officers and directors provide their services to us. A number of our
capital transactions also have involved affiliated persons. Although these
transactions are not the result of "arms-length" negotiations, we do not believe
that this fact has had a material impact on our results of operations or
financial position.
12
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 believe that the adoption of SFAS No. 131
will not have 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.
13
OUR 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 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.
14
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, 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;
15
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.
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
16
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.
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.
17
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 approximately
40% 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.
Intellectual Property
Our large molecule drug delivery technology is covered by one or more of
six US patent applications pending as of June 30, 1999. One of these patents has
been allowed but is 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
18
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.
In consideration for his assignment of intellectual property to us, Dr.
Modi received a portion of the shares of Generex Pharmaceuticals, Inc. common
stock which were received by the founders of Generex Pharmaceuticals upon the
organization of that company. These shares subsequently were converted into
1,100,000 shares of our common stock when we acquired Generex Pharmaceuticals.
In addition, Generex Pharmaceuticals agreed to reimburse to Dr. Modi
approximately $100,000 for expenses incurred by him in connection with his
research activities prior to October 1, 1996.
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. In November 1998,
Inhale announced that it had "kicked off" Phase III trials.
The announcement did not disclose when actual dosing of
patients was expected to begin.
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.
19
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.
20
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 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 April 30, 1999, our expenditures on
research and development were $3,458,228. These included $1,787,203 in the nine
months ended April 30, 1999, $876,404 in the year ended July 31, 1998, and
$727,479 in the year ended July 31, 1997.
Facilities
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, 1999.
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
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.
21
Employees
On June 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.
Legal Proceedings and Insurance
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 has alleged that it has the right to
receive, for nominal consideration, approximately 1.6 to 2.5 million shares of
our common stock. This claim is based upon an October 1997 letter agreement
which purports 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 include
additional shares as a fee related to that acquisition, and $144,000 in monthly
fees due under the terms of the purported agreement. Sands has never performed
any services for us, and we have denied that the individual who is alleged to
have signed the purported agreement had the authority to act on Generex
Pharmaceutical's behalf. Hearings were held before a NYSE arbitration panel the
week of June 7, 1999, and on July 6, 1999. Additional hearings are expected to
be held in July 1999. We are unable to predict the outcome of the arbitration 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 Taylor v. Generex Pharmaceuticals, Inc.). We
believe that the claim is without merit, and no reserve or other
provision has been made for any loss that may result from the
litigation.
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
22
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
have caused a notice of default to be entered against us. We have
applied to the court to have the notice of default set aside, and to
permit us to file a Statement of Defense. This application should be
heard this summer. 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.
MANAGEMENT
Executive Officers and Directors
The current executive officers and directors of are as follows:
Name Age Position
- ---- --- --------
E. Mark 37 Chairman, Chief Financial Officer
and a Director
Anna E. Gluskin 47 President, Chief Executive Officer and a Director
Pankaj Modi, Ph.D. 45 Vice President of Research & Development and a
Director
Rose C. Perri 31 Chief Operating Officer, Secretary, Treasurer and a
Director
23
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 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).
24
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.
Scientific Advisory Board and Consultants
We have established a Scientific Advisory Board to provide us with advice
regarding research direction, product development, analysis of data and general
scientific, medical and business counseling. We consult with individual members
of this Board on a non-scheduled basis. Brief descriptions of the backgrounds of
our Scientific Advisory Board members are set forth below.
Jaime Guevara-Aguirre, M.D., Institute of Endocrinology, Metabolism and
Reproduction, Quito, Ecuador. Dr. Jaime Guevara-Aguirre founded the Institute of
Endocrinology, Metabolism and Reproduction IEMIR in Quito, Ecuador in 1987 and
continues to be a director of that Institute. He has been involved extensively
in medical research in such areas as growth hormone insensitivity, body and bone
composition and insulin-like growth factor therapy. Dr. Guevara-Aguirre was the
principal investigator who conducted our 1998 clinical work in Ecuador.
Dr. Guevara-Aguirre was a professor of Endocrinology for the Department of
Internal Medicine, Central University in Quito between 1980-1994. He also serves
as a director of Centro Medico de Neuro-Endocrinologia in Quito.
Gerald Bernstein, M.D., Director, Diabetes Management Program, Beth Israel
Health Care Systems, New York City. Dr. Bernstein was the 1998-1999 President of
the American Diabetes Association, and has served on the Board of Directors of
that organization since 1993. Dr. Bernstein has also served on the Board of
Directors and as President of state and local chapters of the American Diabetes
Association. He received his medical degree form Tufts University School of
Medicine, and after his internships and residency, completed a Postdoctoral
fellowship at the Endocrine Research Laboratory, Montefiore Hospital, Bronx, New
York. Dr. Bernstein has been an Associate Clinical Professor of Medicine at
Albert Einstein College of Medicine, Bronx, New York since 1996.
Edward C. Keystone, M.D., F.R.C.P.(C), Chief, Rheumatic Disease Unit,
Wellesley Hospital and Director, Division of Advanced Therapeutic Studies, The
Toronto Wellesley Arthritis & Immune Disorder Research Centre, Toronto Hospital.
Dr. Keystone is a certified specialist in both Internal Medicine and
Rheumatology. Since 1992, he has served as the Director, Division of
Rheumatology at the Wellesley Central Hospital in Toronto, Canada, In 1991, he
25
became the Director of Research, Department of Medicine and was named the
Assistant Chief of Medicine, positions he continues to hold at the hospital. He
is a full professor in the Department of Medicine at the University of Toronto.
Dr. Keystone is actively involved in conducting clinical research trials in
rheumatoid arthritis with an emphasis on biological therapies. His research
laboratory interest is in the immunopathologic processes contributing to the
perpetuation of rheumatoid arthritis.
Bhushan M. Kapur, Ph.D., C.Chem., F.R.S.C., F.A.C.B., F.C.A.C.B., Assistant
Professor, Department of Laboratory Medicine and Pathology, University of
Toronto. Dr. Kapur received his doctorate in organic chemistry from Basel
University, Switzerland. He has been on the Faculty of Medicine at the
University of Toronto since 1978.
Dr. Kapur specializes in clinical biochemistry with particular emphasis on
toxicology. He serves as a consulting toxicologist to the Hospital for Sick
Children, Division of Pharmacology and Toxicology, in Toronto, and is the
President of CliniTox, Inc., a company which provides consulting services in
clinical biochemistry and toxicology.
Sigmund Krajden, M.D., C.M., F.R.C.P.(C), Department of Medicine &
Laboratory Medicine, St. Joseph's Health Centre, Toronto, Canada. Dr. Krajden
received his medical degree in 1971 from McGill University, Montreal, Quebec and
has trained in Quebec, Ontario and California. He specializes in the field of
microbiology and infectious diseases and is currently the Director of the
Medical Microbiology Department and Chief of Infectious Diseases at St. Joseph's
Health Centre in Toronto, Canada. In addition, Dr. Krajden is an Assistant
Professor at the University of Toronto.
Arthur Krosnick, M.D., F.A.C.P., C.D.A., received his medical degree from
Temple University School of Medicine, following which he served a rotating
internship at Mercer Hospital, Trenton, New Jersey, and a three year residency
in Internal Medicine, with emphasis on diabetes, at the Graduate and
Presbyterian Hospitals of the University of Pennsylvania. Among his current
appointments, Dr. Krosnick serves as Research Director, Joslin Center for
Diabetes at St. Barnabas Hospital, Chairman of the New Jersey State Diabetes
Advisory Counsel and the Advisory Committee on Diabetes, New Jersey State
Department of Health, and Clinical Associate Professor, Department of
Occupational and Environmental Medicine, Robert Wood Johnson Medical School.
Dr. Krosnick is Chairman of our Scientific Advisory Board, and also is
acting as an investigator in our initial Phase II clinical trials in the United
States.
Kusiel Perlman, M.D., F.R.C.P.(C), Division of Endocrinology, Hospital for
Sick Children, Toronto, Canada. Dr. Perlman received his medical degree from the
University of Manitoba in 1972 and pursued post-graduate studies in the
Department of Pediatrics at the University of Manitoba, Case Western Reserve
University and the University of Toronto from 1973 to 1979. Presently, he is a
Project Director in the Research Institute at the Hospital for Sick Children in
Toronto. Concurrently, he is an Assistant Professor in the Division of
Endocrinology at both The Hospital for Sick Children and the Toronto Hospital
Corporation.
Dr. Perlman's association with The Hospital for Sick Children in Toronto
started in July 1978, where he received his training as a Clinical Fellow in
Endocrinology (Pediatrics) and as a Research Fellow (Pediatrics). In 1980, Dr.
Perlman was appointed as a Senior Research Associate and in 1988 became the
director of the hospital's Clinical Investigation Unit.
William Steinbrink, M.D., received his medical degree in 1974 from the
Pittsburgh School of Medicine, and received his graduate training at Harvard
Medical School, at Beth Israel Hospital in Boston, and at Western Pennsylvania
26
Hospital in Pittsburgh. Dr. Steinbrink currently is on staff at the Department
of Obstetrics and Gynecology at Harmot Medical Center and Saint Vincent Health
Center in Erie, Pennsylvania and with Bayside Inc., a private clinic in Erie,
Pennsylvania, specializing in obstetrics, gynecology and infertility. He is a
Fellow of the American College of Obstetrics and Gynecology.
Bernard Zinman, M.D.C.M., F.R.C.P.(C), F.A.C.P., Director of the Banting &
Best Diabetes Centre, University of Toronto, Toronto, Canada. Dr. Zinman is a
certified specialist in endocrinology and metabolism and is a Professor in the
Department of Medicine at the University of Toronto. Since 1991, he has served
as Head of the Division of Endocrinology and Metabolism at the Mount Sinai
Hospital and The Toronto Hospital in Toronto, Canada. Since 1993, Dr. Zinman has
been the Director of the Banting and Best Diabetes Centre and is a Senior
Scientist at The Samuel Lunefeld Research Institute.
Dr. Zinman was the principal investigator for the initial Canadian clinical
trials of our oral insulin formulation. Previously, he has acted as the
principal investigator of the University of Toronto Diabetes Control and
Complications Control Trial ("DCCT") Centre and headed the follow up of EDIC
(Epidemiology) of Diabetes Intervention and Complication Toronto Centre. Between
1985 and 1994, he was Chair of the Treatment Committee (DCCT) for the National
Institute of Health, a member of the Professional Practice Committee and
Vice-Chair of the Exercise Council for the American Diabetes Association.
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 $420,000 CAD (approximately $277,500 US).
The following table sets forth information concerning compensation paid to
Anna E. Gluskin, as President and Chief Executive Officer of , in the fiscal
year ended July 31, 1998. No officer of our received compensation in excess of
$100,000 in that year. Mark Perri, Rose Perri and Anna Gluskin all received
substantial benefits from us through non-interest bearing loans. These are
discussed later in this prospectus under the heading "Certain Relationships and
Related Transactions."
Summary Compensation Table
- -----------------------------------------------------------------------------------------------------------------------
Annual Compensation Long-Term Compensation
----------------------------- ------------------------------------
Awards Payouts
Securities
Other Under-
Annual Restricted lying All Other
Name and Year Compen- Stock Options/ LTIP Compen-
Principal Ended Salary Bonus sation Award(s) SARs Payouts sati
Position July 31 ($) ($) ($) ($) (#) ($) ($)
(a) (b) (c) (d) (e) (f) (g) (h) (i)
- ------------------------------------------------------------------------------------------------------------------------
Anna E. Gluskin, 1998 92,488 -0- Less than -0- -0- -0- -0-
Chief Executive $50,000
Officer
- ------------------------------------------------------------------------------------------------------------------------
27
Ms. Gluskin's salary is stated in the table in U.S. dollars and is based on the
Canadian/U.S. dollar exchange rate on July 31, 1998. 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 within
the next 60 days.
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.
PRINCIPAL SHAREHOLDERS
The following table 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
28
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 June 30, 1999. At that date, we
had 14,746,074 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.
29
- ----------------------------------------------------------------------------------------------------------------
Name and Address of
Beneficial Owner Beneficial Ownership
- ----------------------------------------------------------------------------------------------------------------
Number of Percent of Class
Shares
- ----------------------------------------------------------------------------------------------------------------
Before Offering After Offering(1)
- ----------------------------------------------------------------------------------------------------------------
(i) Directors and Executive
Officers
- ----------------------------------------------------------------------------------------------------------------
E. Mark Perri
33 Harbour Square, Ste. 3502
Toronto, Ontario 4,330,086(2) 29.4% 28.9%
M5J 2G2
- ----------------------------------------------------------------------------------------------------------------
Anna E. Gluskin
33 Harbour Square, Ste. 2409 1,188,179(3) 8.1% 7.9%
Toronto, Ontario
M5J 2G2
- ----------------------------------------------------------------------------------------------------------------
Rose C. Perri
33 Harbour Square, Ste. 2409
Toronto, Ontario 1,188,100(3) 8.1% 7.9%
M5J 2G2
- ----------------------------------------------------------------------------------------------------------------
Pankaj Modi, Ph.D.(3)
519 Golf Links Road
Ancaster, Ontario 1,100,200(4) 7.5% 7.3%
L9G 4X6
- ----------------------------------------------------------------------------------------------------------------
Officers and directors as a group 7,806,565 53.0% 52.0%
(4 persons)
- ----------------------------------------------------------------------------------------------------------------
(ii) Other Beneficial Owners
- ----------------------------------------------------------------------------------------------------------------
EBI, Inc. In Trust
c/o Miller & Simons
First Floor, Butterfield Square
P.O. Box 260 1,501,496(5) 10.2% 10.0%
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(6) 17.0% 16.7%
Providencials
Turks and Calcos Islands
British West Indies
- ----------------------------------------------------------------------------------------------------------------
30
- ----------------------
(1) Assuming all Placement Warrant Shares are sold.
(2) Includes 45,888 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 401,496 shares owned of record
by EBI, Inc., which Mr. Perri 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.
(3) Includes 1,188,000 shares owned of record by GHI, Inc.
(4) Dr. Modi also owns all the outstanding shares of our Special Voting
Rights Preferred Stock. This stock is not convertible into common
stock.
(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 otherwise is entitled to the economic benefits of
ownership of 1,100,000 of the shares owned of record by EBI, Inc.
(6) 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.
31
SELLING SHAREHOLDERS
The following table lists each Selling Shareholder and:
o the number of shares owned by each Selling Shareholders prior to the
offering;
o the number of shares each is registering for sale in the offering; and
o the percentage of common stock owned by each after the offering,
assuming each sells all of the shares registered for his/her/its
benefit.
None of the Selling Shareholders now or within the past three years has held any
office or position with us, or had any material relationship with us other than
as an investor.
- ---------------------------------------------------------------------------------------------------------------------
Shares Owned,
Shares Bene- Shares After the
Name ficially Owned Registered Offering
Prior to Offering for Sale (percentage of class)
- ---------------------------------------------------------------------------------------------------------------------
Cranshire Capital, L.P. 177,274 177,274 -0-
- ---------------------------------------------------------------------------------------------------------------------
Keyway Investments Ltd. 154,545 154,545 -0-
- ---------------------------------------------------------------------------------------------------------------------
Headwaters Capital 90,909 90,909 -0-
- ---------------------------------------------------------------------------------------------------------------------
The Aries Master Fund 63,637 63,637 -0-
- ---------------------------------------------------------------------------------------------------------------------
ICN Capital Ltd. 59,092 59,092 -0-
- ---------------------------------------------------------------------------------------------------------------------
Aries Domestic Fund, L.P. 27,000 27,000 -0-
- ---------------------------------------------------------------------------------------------------------------------
32
- ---------------------------------------------------------------------------------------------------------------------
Shares Owned,
Shares Bene- Shares After the
Name and Address ficially Owned Registered Offering
Prior to Offering for Sale (percentage of class)
- ---------------------------------------------------------------------------------------------------------------------
Howard Todd Horberg 27,727 22,727 5,000(*)
- ---------------------------------------------------------------------------------------------------------------------
Steve Levy 27,727 22,727 5,000(*)
- ---------------------------------------------------------------------------------------------------------------------
Gilford Partners, L.P. 18,182 18,182 -0-
- ---------------------------------------------------------------------------------------------------------------------
Aries Domestic Fund II, L.P. 272 272 -0-
- ---------------------------------------------------------------------------------------------------------------------
*Less than one percent
The next table lists each holder of Placement Warrants and:
o the number of shares of common stock beneficially owned by each
Placement Warrant holder at , 1999;
o the number of Placement Warrant Shares which each holder has the
right to purchase upon exercise of the Placement Warrants; and
o the number of shares owned beneficially by such holders and
percentage ownership of our common stock after the offering, assuming
all Placement Warrant Shares are resold.
This prospectus covers our potential sale of all of the Placement Warrant
Shares to such holders, and resales by them of the Shares which they are
entitled to purchase from us.
Coleman & Company Securities, Inc. has an investment banking relationship
with us, and GIA Securities, Inc. acted as a broker in connection with a private
placement that Coleman managed for us. Messrs. Puccio, Pellegrino, Ishak and
Port are employees of Coleman. James Baxter and Barbara Brooks-Baxter are
employees of GIA. Zazoff Associates, L.L.C. and Patrick Nolan introduced us to
an investor in the private placement managed by Coleman, and received Placement
Warrants from us as compensation for this service.
33
- --------------------------------------------------------------------------------------------------------------
Shares
Number of Beneficially
Shares Bene- Placement Owned After the
ficially Owned Warrant Shares Offering
Prior to Offering(1) Registered (percentage of
Name For Sale class)
- --------------------------------------------------------------------------------------------------------------
Coleman & Company Securities, Inc. 79,091(2) --*
- --------------------------------------------------------------------------------------------------------------
Philip C. Puccio, Sr. 65,591(3) --*
- --------------------------------------------------------------------------------------------------------------
Ernest G. Pellegrino 65,591(3) --*
- --------------------------------------------------------------------------------------------------------------
Teddy Ishak 22,000(4) --*
- --------------------------------------------------------------------------------------------------------------
James E. Port 15,000(5) --*
- --------------------------------------------------------------------------------------------------------------
James N. Baxter 8,182(6) --*
- --------------------------------------------------------------------------------------------------------------
Zazoff Associates, L.L.C. 3,637(6) --*
- --------------------------------------------------------------------------------------------------------------
Patrick G. Nolan 3,637(6) --*
- --------------------------------------------------------------------------------------------------------------
Barbara Brooks-Baxter 909(6) --*
- --------------------------------------------------------------------------------------------------------------
*Less than one percent.
(1) Includes, in each case, the Placement Warrant Shares issuable upon exercise
of the Placement Warrants.
(2) Includes 50,000 Placement Warrants exercisable at a price of $7.50 per
share, and 29,091 Placement Warrants exercisable at a price of $5.50
per share.
(3) Includes 57,500 Placement Warrants exercisable at a price of $6.00 per
share, and 8,091 Placement Warrants exercisable at a price of $5.50
per share.
(4) Includes 20,000 Placement Warrants exercisable at a price of $6.00 per
share, and 2,000 Placement Warrants exercisable at a price of $5.50 per
share.
(5) Represents Placement Warrants exercisable at a price of $6.00 per share.
(6) Represents Placement Warrants exercisable at a price of $5.50 per share.
34
PLAN OF DISTRIBUTION
We will sell the Placement Warrant Shares to holders of the Placement
Warrants only upon the exercise of such Warrants. If all outstanding Placement
Warrants were exercised for cash, we would issue 263,638 Placement Warrant
Shares, and would receive $1,625,000 in payment for such Shares. As described
above under the caption "Use of Proceeds", holders of Placement Warrants may use
the equity value of their warrants in lieu of cash to exercise Warrants. To the
extent that holders of Placement Warrants use the cashless exercise method, cash
proceeds and the number of Placement Warrant Shares issued upon exercise of the
Placement Warrants would be reduced.
Shares of common stock which have been registered for sale by the Selling
Shareholders will be sold by them for their own accounts and we will not receive
proceeds from any of these sales.
Shares sold by the Selling Shareholders may be offered and sold from time
to time as market conditions permit. Similarly, shares that we sell to holders
of Placement Warrants upon the exercise of their Warrants may be resold by them
from time to time as market conditions permit. These sales and resale
transactions may take place in privately negotiated transactions or in the over
the counter market, and may include large block transactions and ordinary
brokers' transactions. These transactions may also include sales through one or
more broker dealers who acquire and sell these shares as principals. Sales may
be at the prevailing market price at the time of the sale, at prices relating to
the prevailing market prices, such as at a specified discount from or premium
over the market price, or at a negotiated price. Ordinary brokerage commissions
may be paid by the sellers in connection with the sales, or the sellers may
specifically negotiate brokerage fees or commissions in connection with the
sales.
We are paying all expenses in connection with the registration of the
shares to be sold by the Selling Shareholders and the shares to be sold to the
Placement Warrant Holders except that we will not pay any underwriting discounts
or selling commissions for any sales by holders of the Selling Shareholders or
resales by the Placement Warrants. We also will not pay any transfer taxes or
fees or expenses of counsel or other advisors to the Selling Stockholders or the
Placement Warrants.
MARKET INFORMATION
"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
35
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 ______________, 1999, were
$______ and $______, respectively. These are "inter-dealer" quotations, without
retail mark-up, mark-down or commissions, and may not represent actual
transactions.
High Low
------- -----
1998
----
First quarter $6.50 $6.375
Second quarter $9.375 $6.125
Third quarter $8.125 $6.50
Fourth quarter $16.650 $7.50
1999
----
First Quarter $__.__ $__.__
Second Quarter $__.__ $__.__
Third Quarter (through ________, $__.__ $__.__
1999)
At July 7, 1999, there were 954 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. We also
issued 7,274 Placement Warrants to two finders who introduced us to one of the
investors who participated in this private placement. The Placement Warrants are
exercisable at prices ranging from $5.50 to $7.50 per share. The weighted
average exercise price is $6.16 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 21, 2003.
o 50,000 shares at a price of $8.00 per share expiring November 13, 2003.
o 300,000 shares at a price of $10.00 per share expiring November 17,
2003.
36
Shares Saleable Under Rule 144
At __, 1999, we had outstanding ________ 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,
________ shares 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. 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.
CERTAIN 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 resulting in a balance due from EBI of $508,165
CAD at July 31, 1998 (approximately $335,710 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.
Real Estate Purchases: Two of the properties purchased by Generex
Pharmaceuticals with funds repaid by EBI (the Brampton and Mississauga
manufacturing facilities described above under the caption "Business
Manufacturing") were purchased from Antonio Perri, Mark Perri's father. The
seller had owned these properties for more than two years prior to their sale.
We believe that the terms of these purchases (the Brampton facility for $680,000
CAD and the Mississauga facility for $810,000 CAD) were at least as favorable to
us as could have been obtained from an unrelated party through arms-length
negotiations.
37
Occupancy of Executive Offices: Prior to December 17, 1997, we occupied
executive offices at Harbour Square Business Center under an Occupancy Agreement
between Generex Pharmaceuticals, Angara Equities, Inc. and 1097346 Ontario, Inc.
Under that agreement, Generex Pharmaceuticals paid Angara a monthly occupancy
fee of $4,880 CAD, which represented the rental and other charges allocable to
its space under Angara's lease for space with the owner. Angara Equities is
owned by Mark Perri, Rose Perri and Anna Gluskin. The arrangement between Angara
and Generex Pharmaceuticals was a direct "pass through" of costs from which
Angara derived no direct economic benefit. At the time the lease was executed in
May 1996, the space was owned by an unrelated party, and the terms of the lease
were negotiated at arms length.
On December 17, 1997, we acquired 100% of the outstanding capital stock of
the owner of the space for $661,769, and our lease with Angara Equities was
terminated.
Loans To and From Stockholders: Between November 1995 and July 31, 1997,
Angara Equities incurred a net indebtedness of $1,127,218 (CAD) to Generex
Pharmaceuticals. The indebtedness arose from cash advances and the payment by
Generex Pharmaceuticals of expenses incurred by Angara and certain of its
affiliates, net of repayments and the payment of Generex Pharmaceuticals
expenses by Angara. The highest amount outstanding at any time during this
period was $1,654,264 CAD (approximately $1,092,860 US).
During this period, Generex Pharmaceuticals also made advances to The Great
Tao, Inc., a company owned by Mark Perri, Rose Perri and Anna Gluskin, through
which they receive compensation for their services to . At July 31, 1997, The
Great Tao was indebted to Generex Pharmaceuticals in the amount of $175,000 CAD.
The highest amount outstanding at any time during this period was $175,000 CAD
(approximately $126,628 US).
During the fiscal year ended July 31, 1998, Generex Pharmaceuticals
advanced a total of $1,556,250 (CAD) to Angara, The Great Tao and other entities
owned by Mr. Perri, Ms. Perri and Ms. Gluskin, and received repayments of
advances and payments on account of past advances in the aggregate amount of
$1,855,997 (CAD). These included $420,000 CAD credited to The Great Tao on
account of compensation we owed to Mr. Perri, Ms. Perri and Ms. Gluskin during
the year. As a result, a total of $952,471 CAD (approximately $629,234 US) was
due to Generex Pharmaceuticals from these entities at fiscal year end. The
highest amount outstanding at any time during the fiscal year was $1,864,288 CAD
(approximately $1,231,610 US).
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.
All advances from Generex Pharmaceuticals to entities owned and controlled by
Mr. Perri, Ms. Perri and Ms. Gluskin are expected to be repaid in full by the
end of the current fiscal year.
Consulting Agreement with Pankaj Modi, Ph.D.: In October 1996, Generex
Pharmaceuticals entered into a Consulting Agreement with Dr. Modi. Under this
Agreement, Dr. Modi assigned to Generex Pharmaceuticals his rights to all
inventions, ideas, designs and discoveries made by him during the term of the
Agreement which relate to the development, manufacturing, marketing,
distribution and sale of generic drug products, including, without limitation,
controlled release drugs, topical insulin, intra-nasal insulin and liposome
creams. Concurrently with execution of this Consulting Agreement, Dr. Modi and
Generex Pharmaceuticals entered into an Assignment and Assumption Agreement.
Under this Agreement Dr. Modi assigned to us his interests in specific drug
38
delivery systems, controlled release drug delivery systems and technology
patents invented/discovered/conceived by Dr. Modi prior to the execution of the
Agreement. These patents include three existing patents covering insulin
delivery systems, applicable to peptides and proteins; drug vaccines and
hormones delivery; and controlled release of drugs and hormones. In addition to
these patents, Dr. Modi assigned to Generex Pharmaceuticals 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.
Under the Consulting Agreement, we pay Dr. Modi an annual compensation of
$132,000.00 CAD (approximately $87,200.00 US). We also reimbursed Dr. Modi for
$150,000.00 CAD (approximately $99,000.00 US) of expenses incurred by Dr. Modi
in research activities prior to his association with Generex Pharmaceuticals.
DESCRIPTION OF SECURITIES
Our authorized capital stock consists of
o 50,000,000 shares of Common Stock, $.001 par value,
o 999,000 shares of undesignated Preferred Stock, $.001 par value, and
o 1,000 shares of Special Voting Rights Preferred Stock.
On June 30, 1999, 14,746,074 shares of common stock and 1,000 shares of
Special Voting Rights Preferred Stock were outstanding.
Common Stock
Holders of Common Stock are entitled to one vote for each share owned of
record on all matters on which shareholders may vote. Holders of Common Stock do
not have cumulative voting rights in the election of directors. Therefore, the
holders of more than 50% of the outstanding shares can elect the entire Board of
Directors. The holders of Common Stock are entitled, upon liquidation or
dissolution of Generex, to receive pro rata all remaining assets available for
distribution to stockholders after payment to any preferred shareholders who may
have preferential rights. The Common Stock has no preemptive or other
subscription rights, and there are no conversion rights or redemption
provisions. All outstanding shares of Common Stock are validly issued, fully
paid, and nonassessable.
Special Voting Rights Preferred Stock
We have 1,000 shares of Special Voting Rights Preferred Stock outstanding.
Dr. Modi, our Vice President - Research, is the owner of all of these shares.
The Special Voting Rights Preferred Stock does not generally have the right to
vote but does have the following special voting rights:
o the Special Voting Rights Preferred Stock has the right to elect a
majority of our Board of Directors if a change in control occurs;
o the Special Voting Rights Preferred Stock has the right to approve
any transaction that would result in a change of control;
39
o the Special Voting Rights Preferred Stock has the right to vote
whenever specifically required by Delaware law.
A "Change of Control" is deemed to occur if our founders (Anna E. Gluskin,
E. Mark Perri, Rose C. Perri and Pankaj Modi) should cease to constitute at
least sixty percent (60%) of our directors, or if any person becomes either our
Chairman of the Board of Directors or Chief Executive Officer without the prior
approval of these founders. If a Change of Control were to occur, Dr. Modi would
thereafter be able to elect a majority of the directors of so long as shares of
the Special Voting Rights Preferred Stock were outstanding.
The Special Voting Rights Preferred Stock is entitled to share in dividends
paid on the common stock.
We have the right to redeem the Special Voting Rights Preferred Stock at
any time after December 31, 2000, for $.10(cent) per share.
Undesignated Preferred Stock
Our Board of Directors has the authority to issue up to 999,000 shares of
preferred stock in one or more series and fix the number of shares constituting
any such series, the voting powers, designations, preferences and relative,
participating, optional or other special rights and qualifications, limitations
or restrictions thereof, including the dividend rights, dividend rate, terms of
redemption (including sinking fund provisions), redemption price or prices,
conversion rights and liquidation preferences of the shares constituting any
series, without any further vote or action by the stockholders. For example, the
Board of Directors is authorized to issue a series of preferred stock that would
have the right to vote, separately or with any other series of preferred stock,
on any proposed amendment to our Certificate of Incorporation or on any other
proposed corporate action, including business combinations and other
transactions.
1998 Stock Option Plan
On July 29, 1998, our Board of Directors approved our 1998 Stock Option
Plan. 1,500,000 shares of common stock have been reserved for issuance upon the
exercise of options granted under the Plan.
We adopted this Plan:
o to provide incentives and rewards to our employees who are in a position
to contribute to our long term growth and profitability;
o to assist us in attracting, retaining and motivating personnel with
experience and ability we need; and
o to make our compensation program more competitive with those of other
employers.
We also anticipate that we will benefit from the added interest which
personnel who receive options will have in our success as a result of their
proprietary interest. The Plan is administered by our Board of Directors.
However, the Board may establish a stock option committee of at least three (3)
directors to administer the Plan.
The Board or committee is authorized to select from among eligible
employees, directors, advisors and consultants those individuals to whom options
are to be granted. The Board or committee also will to determine the number of
40
shares each person may acquire and the terms and conditions of the options. The
Board or committee also is authorized to prescribe, amend and rescind terms
relating to options granted under the plan. Generally, the interpretation and
construction of any provision of the Plan or any options granted thereunder is
within the discretion of the Board or committee.
The Plan provides that options may or may not be incentive stock options
within the meaning of Section 422 of the Internal Revenue Code. Only persons
classified as employees are eligible to receive incentive stock options.
Non-employee directors, advisors and consultants are eligible to receive options
which do not qualify as incentive stock options under applicable Internal
Revenue Code. The options granted by the Board in connection with its adoption
of the Plan are not incentive stock options.
The terms of options granted under the Plan are determined by the Board or
committee at the time the option is granted. Each option is evidenced by a
written option document. The option documents, together with the provisions of
the Plan, determine such terms as:
o when options under the Plan become exercisable;
o the exercise price of options, which, for incentive stock options,
may not be less than 100% of the fair market value of our common
stock on the date the option is granted (110% in the case of
optionees who own 10% or more of our common stock);
o the term of the option;
o vesting provisions; and
o special termination provisions.
An option may not be transferred, other than to the heirs of the option
holder and is exercisable only by the original option holder during his lifetime
or, in the event of his death, by his heirs.
As of June 30, 1999, we had issued options for 50,000 shares under the
Plan, exercisable at a price of $8.00 per share until November 13, 2002.
Placement Warrants
The Placement Warrants were issued to two broker dealers and their
employees and to two finders in connection with an investment banking agreement
and private placement of securities between February and May 1999. These
Warrants are exercisable at prices ranging from $5.50 to $7.50 per share, and
expire in February and April, 2004. Among other terms, the Placement Warrants
required that we register the Placement Warrant Shares at such time as we
registered any other shares for sale under the Securities Act.
Other Warrants
We also have outstanding warrants to purchase shares of common stock as
follows:
o to purchase 7,937 shares at a price of $21.82 per share until
September 6, 2002.
o to 500,000 shares at a price of $2.50 per share until March 31, 2003.
o to purchase 300,000 shares at a price of $10.00 per share until
November 17, 2003.
41
Anti-Takeover Provisions
We are not aware of any pending takeover attempt or interest in making such
an attempt. Our Certificate of Incorporation and Bylaws and the Delaware
Corporation Law contain certain provisions which may be deemed to be
"anti-takeover" in that they may deter, discourage or make more difficult the
assumption of control of Generex by another corporation or person through a
tender offer, merger, proxy contest or similar transaction or series of
transactions.
Special Voting Rights Preferred Stock: As indicated above, our outstanding
Special Voting Rights Preferred Stock prevents a "change of control" of Generex
without the consent of the holders of those shares. At the present time, all of
these shares are owned by Pankaj Modi, a Generex officer and director.
Authorized but Unissued Shares: Our authorized capital stock is 50,000,000
shares of common stock, 999,000 shares of preferred stock and 1,000 shares of
Special Voting Rights preferred stock. The Board of Directors may set the
rights, preferences and terms of new preferred stock, without shareholder
approval. Shares of preferred stock could be issued quickly without shareholder
approval, with terms calculated to delay or prevent a change in control of
Generex. Our stockholders do not have preemptive rights with respect to the
purchase of these shares. Therefore, such issuance could result in a dilution of
voting rights and book value per share of the common stock. No shares of
preferred stock other than the Special Voting Rights Preferred Stock have been
issued, and we have no present plan to issue any preferred stock.
Delaware Anti-Takeover Statute. Section 203 of the Delaware corporations
statute is applicable to publicly held corporations organized under the laws of
Delaware, including Generex. Subject to various exceptions, Section 203 provides
that a corporation may not engage in any "business combination" with any
"interested stockholder" of the corporation for a three-year period after such
stockholder becomes an interested stockholder unless the interested stockholder
attained that status with the approval of the board of directors of the
corporation or the business combination is approved in a manner described in the
statute. A "business combination" includes mergers, asset sales and other
transactions which result in a financial benefit to the interested stockholder.
Subject to various exceptions, an interested stockholder is a person who,
together with affiliates and associates, owns 15% or more of the corporation's
outstanding voting stock or was the owner of 15% or more of the outstanding
voting stock within the previous three years. Under certain circumstances,
Section 203 makes it more difficult for an interested stockholder to effect
various business combinations with a corporation for a three-year period. The
stockholders may elect not to be governed by Section 203, by adopting an
amendment to the corporation's certificate of incorporation or by-laws which
becomes effective twelve months after adoption. Our Certificate of Incorporation
and by-laws do not exclude Generex from the restrictions imposed by Section 203.
It is anticipated that the provisions of Section 203 may encourage companies
interested in acquiring Generex to negotiate in advance with our Board of
Directors.
General Effect of Anti-Takeover Provisions: The overall effect of these
provisions may be to deter a future tender offer or other takeover attempt that
some stockholders might view to be in their best interests at that time. In
addition, these provisions may have the effect of assisting our current
management in retaining its position and place it in a better position to resist
changes which some stockholders may want to make if dissatisfied with the
conduct of our business.
42
Dividend Policy
Holders of our common stock are entitled to receive such dividends as the
Board of Directors may from time to time declare. The Board may declare
dividends only when dividends are legally available. Under the Delaware General
Corporation Law, the Board may only declare dividends out of our capital surplus
(generally the amount of its paid-in capital above the par value of the
outstanding stock) or out of net profits for the fiscal year with respect to
which the dividends are paid. Holders of our Special Voting Rights Preferred
Stock are entitled to receive a dividend per share equal to the dividends paid
on share of common stock when and if such dividends are declared and paid. We
have never paid any dividends on our common stock and do not anticipate paying
dividends in the foreseeable future.
Transfer Agent
StockTrans, Inc., 7 East Lancaster Avenue, Ardmore, PA 19003, is the
transfer agent and registrar for our common stock.
DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION
FOR SECURITIES ACT LIABILITIES
Our by-laws require us to indemnify any of our officers or directors, and
certain other persons, under certain circumstances against all expenses and
liabilities incurred or suffered by such persons because of a lawsuit or similar
proceeding to which the person is made a party by reason of a his being a
director or officer of Generex or our subsidiaries, unless that indemnification
is prohibited by law. We may also purchase and maintain insurance for the
benefit of any officer which may cover claims for which we could not indemnify a
director or officer. We have been advised that in the opinion of the Securities
and Exchange Commission, indemnification of our officers, directors and
controlling persons under these provisions, or otherwise, is against public
policy and is unenforceable.
LEGAL MATTERS
The validity of the issuance of the shares of common stock offered in this
prospectus will be passed upon for us by Eckert Seamans Cherin & Mellott, LLC,
1515 Market Street, 9th Floor, Philadelphia, PA 19102. The firm of Eckert
Seamans owns 158,172 shares of common stock which it received in payment of
legal fees and expenses in 1998 (60,000 shares) and the exercise of warrants in
June 1999 (98,172 shares). Members of the firm own additional shares (less than
one percent in total) that they purchased from time to time for cash, either
from us or in the public market.
EXPERTS
Our financial statement as of and for the year ended July 31, 1998,
appearing in this prospectus and the registration statement of which it is a
part have been audited by Withum Smith & Brown, independent accountants, as set
forth in their report on such financial statements. This report contains an
explanatory paragraph describing conditions that raise doubt about our ability
to continue as a going concern as described in Note 2 to the financial
statements.
Our financial statements as of and for the fiscal year ended July 31, 1997,
and for the period November 2,1995 (inception) to July 31, 1996, appearing in
this prospectus and the registration statement have been audited jointly by
Withum, Smith & Brown and Mintz & Partners, independent auditors, as set forth
in their report on such financial statements.
43
Our financial statements are included in this prospectus in reliance upon
the reports of Withum, Smith & Brown and Mintz & Partners on such financial
statements and on the authority of such firms as experts in accounting and
auditing.
ADDITIONAL INFORMATION
We have filed a registration statement under the Securities Act of 1933,
covering the shares offered by this prospectus, with the United States
Securities and Exchange Commission, 450 Fifth Street, N.W., Washington, DC
20549. This prospectus, which is a part of the registration statement, does not
contain all of the information contained in the registration statement and
exhibits and schedules to the registration statement. For further information
with regard to Generex and the shares offered by this Prospectus, you should
review the registration statement.
We are required to file annual, quarterly and current reports, proxy
statements and other information (annual and quarterly) with the SEC. Copies of
materials we file with the SEC may be read and copied at the SEC's public
reference room at 450 Fifth Street, N.W., Washington, DC 20549. You may obtain
information on the operation of the public reference room by calling the SEC at
1-800-SEC-0300. The SEC maintains an Internet site which contains reports, proxy
and information statements, and other information regarding issuers that file
electronically with the SEC. The address of the SEC's Internet site is
http:\\www.sec.gov. You may also obtain copies of these reports directly from us
by sending a written request to us at our principal offices located at 33 Harbor
Square, Suite 202, Toronto, Canada M5J2G.
44
GENEREX BIOTECHNOLOGY CORPORATION
AND SUBSIDIARIES
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
PAGE
----
Independent Auditors' Reports F-2 to F-3
Consolidated Balance Sheets
July 31, 1998 and 1997, and April 30, 1999 (unaudited) F-4
Consolidated Statements of Operations
For the Years Ended July 31, 1998 and 1997,
For the Period November 2, 1995 (Date of Inception)
to July 31, 1996, for the Nine Months Ended April 30, 1999 and 1998 (unaudited)
and Cumulative From Inception to April 30, 1999 (unaudited) F-5
Consolidated Statements of Changes in Stockholders' Equity
For the Period November 2, 1995 (Date of Inception)
to July 31, 1998, and for the Nine Month Periods Ended April 30, 1999
(unaudited) F-6 to F-9
Consolidated Statements of Cash Flows
For the Years Ended July 31, 1998 and 1997,
For the Period November 2, 1995 (Date of Inception)
to July 31, 1996, for the Nine Months Ended April 30, 1999 and 1998 (unaudited)
and Cumulative From Inception to April 30, 1999 (unaudited) F-10
Notes to Consolidated Financial Statements F-11 to F-29
F-1
INDEPENDENT AUDITORS' REPORT
To the Board of Directors and Stockholders,
Generex Biotechnology Company:
We have audited the accompanying consolidated balance sheet of Generex
Biotechnology Company and Subsidiaries (a development stage company) as of July
31, 1998, and the related consolidated statements of operations, changes in
stockholders' equity and cash flows for the year then ended and the cumulative
amounts of operations and cash flows for the period November 2, 1995 (date of
inception) to July 31, 1998. These financial statements are the responsibility
of the Company's management. Our responsibility is to express an opinion on
these financial statements based on our audit.
We conducted our audit in accordance with 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 audit provides a reasonable basis for our opinion.
In our opinion, the consolidated 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, 1998 and the consolidated
results of its operations and its cash flows for the year then ended and the
cumulative amounts of operations and cash flows for the period November 2, 1995
(date of inception) to July 31, 1998, 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
October 15, 1998
F-2
INDEPENDENT AUDITORS' REPORTS
To the Board of Directors and Stockholders,
Generex Biotechnology Company:
We have audited the accompanying consolidated balance sheet of Generex
Biotechnology Company and Subsidiaries (a development stage company) as of July
31, 1997, and the related consolidated statements of operations, changes in
stockholders' equity and cash flows for the year then ended and for the period
November 2, 1995 (date of inception) to July 31, 1996. 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 financial position of Generex
Biotechnology Company and Subsidiaries as of July 31, 1997 and the consolidated
results of its operations and its cash flows for the year ended July 31, 1997
and for the period November 2, 1995 (date of inception) to July 31, 1996, 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
F-3
GENEREX BIOTECHNOLOGY CORPORATION
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED BALANCE SHEETS
July 31 April 30
---------------------------- ------------
1998 1997 1999
----------- ----------- ------------
(Unaudited)
ASSETS
Current Assets:
Cash and cash equivalents $ 2,090,827 $ 196,004 $ 3,859,362
Restricted cash 106,527 -- --
Miscellaneous receivables 209,090 168,234 159,629
Notes receivable -- 102,750 --
Other current assets 131,340 46,790 132,924
----------- ----------- ------------
Total Current Assets 2,537,784 513,778 4,151,915
Property and Equipment, Net 1,634,447 45,959 2,222,257
Deposits 82,509 -- 68,434
Due From Related Parties 1,200,968 3,113,038 824,437
----------- ----------- ------------
TOTAL ASSETS $ 5,455,708 $ 3,672,775 $ 7,267,043
=========== =========== ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Accounts payable and accrued expenses $ 1,253,004 $ 223,939 $ 520,541
Current maturities of long-term debt 411,565 -- 417,919
----------- ----------- ------------
Total Current Liabilities 1,664,569 223,939 938,460
Long-Term Debt, Less Current Maturities 912,817 -- 635,084
Due to Related Parties 236,024 -- 160,727
Commitments and Contingencies
Stockholders' Equity:
Preferred stock, $.001 par value; authorized 1,000,000 shares,
issued and outstanding 1,000, -0- and 1,000 shares at
July 31, 1998 and 1997 and April 30, 1999, respectively 1 -- 1
Common stock, $.001 par value; authorized 50,000,000 shares,
issued and outstanding 11,971,272, 9,000,118 and 13,727,937
shares at July 31, 1998 and 1997 and April 30, 1999, respectively 11,971 9,000 13,728
Additional paid-in capital 9,162,329 5,159,276 16,324,510
Deficit accumulated during the development stage (6,332,570) (1,718,966) (10,679,456)
Accumulated other comprehensive income (loss) (199,433) (474) (126,011)
----------- ----------- ------------
Total Stockholders' Equity 2,642,298 3,448,836 5,532,772
----------- ----------- ------------
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 5,455,708 $ 3,672,775 $ 7,267,043
=========== =========== ============
The Notes to Consolidated Financial Statements are an integral part of these
statements.
F-4
GENEREX BIOTECHNOLOGY CORPORATION
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENTS OF OPERATIONS
For the
Period Cumulative
November 2, from
1995 November 2,
(Date of (Date of
For the Years Ended Inception) For the Nine Months Ended Inception)
July 31, to April 30, to
-------------------------- July 31, -------------------------- April 30,
1998 1997 1996 1999 1998 1999
----------- ----------- ---------- ----------- ----------- ------------
(Unaudited) (Unaudited) (Unaudited)
Revenues $ -- $ -- $ -- $ -- $ -- $ --
Operating Expenses:
Research and development 707,520 676,145 67,142 1,716,514 335,304 3,167,321
Research and development - related party 168,884 51,334 -- 70,689 165,452 290,907
General and administrative 3,359,581 628,064 296,281 2,333,875 1,305,644 6,617,801
General and administrative - related party 314,328 -- -- 198,817 219,298 513,145
----------- ----------- --------- ----------- ----------- ------------
Total Operating Expenses 4,550,313 1,355,543 363,423 4,319,895 2,025,698 10,589,174
----------- ----------- --------- ----------- ----------- ------------
Operating Loss (4,550,313) (1,355,543) (363,423) (4,319,895) (2,025,698) (10,589,174)
Other Expense:
Interest income -- -- -- (6,934) -- (6,934)
Interest expense 63,291 -- -- 33,925 -- 97,216
----------- ----------- --------- ----------- ----------- ------------
Net Loss $(4,613,604) $(1,355,543) $(363,423) $(4,346,886) $(2,025,698) $(10,679,456)
=========== =========== ========= =========== =========== ============
Basic and Diluted Net Loss Per Common Share $ (.46) $ (.25) $ (.40) $ (.34) $ (.21)
=========== =========== ========= =========== ===========
Weighted Average Number of Shares of
Common Stock Outstanding 10,078,875 5,512,840 903,972 12,890,760 9,583,302
=========== =========== ========= =========== ===========
The Notes to Consolidated Financial Statements are an integral part of these
statements.
F-5
GENEREX BIOTECHNOLOGY CORPORATION
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY
FOR THE PERIOD NOVEMBER 2, 1995 (DATE OF INCEPTION) TO APRIL 30, 1999
Common Stock Preferred Stock
-------------------- ------------------
Shares Amount Shares Amount
--------- ------ ------ ------
Balance - November 2, 1995 (Inception) -- $ -- -- $ --
Issuance of common stock for cash,
February 1996, $.0254 321,429 321 -- --
Issuance of common stock for cash,
February 1996, $.0510 35,142 35 -- --
Issuance of common stock for cash,
February 1996, $.5099 216,428 216 -- --
Issuance of common stock for cash,
March 1996, $10.2428 2,500 3 -- --
Issuance of common stock for cash,
April 1996, $.0516 489,850 490 -- --
Issuance of common stock for cash,
May 1996, $.0512 115,571 116 -- --
Issuance of common stock for cash,
May 1996, $.5115 428,072 428 -- --
Issuance of common stock for cash,
May 1996, $10.2302 129,818 130 -- --
Issuance of common stock for cash,
July 1996, $.0051 2,606,528 2,606 -- --
Issuance of common stock for cash,
July 1996, $.0255 142,857 143 -- --
Issuance of common stock for cash,
July 1996, $.0513 35,714 36 -- --
Issuance of common stock for cash,
July 1996, $10.1847 63,855 64 -- --
Costs related to issuance of common stock -- -- -- --
Equity adjustment for foreign currency
translation -- -- -- --
Net loss -- -- -- --
--------- ------ -- -----
Balance - July 31, 1996 4,587,764 $4,588 -- $ --
========= ====== == =====
Equity
Adjustment Deficit
for Accumulated
Additional Foreign During the Total
Paid-In Currency Development Shareholders'
Capital Translation Stage Equity
---------- ----------- ----------- -------------
Balance - November 2, 1995 (Inception) $ -- $ -- $ -- $ --
Issuance of common stock for cash,
February 1996, $.0254 7,838 -- -- 8,159
Issuance of common stock for cash,
February 1996, $.0510 1,757 -- -- 1,792
Issuance of common stock for cash,
February 1996, $.5099 110,142 -- -- 110,358
Issuance of common stock for cash,
March 1996, $10.2428 25,604 -- -- 25,607
Issuance of common stock for cash,
April 1996, $.0516 24,773 -- -- 25,263
Issuance of common stock for cash,
May 1996, $.0512 5,796 -- -- 5,912
Issuance of common stock for cash,
May 1996, $.5115 218,534 -- -- 218,962
Issuance of common stock for cash,
May 1996, $10.2302 1,327,934 -- -- 1,328,064
Issuance of common stock for cash,
July 1996, $.0051 10,777 -- -- 13,383
Issuance of common stock for cash,
July 1996, $.0255 3,494 -- -- 3,637
Issuance of common stock for cash,
July 1996, $.0513 1,797 -- -- 1,833
Issuance of common stock for cash,
July 1996, $10.1847 650,282 -- -- 650,346
Costs related to issuance of common stock (10,252) -- -- (10,252)
Equity adjustment for foreign currency
translation -- (4,017) -- (4,017)
Net loss -- -- (363,423) (363,423)
---------- ------- --------- ----------
Balance - July 31, 1996 $2,378,476 $(4,017) $(363,423) $2,015,624
========== ======= ========= ==========
The Notes to Consolidated Financial Statements are an integral part of these
statements.
F-6
GENEREX BIOTECHNOLOGY CORPORATION
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY
FOR THE PERIOD NOVEMBER 2, 1995 (DATE OF INCEPTION) TO APRIL 30, 1999
Common Stock Preferred Stock
-------------------- -----------------
Shares Amount Shares Amount
--------- ------ ------ ------
Balance - August 1, 1996 4,587,764 $4,588 -- $ --
Issuance of common stock for cash,
September 1996, $.0509 2,143 2 -- --
Issuance of common stock for cash,
December 1996, $10.2421 1,429 1 -- --
Issuance of common stock for cash,
January 1997, $.0518 1,466 1 -- --
Issuance of common stock for cash,
March 1997, $10.0833 12 -- -- --
Issuance of common stock for cash,
May 1997, $.0513 4,233 4 -- --
Issuance of common stock for cash,
May 1997, $.5060 4,285,714 4,286 -- --
Costs related to issuance of common
stock, May 1997 -- -- -- --
Issuance of common stock for cash,
May 1997, $10.1194 18,214 18 -- --
Issuance of common stock for cash,
June 1997, $.0504 10,714 11 -- --
Issuance of common stock for cash,
June 1997, $.5047 32,143 32 -- --
Issuance of common stock for cash,
June 1997, $8.9810 29,579 30 -- --
Issuance of common stock for cash,
June 1997, $10.0980 714 1 -- --
Issuance of common stock for cash,
July 1997, $10.1214 25,993 26 -- --
Costs related to issuance of common stock -- -- -- --
Equity adjustment for foreign currency
translation -- -- -- --
Net loss -- -- -- --
--------- ------ -- -----
Balance - July 31, 1997 9,000,118 $9,000 -- $ --
========= ====== == =====
Equity
Adjustment Deficit
for Accumulated
Additional Foreign During the Total
Paid-In Currency Development Shareholders'
Capital Translation Stage Equity
---------- ----------- ----------- -------------
Balance - August 1, 1996 $2,378,476 $(4,017) $ (363,423) $2,015,624
Issuance of common stock for cash,
September 1996, $.0509 107 -- -- 109
Issuance of common stock for cash,
December 1996, $10.2421 14,635 -- -- 14,636
Issuance of common stock for cash,
January 1997, $.0518 75 -- -- 76
Issuance of common stock for cash,
March 1997, $10.0833 121 -- -- 121
Issuance of common stock for cash,
May 1997, $.0513 213 -- -- 217
Issuance of common stock for cash,
May 1997, $.5060 2,164,127 -- -- 2,168,413
Costs related to issuance of common
stock, May 1997 (108,421) -- -- (108,421)
Issuance of common stock for cash,
May 1997, $10.1194 184,297 -- -- 184,315
Issuance of common stock for cash,
June 1997, $.0504 529 -- -- 540
Issuance of common stock for cash,
June 1997, $.5047 16,190 -- -- 16,222
Issuance of common stock for cash,
June 1997, $8.9810 265,618 -- -- 265,648
Issuance of common stock for cash,
June 1997, $10.0980 7,209 -- -- 7,210
Issuance of common stock for cash,
July 1997, $10.1214 263,060 -- -- 263,086
Costs related to issuance of common stock (26,960) -- -- (26,960)
Equity adjustment for foreign currency
translation -- 3,543 -- 3,543
Net loss -- -- (1,355,543) (1,355,543)
---------- ------- ----------- ----------
Balance - July 31, 1997 $5,159,276 $ (474) $(1,718,966) $3,448,836
========== ======= =========== ==========
The Notes to Consolidated Financial Statements are an integral part of these
statements.
F-7
GENEREX BIOTECHNOLOGY CORPORATION
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY
FOR THE PERIOD NOVEMBER 2, 1995 (DATE OF INCEPTION) TO APRIL 30, 1999
Common Stock Preferred Stock
---------------------- -----------------
Shares Amount Shares Amount
---------- ------- ------ ------
Balance - August 1, 1997 9,000,118 $ 9,000 -- $--
Issuance of warrants in exchange for
services rendered, October 1997, $.50 -- -- -- --
Exercise of warrants for cash, December
1997, $0.0467 234,000 234 -- --
Shares issued pursuant to the January 9, 1998
reverse merger between GBT-Delaware, Inc.
and Generex Biotechnology Corporation 1,105,000 1,105 -- --
Issuance of preferred stock for
services rendered, January 1998, $.001 -- -- 1,000 1
Issuance of common stock for cash,
March 1998, $2.50 70,753 71 -- --
Issuance of common stock for cash,
April 1998, $2.50 60,000 60 -- --
Issuance of common stock in exchange
for services rendered, April 1998, $2.50 38,172 38 -- --
Issuance of common stock for cash,
May 1998, $2.50 756,500 757 -- --
Issuance of warrants in exchange for
services rendered, May 1998, $.50 -- -- -- --
Issuance of common stock in exchange
for services rendered, May 1998, $2.50 162,000 162 -- --
Issuance of common stock for cash,
June 1998, $2.50 286,000 286 -- --
Exercise of warrants for cash, June 1998,
$.0667 234,000 234 -- --
Issuance of common stock in exchange
for services rendered, June 1998, $2.50 24,729 24 -- --
Equity adjustment for foreign currency
translation -- -- -- --
Net loss -- -- -- --
---------- ------- ----- ---
Balance - July 31, 1998 11,971,272 $11,971 1,000 $ 1
========== ======= ===== ===
Equity
Adjustment Deficit
for Accumulated
Additional Foreign During the Total
Paid-In Currency Development Shareholders'
Capital Translation Stage Equity
---------- ----------- ------------ -------------
Balance - August 1, 1997 $5,159,276 $ (474) $(1,718,966) $3,448,836
Issuance of warrants in exchange for
services rendered, October 1997, $.50 234,000 -- -- 234,000
Exercise of warrants for cash,
December 1997, $0.0467 10,698 -- -- 10,932
Shares issued pursuant to the January 9, 1998
reverse merger between GBT-Delaware, Inc.
and Generex Biotechnology Corporation (1,105) -- -- --
Issuance of preferred stock for
services rendered, January 1998, $.001 99 -- -- 100
Issuance of common stock for cash,
March 1998, $2.50 176,812 -- -- 176,883
Issuance of common stock for cash,
April 1998, $2.50 149,940 -- -- 150,000
Issuance of common stock in exchange
for services rendered, April 1998, $2.50 95,392 -- -- 95,430
Issuance of common stock for cash,
May 1998, $2.50 1,890,493 -- -- 1,891,250
Issuance of warrants in exchange for
services rendered, May 1998, $.50 250,000 -- -- 250,000
Issuance of common stock in exchange
for services rendered, May 1998, $2.50 404,838 -- -- 405,000
Issuance of common stock for cash,
June 1998, $2.50 714,714 -- -- 715,000
Exercise of warrants for cash, June 1998,
$.0667 15,373 -- -- 15,607
Issuance of common stock in exchange
for services rendered, June 1998, $2.50 61,799 -- -- 61,823
Equity adjustment for foreign currency
translation -- (198,959) -- (198,959)
Net loss -- -- (4,613,604) (4,613,604)
---------- --------- ----------- ----------
Balance - July 31, 1998 $9,162,329 $(199,433) $(6,332,570) $2,642,298
========== ========= =========== ==========
The Notes to Consolidated Financial Statements are an integral part of these
statements.
F-8
GENEREX BIOTECHNOLOGY CORPORATION
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY
FOR THE PERIOD NOVEMBER 2, 1995 (DATE OF INCEPTION) TO APRIL 30, 1999
Common Stock Preferred Stock
---------------------- -----------------
Shares Amount Shares Amount
---------- ------- ------ ------
Balance - August 1, 1998 11,971,272 $11,971 1,000 $ 1
Issuance of common stock for cash,
August 1998, $3.00 100,000 100 -- --
Issuance of common stock for cash,
August 1998, $3.50 19,482 19 -- --
Redemption of common stock for cash,
September 1998, $9.1732 (15,357) (15) -- --
Issuance of common stock for cash,
September - October 1998, $3.00 220,297 220 -- --
Issuance of common stock for cash,
August - October 1998, $4.10 210,818 211 -- --
Issuance of common stock in exchange
for services rendered, August -
October 1998, $2.50 21,439 21 -- --
Issuance of common stock in exchange
for services rendered, August -
October 1998, $4.10 18,065 18 -- --
Issuance of common stock to satisfy
accrued liability, September 1998, $4.10 180,000 180 -- --
Issuance of common stock for cash,
November 1998 - January 1999, $3.50 180,000 180 -- --
Issuance of common stock for cash,
November 1998 - January 1999, $4.00 275,000 275 -- --
Issuance of common stock for cash,
November 1998 - January 1999, $4.10 96,852 97 -- --
Issuance of common stock in exchange
for services rendered, November 1998
- January 1999, $4.10 28,718 29 -- --
Issuance of common stock for cash,
November 1998 - January 1999, $5.00 20,000 20 -- --
Issuance of common stock for cash,
November 1998 - January 1999, $5.50 15,000 15 -- --
Issuance of stock options in exchange
for services rendered November 1998, $1.00 -- -- -- --
Issuance of warrants in exchange for
services rendered November 1998, $1.00 -- -- -- --
Issuance of common stock for cash,
February 1999, $5.00 6,000 6 -- --
Issuance of common stock in exchange
for services rendered February 1999, $6.00 5,000 5 -- --
Issuance of common stock for cash,
March 1999, $6.00 11,000 11 -- --
Issuance of common stock for cash,
April 1999, $5.50 363,637 364 -- --
Issuance of warrants in exchange for
services rendered April 1999, $2.00 -- -- -- --
Stock adjustment 714 1 -- --
Cost related to issuance of common stock -- -- -- --
Equity adjustment for foreign currency
translation -- -- -- --
Net loss -- -- -- --
---------- ------- ----- ----
Balance - April 30, 1999 (Unaudited) 13,727,937 $13,728 1,000 $ 1
========== ======= ===== ====
Equity
Adjustment Deficit
for Accumulated
Additional Foreign During the Total
Paid-In Currency Development Shareholders'
Capital Translation Stage Equity
---------- ----------- ------------- -------------
Balance - August 1, 1998 $ 9,162,329 (199,433) $ (6,332,570) $2,642,298
Issuance of common stock for cash,
August 1998, $3.00 299,900 -- -- 300,000
Issuance of common stock for cash,
August 1998, $3.50 68,168 -- -- 68,187
Redemption of common stock for cash,
September 1998, $9.1732 (140,858) -- -- (140,873)
Issuance of common stock for cash,
September - October 1998, $3.00 660,671 -- -- 660,891
Issuance of common stock for cash,
August - October 1998, $4.10 864,142 -- -- 864,353
Issuance of common stock in exchange
for services rendered, August -
October 1998, $2.50 53,577 -- -- 53,598
Issuance of common stock in exchange
for services rendered, August -
October 1998, $4.10 74,048 -- -- 74,066
Issuance of common stock to satisfy
accrued liability, September 1998, $4.10 737,820 -- -- 738,000
Issuance of common stock for cash,
November 1998 - January 1999, $3.50 629,820 -- -- 630,000
Issuance of common stock for cash,
November 1998 - January 1999, $4.00 1,099,725 -- -- 1,100,000
Issuance of common stock for cash,
November 1998 - January 1999, $4.10 397,003 -- -- 397,100
Issuance of common stock in exchange
for services rendered, November 1998
- January 1999, $4.10 117,715 -- -- 117,744
Issuance of common stock for cash,
November 1998 - January 1999, $5.00 99,980 -- -- 100,000
Issuance of common stock for cash,
November 1998 - January 1999, $5.50 82,485 -- -- 82,500
Issuance of stock options in exchange
for services rendered November 1998, $1.00 50,000 -- -- 50,000
Issuance of warrants in exchange for
services rendered November 1998, $1.00 150,000 -- -- 150,000
Issuance of common stock for cash,
February 1999, $5.00 29,994 -- -- 30,000
Issuance of common stock in exchange
for services rendered February 1999, $6.00 29,995 -- -- 30,000
Issuance of common stock for cash,
March 1999, $6.00 65,989 -- -- 66,000
Issuance of common stock for cash,
April 1999, $5.50 1,999,640 -- -- 2,000,004
Issuance of warrants in exchange for
services rendered April 1999, $2.00 400,000 -- -- 400,000
Stock adjustment (1) -- -- --
Cost related to issuance of common stock (607,632) -- -- (607,632)
Equity adjustment for foreign currency
translation -- 73,422 -- 73,422
Net loss -- -- (4,346,886) (4,346,886)
----------- --------- ------------ ----------
Balance - April 30, 1999 (Unaudited) $16,324,510 $(126,011) $(10,679,456) $5,532,772
=========== ========= ============ ==========
The Notes to Consolidated Financial Statements are an integral part of these
statements.
F-9
GENEREX BIOTECHNOLOGY CORPORATION
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENTS OF CASH FLOWS
For the
Period
November 2,
1995
(Date of
For the Years Ended Inception)
July 31, to
---------------------------- July 31,
1998 1997 1996
----------- ----------- ----------
Cash Flows From Operating Activities:
Net loss $(4,613,604) $(1,355,543) $(363,423)
Adjustments to reconcile net loss to net cash used in
operating activities:
Depreciation 31,096 10,411 2,578
Common stock issued for services rendered 562,253 -- --
Stock options and warrants issued for services rendered 484,000 -- --
Preferred stock issued for services rendered 100 -- --
Changes in operating assets and liabilities:
Miscellaneous receivables -- (119,967) (50,212)
Other current assets (89,268) (37,020) (10,289)
Accounts payable and accrued liabilities 1,099,815 226,131 --
Other, net 110,317 -- --
----------- ----------- ----------
Net Cash Used in Operating Activities (2,415,291) (1,275,988) (421,346)
Cash Flows From Investing Activities:
Purchase of property and equipment (16,287) (41,987) (17,499)
Change in restricted cash (111,250) -- --
Change in deposits (17,601) -- --
Change in notes receivable 104,153 (104,153) --
Increase (decrease) in subscriptions receivable -- 1,527,606 (1,527,606)
Change in due from related parties 154,945 (2,740,260) (389,071)
Other, net 89,683 -- --
----------- ----------- ----------
Net Cash Provided By (Used in) Investing Activities 203,643 (1,358,794) (1,934,176)
Cash Flows From Financing Activities:
Proceeds from issuance of long-term debt 993,149 -- --
Repayment of long-term debt (63,389) -- --
Change in due to related parties 236,024 -- --
Proceeds from issuance of common stock, net 2,959,672 2,785,212 2,383,064
Purchase and retirement of common stock -- -- --
----------- ----------- ----------
Net Cash Provided By Financing Activities 4,125,456 2,785,212 2,383,064
Effect of Exchange Rates on Cash (18,985) 17,251 781
----------- ----------- ----------
Net Increase (Decrease) in Cash and Cash Equivalents 1,894,823 167,681 28,323
Cash and Cash Equivalents, Beginning of Period 196,004 28,323 --
---------- ----------- ----------
Cash and Cash Equivalents, End of Period $ 2,090,827 $ 196,004 $ 28,323
=========== =========== ==========
Cumulative
From
November 2,
1995
(Date of
For the Nine Months Ended Inception)
April 30, to
---------------------------- April 30,
1999 1998 1999
------------ ----------- ------------
(Unaudited) (Unaudited) (Unaudited)
Cash Flows From Operating Activities:
Net loss $(4,346,886) $(2,025,698) $(10,679,456)
Adjustments to reconcile net loss to net cash used in
operating activities:
Depreciation 29,161 21,394 73,246
Common stock issued for services rendered 275,408 433,245 837,661
Stock options and warrants issued for services rendered 600,000 234,000 1,084,000
Preferred stock issued for services rendered -- 100 100
Changes in operating assets and liabilities:
Miscellaneous receivables 55,227 -- (114,952)
Other current assets 146 21,252 (136,431)
Accounts payable and accrued liabilities 578 345,864 1,326,524
Other, net 67,836 (8,969) 178,153
------------ ----------- ------------
Net Cash Used in Operating Activities (3,318,530) (978,812) (7,431,155)
Cash Flows From Investing Activities:
Purchase of property and equipment (465,358) (15,713) (541,131)
Change in restricted cash 105,655 (76,047) (5,595)
Change in deposits 16,581 -- (1,020)
Change in notes receivable -- 100,453 --
Increase (decrease) in subscriptions receivable -- -- --
Change in due from related parties 405,728 919 (2,568,658)
Other, net -- -- 89,683
------------ ----------- ------------
Net Cash Provided By (Used in) Investing Activities 62,606 9,612 (3,026,721)
Cash Flows From Financing Activities:
Proceeds from issuance of long-term debt -- 850,365 993,149
Repayment of long-term debt (391,860) -- (455,249)
Change in due to related parties (80,981) 62,046 155,043
Proceeds from issuance of common stock, net 5,691,403 -- 13,819,351
Purchase and retirement of common stock (140,873) -- (140,873)
------------ ----------- ------------
Net Cash Provided By Financing Activities 5,077,689 912,411 14,371,421
Effect of Exchange Rates on Cash (53,230) 5,311 (54,183)
------------ ----------- ------------
Net Increase (Decrease) in Cash and Cash Equivalents 1,768,535 (51,478) 3,859,362
Cash and Cash Equivalents, Beginning of Period 2,090,827 196,004 --
------------ ----------- ------------
Cash and Cash Equivalents, End of Period $ 3,859,362 $ 144,526 $ 3,859,362
============ =========== ============
F-10
GENEREX BIOTECHNOLOGY CORPORATION
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(INFORMATION RELATING TO THE NINE MONTHS ENDED APRIL 30, 1999
AND 1998 AND CUMULATIVE FROM NOVEMBER 2, 1995 (DATE OF INCEPTION)
TO APRIL 30, 1999 IS UNAUDITED)
Note 1 - Organization and Business:
Generex Biotechnology Corporation (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 GBT -
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
GBT - Delaware, Inc. were the same shareholders of Generex
Pharmaceuticals. As a result of this acquisition, the former
shareholders of GBT -Delaware, Inc. acquired approximately 90 percent
of the Company's outstanding capital stock. GBT - Delaware, Inc. was
treated as the acquiror in this transaction for accounting purposes,
and accordingly, the historical financial statements of GBT -
Delaware, Inc., prior to the acquisition date, are deemed to be the
historical financial statements of the Company.
On April 30, 1999, the Company reincorporated in the State of
Delaware. This was accomplished by a merger of the Company with its
wholly owned subsidiary GBC-Delaware, Inc. The reincorporation will
not have an effect on the Company's capitalization, management or
business operations.
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.
F-11
GENEREX BIOTECHNOLOGY CORPORATION
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(INFORMATION RELATING TO THE NINE MONTHS ENDED APRIL 30, 1999
AND 1998 AND CUMULATIVE FROM NOVEMBER 2, 1995 (DATE OF INCEPTION)
TO APRIL 30, 1999 IS UNAUDITED)
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.
Restricted Cash
The Company maintains cash funds held in trust by an attorney for the
future purchase of the Company's stock pursuant to an agreement (see
Note 7).
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 $153,597, $168,234 and $159,629 of such
a receivable due from the Canadian government at July 31, 1998 and
1997 and April 30, 1999, respectively.
Income Taxes
Income taxes are accounted for under the asset and liability method
prescribed by SFAS No. 109, "Accounting for Income Taxes." Deferred
income taxes are recorded for temporary differences between financial
statement carrying amounts and the tax bases 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.
F-12
GENEREX BIOTECHNOLOGY CORPORATION
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(INFORMATION RELATING TO THE NINE MONTHS ENDED APRIL 30, 1999
AND 1998 AND CUMULATIVE FROM NOVEMBER 2, 1995 (DATE OF INCEPTION)
TO APRIL 30, 1999 IS UNAUDITED)
Note 3 - Summary of Significant Accounting Policies (Continued):
Net Loss Per Common Share
The Company has adopted SFAS No. 128, "Earnings per Share" ("FAS
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). FAS 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 Income/(Loss)
Effective August 1, 1998, the Company adopted the provisions of
Statement No. 130, "Reporting Comprehensive Income," which modifies
the financial statement presentation of comprehensive income and its
components. Adoption of this statement had no effect on the Company's
financial position or operating results.
Comprehensive loss amounted to $(4,812,563), $(1,352,000) and
$(367,440) for the years ended July 31, 1998 and 1997 and for the
period November 2, 1995 (date of inception) to July 31, 1996,
respectively, and for the nine months ended April 30, 1999 and 1998
amounted to $(4,273,464) and $(2,124,799), respectively.
New Accounting Standards
The Company will adopt FAS No. 131, "Disclosures about Segments of an
Enterprise and Related Information" in fiscal 1999. This statement
supercedes FAS No. 14, "Financial Reporting for Segments of a
Business Enterprise," but retains the requirement to report
information about major customers. This statement establishes
standards for reporting information about operating segments in
annual financial statements. Operating segments are defined as
components of an enterprise evaluated regularly by the Company's
senior management in deciding how to allocate resources and in
assessing performance. The Company believes that adoption of this
statement will not have a material effect on its financial
statements.
In 1998, Statement of Financial Accounting Statement No. 133,
"Accounting for Derivative Instruments and Hedging Activities" (SFAS
No. 133) was issued. SFAS No. 133 modifies the accounting for
derivative and hedging activities and is effective for fiscal years
beginning after December 15, 1999. The Company believes that the
adoption of SFAS No. 133 will not have a material impact on the
Company's financial reporting.
F-13
GENEREX BIOTECHNOLOGY CORPORATION
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(INFORMATION RELATING TO THE NINE MONTHS ENDED APRIL 30, 1999
AND 1998 AND CUMULATIVE FROM NOVEMBER 2, 1995 (DATE OF INCEPTION)
TO APRIL 30, 1999 IS UNAUDITED)
Note 3 - Summary of Significant Accounting Policies (Continued):
Concentration of Credit Risk
The Company maintains cash balances, at times, with financial
institutions in excess of amounts insured by the Federal 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 resulting
from transactions which have been consummated, but final funds have
not yet been disbursed. 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.
Interim Financial Data (Unaudited)
The unaudited financial data as of and for the nine months ended
April 30, 1999 and 1998 have been prepared by management and include
all adjustments which, in management's opinion, are necessary to
present fairly the Company's financial condition, results of
operations and cash flows. The results of operations for the nine
months ended April 30, 1999 and are not necessarily indicative of the
operating results to be expected for the year ended July 31, 1999.
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 rate which were in
effect during the period. Translation adjustments that arise from
translating the foreign subsidiary's financial statements from local
currency US dollars 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.
Note 4 - Property and Equipment:
The costs and accumulated depreciation of property and equipment are
summarized as follows:
July 31, April 30,
----------------------------- -------------
1998 1997 1999
-------------- ----------- -------------
Land $ 239,810 $ -- $ 269,519
Buildings 1,366,956 -- 1,954,422
Furniture and Fixtures 7,998 5,938 8,312
Office Equipment 60,850 52,869 63,240
-------------- ----------- -------------
Total Property and Equipment 1,675,614 58,807 2,295,493
Less: Accumulated Depreciation 41,167 12,848 73,236
-------------- ----------- -------------
Property and Equipment, Net $ 1,634,447 $ 45,959 $ 2,222,257
============== =========== =============
F-14
GENEREX BIOTECHNOLOGY CORPORATION
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(INFORMATION RELATING TO THE NINE MONTHS ENDED APRIL 30, 1999
AND 1998 AND CUMULATIVE FROM NOVEMBER 2, 1995 (DATE OF INCEPTION)
TO APRIL 30, 1999 IS UNAUDITED)
Note 4 - Property and Equipment (Continued):
Depreciation expense amounted to $31,096, $10,411 and $2,578 for the
years ended July 31, 1998 and 1997, and the period November 2, 1995
(date of inception) to July 31, 1996, respectively, and $29,161 and
$21,394 for the nine months ended April 30, 1999 and 1998,
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 $4,500,000 at July 31, 1998 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 2018.
These loss carryforwards are subject to limitation on future years
utilization should certain ownership changes occur.
For the years ended July 31, 1998 and 1997 and for the period
November 2, 1995 (date of inception) to July 31, 1996, 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,
--------------------------------
1998 1997
--------------- -------------
Net operating loss carryforwards $ 2,008,795 $ 750,500
Research and development tax credits 75,705 22,362
Depreciation and amortization 204,755 23,035
Accrued liabilities 118,914 --
--------------- -------------
Total deferred tax assets 2,408,169 795,897
Valuation allowance (2,408,169) (795,897)
--------------- -------------
Net deferred tax assets $ -- $ --
=============== =============
Note 6 - Accounts Payable and Accrued Expense:
Accounts payable and accrued expenses consist of the following:
July 31, April 30,
-------------------------------- --------------
1998 1997 1999
--------------- ------------- --------------
Accounts Payable $ 336,634 $ 223,939 $ 449,055
Penalty Arising from Violation of
Financing Agreement (A) 738,000 -- --
Consulting Accruals 151,945 -- 71,486
Building Purchase Liability 26,425 -- --
--------------- ------------- ------------
Total $ 1,253,004 $ 223,939 $ 520,541
=============== ============= =============
(A) See Note 9 for further discussion of underlying debt and penalty
amount.
F-15
GENEREX BIOTECHNOLOGY CORPORATION
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(INFORMATION RELATING TO THE NINE MONTHS ENDED APRIL 30, 1999
AND 1998 AND CUMULATIVE FROM NOVEMBER 2, 1995 (DATE OF INCEPTION)
TO APRIL 30, 1999 IS UNAUDITED)
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, 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, all of which
was included in accounts payable at July 31, 1998.
On March 17, 1998, the Company entered into separate consulting
agreements with two consultants to assist the Company: to test and
evaluate the therapeutic effects of its formulations; to develop
protocols for testing its formulations; to review and provide
suggestions in respect of draft submissions to regulatory authorities
and otherwise assist the Company in its efforts to obtain regulatory
approvals for its formulations in various jurisdictions, including
its efforts to obtain approvals of any Ethics Committees of
institutions with which the Consultants are ordinarily affiliated; to
arrange and in some cases to conduct clinical trials of its
formulations in Canada; and to provide input and assistance with
respect to, and evaluate results of, clinical trials in other
jurisdictions. The Consultants shall also attend meetings with
regulators and assist the Company in making presentations to
regulators when reasonably convenient.
F-16
GENEREX BIOTECHNOLOGY CORPORATION
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(INFORMATION RELATING TO THE NINE MONTHS ENDED APRIL 30, 1999
AND 1998 AND CUMULATIVE FROM NOVEMBER 2, 1995 (DATE OF INCEPTION)
TO APRIL 30, 1999 IS UNAUDITED)
Note 7 - Commitments and Contingent Liabilities (Continued):
Consulting Services (Continued)
Under the terms of the agreement, the Company will pay retainer fees
of $10,000 per consultant each on August 1, 1998, December 1, 1998,
March 1, 1999 and July 1, 1999. In addition, the Company will pay an
hourly or per diem amount for all services actually rendered and
reimburse reasonable and necessary travel and lodging expenses
incurred incident to services rendered. The agreement shall terminate
on December 31, 2000.
Also on March 17, 1998, the Company entered into separate consulting
agreements with two additional consultants to assist the Company: to
test and evaluate the therapeutic effects of its formulations; to
develop protocols for testing its formulations; to review and provide
suggestions in respect of draft submissions to regulatory authorities
and otherwise assist the Company in its efforts to obtain regulatory
approvals for its formulations in various jurisdictions, including
its efforts to obtain approvals of any Ethics Committees of
institutions with which the Consultants' representatives are
ordinarily affiliated; and to provide input and assistance with
respect to, and evaluate results of, clinical trials in other
jurisdictions. The additional Consultants shall also attend meetings
with regulators and assist the Company in making presentations to
regulators when reasonably convenient.
Under the terms of the agreement, the Company will pay an hourly or
per diem fee for all services actually rendered and reimburse
reasonable and necessary travel and lodging expenses incurred
incident to services rendered. The agreement shall terminate on
December 31, 2000.
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 under the 1998 stock option plan.
The agreement shall terminate on December 31, 2000.
On December 1, 1998, the Company entered into a consulting agreement
with a consultant to assist the Company: to test and evaluate the
therapeutic effects of its formulations; to develop protocols for
testing its formulations; to review and provide suggestions in
respect of draft submissions to regulatory authorities and otherwise
assist the Company in its efforts to obtain regulatory approvals for
its formulations in various jurisdictions, including its efforts to
obtain approvals of any Ethics Committees of institutions with which
the Consultant is ordinarily affiliated; to arrange and in some cases
to conduct clinical trials of its formulations in the Untied States;
and to provide input and assistance with respect to, and evaluate
results of, clinical trials in other jurisdictions. The Consultant
shall also act as the Principal Investigator in the United States for
Phase II and Phase III clinical trials of the Company's oral insulin
formulation that are contemplated by the Investigational New Drug
application filed by the Company with the Food and Drug
Administration on October 31, 1998. The Consultant shall also attend
meetings with regulators and assist the Company in making
presentations to regulators when reasonably convenient.
Under the terms of the agreement, the Company will pay retainer fees
of $10,000 on January 1, 1999 and an additional retainer of $7,500 on
April 30, 1999 and October 31, 1999. In addition, the Company will
pay an hourly or per diem amount for all services actually rendered
and reimburse reasonable and necessary travel and lodging expenses
incurred incident to services rendered. The agreement shall terminate
on December 31, 2000.
F-17
GENEREX BIOTECHNOLOGY CORPORATION
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(INFORMATION RELATING TO THE NINE MONTHS ENDED APRIL 30, 1999
AND 1998 AND CUMULATIVE FROM NOVEMBER 2, 1995 (DATE OF INCEPTION)
TO APRIL 30, 1999 IS UNAUDITED)
Note 7 - Commitments and Contingent Liabilities (Continued):
Consulting Services (Continued)
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, 1998 are as follows:
Year Amount
---- -----------
1999 $ 13,078
2000 10,004
2001 5,990
2002 4,446
Thereafter 253
-----------
Total Minimum Lease Payments $ 33,771
===========
Lease expense amounted to $50,757, $9,206 and $6,946 for the years
ended July 31, 1998 and 1997 and for the period November 2, 1995
(date of inception) to July 31, 1996, respectively and $12,995 for
the nine months ended April 30, 1999.
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.
F-18
GENEREX BIOTECHNOLOGY CORPORATION
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(INFORMATION RELATING TO THE NINE MONTHS ENDED APRIL 30, 1999
AND 1998 AND CUMULATIVE FROM NOVEMBER 2, 1995 (DATE OF INCEPTION)
TO APRIL 30, 1999 IS UNAUDITED)
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. The Company, pursuant to a debt
agreement with Romspen Investment Corporation, has assigned their
interest in these lease payments to a management company who then
also pays certain expenses related to these rental units. This
assignment will end on December 31, 1998, or when the additional
amount of $26,425 (see Note 6) is paid to the prior owner of the
properties. Once the assignment period ends, the Company will be
entitled to the sublease rental income from the other tenants. Based
upon the estimated ending of the assignment period of February 28,
1999, the following represents the approximate amount of sublease
income to be received in years ending after July 31, 1998:
Year Amount
---- -------------
1999 $ 126,000
2000 104,000
2001 6,000
2002 --
2003 --
-------------
Total $ 236,000
=============
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 (NYSE) 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 GBT - 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 GBT - 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. Hearings were held before an arbitration panel of the NYSE
the week of June 7, 1999, and on July 6, 1999. Additional hearings
are expected to be held in July 1999. The Company is unable to
predict the outcome at this time. However, the Company intends to
vigorously defend itself in this matter and does not expect that the
ultimate resolution of this matter will have a material effect on its
results of operations and financial condition.
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.
F-19
GENEREX BIOTECHNOLOGY CORPORATION
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(INFORMATION RELATING TO THE NINE MONTHS ENDED APRIL 30, 1999
AND 1998 AND CUMULATIVE FROM NOVEMBER 2, 1995 (DATE OF INCEPTION)
TO APRIL 30, 1999 IS UNAUDITED)
Note 7 - Commitments and Contingent Liabilities (Continued):
An action was also commenced against GPI and other companies and
individuals seeking approximately $4,080,000 for allegedly causing
certain adverse consequences of a plaintiff's investment in a
particular company. The Plantiff's amended Statement of Claim refers
to GPI and mis-identifies it as a subsidiary of another corporation.
The specific acts alleged in the Statement of Claim are attributed to
other defendants and occurred prior to GPI's incorporation in
November 1995. 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 an permit
the Company to enter a statement of defense. Due to the delay in
filing the application there is substantial doubt that the Company
will be successful in setting aside the notice of default which would
also 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.
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 for a total purchase price of $142,035, payable in four
equal installments commencing December 31, 1997, to be held in trust
by the shareholder's legal counsel. Each installment is to be
released to the shareholder upon delivery of the related shares to
the Company or its legal counsel (the Company). The shareholder
maintains the right at any time to advise the Company, in writing,
which shall be irrevocable, that the shareholder will forego any of
the four installments, in which case the Company shall have no
obligation to deliver payment for that portion of the shares. As of
July 31, 1998, the Company had not been advised that the shareholder
would forego any payments and had not received any of the shares for
which funds were held in trust. The Company's funding for this
potential share repurchase is being maintained in an attorney trust
account and has been labeled "Restricted Cash" on the July 31, 1998
consolidated balance sheet (see Note 14). The settlement was
concluded in September 1998.
F-20
GENEREX BIOTECHNOLOGY CORPORATION
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(INFORMATION RELATING TO THE NINE MONTHS ENDED APRIL 30, 1999
AND 1998 AND CUMULATIVE FROM NOVEMBER 2, 1995 (DATE OF INCEPTION)
TO APRIL 30, 1999 IS UNAUDITED)
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.
----------- ---------- ----------- --------- ----------- --------------
Balance, Nov. 2,
1995 (Date of
Inception) $ -- $ -- $ -- $ -- $ -- $ --
Company expenses
paid by related parties -- (6,946) -- -- -- --
Related party expenses
paid by the Company 55,127 340,891 -- -- -- --
Other (570) (3,450) -- -- -- --
------------ ----------- ----------- --------- ----------- --------------
Ending Balance,
July 31, 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 -- (82,345) -- -- (16,883) --
Company expenses
paid by related parties -- (262,459) (60,434) -- (53,281) --
Related party expenses
paid by the Company -- 3,456 141,414 -- -- --
Other (4,012) 9,228 (1,667) (4) 12,569 13,184
------------ ----------- ----------- --------- ----------- -------------
Ending Balance,
April 30, 1999 $ (106,167) $ 287,761 $ (54,462) $ (98) $ 187,782 $ 348,894
============ =========== =========== ========= =========== =============
F-21
GENEREX BIOTECHNOLOGY CORPORATION
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(INFORMATION RELATING TO THE NINE MONTHS ENDED APRIL 30, 1999
AND 1998 AND CUMULATIVE FROM NOVEMBER 2, 1995 (DATE OF INCEPTION)
TO APRIL 30, 1999 IS UNAUDITED)
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
July 31, 1998 Parties Parties
------------- ---------- ----------
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
========== ==========
July 31, 1997
-------------
The Great Tao, Inc. $ 126,628 $ --
Angara Equities, Inc. 815,643 --
Angara Investments, Inc. -- --
Ching Chew An Breweries -- --
Golden Bull Estates, Inc. -- --
EBI, Inc. 2,170,767 --
---------- ----------
Total $3,113,038 $ --
========== ==========
April 30, 1999
--------------
The Great Tao, Inc. $ -- $ 106,167
Angara Equities, Inc. 287,761 --
Angara Investments, Inc. -- 54,462
Ching Chew An Breweries -- 98
Golden Bull Estates, Inc. 187,782 --
EBI, Inc. 348,894 --
---------- ----------
Total $ 824,437 $ 160,727
========== ==========
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.
F-22
GENEREX BIOTECHNOLOGY CORPORATION
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(INFORMATION RELATING TO THE NINE MONTHS ENDED APRIL 30, 1999
AND 1998 AND CUMULATIVE FROM NOVEMBER 2, 1995 (DATE OF INCEPTION)
TO APRIL 30, 1999 IS UNAUDITED)
Note 8 - Related Party Transactions (Continued):
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 1996 and 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 Period
For the Years Ended July 31, November 2, 1995
---------------------------------- (Date of Inception)
1998 1997 to July 31, 1996
------------- ------------- -------------------
Rental Expense $ -- $ 36,826 $ 27,784
Interest Income $ 273,429 $ 75,488 $ 13,382
Interest Expense $ 113,064 339 132
The interest income/expense amounts were computed at estimated
prevailing rates based on the weighted average receivable/payable
balance outstanding during the periods reflected. The weighted
average receivable amount was $3,621,422, $1,015,783 and $198,679
during the years ended 1998 and 1997 and for the period November 2,
1995 (date of inception) to July 31, 1996. The weighted average
amount payable was $1,043,413, $3,932 and $899 during the years ended
1998 and 1997 and for the period November 2, 1995 (date of inception)
to July 31, 1996.
As of July 31, 1998, 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 $280,000, $-0- and $-0- for
the years ended July 31, 1998 and 1997 and for the period November 2,
1995 (date of inception) to July 31, 1996.
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.
F-23
GENEREX BIOTECHNOLOGY CORPORATION
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(INFORMATION RELATING TO THE NINE MONTHS ENDED APRIL 30, 1999
AND 1998 AND CUMULATIVE FROM NOVEMBER 2, 1995 (DATE OF INCEPTION)
TO APRIL 30, 1999 IS UNAUDITED)
Note 9 - Long-Term Debt:
Long-term debt consists of the following:
July 31, April 30,
------------------------- ----------
1998 1997 1999
---------- -------- ----------
Mortgage payable - Romspen Investment Corporation, 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 Suites #202 and #3501,
which is owned personally by the Company's Chairman of the
Board, and an assignment of all rents until December 31, 1998 $ 528,506 $ -- $ 549,262
Mortgage payable - Laurential Bank, interest at 9.25 percent per
annum, final payment due February 1, 2001, secured by real property
located at 98 Stafford Drive, Brampton and 1740
Sismet Road, Mississauga 402,126 -- 417,918
Note payable - Berckeley Investment Group, Ltd., inclusive of
interest, balance originally was to be paid in full June 1998 (A) 393,750 -- --
Promissory note payable - Individual, interest at 12 percent per
annum, principal together with interest due September 9, 1999
-- -- 85,823
---------- ------ ----------
Total Debt 1,324,382 -- 1,053,003
Less Current Maturities 411,565 -- 417,919
---------- ------ ----------
Long-Term Debt, Less Current Maturities $ 912,817 $ -- $ 635,084
========== ====== ==========
(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
---- ---------
1999 $ 411,565
2000 548,006
2001 364,811
2002 --
2003 --
----------
$1,324,382
==========
F-24
GENEREX BIOTECHNOLOGY CORPORATION
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(INFORMATION RELATING TO THE NINE MONTHS ENDED APRIL 30, 1999
AND 1998 AND CUMULATIVE FROM NOVEMBER 2, 1995 (DATE OF INCEPTION)
TO APRIL 30, 1999 IS UNAUDITED)
Note 10 - Stockholders' Equity:
Reverse Merger
On January 9, 1998, the Company issued 9,234,118 of common stock to
acquire GBT - Delaware, Inc. (see Note 1). For accounting purposes,
the acquisition of GBT - Delaware, Inc. by the Company has been
treated as a reverse merger. Accordingly, the 9,234,118 shares issued
to acquire GBT - Delaware, Inc. have been treated as outstanding from
November 2, 1995 (as adjusted for historical issuances of GBT -
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
The Company has outstanding 1,153,425 Series A Redeemable Common
Stock Purchase Warrants, each of which is exercisable to purchase one
(1) share of common stock at a price of $5.00 per share. The warrants
are redeemable, at the option of the Company, at any time after
September 1, 1998, upon written notice of not less than twenty (20)
days, at a redemption price of $.025 per warrant. These warrants
expire December 31, 2000. (See Note 15).
The warrants were sold between March 1, 1998 and June 30, 1998, in
units, with each unit consisting of one warrant and one share of
common stock, in a private placement effected by the Company pursuant
to Rule 506, Regulation D, under the Act, and applicable Canadian
securities laws. Included in these transactions were 993,253 units
sold for cash at $2.50, and 160,172 units issued in payment for
various services rendered and valued at $2.50 per unit.
The Company also has outstanding warrants to purchase 500,000 shares
of Common Stock at a price of $2.50 which expire on March 31, 2003,
and warrants to purchase 7,937 shares at a price of $21.82 per share
which expire on September 6, 2002.
For consideration of financial consulting services provided, the
Company issued warrants to purchase 150,000 shares of common stock at
$10 per share, which expire on November 17, 2003.
The Company issued warrants to purchase 150,000 shares of common
stock at $6.00 per share and 50,000 shares of common stock at $7.50
per share. All warrants expire February through April 2004 and were
granted in consideration of financial consulting services received.
Preferred Stock
The Company has authorized 1,000,000 shares with a par value of
one-tenth of a cent ($.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.
F-25
GENEREX BIOTECHNOLOGY CORPORATION
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(INFORMATION RELATING TO THE NINE MONTHS ENDED APRIL 30, 1999
AND 1998 AND CUMULATIVE FROM NOVEMBER 2, 1995 (DATE OF INCEPTION)
TO APRIL 30, 1999 IS UNAUDITED)
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.
Note 11 - Stock Based Compensation:
The Company intends to apply Accounting Principles board Opinion No.
25, "Accounting for Stock issued to Employees," and related
interpretations in accounting for options as allowed by Statement of
Financial Accounting Standards No. 123 "Accounting for Stock Based
Compensation." During the years ended July 31, 1998 and 1997 and for
the period November 2, 1995 (date of inception) to July 31, 1996, the
Company did not grant options; thus no compensation expense was
recorded in these years.
1998 Stock Option Plan
On January 22, 1998, the Company's Board of Directors approved the
1998 Stock Option Plan (1998 Plan), subject to shareholder approval
of the Plan, and reserved 1,000,000 shares of Common Stock for
issuance upon options granted under the Plan.
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.
The Plan provides that options may or may not be Incentive Stock
Options within the meaning of Section 422 of the Internal Revenue
Code (ISOs). 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 1998 Plan was not submitted for shareholder approval and
terminated on February 1, 1999. A new plan, substantially identical
to the 1998 Plan, has been adopted. All options granted under the
1998 Plan are not affected by the termination.
F-26
GENEREX BIOTECHNOLOGY CORPORATION
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(INFORMATION RELATING TO THE NINE MONTHS ENDED APRIL 30, 1999
AND 1998 AND CUMULATIVE FROM NOVEMBER 2, 1995 (DATE OF INCEPTION)
TO APRIL 30, 1999 IS UNAUDITED)
Note 11 - Stock Based Compensation (Continued):
The following is a summary of the common stock options granted,
canceled or exercised under the Plan for the period August 1, 1998
through April 30, 1999.
Exercise Price Per
Shares Share
-------- ------------------
Outstanding - August 1, 1998 --
Granted 50,000 $ 8.00
Canceled --
Exercised -- --
------ --------
Outstanding - April 30, 1999 50,000 $ 8.00
====== ========
The following table summarizes information on stock options
outstanding at April 30, 1999:
Options Outstanding Options Exercisable
---------------------------------------------- ---------------------------
Weighted Number
Number Average Weighted Weighted
Outstanding Contractual Average Exercisable Average
Range of at Life Exercise at Exercise
Exercise Price April 30, 1999 (Years) Price April 30, 1999 Price
-------------- -------------- ----------- --------- -------------- --------
$8.00 50,000 5 $8.00 50,000 $8.00
Note 12 - Net Loss Per Share:
Basic EPS and Diluted EPS for the years ended July 31, 1998, 1997 and
for the period November 2, 1995 (date of inception) to July 31, 1996
and for the nine months ended April 30, 1999 and 1998 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.
Note 13 - Supplemental Disclosure of Cash Flow Information:
For the Years Ended For the Period For the Nine Months
July 31, November 2, 1995 Ended April 30,
---------------------- (Date of Inception) ------------------------
1998 1997 to July 31,1996 1999 1998
-------- -------- ---------------- ------- ------
Cash paid during the year for:
Interest $63,291 $ -- $ -- $33,925 $ --
Income taxes $ -- $ -- $ -- $ -- $ --
F-27
GENEREX BIOTECHNOLOGY CORPORATION
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(INFORMATION RELATING TO THE NINE MONTHS ENDED APRIL 30, 1999
AND 1998 AND CUMULATIVE FROM NOVEMBER 2, 1995 (DATE OF INCEPTION)
TO APRIL 30, 1999 IS UNAUDITED)
Note 13 - Supplemental Disclosure of Cash Flow Information (Continued):
Disclosure of non-cash investing and financing activities:
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
Nine Months Ended April 30, 1999
--------------------------------
Long-term debt was assumed in conjunction with acquisition
of property $ 82,183
Settlement of liability arising from the violation of financing
agreement with issuance of common stock $ 738,000
Note 14 - Segment Information:
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
----------- ----------
1998
----
United States $ -- $ --
Canada 1,926,046 3,565,378
Corporate 3,529,662 984,935
---------- ----------
Total $5,455,708 $4,550,313
========== ==========
1997
----
United States $ -- $ --
Canada 316,943 1,355,543
Corporate 3,355,832 --
---------- ----------
Total $3,672,775 $1,355,543
========== ==========
1996
----
United States $ -- $ --
Canada 473,251 363,423
Corporate 14,767 --
---------- ----------
Total $ 488,018 $ 363,423
========== ==========
F-28
GENEREX BIOTECHNOLOGY CORPORATION
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(INFORMATION RELATING TO THE NINE MONTHS ENDED APRIL 30, 1999
AND 1998 AND CUMULATIVE FROM NOVEMBER 2, 1995 (DATE OF INCEPTION)
TO APRIL 30, 1999 IS UNAUDITED)
Note 15 - Subsequent Events (Unaudited):
Subsequent events occurring after April 30, 1999 consist of the
following:
The Company received a total of $1,500,004 from the sale of 272,728
shares of common stock at $5.50 per share.
The Company issued 45,000 shares valued at $5.50 per share in
consideration for services received.
On May 8, 1999, the Company announced that it exercised its right to
redeem all outstanding Series A Redeemable Common Stock Warrants
which were exercisable at $5.00 per share. The effective date of the
redemption was June 4, 1999. Subsequent to June 4, 1999, the warrants
ceased to be exercisable and the sole right of the holder who did not
exercise their warrant(s) was to receive $.025 per warrant upon
surrender of the warrant certificate to the Company. For 496,547
newly issued shares and the surrender of warrant certificates, the
Company received the following:
Cash $1,941,875
Services Rendered 67,158
Promissory Notes Receivable 473,702
----------
$2,482,735
==========
In addition to the above, the Company received 323,920 previously
outstanding shares, valued for this purpose at $7.8125 per share, and
surrender of warrant certificates in exchange for 506,125 newly
issued shares. The Company issued 6,300 shares valued at $5.50 per
share plus $43,781 in cash for services rendered in conjunction with
the warrant redemption.
F-29
PART II - INFORMATION NOT REQUIRED IN PROSPECTUS
Item 24. Indemnification of Directors and Officer.
Our bylaws require us to indemnify each person who is or was a director or
officer of Generex against all expenses, liabilities, and loss actually and
reasonably incurred in connection with any civil, criminal, administrative or
investigative proceeding brought by reason of the fact that such person is or
was a director or executive officer of Generex or is or was serving at our
request in certain other capacities, to the extent such person is not otherwise
indemnified and such indemnification is not prohibited by law. Under the
Delaware General Corporation Law, we may indemnify such persons if they acted in
good faith and in a manner which they reasonably believed to be in or not
opposed to the best interests of the corporation, and with respect to any
criminal action or proceeding had no reasonable cause to believe their conduct
was unlawful. With respect to a proceeding brought in the right of , we may
indemnify such person if such person acted in good faith and in a manner he
reasonably believed to be in or not opposed to the best interest of the
corporation, except that we may indemnify a person in that situation only to the
extent the Court of Chancery or other court determines that such person is
fairly and reasonably entitled to indemnification. Subject to the standards
stated in the last two sentences, our by-laws require us to advance the expense
(including attorneys' fees) incurred by such person in defending such action.
Insofar as indemnification for liabilities arising under the Securities Act may
be permitted to directors, officers, or persons controlling Generex pursuant to
the foregoing provisions, we are informed that in the opinion of the Securities
and Exchange Commission, such indemnification is against public policy as
expressed in the Securities Act and is therefore unenforceable.
Item 25. Other Expenses of Issuance and Distribution
The following table sets forth the estimated amount of various expenses
in connection with the sale and distribution of the securities being registered:
SEC registration fee $_______
Printing and engraving expenses 25,000
Legal fees and expenses
(including blue sky fees and expenses) 50,000
Accounting fees and expenses 15,000
Miscellaneous --
--------
Total $100,000
========
Item 26. Recent Sales of Unregistered Securities.
Sales of unregistered securities by Generex within the past three years which
occurred on or prior to February 12, 1998, are set forth in Item 10 of our
Registration Statement on Form 10, as amended on February 24, 1999. The
information set forth in Item 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
II-1
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:
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
All of these shares have been registered for sale in this Registration
Statement.
(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.
II-2
Shares underlying the warrants have been registered for sale in this
Registration Statement, and information pertaining to holders of the warrants
which appears under the caption "Selling Shareholders" in the prospectus
included in this Registration Statement is incorporated by reference herein.
(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.
Item 27. Exhibits
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 between and Dr. William Steinbrink**
4.5.2 Form of Subscription/Voting Agreement executed by purchasers of 337,670
shares of Common Stock**
4.6 Registration Rights Agreement between the Company and certain purchasers of Common Stock.
II-3
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
23.1.1 Consent of Withum, Smith & Brown, independent auditors
23.1.2 Consent of Mintz & Partners, independent auditors
23.1.3 Consent of Eckert Seamans Cherin & Mellot, LLC (included in Exhibit 5)***
27. Financial Data Schedules
* Exhibit 3.1 to our Quarterly Report on Form 10-Q for the quarter ended is
incorporated by reference.
** Incorporated by reference to the identical numbered exhibit contained in our
Registration Statement on Form 10 filed with the Commission on December 14,
1998, as amended February 24, 1999.
*** To be filed by amendment.
Item 27. Undertakings.
We undertake to:
1. File, during any period in which we offer or sell securities, a
post-effective amendment to this Registration Statement to:
(i) Include any prospectus required by Section 10(a)(3) of the
Securities Act;
(ii) Reflect in the Prospectus any facts or events which,
individually or in the aggregate, represent a fundamental change in the
information set forth in the Registration Statement; and
(iii) Include any additional or changed material information on
the Plan of Distribution described in the Registration Statement.
2. For the purpose of determining any liability under the Securities
Act, treat each post-effective amendment as a new registration of the securities
offered, and the offering of the securities at that time to be the initial bona
fide offering thereof.
3. To file a post-effective amendment to remove from registration any
of the securities that remain unsold at the end of the offering.
Insofar as indemnification for liabilities arising under the Securities Act may
be permitted to our directors, officers and controlling persons pursuant to the
foregoing provisions, or otherwise, we have
II-4
been advised that in the opinion of the Securities and Exchange Commission such
indemnification is against public policy as expressed in the Securities Act and
is, therefore, unenforceable.
In the event that a claim for indemnification against such liabilities (other
than our payment of expenses incurred or paid by a director, officer or
controlling person in the successful defense of any action, suit or proceeding)
is asserted by such director, officer or controlling person in connection with
the securities being registered, we will, unless in the opinion of its counsel
the matter has been settled by controlling precedent, submit to a court of
appropriate jurisdiction the question whether such indemnification by it is
against public policy as expressed in the Securities Act and will be governed by
the final adjudication of such issue.
We hereby undertake that:
For purposes of determining any liability under the Securities Act, the
information omitted from the form of prospectus filed as part of this
Registration Statement in reliance upon Rule 430A and contained in a form of
prospectus filed pursuant to Rule 424(b)(1) or (4) or 497(h) under the
Securities Act shall be deemed to be a part of this Registration Statement as of
the time the Commission declared it effective.
For purposes of determining any liability under the Securities Act,
each post-effective amendment that contains a form of prospectus as a new
registration statement for the securities offered in this Registration
Statement, and the offering of the securities at that time, shall be deemed to
be the initial bona fide offering of those securities.
II-5
SIGNATURES
In accordance with the requirements of the Securities Act of 1933, we
certify that we have reasonable grounds to believe that we meet all of the
requirements of filing on Form S-1 and have authorized this Registration
Statement to be signed on our behalf by the undersigned, our President, on the
8th day of July, 1999.
GENEREX BIOTECHNOLOGY CORPORATION
By: /s/ Anna E. Gluskin
--------------------------
Anna E. Gluskin, President
SIGNATURES
In accordance with the requirements of the Securities Act of 1933, this
Registration Statement was signed by the following persons in the capacities and
on the dates stated.
Signatures Title Date
/s/ Anna E. Gluskin
- -------------------
Anna E. Gluskin President, Chief Executive Officer and July 8, 1999
Director
/s/ E. Mark Perri
- -------------------
E. Mark Perri Chairman of the Board, Chief Financial July 8, 1999
Officer and Director
/s/ Rose C. Perri
- -------------------
Rose C. Perri Director July 8, 1999
/s/ Pankaj Modi
- -------------------
Pankaj Modi, Ph.D. Director July 8, 1999
II-6