0000950116-01-501022.txt : 20011031 0000950116-01-501022.hdr.sgml : 20011031 ACCESSION NUMBER: 0000950116-01-501022 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 8 CONFORMED PERIOD OF REPORT: 20010731 FILED AS OF DATE: 20011029 FILER: COMPANY DATA: COMPANY CONFORMED NAME: GENEREX BIOTECHNOLOGY CORP CENTRAL INDEX KEY: 0001059784 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 820490211 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-25169 FILM NUMBER: 1768396 BUSINESS ADDRESS: STREET 1: 33 HARBOUR SQ STREET 2: STE 202 CITY: TORONTO ONTARIO CANA STATE: A1 BUSINESS PHONE: 4163642551 MAIL ADDRESS: STREET 1: 33 HARBOUR SQ STREET 2: STE 202 CITY: TORONTO ONTARIO M5J STATE: A1 10-K 1 tenk.txt 10-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) [ X ] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended July 31, 2001 [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to _______________ Commission file number 000-25169 --------------- GENEREX BIOTECHNOLOGY CORPORATION ---------------------------------------------------- (Exact name of registrant as specified in its charter) Delaware 98-0178636 --------------------------- ----------------------------------- (State or other jurisdiction of (IRS Employer Identification No.) incorporation or organization) 33 Harbour Square, Suite 202, Toronto, Canada M5J 2G2 ---------------------------------------- -------------- (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: 416/364-2551 ------------ Securities registered pursuant to Section 12(b) of the Act: None Securities registered pursuant to section 12(g) of the Act: Common Stock, par value $.001 per share (Title of Class) Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such report(s), and (2) has been subject to such filing requirements for the past 90 days. Yes [X] No [ ] Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. [ ] The aggregate market value of the voting stock held by non-affiliates of the registrant at October 15, 2001, based on the closing price as of that date, was approximately $20,283,528. At October 15, 2001, the registrant had 20,682,634 shares of Common Stock outstanding. Documents incorporated by reference: None Forward-Looking Statements Certain statements in the "Business" (Item 1) section, "Management's Discussion and Analysis of Financial Conditions and Results of Operations" (Item 7), the notes to our audited financial statements (Item 8) and elsewhere in this Annual Report on Form 10-K constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects", "plans", "intends", "believes", "will", "estimates", "forecasts", "projects" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements address, among other things, our expectations concerning the efficacy of our platform buccal delivery technology, our expectations concerning product candidates for our technology, our expectations concerning our development and license agreement with Lilly, our expectations of when different phases of clinical activity may commence and our expectations of when regulatory submissions may be filed or when regulatory approvals may be received. Any or all of our forward-looking statements may turn out to be wrong. They can be affected by inaccurate assumptions that we might make or by known or unknown risks and uncertainties. Actual outcomes and results may differ materially from what is expressed or implied in our forward-looking statements. Among the factors that could affect future results are: o the inherent uncertainties of product development based on a new and as yet not fully proven drug delivery technology, o the risks and uncertainties regarding the actual effect on humans of seemingly safe and efficacious formulations when tested clinically, o the inherent uncertainties associated with clinical trials of product candidates, o the inherent uncertainties associated with the process of obtaining regulatory approval to market product candidates, and o adverse developments in our collaboration with Lilly regarding oral insulin, which is currently our only product candidate that has moved beyond preliminary research and development. Additional factors that could affect future results are set forth throughout the "Business" (Item 1) section, including the subsection entitled "Certain Additional Risk Factors", and elsewhere in this Annual Report on Form 10-K. PART I Item 1. Business. Overview Generex Biotechnology Corporation is engaged in the research and development of drug delivery technologies. Our primary focus at the present time is our proprietary technology for the administration of formulations of large molecule drugs to the oral (buccal) cavity using a hand-held aerosol applicator. A substantial number of large molecule drugs (i.e., drugs composed of molecules with a higher than specified molecular weight) have been approved for sale in the United States or are presently undergoing clinical trials as part of the process to obtain such approval, including various proteins, peptides, monoclonal antibodies, hormones and vaccines. Unlike small molecule drugs, which generally can be administered by various methods, large molecule drugs historically have been administered predominately by injection. The principal reasons for this have been the vulnerability of large molecule drugs to digestion and the relatively large size of the molecule itself, which makes absorption into the blood stream through the skin or mucosa inefficient or ineffective. All injection therapies involve varying degrees of discomfort and inconvenience. With chronic and sub-chronic diseases, the discomfort and inconvenience associated with injection therapies frequently results in less than optimal patient acceptance of and compliance with the prescribed treatment plan. Poor acceptance and compliance can lead to medical complications and higher disease management costs. Also, elderly, infirm and pediatric patients with chronic or sub-chronic conditions may not be able to self-inject their medications. In such cases assistance is required which increases both the cost and inconvenience of the therapy. Our goal is to develop proprietary formulations of large molecule drugs that can be administered through the buccal mucosa, primarily the inner cheek walls, thereby eliminating or reducing the need for injections. We believe that our buccal delivery technology is a platform technology that has application to many large molecule drugs, and provides a convenient, non-invasive, accurate and cost effective way to administer such drugs. We have identified several large molecule drugs as possible candidates for development, but to date have focused our development efforts on a buccal insulin product. Between January 1999 and September 2000, we conducted clinical trials of our buccal insulin product in the United States, Canada and Europe. In September 2000, we entered into a Development and License Agreement with Eli Lilly and Company to develop this product. Prior to entering into the agreement with Lilly, we had not reached a point in our clinical program at which we were prepared to apply for regulatory approvals to market the product in any country, and we did not anticipate receiving any such approvals for a number of years. Under the terms of our agreement with Lilly, Lilly will be responsible generally for clinical trials and regulatory approvals on a worldwide basis for all products developed under the agreement. Lilly also will have the exclusive right to market the products worldwide. Our principal responsibilities under the Lilly agreement will be to continue development, as required, of our proprietary formulation and on our RapidMist(TM) device, which is described below. In January 2001, we established a joint venture with a wholly owned subsidiary of Elan Corporation, plc. The joint venture will pursue the application of certain of our and Elan's drug delivery technologies, including our platform technology for the buccal delivery of pharmaceutical products, for the treatment of prostate cancer, endometriosis and/or the suppression of testosterone and estrogen. The parties intend to select at least one pharmaceutical product for research and development under the joint venture within one year's time. The parties will conduct the joint venture through Generex (Bermuda), Ltd., a Bermuda limited liability company. Generex (Bermuda), Ltd. was granted non-exclusive licenses to utilize our buccal delivery technology and certain Elan drug delivery technologies. We are a development stage company, and prior to the first quarter of the current fiscal year had 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. As noted above, however, we believe that our buccal delivery technology is a platform technology that has application to a large number of large molecule drugs in addition to insulin. Fentanyl, morphine, estrogen, heparin, monoclonal antibodies, human growth hormone, fertility hormone, as well as a number of vaccines are among the compounds that we have identified as possible candidates for product development. Buccal Delivery Technology Our buccal delivery technology involves the preparation of a proprietary formulation in which an active pharmaceutical agent is placed in solution with a combination of absorption enhancers and other excipients classified generally recognized as safe ("GRAS") by the Food and Drug Administration when used in accordance with specified quantity and other limitations. The resulting formulation, which is stable at room temperature, is aerosolized with a pharmaceutical grade chemical propellant and is administered to the patient using our proprietary RapidMist(TM) device. The device is a small, lightweight, hand-held, easy-to- use aerosol applicator comprised of a container for the formulation, a metered dose valve, an actuator and dust cap. Using the device, the patient self-administers the formulation by spraying it into the mouth. The device contains multiple applications, the number being dependent, among other things, on the concentration of the formulation. Absorption of the pharmaceutical agent occurs in the buccal cavity, principally through the inner cheek walls. In clinical studies of our insulin product, insulin absorption in the buccal cavity has been shown to be very rapid. Buccal Insulin Product Insulin is a hormone that is naturally secreted by the pancreas to regulate the level of glucose, a type of sugar, in the bloodstream. The term diabetes refers to a group of disorders that are characterized by the inability of the body to properly regulate blood glucose levels. 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. Insulin acts by stimulating the use of glucose as fuel and by inhibiting the production of glucose. In a healthy individual, a balance is maintained between insulin secretion and glucose metabolism. There are two major types of diabetes. Type 1 diabetes (juvenile onset diabetes or insulin dependent diabetes) refers to the condition where the pancreas produces little or no insulin. Type 1 diabetes accounts for 5-10 percent of diabetes cases. It often occurs in children and young adults. Type 1 diabetics must take daily insulin injections, typically 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 does not produce enough insulin, or cannot properly use the insulin produced. Type 2 diabetes is the most common form of the disease and accounts for 90-95 percent of diabetes cases. In addition to insulin therapy, Type 2 diabetics may take oral drugs that stimulate the production of insulin by the pancreas or that help the body to more effectively use insulin. If not treated, diabetes can lead to blindness, kidney disease, nerve disease, amputation, heart disease and stroke. Each year, from 12,000 to 24,000 people lose their sight because of diabetes. Diabetes is also the leading cause of end-stage renal disease (kidney failure), accounting for about 40% of new cases. In addition, about 60-70 percent of people with diabetes have mild to severe forms of diabetic nerve damage, which, in severe forms, can lead to lower limb amputations. Diabetics are also 2 to 4 times more likely to have heart disease, which is present in 75 percent of diabetes-related deaths, and are 2 to 4 times more likely to suffer a stroke. There is no known cure for diabetes. The World Health Organization estimates that there are currently over 1.5 billion diabetics worldwide. It is further estimated that this number will almost double by the year 2025. There are estimated to be 17 million people suffering from diabetes in North America alone, approximately 5 million of whom are undiagnosed, and diabetes is the second largest cause of death by disease in North America. We conducted the first clinical trials of our buccal insulin formulation with human subjects in Ecuador in January 1998. We ultimately conducted a number of studies in Ecuador in 1998, each of which 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. 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 filed an Investigational New Drug Application with the Food and Drug Administration in October 1998, and received FDA approval to proceed with human trials in November 1998. We began our clinical trial programs in Canada and the United States in January 1999. Between January 1999 and September 2000 we conducted clinical trials of our insulin formulation involving approximately 200 Type 1 and Type 2 diabetic patients and healthy volunteers. The study protocol in most trials involved administration of two different doses of our insulin formulation following either a liquid sustacal meal or a standard meal challenge. The objective of these studies was to evaluate our insulin formulation's efficacy in controlling post-prandial (meal related) glucose levels. These trials demonstrated that our insulin formulation controlled post-prandial hyperglycemia in a manner comparable to injected insulin. As noted above, in September 2000 we entered into a Development and License Agreement with Eli Lilly and Company covering an insulin product based upon our buccal delivery technology. Under this agreement, Lilly will be responsible generally for clinical trials and regulatory approvals for this product on a worldwide basis. Lilly has not yet authorized the commencement of clinical trials under the agreement. However, in furtherance of our product development responsibilities under the agreement with Lilly, we are conducting limited clinical studies in the United States, Canada, Europe and Ecuador. Other Large Molecule Drug Projects We have identified numerous compounds, other than insulin, as candidates for product development. We have had discussions of possible research collaborations with various pharmaceutical companies concerning use of our large molecule drug delivery technology with these compounds, which include monoclonal antibodies, human growth hormone, fertility hormone, fentanyl, morphine, estrogen and heparin, and a number of vaccines. Prior to entering into our agreement with Lilly covering the insulin product, we had not aggressively pursued development opportunities apart from insulin because we believed it was more advantageous to concentrate our resources, particularly our financial resources, on developing the insulin product. While the insulin product remains our first priority, we believe that Lilly's involvement will relieve us of a substantial portion of the costs associated with conducting the clinical program for the insulin product. We also raised approximately $37 million from private placements of our common stock during the last fiscal year. Based on the financial structure of the Lilly agreement and the amounts raised through private placements, we believe we now have sufficient financial resources to pursue development of additional products. Corporate History We were incorporated in Delaware in September 1997 for the purpose of acquiring Generex Pharmaceuticals, Inc., a Canadian corporation formed in November 1995 to engage in pharmaceutical and biotechnological research and other activities. Our acquisition of Generex Pharmaceuticals was completed in October 1997 in a transaction in which the holders of all outstanding shares of Generex Pharmaceuticals exchanged their shares for shares of our common stock. In January 1998, we participated in a "reverse acquisition" with Green Mt. P. S., Inc., a previously inactive Idaho corporation formed in 1983. As a result of this transaction, our shareholders (the former shareholders of Generex Pharmaceuticals) acquired a majority (approximately 90%) of the outstanding capital stock of Green Mt., we became a wholly-owned subsidiary of Green Mt., Green Mt. changed its corporate name to Generex Biotechnology Corporation ("Generex Idaho"), and we changed our corporate name to GBC Delaware, Inc. Because the reverse acquisition resulted in our shareholders becoming the majority holders of Generex Idaho, we were treated as the acquiring corporation in the transaction for accounting purposes. Thus, our historical financial statements, which essentially represented the historical financial statements of Generex Pharmaceuticals, were deemed to be the historical financial statements of Generex Idaho. In April 1999, we completed a reorganization in which we merged with Generex Idaho. In this transaction, all outstanding shares of Generex Idaho were converted into our shares, Generex Idaho ceased to exist as a separate entity, and we changed our corporate name back to "Generex Biotechnology Corporation". This reorganization did not result in any material change in our historical financial statements or current financial reporting. Government Regulation Our research and development activities, and the eventual manufacturing and marketing of our products, are subject to extensive regulation by the Food and Drug Administration in the United States (FDA) and comparable regulatory authorities in other countries. Among other things, extensive regulation puts a burden on our ability to bring products to market. While these regulations apply to all competitors in our industry, 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 now do. If requisite regulatory approvals are not obtained and maintained, our business will be substantially harmed. In many if not all cases, we expect that our development partners will control or participate extensively in the regulatory approval process once a development agreement is in place. The following discussion summarizes the principal features of food and drug regulation in the United States and other countries as they affect our business. United States. All aspects of our research, development and foreseeable commercial activities are subject to extensive regulation by 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. The regulatory approval process, including clinical trials, usually takes several years and requires 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; and 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 assess 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 Investigational New Drug application, 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. 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. 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 FDA approval. Even if approved by FDA, our products and the facilities used to manufacture our products will remain subject to review and periodic inspection by FDA. To supply drug products for use in the United States, foreign and domestic manufacturing facilities must be registered with, and approved by, FDA. Manufacturing facilities must also comply with FDA's Good Manufacturing Practices, and domestic facilities are subject to periodic inspection by FDA. Products manufactured outside the United States are inspected by regulatory authorities in those countries under agreements with FDA. To comply with Good Manufacturing Practices, manufacturers must expend substantial funds, time and effort in the area of production and quality control. FDA stringently applies its regulatory standards for manufacturing. Discovery of previously unknown problems with respect to a product, manufacturer or facility may result in consequences with commercial significance. These include restrictions on the product, manufacturer or facility, suspensions of regulatory approvals, operating restrictions, delays in obtaining new product approvals, withdrawals of the product from the market, product recalls, fines, injunctions and criminal prosecution. Foreign Countries. Before we are permitted to market any of our products outside of the United States, those products will be subject to regulatory approval by foreign government agencies similar to FDA. These requirements vary widely from country to country. Generally, however, no action can be taken to market any drug product in a country until an appropriate application has been approved by the regulatory authorities in that country. FDA approval does not assure approval by other regulatory authorities. The current approval process varies from country to country, and the time spent in gaining approval varies from that required for FDA approval. The Canadian regulatory process is substantially similar to that of the United States. We obtained regulatory approval to begin clinical trials in Canada in November 1998. In Ecuador, regulatory authorities approved the limited non-commercial distribution of our oral insulin formulation in September 1998. Marketing We intend to rely on collaborative arrangements with one or more other companies that possess strong pharmaceutical marketing and distribution resources to perform these functions for us. Accordingly, we will not have the same control over marketing and distribution that we would have if we conducted these functions ourselves. With respect to our insulin product, Lilly has exclusive, worldwide marketing rights to the product under our development and license agreement. Except for our agreement with Lilly with respect to our oral insulin product, we do not have any agreements with any other companies for marketing or distributing our products. Manufacturing To date, we have produced our oral insulin formulation only under laboratory conditions on a small scale. In December 2000, we completed our pilot manufacturing facility in Toronto in the same commercial complex in which our original laboratory is located, and we are in the process of obtaining regulatory approval for the facility. We believe that this facility will be capable of producing our insulin 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. Under our agreement with Lilly, Lilly may select us, but is not required to select us, to manufacture products developed under that agreement. In order to qualify for consideration in this role, we will have to satisfy Lilly that we can supply such products at the requisite levels of quality, cost and reliability in compliance with all applicable regulatory requirements. 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 would lead to loss of any opportunity to manufacture products developed under our agreement with Lilly, and could delay or prevent our ability to bring other products to market and inhibit sales after a product comes to market. In any event, we will need to significantly increase our manufacturing capability in order to manufacture any product in commercial quantities. We own facilities in Brampton, Ontario, and Mississauga, Ontario, both within 25 miles from downtown Toronto, that were purchased with the intention of improving and equipping them for manufacturing. These facilities are currently leased to unrelated third parties, however, we believe we can place these facilities into production of our insulin product or other products within 12 to 18 months lead time if additional production capabilities are necessary. Raw Material Supplies The excipients used in our formulation are available from numerous sources in sufficient quantities for clinical purposes, and we believe that they will be available in sufficient quantities for commercial purposes when required, although we have not yet attempted to secure a commercial supply of any such products. Components suitable for our RapidMist device are available from a limited number of potential suppliers, as is the chemical propellant used in the device. We believe that the components which now comprise the device will be utilized with the commercial version of our insulin product irrespective of what manufacturing arrangements are ultimately chosen by Lilly, i.e., whether or not we perform the formulating and filling function. We have secured supply arrangements with the manufacturers of all components and the propellant that we presently use in our RapidMist device for commercial quantities of such components and the propellant. All such suppliers are prominent, reputable and reliable suppliers to the pharmaceutical industry. Because we now have a single supplier for each of these components and propellant, however, we are more vulnerable to supply interruptions than would be the case if we had multiple suppliers for each component. We do not believe that the risk of a single source of supply for proprietary raw materials or device components is unusual in the pharmaceutical industry. Lilly will supply the pharmaceutical compounds that are used in products developed under our agreement with Lilly. We expect that similar arrangements will be made with future development and marketing partners under licensing and development agreements covering other products. Intellectual Property We currently have been issued five U.S. patents pertaining to aspects of buccal delivery technology, and we have eleven U.S. patent applications and one Canadian patent application pending, including applications that cover our oral insulin formulation and technology. In addition, we hold one U.S. patent and one Canadian patent and have two Canadian applications pending that pertain to delivery technologies other than our buccal delivery technology. We also have an indirect interest in three drug delivery patents held by another company, Centrum Biotechnologies, Inc., which is fifty (50%) percent owned by us. Our long-term success will substantially depend upon our ability to obtain patent protection for our technology and our ability to protect our technology from infringement, misappropriation, discovery and duplication. We cannot be sure that any of our pending patent applications will be granted, or that any patents which we own or obtain in the future will fully protect our 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. We believe our patent rights will provide meaningful protection against others duplicating our proprietary technologies. We cannot be sure of this, however, because of the complexity of the legal and scientific issues that could arise in litigation over these issues. (See "Legal Proceedings" (Item 3) for discussion of certain legal proceedings involving intellectual property issues.) 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. Competition We expect that products based upon our buccal delivery technology and any other products that we may develop will compete directly with products developed by pharmaceutical companies, universities, government agencies and public and private research organizations. Products developed by our competitors may use a different active pharmaceutical agent to treat the same medical condition or indication as our product or may provide for the delivery of substantially the same active pharmaceutical ingredient as our products using different methods of administration. For example, a number of 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 methods of delivering insulin. These methods, including nasal, transdermal and pulmonary, may ultimately successfully deliver insulin to diabetic patients. 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. Where the same or substantially the same active ingredient is available using alternative delivery means, we expect that competition among products will be based, among other things, on product safety, efficacy, ease of use, availability, price, marketing and distribution. When different active pharmaceutical ingredients are involved, these same competitive factors will apply to both the active agent and the delivery method. We consider other drug delivery companies to be direct competitors for the cooperation and support of major drug and biotechnology companies that own or market proprietary pharmaceutical compounds, as well as for the ultimate patient market. Among drug delivery companies, those that are known to be developing delivery systems for insulin and other pharmaceutical agents that we have identified as product candidates using our technology are of primary concern. Within this category, we consider Inhale Therapeutics, Inc. to be our principal competitor for our insulin product. Inhale Therapeutics, Inc. is developing a customized insulin formulation that is processed into a fine, dry powder and administered to the deep lung using a proprietary inhalation device developed for this purpose. Inhale has announced successful results using its inhaled product in Phase II clinical trials, and is now engaged in Phase III trials. Inhale is developing its insulin product in collaboration with Pfizer, Inc., which in turn has announced agreements to co-develop and co-promote the use of inhaled insulin with Aventis, a leading pharmaceutical company which presently manufactures insulin for sale primarily in Europe. Inhale is also developing pulmonary products with large molecule drugs other than insulin, and has stated that it is investigating the use of its inhalation technology with small molecule drugs. Aradigm Corporation, which has announced a joint development agreement with Novo Nordisk A/S to jointly develop a pulmonary delivery system for insulin by inhalation, also may be considered a direct competitor of ours in the insulin area. Novo Nordisk is one of the two leading manufacturers of insulin in the world, the other being Eli Lilly and Company. Aradigm began Phase II testing of its inhalation product in the second half of 1998. Other companies have announced development efforts relating to alternative (to injection) methods of delivering insulin or other large molecule drugs, including Dura Pharmaceuticals, which announced a collaboration with Eli Lilly and Company in 1998 to develop a pulmonary method of administering insulin, and Alkermes, which announced a collaboration with Eli Lilly and Company in April 2000 to develop a pulmonary method of administering insulin. Other companies developing alternative means of delivering insulin and other large molecule drugs include: Emisphere (pills taken orally), Nobex (pills taken orally), and Nastech (nasal), among others. These companies are at various stages of clinical development. 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 may also be considered competitive with insulin products. 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 July 31, 2001, our expenditures on research and development were $26,316,114. These included $19,149,860 in the year ended July 31, 2001, which includes a one-time charge for the licensing fee in connection with the Elan transaction, $3,476,436 in the year ended July 31, 2000 and $1,853,108 in the year ended July 31, 1999. (See "Management's Discussion and Analysis of Financial Condition and Results of Operations" (Item 7) for discussion of the licensing fee in connection with the Elan transaction.) Employees At September 30, 2001, 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. Thirteen of our employees are executive and administrative, five are scientific and technical personnel who engage primarily in development activities and in preparing formulations for testing and clinical trials, and four 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. 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 business could be materially harmed if we are unable to recruit and retain qualified scientific, administrative and executive personnel to support our expanding activities, or if one or more members of our limited scientific and management staff were unable or unwilling to continue their association with us. We do not have fixed term agreements with any of our key management or scientific staff, 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 also use 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 development of one or more of our products or otherwise adversely affect our business plans. Certain Additional Risk Factors In addition to historical facts or statements of current condition, this Annual Report on Form 10-K contains forward-looking statements. Forward-looking statements provide our current expectations or forecasts of future events. The following discussion outlines certain factors that we think could cause our actual outcomes and results to differ materially from our forward-looking statements. These factors are in addition to those set forth elsewhere in this Annual Report on Form 10-K. Our technologies and products are at an early stage of development. We are a development stage company. We have a very limited history of operations, and we do not expect ongoing revenues from operations in the immediately foreseeable future. We have no products approved for commercial sale at the present time. We may not be successful in obtaining regulatory clearance for the sale of existing or any future products, or any of these products may not be commercially viable. In September 2000, as noted above, we entered into a development and license agreement to work with Eli Lilly and Company on the development of our oral insulin product. Under the terms of the agreement with Lilly, we will receive milestone payments only if the project reaches specified development milestones and we will be entitled to license royalties based on product sales only if the product is successfully brought to market. Prior to entering into the agreement with Lilly, we had conducted some preliminary clinical trials of our oral insulin product in the United States, Canada and Europe. Our clinical program, however, had not reached a point where we were prepared to apply for regulatory approvals to market the product in any country. Going forward under the agreement, Lilly will be responsible generally for clinical trials and regulatory approvals on a worldwide basis. Lilly also will have the exclusive right to market the product worldwide. Our principal responsibilities will be to continue development, as required, on our oral insulin formulation and on the RapidMist(TM) device. Clinical trials under the agreement have not yet commenced. At this time, we cannot predict when or if we will reach any of the development milestones under the agreement and when or if any clinical trials might commence under the agreement. We believe that we can use our buccal delivery successfully with other large molecule drugs in addition to insulin. We have engaged in preliminary research and development work on other applications, but we have not devoted significant time or resources to this effort to date. In January 2001, as noted above, we entered into a joint venture with a subsidiary of Elan Corporation, plc. The purpose of the joint venture is to pursue the application of certain of our and Elan's drug delivery technologies -- including our large molecule drug delivery technology -- to pharmaceutical products for the treatment of prostate cancer and endometriosis and/or the suppression of testosterone and estrogen. However, we and Elan have not yet selected a specific product for research and development under the joint venture, and we cannot predict whether our technology can be applied successfully to any such product, when or if selected. We have not, and may not, receive regulatory approval to sell our products. We have engaged primarily in research and development activities since our inception. We have no products approved for commercial sale by drug regulatory authorities. We have begun the regulatory approval process for only one product, our oral insulin formulation. Notwithstanding our development and license agreement with Lilly and the participation of Lilly in the research and development process, we may not be able to develop our insulin product successfully. In order to obtain regulatory approvals for our insulin product, it will be necessary to demonstrate, among other things, that: o the product is physically and chemically stable under a range of storage, shipping and usage conditions; o the results of administering the product to patients are reproducible in terms of the amounts of insulin delivered to the oral cavity and absorbed in the bloodstream; and o there are no serious adverse safety issues associated with use of the product. Under our agreement, Lilly also has the option of developing a number of additional products using our platform buccal delivery technology. There is even greater uncertainty and risk related to the regulatory approval process for other products besides our insulin product that may be developed, whether with Lilly or independently of Lilly. This is because we have not developed any other product candidate to the extent that we have developed the insulin product. We may not become, or stay, profitable even if our products are approved for sale. Even if regulatory approval to market our oral insulin product is obtained, many factors may prevent the product from ever being sold in commercial quantities. Some of these factors are beyond our control, such as: o acceptance of the formulation by health care professionals and diabetic patients; o the availability, effectiveness and relative cost of alternative diabetes treatments that may be developed by competitors; and o the availability of third-party (i.e., insurer and governmental agency) reimbursements. We may not be able to compete with diabetes treatments now being marketed and developed 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 insulin, as well as new drugs intended to replace insulin therapy at least in part. In the longer term, we also face competition from companies that seek to develop cures for diabetes through techniques for correcting the genetic deficiencies that underlie diseases such as diabetes. We will have to depend upon others for marketing and distribution of our products, and we may be forced to enter into contracts limiting the benefits we may receive and the control we have over our products. We intend to rely on collaborative arrangements with one or more other companies that possess strong marketing and distribution resources to perform these functions for us. Except for the agreement with Lilly relating to our oral insulin product, we do not 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 that substantially limit the potential benefits to us from commercializing these products. In addition, we will not have the same control over marketing and distribution that we would have if we conducted these functions ourselves. We will need additional capital, which may not be available to us when we need it. We have incurred substantial losses from operations since our inception, and we expect to continue to incur substantial losses for the immediately foreseeable future. Under our agreement with Lilly, we expect Lilly to fund a substantial portion of the costs relating to the clinical program and regulatory approvals for our insulin product, and for any other products that may be developed under the agreement should we reach that stage of activity. We may, however, incur significant costs to fulfill our responsibilities under the agreement with Lilly. We also may require funds in excess of our existing cash resources: o to proceed under our joint venture with Elan, which requires us to fund 80% of initial product development costs; o to develop new products based on our oral delivery technology, including clinical testing relating to new products; o to develop or acquire other delivery technologies or other lines of business; o to establish and expand our manufacturing capabilities; and o to finance general and administrative and research activities that are not related to specific products under development. Our agreement with Lilly provides for us to receive milestone payments if the project reaches specified development milestones and for us to receive license royalties based on product sales if the product is successfully brought to market. Given that these payments are contingent on events that we cannot be sure will occur, we cannot be certain of when or if we will receive any further payments from Lilly. In any event, we do not expect to receive revenues under the agreement with Lilly or under any future development agreements that are sufficient to satisfy all of our cash requirements. In the past, we have funded most of our development and other costs through equity financing. Unforeseen problems, including materially negative developments in our relationship with Lilly, in our clinical trials or in general economic conditions could interfere with our ability to raise additional equity capital or materially adversely affect the terms upon which such funding is available. It is also possible that we will be unable to obtain additional funding as and when we need it. If we were unable to obtain additional funding as and when needed, we could be forced to delay the progress of certain development efforts. Such a scenario poses risks. For example, our ability to bring a product to market and obtain revenues could be delayed, our competitors could develop products ahead of us, and/or we could be forced to relinquish rights to technologies, products or potential products. If we are not able to obtain sufficient patent protection for our buccal delivery technology, we may face competition from potential competitors who may use the unprotected aspects of our technology to our disadvantage. Our long-term success will substantially depend upon protecting our technology from infringement, misappropriation, discovery and duplication. We currently have been issued five U.S. patents pertaining to aspects of buccal delivery technology, and we have eleven U.S. patent applications and one Canadian patent application pending, including applications that, if granted, would cover our oral insulin formulation and technology. In addition, we hold one U.S. patent and one Canadian patent and have two Canadian applications pending that pertain to delivery technologies other than our buccal delivery technology. We also have an indirect interest in three drug delivery patents held by another company, Centrum Biotechnologies, Inc., which is 50% owned by us. We cannot be sure that any of our pending patent applications will be granted, or that any patents that we own or will obtain in the future will fully protect our 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 we hold or have applied for do not infringe any one else's patent rights. We believe our patent rights will provide meaningful protection against others duplicating our proprietary technologies. We cannot be sure of this, however, because of the complexity of the legal and scientific issues that could arise in litigation over these issues. (See "Legal Proceedings" (Item 3) for discussion of certain legal proceedings invoving intellectual property issues.) Furthermore, patent applications are maintained in secrecy in the United States until the patents are approved, and in most foreign countries for a period of time following the date from which priority is claimed. A third party's pending patent applications may cover any technology that we currently are developing. We also hold some of our technology as trade secrets. We seek to protect this information, in part, by confidentiality agreements with our employees, consultants, advisors and collaborators. Enforcement of an arbitration award may result in adverse effects upon Generex. On October 2, 1998, 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. Sands alleged that it had the right to receive, for nominal consideration, approximately 1.5 million shares of our common stock. Sands based its claim upon an October 1997 letter agreement that was purported by Sands to confirm an agreement appointing Sands as the exclusive financial advisor to Generex Pharmaceuticals, Inc., a subsidiary that we acquired in late 1997. In exchange therefor, the letter agreement purported to grant Sands the right to acquire 17% of Generex Pharmaceuticals common stock for nominal consideration. Sands claimed that its right to receive shares of Generex Pharmaceuticals common stock applies to our common stock since outstanding shares of Generex Pharmaceuticals common stock were converted into shares of our common stock in the acquisition. Sands' claims also included additional shares allegedly due as a fee related to that acquisition, and $144,000 in monthly fees allegedly due under the terms of the purported agreement. Pursuant to an arbitration award dated September 22, 1999, the arbitration panel that heard this case awarded Sands $14,070 and issued a declaratory judgment requiring us to issue to Sands a warrant to purchase 1,530,020 shares of our common stock pursuant to and in accordance with the terms of the purported October 1997 letter agreement. On October 13, 1999, Sands commenced a special proceeding to confirm the arbitration award in the Supreme Court of the State of New York, County of New York (the "New York Supreme Court"). On November 10, 1999, we moved to vacate the arbitration award. On March 20, 2000, the New York Supreme Court granted Sands' petition to confirm the award and denied our motion to vacate the award. We appealed and on January 23, 2001, the New York State Appellate Division, First Department (the "Appellate Division"), modified the judgment of the New York Supreme Court that had confirmed the arbitration award against us. The Appellate Division affirmed the portion of the New York Supreme Court judgment that had confirmed the granting of monetary relief of $14,070 to Sands but modified the judgment to vacate the portion of the arbitration award directing the issuance to Sands of a warrant to purchase 1,530,020 shares of the our common stock. The Appellate Division held that the portion of the award directing us to issue warrants to Sands is too indefinite to be enforceable and remanded the matter to the arbitration panel for a final and definite award with respect to such relief or its equivalent (including possibly an award of monetary damages). The arbitration panel commenced hearings on the matters remanded by the Appellate Division in June 2001 and is expected to conclude its consideration of such matters and render its decision during the fourth calendar quarter of 2001. We are not able to estimate an amount or range of potential loss from this legal proceeding at the present time. Our consolidated financial condition would be materially adversely affected to the extent that Sands receives shares of our common stock for little or no consideration or substantial monetary damages as a result of this legal proceeding. We face significant product liability risks, which may have a negative effect on our financial performance. The administration of drugs to humans, whether in clinical trials or commercially, can result in product liability claims whether or not the drugs are actually at fault for causing an injury. Furthermore, our products may cause, or may appear to have caused, serious adverse side effects (including death) or potentially dangerous drug interactions that we may not learn about or understand fully until the drug has been administered to patients for some time. Product liability claims can be expensive to defend and may result in large judgments or settlements against us, which could have a negative effect on our financial performance. We maintain product liability insurance in amounts we believe to be commercially reasonable for our current level of activity and exposure, but claims could exceed our coverage limits. Furthermore, we cannot be certain that we will always be able to purchase sufficient insurance at an affordable price. Even if a product liability claim is not successful, the adverse publicity and time and expense of defending such a claim may interfere with our business. The results and timing of our research and development activities, including future clinical trials, are difficult to predict, subject to future setbacks and, ultimately, may not result in any additional pharmaceutical products, which may adversely affect our business. We are focused on the development of our oral insulin product in the immediate future, and ultimately upon additional products using our platform buccal delivery technology. In pursuing these objectives, we may undertake a range of activities, which include engaging in discovery research and process development, conducting preclinical and clinical studies, and seeking regulatory approval in the United States and abroad. In all of these areas, we have relatively limited resources and compete against larger multinational pharmaceutical companies. Moreover, even if we undertake these activities in an effective and efficient manner, regulatory approval for the sale of new pharmaceutical products remains highly uncertain since, in our industry, the majority of compounds discovered do not enter clinical studies and the majority of therapeutic candidates fail to show the human safety and efficacy necessary for regulatory approval and successful commercialization. Preclinical testing and clinical trials must demonstrate that a product candidate is safe and efficacious. The results from preclinical testing and early clinical trials may not be predictive of results obtained in subsequent clinical trials, and we cannot be sure that these clinical trials would demonstrate the safety and efficacy necessary to obtain regulatory approval for any product candidates. A number of companies in the biotechnology and pharmaceutical industries have suffered significant setbacks in advanced clinical trials, even after obtaining promising results in earlier trials. In addition, certain clinical trials are conducted with patients having the most advanced stages of disease. During the course of treatment, these patients may die or suffer other adverse medical effects for reasons that may not be related to the pharmaceutical agent being tested. Such events can have a negative impact on the statistical analysis of clinical trial results. The completion of clinical trials of product candidates may be delayed by many factors. One such factor is the rate of enrollment of patients. We cannot control the rate at which patients would present themselves for enrollment, and we cannot be sure that the rate of patient enrollment would be consistent with our expectations or be sufficient to enable clinical trials of product candidates to be completed in a timely manner or at all. Any significant delays in, or termination of, clinical trials of product candidates can have a material adverse effect on our business. We cannot be sure that we will be permitted by regulatory authorities to undertake additional clinical trials for any product candidates, or that if such trials are conducted, any product candidates will prove to be safe and efficacious or will receive regulatory approvals. Any delays in or termination of these clinical trial efforts can have a material adverse effect on product development. Our research and development and marketing efforts are highly dependent at present on corporate collaborators and other third parties who may not devote sufficient time, resources and attention to our programs, which may limit our efforts to successfully develop and market potential products. Because we have limited resources, we have sought to enter into collaboration agreements with other pharmaceutical companies. Our primary collaboration agreement at present is our development and license agreement with Eli Lilly and Company. As is often the case in such collaboration agreements, Lilly has substantial control over the supply of bulk drugs for commercial use or for use in clinical trials; the design and execution of clinical studies; the process of obtaining regulatory approval to market the product; and/or the eventual marketing and selling of any approved product. In each of these areas, Lilly, or any other collaborator with whom we may enter into such collaboration agreements, may not support fully our research and commercial interests since our program may compete for time, attention and resources with such collaborator's internal programs. As such, we cannot be sure that either Lilly or any other corporate collaborators will share our perspectives on the relative importance of our program, that they will commit sufficient resources to our program to move it forward effectively, or that the program will advance as rapidly as it might if we had retained complete control of all research, development, regulatory and commercialization decisions. Additionally, we may find it necessary from time to time to seek new or additional partners to assist us in commercializing our products. It is uncertain whether we would be successful in establishing any such new or additional relationships. We may incur additional losses. To date, we have not been profitable and our accumulated net loss was approximately $49 million at July 31, 2001. Our losses have resulted principally from costs incurred in research and development, including clinical trials, and from general and administrative costs associated with our operations. While we seek to attain profitability, we cannot be sure that we will ever achieve product and other revenue sufficient for us to attain this objective. We cannot be sure that we will obtain required regulatory approvals, or successfully develop, commercialize, manufacture and market any other product candidates. The price of our shares may be volatile. There may be wide fluctuation in the price of our shares. 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 that grant special voting rights to the holders of such shares that make it more difficult to obtain shareholder approval for an acquisition of Generex or increase the cost of any such acquisition. Item 2. Properties. Our executive and principal administrative offices 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 9,100 square feet of usable space. The space in the Centre that is not used by us is leased to third parties. Rental income is accounted for as a reduction of our occupancy costs. We also own a laboratory facility in Toronto that we have used for limited production of our oral insulin formulation for clinical purposes, and have completed a pilot manufacturing facility for our insulin product in the same commercial complex. Our laboratory facility is approximately 2,650 square feet. Our pilot manufacturing facility, which also includes laboratory facilities, is approximately 4,800 square feet, a portion of which has been leased to third parties. We have obtained regulatory approval for the laboratory facility, and we are currently in the process of obtaining regulatory approval for the pilot manufacturing facility. We have first mortgages on our Toronto properties totaling $692,660 at July 31, 2001. Our mortgages require the payment of interest, with minimal principal reduction, prior to their due date (November 1, 2002 with respect to $174,565 and May 25, 2005 with respect to $518,095). At this time, we do not expect to need manufacturing capabilities beyond our pilot facility before the end of the current fiscal year. We have acquired, however, an 11,625 square foot building in Brampton, Ontario, which is approximately 25 miles outside Toronto, and a 13,500 square foot building in Mississauga, Ontario, which is about 20 miles from downtown Toronto, for ultimate use in manufacturing. We have done preliminary work on these facilities, but we do not expect to make a substantial investment in improving and equipping them for manufacturing operations until our requirements in this area are better defined. Both properties are currently leased to third parties. Item 3. Legal Proceedings. Sands Brothers & Co. Ltd. v. Generex Biotechnology Corporation. On October 2, 1998, 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. Sands alleged that it had the right to receive, for nominal consideration, approximately 1.5 million shares of our common stock. Sands based its claim upon an October 1997 letter agreement that was purported by Sands to confirm an agreement appointing Sands as the exclusive financial advisor to Generex Pharmaceuticals, Inc., a subsidiary that we acquired in late 1997. In exchange therefor, the letter agreement purported to grant Sands the right to acquire 17% of Generex Pharmaceuticals common stock for nominal consideration. Sands claimed that its right to receive shares of Generex Pharmaceuticals common stock applies to our common stock since outstanding shares of Generex Pharmaceuticals common stock were converted into shares of our common stock in the acquisition. Sands' claims also included additional shares allegedly due as a fee related to that acquisition, and $144,000 in monthly fees allegedly due under the terms of the purported agreement. Pursuant to an arbitration award dated September 22, 1999, the arbitration panel that heard this case awarded Sands $14,070 and issued a declaratory judgment requiring us to issue to Sands a warrant to purchase 1,530,020 shares of our common stock pursuant to and in accordance with the terms of the purported October 1997 letter agreement. On October 13, 1999, Sands commenced a special proceeding to confirm the arbitration award in the Supreme Court of the State of New York, County of New York (the "New York Supreme Court"). On November 10, 1999, we moved to vacate the arbitration award. On March 20, 2000, the New York Supreme Court granted Sands' petition to confirm the award and denied our motion to vacate the award. We appealed and on January 23, 2001, the New York State Appellate Division, First Department (the "Appellate Division"), modified the judgment of the New York Supreme Court that had confirmed the arbitration award against us. The Appellate Division affirmed the portion of the New York Supreme Court judgment that had confirmed the granting of monetary relief of $14,070 to Sands but modified the judgment to vacate the portion of the arbitration award directing the issuance to Sands of a warrant to purchase 1,530,020 shares of the our common stock. The Appellate Division held that the portion of the award directing us to issue warrants to Sands is too indefinite to be enforceable and remanded the matter to the arbitration panel for a final and definite award with respect to such relief or its equivalent (including possibly an award of monetary damages). The arbitration panel commenced hearings on the matters remanded by the Appellate Division in June 2001 and is expected to conclude its consideration of such matters and render its decision during the fourth calendar quarter of 2001. We are not able to estimate an amount or range of potential loss from this legal proceeding at the present time. MQS, Inc. v. Generex Biotechnology Corporation. 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 $243,066 are due to it for services that it rendered through December 22, 1998. MQS claimed that we used proprietary technology of MQS in developing our aerosol applicator and in formulating our oral insulin formulation for aerosol application. We filed our answer to MQS's claims in May 1999, in which we denied that MQS is entitled to the relief that it was seeking and denied that any of our products or technology incorporates any proprietary technology belonging to MQS. We also filed a counterclaim against MQS for breach of contract, as well as claims based upon unauthorized use and misappropriation of our trade secrets and technology. In January 2001, we entered into a settlement agreement with MQS whereby we paid the plaintiff certain amounts in cash and common stock that were not material to the consolidated financial position of the Company and whereby the claims of the parties were dismissed with prejudice. The settlement agreement prohibits MQS from developing, manufacturing, licensing or marketing any insulin or non-insulin product that uses our platform technology. Subash Chandarana et al. v Generex Biotechnology Corporation et al. In February 2001, Subash Chandarana, a former business associate of Dr. Pankaj Modi, our Vice President of Research and Development, and an entity called Centrum Technologies Inc. commenced an action in the Ontario Superior Court of Justice against us and Dr. Modi seeking, among other things, damages for alleged breaches of contract and tortious acts related to a business relationship between Chandarana and Modi that ceased in July 1996. The plaintiffs' statement of claim also seeks to enjoin the use, if any, by us of three patents allegedly owned by the company called Centrum Technologies Inc. On July 20, 2001, we filed a preliminary motion to dismiss the action of Centrum Technologies Inc. as a nonexistent entity or, alternatively, to stay such action on the grounds of want of authority of such entity to commence the action and, in the further alternative, to dismiss such action for failure to produce documents referred to in the statement of claim. We intend to defend this action vigorously. We are not able to predict the ultimate outcome of this legal proceeding at the present time or to estimate an amount or range of potential loss, if any, from this legal proceeding. We maintain product liability coverage for claims arising from the use of our products in clinical trials, but do not have any insurance that covers our potential liability in any of the legal proceedings described above. Item 4. Submission of Matters to a Vote of Security Holders. We did not submit any matters to a vote of stockholders in the fourth quarter of the fiscal year ended July 31, 2001. EXECUTIVE OFFICERS OF THE REGISTRANT The following table sets forth the names, ages and positions of the executive officers of the Company:
Name Age Position Held ---- --- ------------- Anna E. Gluskin 50 President, Chief Executive Officer and Director Pankaj Modi, Ph.D. 47 Vice President, Research & Development and Director E. Mark Perri 40 Chairman, Chief Financial Officer and Director Rose C. Perri 34 Chief Operating Officer, Treasurer, Secretary and Director
Anna E. Gluskin - Director since September 1997. Ms. Gluskin has served as the President and Chief Executive Officer of Generex since October 1997. She held comparable positions with Generex Pharmaceuticals, Inc. from its formation in 1995 until its acquisition by Generex in October 1997. Pankaj Modi, Ph.D. - Director since September 1997. Dr. Modi has served as Vice President, Research and Development, since October 1997. Prior to that time, Dr. Modi was Director of Insulin Research for Generex Pharmaceuticals, Inc., a position he assumed in October 1996. Prior to joining Generex Pharmaceuticals Inc., Dr. Modi was engaged in independent research and was employed as a senior researcher at McMaster University in Hamilton, Ontario from February 1994 through October 1996. E. Mark Perri - Director since September 1997. Mr. Perri has served as the Chairman and Chief Financial Officer of Generex since October 1997. He held comparable positions with Generex Pharmaceuticals, Inc. from its formation in 1995 until its acquisition by Generex in October 1997. Rose C. Perri - Director since September 1997. Ms. Perri has served as Treasurer and Secretary of Generex since October 1997, and as Chief Operating Officer since August 1998. She was an officer of Generex Pharmaceuticals, Inc. from its formation in 1995 until its acquisition by Generex in October 1997. PART II Item 5. Market for Registrant's Common Equity and Related Stockholder Matters. "Bid" and "asked" prices for our common stock were quoted on the Nasdaq OTC Electronic Bulletin Board from February 1998 to May 2000. On May 5, 2000, our common stock began trading on The Nasdaq Stock Market's National Market (the "Nasdaq National Market"). Prior to February 1998, there was no public market for our common stock. The table below sets forth the high and low inter-dealer bid quotations for our common stock for certain periods prior to May 5, 2000, as furnished by the Nasdaq OTC Bulletin Board. These are "inter-dealer" quotations, without retail mark-up, mark-down or commissions, and may not represent actual transactions. The table also sets forth the high and low sales prices of our common stock reported by The Nasdaq Stock Market for these periods beginning May 5, 2000.
Interdealer Bid Quotations Sales Prices (not actual transactions) (actual transactions) High Low High Low 2000 ---- First quarter $9.88 $4.62 -- -- Second quarter $13.88 $1.06 $ .38 $4.78 Third quarter $24.75 $4.00 $24.88 $7.56 Fourth quarter $14.69 $.03 $14.75 $10.00 2001 ---- First quarter $11.50 $4.25 Second quarter $11.60 $4.58 Third quarter $10.00 $2.91 Fourth quarter (through $ 4.35 $3.55 October 15, 2001)
The closing sales price for our common stock reported on October 15, 2001, was $4.25. At October 15, 2001, there were 674 holders of record of our common stock. Dividends We have not paid dividends on our common stock in the past and have no present intention of paying dividends in the foreseeable future. Recent Sales of Unregistered Securities In the period from August 1, 2000 until July 31, 2001, we have offered and sold common stock and other securities in a number of transactions, including the transactions described below, in reliance upon exemptions from the registration requirements of the Securities Act of 1933. In the transactions described below, unless otherwise indicated, we relied upon the exemptions from registration provided in Section 4(2) of the Securities Act, and Rule 506 of Regulation D thereunder. No "public solicitation", as that term is defined in Rule 502(c) of Regulation D, was employed by or in connection with the sale of these securities. All purchasers were, to our reasonable belief, accredited investors who purchased for investment. All disclosures required under Rule 502(d) of Regulation 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 placed a legend evidencing the restrictions on all certificates representing the shares, and issued "stop transfer" instructions to our transfer agent to prevent unapproved transfers. Transactions in the year ended July 31, 2001, and not previously reported on a Quarterly Report on Form 10-Q were as follows: (a) On or about July 6, 2001, we completed a private placement of 1,189,189 units of securities ("Units") for cash at a price of $9.25 per Unit. Each Unit consisted of a share of common stock and a warrant to purchase .25 shares of common stock at an initial exercise price of $10.175 per share. The Units were sold without registration under the Securities Act of 1933 (the "1933 Act") in reliance upon the exemption from registration provided in Section 4(2) thereof and Rule 506 of Regulation D promulgated thereunder. Under the terms of sale, we have agreed to register the shares of common stock issued to the investors and the shares of common stock issuable upon exercise of the warrants for sale under the 1933 Act. (b) On or about July 6, 2001, we also completed a second private placement of 64,864 units of securities ("Units") for cash at a price of $9.25 per Unit. Each Unit consisted of a share of common stock and a warrant to purchase .25 shares of common stock at an initial exercise price of $10.175 per share. The Units were sold without registration under the 1933 Act in reliance upon the exemption from registration provided in Section 4(2) thereof and Rule 506 of Regulation D promulgated thereunder. Under the terms of sale, we have agreed to register the shares of common stock issued to the investors and the shares of common stock issuable upon exercise of the warrants for sale under the 1933 Act. Item 6. 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 annual report. Our financial statements as of July 31, 2001 and for the year ended July 31, 2001 have been audited by Deloitte & Touche LLP. Our financial statements for the years ended July 31, 2000 and 1999 were audited by WithumSmith+Brown.
Years Ended July 31 ------------------- (In thousands, except per share data) 2001 2000 1999 1998 1997 2001* Operating Results Revenue $ 1,000 -- -- -- -- $1,000 Net Loss $(27,097) $(8,841) $(6,240) $(4,664) (1,379) $(48,914) Cash dividends per share -- -- -- -- -- -- Loss per common share: Basic and diluted net loss per common share (1.44) (.58) (.47) (.46) (.25) -- Financial Positions: Total Assets 42,666 10,341 8,890 5,456 3,673 -- Long-term Debt 693 722 996 1,324 -- -- Stockholder's Investment 39,322 8,415 7,310 2,642 3,449 --
*Cumulative from November 2, 1995 (Date of Inception) to July 31, 2001 Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operation. General Corporate History. We were incorporated in Delaware in September 1997 for the purpose of acquiring Generex Pharmaceuticals, Inc., a Canadian corporation formed in November 1995 to engage in pharmaceutical and biotechnological research and other activities. Our acquisition of Generex Pharmaceuticals was completed in October 1997 in a transaction in which the holders of all outstanding shares of Generex Pharmaceuticals exchanged their shares for shares of our common stock. In January 1998, we participated in a "reverse acquisition" with Green Mt. P. S., Inc., a previously inactive Idaho corporation formed in 1983. As a result of this transaction, our shareholders (the former shareholders of Generex Pharmaceuticals) acquired a majority (approximately 90%) of the outstanding capital stock of Green Mt., we became a wholly-owned subsidiary of Green Mt., Green Mt. changed its corporate name to Generex Biotechnology Corporation ("Generex Idaho"), and we changed our corporate name to GBC Delaware, Inc. Because the reverse acquisition resulted in our shareholders becoming the majority holders of Generex Idaho, we were treated as the acquiring corporation in the transaction for accounting purposes. Thus, our historical financial statements, which essentially represented the historical financial statements of Generex Pharmaceuticals, were deemed to be the historical financial statements of Generex Idaho. In April 1999, we completed a reorganization in which we merged with Generex Idaho. In this transaction, all outstanding shares of Generex Idaho were converted into our shares, Generex Idaho ceased to exist as a separate entity, and we changed our corporate name back to "Generex Biotechnology Corporation". This reorganization did not result in any material change in our historical financial statements or current financial reporting. Business History. We are engaged in the development of proprietary drug delivery technology. Our principal business focus has been to develop a technology for buccal delivery (absorption through the inner cheek walls) of large molecule drugs, i.e., drugs composed of molecules with molecular weights above a specified level. Large molecule drugs historically have been administered only by injection because their size inhibits or precludes absorption if administered by oral, transdermal, transnasal or other means. Our first product is an insulin formulation that is administered as a fine spray into the oral cavity using a hand-held aerosol spray applicator. Between January 1999 and September 2000, we conducted clinical trials on this product in the United States, Canada and Europe. In September 2000, we entered into an agreement to develop this product with Eli Lilly and Company. Under this agreement, Lilly is responsible for conducting clinical trials of the product, securing regulatory approvals and marketing on a worldwide basis. Lilly also has the option to develop certain additional products using our buccal delivery technology depending on the success of the initial product. We received $1,000,000 in connection with our entry into the agreement and will receive certain other initial fees and milestone payments subject to the attainment of certain product development milestones, as well as royalty payments based on product sales should any products be approved for commercial sale. Lilly also has the option to develop certain additional products using our buccal delivery technology depending on the success of the initial product. In January 2001, we established a joint venture with Elan International Services, Ltd. ("EIS"), a wholly owed subsidiary of Elan Corporation, plc (EIS and Elan Corporation, plc being collectively referred to as "Elan"). The joint venture will pursue the application of certain of our and Elan's drug delivery technologies, including our platform technology for the buccal delivery of pharmaceutical products, for the treatment of prostate cancer, endometriosis and/or the suppression of testosterone and estrogen. The parties intend to select at least one pharmaceutical product for research and development under the joint venture within one year's time. The parties will conduct the joint venture through Generex (Bermuda), Ltd., a Bermuda limited liability company. In connection with the joint venture, EIS purchased 1,000 shares of a new series of our preferred stock, designated as Series A Preferred Stock, for $12,015,000. We applied the proceeds from the sale of the Series A Preferred Stock to subscribe for an 80.1% equity ownership interest in Generex (Bermuda), Ltd. EIS paid in capital of $2,985,000 to subscribe for a 19.9% equity interest in Generex (Bermuda), Ltd. While we initially own 80.1% of the joint venture entity, EIS has the right, subject to certain conditions, to increase its ownership up to 50% by exchanging the Series A Preferred Stock for 30.1% of our interest in the joint venture entity. Generex (Bermuda), Ltd. was granted non-exclusive licenses to utilize our buccal delivery technology and certain Elan drug delivery technologies. Using the funds from its initial capitalization, Generex (Bermuda), Ltd. paid a non-refundable license fee of $15,000,000 to Elan in consideration for being granted the rights to utilize the Elan drug delivery technologies. EIS also purchased 344,116 shares of our common stock for $5,000,000. We may use the proceeds of this sale for any corporate purpose. If the joint venture achieves certain milestones, we may require EIS to purchase an additional $1,000,000 of our common stock at a 30% premium to the then prevailing fair market value of our common stock. Our buccal delivery technology is a platform technology that we believe has application to a significant number of large molecule drugs in addition to insulin. In the future, we expect to undertake development of additional products based on this technology that are not covered by our agreement with Lilly. We do not expect to receive any revenues from product sales in the current fiscal year. We received a $1,000,000 signing fee, which is included in revenues as all necessary requirements have been satisfied, under the terms of the agreement with Lilly in the first fiscal quarter of FY 2001. We expect, however, to satisfy a substantial majority of our cash needs during the current year from capital raised through prior equity financing. Results of Operations - - 2001 Compared with 2000 We had a net loss of $27,097,210 in the year ended July 31, 2001 (FY 2001) compared to a loss of $8,841,047 in the year ended July 31, 2000 (FY 2000). The increase in our FY 2001 net loss resulted from increases in research and development expenses (to $19,149,860 from $3,476,436) and in general and administrative expenses (to $13,287,679 from $5,567,520). Our interest and miscellaneous income in FY 2001 increased to $1,355,329 from $202,909 in FY 2000. The accounting treatment of the minority shareholder's share of the loss generated by Generex (Bermuda), Ltd., resulted in a $2,985,000 minority interest share of loss. In addition, we received $1,000,000 in revenues in connection with the agreement with Lilly. The principal reasons for the increase in our research and development expense in FY 2001 were: o the accounting treatment for our joint venture with Elan, which resulted in a $15,000,000 research and development expense for the license fee paid by Generex (Bermuda) Ltd. to Elan for technology rights (The Company's consolidated net loss, which includes this expense, however, was partially offset by approximately $2.9 million of minority interest, reflecting Elan's 19.9% ownership interest in the joint venture.); and o increased expenditures relating to clinical studies of our oral insulin formulation. The principal reasons for the increase in our general and administrative expenses in FY 2001 were: o expenses incurred in connection with the termination in August 2001 of the equity line facility, pursuant to which the Company paid $245,000 to Tradersbloom Limited, $750,000 to Ladenburg Thalman & Co., and expensed the deferred financing costs (the fair value of the warrants, approximately $3,406,196), all of which were included in FY 2001; o increased travel and other costs of $1,524,997 (to $2,663,059 from $538,062) associated with attendance at and sponsorship of industry seminars and exhibitions and other promotional activities; o an increase of $959,124 in legal and accounting fees and expenses (to $2,479,850 from $1,520,726) related primarily to legal and accounting services in connection with reporting requirements under the Securities and Exchange Act of 1934, litigation defense costs and increased legal activity necessitated by increased equity financing and business activity; o increased personnel costs of $207,658 (to $576,665 from $369,007) related primarily to additions in our technical and administrative staff during FY 2001; and o expenses associated with the 2001 annual meeting of stockholders. Results of Operations - - 2000 Compared With 1999 We had a net loss of $8,841,047 in the year ended July 31, 2000 (FY 2000) compared to a loss of $6,239,602 in the year ended July 31, 1999 (FY 1999). The increase in our FY 2000 net loss resulted from increases in research and development expenses (to $3,476,436 from $1,853,108) and in general and administrative expenses (to $5,567,520 from $4,374,523). Our net interest and miscellaneous income in FY 2000 increased to $202,909 from a net expense of $11,971 in FY 1999, primarily as a result of increased interest income in FY 2000. The principal reasons for the increase in our research and development expense in FY 2000 were: o increased expenditures relating to clinical trials of our oral insulin formulation primarily attributable to the expanded scope of these trials in FY 2000 to include additional sites in the United States and Europe, and the fact that trials did not commence in FY 1999 until the second quarter; and o costs associated with operations of our pilot manufacturing facility in Toronto which supports our clinical program. The principal reasons for the increase in our general and administrative expenses in FY 2000 were: o an increase of $684,344 in legal and accounting fees and expenses (to $1,520,726 from $836,382) related primarily to legal and accounting services in connection with reporting requirements under the Securities and Exchange Act of 1934, litigation defense costs and increased legal activity necessitated by increased business activity; o increased personnel costs of $198,122 (to $369,007 from $170,885) related primarily to additions to our technical and administrative staff during FY 2000; and o increased travel and other costs of $93,298 (to $538,062 from $444,764) associated with attendance at and sponsorship of industry seminars and exhibitions and other promotional activities. In both of the last two fiscal years, we incurred substantial expenses for financial advisory and other financing services that were not related to a specific financing and, therefore, were accounted for as general and administrative expenses. These expenses ($1,845,408 in FY 2001 and $1,573,604 in FY 2000) were paid primarily through the issuance of shares of common stock and/or warrants and options to purchase common stock. We believe that any similar expenses incurred in the current fiscal year will not exceed the level of such expenses in FY 2001. Liquidity and Capital Resources To date we have financed our development stage activities primarily through private placements of common stock. In FY 2001, we issued approximately 3.82 million shares of common stock for cash proceeds of approximately $37.4 million (net of financing costs of approximately $2.9 million). Additionally, we granted stock options, warrants and shares of common stock to consultants, advisors and employees with a value of $5,742,592 for services rendered, of which $292,592 was included in financing costs. As a result of our sales of common stock for cash and our use of stock options, warrants and shares of common stock to pay for certain services during FY 2001, our stockholders' equity increased to approximately $39.3 million at July 31, 2001, versus approximately $8.42 million at July 31, 2000, notwithstanding our net loss during the year. At July 31, 2001, we had on hand cash and short term investments (primarily notes of U.S. corporations) of approximately $37 million versus $7.17 million at July 31, 2000. In the final quarter of FY 2001, we received additional equity capital of approximately $531,000 from the sale of 103,500 shares of common stock upon exercise of outstanding warrants. In the final quarter of FY 2001, we received additional equity capital of approximately $10.8 million (net of financing costs of approximately $.75 million) from two private placements of units of securities consisting of 1.0 shares of common stock and warrants to purchase an additional .25 shares of common stock at a price of $9.25 per unit. We believe that our current cash position is sufficient to meet all of our working capital needs for at least the next 12 months. Beyond that, we may require additional funds to support our working capital requirements or for other purposes and may seek to raise funds through private or public equity financing or from other sources. 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. In the past we have funded most of our development and other costs with equity financing. While we have been able to raise equity capital as required, unforeseen problems with our clinical program or materially negative developments in general economic conditions could interfere with our ability to raise additional equity capital as needed, or materially adversely affect the terms upon which such capital is available. Transactions with Affiliates On May 3, 2001, the Company's three senior officers, who are also shareholders of the Company, were advanced $334,300 each, in exchange for promissory notes. These notes bear interest at 8.5 percent per annum and are payable in full on May 1, 2002. These notes are guaranteed by a related company owned by these officers and secured by a pledge of 2,500,000 shares of the Company's common stock currently owned by this related company. As of July 31, 2001, the balance outstanding on these notes, including accrued interest, was $1,023,743. Prior to January 1, 1999, a portion of our general and administrative expenses resulted from transactions with affiliated persons, and a number of capital transactions also involved affiliated persons. Although these transactions were not the result of "arms-length" negotiations, we do not believe that this fact had a material impact on our results of operations or financial position. Prior to December 31, 1998, we classified certain payments to executive officers for compensation and expense reimbursements as "Research and development - related party" because the executive officers received such payments through personal services corporations rather than directly. After December 31, 1998, these payments have been and will continue to be accounted for as though the payments were made directly to the officers, and not as a related party transaction. We do not foresee a need for, and therefore do not anticipate, any related party transactions in the current fiscal year. New Accounting Pronouncements In June 1998, 1999, and 2000, the FASB issued SFAS No. 133, Accounting for Derivative Instruments and Hedging Activities, SFAS No. 137, Accounting for Derivative Instruments and Hedging Activities - Deferral of the Effective Date of FASB Statement No. 133, and SFAS No. 138, Accounting for Certain Derivative Instruments and Certain Hedging Activities, respectively. These statements require companies to record derivatives on the balance sheet as assets or liabilities, measured at fair value. Gains or losses resulting from changes in the values of those derivatives would be accounted for depending on the use of the derivative and whether it qualifies for hedge accounting. The adoption on August 1, 2000 of these statements did not have a significant impact on the Company's financial position or results of operations. In December 1999, the SEC issued Staff Accounting Bulletin No. 101 (SAB 101), Revenue Recognition in Financial Statements. SAB 101 provides guidance on the recognition, presentation, and disclosure of revenues in financial statements of all public registrants. In October 2000, the SEC issued a Frequently Asked Questions document related to SAB 101 which provides interpretive guidance. The Company adopted SAB 101 in fiscal year 2001, and the adoption of SAB 101 did not have a significant impact on the Company's financial position or results of operations. In June 2001, the FASB issued SFAS No. 141, Business Combinations. SFAS No. 141 addresses the initial recognition and measurement of goodwill and other intangible assets acquired in a business combination. SFAS No. 141 is applicable to business combinations beginning July 1, 2001. The adoption of this statement did not have a significant impact on the Company's financial position or results of operations. In June 2001, the FASB issued SFAS No. 142, Goodwill and Other Intangible Assets. SFAS No. 142 addresses the recognition and measurement of goodwill and other intangible assets subsequent to their acquisition. SFAS No. 142 also addresses the initial recognition and measurement of intangible assets acquired outside of a business combination whether acquired individually or with a group of other assets. Goodwill and intangible assets previously recorded, in the Company's financial statements, will be affected by the provisions of SFAS No. 142. This statement provides that intangible assets with finite useful lives be amortized and that intangible assets with indefinite lives and goodwill will not be amortized, but will rather be tested at least annually for impairment. SFAS No. 142 will be effective for the Company's fiscal year 2002, however management is assessing the impact that SFAS No. 142 will have on the Company's financial position and results of operations. Item 7A. Quantitative and Qualitative Disclosures About Market Price We are not presently subject to any material market risk exposures. We are exposed to market risk associated with interest rate changes in the exchange rates between U.S. and Canadian currencies. We have neither issued nor own any long term debt instruments, or any other financial instruments as to which we would be subject to material risks, including market risks, related to interest rate movements. At the present time, we maintain our cash in short term government or government guaranteed instruments, short term commercial paper, interest bearing bank deposits or demand bank deposits which do not earn interest. A substantial majority of these instruments and deposits are denominated in U.S. dollars, with the exception of funds denominated in Canadian dollars on deposit in Canadian banks to meet short term operating needs in Canada. At the present time, with the exception of professional fees and costs associated with the conduct of clinical trials in the United States and Europe, substantially all of our operating expense obligations are denominated in Canadian dollars. We do not presently employ any hedging or similar strategy intended to mitigate against losses that could be incurred as a result of fluctuations in the exchange rates between U.S. and Canadian currencies GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES (A DEVELOPMENT STAGE COMPANY) INDEX TO CONSOLIDATED FINANCIAL STATEMENTS PAGE ---- Independent Auditors' Reports F-1-2 Consolidated Balance Sheets July 31, 2001 and 2000 F-3 Consolidated Statements of Operations For the Years Ended July 31, 2001, 2000 and 1999 and Cumulative From Inception to July 31, 2001 F-4 Consolidated Statements of Changes in Stockholders' Equity For the Period November 2, 1995 (Date of Inception) to July 31, 2001 F-5-10 Consolidated Statements of Cash Flows For the Years Ended July 31, 2001, 2000 and 1999 and Cumulative From Inception to July 31, 2001 F-11 Notes to Consolidated Financial Statements F-12-31 Item 8. Financial Statements and Supplementary Data Independent Auditors' Report To the Board of Directors and Stockholders of Generex Biotechnology Corporation We have audited the accompanying consolidated balance sheet of Generex Biotechnology Corporation and Subsidiaries (a development stage company) as at July 31, 2001 and the consolidated statement of operations, shareholders' equity and of cash flows for the year then ended. These consolidated financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audit. We conducted our audit in accordance with auditing standards generally accepted in the United States of America. Those standards require that we plan and perform an 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, such consolidated financial statements present fairly, in all material respects, the financial position of the Company as at July 31, 2001 and the results of its operations and its cash flows for the year then ended in conformity with accounting principles generally accepted in the United States of America. DELOITTE & TOUCHE LLP ----------------------------------- DELOITTE & TOUCHE LLP Chartered Accountants Toronto, Ontario October 2, 2001 F-1 INDEPENDENT AUDITORS' REPORT To the Board of Directors and Stockholders, Generex Biotechnology Corporation: We have audited the accompanying consolidated balance sheet of Generex Biotechnology Corporation and Subsidiaries (a development stage company) as of July 31, 2000 and the related consolidated statements of operations, changes in stockholders' equity and cash flows for each of the years in the two-year period ended July 31, 2000, and the cumulative amounts of operations and cash flows for the period November 2, 1995 (date of inception) to July 31, 2000. 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 auditing standards generally accepted in the United States of America. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion. In our opinion, the financial statements referred to above present fairly, in all material respects, the consolidated financial position of Generex Biotechnology Corporation and Subsidiaries as of July 31, 2000 and the consolidated results of their operations, and their cash flows for each of the years in the two-year period ended July 31, 2000, and the cumulative amounts of operations and cash flows for the period November 2, 1995 (date of inception) to July 31, 2000 in conformity with accounting principles generally accepted in the United States of America. WithumSmith+Brown New Brunswick, New Jersey September 14, 2000 F-2 GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES (A DEVELOPMENT STAGE COMPANY) CONSOLIDATED BALANCE SHEETS
July 31, ----------------------------------- 2001 2000 ---------------- -------------- ASSETS Current Assets: Cash and cash equivalents $ 10,109,559 $ 3,204,905 Short-term investments 26,892,729 3,966,263 Officers' loans receivable 1,023,743 -- Miscellaneous receivables 12,865 16,138 Other current assets 112,620 99,041 ------------ ------------ Total Current Assets 38,151,516 7,286,347 Property and Equipment, Net 3,727,761 2,395,867 Patents, Net 434,307 267,369 Deposits 20,000 47,914 Due From Related Parties 332,289 343,773 ------------ ------------ TOTAL ASSETS $ 42,665,873 $ 10,341,270 ============ ============ LIABILITIES AND STOCKHOLDERS' EQUITY Current Liabilities: Accounts payable and accrued expenses $ 2,650,773 $ 1,204,282 Current maturities of long-term debt 9,634 9,404 ------------ ------------ Total Current Liabilities 2,660,407 1,213,686 Long-Term Debt, Less Current Maturities 683,026 712,559 Commitments and Contingencies (Note 7) Stockholders' Equity: Series A, preferred stock, $.001 par value; (liquidation preference $12,015,000); authorized 1,000,000 shares, issued and outstanding 1,000 and -0- at July 31, 2001 and 2000, respectively 1 -- Special Voting Rights Preferred stock, $.001 par value; authorized, issued and outstanding 1,000 shares at July 31, 2001 and 2000 1 1 Common stock, $.001 par value; authorized 50,000,000 shares, issued and outstanding 20,681,526 and 16,326,333 shares at July 31, 2001 and 2000, respectively 20,681 16,327 Additional paid-in capital 88,776,859 30,435,066 Notes receivable - common stock (314,300) (54,118) Deficit accumulated during the development stage (48,913,935) (21,816,725) Accumulated other comprehensive loss (246,867) (165,526) ------------ ------------ Total Stockholders' Equity 39,322,440 8,415,025 ------------ ------------ TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 42,665,873 $ 10,341,270 ============ ============
The Notes to Consolidated Financial Statements are an integral part of these statements. F-3 GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES (A DEVELOPMENT STAGE COMPANY) CONSOLIDATED STATEMENTS OF OPERATIONS
Cumulative For the Years Ended November 2, July 31, 1995 (Date of -------------------------------------------- Inception) to 2001 2000 1999 July 31, 2001 ------------- ------------ ------------- --------------- Revenues 1,000,000 $ -- $ -- $ 1,000,000 Operating Expenses: Research and development 19,149,860 3,476,436 1,853,108 26,095,896 Research and development - related party -- -- -- 220,218 General and administrative 13,287,679 5,567,520 4,374,523 27,751,469 General and administrative- related party -- -- -- 314,328 ------------ ----------- ----------- ------------ Total Operating Expenses 32,437,539 9,043,956 6,227,631 54,381,911 ------------ ----------- ----------- ------------ Operating Loss (31,437,539) (9,043,956) (6,227,631) (53,381,911) Other Income (Expense): Miscellaneous income 10,664 7,906 -- 18,570 Interest income 1,417,847 272,808 55,190 1,745,845 Interest expense (73,182) (77,805) (67,161) (281,439) ------------ ----------- ----------- ------------ Net Loss Before the Undernoted (30,082,210) (8,841,047) (6,239,602) (51,898,935) Minority Interest Share of Loss 2,985,000 -- -- 2,985,000 ------------ ----------- ------------ ------------ Net Loss $(27,097,210) $(8,841,047) $(6,239,602) $(48,913,935) ============ =========== =========== ============ Basic and Diluted Net Loss Per Common Share $ (1.44) $ (.58) $ (.47) ============ =========== =========== Weighted Average Number of Shares of Common Stock Outstanding 18,769,077 15,189,781 13,260,260 ============ =========== ===========
The Notes to Consolidated Financial Statements are an integral part of these statements. F-4 GENEREX BIOTECHOLOGY CORPORATION (A DEVELOPMENT STAGE COMPANY) STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY FOR THE PERIOD NOVEMBER 2, 1995 (DATE OF INCEPTION) TO JULY 31, 2001
Series A SVR Common Preferred Preferred Stock Stock Stock ------------------------ ------------------------ ------------------------ Shares Amount 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 -- -- -- -- -- -- Founders Shares transferred for services Rendered -- -- -- -- -- -- Comprehensive Income (Loss): Net loss -- -- -- -- -- -- Other comprehensive income (loss) Currency translation adjustment -- -- -- -- -- -- Total Comprehensive Income (Loss) --------- ----------- --------- ---------- --------- ---------- Balance, July 31, 1996 4,587,764 $ 4,588 -- $ -- -- $ -- ========= =========== ========= ========== ========= ==========
[RESTUBBED]
Deficit Notes Accumulated Additional Receivable Other During the Total Paid-In - Common Comprehensive Development Stockholders' Capital Stock Income (Loss) 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) Founders Shares transferred for services Rendered 330,025 -- -- -- 330,025 Comprehensive Income (Loss): Net loss -- -- -- (693,448) (693,448) Other comprehensive income (loss) Currency translation adjustment -- -- (4,017) -- (4,017) ----------- ----------- ------------ Total Comprehensive Income (Loss) (4,017) (693,448) (697,465) ---------- --------- ----------- ----------- ------------ Balance, July 31, 1996 $2,708,501 $ -- $ (4,017) $ (693,448) $ 2,015,624 ========== ========= =========== =========== ============
F-5 GENEREX BIOTECHNOLOGY CORPORATION (A DEVELOPMENT STAGE COMPANY) STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY FOR THE PERIOD NOVEMBER 2, 1995 (DATE OF INCEPTION) TO JULY 31, 2001
Series A SVR Common Preferred Preferred Stock Stock Stock ------------------------ ------------------------ ------------------------ Shares Amount 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, $.0512 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, $10.0978 714 1 -- -- -- -- Issuance of common stock for cash, July 1997, $10.1214 25,993 26 -- -- -- -- Costs related to issuance of common stock -- -- -- -- -- -- Founders Shares transferred for services rendered -- -- -- -- -- -- Comprehensive Income (Loss): Net loss -- -- -- -- -- -- Other comprehensive income (loss) Currency translation adjustment -- -- -- -- -- -- Total Comprehensive Income (Loss) --------- ----------- --------- ---------- --------- ---------- Balance, July 31, 1997 9,000,118 $ 9,000 -- $ -- -- $ -- ========= =========== ========= ========== ========= ==========
[RESTUBBED TABLE] GENEREX BIOTECHNOLOGY CORPORATION (A DEVELOPMENT STAGE COMPANY) STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY FOR THE PERIOD NOVEMBER 2, 1995 (DATE OF INCEPTION) TO JULY 31, 2001-- (Continued)
Deficit Notes Accumulated Additional Receivable Other During the Total Paid-In - Common Comprehensive Development Stockholders' Capital Stock Income (Loss) Stage Equity ---------- ---------- ------------- ----------- ------------- Balance, August 1, 1996 $2,708,501 $ -- $ (4,017) $ (693,448) $ 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, $.0512 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, $10.0978 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) Founders Shares transferred for services rendered 23,481 -- -- -- 23,481 Comprehensive Income (Loss): Net loss -- -- -- (1,379,024) (1,379,024) Other comprehensive income (loss) Currency translation adjustment -- -- 3,543 -- 3,543 ------------- ----------- ------------ Total Comprehensive Income (Loss) 3,543 (1,379,024) (1,375,481) ---------- ---------- ------------- ----------- ------------ Balance, July 31, 1997 $5,512,782 -- $ (474) $(2,072,472) $ 3,448,836 ========== ========== ============= =========== ============ The Notes to Consolidated Financial Statements are an integral part of these statements.
F-6 GENEREX BIOTECHNOLOGY CORPORATION (A DEVELOPMENT STAGE COMPANY) STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY FOR THE PERIOD NOVEMBER 2, 1995 (DATE OF INCEPTION) TO JULY 31, 2001
Series A SVR Common Preferred Preferred Stock Stock Stock Additional ----- ----- ----- Paid-In Shares Amount Shares Amount Shares Amount Capital --------- ------- --------- ------ ---------- ------ ---------- Balance, August 1, 1997 9,000,118 $ 9,000 -- $-- -- $-- $5,512,782 Issuance of warrants issued in exchange for services rendered, October 1997, $.50 -- -- -- -- -- -- 234,000 Issuance of common stock in exchange for services rendered, December 1997, $0.0467 234,000 234 -- -- -- -- 10,698 Issuance of SRV Preferred Sock in exchange for services rendered, January 1998, $.001 -- -- -- -- 1,000 1 99 Shares issued pursuant to the January 9, 1998 reverse merger between GBC-Delaware, Inc. and Generex Biotechnology Corporation 1,105,000 1,105 -- -- -- -- (1,105) Issuance of common stock for cash, March 1998, $2.50 70,753 71 -- -- -- -- 176,812 Issuance of common stock for cash, April 1998, $2.50 60,000 60 -- -- -- -- 149,940 Issuance of common stock in exchange for services rendered, April 1998, $2.50 38,172 38 -- -- -- -- 95,392 Issuance of common stock for cash, May 1998, $2.50 756,500 757 -- -- -- -- 1,890,493 Issuance of common stock in exchange for services rendered, May 1998, $2.50 162,000 162 -- -- -- -- 404,838 Issuance of warrants issued in exchange for services rendered, May 1998, $.60 -- -- -- -- -- -- 300,000 Issuance of common stock for cash, June 1998, $2.50 286,000 286 -- -- -- -- 714,714 Exercise of warrants for cash, June 1998, $0.0667 234,000 234 -- -- -- -- 15,374 Issuance of common stock in exchange for services rendered, June 1998, $2.50 24,729 24 -- -- -- -- 61,799 Net loss Other comprehensive income (loss) Currency translation adjustment -- -- -- -- -- -- -- Total Comprehensive Income (Loss) ---------- ------- ---- ---- ----- ---- ---------- Balance, July 31, 1998 11,971,272 $11,971 -- $-- 1,000 $ 1 $9,565,836 ========== ======= ==== ==== ===== ==== ==========
(RESTUBBED TABLE) GENEREX BIOTECHNOLOGY CORPORATION (A DEVELOPMENT STAGE COMPANY) STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY FOR THE PERIOD NOVEMBER 2, 1995 (DATE OF INCEPTION) TO JULY 31, 2001-- (Continued)
Deficit Notes Accumulated Receivable Other During the Total - Common Comprehensive Development Stockholders' Stock Income (Loss) Stage Equity ---------- -------------- ------------ ------------ Balance, August 1, 1997 $-- $ (474) $(2,072,472) $3,448,836 Issuance of warrants issued in exchange for services rendered, October 1997, $.50 -- -- -- 234,000 Issuance of common stock in exchange for services rendered, December 1997, $0.0467 -- -- -- 10,932 Issuance of SRV Preferred Sock in exchange for services rendered, January 1998, $.001 -- -- -- 100 Shares issued pursuant to the January 9, 1998 reverse merger between GBC-Delaware, Inc. and Generex Biotechnology Corporation -- -- -- -- Issuance of common stock for cash, March 1998, $2.50 -- -- -- 176,883 Issuance of common stock for cash, April 1998, $2.50 -- -- -- 150,000 Issuance of common stock in exchange for services rendered, April 1998, $2.50 -- -- -- 95,430 Issuance of common stock for cash, May 1998, $2.50 -- -- -- 1,891,250 Issuance of common stock in exchange for services rendered, May 1998, $2.50 -- -- -- 405,000 Issuance of warrants issued in exchange for services rendered, May 1998, $.60 -- -- -- 300,000 Issuance of common stock for cash, June 1998, $2.50 -- -- -- 715,000 Exercise of warrants for cash, June 1998, $0.0667 -- -- -- 15,608 Issuance of common stock in exchange for services rendered, June 1998, $2.50 -- -- -- 61,823 Net loss (4,663,604) (4,663,604) Other comprehensive income (loss) Currency translation adjustment -- (198,959) -- (198,959) --------- ----------- ---------- Total Comprehensive Income (Loss) (198,959) (4,663,604) (4,862,563) ---- --------- ----------- ---------- Balance, July 31, 1998 $-- $(199,433) $(6,736,076) $2,642,299 ==== ========= =========== ========== The Notes to Consolidated Financial Statements are an integral part of these statements.
F-7 GENEREX BIOTECHNOLOGY CORPORATION (A DEVELOPMENT STAGE COMPANY) STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY FOR THE PERIOD NOVEMBER 2, 1995 (DATE OF INCEPTION) TO JULY 31, 2001
Series A SVR Common Preferred Preferred Stock Stock Stock Additional ------ ----- ----- Paid-In Shares Amount Shares Amount Shares Amount Capital -------- -------- ------- ------ ------ ----------- ----------- Balance, August 1, 1998 11,971,272 $ 11,971 -- $ -- 1,000 $ 1 $ 9,565,836 Issuance of common stock for cash, August 1998, $3.00 100,000 100 -- -- -- -- 299,900 Issuance of common stock for cash, August 1998, $3.50 19,482 19 -- -- -- -- 68,168 Redemption of Common Stock for cash, September 1998, $7.75 (15,357) (15) -- -- -- -- (119,051) Issuance of common stock for cash, September - October 1998, $3.00 220,297 220 -- -- -- -- 660,671 Issuance of common stock for cash, August - October 1998, $4.10 210,818 211 -- -- -- -- 864,142 Issuance of common stock in exchange for services rendered, August - October 1998, $2.50 21,439 21 -- -- -- -- 53,577 Issuance of common stock in exchange for services rendered, August - October 1998, $4.10 18,065 18 -- -- -- -- 74,048 Issuance of Common Stock in exchange for services rendered, September 1998, $4.10 180,000 180 -- -- -- -- 737,820 Issuance of warrants in exchange for services rendered, October 1998, $.26 -- -- -- -- -- -- 2,064 Issuance of stock options in exchange for services rendered, November 1998, $1.85 -- -- -- -- -- -- 92,500 Issuance of warrants in exchange for services rendered, November 1998, $1.64 -- -- -- -- -- -- 246,000 Issuance of common stock for cash, November 1998 - January 1999, $3.50 180,000 180 -- -- -- -- 629,820 Issuance of common stock for cash, November 1998 - January 1999, $4.00 275,000 275 -- -- -- -- 1,099,725 Issuance of common stock for cash, November 1998 - January 1999, $4.10 96,852 97 -- -- -- -- 397,003 Issuance of common stock in exchange for services rendered, November 1998 - January 1999, $4.10 28,718 29 -- -- -- -- 117,715 Issuance of common stock for cash, November 1998 - January 1999, $5.00 20,000 20 -- -- -- -- 99,980 Issuance of common stock for cash, November 1998 - January 1999, $5.50 15,000 15 -- -- -- -- 82,485 Issuance of common stock in exchange for services rendered, January 1999, $5.00 392 -- -- -- -- -- 1,960 Issuance of common stock for cash, February 1999, $5.00 6,000 6 -- -- -- -- 29,994 Issuance of common stock in exchange for services rendered, February 1999, $6.00 5,000 5 -- -- -- -- 29,995 Issuance of common stock for cash, March 1999, $6.00 11,000 11 -- -- -- -- 65,989 Issuance of common stock for cash, April 1999, $5.50 363,637 364 -- -- -- -- 1,999,640 Issuance of warrants in exchange for services rendered, April 1999, $3.21 -- -- -- -- -- -- 160,500 Issuance of warrants in exchange for services rendered, April 1999, $3.17 -- -- -- -- -- -- 317,000 Issuance of warrants in exchange for services rendered, April 1999, $2.89 -- -- -- -- -- -- 144,500 Issuance of warrants in exchange for services rendered, April 1999, $3.27 -- -- -- -- -- -- 184,310 Stock adjustment 714 1 -- -- -- -- (1) Issuance of common stock for cash, May 1999, $5.50 272,728 273 -- -- -- -- 1,499,731 Issuance of common stock in exchange for services rendered, May - June 1999, $5.50 60,874 61 -- -- -- -- 334,746 Exercise of warrants for cash, June 1999, $5.00 388,375 389 -- -- -- -- 1,941,484 Exercise of warrants in exchange for note receivable, June 1999, $5.00 94,776 95 -- -- -- -- 473,787 Exercise of warrants in exchange for services rendered, June 1999, $5.00 13,396 13 -- -- -- -- 66,967 Reduction of note receivable in exchange for services rendered -- -- -- -- -- -- -- Shares tendered in conjunction with warrant exercise, June 1999, $7.8125 (323,920) (324) -- -- -- -- (2,530,301) Exercise of warrants for shares tendered, June 1999, $5.00 506,125 506 -- -- -- -- 2,530,119 Cost of warrants redeemed for cash -- -- -- -- -- -- (3,769) Cost related to warrant redemption, June 1999 -- -- -- -- -- -- (135,431) Costs related to issuance of common stock -- -- -- -- -- -- (1,179,895) Comprehensive Income (Loss): Net Loss -- -- -- -- -- -- -- Other comprehensive income: Currency translation adjustment -- -- -- -- -- -- -- Total Comprehensive Income (Loss) ----------- ----------- ------- ------- ------- ------- ------------ Balance, July 31, 1999 14,740,683 $ 14,741 -- $ -- 1,000 $ 1 $ 20,903,728 =========== ============ ======= ======= ======= ======= ============ The Notes to Consolidated Financial Statements are an integral part of these statements.
GENEREX BIOTECHNOLOGY CORPORATION (A DEVELOPMENT STAGE COMPANY) STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY FOR THE PERIOD NOVEMBER 2, 1995 (DATE OF INCEPTION) TO JULY 31, 2001-- (Continued) [RESTUBBED TABLE]
Deficit Notes Accumulated Receivable Other During the Total - Common Comprehensive Development Stockholders' Stock Income (Loss) Stage Equity ------------ ------------- ------------ ------------- Balance, August 1, 1998 $ -- $ (199,433) $(6,736,076) $ 2,642,299 Issuance of common stock for cash, August 1998, $3.00 -- -- -- 300,000 Issuance of common stock for cash, August 1998, $3.50 -- -- -- 68,187 Redemption of Common Stock for cash, September 1998, $7.75 -- -- -- (119,066) Issuance of common stock for cash, September - October 1998, $3.00 -- -- -- 660,891 Issuance of common stock for cash, August - October 1998, $4.10 -- -- -- 864,353 Issuance of common stock in exchange for services rendered, August - October 1998, $2.50 -- -- -- 53,598 Issuance of common stock in exchange for services rendered, August - October 1998, $4.10 -- -- -- 74,066 Issuance of Common Stock in exchange for services rendered, September 1998, $4.10 -- -- -- 738,000 Issuance of warrants in exchange for services rendered, October 1998, $.26 -- -- -- 2,064 Issuance of stock options in exchange for services rendered, November 1998, $1.85 -- -- -- 92,500 Issuance of warrants in exchange for services rendered, November 1998, $1.64 -- -- -- 246,000 Issuance of common stock for cash, November 1998 - January 1999, $3.50 -- -- -- 630,000 Issuance of common stock for cash, November 1998 - January 1999, $4.00 -- -- -- 1,100,000 Issuance of common stock for cash, November 1998 - January 1999, $4.10 -- -- -- 397,100 Issuance of common stock in exchange for services rendered, November 1998 - January 1999, $4.10 -- -- -- 117,744 Issuance of common stock for cash, November 1998 - January 1999, $5.00 -- -- -- 100,000 Issuance of common stock for cash, November 1998 - January 1999, $5.50 -- -- -- 82,500 Issuance of common stock in exchange for services rendered, January 1999, $5.00 -- -- -- 1,960 Issuance of common stock for cash, February 1999, $5.00 -- -- -- 30,000 Issuance of common stock in exchange for services rendered, February 1999, $6.00 -- -- -- 30,000 Issuance of common stock for cash, March 1999, $6.00 -- -- -- 66,000 Issuance of common stock for cash, April 1999, $5.50 -- -- -- 2,000,004 Issuance of warrants in exchange for services rendered, April 1999, $3.21 -- -- -- 160,500 Issuance of warrants in exchange for services rendered, April 1999, $3.17 -- -- -- 317,000 Issuance of warrants in exchange for services rendered, April 1999, $2.89 -- -- -- 144,500 Issuance of warrants in exchange for services rendered, April 1999, $3.27 -- -- -- 184,310 Stock adjustment -- -- -- -- Issuance of common stock for cash, May 1999, $5.50 -- -- -- 1,500,004 Issuance of common stock in exchange for services rendered, May - June 1999, $5.50 -- -- -- 334,807 Exercise of warrants for cash, June 1999, $5.00 -- -- -- 1,941,873 Exercise of warrants in exchange for note receivable, June 1999, $5.00 (473,882) -- -- -- Exercise of warrants in exchange for services rendered, June 1999, $5.00 -- -- -- 66,980 Reduction of note receivable in exchange for services rendered 38,979 -- -- 38,979 Shares tendered in conjunction with warrant exercise, June 1999, $7.8125 -- -- -- (2,530,625) Exercise of warrants for shares tendered, June 1999, $5.00 -- -- -- 2,530,625 Cost of warrants redeemed for cash -- -- -- (3,769) Cost related to warrant redemption, June 1999 -- -- -- (135,431) Costs related to issuance of common stock -- -- -- (1,179,895) Comprehensive Income (Loss): Net Loss -- -- (6,239,602) (6,239,602) Other comprehensive income: Currency translation adjustment -- 1,393 -- 1,393 ---------- ------------ ------------ Total Comprehensive Income (Loss) 1,393 (6,239,602) (6,238,209) ---------- ---------- ------------ ------------ Balance, July 31, 1999 $ (434,903) $ (198,040) $(12,975,678) $ 7,309,849 ========== ========== ============ ============ The Notes to Consolidated Financial Statements are an integral part of these statements.
F-8 GENEREX BIOTECHNOLOGY CORPORATION (A DEVELOPMENT STAGE COMPANY) STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY FOR THE PERIOD NOVEMBER 2, 1995 (DATE OF INCEPTION) TO JULY 31, 2001
Series A SVR Common Preferred Preferred Stock Stock Stock Additional ----- ----- ----- Paid-In Shares Amount Shares Amount Shares Amount Capital ---------- ------- ------ ------ ------ ------ ------------ Balance, August 1, 1999 14,740,683 $ 14,741 -- $ -- 1,000 $ 1 $ 20,903,728 Adjustment for exercise of warrants recorded June 1999, $5.00 (2,300) (2) -- -- -- -- 2 Issuance of common stock for cash, September 1999, $6.00 2,500 2 -- -- -- -- 14,998 Issuance of common stock for cash pursuant to private placement, January 2000, $4.25 470,590 471 -- -- -- -- 1,999,537 Financing costs associated with private placement, January, 2000 -- -- -- -- -- -- (220,192) Issuance of stock in exchange for services rendered, January 2000, $5.00 8,100 8 -- -- -- -- 40,492 Granting of stock options for services rendered, January 2000 -- -- -- -- -- -- 568,850 Granting of 150,000 stock warrants for services rendered, January 2000 -- -- -- -- -- -- 355,500 Exercise of stock warrants for cash, February 2000, $5.50 2,000 2 -- -- -- -- 10,998 Exercise of stock warrants for cash, March 2000, $5.50 29,091 29 -- -- -- -- 159,972 Exercise of stock warrants for cash, March 2000, $6.00 2,000 2 -- -- -- -- 11,998 Exercise of stock warrants for cash, March 2000, $7.50 8,000 8 -- -- -- -- 59,992 Issuance of common stock for cash pursuant to private placement, June 2000, $6.00 1,041,669 1,042 -- -- -- -- 6,248,972 Financing costs associated with private placement, June 2000 -- -- -- -- -- -- (385,607) Issuance of common stock for services, June 2000, $6.00 4,300 4 -- -- -- -- 25,796 Exercise of warrants for cash, July 2000, $6.00 3,000 3 -- -- -- -- 17,997 Exercise of warrants for cash, July 2000, $7.50 16,700 17 -- -- -- -- 125,233 Granting of stock options for services rendered, July 2000 -- -- -- -- -- -- 496,800 Reduction of note receivable in exchange for services rendered -- -- -- -- -- -- -- Accrue interest on note receivable -- -- -- -- -- -- -- Comprehensive Income (Loss): Net Loss -- -- -- -- -- -- -- Other comprehensive income (loss): Currency translation adjustment -- -- -- -- -- -- -- Total Comprehensive Income (Loss) ---------- -------- ---- ---- ----- ---- ------------ Balance, July 31, 2000 16,326,333 $ 16,327 -- $ -- 1,000 $ 1 $ 30,435,066 ========== ======== ==== ==== ===== ==== ============
GENEREX BIOTECHNOLOGY CORPORATION (A DEVELOPMENT STAGE COMPANY) STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY FOR THE PERIOD NOVEMBER 2, 1995 (DATE OF INCEPTION) TO JULY 31, 2001-- (Continued) (RESTUBBED TABLE)
Deficit Notes Accumulated Receivable Other During the Total - Common Comprehensive Development Stockholders' Stock Income (Loss) Stage Equity ---------- ------------- -------------- ------------- Balance, August 1, 1999 $ (434,903) $ (198,040) $(12,975,678) $ 7,309,849 Adjustment for exercise of warrants recorded June 1999, $5.00 -- -- -- -- Issuance of common stock for cash, September 1999, $6.00 -- -- -- 15,000 Issuance of common stock for cash pursuant to private placement, January 2000, $4.25 -- -- -- 2,000,008 Financing costs associated with private placement, January, 2000 -- -- -- (220,192) Issuance of stock in exchange for services rendered, January 2000, $5.00 -- -- -- 40,500 Granting of stock options for services rendered, January 2000 -- -- -- 568,850 Granting of 150,000 stock warrants for services rendered, January 2000 -- -- -- 355,500 Exercise of stock warrants for cash, February 2000, $5.50 -- -- -- 11,000 Exercise of stock warrants for cash, March 2000, $5.50 -- -- -- 160,001 Exercise of stock warrants for cash, March 2000, $6.00 -- -- -- 12,000 Exercise of stock warrants for cash, March 2000, $7.50 -- -- -- 60,000 Issuance of common stock for cash pursuant to private placement, June 2000, $6.00 -- -- -- 6,250,014 Financing costs associated with private placement, June 2000 -- -- -- (385,607) Issuance of common stock for services, June 2000, $6.00 -- -- -- 25,800 Exercise of warrants for cash, July 2000, $6.00 -- -- -- 18,000 Exercise of warrants for cash, July 2000, $7.50 -- -- -- 125,250 Granting of stock options for services rendered, July 2000 -- -- -- 496,800 Reduction of note receivable in exchange for services rendered 384,903 -- -- 384,903 Accrue interest on note receivable (4,118) -- -- (4,118) Comprehensive Income (Loss): Net Loss -- -- (8,841,047) (8,841,047) Other comprehensive income (loss): Currency translation adjustment -- 32,514 -- 32,514 ------- ---------- ------------ ----------- Total Comprehensive Income (Loss) 32,514 (8,841,047) (8,808,533) ---------- ---------- ------------ ----------- Balance, July 31, 2000 $ (54,118) $ (165,526) $(21,816,725) $ 8,415,025 ========== ========== ============ =========== The Notes to Consolidated Financial Statements are an integral part of these statements.
F-9 GENEREX BIOTECHNOLOGY CORPORATION (A DEVELOPMENT STAGE COMPANY) STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY FOR THE PERIOD NOVEMBER 2, 1995 (DATE OF INCEPTION) TO JULY 31, 2001
Series A SVR Common Preferred Preferred Stock Stock Stock Additional ------ ----- ----- Paid-In Shares Amount Shares Amount Shares Amount Capital -------- -------- ------- ------ ------ ----------- ----------- Balance, August 1, 2000 16,326,333 $ 16,327 -- $ -- 1,000 $ 1 $ 30,435,066 Exercise of stock warrants for cash, August 2000, $6.00 2,000 2 -- -- -- -- 11,998 Issuance of common stock for services rendered August 2000 35,000 35 -- -- -- -- 411,215 Issuance of stock warrants in exchange for equity line agreement, August 2000 -- -- -- -- -- -- 3,406,196 Exercise of stock warrants for cash, August 2000, $7.50 30,300 30 -- -- -- -- 227,220 Exercise of stock warrants for cash, August 2000, $8.6625 30,000 30 -- -- -- -- 259,845 Cashless exercise of stock warrants, August 2000 8,600 9 -- -- -- -- (9) Exercise of stock warrants for cash, August 2000, $10.00 10,000 10 -- -- -- -- 99,990 Exercise of stock warrants for cash, September 2000, $8.6625 63,335 63 -- -- -- -- 548,576 Exercise of stock warrants for cash, September 2000, $5.50 16,182 16 -- -- -- -- 88,986 Exercise of stock warrants for cash, September 2000, $6.00 53,087 53 -- -- -- -- 318,470 Exercise of stock warrants for cash, September 2000, $10.00 9,584 10 -- -- -- -- 95,830 Exercise of stock warrants for cash, September 2000, $7.50 32,416 32 -- -- -- -- 243,088 Issuance of common stock for cash pursuant to private placement, October 2000, $11.00 2,151,093 2,151 -- -- -- -- 23,659,872 Exercise of stock warrants for cash, Oct. 2000, $6.00 1,000 1 -- -- -- -- 5,999 Financing costs associated with private placement, October 2000 -- -- -- -- -- -- (1,956,340) Exercise of stock warrants for cash, November - December 2000, $4.25 23,528 23 -- -- -- -- 99,971 Cashless exercise of stock warrants, December 2000 3,118 3 -- -- -- -- (3) Exercise of stock warrants for cash, November - December 2000, $6.00 22,913 23 -- -- -- -- 137,455 Exercise of stock warrants for cash, December 2000, $7.00 8,823 9 -- -- -- -- 61,752 Issuance of common stock as employee compensation, December 2000 8,650 8 -- -- -- -- 100,548 Exercise of stock warrants for cash, January 2001, $6.00 3,000 3 -- -- -- -- 17,997 Issuance of common stock for cash pursuant to private placement, January 2001, $14.53 344,116 344 -- -- -- -- 4,999,656 Financing costs associated with private placement, January 2001 -- -- -- -- -- -- (200,000) Issuance of common stock pursuant to litigation settlement, January 2001 2,832 2 -- -- -- -- 21,096 Issuance of Series A Preferred Stock, January 2001 -- -- 1,000 1 -- -- 12,014,999 Granting of stock options in exchange for services rendered, January 2001 -- -- -- -- -- -- 745,000 Granting of stock options in exchange for services rendered, February 2001 -- -- -- -- -- -- 129,600 Exercise of stock options for cash, February 2001, $5.00 50,000 50 -- -- -- -- 249,950 Exercise of stock warrants for cash, March 2001, $6.00 500 1 -- -- -- -- 2,999 Exercise of stock options in exchange for note receivable, March 2001 50,000 50 -- -- -- -- 249,950 Issuance of common stock in exchange for services rendered, March 2001, $5.50 8,000 8 -- -- -- -- 43,992 Granting of stock options in exchange for services rendered, May 2001 -- -- -- -- -- -- 592,300 Exercise of stock options for cash, June 2001, $5.00 75,000 75 -- -- -- -- 374,925 Exercise of stock options for cash, June 2001, $5.50 12,500 12 -- -- -- -- 68,738 Exercise of warrants for cash, June 2001, $6.00 4,000 4 -- -- -- -- 23,996 Exercise of stock options for cash, July 2001, $5.00 7,500 8 -- -- -- -- 37,492 Exercise of stock options for cash, July 2001, $5.50 2,500 3 -- -- -- -- 13,747 Exercise of warrants for cash, July 2001, $6.00 2,000 2 -- -- -- -- 11,998 Issuance of common stock for cash pursuant to private placement, July 2001, $9.25 1,254,053 1,254 -- -- -- -- 11,598,736 Financing costs associated with private placement, July 2001 -- -- -- -- -- -- (768,599) Shares issued in exchange for services rendered, July 2001, 9.25 23,784 24 -- -- -- -- 219,978 Shares issued for Anti-Dilution Provisions, July 2001 5,779 6 -- -- -- -- 53,450 Issuance of stock warrants in exchange for services, rendered, July 2001 -- -- -- -- -- -- 19,134 Accrued interest on note receivable -- -- -- -- -- -- -- Comprehensive Income (Loss): Net Loss -- -- -- -- -- -- -- Other comprehensive income (loss): Currency translation adjustment -- -- -- -- -- -- -- Total Comprehensive Income (Loss) ----------- ----------- ------- ------- ------ -------- ------------ Balance at July 31, 2001 20,681,526 $ 20,681 1,000 $ 1 1,000 $ 1 $ 88,776,859 =========== =========== ======= ======= ====== ======= ============ The Notes to Consolidated Financial Statements are an integral part of these statements.
GENEREX BIOTECHNOLOGY CORPORATION (A DEVELOPMENT STAGE COMPANY) STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY FOR THE PERIOD NOVEMBER 2, 1995 (DATE OF INCEPTION) TO JULY 31, 2001-- (Continued) [RESTUBBED TABLE]
Deficit Notes Accumulated Receivable Other During the Total - Common Comprehensive Development Stockholders' Stock Income (Loss) Stage Equity ------------ ------------- ------------ ------------- Balance, August 1, 2000 $ (54,118) $ (165,526) $ (21,816,725) $ 8,415,025 Exercise of stock warrants for cash, August 2000, $6.00 -- -- -- 12,000 Issuance of common stock for services rendered August 2000 -- -- -- 411,250 Issuance of stock warrants in exchange for equity line agreement, August 2000 -- -- -- 3,406,196 Exercise of stock warrants for cash, August 2000, $7.50 -- -- -- 227,250 Exercise of stock warrants for cash, August 2000, $8.6625 -- -- -- 259,875 Cashless exercise of stock warrants, August 2000 -- -- -- -- Exercise of stock warrants for cash, August 2000, $10.00 -- -- -- 100,000 Exercise of stock warrants for cash, September 2000, $8.6625 -- -- -- 548,639 Exercise of stock warrants for cash, September 2000, $5.50 -- -- -- 89,002 Exercise of stock warrants for cash, September 2000, $6.00 -- -- -- 318,523 Exercise of stock warrants for cash, September 2000, $10.00 -- -- -- 95,840 Exercise of stock warrants for cash, September 2000, $7.50 -- -- -- 243,120 Issuance of common stock for cash pursuant to private placement, October 2000, $11.00 -- -- -- 23,662,023 Exercise of stock warrants for cash, Oct. 2000, $6.00 -- -- -- 6,000 Financing costs associated with private placement, October 2000 -- -- -- (1,956,340) Exercise of stock warrants for cash, November - December 2000, $4.25 -- -- -- 99,994 Cashless exercise of stock warrants, December 2000 -- -- -- -- Exercise of stock warrants for cash, November - December 2000, $6.00 -- -- -- 137,478 Exercise of stock warrants for cash, December 2000, $7.00 -- -- -- 61,761 Issuance of common stock as employee compensation, December 2000 -- -- -- 100,556 Exercise of stock warrants for cash, January 2001, $6.00 -- -- -- 18,000 Issuance of common stock for cash pursuant to private placement, January 2001, $14.53 -- -- -- 5,000,000 Financing costs associated with private placement, January 2001 -- -- -- (200,000) Issuance of common stock pursuant to litigation settlement, January 2001 -- -- -- 21,098 Issuance of Series A Preferred Stock, January 2001 -- -- -- 12,015,000 Granting of stock options in exchange for services rendered, January 2001 -- -- -- 745,000 Granting of stock options in exchange for services rendered, February 2001 -- -- -- 129,600 Exercise of stock options for cash, February 2001, $5.00 -- -- -- 250,000 Exercise of stock warrants for cash, March 2001, $6.00 -- -- -- 3,000 Exercise of stock options in exchange for note receivable, March 2001 (250,000) -- -- -- Issuance of common stock in exchange for services rendered, March 2001, $5.50 -- -- -- 44,000 Granting of stock options in exchange for services rendered, May 2001 -- -- -- 592,300 Exercise of stock options for cash, June 2001, $5.00 -- -- -- 375,000 Exercise of stock options for cash, June 2001, $5.50 -- -- -- 68,750 Exercise of warrants for cash, June 2001, $6.00 -- -- -- 24,000 Exercise of stock options for cash, July 2001, $5.00 -- -- -- 37,500 Exercise of stock options for cash, July 2001, $5.50 -- -- -- 13,750 Exercise of warrants for cash, July 2001, $6.00 -- -- -- 12,000 Issuance of common stock for cash pursuant to private placement, July 2001, $9.25 -- -- -- 11,599,990 Financing costs associated with private placement, July 2001 -- -- -- (768,599) Shares issued in exchange for services rendered, July 2001, 9.25 -- -- -- 220,002 Shares issued for Anti-Dilution Provisions, July 2001 -- -- -- 53,456 Issuance of stock warrants in exchange for services, rendered, July 2001 -- -- -- 19,134 Accrued interest on note receivable (10,182) -- -- (10,182) Comprehensive Income (Loss): Net Loss -- -- (27,097,210) (27,097,210) Other comprehensive income (loss): Currency translation adjustment -- (81,341) -- (81,341) ----------- ------------ ----------- Total Comprehensive Income (Loss) (81,341) (27,097,210) (27,178,551) ---------- ---------- ------------ ----------- Balance at July 31, 2001 $ (314,300) $ (246,867) $(48,913,935) $39,322,440 ========== ========== ============ =========== The Notes to Consolidated Financial Statements are an integral part of these statements.
F-10 GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES (A DEVELOPMENT STAGE COMPANY) CONSOLIDATED STATEMENTS OF CASH FLOWS
Cumulative For the Years Ended November 2, July 31, 1995 (Date of ------------------------------------------------ Inception) to 2001 2000 1999 July 31, 2001 -------------- --------------- ------------- ------------- Cash Flows Used in Operating Activities: Net loss $(27,097,210) $(8,841,047) $(6,239,602) $(48,913,935) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 230,600 86,804 79,784 441,277 Minority interest share of loss (2,985,000) -- -- (2,985,000) Reduction of notes receivable - common stock in exchange for services rendered -- 384,903 38,979 423,882 Write-off of deferred offering costs 3,406,196 -- -- 3,406,196 Common stock issued for services rendered 829,264 66,300 612,175 2,069,992 Stock options and warrants issued for services rendered 1,486,036 1,421,150 1,146,874 4,588,060 Preferred stock issued for services rendered -- -- -- 100 Founders' shares transferred for services rendered -- -- -- 353,506 Changes in operating assets and liabilities: Miscellaneous receivables 2,747 170,481 27,571 30,620 Other current assets (14,858) 21,219 12,610 (117,606) Accounts payable and accrued expenses 1,479,803 773,506 (87,134) 3,492,121 Other, net -- -- -- 110,317 ------------ ----------- ----------- ------------ Net Cash Used in Operating Activities (22,662,422) (5,916,684) (4,408,743) (37,100,470) Cash Flows From Investing Activities: Purchase of property and equipment (1,623,017) (381,163) (217,018) (2,296,971) Costs incurred for patents (197,434) (269,499) -- (466,933) Change in restricted cash -- -- 105,655 (5,595) Increase in officers' loans receivable (1,023,743) -- -- (1,023,743) Purchase of short-term investments (22,926,466) (3,733,918) (232,345) (26,892,729) Change in deposits 27,396 19,720 -- 29,515 Change in notes receivable - common stock (10,182) (4,118) -- (14,300) Change in due from related parties -- 290,973 428,216 (2,255,197) Other, net -- -- -- 89,683 ------------ ----------- ----------- ------------ Net Cash (Used in)Provided By Investing Activities (25,753,446) (4,078,005) 84,508 (32,836,270) Cash Flows From Financing Activities: Proceeds from issuance of long-term debt -- -- -- 993,149 Repayment of long-term debt (5,208) (480,738) (416,649) (965,984) Change in due to related parties -- -- (81,483) 154,541 Proceeds from exercise of warrants 2,256,482 -- -- 2,256,482 Proceeds from exercise of stock options 745,000 -- -- 745,000 Proceeds from minority interest investment 2,985,000 -- -- 2,985,000 Proceeds from issuance of common stock, net 37,337,074 8,045,474 8,488,798 61,999,294 Proceeds from issuance of preferred stock 12,015,000 -- -- 12,015,000 Purchase and retirement of common stock -- -- (119,066) (119,066) ------------ ----------- ----------- ------------ Net Cash Provided By Financing Activities 55,333,348 7,564,736 7,871,600 80,063,416 Effect of Exchange Rates on Cash (12,826) 1,657 (4,991) (17,117) ------------ ----------- ----------- ------------ Net Increase (Decrease) in Cash and Cash Equivalents 6,904,654 (2,428,296) 3,542,374 10,109,559 Cash and Cash Equivalents, Beginning of Year 3,204,905 5,633,201 2,090,827 -- ------------ ----------- ----------- ------------ Cash and Cash Equivalents, End of Year $ 10,109,559 $ 3,204,905 $ 5,633,201 $ 10,109,559 ============ =========== =========== ============
The Notes to Consolidated Financial Statements are an integral part of these statements. F-11 GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Note 1 - Organization and Business: ----------------------------------- Generex Biotechnology Corporation (the Company) was incorporated in Delaware in September 1997 for the purpose of acquiring Generex Pharmaceuticals, Inc. (Generex Pharmaceuticals), a Canadian corporation formed in November 1995 to engage in pharmaceutical and biotechnological research and other activities. The Company's acquisition of Generex Pharmaceuticals was completed in October 1997 in a transaction in which the holders of all outstanding shares of Generex Pharmaceuticals exchanged their shares for shares of the Company's common stock. In January 1998, the Company participated in a "reverse acquisition" with Green Mt. P.S., Inc., a previously inactive Idaho corporation formed in 1983. As a result of this transaction, the Company's shareholders (the former shareholders of Generex Pharmaceuticals) acquired a majority (approximately 90%) of the outstanding capital stock of Green Mt. P.S., Inc., the Company became a wholly-owned subsidiary of Green Mt. P. S., Inc., Green Mt. P.S., Inc. changed its corporate name to Generex Biotechnology Corporation (Generex Idaho), and the Company changed its corporate name to GBC Delaware, Inc. Because the reverse acquisition resulted in the Company's shareholders becoming the majority holders of Generex Idaho, the Company was treated as the acquiring corporation in the transaction for accounting purposes. Thus, the Company's historical financial statements, which essentially represented the historical financial statements of Generex Pharmaceuticals, were deemed to be the historical financial statements of Generex Idaho. In April 1999, the Company completed a reorganization in which the Company merged with Generex Idaho. In this transaction, all outstanding shares of Generex Idaho were converted into the Company's shares, Generex Idaho ceased to exist as a separate entity, and the Company changed its corporate name back to Generex Biotechnology Corporation. This reorganization did not result in any material change in the Company's historical financial statements or current financial reporting. 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 limited history of operations and has not generated any revenues from operations with the exception of the $1 million received in conjunction with the execution of a development agreement (see Note 7). 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 - Summary of Significant Accounting Policies: ---------------------------------------------------- Principles of Consolidation The consolidated financial statements include the accounts of the Company and all of its subsidiaries in which a controlling interest is maintained. For those consolidated subsidiaries where the Company ownership is less than 100 percent, the outside stockholders' interests are shown as minority interests. All significant intercompany transactions and balances have been eliminated. F-12 GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Note 2 - Summary of Significant Accounting Policies (Continued): ---------------------------------------------------------------- Development Stage Corporation The accompanying consolidated financial statements have been prepared in accordance with the provisions of Statement of Financial Accounting Standard No. 7, "Accounting and Reporting by Development Stage Enterprises." Cash and Cash Equivalents The Company considers all highly liquid investments purchased with a maturity of three months or less to be cash equivalents. Short-Term Investments At July 31, 2001 and 2000, short-term investments consisted of short-term notes of U.S. corporations with original maturities of between three to twelve months. At July 31, 2001 and 2000, the cost of the investments approximated market value. Property and Equipment 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. Patents Legal costs incurred to establish patents are capitalized. Capitalized costs are amortized on the straight-line method over the related patent term. 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 governments under research and development tax credit arrangements are offset against the related expenses. Included in miscellaneous receivables is $12,865 and $16,138 of such a receivable due from the Canadian government at July 31, 2001 and 2000, respectively. Income Taxes Income taxes are accounted for under the asset and liability method prescribed by Statement of Financial Accounting Standards No. 109, "Accounting for Income Taxes." Deferred income taxes are recorded for temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities. Deferred tax assets and liabilities reflect the tax rates expected to be in effect for the years in which the differences are expected to reverse. A valuation allowance is provided if it is more likely than not that some or all of the deferred tax asset will not be realized. Reclassification Certain amounts reported in the 2000 financial statements have been reclassified to conform to the 2001 presentation. F-13 GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Note 2 - Summary of Significant Accounting Policies (Continued): ---------------------------------------------------------------- Stock-Based Compensation As permitted by the provisions of Statement of Financial Accounting Standards No. 123, "Accounting for Stock-Based Compensation" (SFAS 123), the Company follows Accounting Principles Board Opinion No. 25, "Accounting for Stock Issued to Employees" (APB 25) and related interpretations in accounting for its employee stock option plans. Under APB 25, if the exercise price of the Company's employee stock options equals or exceeds the fair market value of the underlying stock on the date of grant, no compensation expense is recognized. Stock options and warrants issued to non employees are accounted for based on the fair value of the consideration received or the fair value of the equity instruments issued, whichever is more reliably measurable. Net Loss Per Common Share The Company has adopted Statement of Financial Accounting Standards No. 128, "Earnings per Share" (SFAS 128), which requires presentation of basic earnings per share (Basic EPS) and diluted earnings per share (Diluted EPS) by all entities that have publicly traded common stock or potential common stock (options, warrants, convertible securities or contingent stock arrangements). Basic EPS is computed by dividing income (loss) available to common stockholders by the weighted average number of common shares outstanding during the period. Diluted EPS gives effect to all dilutive potential common shares outstanding during the period. The computation of Diluted EPS does not assume conversion, exercise or contingent exercise of securities that would have an antidilutive effect on earnings. Refer to Note 12 for methodology for determining net loss per share. Comprehensive Loss The Company has adopted Statement of Financial Accounting Standards No. 130, "Reporting Comprehensive Income." Other comprehensive income (loss), which includes only foreign currency translation adjustments, is shown in the Statement of Changes in Stockholders' Equity. Effects of Recent Accounting Pronouncements In June 1998, 1999, and 2000, the FASB issued SFAS No. 133, Accounting for Derivative Instruments and Hedging Activities, SFAS No. 137, Accounting for Derivative Instruments and Hedging Activities - Deferral of the Effective Date of FASB Statement No. 133, and SFAS no. 138, Accounting for Certain Derivative Instruments and Certain Hedging Activities, respectively. These statements require companies to record derivatives on the balance sheet as assets or liabilities, measured at fair value. Gains or losses resulting from changes in the values of those derivatives would be accounted for depending on the use of the derivative and whether it qualifies for hedge accounting. The adoption of these statements on August 1, 2000 did not have a significant impact on the Company's financial position or results of operations. In December 1999, the SEC issued Staff Accounting Bulletin No. 101 (SAB 101), Revenue Recognition in Financial Statements. SAB 101 provides guidance on the recognition, presentation, and disclosure of revenues in financial statements of all public registrants. In October 2000, the SEC issued a Frequently Asked Questions document related to SAB 101 which provides interpretive guidance. The Company adopted SAB 101 in fiscal year 2001, and the adoption of SAB 101 did not have a significant impact on the Company's financial position or results of operations. F-14 GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Note 2 - Summary of Significant Accounting Policies (Continued): ---------------------------------------------------------------- Effects of Recent Accounting Pronouncements (Continued) In June 2001, the FASB issued SFAS No. 141, Business Combinations. SFAS No. 141 addresses the initial recognition and measurement of goodwill and other intangible assets acquired in a business combination. SFAS No. 141 is applicable to business combinations beginning July 1, 2001. The adoption of this statement did not have a significant impact on the Company's financial position or results of operations. In June 2001, the FASB issued SFAS No. 142, Goodwill and Other Intangible Assets. SFAS No. 142 addresses the recognition and measurement of goodwill and other intangible assets subsequent to their acquisition. SFAS No. 142 also addresses the initial recognition and measurement of intangible assets acquired outside of a business combination whether acquired individually or with a group of other assets. Goodwill and intangible assets previously recorded, in the Company's financial statements, will be affected by the provisions of SFAS No. 142. This statement provides that intangible assets with finite useful lives be amortized and that intangible assets with indefinite lives and goodwill will not be amortized, but will rather be tested at least annually for impairment. SFAS No. 142 will be effective for the Company's fiscal year 2002, however management is assessing the impact that SFAS No. 142 will have on the Company's financial position and results of operations. Concentration of Credit Risk The Company maintains cash balances, at times, with financial institutions in the amount which are more than amounts insured by the Canada Deposit Insurance Corporation and the Federal Deposit Insurance Corporation. Management monitors the soundness of these institutions and considers the Company's risk negligible. The Company places its short-term investments in short-term debt instruments of high quality U.S. corporations. The Company does not believe there is a significant credit risk relating to these investments. Use of Estimates The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the dates of the financial statements and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates. Foreign Currency Translation Foreign denominated assets and liabilities of the Company are translated into US dollars at the prevailing exchange rates in effect at the end of the reporting period. Income statement accounts are translated at a weighted average of exchange rates which were in effect during the period. Translation adjustments that arise from translating the foreign subsidiary's financial statements from local currency to US currency are recorded in the other comprehensive income (loss) 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. F-15 GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Note 3 - Property and Equipment: -------------------------------- The costs and accumulated depreciation of property and equipment are summarized as follows:
July 31, ----------------------------------- 2001 2000 -------------- -------------- Land $ 293,902 $ 304,060 Buildings and Improvements 1,901,907 1,814,724 Furniture and Fixtures 68,229 8,190 Office Equipment 60,229 62,311 Lab Equipment 1,814,028 415,753 ---------- ---------- Total Property and Equipment 4,138,295 2,605,038 Less: Accumulated Depreciation 410,534 209,171 ---------- ---------- Property and Equipment, Net $3,727,761 $2,395,867 ========== ==========
Depreciation expense amounted to $209,114, $85,781 and $79,784 for the years ended 2001, 2000 and 1999, respectively. Note 4 - Patents: ----------------- The costs and accumulated amortization of patents are summarized as follows:
July 31, ------------------------------- 2001 2000 ------------ ---------- Patents $456,860 $268,392 Less: Accumulated Amortization 22,553 1,023 -------- -------- Patents, Net $434,307 $267,369 ======== ========
Amortization expense amounted to $21,486, $1,023 and $-0- for the years ended July 31, 2001 2000 and 1999, respectively. Note 5 - Income Taxes: ---------------------- The Company has incurred losses since inception, which have generated net operating loss carryforwards. The net operating loss carryforwards arise from both United States and Canadian sources. As of July 31, 2001, the Company has approximately $19,730,659 and $10,270,030 in net operating loss carryforwards to offset taxable income in the United States, which expire in 2013 through 2016, and Canada, which expire in 2005 through 2008, respectively. These loss carryforwards are subject to limitation in future years should certain ownership changes occur. For the years ended July 31, 2001, 2000 and 1999, 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. F-16 GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Note 5 - Income Taxes (Continued): ---------------------------------- Deferred tax assets consist of the following:
July 31, ---------------------------------- 2001 2000 -------------- ------------- Net operating loss carryforwards $ 12,513,777 $ 7,169,137 Amortization of financing fees 80,922 84,629 Amortization of reorganization costs 214,392 -- ------------ ----------- Total deferred tax assets 12,809,091 7,253,766 Valuation allowance (12,809,091) (7,253,766) ------------ ----------- Net deferred tax assets $ -- $ -- ============ ==========
Note 6 - Accounts Payable and Accrued Expense: --------------------------------------------- Accounts payable and accrued expenses consist of the following:
July 31, ----------------------------------- 2001 2000 --------------- --------------- Accounts Payable $ 896,061 $ 863,660 Litigation 191,653 234,504 Clinical 147,699 -- Accrued Legal Fees 420,360 106,118 Financial Services 995,000 -- ---------- ---------- Total $2,650,773 $1,204,282 ========== ==========
Note 7 - Commitments and Contingent Liabilities: ------------------------------------------------ Consulting Services In October 1996, the Company entered into a Consulting Agreement with its Vice President of Research and Development (the V.P.) pursuant to which, among other things, the V.P. assigned to the Company his entire right, title and interest in and to all inventions, ideas, designs and discoveries made by him during the term of such agreements which relate in any manner to the actual or demonstratably anticipated business, work, undertaking or research and development of the Company. Concurrently with execution of this Consulting Agreement, the V.P. and the Company entered into an Assignment and Assumption Agreement pursuant to which the V.P. assigned to the Company his interests in and to specific drug delivery systems, controlled release drug delivery systems, and technology patents invented/discovered/conceived by the V.P. prior to the execution of the Agreement, including three existing patents covering insulin delivery systems, applicable to peptides and proteins; drug vaccines and hormones delivery; and controlled release of drugs and hormones (the "Existing Patents"). In addition to the Existing Patents, the V.P. assigned to the Company his interest in four US and/or Canadian patent applications and certain abstracts covering, among other things, liposomes drug delivery for vaccines, drugs, hormones, peptides and cosmetic delivery; transdermal drug delivery for proteins, peptides, hormones and small molecules; controlled release drug delivery systems for capsules, caplets, and liquid suspensions; and DNA technology relating to insulin preparation (collectively, "Other Existing Technology"). At the time of this assignment, the Existing Patents were owned of record by a Canadian corporation, which was 50 percent owned by the V.P. The Company subsequently acquired the V.P.'s interest in this corporation for no additional consideration. F-17 GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Note 7 - Commitments and Contingent Liabilities (Continued): ------------------------------------------------------------ Consulting Services (Continued) The Consulting Agreement was amended and supplemented as of January 7, 1998 and further amended and supplemented as of December 31, 2000. The Consulting Agreement, as amended and supplemented, continues through July 31, 2010, subject to termination without cause by the V.P. or the Company at any time after January 31, 2003 upon 12 months' prior written notice. The Consulting Agreement provides for an annual base compensation of $250,000 per year (starting August 1, 2000), subject to annual increases. In addition, the Consulting Agreement provides for certain bonus compensation to be paid to the V.P. for achievement of certain milestones under the Company's development agreements with pharmaceutical companies. During the 2001 fiscal year, the Company paid the V.P. $300,000 for his involvement in securing a development agreement for a specific product with a pharmaceutical company. The Consulting Agreement also provides for the V.P. to be granted options to purchase 150,000 shares of common stock in each of the next 10 fiscal years, starting with the 2001 fiscal year. The options must be granted under option plans approved by the Company's stockholders. In connection with amending and supplementing the Consulting Agreement in January 1998, the Company issued 1,000 shares of Special Voting Rights Preferred Stock to the V.P. See Note 10 for description of Special Voting Rights Preferred Stock. 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, 2001 are as follows: Year Amount ---- ------ 2002 $22,008 2003 18,099 2004 9,801 2005 3,431 Thereafter -- ------- Total Minimum Lease Payments $53,339 ======= Lease expense amounted to $20,753, $20,175 and $19,240 for the years ended July 31, 2001, 2000 and 1999, respectively. The preceding data reflects existing leases and does not include replacements upon their expiration. In the normal course of business, operating leases are generally renewed or replaced by other leases. F-18 GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Note 7 - Commitments and Contingent Liabilities (Continued): ------------------------------------------------------------ Rental Operations The Company leases a portion of the floor that it owns in an office building located in Toronto, Canada, as well as two commercial buildings. The following represents the approximate minimum amount of sublease income to be received in years ending after July 31, 2001: Year Amount ---- ------ 2002 $ 36,240 2003 24,817 2004 24,817 2005 24,817 2006 4,136 Thereafter -- -------- Total $114,827 ======== Supply Agreements On July 19, 2000, the Company entered into a supply agreement with Valois, S.A. and Valois of America, Inc. (collectively Valois), to supply the Company with certain products developed and manufactured by Valois. In August 2000, in conjunction with the execution of the exclusive supply agreement, the Company delivered 35,000 shares of its common stock to Valois and recorded an expense of $411,250. Pursuant to the agreement, the Company shall pay milestone payments to Valois within 30 days of July 19 beginning in fiscal 2001 for the next five years. If the milestone obligations are not met after a five-year period, the Company shall pay Valois an annual payment of $50,000. In the event the Company chooses to end the agreement after the fifth anniversary, the Company shall pay Valois a one-time payment of $350,000. On August 28, 2000, the Company entered into a supply agreement with Presspart Manufacturing Limited, whereby the Company will purchase its entire requirements for products to use in the administration of insulin through the buccal mucosa and shall not purchase the products or any metal containers competitive to the products from any other person in exchange for an exclusive non-transferable royalty free irrevocable license to use the products. The contract shall continue for a minimum period of four contract years from the end of the first contract year in which the quantity of products purchased by the Company from Presspart exceeds 10,000,000, and thereafter, shall continue until terminated by either party by giving twelve months written notice. Pending Litigation On October 2, 1998, Sands Brothers & Co. Ltd., a New York City-based investment banking and brokerage firm, initiated an arbitration against the Company under New York Stock Exchange rules. Sands alleged that it had the right to receive, for nominal consideration, approximately 1.5 million shares of the Company's common stock. Sands based its claim upon an October 1997 letter agreement that was purported by Sands to confirm an agreement appointing Sands as the exclusive financial advisor to Generex Pharmaceuticals, Inc., a subsidiary of the Company that was acquired in late 1997. In exchange, the letter agreement purported to grant Sands the right to acquire 17% of Generex Pharmaceuticals common stock for nominal consideration. Sands claimed that its right to receive shares of Generex Pharmaceuticals common stock applies to the Company's common stock since outstanding shares of Generex Pharmaceuticals common stock were converted into shares of the Company's common stock in the acquisition. Sands' claims also included additional shares allegedly due as a fee related to that acquisition, and $144,000 in monthly fees allegedly due under the terms of the purported agreement. F-19 GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Note 7 - Commitments and Contingent Liabilities (Continued): ------------------------------------------------------------ Pending Litigation (Continued) Pursuant to an arbitration award dated September 22, 1999, the arbitration panel that heard this case awarded Sands $14,070 and issued a declaratory judgment requiring the Company to issue to Sands a warrant to purchase 1,530,020 shares of the Company's common stock pursuant to and in accordance with the terms of the purported October 1997 letter agreement. On October 13, 1999, Sands commenced a special proceeding to confirm the arbitration award in the Supreme Court of the State of New York, County of New York (the "New York Supreme Court"). On November 10, 1999, the Company moved to vacate the arbitration award. On March 20, 2000, the New York Supreme Court granted Sands' petition to confirm the award and denied the Company's motion to vacate the award. The Company appealed and on January 23, 2001, the New York State Appellate Division, First Department (the "Appellate Division"), modified the judgment of the New York Supreme Court that had confirmed the arbitration award against the Company. The Appellate Division affirmed the portion of the New York Supreme Court judgment that had confirmed the granting of monetary relief of $14,070 to Sands but modified the judgment to vacate the portion of the arbitration award directing the issuance to Sands of a warrant to purchase 1,530,020 shares of the Company's common stock. The Appellate Division held that the portion of the award directing the Company to issue warrants to Sands is too indefinite to be enforceable and remanded the matter to the arbitration panel for a final and definite award with respect to such relief or its equivalent (including possibly an award of monetary damages). The arbitration panel commenced hearings on the matters remanded by the Appellate Division in June 2001 and is expected to conclude its consideration of such matters and render its decision during the fourth calendar quarter of 2001. The Company is not able to estimate an amount or range of potential loss from this legal proceeding at the present time. Therefore, no provision has been recorded in the accompanying financial statements. In February 1999, MQS, Inc., a former consultant, commenced a civil action against the Company in the United States District Court for the District of New Jersey claiming, among other things, that 242,168 shares of common stock and $243,066 were due to it for services that it rendered through December 22, 1998. In January 2001, the Company entered into a settlement agreement with MQS whereby the Company paid the plaintiff certain amounts in cash and common stock that were not material to the consolidated financial position of the Company and whereby the claims of the parties were dismissed with prejudice. In February 2001, a former business associate of the Vice President of Research and Development (VP), and an entity called Centrum Technologies Inc. commenced an action in the Ontario Superior Court of Justice against the Company and the VP seeking, among other things, damages for alleged breaches of contract and tortious acts related to a business relationship between this former associate and the VP that ceased in July 1996. The plaintiffs' statement of claim also seeks to enjoin the use, if any, by the Company of three patents allegedly owned by the company called Centrum Technologies Inc. On July 20, 2001, the Company filed a preliminary motion to dismiss the action of Centrum Technologies Inc. as a nonexistent entity or, alternatively, to stay such action on the grounds of want of authority of such entity to commence the action and, in the further alternative, to dismiss such action for failure to produce documents referred to in the statement of claim. The Company intends to defend this action vigorously. The Company is not able to predict the ultimate outcome of this legal proceeding at the present time or to estimate an amount or range of potential loss, if any, from this legal proceeding. F-20 GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Note 7 - Commitments and Contingent Liabilities (Continued): ------------------------------------------------------------ Pending Litigation (Continued) In February 1997, a former employee of Generex Pharmaceuticals, Inc., commenced an action in the Ontario Superior Court of Justice for wrongful dismissal. The Ontario Superior Court of Justice rendered judgment in favor of the plaintiff for approximately $127,000 plus interest in November 1999 and further awarded costs to the plaintiff in March 2000. An appeal of the judgment was filed with the Court of Appeal for Ontario in April 2000. The Company intends to continue its vigorous defense of this action. The Company does not believe that the ultimate resolution of this legal proceeding will have a material effect on the consolidated financial position of the Company. The Company has established a reserve for potential loss contingencies related to the resolution of this legal proceeding, the amount of which of is not material to the consolidated financial position of the Company. In March 1999, a former consultant to the Company commenced an action in the Ontario Superior Court of Justice against the Company seeking approximately $94,000 and 1,465 shares of the Company's Common Stock for alleged breach of contract damages and additional amounts in punitive damages. In April 1999, the Company filed a counterclaim for monies the Company believes are due to the Company from this former consultant. The parties have nearly completed discovery, pending the resolution of certain outstanding motions. The Company intends to continue its vigorous defense of this action. The Company does not believe that the ultimate resolution of this legal proceeding will have a material effect on the consolidated financial position of the Company. The Company has established a reserve for potential loss contingencies related to the resolution of this legal proceeding, the amount of which of is not material to the consolidated financial position of the Company. The Company is involved in certain other legal proceedings in addition to those specifically described herein. Subject to the uncertainty inherent in all litigation, the Company does not believe at the present time that the resolution of any of these legal proceedings is likely to have a material adverse effect on the Company's consolidated financial position. With respect to all litigation, as additional information concerning the estimates used by the Company become known, the Company reassesses its position both with respect to accrued liabilities and other potential exposures. Estimates that are particularly sensitive to future change relate to legal matters, which are subject to change as events evolve and as additional information becomes available during the administration and litigation process. Concentrations In Development Arrangements The Company has a development arrangement with a major pharmaceutical company, whereby the pharmaceutical company is primarily responsible for conducting clinical trials related to a specific agreed upon product, securing regulatory approvals and marketing on a worldwide basis. The Company is primarily responsible for completing all necessary product research and development. Although the Company presently has sufficient funds to meet its foreseeable obligations, the costs of the Company's obligations may be significant, and may exceed current funds. If the development arrangement were to be curtailed or terminated, the market perception of the prospects for the Company's product, the timing of regulatory approvals, and the Company's ability to raise funds could be adversely affected. In conjunction with the execution of this development arrangement, the Company received an agreement signing fee of $1,000,000 which is included in revenues as all necessary requirements have been satisfied. F-21 GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Note 8 - Related Party Transactions: ------------------------------------ The amounts due from (to) related parties at July 31, exclusive of the officers' loans receivable, are as follows:
Golden The Angara Angara Ching Bull Great Tao Equities Investments, Chew An Estates, Inc. Inc. Inc. Breweries Inc. EBI, Inc. -------------- -------------- --------------- --------- ------------ ------------ Beginning Balance, August 1, 1999 $(102,638) $ 274,700 $(52,651) $(94) $164,998 $337,293 Cash advance -- (213,871) -- -- (30,300) -- Company expenses paid by related parties -- -- -- -- (46,953) -- Other (b) (2,457) 6,578 (1,261) (3) 3,952 6,480 Transfer/assumption of related party liabilities (a) 105,095 (67,407) 53,912 97 (91,697) -- --------- --------- -------- ----- -------- -------- Ending Balance, July 31, 2000 -- -- -- -- -- 343,773 Other (b) -- -- -- -- -- (11,484) --------- --------- -------- ----- -------- -------- Ending Balance, July 31, 2001 $ -- $ -- $ -- $ -- $ -- $332,289 ========= ========= ======== ===== ======== ========
(a) Officers of the Company are also shareholders in the related companies and have agreed to the transfer/assumption of the offsetting amounts which were due from (to) related parties. (b) Effect of foreign currency translation adjustments. These amounts are non-interest bearing. There are no fixed terms of repayment. Each of the above related parties is owned in whole or in part by the Company's Chairman of the Board. In addition, EBI, Inc. and Golden Bull Estates, Inc. are shareholders of the Company. Management feels that the 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 the non-recording of interest income and expense on the balances due to/from related parties. The Company estimates the following additional amounts would have been recorded if such transactions were consummated under arms length agreements:
For the Years Ended July 31, ----------------------------------------------------------- 2001 2000 1999 ----------------- ----------------- ----------------- Interest Income $32,209 $60,962 $79,118 Interest Expense $ -- $14,938 $18,117
F-22 GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Note 8 - Related Party Transactions (Continued): ------------------------------------------------ The interest income/expense amounts were computed at estimated prevailing rates based on the average receivable/payable balance outstanding during the periods reflected. As of July 31, 2001, the Company's four senior officers, who are also shareholders of the Company were compensated indirectly by the Company through management services contracts between the Company and management firms of which they are owners. The amounts paid to these management firms amounted to $672,477 for the year ended July 31, 2001. As of July 31, 2000, the Company's three senior officers, who are also shareholders of the Company were compensated indirectly by the Company through management services contracts between the Company and a management firm of which they were equal owners. The amounts paid to this management firm amounted to $343,594 and $388,420 for the years ended July 31, 2000 and 1999 respectively. See Note 7 for a discussion of the consulting agreement with the Company's Vice President of Research and Development. On May 3, 2001, the Company's three senior officers, who are also shareholders of the Company, were given loans of $334,300 each, in exchange for promissory notes. These notes bear interest at 8.5 percent per annum and are payable in full on May 1, 2002. These notes are guaranteed by a related company owned by these officers and secured by 2,500,000 pledged shares of the Company Common Stock currently owned by this related company. As of July 31, 2001, the balance outstanding on these notes, including accrued interest, was $1,023,743. Note 9 - Long-Term Debt: ------------------------ Long-term debt consists of the following:
July 31, ---------------------------- 2001 2000 ------------ ------------ Mortgage payable - interest at 9.7 percent per annum, monthly payments of principal and interest of $4,778, final payment due May 25, 2005, secured by all assets of the Company $518,095 $541,661 Mortgage payable - interest at 10 percent per annum, monthly payments of principal and interest of $1,782, final payment due November 1, 2002, secured by real property located at 11 Carlaw Avenue, Toronto, Canada 174,565 180,302 -------- -------- Total Debt 692,660 721,963 Less Current Maturities 9,634 9,404 -------- -------- Long-Term Debt, Less Current Maturities $683,026 $712,559 ======== ========
F-23 GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Note 9 - Long-Term Debt (Continued): ------------------------------------ Aggregate maturities of long-term debt of the Company due within the next five years ending July 31, are as follows: Year Amount ---- ------ 2002 $ 9,634 2003 177,556 2004 7,268 2005 498,202 Thereafter -- -------- Total $692,660 ======== Note 10 - Stockholders' Equity: ------------------------------- Reverse Merger On January 9, 1998, the Company issued 9,234,118 shares of common stock to acquire GBC - Delaware, Inc.. For accounting purposes, the acquisition of GBC - Delaware, Inc. by the Company has been treated as a reverse merger. Accordingly, the 9,234,118 shares issued to acquire GBC - Delaware, Inc. have been treated as outstanding from November 2, 1995 (as adjusted for historical issuances of GBC - Delaware, Inc. and Generex Pharmaceuticals, Inc. during the period from November 2, 1995 to January 8, 1998) and the previously outstanding 1,105,000 shares have been treated as issued on the acquisition date. Since the assets and liabilities acquired on this date were immaterial, no amounts have been assigned to common stock as a result of this transaction. (See Note 1) Warrants As of July 31, 2001, the Company has the following warrants to purchase common stock outstanding:
Number of Shares Warrant Exercise Warrant To be Purchased Price Per Share Expiration Date ---------------- ----------------- ----------------- 7,937 $21.82 September 6, 2002 370,589 $ 7.00 January 17, 2003 500,000 $ 2.50 March 31, 2003 568,647 $12.15 August 15, 2003 150,000 $10.00 November 17, 2003 112,584 $ 7.50 January 31, 2004 3,500 $ 6.00 February 17, 2004 53,000 $ 6.00 April 6, 2004 9,091 $ 5.50 April 26, 2004 3,243 $14.53 July 6, 2004 11,764 $ 4.25 January 7, 2005 948,334 $ 8.66 May 17, 2005 19,584 $10.00 May 17, 2005 543,987 $12.99 September 29, 2005 75,000 $25.15 January 16, 2006 313,515 $10.18 July 6, 2006
F-24 GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Note 10 - Stockholders' Equity (Continued): ------------------------------------------- Notes Receivable - Common Stock Notes receivable - common stock consists of two separate promissory notes. The first promissory note was issued in conjunction with the redemption of Series A Redeemable Common Stock Purchase Warrants in June 1999, and was for $50,000. This note, which was originally due on December 1, 1999, was initially extended until October 1, 2000, and then extended until June 1, 2001. On July 31, 2001 the uncollected balance on this note, including accrued interest at 7 percent was $57,720 and a new promissory note was signed. Under the terms of the new note, the principal of $57,720, together with accrued interest at 7 percent per annum, is due July 31, 2002. The second promissory note was issued in conjunction with the exercise of 50,000 Common Stock Options in March 2001, and was for $250,000. This note is due on March 15, 2002. As of July 31, 2001 the outstanding balance on this note, including accrued interest at 7 percent was $256,580. Preferred Stock The Company has authorized 1,000,000 shares with a par value of one-tenth of a cent ($.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. Series A Preferred Stock The Company has issued 1,000 shares of Series A Preferred Stock (Series A) with a par value of $.001. The holder has the right at any time after January 16, 2004 to convert Series A shares into shares of common stock of the Company; the number of shares of common stock issuable upon conversion is variable based on a formula which reflects the common stock price. The holder also has the option to exchange the shares of the Company's Series A Preferred stock for 3,612 shares of the Company's convertible preferred shares of Generex (Bermuda), Ltd. which represents 30.1% of the Company's equity ownership in Generex (Bermuda) Ltd. Upon exercise, the holder and the Company would each own 50% of Generex (Bermuda) Ltd. (See Note 16 for discussions of Generex (Bermuda), Ltd.) Holders of Series A shares are not entitled to vote. In addition, the holders of Series A 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 and are also entitled to receive a mandatory annual dividend equal to 6 percent per year on the original issue price of $12,015 per share. This dividend is to be compounded each anniversary of the date of issuance of the Series A shares and payable by issuance of additional Series A shares valued at the original issue price. The Company has the right to redeem all outstanding Series A shares on January 16, 2007 for cash or shares of common stock upon written notice. 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 applicable 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. F-25 GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Note 11 - Stock Based Compensation: ----------------------------------- Stock Option Plans The Company has three stock option plans under which options exercisable for shares of common stock have been or may be granted to employees, directors, consultants and advisors. A total of 1,500,000 shares of common stock are reserved for issuance under the 1998 Stock Option Plan (the 1998 Plan), a total of 2,000,000 shares of common stock are reserved for issuance under the 2000 Stock Option Plan (the 2000 Plan) and a total of 4,000,000 shares of common stock are reserved for issuance under the 2001 Stock Option Plan (the 2001 Plan). The 2001 Plan was adopted in May 2001 by the Board of Directors, but is subject to stockholder approval at the next annual meeting of stockholders. The 1998, 2000 and 2001 Plans (the Plans) have been administered by the Board of Directors, but are expected to be administered by the Compensation Committee (the Committee) in the future. References to the Committee herein include the Board of Directors so long as it continues to administer the Plans 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 Plans and the interpretation of options. Generally, the interpretation and construction of any provision of the Plans or any options granted thereunder is within the discretion of the Committee. The Plans provide that options may or may not be Incentive Stock Options (ISOs) within the meaning of Section 422 of the Internal Revenue Code. Only employees of the Company are eligible to receive ISOs, while employees and non-employee directors, advisors and consultants are eligible to receive options which are not ISOs, i.e. "Non-Qualified Options." The options granted by the Board in connection with its adoption of the Plans are Non-Qualified Options. The following is a summary of the common stock options granted, canceled or exercised under the Plan:
Weighted Average Exercise Price Per Shares Share ------------- ------------------- Outstanding - August 1, 1998 -- -- Granted 50,000 $8.00 Canceled -- -- Exercised -- -- --------- Outstanding - July 31, 1999 50,000 $8.00 Granted 3,004,500 6.35 Canceled -- -- Exercised -- -- --------- Outstanding - July 31, 2000 3,054,500 6.38 Granted 1,455,000 6.14 Canceled -- -- Exercised 197,500 5.04 --------- Outstanding - July 31, 2001 4,312,000 $6.59 =========
F-26 GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Note 11 - Stock Based Compensation (Continued): ----------------------------------------------- Stock Option Plans (continued) The following table summarizes information on stock options outstanding at July 31, 2001:
Options Outstanding Options Exercisable ------------------------------------------------ ------------------------------- Weighted Number Average Weighted Number Weighted Outstanding Contractual Average Exercisable Average Range of at Life Exercise at Exercise Exercise Price July 31, 2001 (Years) Price July 31, 2001 Price -------------- ---------------- ------------ ----------- ------------- ------------ $5.00-$5.50 2,237,500 4.12 $ 5.09 1,217,500 $ 5.01 $7.56-$8.00 1,974,500 3.89 $ 7.60 1,924,500 $ 7.60 $10.21 100,000 3.50 $10.21 40,000 $10.21
Options exercisable at July 31 are as follows: 1999 50,000 2000 1,162,500 Had compensation cost for the Company's options granted to employees been determined consistent with SFAS 123, the Company's net loss and loss per share would be affected as follows:
For the Years Ended July 31, ---------------------------------------------------- 2001 2000 1999 ----------------- ---------------- -------------- Net Loss: As reported $27,097,210 $ 8,841,047 $6,239,602 =========== =========== ========== Pro forma $31,755,510 $17,230,637 $6,239,602 =========== =========== ========== Loss Per Share: As reported $ (1.44) $ (.58) $ (.47) =========== ========== ========= Pro forma $ (1.69) $ (1.13) $ (.47) =========== ========== =========
The fair value of each option granted is estimated on grant date using the Black-Scholes option pricing model which takes into account as of the grant date the exercise price and expected life of the option, the current price of the underlying stock and its expected volatility, expected dividends on the stock and the risk-free interest rate for the term of the option. The following is the average of the data used to calculate the fair value:
Risk-Free Expected Expected Expected Interest Rate Life (Years) Volatility Dividends ------------- ----------- ---------- --------- July 31, 2001 4.66% 5 .9332 -- July 31, 2000 4.80% 5 .6200 --
The weighted average fair value of the Company's stock options calculated using the Black-Scholes option-pricing model for options granted during the years ended July 31, 2001, 2000 and 1999 was $4.12, $3.22 and $1.85 per share, respectively. F-27 GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Note 12 - Net Loss Per Share: ----------------------------- Basic EPS and Diluted EPS for the years ended July 31, 2001, 2000 and 1999 have been computed by dividing the net loss for each respective period by the weighted average shares outstanding during that period. All outstanding warrants and options have been excluded from the computation of Diluted EPS as they are antidilutive due to the losses generated in each year. Note 13 - Supplemental Disclosure of Cash Flow Information: -----------------------------------------------------------
For the Years Ended July 31, --------------------------------------------------------------- 2001 2000 1999 ------------------- ------------------- ----------------- Cash paid during the year for: Interest $77,230 $73,687 $67,161 Income taxes $ -- $ -- $ --
Disclosure of non-cash investing and financing activities:
Year Ended July 31, 2001 ------------------------ The fair value of warrants issued as consideration for an equity financing agreement was initially capitalized as deferred offering costs and subsequently expensed $3,406,196 Note receivable was accepted in conjunction with exercise of common stock options $ 250,000 Common stock was issued as settlement of an accrued liability $ 21,098 Year Ended July 31, 2000 ------------------------ Long-term debt was assumed in conjunction with acquisition of property $ 186,805 Long-term debt was refinanced with new long-term debt $ 541,200 Amounts due from related parties were transferred in conjunction with the assumption of amounts due to related parties $ 159,022 Year Ended July 31, 1999 ------------------------ Long-term debt was assumed in conjunction with acquisition of property $ 82,968 Settlement of liability arising from the violation of financing agreement with issuance of common stock $ 738,000 Deposit was utilized to acquire property and equipment $ 16,740 Notes receivable were accepted in conjunction with issuance of common stock $ 473,882
Note 14 - Segment Information: ------------------------------ The Company follows Statement of Financial Accounting Standards No. 131, "Disclosures about Segments of an Enterprise and Related Information: (SFAS 131). SFAS 131 superseded Statement of Financial Accounting Standards No. 14, "Financial Reporting for Segments of a Business Enterprise." SFAS 131 establishes standards for the way that public business enterprises report information about operating segments in annual financial statements and requires that those enterprises report selected information about operating segments in interim financial reports. SFAS 131 also establishes standards for related disclosures about products and services, geographic areas, and major customers. F-28 GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Note 14 - Segment Information (Continued): ------------------------------------------ The Company has three reportable operating segments, United States, Canada and Bermuda, which are organized, managed and analyzed geographically and operate in one industry segment: the development of proprietary drug delivery technology focused on formulations to administer large molecule drugs by mouth. The Company evaluates operating segment performance based primarily on certain operating expenses. 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. Operating loss by geographic segment does not include an allocation of general corporate expenses.
Identifiable Operating Assets Loss ---------------- --------------- 2001 ---- General Corporate $38,227,315 $11,768,696 Canada 4,438,558 19,668,843 United States -- -- Bermuda -- -- ----------- ----------- Total $42,665,873 $31,437,539 =========== =========== 2000 ---- General Corporate $ 7,314,834 $ 4,741,225 Canada 3,026,436 4,302,731 United States -- -- ----------- ----------- Total $10,341,270 $ 9,043,956 =========== =========== 1999 ---- General Corporate $ 5,427,170 $ 3,758,685 Canada 3,462,496 2,468,946 United States -- -- ----------- ----------- Total $ 8,889,666 $ 6,227,631 =========== ===========
F-29 GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Note 15 - Quarterly Information (Unaudited): -------------------------------------------- The following schedule sets forth certain unaudited financial data for the preceding eight quarters ending July 31, 2001. In our opinion, the unaudited information set forth below has been prepared on the same basis as the audited information and includes all adjustments necessary to present fairly the information set forth herein. The operating results for the quarter are not indicative of results for any future period.
Q1 Q2 Q3 Q4 --------------- ---------------- --------------- ---------------- Fiscal Year July 31, 2001: ------------------------- Previously reported Contract research revenue $ 1,000,000 $ -- $ -- $ -- Operating loss $(1,344,532) $(17,673,192) $(3,087,422) $(8,587,393) Net loss $(1,144,207) $(14,205,305) $(2,714,097) $(8,288,601) Net loss per share $ (0.07) $ (0.75) $ (0.14) $ (0.42) As Restated Contract research revenue $ 1,000,000 $ -- $ -- $ -- Operating loss $(1,344,532) $(18,418,192) $(3,087,422) $(8,587,393) Net loss $(1,144,207) $(14,950,305) $(2,714,097) $(8,288,601) Net loss per share $ (0.07) $ (0.79) $ (0.14) $ (0.42) Fiscal Year July 31, 2000: ------------------------- Contract research revenue $ -- $ -- $ -- $ -- Operating loss $(1,182,342) $ (2,913,996) $(2,323,101) $(2,624,517) Net loss $(1,118,772) $ (2,878,873) $(2,291,130) $(2,552,272) Net loss per share $ (0.08) $ (0.19) $ (0.15) $ (0.16)
The Company's interim financial information for Q2 has been restated to recognize additional compensation expense related to stock options issued to a consultant. Note 16 - Collaborative Agreements: ----------------------------------- On January 16, 2001, the Company established a joint venture with Elan International Services, Ltd. ("EIS"), a wholly owned subsidiary of Elan Corporation, plc (EIS and Elan Corporation, plc being collectively referred to as "Elan"). Through the joint venture, the parties will pursue the application of certain of the Company's and Elan's drug delivery technologies, including the Company's platform technology for the buccal delivery of large molecule drugs, to pharmaceutical products for the treatment of prostate cancer, endometriosis and/or the suppression of testosterone and estrogen. The parties will conduct the joint venture through Generex (Bermuda), Ltd., a Bermuda limited liability company. The parties are free to develop other products on their own outside the field of the joint venture. The Company applied the $12,015,000 that it received from EIS for the shares of the Company's Series A Preferred Stock (see Note 10) to form Generex (Bermuda), Ltd. The Company's interest in this company consists of 6,000 shares of Generex (Bermuda) Ltd. common stock and 3,612 shares of convertible preferred stock, representing an 80.1% equity ownership interest in Generex (Bermuda) Ltd. At the same time, EIS remitted $2,985,000 to purchase 2,388 shares of Generex (Bermuda) Ltd. convertible preferred stock, representing a 19.9% equity ownership interest in Generex (Bermuda) Ltd. As of July 31, 2001, the minority interest has been reduced to $-0- due to their share of Generex (Bermuda), Ltd.'s net loss. F-30 GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Note 16 - Collaborative Agreements (Continued): ----------------------------------------------- The parties intend to select at least one pharmaceutical product for research and development under the joint venture by January 2002. The parties will establish a research and development plan and budget upon selection of the pharmaceutical product that will be the initial focus of the joint venture. Generex (Bermuda), Ltd. has been granted rights to use the Company's buccal delivery technology and certain Elan drug delivery technologies for purposes of the joint venture. Using the funds from the initial capitalization, Generex (Bermuda) Ltd. paid a nonrefundable license fee of $15,000,000 to Elan in consideration for being granted rights to use the Elan drug delivery technologies. The Company expensed the entire cost of the license as a research and development expense because of the uncertainties surrounding the future realization of revenue from the use of the license. Note 17 - Subsequent Events (Unaudited): ---------------------------------------- Subsequent events occurring after July 31, 2001 consist of the following: On August 7, 2001, the Company entered into a termination agreement with Tradersbloom, Limited, pursuant to which the parties terminated the equity draw down facility entered into August 14, 2000. Under the terms of this facility, the Company was able to sell to Tradersbloom, from time to time, shares of their common stock up to a maximum sale of $50,000,000. In conjunction with the execution of this agreement, warrants to purchase 568,647 shares of common stock were issued. The fair value of these warrants was capitalized as deferred financing costs. In conjunction with the termination of this agreement, the Company paid $245,000 to satisfy its obligations to Tradersbloom and expensed the deferred financing costs in the year ended July 31, 2001. Neither the Company nor Tradersbloom has any further rights or obligations under the equity draw down facility. On September 25, 2001, the Board of Directors of the Company authorized the repurchase of up to $1 million of the Company's common stock from the open market. F-31 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. Not applicable. PART III The information required by Item 10 "Directors and Executive Officers of the Registrant"; Item 11 "Executive Compensation"; Item 12 "Security Ownership of Certain Beneficial Owners and Management"; and Item 13 "Certain Relationships and Related Transactions" will be provided in an amendment to this Annual Report on Form 10-K to be filed with the Commission not later than 120 days after the end of the fiscal year to which this report relates. PART IV Item 14. Exhibits, Financial Statement Schedules and Reports on Form 8-K (a) Exhibits Exhibit No. Description ----------- ----------- 3.1 Restated Certificate of Incorporation of Generex Biotechnology Corporation filed as Exhibit 3.1 to our Quarterly Report on Form 10-Q for the quarter ended April 30, 1999 filed June 14, 1999 is incorporated herein by reference. 3.2 Bylaws of the Company filed as Exhibit 3.2 to our Registration Statement on Form S-1 (File no. 333-82667) filed July 12, 1999 ("1999 S-1") is incorporated herein by reference. 4.1 Form of common stock certificate filed as Exhibit 4.2 with our 1999 S-1 is incorporated herein by reference. 4.2.1 1998 Stock Option Plan filed as Exhibit 4.3 to our 1999 S-1 is incorporated herein by reference. 4.2.2 2000 Stock Option Plan, filed as Exhibit 4.3.2 to our Form 10-K filed with the Commission on October 30, 2001, is incorporated herein by reference. 4.2.3* 2001 Stock Option Plan. 4.3 Form of Securities Purchase Agreement entered into with Cranshire Capital, L.P.; RAM Trading Ltd.; Gryphon Master Fund; Kodiak Opportunity, L.P.; Kodiak Opportunity 3C7, L.P.; Kodiak Opportunity Offshore, Ltd.; Novelly Exempt Trust; Langley Partners, L.P.; Montrose Investments, Ltd.; WEC Asset Management, LLC; ZLP Master Technology Fund, Ltd.; Alpha Capital Aktiengesellschaft; and The dotCOM Fund, LLC, dated July 3, 2001 filed as an exhibit to our Report on Form 8-K dated July 6, 2001 and filed on July 17, 2001 ("July 2001 8-K") is incorporated herein by reference. 4.4 Form of Registration Rights Agreement entered into with Cranshire Capital, L.P.; RAM Trading Ltd.; Gryphon Master Fund; Kodiak Opportunity, L.P.; Kodiak Opportunity 3C7, L.P.; Kodiak Opportunity Offshore, Ltd.; Novelly Exempt Trust; Langley Partners, L.P.; Montrose Investments, Ltd.; WEC Asset Management, LLC; ZLP Master Technology Fund, Ltd.; Alpha Capital Aktiengesellschaft; and The dotCOM Fund, LLC, dated July 3, 2001 filed as an exhibit to our July 2001 8-K is incorporated herein by reference. 4.5 Form of Warrant granted to Cranshire Capital, L.P.; RAM Trading Ltd.; Gryphon Master Fund; Kodiak Opportunity, L.P.; Kodiak Opportunity 3C7, L.P.; Kodiak Opportunity Offshore, Ltd.; Novelly Exempt Trust; Langley Partners, L.P.; Montrose Investments, Ltd.; WEC Asset Management, LLC; ZLP Master Technology Fund, Ltd.; Alpha Capital Aktiengesellschaft; and The dotCOM Fund, LLC, dated July 6, 2001, filed as an exhibit to our July 2001 8-K, is incorporated herein by reference. 4.6 Securities Purchase Agreement entered into with Capital Ventures International, dated July 3, 2001, filed as an exhibit to our July 2001 8-K, is incorporated herein by reference. 4.7 Registration Rights Agreement entered into with Capital Ventures International, dated July 3, 2001, filed as an exhibit to our July 2001 8-K, is incorporated herein by reference. 4.8 Warrant granted to Capital Ventures International, dated July 3, 2001, filed as an exhibit to our July 2001 8-K, is incorporated herein by reference. 4.9 Form of Securities Purchase Agreement entered into with Elliott International, L.P.; and Elliott Associates, L.P., dated July 3, 2001, filed as an exhibit to our July 2001 8-K, is incorporated herein by reference. 4.10 Form of Registration Rights Agreement entered into with Elliott International, L.P.; and Elliott Associates, L.P., dated July 3, 2001, filed as an exhibit to our July 2001 8-K, is incorporated herein by reference. 4.11 Warrant issued to Elliott International, L.P. and Elliott Associates, L.P., dated July 5, 2001, filed as an exhibit to our July 2001 8-K, is incorporated herein by reference. 4.12 Form of Warrant issued to Ladenburg Thalmann & Co., Inc. dated July 6, 2001, filed as an exhibit to our Registration Statement on Form S-3 (File No. 333-67118) filed August 8, 2001, is incorporated herein by reference. 4.13 Registration Rights Agreement dated January 16, 2001 between Generex Biotechnology Corporation and Elan International Services, Ltd. filed as an exhibit to our Report on Form 8-K dated January 16, 2001 and filed on January 23, 2001 ("January 2001 8-K") is incorporated herein by reference. 4.14 Form of Warrant issued to Elan International Services, Ltd. filed as an exhibit to our January 2001 8-K is incorporated herein by reference. 4.15 Certificate of Designations, Preferences and Rights of Series A Preferred Stock filed as an exhibit to our January 2001 8-K is incorporated herein by reference. 4.16 Securities Purchase Agreement dated January 16, 2001, between Generex Biotechnology Corporation, Elan International Services, Ltd. and Elan Corporation, plc., filed as an exhibit to our Report on Form 8-K/A dated January 16, 2001 and filed on February 1, 2001 is incorporated herein by reference. 4.17 Form of Securities Purchase Agreement entered into with certain parties to October 2000 Private Placement filed as an exhibit to our Report on Form 8-K dated October 4, 2000 and filed on October 16, 2000 ("October 2000 8-K") is incorporated herein by reference. 4.18 Form of Registration Rights Agreement entered into with certain parties to October 2000 Private Placement filed as an exhibit to our October 2000 8-K is incorporated herein by reference. 4.19 Form of Warrant issued to certain parties to October 2000 Private Placement filed as an exhibit to our October 2000 8-K is incorporated herein by reference. 10.1.1 Consulting Agreement with Pankaj Modi filed as Exhibit 10.1.1 to our Registration Statement on Form 10 filed December 14, 1999 ("1999 Form 10") is incorporated herein by reference. 10.1.2 Assignment and Assumption Agreement with Pankaj Modi filed as Exhibit 10.1.2 to our 1999 Form 10 is incorporated herein by reference. 10.1.3* Memorandum of Agreement dated January 7, 1998 between Generex Pharmaceuticals, Inc., GHI Inc., Generex Biotechnology Corporation, Dr. Pankaj Modi and Galaxy Technology, Canada. 10.1.4* Supplemental Agreement dated December 31, 2000 between Generex Pharmaceuticals, Inc., Generex Biotechnology Corporation and Dr. Pankaj Modi. 21* Subsidiaries of the Registrant 23.1.1* Consent of Deloitte & Touche LLP, independent public accountants. 23.1.2* Consent of WithumSmith+Brown, independent public accountants. 24* Powers of Attorney ------------------------------------- * Filed herewith. All other exhibits are incorporated by reference, as described. (b) Reports on Form 8- K The following Reports on Form 8-K were filed during the last quarter of the fiscal year: 1. Report on Form 8-K, filed with the Commission on May 22, 2001, announcing an increase in the size of Generex's Board of Directors from six to seven members, the appointment of Ivan Lieberburg, Ph.D., M.D. as a director of Generex, and the removal of Generex from the Nasdaq Biotechnology Index. 2. Report on Form 8-K, filed with the Commission on July 17, 2001, announcing two private placements completed on or about July 6, 2001 in which Generex raised $11,59,994.75 through the sale of units consisting of one share of common stock and a warrant to purchase .25 shares of common stock. The units were sold without registration under the Securities Act of 1933 in reliance upon the exemption from registration provided in Section 4(2) thereof and Rule 506 of Regulation D promulgated thereunder. 3. Report on Form 8-K, filed with the Commission on August 15, 2001, announcing that Generex had entered into a termination agreement with Tradersbloom Limited pursuant to which the equity draw down facility was terminated. SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized this 23rd day of October 2001. GENEREX BIOTECHNOLOGY CORPORATION By: /s/ Anna E. Gluskin ---------------------------- Anna E. Gluskin, President Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Capacity in Which Name Signed Date ---- ----------------- ---- /s/ Anna E. Gluskin President and Chief October 23, 2001 -------------------- Executive Officer Anna E. Gluskin /s/ E. Mark Perri Chairman, Chief October 23, 2001 -------------------- Financial and Accounting Officer E. Mark Perri /s/ Rose C. Perri Secretary, Treasurer and October 23, 2001 ------------------- Chief Operating Officer Rose C. Perri /s/Pankaj Modi* Vice President, Research October 23, 2001 ------------------ and Development Pankaj Modi /s/ Michael Hawke* Director October 23, 2001 ------------------ Michael Hawke /s/ Ivan M. Lieberburg* Director October 23, 2001 ----------------------- Ivan M. Lieberburg /s/ Jan Michael Rosen* Director October 23, 2001 ----------------------- Jan Michael Rosen *By: /s/ E. Mark Perri ---------------------- E. Mark Perri, as Attorney-in-fact
EX-4 3 ex4-2_3.txt EXHIBIT 4.2.3 EXHIBIT 4.2.3 GENEREX BIOTECHNOLOGY CORPORATION 2001 STOCK OPTION PLAN ---------------------- The purpose of the Generex Biotechnology Corporation 2001 Stock Plan (the "Plan") is to provide (i) designated employees of Generex Biotechnology Corporation (the "Company") and its subsidiaries, (ii) certain consultants and advisors who perform services for the Company or its subsidiaries and (iii) non-employee members of the Board of Directors of the Company (the "Board") with the opportunity to receive grants of incentive stock options and nonqualified stock options (collectively, "Options"). The Company believes that the Plan will encourage the participants to contribute materially to the growth of the Company, thereby benefiting the Company's stockholders, and will align the economic interests of the participants with those of the stockholders. 1. Administration (a) Committee. The Plan shall be administered and interpreted by the Compensation Committee (the "Committee") of the Board, which consists of two or more persons who are "outside directors" as defined under Section 162(m) of the Internal Revenue Code of 1986, as amended (the "Code"), and related Treasury regulations and "non-employee directors" as defined under Rule 16b-3 under the Securities Exchange Act of 1934, as amended (the "Exchange Act"). However, the Board may ratify or approve any Option grants as it deems appropriate. (b) Committee Authority. The Committee shall have the sole authority to (i) determine the individuals to whom Options shall be granted under the Plan, (ii) determine the type, size and terms of the Options to be made to each such individual, (iii) determine the time when the Options will be granted and the duration of any applicable exercise period, including the criteria for exercisability and the acceleration of exercisability, (iv) amend the terms of any previously issued Option and (v) deal with any other matters arising under the Plan. (c) Delegation. The Committee may delegate certain of its duties to one or more of its members or to one or more agents as it may deem advisable. The Committee may employ attorneys, agents, consultants, accountants or other persons, and shall be entitled to rely upon the advice, opinions or valuations of such persons. (d) Committee Determinations. The Committee shall have full power and authority to administer and interpret the Plan, to make factual determinations and to adopt or amend such rules, regulations, agreements and instruments for implementing the Plan and for the conduct of its business as it deems necessary or advisable, in its sole discretion. The Committee's interpretations of the Plan and all determinations made by the Committee pursuant to the powers vested in it hereunder shall be conclusive and binding on all persons having any interest in the Plan or in any awards granted hereunder. All powers of the Committee shall be executed in its sole discretion, in the best interest of the Company, not as a fiduciary, and in keeping with the objectives of the Plan and need not be uniform as to similarly situated individuals. 2. Shares Subject to the Plan (a) Shares Authorized. Subject to adjustment as described below, the aggregate number of shares of common stock of the Company ("Company Stock") that may be issued or transferred under the Plan or upon which awards under the Plan may be granted is 4,000,000 shares. The maximum aggregate number of shares of Company Stock that shall be subject to Options granted under the Plan to any individual during any calendar year shall be 400,000 shares.. The shares may be authorized but unissued shares of Company Stock or reacquired shares of Company Stock, including shares purchased by the Company on the open market for purposes of the Plan. If and to the extent Options granted under the Plan terminate, expire, or are canceled, forfeited, exchanged or surrendered without having been exercised, the shares subject to such Options shall again be available for purposes of the Plan, unless otherwise provided by the Committee. (b) Adjustments. If there is any change in the number or kind of shares of Company Stock outstanding by reason of (i) stock dividend, spinoff, recapitalization, stock split or combination or exchange of shares, (ii) merger, reorganization or consolidation, (iii) reclassification or change in par value or (iv) any other extraordinary or unusual event affecting the outstanding Company Stock as a class without the Company's receipt of consideration, or if the value of outstanding shares of Company Stock is substantially reduced as a result of a spinoff or the Company's payment of an extraordinary dividend or distribution, the maximum number of shares of Company Stock available under the Plan, the maximum number of shares of Company Stock that any individual participating in the Plan may be granted in any year, the number of shares covered by outstanding Options, the kind of shares issued under the Plan, and the price per share or the applicable market value of such Options may be appropriately adjusted by the Committee to reflect any increase or decrease in the number of, or change in the kind or value of, issued shares of Company Stock to preclude, to the extent practicable, the enlargement or dilution of rights and benefits under such Options; provided, however, that any fractional shares resulting from such adjustment shall be eliminated. Any adjustments determined by the Committee shall be final, binding and conclusive. 3. Eligibility for Participation (a) Eligible Persons. All employees of the Company and its subsidiaries ("Employees") and members of the Board who are not Employees ("Non-Employee Directors") shall be eligible to participate in the Plan. Consultants and advisors who perform services for the Company or any of its subsidiaries ("Key Advisors") shall be eligible to participate in the Plan if the Key Advisors render bona fide services to the Company or its subsidiaries, the services are not in connection with the offer and sale of securities in a capital-raising transaction and the Key Advisors do not directly or indirectly promote or maintain a market for the Company's securities. (b) Selection of Optionees. The Committee shall select the Employees, Non-Employee Directors and Key Advisors to receive Options and shall determine the number of shares of Company Stock subject to a particular Option in such manner as the Committee determines. Employees, Key Advisors and Non-Employee Directors who receive Options under this Plan shall hereinafter be referred to as "Optionees." 4. Granting of Options (a) Option Agreements. All Options shall be subject to the terms and conditions set forth herein and to such other terms and conditions consistent with this Plan as the Committee deems appropriate and as are specified in writing by the Committee to the individual in a grant instrument or an amendment to the grant instrument (the "Option Agreement"). The Committee shall approve the form and provisions of each Option Agreement. (b) Number of Shares. The Committee shall determine the number of shares of Company Stock that will be subject to each Option. (c) Type of Option and Price. (i) The Committee may grant Options that are intended to qualify as "incentive stock options" within the meaning of Section 422 of the Code ("Incentive Stock options") or Options that are not intended so to qualify ("Nonqualified Stock Options") or any combination of Incentive Stock Options and Nonqualified Stock Options, all in accordance with the terms and conditions set forth herein. Incentive Stock Options may be granted only to Employees of the Company or a parent or subsidiary (within the meaning of Section 424(f) of the Code). Nonqualified Stock Options may be granted to Employees, Non-Employee Directors and Key Advisors. Unless otherwise provided in the Option Agreement, any Option granted under this Plan to an Employee is intended to be an Incentive Stock Option. (ii) The purchase price (the "Exercise Price") of Company Stock subject to an Option shall be determined by the Committee and may be equal to or less than the Fair Market Value (as defined below) of a share of Company Stock on the date the Option is granted; provided, however, that (x) the Exercise Price of an Incentive Stock Option shall be equal to the Fair Market Value of a share of Company Stock on the date the Incentive Stock Option is granted and (y) an Incentive Stock Option may not be granted to an Employee who, at the time of grant, owns stock possessing more than ten percent of the total combined voting power of all classes of stock of the Company or any parent or subsidiary of the Company, unless the Exercise Price per share is not less than 110% of the Fair Market Value of Company Stock on the date of grant. (iii) The Fair Market Value per share shall be the closing price of the Company Stock on the relevant date or (if there were no trades on that date) the latest preceding date upon which a sale was reported. (d) Option Term. The Committee shall determine the term of each Option. The term of any Option shall not exceed ten years from the date of grant, which date of grant is determined by the Committee. However, an Incentive Stock Option that is granted to an Employee who, at the time of grant, owns stock possessing more than ten percent of the total combined voting power of all classes of stock of the Company, or any parent or subsidiary of the Company, may not have a term that exceeds five years from the date of grant. (e) Exercisability of Options. Options shall become exercisable in accordance with such terms and conditions, consistent with the Plan, as may be determined by the Committee and specified in the Option Agreement. Unless a different vesting schedule is specified by the Committee in an Option Agreement, Options granted under this Plan shall vest in one-half increments on each annual anniversary of the date of grant over a period of two years. The Committee may accelerate, and may provide in the Option Agreement for the acceleration of, the exercisability of any or all outstanding Options at any time for any reason. (f) Reload Options. In the event that shares of Company Stock are used to exercise an Option, the terms of such Option may provide for the grant of additional Options, or the Committee may grant additional Options, to purchase a number of shares of Company Stock equal to the number of whole shares used to exercise the Option and the number of whole shares, if any, withheld in payment of any taxes. Such Options shall be granted with an Exercise Price equal to the Fair Market Value of the Company Stock on the date of grant of such additional Options, or at such other Exercise Price as the Committee may establish, for a term not longer than the unexpired term of the exercised Option and on such other terms as the Committee shall determine. (g) Limit on Incentive Stock Options. Each Incentive Stock Option shall provide that, if the aggregate Fair Market Value of the stock on the date of the grant with respect to which Incentive Stock Options are exercisable for the first time by an Optionee during any calendar year, under the Plan or any other stock option plan of the Company or a parent or subsidiary, exceeds $100,000, then the Option, as to the excess, shall be treated as a Nonqualified Stock Option. 5. Termination of Employment, Disability or Death (a) General Rule. Except as provided below, an Option may only be exercised while the Optionee is employed by, or providing service to, the Company as an Employee, Key Advisor or member of the Board. In the event that an Optionee ceases to be employed by, or provide service to, the Company for any reason other than (i) termination by the Company without Cause (as defined below), (ii) voluntary termination by the Optionee, (iii) Disability (as defined below) or (iv) death, any Option held by the Optionee shall terminate immediately (unless the Committee specifies otherwise). In addition, notwithstanding any other provision of this Plan, if the Committee determines that the Optionee has engaged in conduct that constitutes Cause at any time while the Optionee is employed by, or providing service to, the Company or after the Optionee's termination of employment or service, any Option held by the Optionee shall immediately terminate and the Optionee shall automatically forfeit all shares underlying any exercised portion of an Option for which the Company has not yet delivered the share certificates, upon refund by the Company of the Exercise Price paid by the Optionee for such shares. Upon any exercise of an Option, the Company may withhold delivery of share certificates pending resolution of an inquiry that could lead to a finding resulting in a forfeiture. (b) Termination Without Cause; Voluntary Termination. In the event that an Optionee ceases to be employed by, or provide service to, the Company as a result of (i) termination by the Company without Cause (as defined below) or (ii) voluntary termination by the Optionee, any Option which is otherwise exercisable by the Optionee shall terminate unless exercised within 90 days after the date on which the Optionee ceases to be employed by, or provide service to, the Company (or within such other period of time as may be specified by the Committee), but in any event no later than the date of expiration of the Option term. Except as otherwise provided by the Committee, any of the Optionee's Options that are not otherwise exercisable as of the date on which the Optionee ceases to be employed by, or provide service to, the Company shall terminate as of such date. (c) Termination Because Disabled. In the event the Optionee ceases to be employed by, or provide service to, the Company because the Optionee is Disabled, any Option which is otherwise exercisable by the Optionee shall terminate unless exercised within one year after the date on which the Optionee ceases to be employed by, or provide service to, the Company (or within such other period of time as may be specified by the Committee), but in any event no later than the date of expiration of the Option term. Except as otherwise provided by the Committee, any of the Optionee's Options which are not otherwise exercisable as of the date on which the Optionee ceases to be employed by, or provide service to, the Company shall terminate as of such date. (d) Death. If the Optionee dies while employed by, or providing service to, the Company or within 90 days after the date on which the Optionee ceases to be employed or provide service on account of a termination specified in Section 5(b) above (or within such other period of time as may be specified by the Committee), any Option that is otherwise exercisable by the Optionee shall terminate unless exercised within one year after the date on which the Optionee dies or otherwise ceased to be employed by, or provide service to, the Company (or within such other period of time as may be specified by the Committee), but in any event no later than the date of expiration of the Option term. Except as otherwise provided by the Committee, any of the Optionee's Options that are not otherwise exercisable as of the date on which the Optionee dies or otherwise ceased to be employed by, or provide service to, the Company shall terminate as of such date. (e) Definitions. (i) The term "Company" shall mean the Company and its parent and subsidiary corporations or other entities, as determined by the Committee. (ii) "Employed by, or provide service to, the Company" shall mean employment or service as an Employee, Key Advisor or member of the Board (so that an Optionee shall not be considered to have terminated employment or service until the Optionee ceases to be an Employee, Key Advisor and member of the Board), unless the Committee determines otherwise. (iii) "Disability" shall mean an Optionee's becoming disabled under the Company's long-term disability plan, or, if the Optionee is not covered under such plan or no such plan is maintained, and in the case of an Incentive Stock Option, "Disability" shall mean an Optionee's becoming disabled within the meaning of Section 22(e)(3) of the Code. (iv) "Cause" shall mean, except to the extent specified otherwise by the Committee, a finding by the Committee that the Optionee has: (i) breached his or her employment or service contract with the Company; (ii) engaged in disloyalty to the Company, including, without limitation, fraud, embezzlement, theft, commission of a felony or proven dishonesty in the course of his or her employment or service; (iii) disclosed trade secrets or confidential information of the Company to persons not entitled to receive such information; (iv) breached any written confidentiality, non-competition or non-solicitation agreement between the Optionee and the Company; or (v) has engaged in such other behavior detrimental to the interests of the Company as the Committee determines. 6. Exercise of Options. (a) Notice of Exercise. A Optionee may exercise an Option that has become exercisable, in whole or in part, by delivering a notice of exercise to the Company. (b) Payment of Exercise Price. Along with the notice of exercise, the Optionee shall pay the Exercise Price for an Option as specified by the Committee (i) in cash, (ii) with the approval of the Committee, by delivering shares of Company Stock owned by the Optionee (including Company Stock acquired in connection with the exercise of an Option, subject to such restrictions as the Committee deems appropriate) valued at Fair Market Value on the date of exercise, (iii) with the approval of the Committee, by surrender of outstanding awards under the Plan or (iv) by such other method as the Committee may approve. Shares of Company Stock used to exercise an Option shall have been held by the Optionee for the requisite period of time to avoid adverse accounting consequences to the Company with respect to the Option. (c) Payment of Tax. The Optionee shall pay the amount of any withholding tax due at the time of exercise. 7. Deferrals The Committee may permit or require an Optionee to defer receipt of the delivery of shares that would otherwise be due to such Optionee in connection with any Option. If any such deferral election is permitted or required, the Committee shall, in its sole discretion, establish rules and procedures for such deferrals. 8. Withholding of Taxes (a) Required Withholding. All Options under the Plan shall be subject to applicable federal (including FICA), state, local and other tax withholding requirements. The Company shall have the right to deduct from any amounts paid to the Optionee, any federal, state, local or other taxes required by law to be withheld with respect to such Options. The Company may require that the Optionee or other person receiving or exercising Options pay to the Company the amount of any federal, state, local or other taxes that the Company is required to withhold with respect to such Options, or the Company may deduct from other wages paid by the Company the amount of any withholding taxes due with respect to such Options. (b) Election to Withhold Shares. If the Committee so permits, an Optionee may elect, in the form and manner prescribed by the Committee, to satisfy the Company's income tax withholding obligation with respect to Options paid in Company Stock by having shares withheld up to an amount that does not exceed the Optionee's minimum applicable withholding tax rate for federal (including FICA), state, local and other tax liabilities. 9. Transferability of Options (a) Nontransferability of Options. Except as provided below, only the Optionee may exercise rights under an Option during the Optionee's lifetime. A Optionee may not transfer those rights except (i) by will or by the laws of descent and distribution or (ii) with respect to Nonqualified Stock Options, if permitted in any specific case by the Committee, pursuant to a domestic relations order or otherwise as permitted by the Committee. When an Optionee dies, the personal representative or other person entitled to succeed to the rights of the Optionee ("Successor Optionee") may exercise such rights. A Successor Optionee must furnish proof satisfactory to the Company of his or her right to receive the Option under the Optionee's will or under the applicable laws of descent and distribution. (b) Transfer of Nonqualified Stock Options. Notwithstanding the foregoing, the Committee may provide that an Optionee may transfer Nonqualified Stock Options to family members, or one or more trusts or other entities for the benefit of or owned by family members, consistent with the applicable securities laws, according to such terms as the Committee may determine; provided that the Optionee receives no consideration for the transfer of an Option and the transferred Option shall continue to be subject to the same terms and conditions as were applicable to the Option immediately before the transfer. 10. Change of Control of the Company As used herein, a "Change of Control" shall be deemed to have occurred if: (a) Unless the Board approves such acquisition, any "person" (as such term is used in Sections 13(d) and 14(d) of the Exchange Act) becomes a "beneficial owner" (as defined in Rule 13d-3 under the Exchange Act), directly or indirectly, in a single transaction or series of transactions, of securities of the Company representing more than 20 percent of the voting power of the then outstanding securities of the Company; provided that a Change of Control shall not be deemed to occur as a result of a change of ownership resulting from the death of a stockholder, and a Change of Control shall not be deemed to occur as a result of a transaction in which the Company becomes a subsidiary of another corporation and in which the stockholders of the Company, immediately prior to the transaction, will beneficially own, immediately after the transaction, shares entitling such stockholders to more than 20 percent of all votes to which all stockholders of the parent corporation would be entitled in the election of directors (without consideration of the rights of any class of stock to elect directors by a separate class vote); (b) A merger or consolidation of the Company is consummated with another corporation where the stockholders of the Company, immediately prior to the merger or consolidation, will not beneficially own, immediately after the merger or consolidation, shares entitling such stockholders to more than 80 percent of all votes to which all stockholders of the surviving corporation would be entitled in the election of directors (without consideration of the rights of any class of stock to elect directors by a separate class vote); (c) A sale or other disposition of all or substantially all of the assets of the Company occurs; (d) A liquidation or dissolution of the Company occurs; or (e) Shares of the Company's Special Voting Rights Preferred Stock are outstanding and a "Change of Control" under the terms and conditions of such securities occurs. 11. Consequences of a Change of Control (a) Notice and Acceleration. Unless the Committee determines otherwise, any outstanding Options that are not yet exercisable or vested shall become exercisable or vested as of the Change of Control. The Committee shall provide notice to Optionees of the Change of Control as soon as practicable. (b) Assumption of Options. Upon a Change of Control where the Company is not the surviving corporation (or survives only as a subsidiary of another corporation), unless the Committee determines otherwise, all outstanding Options that are not exercised shall be assumed by, or replaced with comparable options or rights by, the surviving corporation (or a parent or subsidiary of the surviving corporation). (c) Other Alternatives. Notwithstanding the foregoing, subject to subsection (d) below, in the event of a Change of Control, the Committee may take one or both of the following actions with respect to any or all outstanding Options: (i) the Committee may require that Optionees surrender their outstanding Options in exchange for a payment by the Company, in cash or Company Stock as determined by the Committee, in an amount equal to the amount by which the then Fair Market Value of the shares of Company Stock subject to the Optionee's unexercised Options exceeds the Exercise Price of the Options; or (ii) the Committee may, after giving Optionees an opportunity to exercise their outstanding Options, terminate any or all unexercised Options at such time as the Committee deems appropriate. Such surrender or termination or settlement shall take place as of the date of the Change of Control or such other date as the Committee may specify. (d) Limitations. Notwithstanding anything in the Plan to the contrary, in the event of a Change of Control, the Committee shall not have the right to take any actions described in the Plan (including without limitation actions described in subsection (c) above) that would make the Change of Control ineligible for pooling of interests accounting treatment or that would make the Change of Control ineligible for desired tax treatment if, in the absence of such right or action, the Change of Control would qualify for such treatments and the Company intends to use such treatments with respect to the Change of Control. 12. Requirements for Issuance or Transfer of Shares (a) Limitations on Issuance or Transfer of Shares. No Company Stock shall be issued or transferred in connection with any Option hereunder unless and until all legal requirements applicable to the issuance or transfer of such Company Stock have been complied with to the satisfaction of the Committee. The Committee shall have the right to condition any Option made to any Optionee hereunder on such Optionee's undertaking in writing to comply with such restrictions on his or her subsequent disposition of such shares of Company Stock as the Committee shall deem necessary or advisable, and certificates representing such shares may be legended to reflect any such restrictions. Certificates representing shares of Company Stock issued or transferred under the Plan will be subject to such stop-transfer orders and other restrictions as may be required by applicable laws, regulations and interpretations, including any requirement that a legend be placed thereon. (b) Lock-Up Period. If so requested by the Company or any representative of the underwriters (the "Managing Underwriter") in connection with any underwritten offering of securities of the Company under the Securities Act of 1933, as amended (the "Securities Act"), an Optionee (including any successors or assigns) shall not sell or otherwise transfer any shares or other securities of the Company during the 30-day period preceding and the 180-day period following the effective date of a registration statement of the Company filed under the Securities Act for such underwritten offering (or such shorter period as may be requested by the Managing Underwriter and agreed to by the Company) (the "Market Standoff Period"). The Company may impose stop-transfer instructions with respect to securities subject to the foregoing restrictions until the end of such Market Standoff Period. 13. Cancellation and Recission of Options (a) Unless the Option Agreement specifies otherwise, the Committee may cancel, rescind, suspend, withhold or otherwise limit or restrict any unexpired, unpaid or deferred Options at any time if the Optionee is not in compliance with all applicable provisions of the Option Agreement and the Plan, or if the Optionee engages in any "Detrimental Activity." For purposes of this Section 16, "Detrimental Activity" shall include: (i) the rendering of services for any organization or engaging directly or indirectly in any business which is or becomes competitive with the Company, or which organization or business, or the rendering of services to such organization or business, is or becomes otherwise prejudicial to or in conflict with the interests of the Company; (ii) the disclosure to anyone outside the Company, or the use in other than the Company's business, without prior written authorization from the Company, of any confidential information or material, in violation of the Company's applicable agreement with the Optionee or of the Company's applicable policy regarding confidential information and intellectual property; (iii) the failure or refusal to disclose promptly and to assign to the Company, pursuant to the Company's applicable agreement with the Optionee or to the Company's applicable policy regarding confidential information and intellectual property, all right, title and interest in any invention or idea, patentable or not, made or conceived by the Optionee during employment by the Company, relating in any manner to the actual or anticipated business, research or development work of the Company, or the failure or refusal to do anything reasonably necessary to enable the Company to secure a patent where appropriate in the United States and in other countries; (iv) activity that results in termination of the Optionee's employment for cause; (v) a violation of any rules, policies, procedures or guidelines of the Company, including (but not limited to) the Company's business conduct guidelines; (vi) any attempt (directly or indirectly) to induce any employee of the Company to be employed or perform services elsewhere or any attempt (directly or indirectly) to solicit the trade or business of any current or prospective customer, supplier or partner of the Company; (vii) the Optionee's being convicted of, or entering a guilty plea with respect to, a crime, whether or not connected with the Company; or (viii) any other conduct or act determined to be injurious, detrimental or prejudicial to any interest of the Company. (b) Upon exercise, payment or delivery pursuant to an Option, the Optionee shall certify in a manner acceptable to the Company that he or she is in compliance with the terms and conditions of the Plan. In the event an Optionee fails to comply with the provisions of paragraphs (a)(i)-(viii) of this Section 13 prior to, or during the six months after, any exercise, payment or delivery pursuant to an Award, such exercise, payment or delivery may be rescinded within two years thereafter. In the event of any such rescission, the Optionee shall pay to the Company the amount of any gain realized or payment received as a result of the rescinded exercise, payment or delivery, in such manner and on such terms and conditions as may be required, and the Company shall be entitled to set-off against the amount of any such gain any amount owed to the Optionee by the Company. (c) The Committee, in its sole discretion, may grant to an Optionee, in exchange for the surrender and cancellation of an Option previously granted to the Optionee, a new Option in the same or different form and containing such terms, including without limitation a price that is higher or lower than any price provided in the award so surrendered or cancelled. 14. Amendment and Termination of the Plan (a) Amendment. The Committee may amend or terminate the Plan at any time; provided, however, that the Committee shall not increase the aggregate number of shares of Company Stock that may be issued or transferred under the Plan or upon which awards under the Plan may be granted, or otherwise materially amend the Plan, without stockholder approval if such approval is required in order to comply with the Code or applicable laws, or to comply with applicable stock exchange requirements. (b) Termination of Plan. No Incentive Stock Option may be granted more than ten years from the Plan's effective date. The Plan may be terminated by the Committee at any time. (c) Termination and Amendment of Outstanding Options. A termination or amendment of the Plan that occurs after an Option is made shall not materially impair the rights of an Optionee unless the Optionee consents or unless the Committee acts under Section 20(b). The termination of the Plan shall not impair the power and authority of the Committee with respect to an outstanding Option. Whether or not the Plan has terminated, an outstanding Option may be terminated or amended under Section 20(b) or may be amended by agreement of the Company and the Optionee consistent with the Plan. (d) Governing Document. The Plan shall be the controlling document. No other statements, representations, explanatory materials or examples, oral or written, may amend the Plan in any manner. The Plan shall be binding upon and enforceable against the Company and its successors and assigns. 15. Funding of the Plan This Plan shall be unfunded. The Company shall not be required to establish any special or separate fund or to make any other segregation of assets to assure the payment of any Options under this Plan. In no event shall interest be paid or accrued on any Option, including unpaid installments of Options. 16. Rights of Participants Nothing in this Plan shall entitle any Employee, Key Advisor, Non-Employee Director or other person to any claim or right to be granted an Option under this Plan. Neither this Plan nor any action taken hereunder shall be construed as giving any individual any rights to be retained by or in the employ of the Company or any other employment rights. 17. No Fractional Shares No fractional shares of Company Stock shall be issued or delivered pursuant to the Plan or any Option. The Committee shall determine whether cash, other awards or other property shall be issued or paid in lieu of such fractional shares or whether such fractional shares or any rights thereto shall be forfeited or otherwise eliminated. 18. Headings Section headings are for reference only. In the event of a conflict between a title and the content of a Section, the content of the Section shall control. 19. Effective Date of the Plan. Subject to approval by the Company's stockholders, the Plan shall be effective as of May 4, 2001. 20. Miscellaneous (a) Options in Connection with Corporate Transactions and Otherwise. Nothing contained in this Plan shall be construed to (i) limit the right of the Committee to grant Options under this Plan in connection with the acquisition, by purchase, lease, merger, consolidation or otherwise, of the business or assets of any corporation, firm or association, including Options to employees thereof who become Employees of the Company, or for other proper corporate purposes, or (ii) limit the right of the Company to grant stock options or make other awards outside of this Plan. Without limiting the foregoing, the Committee may grant an Option to an employee of another corporation who becomes an Employee by reason of a corporate merger, consolidation, acquisition of stock or property, reorganization or liquidation involving the Company or any of its subsidiaries in substitution for a stock option or stock awards grant made by such corporation. The terms and conditions of the substitute Options may vary from the terms and conditions required by the Plan and from those of the substituted stock incentives. The Committee shall prescribe the provisions of the substitute grants. (b) Compliance with Law. The Plan, the exercise of Options and the obligations of the Company to issue or transfer shares of Company Stock under Options shall be subject to all applicable laws and to approvals by any governmental or regulatory agency as may be required. The Committee may revoke any Option if it is contrary to law or modify an Option to bring it into compliance with any valid and mandatory government regulation. The Committee may also adopt rules regarding the withholding of taxes on payments to Optionees. The Committee may, in its sole discretion, agree to limit its authority under this Section. (c) Governing Law. The validity, construction, interpretation and effect of the Plan and Option Agreements issued under the Plan shall be governed and construed by and determined in accordance with the laws of State of Delaware, without giving effect to the conflict of laws provisions thereof. EX-10.13 4 ex10-13.txt EXHIBIT 10.13 EXHIBIT 10.1.3 MEMORANDUM OF AGREEMENT THIS AGREEMENT made as of the 7th day of January, 1998, between GENEREX PHARMACEUTICALS INC., an Ontario corporation, GHI, INC. ("GHI"), a Turks and Cacos corporation, GENEREX BIOTECHNOLOGY CORPORATION, a Delaware corporation, DR. PANKAJ MODI ("Modi"), an individual, and GALAXY TECHNOLOGY, CANADA ("Galaxy"), a proprietorship of Modi's. WHEREAS, Modi was engaged by Generex Pharmaceuticals, Inc. ("GPI") to provide certain services to GPI in connection with its research and development initiatives pursuant to a Consulting Agreement made as of the 1st day of October, 1996 (the "Consulting Agreement") between CPI and Modi; and WHEREAS, pursuant to an Assignment and Assumption Agreement made as of the 1st day of October, 1997 (the "Assignment and Assumption Agreement"), Modi assigned to GPI all of his rights, title and interests in and to certain drug delivery systems and the intellectual property associated therewith (collectively, the "Technology") and, in that regard, has executed and delivered to GPI a number of related specific assignments (the "Specific Assignments"); and WHEREAS, in connection with the execution of the Consulting Agreement and Assignment of certain technology to GPI, Modi received shares of GPI common stock, which shares were held of record by GHI for Modi's benefit, and subsequently exchanged by GHI for shares of Generex Biotechnology corporation ("GBC"); and WHEREAS, GBC now owns 100% of the outstanding capital stock of GPI; and WHEREAS, Modi owns and controls Galaxy; and WHEREAS, Modi has approached management of GPI and GBC, and indicated that he executed and delivered the Consulting Agreement, Assignment and Assumption Agreement and the Specific Assignments because he had satisfied himself that E. Mark Perri, the current Chairman of the Board of GPI, Anna E. Gluskin, the current President of GPI, and Rose C. Perri (collectively, the "Management Group"), the founders and directing mind and will of GPI and the individuals who currently manage or supervise the management of the business and affairs of GPI, had the requisite skills, motivation and vision to make the Technology a medical and commercial success on a worldwide basis, and in reliance upon their representations to him that he would have a central role in the ongoing research and development of the Technology; and WHEREAS, Modi considers that his and the Management Group's continued involvement is crucial to the successful development of the Technology and the successful commercial marketing and sale of products employing the Technology ("Technology Products"); and WHEREAS, Modi has advised GPI that he intends to exercise his right to terminate the Consulting Agreement in the absence of agreements and procedures that will assure the continued involvement of Modi and the Management Group in the development of the Technology and, ultimately, the manufacture of Technology Products; and WHEREAS, GPI and GBC consider that the continued involvement and dedication of Modi is crucial to the successful creation and implementation of the research and development initiatives required to create commercially viable Technology Products; NOW, THEREFORE, in consideration of Modi's continued support of GPI and the Technology pursuant to the Consulting Agreement and for other good and valuable consideration, the parties agree as follows: 1. Extension of Terms of Consulting Agreement. The Consulting Agreement is hereby extended to and including December 31, 2004, and paragraph 5 of the Consulting Agreement is amended accordingly. During the term of the Consulting Agreement, Modi shall have the title of Vice President, Research and Development of GPI and of GBC. 2. Compensation. Modi's annual fee for services is increased to $132,000 (CDN) per year, payable in equal monthly installments of $11,000, effective as of the earlier of (a) first day of the first month following the date that GPI and GBC, collectively, receive additional equity capital of $2,000,000 (US) or more, or (b) April 1, 1998. 3. Revisions of Section 7 of Consulting Agreement. Section 7 of the Consulting Agreement is amended and restated in its entirety to provide the following: 7. Termination This Agreement shall terminate upon the death of the Consultant or declaration by a court of competent jurisdiction that the Consultant is a mentally incompetent person or incapable of handling his affairs due to mental incompetence, and may be terminated: (a) at any time by mutual agreement of the Corporation and the Consultant in writing; (b) by Consultant at any time after January 1, 2001, upon twelve (12) months notice; (c) by the Corporation for just cause at any time by giving thirty (30) days written notice thereof to the Consultant. As used herein, the term "just cause" shall mean and be limited to: (i) a material breach of trust by the Consultant which causes or threatens serious injury to the Corporation; (ii) gross negligence or incompetence on the part of the Consultant; (iii) a material breach of any provision of this Agreement by the Consultant; (iv) inability of the Consultant as a result of a bona fide illness, physical or mental, to attend to his duties hereunder for a period of twenty-four (24) consecutive weeks, which period shall be deemed to commence with such inability and shall continue until the Consultant is once again able to attend to his duties hereunder on a regular basis; (v) disobedience or intentional neglect by the Consultant of any written directive of the Chief Executive Officer of the Corporation which is neither inconsistent with Consultant's duties, authority or rights under this or any other agreement between Consultant and the Corporation, nor outside the scope of his normal duties as Vice President, Research and Development; or (vi) any action by the Consultant taken with the intent to materially and adversely affect a material interest of the Corporation. 4. Consent Required. During the term of the Consultant Agreement, neither GPI nor GBC, without first consulting with Modi and obtaining his express consent or approval, which consent or approval shall not be withheld by Dr. Modi unreasonably, shall do any of the following or suffer or permit any affiliate of theirs or any other person to do any of the following: (a) Publish any papers or otherwise make any public disclosure of previously unpublished research, formulations, test results or other confidential and/or proprietary data relating to the Technology; or (b) Enter into a contract for the manufacture of Technology Products, or components of Technology Products; or (c) License any other person or entity to use the Technology. For purposes hereof, in determining whether or not withholding consent to any of the foregoing actions is unreasonable, among the factors that shall be considered, in the case of (a), are the possible injury to the Corporation and/or the Corporation's research and development program and, in the case of (b) and (c), the commercial and scientific reputation and expertise and financial strength of a prospective manufacturer or licensee. 5. Election of Modi as a Director. So long as the Consulting Agreement is in force, GPI and GBC shall use their best efforts to cause Modi to be nominated for election and elected a director of both GPI and GBC. 6. Issuance of Special Voting Rights Preferred Stock. Simultaneously with the execution and delivery of this Agreement, and in consideration of his execution of this Agreement and the sum of $100.00 (US), receipt of which is acknowledged, GBC shall issue and deliver to Modi one thousand (1,000) shares of GBC's Special Voting Rights Preferred Stock (the "SVR Preferred"), the special voting and other rights of which are set forth in the form of "Designation of Special Voting Rights Preferred Stock" attached hereto as Exhibit "A". So long as the SVR Preferred is outstanding, GBC shall not issue any shares of capital stock or take any other corporate actions which would limit or interfere with the exercise of the voting rights of holders of SVR Preferred. 7. Reimbursement for Prior Costs Incurred. GPI shall pay $150,000 (CDN) to Modi to reimburse Modi for costs previously incurred by him in connection with preparation and filing of patent applications and conducting of tests and clinical trials relating to the Technology. This amount shall be paid in three $50,000 installments on March 31, 1998, June 30, 1998 and September 30, 1998. 8. Counsel for the Transaction. (a) each of the parties hereto has requested Joseph Chicco ("Chicco") of the firm Connolly Epstein Chicco Foxman Engelmyer & Ewing, Philadelphia, PA, to represent him/it in connection with the preparation and execution of this Memorandum of Agreement. Each of the parties understands that Chicco represents GPI and GBC in matters wholly unrelated to this transaction, but that the business of GPI and GPC is materially dependent on Modi's research and inventions. The parties understand that, with respect to the transactions contemplated by this Memorandum of Agreement, no communications to Chicco by a party shall be considered confidential so as to preclude disclosure to other parties, and the parties acknowledge that Chicco has advised them that he may communicate information obtained from one party to one or more other parties, and will communicate all such information received to another party upon its request. The parties understand that, in this capacity, Chicco cannot be an advocate for his or its interest against the interest of one or more of the other parties. Rather , his role shall be to advise each party on the effect and meaning of various terms that may be proposed by one or more of the parties, and to attempt to mediate and facilitate a resolution of any disputed proposals. Chicco's fees and expenses in connection with this representation shall be paid by GBC. (b) Each of the parties waives all real and potential conflicts of interests that arise out of Chicco's multiple representation of the parties in this transaction. 9. GBC Common Stock. GHI presently owns 8,688,427 shares of GBC Common Stock. GHI and each of the other parties hereto acknowledge that 3,095,238 of such shares (the "Modi Shares") are held in trust for Modi. At Modi's request, record ownership of the Modi Shares shall be transferred to Modi or his nominee by GHI. 10. Galaxy. All assignments of Technology heretofore made by Modi are intended to include all rights, title and interest of Galaxy in and to such Technology. 11. Governing Law. This Memorandum of Agreement shall be governed by the laws of the Province of Ontario and of Canada applicable therein, and the parties hereby irrevocably attorn to the jurisdiction of the courts of the Province of Ontario, except that the parties' rights and obligations with respect to paragraph 6 above shall be governed by the laws of the State of Delaware. 12. Assignment. The benefits of this Memorandum of Agreement may not be assigned, in whole or in part, by any party without the prior written consent of the others, but this Agreement nevertheless shall be binding upon the parties, their respective heirs, legal personal representatives, successors and permitted assigns. IN WITNESS WHEREOF, the parties have executive and delivered this Memorandum of Agreement as of the date first written above. Witness:
S/ S/Pankaj Modi ------------------------------------ -------------------------------------------- Pankaj Modi, individually and on behalf Of Galaxy Technology, Canada GENEREX PHARMACEUTICALS INC. Per: S/Anna E. Gluskin ---------------------------------------- Anna E. Gluskin, President Per: S/E. Mark Perri ---------------------------------------- E. Mark Perri, Chairman GENEREX BIOTECHNOLOGY CORP. Per: S/Anna E. Gluskin ---------------------------------------- Anna E. Gluskin, President Per: S/E. Mark Perri ---------------------------------------- E. Mark Perri, Chairman GHI, INC. Per: S/Anna E. Gluskin ---------------------------------------- Anna E. Gluskin, President Per: S/E. Mark Perri ---------------------------------------- E. Mark Perri, Chairman
EX-10.14 5 ex10-14.txt EXHIBIT 10.14 EXHIBIT 10.1.4 SUPPLEMENTAL AGREEMENT THIS AGREEMENT, made as of the 31st day of December, 2000, by and among GENEREX PHARMACEUTICALS, INC. ("GPI"), an Ontario corporation, GENEREX BIOTECHNOLOGY CORPORATION ("GBC"), a Delaware corporation, and PANKAJ MODI ("Modi"), an individual. WHEREAS, effective October 1, 1996, pursuant to a Consulting Agreement dated as of that date between GPI and Modi (the "Consulting Agreement"), Modi was engaged as a consultant by GPI and assigned and transferred to GPI all Inventions (as defined in the Consulting Agreement) relating to the actual or demonstrably anticipated business, work, undertaking or research and development of GPI made or conceived by Modi during the term of the Consulting Agreement; and WHEREAS, on January 7, 1998, the parties to this Supplemental Agreement, together with GHI, Inc., a Turks and Cacos corporation, entered into a Memorandum of Agreement (the "Memorandum of Agreement") that modified or superseded portions of the Consulting Agreement, primarily relating to the compensation due to Modi for his past and future services to GPI and GBC; and WHEREAS, the parties now wish to amend the term and compensation arrangements provided for in the Consulting Agreement and the Memorandum of Agreement (collectively, the "Prior Agreements"), and to provide additional terms of Modi's engagement. NOW, THEREFORE, in consideration of the mutual promises herein contained and for other good and valuable consideration, the parties agree as follows: 4. Extension of Terms of Consulting Agreement. Subject to the early termination provisions set forth in Section 6 below, the Consulting Agreement, as amended hereby, is extended to and including July 31, 2010 (the "Termination Date"), and is hereinafter referred to as "this Agreement". During the extended term of this Agreement, Modi shall continue to hold the position of Vice President, Research and Development of GPI and of GBC. 5. Base Compensation and Car Allowance. (a) For all services rendered to GBC, GPI and other subsidiaries of GBC (collectively, "Generex"), Modi will receive annual base compensation of $250,000* effective as of August 1, 2000. The base compensation and all other compensation payable to Modi under this Agreement may be allocated within Generex in the discretion of GBC. Whatever allocation is made, however, GBC and GPI shall be jointly and severally responsible for the payment to Modi of all amounts due under this Agreement. (b) The difference between (i) the base compensation due to Modi under paragraph 2(a) above for the period August 1, 2000, through December 31, 2000 (i.e., 5/12ths of $250,000, or $104,166.65, and (ii) the compensation actually paid to Modi for services to Generex during that period, shall be paid to Modi in a lump sum upon execution of this Agreement. Thereafter, commencing January 1, 2001, Modi's Base Compensation shall be paid to him no less frequently than semi-monthly, in arrears, or on such other basis as Modi and GBC may agree upon. (c) Commencing January 1, 2001, Modi shall be paid a monthly car allowance of $1,500 for the lease, use and maintenance of, and insurance upon, an automobile for his personal and business use. Modi shall maintain insurance on such automobile for his own and Generex' benefits with carriers, coverage and policy limits consistent with policies adopted by Generex for insurance on company-owned automobiles and automobiles owned by Generex executives but used from time to time on Generex business. The car allowance shall be paid monthly in advance, unless Modi and GNBT otherwise agree. -------------- * All dollar figures in this Agreement refer to US dollars. (d) Modi's Base Compensation and car allowance shall be increased by 5% annually effective on January 1st in each calendar year beginning in 2002 (e.g., to illustrate, in calendar year 2002, Modi's Base Compensation shall be $262,500, and in calendar year 2003, Base Compensation shall be $275,625). 6. Bonus Compensation. In addition to base compensation, during the term of this Agreement Modi shall receive bonus and incentive compensation for services to Generex as follows: (a) A bonus of $300,000 shall be paid in respect of Modi's services in securing the development and license agreement dated September 5, 2000, between GBC and Eli Lilly and Company (the "Lilly Agreement"). This bonus shall be paid as follows: $150,000 upon execution of this Agreement and $150,000 on February 15, 2001. (b) Modi shall receive a bonus of 5% of all milestone payments, additional signing fees or initial fees received by Generex pursuant to Sections 6.2 and 6.4 of the Lilly Agreement and any subsequent agreement between Generex and Lilly providing for comparable payments (the "Lilly Payments"), excluding the $1,000,000 signing fee received in October 2000. Stated otherwise for purposes of clarity, Modi shall receive as a bonus $.05 for each $1.00 of Lilly Payments that Generex receives after the date of this Agreement. These bonus payments will be paid to Modi as and when the Lilly Payments are received by Generex from Lilly. (c) In addition to the bonus payable under paragraph (b) above relating to Lilly Payments, Modi shall receive additional bonuses equal to (i) 25% of the first $1,000,000 of any signing fee, licensing fee or similar "up front" payment not tied to a GBT performance milestone that is received during the term of this Agreement (excluding Lilly Payments) pursuant to development, marketing, licensing or similar agreements hereafter entered into by Generex to the extent that such payments are received in consideration of rights granted to third parties to develop, manufacture and/or market products based upon Inventions ("Other Products"); (ii) 5% of all "up front fees of the nature described in the preceding clause to the extent such fees exceed $1,000,000; and (iii) 5% of all of milestone payments and similar payments tied to the development of Other Products that are received by Generex. As used in this Agreement, the term "Inventions" shall have the same meaning as in Section 9 of the Consulting Agreement, except that "Generex", as defined herein, shall be substituted for "Corporation" in such definition. 9. Stock Options. (a) Modi shall be granted options to purchase 150,000 shares of GBC's common stock in each of the next ten fiscal years of GBC ending during the term of this Agreement, i.e., beginning with the present fiscal year ending July 31, 2001, and ending with the fiscal year ending July 31, 2010. The options shall be granted as of the last Friday in July (the "date of grant") of each such fiscal year, and shall have the following terms: (i) The option price shall equal the average closing sale price of publicly-traded shares of GBC common stock during normal trading hours reported for the five trading days preceding the date of grant (the "valuation period"). If GBC's common stock is not traded on an exchange or quotation system that reports actual sales transactions on the date of grant, the average closing bid price for the shares shall be used in lieu of the closing sale price. If neither closing sales prices nor bid prices are reported during the valuation period, the option price shall be the fair market value of GBC's publicly traded shares of common stock on the date of grant as determined by GBC's Board of Directors. (ii) The terms of the options shall be five (5) years from the date of grant, subject, however, to early termination pursuant to Sections 7(c), (d) and (e) below. (iii) The options shall vest immediately on the date of grant. (iv) The options shall not be transferable except by gift or bequest to Modi's "family members" or pursuant to a "domestic relations order", as those terms are described in the instruction to Form S-8 adopted under the Securities Act of 1933. (v) The number and kind of shares issuable upon the exercise of options to be granted under this Agreement shall be adjusted to reflect stock splits, recapitalizations, reorganizations and similar corporate events affecting GBC. The exercise price of and number and kind of shares subject to outstanding options shall be adjusted in the same manner as options granted under GBC's 2000 Stock Option Plan pursuant to the express terms of that Plan. (vi) GBC shall use its best efforts to register under the Securities Act of 1933 on Form S-8 or other available form for sale to Modi and for resale by Modi all shares issuable upon the exercise of options granted under this Agreement. (b) In accordance with the qualification requirements applicable to issuers with securities included in The Nasdaq Stock Market, GBC's obligations under this Section 4 are subject to approval by GBC's stockholders. GBC agrees to submit these terms to shareholders for their approval at the Year 2000 Annual Meeting of GBC's shareholder. If for any reason the stock option grants contemplated by this Agreement are not approved by shareholders, GBC shall grant to Modi in lieu thereof stock appreciation rights (SARs) that will provide to Modi the same potential economic benefits as the option plan, excluding consideration of differences, if any, in income tax treatment under applicable laws. 10. Additional Authority. During the term of this Agreement, Modi shall have final authority with respect to the hiring and continued employment of all Generex personnel (including consultants) engaged in research and development activities relating to products based upon Inventions, within budgetary and personnel constraints approved by Boards of Directors of GBC (or GPI in the case of employees or consultants employed or engaged by GPI). Notwithstanding the foregoing, if Modi fails to fill any research and development position that (a) is created by GBC's Board of Directors (or GPI's Board of Directors in the case of employees or consultants employed or engaged by GPI), or (b) becomes available due to termination of the employment or engagement of another employee or consultant, within the 90 day period following the creation or opening of such position, such position may be filled by a candidate approved by the President of GBC (or GPI, in the case of employees or consultants employed or engaged by GPI). 11. Early Termination. Section 7 of the Consulting Agreement, as amended and restated by Section 3 of the Memorandum of Agreement, is superseded in its entirety by the following provisions of this Agreement: (a) This Agreement shall terminate upon Modi's death or the declaration by a court of competent jurisdiction that Modi is a mentally incompetent person or incapable of handling his affairs due to mental incompetence. (b) This Agreement may be terminated by GBC if Modi is unable, as a result of a bona fide illness, physical or mental, to attend to his duties hereunder for a period of six (6) consecutive months, which period shall be deemed to commence with such inability and shall continue until Modi is once again able to attend to his duties hereunder on a regular basis. (c) This Agreement may be terminated at any time by mutual agreement, in writing, of GBC and Modi. (d) This Agreement may be terminated by Modi or by GBC, without cause, at any time after January 1, 2003, upon twelve (12) months prior written notice. (e) This Agreement may be terminated by GBC for just cause at any time by giving thirty (30) days written notice thereof to Modi. As used herein, the term "just cause" shall mean and be limited to (i) a material breach of trust by Modi which causes or threatens serious injury to Generex, or (ii) any action by Modi taken with the intent to materially and adversely affect a material interest of Generex, or with knowledge that such action would result in such a material adverse affect to Generex, whether or not such affect is prevented from occurring by Generex or any other person or by events unrelated to Modi's actions. 12. Effect of Early Termination. If this Agreement is terminated prior to the Termination Date pursuant to Section 6 hereof, then, lieu of base compensation, bonus and incentive compensation and stock options to which Modi is entitled under this Agreement, the following provisions shall apply (a) If this Agreement is terminated under Section 6(a) or (b) above: (i) Generex shall pay to Modi (or his legal representative) in a lump sum within sixty (60) days from such early termination an amount equal to the lesser of $500,000 or the aggregate amount that would have been paid to Modi under Section 2 above from the date of such termination to the Termination Date had such early termination not occurred; (ii) Generex shall pay to Modi all bonus payments that would have been paid to Modi under Sections 3(b) and 3(c) of this Agreement as and when such payment would have been made had such early termination not occurred, provided that no bonus payments shall be due with respect to milestone payments, signing fees or similar payments received by Generex under license or other agreements entered into by Generex after the date of such early termination unless and to the extent that such post-early termination contracts replace or supersede contractual obligations in force as of the date of such early termination; and (iii) All options granted to Modi prior to the date of such early termination shall remain in full force, unaffected by such early termination. (b) If this Agreement is terminated under Section 6(c), the provisions of Section 7(a) above shall apply unless the parties otherwise provide in the written agreement pursuant to which such early termination is effected. (c) If this Agreement is terminated by GBC under Section 6(d) above, then the provisions of Section 7(a) shall apply except (x) that the minimum payment referred to in Section 7(a)(i) shall be the greater of $1,000,000 or the amount that would have been paid to Modi under Section 2 above from the date of such early termination to the Termination Date had such early termination not occurred, and (y) Modi shall be entitled to bonus payments in respect of any milestone payments, signing fees or similar payments received by Generex pursuant to license or other agreements relating to Inventions, irrespective of whether or not such licenses or agreements were entered into prior to the date of such early termination. (d) If this Agreement is terminated by Modi under Section 6(d) above, then (i)Generex shall pay to Modi all bonus payments that would have been paid to Modi under Sections 3(b) and 3(c) of this Agreement as and when such payment would have been made had such early termination not occurred, provided that no bonus payments shall be due with respect to milestone payments, signing fees or similar payments received by Generex under license or other agreements entered into by Generex after the date of such early termination unless and to the extent that such post-early termination contracts replace or supersede contractual obligations in force as of the date of such early termination; and (ii) all options granted to Modi under this Agreement prior to the date of such early termination shall terminate on the first anniversary of the date of such early termination. (e) If this Agreement is terminated by Generex under Section 6(e), then Modi shall be entitled to base compensation and bonus payments accrued to the date of such early termination, and no more, and all options granted pursuant to Section 4 above shall terminate at the close of business on the fifth business day following the date of such early termination. 13. Counsel for the Transaction. Each of the parties hereto has requested Joseph Chicco ("Chicco") of the firm Eckert Seamans Cherin & Mellott, LLC, Philadelphia, PA, to represent him/it in connection with the preparation and execution of this Supplemental Agreement. Each such party understands that Chicco and his firm are regularly employed as attorneys for GBC and GPI in numerous matters wholly unrelated to this transaction, but that the business of GPI and GPC is materially dependent on Modi's research and inventions. With respect to the transactions contemplated by this Agreement, however, no communications to Chicco by a party shall be considered confidential so as to preclude disclosure to other parties, and the parties acknowledge that Chicco has advised them that he may communicate information obtained from one party to one or more other parties, and will communicate all such information received to another party upon its request. The parties understand that, in this capacity, Chicco cannot be and will not be an advocate for the interest of any party against the interest of one or more of the other parties. Rather , Chicco's role shall be to advise each party on the effect and meaning of various terms that may be proposed by one or more of the parties, and to attempt to mediate and facilitate a resolution of any disputed proposals. (b) Each of the parties waives all real and potential conflicts of interests that arise out of Chicco's multiple representation of the parties in this transaction, and agrees that Chicco's fees and expenses in connection with the negotiation, preparation and execution of this Agreement shall be paid by GBC. 14. Governing Law. This Agreement shall be governed by the laws of the Province of Ontario and of Canada applicable therein, and the parties hereby irrevocably consent to the jurisdiction of the courts of the Province of Ontario, except that (a) the parties' rights and obligations with respect to Section 6 of the Consulting Agreement relating to Modi's Special Voting Rights Preferred Stock and the provisions of this Agreement relating to the grant of stock options shall be governed by the laws of the State of Delaware, and (b) where applicable, US securities laws shall control the construction and enforcement of this Agreement. 15. Prior Agreements. (a) The Consulting Agreement, the Memorandum of Agreement and the Supplemental Agreement shall be construed as a single Agreement. In the event of any inconsistency between the Consulting Agreement and the Memorandum of Agreement, the Memorandum of Agreement shall control. In the event of any inconsistency between either of the Prior Agreements and the Supplemental Agreement, the Supplemental Agreement shall control. To the extent that they relate to Modi's compensation, the terms of the Prior Agreements are intended to be and are superseded by the terms of the Supplemental Agreement. (b) Modi acknowledges that he has received all compensation to which he is entitled under the Prior Agreements, including shares of GBC common stock held by GHI referred to in the Memorandum of Agreement. (c) Except to the extent that they are superseded by a later term of this Agreement, the Prior Agreements remain in full force and effect. (d) The parties expressly acknowledge that Modi's obligations under Section 9 of the Consulting Agreement shall survive any termination of this Agreement. IN WITNESS WHEREOF, the parties have executive and delivered this Memorandum of Agreement as of the date first written above. Witness: GENEREX PHARMACEUTICALS INC. Per: /s/ Anna E. Gluskin ------------------------------------ Anna E. Gluskin, President Per: /s/ E. Mark Perri ------------------------------------ E. Mark Perri, Chairman GENEREX BIOTECHNOLOGY CORPORATION Per: /s/ Anna E. Gluskin ------------------------------------ Anna E. Gluskin, President Per: /s/ E. Mark Perri ------------------------------------ E. Mark Perri, Chairman /s/ Pankaj Modi ---------------------------------------- Pankaj Modi EX-21 6 ex21.txt EXHIBIT 21 Exhibit 21 SUBSIDIARIES OF GENEREX BIOTECHNOLOGY CORPORATION Name Place of Incorporation ----- ---------------------- Generex Pharmaceuticals, Inc. Ontario, Canada Generex (Bermuda) Inc. Bermuda All subsidiaries are 100% owned except for Generex (Bermuda), which is 80.1% owned. All subsidiaries conduct business only under their respective corporate names. EX-23.1.1 7 ex23-1_1.txt EX-23.1.1 INDEPENDENT AUDITORS' CONSENT We consent to the incorporation by reference in Registration Statements No. 333-67118, 333-51194 and No. 333-42452 of Generex Biotechnology Corporation and Subsidiaries (the Company) on Amendment No. 1 to Forms S-3, Amendment No. 3 to Form S-3, and Amendment No. 2 to Form S-3, respectively, of our report dated October 2, 2001 appearing in this Annual Report on Form 10-K of the Company for the year ended July 31, 2001. /s/ DELOITTE & TOUCHE LLP ------------------------- DELOITTE & TOUCHE LLP Toronto, Ontario October 26, 2001 EX-23.1.2 8 ex23-1_2.txt EX-23.1.2 CONSENT OF INDEPENDENT AUDITORS The Annual Report of Generex Biotechnology Corporation and Subsidiaries (the Company) for its fiscal year ended July 31, 2001, includes our report dated September 14, 2000, on the consolidated financial statements of the Company as of July 31, 2000 and 1999 and for the years ended July 31, 2000 and 1999. We consent to the incorporation by reference of our report on such consolidated financial statements in the following registration statements of the Company on Form S-3: registration numbers 333-67118, 333-51194, and 333-42452. WithumSmith+Brown New Brunswick, New Jersey October 26, 2001 EX-24 9 ex24.txt EXHIBIT 24 EXHIBIT 24 GENEREX BIOTECHNOLOGY CORPORATION POWER OF ATTORNEY Each person whose signature appears below hereby constitutes and appoints Anna E. Gluskin, E. Mark Perri and Rose C. Perri, and each of them, his or her true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution, for him or her and in his or her name, place and stead, in any and all capacities, in connection with any outstanding securities of Generex Biotechnology Corporation (the "Company"), or any public offering or other issuance of any securities of the Company authorized by the Board of directors of the Company pursuant to due authorization by such Board, (1) to execute and file, or cause to be filed, with the United States Securities and Exchange Commission (the "Commission"), (A) registration statements and any and all amendments (including post-effective amendments), and exhibits thereto and any and all other documents in connection therewith as required by the Commission in connection with such registration under the Securities Act of 1933, as amended, and (B) any report or other document required to be filed by the Company with the Commission pursuant to the Securities Exchange Act of 1934, as amended, (2) to execute and file, or cause to be filed, any application for registration or exemption therefrom, any report or any other document required to be filed by the Company under the Blue Sky or securities law of any state and to furnish any other information required in connection therewith, (3) to execute and file, or cause to be filed, any application for registration or exemption therefrom under the securities laws of any jurisdiction outside the United States of America, including any reports or other documents required to be filed subsequent to the issuance of such securities, and (4) to execute and file, or cause to be filed, any application for listing such securities on the Nasdaq National Market, or any other securities exchange in any other jurisdiction where any such securities are proposed to be sold, granting to such attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act required to be done as he or she might or could do in person, hereby ratifying and confirming all that such attorneys-in-fact and agents, and each of them, may lawfully do or cause to be done by virtue of this power of attorney. Each person whose signature appears below may at any time revoke this power of attorney as to himself or herself only by an instrument in writing specifying that this power of attorney is revoked as to him or her as of the date of execution of such instrument or at a subsequent specified date. This power of attorney shall be revoked automatically with respect to any person whose signature appears below effective on the date he or she ceases to be a member of the Board of Directors or an officer of the Company. Any revocation hereof shall not void or otherwise affect any acts performed by any attorney-in-fact and agent named herein pursuant to this power of attorney prior to the effective date of such revocation. Dated: October 23, 2001 SIGNATURE TITLE --------- ------ /s/ Anna E. Gluskin President, Chief Executive Officer and Director --------------------------- Anna E. Gluskin /s/ E. Mark Perri Vice President, Chief Financial Officer --------------------------- and Director E. Mark Perri /s/ Rose C. Perri Chief Operating Officer, Treasurer, --------------------------- Secretary and Director Rose C. Perri /s/ Pankaj Modi, Ph.D. Vice President, Research and Development --------------------------- and Director Pankaj Modi, Ph.D. /s/ Michael Hawke, M.D. Director --------------------------- Michael Hawke, M.D. /s/ Ivan M. Lieberburg Director --------------------------- Ivan M. Lieberburg /s/ Jan Michael Rosen Director --------------------------- Jan Michael Rosen