-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, WDeDwVIDIN59sjaQ12l5jXiXKLo8jD0huLBLImybXdW74vYSD6DrsCI5LO0Xayws n8MfF6uX1GoD4ZMw85MM8g== 0000950115-99-001353.txt : 19991101 0000950115-99-001353.hdr.sgml : 19991101 ACCESSION NUMBER: 0000950115-99-001353 CONFORMED SUBMISSION TYPE: 10-Q/A PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19990131 FILED AS OF DATE: 19991029 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-Q/A SEC ACT: SEC FILE NUMBER: 000-25169 FILM NUMBER: 99737766 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-Q/A 1 AMENDED QUARTERLY REPORT UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q Amendment No. 1 [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the quarterly period ended January 31, 1999 [ ] TRANSITION REPORTS PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the transition period from ________________ to __________________. COMMISSION FILE NUMBER: 0-25169 GENEREX BIOTECHNOLOGY CORPORATION (Exact name of registrant as specified in its charter) IDAHO 82-0490211 ------------------------------- -------------------------------- (State of other jurisdiction of (IRS Employer Identification No.) incorporation or organization) 33 HARBOR SQUARE, SUITE 202 TORONTO, ONTARIO CANADA M5J 2G2 (Address of principal executive offices) 416/364-2551 (Registrant's telephone number, including area code) Not applicable -------------------------------------------------- (Former name, former address and former fiscal year if changed since last report) Indicate by check mark whether the registrant (1) has filed all reports required 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 reports), and (2) has been subject to such filing requirements for the past 90 days. [ ] Yes [X] No - subject to filing requirements since February 12, 1999 APPLICABLE ONLY TO CORPORATE ISSUERS The number of outstanding shares of the registrant's Common Stock, par value $.001, was 13,363,586 as of March 22, 1999. Page 1 of 14 GENEREX BIOTECHNOLOGY CORPORATION INDEX PART 1: FINANCIAL INFORMATION Item 1. Consolidated Financial Statements - unaudited Consolidated Balance Sheets - January 31, 1999 and July 31, 1998 ................................. 3 Consolidated Statements of Operations for the three months ended January 31, 1999 and 1998, the six months ended January 31, 1999 and 1998, and cumulative from November 2, 1995, to January 31, 1999 ................................................... 4 Consolidated Statements of Cash Flows for the six months ended January 31, 1999 and 1998, and cumulative from November 1995, to January 31, 1999 ................................................... 5 Notes to Consolidated Financial Statements ......................... 6 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations ................................ 10 PART II: OTHER INFORMATION Item 1. Legal Proceedings .................................................. 14 Item 5. Other Information .................................................. 14 Item 6. Exhibits and Reports on Form 8-K ................................... 14 Signatures ......................................................... 14 Page 2 of 14 Item I. Consolidated financial statements GENEREX BIOTECHNOLOGY CORPORATION (A DEVELOPMENT STAGE COMPANY) CONSOLIDATED BALANCE SHEETS (UNAUDITED) (Restated)
January 31, July 31, 1999 1998 ------------ ------------ ASSETS Current Assets: Cash $ 3,094,694 $ 2,090,827 Restricted cash -- 106,527 Miscellaneous receivables 209,533 209,090 Other current assets 156,108 131,340 ------------ ------------ Total Current Assets 3,460,335 2,537,784 Property and Equipment, Net 2,379,137 1,634,447 Deposits 65,988 82,509 Due From Related Parties 793,804 1,200,968 ------------ ------------ TOTAL ASSETS $ 6,699,264 $ 5,455,708 ============ ============ LIABILITIES AND STOCKHOLDERS' EQUITY Current Liabilities: Accounts payable and accrued expenses $ 674,703 $ 1,253,003 Current maturities of long-term debt 402,978 411,565 ------------ ------------ Total Current Liabilities 1,077,681 1,664,568 Long-Term Debt, Less Current Maturities 612,380 912,817 Due to Related Parties 154,981 236,024 Commitments and Contingencies Stockholders' Equity: Preferred stock, $.001 par value; authorized 1,000,000 shares, issued and outstanding 1,000 shares at January 31, 1999 and July 31, 1998 1 1 Common stock, $.001 par value; authorized 50,000,000 shares, issued and outstanding 13,341,586 and 11,971,272 shares at January 31, 1999 and July 31, 1998, respectively 13,342 11,971 Additional paid-in capital 14,761,312 9,565,836 Deficit accumulated during the development stage (9,713,402) (6,736,076) Accumulated other comprehensive income (loss) (207,031) (199,433) ------------ ------------ Total Stockholders' Equity 4,854,222 2,642,299 ------------ ------------ TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 6,699,264 $ 5,455,708 ============ ============
The Notes to Consolidated Financial Statements are an integral part of these statements. Page 3 of 14 GENEREX BIOTECHNOLOGY CORPORATION (A DEVELOPMENT STAGE COMPANY) CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
Cumulative From November 2, 1995 (Date of For the Three Months Ended For the Six Months Ended Inception) January 31, January 31, to January 31, 1999 1998 1999 1998 1999 ------------ ------------ ------------ ------------ -------------- (Restated) (Restated) (Restated) Revenues $ -- $ -- $ -- $ -- $ -- Operating Expenses: Research and development 654,719 148,978 1,240,977 179,287 2,857,468 Research and development - related party -- 129,331 -- 150,786 220,218 General and administrative 1,250,224 595,016 1,702,775 870,888 6,224,523 General and administrative - related party -- 70,157 -- 141,955 314,328 ------------ ------------ ------------ ------------ ------------ Total Operating Expenses 1,904,943 943,482 2,943,752 1,342,916 9,616,537 ------------ ------------ ------------ ------------ ------------ Operating Loss (1,904,943) (943,482) (2,943,752) (1,342,916) (9,616,537) Other Income (Expense) Interest income -- -- 66 -- 66 Interest expense (18,578) -- (33,640) -- (96,931) ------------ ------------ ------------ ------------ ------------ Net Loss $ (1,923,521) $ (943,482) $ (2,977,326) $ (1,342,916) $ (9,713,402) ============ ============ ============ ============ ============ Basic and Diluted Net Loss Per Common Share $ (.15) $ (.10) $ (.24) $ (.15) ============ ============ ============ ============ Weighted Average Number of Shares of Common Stock Outstanding 13,029,867 9,379,825 12,637,233 9,192,040 ============ ============ ============ ============
The Notes to Consolidated Financial Statements are an integral part of these statements. Page 4 of 14 GENEREX BIOTECHNOLOGY CORPORATION (A DEVELOPMENT STAGE COMPANY) CONSOLIDATED STATEMENTS OF CASH FLOWS
Cumulative From November 2, 1995 (Date of For the Six Months Ended Inception) January 31, to January 31, 1999 1998 1999 ------------ ------------ --------------- (Restated) (Restated) Cash Flows From Operating Activities: Net loss $ (2,977,326) $ (1,342,916) $ (9,713,402) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation 19,277 -- 63,362 Common stock issued for services rendered 245,408 10,932 807,661 Stock options and warrants issued for services rendered 340,564 234,000 1,228,070 Preferred stock issued for services rendered -- -- 100 Changes in operating assets and liabilities: Miscellaneous receivables -- -- (170,179) Other current assets (24,387) 29,268 (160,964) Accounts payable and accrued liabilities 158,984 (34,957) 1,484,930 Other, net (9,215) 69,545 101,102 ------------ ------------ ------------ Net Cash Used in Operating Activities (2,246,695) (1,034,128) (6,359,320) Cash Flows From Investing Activities: Purchase of property and equipment (676,994) (15,765) (752,767) Change in restricted cash 105,655 -- (5,595) Change in deposits 16,442 -- (1,159) Change in notes receivable -- 64,645 -- Change in due from related parties 403,459 8,232 (2,570,927) Other, net -- -- 89,683 ------------ ------------ ------------ Net Cash Provided By (Used in) Investing Activities (151,438) 57,112 (3,240,765) Cash Flows From Financing Activities: Proceeds from issuance of long-term debt -- 792,687 993,149 Repayment of long-term debt (388,565) -- (451,954) Change in due to related parties (80,299) 36,621 155,725 Proceeds from issuance of common stock, net 3,991,942 -- 12,119,890 Purchase and retirement of common stock (119,066) -- (119,066) ------------ ------------ ------------ Net Cash Provided By Financing Activities 3,404,012 829,308 12,697,744 Effect of Exchange Rates on Cash (2,012) 8,667 (2,965) ------------ ------------ ------------ Net Increase (Decrease) in Cash 1,003,867 (139,041) 3,094,694 Cash, Beginning of Period 2,090,827 196,004 -- ------------ ------------ ------------ Cash, End of Period $ 3,094,694 $ 56,963 $ 3,094,694 ============ ============ ============
The Notes to Consolidated Financial Statements are an integral part of these statements. Page 5 of 14 GENEREX BIOTECHNOLOGY CORPORATION (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) 1. Basis of Presentation The accompanying unaudited interim consolidated financial statements have been prepared pursuant to the rules and regulations for reporting Form 10-Q. Accordingly, certain information and disclosures required by generally accepted accounting principles for complete financial statements are not included herein. The interim statements should be read in conjunction with the financial statements and notes thereto included in the Company's latest Annual Report on Form 10. Interim statements are subject to possible adjustments in connection with the annual audit of the Company's accounts for the fiscal year 1999; in the Company's opinion, all adjustments necessary for a fair presentation of these interim statements have been included and are of a normal and recurring nature. 2. Comprehensive Income/(Loss) Effective August 1, 1998, the Company adopted the provisions of Statement No. 130, Reporting Comprehensive Income, which modifies the financial statement presentation of comprehensive income and its components. Adoption of this statement had no effect on the Company's financial position or operating results. Comprehensive loss, which includes net loss and the change in the foreign currency translation account during the period, for the six months ended January 31, 1999 and 1998 was $(2,984,924) and $(1,483,145), respectively. 3. Accounts Payable and Accrued Expense Accounts payable and accrued expenses consist of the following: January 31, July 31, 1999 1998 --------- ---------- Accounts Payable $ 548,282 $ 336,633 Penalty Arising from Violation of Financing Agreement -- 738,000 Consulting Accruals 113,438 151,945 Building Purchase Liability 26,425 26,425 --------- ---------- Total $ 688,145 $1,253,003 ========= ========== Page 6 of 14 GENEREX BIOTECHNOLOGY CORPORATION (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) 4. Pending Litigation Sands Brothers & Co., Ltd. (Sands), a New York City-based investment banking and brokerage firm, initiated arbitration against the Company under New York Stock Exchange rules in September 1998. This claim is based upon a claim that Sands has the right to purchase, for nominal consideration, approximately 1.5 million shares of the Company's common stock. This claim is based upon an October 1997 letter agreement which purportedly confirmed the terms of an agreement appointing Sands as the exclusive financial advisor to Generex Pharmaceuticals, Inc. (GPI) and granting Sands the right to receive shares representing 17 percent of the outstanding capital stock of GPI on a fully diluted basis. Following the acquisition of GPI by GBC - Delaware, Inc., Sands' claimed a right to receive shares of GPI common stock that would, allegedly, now apply to the Company's common stock. Sands also claims that it is entitled to additional shares of the Company as a result of the GBC - Delaware, Inc.'s acquisition of GPI (approximately 460,000 shares), and $144,000 in fees under the terms of the purported Agreement. Sands has never performed any services for the Company, and the Company and GPI have denied that the individual who is alleged to have entered into the purported agreement between Sands and GPI, had the authority to act on GPI's behalf, and accordingly, is defending against Sands' claim primarily on the basis that no agreement has ever existed between GPI and Sands. During a series of hearings before a NYSE arbitration panel commencing June 8, 1999, Sands amended its claim to include, in the alternative, an entitlement in the form of an order of specific performance with regard to the issuance of the warrant as discussed in the October 1997 letter. By an award dated September 24, 1999, the panel awarded Sands $12,000 plus $2,070 in interest, a declaratory judgment that the Company is required to issue Sands a warrant for 1,530,020 shares in accordance with the October 1997 letter, and denied all other relief and split the $22,800 in forum fees equally between Sands and the Company. The award must be confirmed by a court of appropriate jurisdiction. The Company intends to seek relief from the award by requesting, among other things, a New York State court to vacate the award on various legal grounds. However, the ultimate legal and financial liability of the Company, including a range of possible losses with respect to the award cannot be estimated at this time. Therefore, no provision has been recorded in the accompanying financial statements. Furthermore, it is management's belief that the final outcome is not reasonably likely to have a material adverse effect on the Company's consolidated financial position. GPI is also contesting a claim for wrongful dismissal in the amount of approximately $300,000 plus special damages, interest and costs. The Company believes that the plaintiff was never employed by the Company or any of its subsidiaries and that the case is without merit. An action was also commenced against GPI and other companies and individuals seeking approximately $3,965,000 for allegedly causing certain adverse consequences of a plaintiff's particular investment in a company. GPI's only involvement was that at one time there was interest on its part in buying certain assets from this company. GPI failed to file a Statement of Defense to the Statement of Claim and GPI was noted in default on October 1, 1996. An application has been filed to set aside that default notice, however that application has been adjourned indefinitely. 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. 5. Stock Redemption Under the terms of a settlement, determined in an Ontario, Canada Court, the Company agreed to purchased 15,357 shares from a shareholder. The total purchase price of $140,873 included $119,066 which was charged against additional paid in capital for the stock redemption and $21,807 which was recorded as litigation settlement expense which represents the excess paid over the fair value at the time of settlement. The settlement was concluded in September 1998. Page 7 of 14 GENEREX BIOTECHNOLOGY CORPORATION (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) 6. Net Loss Per Share Basic EPS and Diluted EPS for the six months ended January 31, 1999 and 1998 have been computed by dividing the net loss for each respective period by the weighted average shares outstanding during that period. All outstanding warrants have been excluded from the computation of Diluted EPS as they are antidilutive. 7. Supplemental Disclosure of Cash Flow Information
For the Six Months Ended January 31, ------------------------ 1998 1997 ---- ---- Cash paid during the year for: Interest $ 33,640 $ -- Income taxes $ -- $ -- Disclosure of non-cash investing and financing activities: Acquisition of property and equipment with collection of related party receivables $ -- $620,725 Issuance of common stock to satisfy accrued liability $738,000 $ -- Long-term debt incurred in conjunction with acquisition of property and equipment $ 81,492 $ --
8. The Company's consolidated financial statements as of January 31, 1999 and for the three months and six months ended January 31, 1999 have been restated to reflect: (1) founders shares issued for services provided, (2) an additional charge to reflect the fair value of warrants issued in exchange for services rendered and (3) additional expense incurred in conjunction with stock redemption. The effect of these restatements are as follows: As Previously As Reported Restated ------------- ------------ For the year ended July 31, 1998 -------------------------------- Balance Sheet: Additional paid-in capital 9,162,329 9,565,836 Deficit accumulated during the development stage (6,332,570) (6,736,076) For the three months ended January 31, 1999 ------------------------------------------- Balance Sheet: Additional paid-in capital 14,195,435 14,761,312 Deficit accumulated during the development stage (9,147,525) (9,713,402) Consolidated Statements of Operations: Research and development 612,219 654,719 General and administrative 1,154,224 1,250,224 Net loss (1,785,021) (1,923,521) Basic and diluted net loss per common share (.14) (.15) For the six months ended January 31, 1999 ----------------------------------------- Consolidated Statements of Operations: Research and development 1,198,477 1,240,977 General and administrative 1,582,904 1,702,775 Net loss (2,814,955) (2,977,326) Basic and diluted net loss per common share (.22) (.24) Page 8 of 14 9. Subsequent Events GENEREX BIOTECHNOLOGY CORPORATION (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) 9. Subsequent Events (Unaudited) Subsequent events occurring after January 31, 1999 consist of the following: The stock option plan adopted in January 1998 was not submitted for shareholder approval and terminated on February 1, 1999. A new plan, substantially identical to the terminated plan, has been adopted. All options granted under the previous plan are not affected by the termination. The Company received a total of $96,000 from the sale of 17,000 shares of common stock at prices ranging from $5.00 to $6.00. For consideration of legal services provided, the Company issued 5,000 shares of common stock at $6.00 per share. In February 1999, MQS, Inc., a former consultant to the Company, commenced a civil action against the Company in the United States District Court for the District of New Jersey claiming that 242,168 shares of the Company's Common Stock, and $243,066 are due to it for services which it rendered through December 22, 1998. MQS also claims compensation on a quantum merit basis for the value of its services, and for punitive damages. The Company has not yet responded to the Complaint in this action. In February 1999, the Company entered into an agreement with an investment banker. Under the terms of the agreement, the investment banker will act as the Company's exclusive investment advisor, exclusive private placement agent and exclusive investment banker for a period of two months. If the investment banker is successful in securing capital for the Company for an agreed upon and stated amount during this period, the term of the agreement will automatically be extended for a period of four months. The Company also has the option to extend the term of the agreement for an additional four months, if it is expressed in writing that it is satisfied with the investment banker's services. In conjunction with the agreement, the investment banker received an option to purchase 100,000 shares of the Company's common stock at an exercise price of $6.00 per share during a five-year period. The investment banker will also receive an additional option to purchase 50,000 shares of the Company's common stock at an exercise price of $7.50 per share during a five-year period for assisting in obtaining financing in an agreed upon and stated amount. In the event of a private placement of the Company's securities, the investment banker is entitled to (i) a transaction fee in the amount of 10 percent of the amount raised, (ii) a 3 percent non-accountable expense allowance and (iii) placement agent warrants equal to 10 percent of the ownership given to any equity raised. Finally in the event that the Company enters into a merger, acquisition, or sale transaction with a party introduced by the investment banker, cash compensation will be paid based on an agreed upon formula. On February 11, 1999, the shareholders of the Company approved the merger of the Company into its wholly-owned subsidiary, GBC-Delaware, Inc. The purpose of the merger is to change the Company's state of incorporation from Idaho to Delaware. The merger is expected to be effected in the Company's third fiscal quarter and will not materially affect the Company's historical financial statements or future financial reporting. Page 9 of 14 Item 2. Management's Discussion And Analysis Of Financial Condition And Results Of Operations When used in this discussion, the words "expect(s)", "feels", "believe(s)", "will", "may", "anticipate(s)" and similar expressions are intended to identify forward-looking statements. Such statements are subject to certain risks and uncertainties, which could cause actual results to differ materially from the possible results described in such statements. Readers are cautioned not to place undue reliance on these forward-looking statements, and are urged to carefully review and consider the various disclosures elsewhere in this Prospectus which discuss factors which affect the Company's business, including the discussion under the caption "Risk Factors". General The Company was incorporated in 1983 as Green Mt. P.S., Inc. In January 1998, the Company acquired all of the outstanding capital stock of Generex Pharmaceuticals, Inc. ("Generex Pharmaceuticals"), a Canadian corporation formed in November 1995 to engage in pharmaceutical and biotechnological research and other activities, and changed its corporate name to Generex Biotechnology Corporation. The acquisition of Generex Pharmaceuticals was effected by the merger of a recently formed Delaware corporation ("Generex Delaware"), which had acquired all of the outstanding capital stock of Generex Pharmaceuticals in October 1997, with a wholly-owned subsidiary of the Company formed for this transaction (the "Reverse Acquisition"). As a result of the Reverse Acquisition, the former shareholders of Generex Delaware acquired a majority of the Company's outstanding capital stock and, for accounting purposes, Generex Delaware was treated as the acquiring corporation. Thus, the historical financial statements of Generex Delaware, which essentially represent the historical financial statements of Generex Pharmaceuticals, are deemed to be the historical financial statements of the Company. In February 1999, the shareholders of the Company approved a reorganization in which the Company will merge into Generex Delaware for the purpose of changing the Company's state of Incorporation from Idaho to Delaware (see Part II, Item 5 below). This reorganization, which is expected to be consummated in the Company's third fiscal quarter, will not result in any material change in the Company's historical financial statements or current financial reporting. The Company is engaged in the development of drug delivery systems. Its principal business focus has been to develop a technology for the administration of large molecule (i.e., molecules above a specified molecular weight) drugs. Historically, large molecule drugs have been administered only by injection because their size inhibits or precludes absorption if administered only or oral, transdermal, transnasal or other means. The principal application to date of the Company's large molecule drug delivery technology is a liquid insulin formulation that is administered with a metered dose applicator developed by the Company. The formulation, which includes insulin and various excipients (i.e., non-active pharmaceutical ingredients) to facilitate the absorption of insulin molecules through the mucous membranes in the mouth and upper gastro-intestinal tract, is sprayed into the mouth and back of the throat, where absorption occurs. The Company intends to market this formulation in the United States under the name Oralgen(TM), and in Canada and elsewhere under the name Oralin(TM). The Company completed pre-clinical studies and proof of concept trials of its oral insulin formulation in early 1998. Phase II clinical trials were commenced in Canada in November Page 10 of 14 1998. The Company's Phase 2 clinical program in the United States commenced in March 1999. The Company also has received regulatory approval in Ecuador for limited, non-commercial distribution of its oral insulin formulation to diabetic patients. This clinical program, which is expected to involve approximately 200 patients, is scheduled to begin later this year. Results of Operations - Three months ended January 31, 1999 and 1998 The Company has been in the development stage since its inception and has not generated any operating revenues to date. Through January 31, 1999, the Company accumulated an operating deficit of $9,147,525 as a result of research and development and general and administrative expenses incurred during the development stage. The Company's accumulated operating deficit at January 31, 1999, includes a net loss of $1,785,021 for the quarter then ended. In the corresponding quarter of the prior year the Company's net loss was $943,482. The principal reason for the increase in the Company's net loss in the quarter ended January 31, 1999, versus the quarter ended January 31, 1998, was an increase in research and development expenses (to $612,219 from $278,309), and in general and administrative expenses (to $1,154,224 from $665,173). The increase in research and development expense in the current period reflects the initiation and conduct of Phase II clinical trials of the Company's oral insulin formulation in Canada, continued development of the Company's metered dose applicator, preparation for the commencement of clinical trials in the United States, continuation and support of the Company's clinical program in Ecuador, and professional services relating to patents. The increase in general and administrative expenses in the quarter ended January 31, 1999, compared the prior year was primarily attributed to a substantial increase ($235,920) in legal and accounting expenses which were related in part to the Company's registration of its Common Stock under Section 12(g) of the Securities and Exchange Act. Other significant increases in general and administrative expenses were attributable to participation in industry seminars and exhibitions ($45,725), a one-time expense associated with the severance of a former executive ($106,000), and increases in executive compensation ($80,066). Results of Operations - Six months ended January 31, 1999 and 1998 The Company's net loss for the six months ended January 31, 1999, was $2,814,995, compared to a loss of $1,342,916 in the first half of the preceding fiscal year. The principal reasons for the increase in the Company's net loss in six month period ended January 31, 1999, was an increase in research and development expenses to $1,198,477 in the six month period ended January 31, 1999, from $330,073 for the six month period ended January 31, 1998, and an increase in general and administrative expenses to $1,582,904 in the six months ended January 31, 1999 versus $1,012,843 in the year earlier period. The increase in research and development expense in the six months ended January 31, 1999, reflects the increase in expenses in the second quarter, discussed above, and a substantial increase (to $586,258 from $51,764) in research and development expenditures in the first quarter, i.e., the quarter ended October 31, 1998, versus the quarter ended October 31, 1997. The first quarter increase in research and development expense increase reflected costs incurred in preparation for the Canadian clinical trial program, development work associated with the Company's metered dose applicator, preparation and the Company's IND to FDA, support of the Page 11 of 14 clinical program in Ecuador, and personnel costs associated with starting up the Company's pilot manufacturing facility in Toronto which supports the clinical programs. As noted above, research and development expenses in the first half of 1997 essentially were limited to laboratory personnel costs and professional expenses relating to patents. The increase in general and administrative expenses the first six months of their current year are primarily the result of the increase in such expenses during the second quarter as discussed above. The Company's general and administrative expenses increased by $81,010 in the first quarter, i.e., the quarter ended October 31, 1998, compared to the first quarter of the prior year, primarily as a result of the addition of new administrative personnel and participation in industry seminars and exhibitions. Liquidity and Capital Resources The Company has financed its development stage activity primarily through private placements of equity securities. During the six months ended January 31, 1999, the Company has received approximately $5 million in additional equity capital, including $200,000 of additional capital attributed to the issuance of warrants for services which resulted in a corresponding expense item, and net of a stock redemption and expenses associated with acquiring the capital. As a result, at January 31, 1999, the Company's stockholders' equity had increased to approximately $4.85 million versus approximately $2.64 million at July 31, 1998, notwithstanding its net loss during the six months ended January 31, 1999. In the quarter, the Company also issued 29,110 shares of Common Stock valued at $119,203 in payment for services, and issued options and warrants to purchase Common Stock valued for this purpose at $338,500 as compensation for past and future services. At January 31, 1999, the Company had cash on hand of approximately $3.1 million. Based on the Company's projections of its cash needs at that time, its cash on hand was sufficient to fund development activities over the remainder of the current fiscal year at the levels then planned. The Company's business plan contemplates raising additional equity capital to satisfy its cash requirements at least through the current calendar year. Beyond that point, the Company expects that a substantial portion of its cash needs for development activities will be met through licensing income, and future marketing partners' contributions to clinical program costs and/or equity investments. Implementation of the Company's business plan will require the availability of sufficient funds from the sources described above. While the Company has been successful in acquiring capital for its development activities as required, it does not have a substantial "cash cushion", nor does it have any commitments for future financing. Thus, the Company faces the risk that unforeseen problems with its clinical program or materially negative developments in general economic conditions could interfere with its ability to raise additional capital or materially adversely affect the terms upon which such capital is available. If funds are not available as needed from these sources, or from alternative sources, the Company will be required to "scale back" or otherwise revise its business plan. Any significant scale back of operations or modification of the Company's business plan required due to a lack of funding could be expected to materially and adversely affect the Company's prospects. Page 12 of 14 Transactions with Affiliates A portion of the Company's administrative expenses have resulted from transactions with affiliated persons. A number of the Company's capital transactions also have involved affiliated persons. Although these transactions were not the result of "arms-length" negotiations, the Company does not believe that this fact had a material impact on the Company's results of operations or financial position. Prior to this fiscal quarter, the Company had classified payments in the nature of executive compensation and expense reimbursements as "Research and development -- related party," and "General and administrative -- related party" because its executive officers received such payments through personal services corporations rather than directly. In this quarter and in the future, these payments are and will be accounted for as though the payments were made directly to the officers, and not as a related party transaction. The Company does not foresee a need for, and therefore does not anticipate, any related party transactions. Year 2000 Many computer systems experience problems handling dates beyond the year 1999. Therefore, some computer hardware and software will need to be modified prior to the year 2000 in order to remain functional. Management of the Company has completed its assessment of year 2000 issues and believes that the consequences of such issues will not have a material effect on the Company's business, results of operations or financial condition, without taking into account any efforts by the Company to avoid such consequences. New Accounting Pronouncements In 1998, the FASB issued Statement of Financial Accounting Statement No. 133, "Accounting for Derivative Instruments and Hedging Activities" ("SFAS No. 133"). SFAS No. 133 modifies the accounting for derivative and hedging activities and is effective for fiscal years beginning after December 15, 1999. The Company believes that the adoption of SFAS No. 133 will not have a material impact on the Company's financial reporting. Page 13 of 14 PART II: OTHER INFORMATION Item 1. Legal Proceedings The Company has filed an Annual Report on Form 10-K for the year ended July 31, 1999. Information set forth in Item 3 of that Report is incorporated herein by reference. Item 5. Other Information On February 11, 1999, the shareholders of the Company approved the merger of the Company into its wholly-owned subsidiary, GBC-Delaware, Inc. The purpose of the merger is to change the Company's state of incorporation from Idaho to Delaware. The transaction was approved by a vote of 7,854,956 shares to zero. The merger had not been effected as of the date of this Report, but is expected to be effected in the Company's third fiscal quarter, i.e., the quarter ending April 30, 1999. The merger will not materially affect the Company's historical financial statements or future financial reporting. Item 6. Exhibits and Reports on Form 8-K (a) Exhibits Exhibit Exhibit Title ------- ------------- 27 Financial Data Schedule (b) Reports on Form 8-K None Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned. GENEREX BIOTECHNOLOGY CORPORATION DATE: October 29, 1999 By: /s/ E. Mark Perri ------------------------------- E. Mark Perri Chairman and Chief Financial Officer Page 14 of 14 EX-27 2 FDS
5 6-MOS JUL-31-1998 JAN-31-1999 $3,094,694 0 209,533 0 0 3,460,335 2,439,967 60,830 6,699,264 1,077,681 612,380 0 1 14,774,654 0 6,699,264 0 0 0 0 2,943,752 0 33,574 0 0 0 0 0 0 (2,977,326) (0.24) (0.24)
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