United States Securities and Exchange Commission Washington, D.C. 20549 Form 10-QSB [X] Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the Quarterly Period Ended December 31, 2001. [ ] Transition Report to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the Transition Period from _____________ to ___________. 000-28371 (Commission File Numbers) ENDOVASC LTD., INC. (Exact name of registrant as specified in its charter) NEVADA 76-0512500 (State or Other Jurisdiction of (IRS Employer Incorporation or Organization) Identification Number) 15001 Walden Road, Suite 108 Montgomery, Texas 77356 (Address of principal executive offices) (Zip Code) (936) 448-2222 (Registrant's Telephone Number, Including Area Code) 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 reports), and (2) has been subject to such filing requirements for the past 90 days. Yes [X] No [ ] As of February 13, 2002, 80,669,267 shares of Common Stock, par value $.001 per share, of Endovasc Ltd., Inc. were outstanding. PART I FINANCIAL INFORMATION ITEM 1. FINANCIAL STATEMENTS - ------- -------------------- Balance Sheet as of December 31, 2001 and June 30, 2001 F-2 Statement of Operations for the three months and six months ended December 31, 2001 and 2000, and for the period from inception, June 10, 1996, to December 31, 2001 F-3 Statement of Stockholders' Deficit for the six months ended December 31, 2001, and for the period from inception, June 10, 1996, to December 31, 2001 F-4 Statement of Cash Flows for the six months ended December 31, 2001 and 2000, and for the period from inception, June 10, 1996, to December 31, 2001 F-6 Notes to Financial Statements F-7 ENDOVASC LTD., INC. (A CORPORATION IN THE DEVELOPMENT STAGE) BALANCE SHEET DECEMBER 31, 2001 AND JUNE 30, 2001 __________ (IN THOUSANDS, EXCEPT SHARE DATA) DECEMBER 31, JUNE 30, 2001 2001 ASSETS (UNAUDITED) (NOTE) ------ -------------- -------------- Current assets: Cash and cash equivalents $ 1 $ 117 Other current assets 24 47 -------------- -------------- Total current assets 25 164 Property and equipment, net 193 214 Other assets, net 136 144 -------------- -------------- Total assets $ 354 $ 522 ============== ============== LIABILITIES AND STOCKHOLDERS' DEFICIT - ------------------------------------- Current liabilities: Current maturities of long-term debt $ 119 $ 43 Current portion of obligations under capital leases 38 35 Note payable to stockholder 124 99 Accounts payable 667 296 Accrued liabilities 113 532 -------------- -------------- Total current liabilities 1,061 1,005 Long-term debt, net of current maturities 21 28 Long-term obligations under capital leases 56 74 Convertible debentures 253 - _ -------------- -------------- Total liabilities 1,391 1,107 -------------- -------------- Commitment and contingencies Stockholders' deficit: Common stock, $.001 par value, 100,000,000 shares authorized, 82,875,267 and 40,253,331 shares issued and 80,669,267 and 38,168,331 shares outstanding at December 31, 2001 and June 30, 2001, respectively 83 40 Preferred stock, $.001 par value, 20,000,000 shares authorized, 9,002 and 15,760 shares of Series A 8% cumulative convertible preferred stock issued and outstanding at December 31, 2001 and June 30, 2001, respectively, stated value $100 per share - - Additional paid-in capital 8,976 8,121 Unissued common stock 560 - Losses accumulated during the development stage (10,634) (8,729) Treasury stock (22) (17) -------------- -------------- Total stockholders' deficit (1,037) (585) -------------- -------------- Total liabilities and stockholders' deficit $ 354 $ 522 ============== ============== Note: The balance sheet at June 30, 2001 has been derived from the audited financial statements at that date but does not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. The accompanying notes are an integral part of these financial statements. F-2 ENDOVASC LTD., INC. (A CORPORATION IN THE DEVELOPMENT STAGE) STATEMENT OF OPERATIONS FOR THE THREE MONTHS AND SIX MONTHS ENDED DECEMBER 31, 2001 AND 2000 AND FOR THE PERIOD FROM INCEPTION, JUNE 10, 1996, TO DECEMBER 31, 2001 __________ (IN THOUSANDS, EXCEPT SHARE DATA) THREE MONTHS ENDED SIX MONTHS ENDED -------------------------- -------------------------- INCEPTION DECEMBER DECEMBER DECEMBER DECEMBER TO DECEMBER 31, 2001 31, 2000 31, 2001 31, 2000 31, 2001 ------------ ------------ ------------ ------------ ------------- Income: Sales $ - $ 75 $ - $ 75 $ 104 Interest income - - 1 - 28 Other income - _ - _ 246 - _ 255 ------------ ------------ ------------ ------------ ------------- Total income - 75 247 75 387 Costs and expenses: Operating, general and administrative expenses 280 319 664 556 4,991 Research and development costs 478 336 739 655 4,263 Interest expense 16 31 193 61 541 Settlement with former employee - _ - _ - _ - _ 408 ------------ ------------ ------------ ------------ ------------- Total costs and expenses 774 686 1,596 1,272 10,203 ------------ ------------ ------------ ------------ ------------- Net loss (774) (611) (1,349) (1,197) (9,816) Extraordinary loss on extin- guishment of convertible debentures - _ - _ - _ - _ 127 ------------ ------------ ------------ ------------ ------------- Net loss $ (774) $ (611) $ (1,349) $ (1,197) $ (9,943) ============ ============ ============ ============ ============= Weighted average shares outstanding 70,603,319 14,023,721 54,119,351 14,023,721 ============ ============ ============ ============ Basic and diluted net loss per common share $ (0.01) $ (0.04) $ (0.02) $ (0.09) ============ ============ ============ ============ The accompanying notes are an integral part of these financial statements. F-3 ENDOVASC LTD., INC. (A CORPORATION IN THE DEVELOPMENT STAGE) STATEMENT OF STOCKHOLDERS' EQUITY (DEFICIT) FOR THE SIX MONTHS ENDED DECEMBER 31, 2001 __________ (IN THOUSANDS, EXCEPT SHARE DATA) LOSSES ACCUMULATED COMMON STOCK PREFERRED STOCK ADDITIONAL UNISSUED DURING THE ------------------- ------------------- PAID-IN COMMON TREASURY DEVELOPMENT AMOUNT SHARES AMOUNT SHARES CAPITAL STOCK STOCK STAGE TOTAL ------- ---------- --------- -------- ------------ --------- ---------- ------------- ------- Balance at June 30, 2001 $ 40 40,253,331 $ - 15,760 $ 8,121 $ - $ (17) $ (8,729) $ (585) Stock issued for services 4 3,735,000 - - 152 - - - 156 Stock issued for employee compensation - 50,367 - - 5 - - - 5 Stock issued in settlement of lawsuit 8 8,000,000 - - 400 - - - 408 Purchase of treasury stock - - - - - 560 (565) - (5) Issuance of treasury stock for conversion of preferred stock to common stock - - - (240) - - 182 (182) - Issuance of treasury stock for conversion of debentures - - - - - - 378 (324) 54 Dividends declared on preferred stock - - - - - - - (50) (50) Conversion of preferred stock to common stock 25 24,711,478 - (6,518) (25) - - - - The accompanying notes are an integral part of these financial statements. F-4 ENDOVASC LTD., INC. (A CORPORATION IN THE DEVELOPMENT STAGE) STATEMENT OF STOCKHOLDERS' EQUITY (DEFICIT) FOR THE SIX MONTHS ENDED DECEMBER 31, 2001 __________ (IN THOUSANDS, EXCEPT SHARE DATA) LOSSES ACCUMULATED COMMON STOCK PREFERRED STOCK ADDITIONAL UNISSUED DURING THE ------------------- ----------------- PAID-IN COMMON TREASURY DEVELOPMENT AMOUNT SHARES AMOUNT SHARES CAPITAL STOCK STOCK STAGE TOTAL ------- ---------- --------- ------ ----------- --------- ---------- ------------- -------- Conversion of debentures to common stock 4 3,764,104 - - 90 - - - 94 Stock issued as payment of interest on debentures - 120,877 - - 3 - - - 3 Stock issued as payment of dividends on preferred stock 2 2,240,110 - - 59 - - - 61 Effect of the beneficial conversion feature of the convertible debentures - - - - 171 - - - 171 Net loss - - - - - - - (1,349) (1,349) ------- ---------- --------- ------ ----------- --------- ---------- ------------- -------- Balance at December 31, 2001 $ 83 82,875,267 $ - _ 9,002 $ 8,976 $ 560 $ (22) $ (10,634) $(1,037) ======= ========== ========= ====== =========== ========= ========== ============= ======== The accompanying notes are an integral part of these financial statements. F-5 ENDOVASC LTD., INC. (A CORPORATION IN THE DEVELOPMENT STAGE) CONDENSED STATEMENT OF CASH FLOWS FOR THE SIX MONTHS ENDED DECEMBER 31, 2001 AND 2000, AND FOR THE PERIOD FROM INCEPTION, JUNE 10, 1996, TO DECEMBER 31, 2001 (IN THOUSANDS) SIX MONTHS ENDED ------------------------------ INCEPTION TO DECEMBER 31, DECEMBER 31, 2001 2000 2001 -------------- -------------- -------------- Cash flows used in operating activities: Net loss $ (1,349) $ (1,197) $ (9,943) Adjustments to reconcile net loss to net cash used in operating activities 747 184 4,738 -------------- -------------- -------------- Net cash used in operating activities (602) (1,013) (5,205) -------------- -------------- -------------- Cash flows used in investing activities: Capital expenditures (6) (66) (148) Proceeds received from repayment of loan to stockholder - - 72 -------------- -------------- -------------- Net cash used in investing activities (6) (66) (76) -------------- -------------- -------------- Cash flows from financing activities: Proceeds from sale of equity securities - - 337 Proceeds from sale of common stock - 25 212 Proceeds from sale of convertible debentures 400 - 1,437 Net proceeds from issuance of preferred stock - 570 2,263 Issuance of notes payable 113 - 218 Repayment of notes payable (26) (5) (90) Payments of obligations under capital leases (15) (5) (38) Proceeds from advances from stockholders 25 - 969 Repayments of notes to stockholder - - (5) Purchase of treasury stock (5) - (22) -------------- -------------- -------------- Net cash provided by financing activities 492 585 5,282 -------------- -------------- -------------- Net increase (decrease) in cash and cash equivalents (116) (494) 1 Cash and cash equivalents at beginning of period 117 926 - -------------- -------------- -------------- Cash and cash equivalents at end of period $ 1 $ 432 $ 1 ============== ============== ============== Supplemental disclosure of cash flow information: Cash paid for interest expense $ 16 $ - $ 114 ============== ============== ============== Cash paid for income taxes $ - $ - $ - ============== ============== ============== The accompanying notes are an integral part of these financial statements. F-6 ENDOVASC LTD., INC. (A CORPORATION IN THE DEVELOPMENT STAGE) NOTES TO FINANCIAL STATEMENTS __________ 1. INTERIM FINANCIAL STATEMENTS ------------------------------ The accompanying unaudited interim financial statements have been prepared in accordance with generally accepted accounting principles and the rules of the U.S. Securities and Exchange Commission, and should be read in conjunction with the audited financial statements and notes thereto for the year ended June 30, 2001. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation of financial position and the results of operations for the interim periods presented have been included. Operating results for the interim periods are not necessarily indicative of the results that may be expected for the respective full year. A summary of the Company's significant accounting policies and other information necessary to understand the interim financial statements is presented in the Company's audited financial statements for the years ended June 30, 2001 and 2000. Accordingly the Company's audited financial statements should be read in connection with these financial statements. 2. INCOME TAXES ------------- The difference between the 34% federal statutory income tax rate and amounts shown in the accompanying interim financial statement is primarily attributable to an increase in the valuation allowance applied against the tax benefit from utilization of net operating loss carryforwards. 3. CONVERTIBLE DEBENTURES ----------------------- During the six months ended December 31, 2001, the Company issued $400,000 in convertible debentures. The debentures bear interest at 8% per year payable quarterly in arrears. The debentures mature in September 2003 and are convertible, at the option of the holder, to shares of the Company's common stock at a conversion price per share equal to the lower of (i) 85% of the average of the three lowest closing prices for the common stock for the thirty days prior to the closing date of the debentures; or (ii) 70% of the average of the three lowest closing prices for the common stock for the thirty days prior to the conversion date. Accordingly, the actual weighted average interest rate on these debentures, including the effect of the cost of the beneficial conversion feature, is approximately 23%. Continued F-7 ENDOVASC LTD., INC. (A DEVELOPMENT STAGE CORPORATION) NOTES TO THE FINANCIAL STATEMENTS __________ 4. PREFERRED STOCK ---------------- The Company's articles of incorporation authorize the issuance of up to 20,000,000 shares of preferred stock with characteristics determined by the Company's board of directors. Effective May 5, 2000, the board of directors authorized the issuance and sale of up to 55,000 shares of Series A 8% convertible preferred stock. On May 9, 2000, the Company issued 15,000 shares of $0.001 par value and $100 per share stated and liquidation value Series A 8% non-voting convertible preferred stock for $1,500,000. The actual proceeds received by the Company were $1,040,300, which are net of related offering costs. The Series A convertible preferred stock can be converted to common stock at any time at the option of the holder. The conversion rate is the stated value per share plus any accrued and unpaid dividends divided by 85% of the average of the three lowest closing bid prices of the Company's common stock for the thirty trading days immediately preceding May 9, 2000, or 70% of the average of the three lowest closing bid prices for the thirty days immediately preceding the conversion of the respective preferred stock. During the six months ended December 31, 2001, 6,518 shares of preferred stock were converted to 24,711,478 shares of common stock. In addition, 1,000,000 shares of treasury stock were issued for the conversion of 240 shares of preferred stock. In addition, the Series A preferred stockholders are obligated to purchase an additional 30,000 shares of Series A 8% convertible preferred stock ("Put Stock") at the option of the Company subject to the Company being in compliance with various covenants. The Company is currently not in compliance with these covenants but the stockholders maintain a right to waive any violations. The purchase price of the additional shares is $100 per share, which is its stated and liquidation value. During November 2000, the Company issued an additional 7,500 shares of this Series A preferred stock for proceeds to the Company of $569,757, which is net of related offering costs. If the conversion price is lower than the initial price on the date of issue, the Company has the right to redeem the shares of Series A 8% convertible preferred stock at 130% of its stated value per share. 5. RESEARCH AGREEMENT ------------------- Effective July 1, 2001, the Company entered into an External Research Agreement with another company (the "Sponsor") whereby the Sponsor has agreed to assist in the funding of the Company's research and development related to its Nicotine Receptor Agonist. The Sponsor has agreed to fund a maximum of $511,829, of which $240,680 was recorded as other income in the accompanying statement of operations for the six months ended December 31, 2001. Continued F-8 ENDOVASC LTD., INC. (A DEVELOPMENT STAGE CORPORATION) NOTES TO THE FINANCIAL STATEMENTS 6. NON-CASH INVESTING AND FINANCING ACTIVITIES ----------------------------------------------- SIX MONTHS ENDED ---------------------------- INCEPTION TO DECEMBER 31, DECEMBER 31, 2001 2000 2001 ------------- ------------- ------------- Non-cash investing and financing activities: Common stock or warrants issued for services and license and patent rights $ 161 $ 157 $ 3,259 ============= ============= ============= Common stock issued for equity securities $ - $ - $ 302 ============= ============= ============= Common stock issued for settlement of lawsuit $ 408 $ - $ 601 ============= ============= ============= Common stock issued upon conversion of debentures $ 148 $ 30 $ 1,437 ============= ============= ============= Reduction of notes payable and accrued liabilities through exercise of stock options or issuance of common stock $ 235 $ 275 $ 1,203 ============= ============= ============= Issuance of note payable for the purchase of equipment $ - $ 56 $ 124 ============= ============= ============= F-9 ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS - ------- ----------------------------------------------------------------------- OF OPERATIONS - -------------- The statements contained in this Form 10-Q that are not historical are forward-looking statements, including statements regarding the Company's expectations, intentions, beliefs or strategies regarding the future. Forward-looking statements include the Company's statements regarding liquidity, anticipated cash needs and availability and anticipated expense levels. All forward-looking statements included in this Report are based on information available to the Company on the date hereof, and the Company assumes no obligation to update any such forward-looking statement. It is important to note that the Company's actual results could differ materially from those in such forward-looking statements. Additionally, the following discussion and analysis should be read in conjunction with the Financial Statements and notes thereto appearing in our annual report filed in Form 10-KSB for the period ending June 30, 2001. OVERVIEW - -------- The Company is in the research and development stage and has had limited operating revenues since its inception on June 10, 1996. From June 10, 1996 through December 31, 2001, the Company had an accumulated deficit of $10,634,303. Our research and development efforts are focused on our core product - Liprostin(TM). We are conducting clinical trial testing of Liprostin(TM) to obtain the approval of the U.S. Food and Drug Administration (FDA) for sale of Liprostin(TM) in the United States. Phase I clinical trials to test the product's safety and tolerance levels using a small group of healthy subjects, as well as providing information about the product's effectiveness and dosage levels was successfully completed in January 2001. With this success, the Company has decided to proceed to Phase III clinical trials, as had been suggested by the FDA in late 1999. An IND and protocol for a Phase III randomized, multicenter study of Liprostin(TM) in conjunction with percutaneous transluminal angioplasty in patients with critical limb ischemia was filed with the FDA in August 2001. Also, the Company filed an Orphan Drug Application with the FDA in July 2001. Orphan Drug is a designation by the FDA to indicate a therapy developed to treat a rare disease (one which afflicts a U.S. population of less than 200,000 people). Because there are few financial incentives for drug companies to develop therapies for diseases that afflict so few people, the U.S. government offers additional incentives to drug companies that develop these drugs, which include: 1) eligibility for an FDA grant of up to $300,000 per year for a maximum of 3 years; 2) a tax credit equal to 50% of the qualified clinical testing expenses for the taxable year in which the clinical study(s) are conducted; and most importantly, 3) a 7 year exclusivity to market the drug as adjunct treatment for the rare disease. We expect to complete Phase III clinical trials by late 2004. In addition, we are conducting feasibility studies with prospective strategic partners to find practical collaborative products that incorporate Liprostin with other technologies. We intend to develop new uses for our core product Liprostin, including applications to hip or bone prostheses, cancer treatment, inflammatory disease, liver disease and wound healing. We have successfully completed preclinical trials in rabbits for our Nicotine Receptor Agonist at Stanford University, and have initiated animal studies in dogs and pigs at Columbia University to continue safety and efficacy studies of this technology. We are currently developing this technology for use in treatment of peripheral occlusive arterial disease, in addition to other applications. We successfully completed a feasibility study of our stent coating technology using our patented Prostaglandin E1 with a major medical device manufacturer in early 2001. We have continued that work with other medical device companies, as well. RESULTS OF OPERATIONS - ----------------------- THREE MONTH PERIOD ENDED DECEMBER 31, 2001 AND 2000 - ----------------------------------------------------------- During the three months ended December 31, 2001, the Company had no revenue compared with $75,000 of revenues for the three months ended December 31, 2000. The revenue during the three months ended December 31, 2000 was a result of a feasibility study agreement, relating to the Company's stent-coating technology, with Advanced Cardiovascular Systems, Inc., a California corporation and subsidiary of Guidant Corporation. During the three months ended December 31, 2001 and 2000, administrative and operating expenses were $280,000 and $319,000, respectively. The decrease in costs and operating expenses is primarily due to a reduction in promotion and general consulting expenses during the three months ended December 31, 2001. Research and development costs totaled $478,000 during the three months ended December 31, 2001, compared to $336,000 during the three months ended December 31, 2000. This increase of $142,000 was related to the increased cost of materials, labor and travel connected to the animal study at Columbia University with NRA, the Phase II clinical studies preparation with Liprostin(TM) and the ongoing, in-house projects for medicinally coated vascular stents and a biodegradable resorbable stent. Interest expense decreased from $31,000 during the three months ended December 31, 2000 to $16,000 during the three months ended December 31, 2001. This decrease is a result of a lower average debt balance and lower interest rates. SIX MONTH PERIOD ENDED DECEMBER 31, 2001 AND 2000 - --------------------------------------------------------- During the six months ended December 31, 2001, the Company had total revenues of $247,000 compared with $75,000 of revenues for the six months ended December 31, 2000. The increase relates to revenue received from an external research agreement with another company entered into in July 2001 whereby the Company received assistance from this company in funding its research and development costs related to its Nicotine Receptor Agonist. During the six months ended December 31, 2001 and 2000, administrative and operating expenses were $664,000 and $556,000, respectively. The increase in costs and operating expenses is primarily due to an increase in facilities cost, personnel and overhead as rent and other costs increased. Financing costs and legal fees associated with securing the convertible debentures were also expensed during the six months ended December 31, 2001. Research and development costs totaled $739,000 during the six months ended December 31, 2001, compared to $655,000 during the six months ended December 31, 2000. This increase of $84,000 was related to the increased cost of materials, labor and travel related to the animal study at Columbia University with NRA, the Phase II clinical studies preparation with Liprostin(TM) and the ongoing, in-house projects for medicinally coated vascular stents and a biodegradable resorbable stent. Interest expense increased from $61,000 during the six months ended December 31, 2000 to $193,000 during the six months ended December 31, 2001. This increase is a result of the cost of the beneficial conversion feature related to the convertible debentures recorded during the six months ended December 31, 2001 of $171,000, offset by lower interest rates during the period. LIQUIDITY AND CAPITAL RESOURCES - ---------------------------------- The Company had a working capital deficit at December 31, 2001 of $1,036,000, compared to a deficit of $350,000 at December 31, 2000. This increase in the working capital deficit is primarily related to the increase in accounts payable and decrease in cash resulting from no revenue during the three months ended December 31, 2001 and less proceeds from issuance of preferred stock. The Company requires significant additional funds to enable it to proceed with its Phase II/III Liprostin(TM) clinical trials, as well as research and development of its licensed product Nicotine Receptor Agonist. In May 2000, the Company completed a $4.5 million financing commitment related to the private placement and sale of its convertible preferred stock in three (3) $1.5 million tranches. Pursuant to the commitment, the Company received $1,040,300 on May 10, 2000, $569,757 on November 2000, and $653,488 on April 12, 2001 which is net of related offering costs. There can be no assurance that the Company will take down the remaining tranches. During the six months ended December 31, 2001 the Company issued $400,000 of convertible debentures, of which it received $333,000, net of related offering costs. The debentures bear interest at 8%, which is due quarterly in arrears, with the principal due September 2003. The Company continues to actively pursue additional financing, collaborations with firms, and other arrangements aimed at increasing its capital resources. Failure to acquire such funds may adversely impact the scheduled marked introduction of Liprostin(TM) and possibly adversely affect the Company's operations. In order to continue as a going concern, the Company must raise additional funds and ultimately achieve profit from its operation. PART II - OTHER INFORMATION ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K - ------- ------------------------------------- (a) Exhibits -- None. (b) Reports on Form 8-K -- None. SIGNATURES Pursuant to the requirements of the Exchange Act, the registrant caused this report to be signed on its behalf by the undersigned, thereto duly authorized. ENDOVASC LTD., INC. Date: February 12, 2002 By: /s/ David P. Summers ------------------------ -------------------------------- David P. Summers Chief Executive Officer Date: February 12, 2002 By: /s/ M. Dwight Cantrell ------------------------ -------------------------------- M. Dwight Cantrell Chief Financial Officer