================================================================================ SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 1996 ------------- OR [_] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 0-27264 UROGEN CORP. ------------ (Exact name of registrant as specified in its charter) DELAWARE 33-0687976 -------- ---------- (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification no.) 3099 SCIENCE PARK ROAD, SUITE A, SAN DIEGO, CA, 92121 (Address of principal executive offices) (Zip code) Registrant's Telephone Number, including area code: (619) 450-5949 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 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 ----- ----- The number of shares of the Common Stock of the registrant outstanding as of August 9, 1996, was 5,955,528. This Common Stock is restricted from transfer until December 31, 1997, except as specified on Page 11 (See Item 5. "Other Information" - "Market for Registrants Common Equity"). UROGEN CORP. (A Development-Stage Enterprise) INDEX TO FORM 10-Q PART I. FINANCIAL INFORMATION ------------------------------ Page No. -------- Item 1. Financial Statements Condensed Balance Sheets........................ 2 June 30, 1996 (Unaudited) and December 31, 1995 Condensed Statements of Operations (Unaudited).. 3 Three and Six Months Ended June 30, 1996 and 1995 and July 1, 1991 (inception) to June 30, 1996 Condensed Statement of Stockholders'/ Division.. 4 Equity (Unaudited) July 1, 1991 (inception) to June 30, 1996 Condensed Statements of Cash Flows (Unaudited).. 5 Three and Six Months Ended June 30, 1996 and 1995 and July 1, 1991 (inception) to June 30, 1996 Notes to Unaudited Condensed Financial Statements.................................... 6 Item 2. Management's Discussion and Analysis of......... 9 Financial Condition and Results of Operations PART II. OTHER INFORMATION --------------------------- Item 1. Legal Proceedings............................... 11 Item 2. Changes in Securities........................... 11 Item 3. Defaults Upon Senior Securities................. 11 Item 4. Submission of Matters to a Vote of Security Holders............................. 11 Item 5. Other Information............................... 11 Market For Registrants Common Equity Item 6. Exhibits and Reports on Form 8-K................ 11 Signatures...................................... 12 1 UROGEN CORP. (A Development-Stage Enterprise) CONDENSED BALANCE SHEETS -------------------------------- June 30, December 31, 1996 1995 ------------- ------------- ASSETS (Unaudited) (Note) - ------ Current assets: Cash and equivalents $ 452,433 $ 1,000 ---------- --------- Total current assets 452,433 1,000 Property and equipment: Equipment 202,036 202,036 Furniture and fixtures 162,699 162,699 ---------- --------- 364,735 364,735 ---------- --------- Less accumulated depreciation and amortization (322,511) (238,063) ---------- --------- Net property and equipment 42,224 126,672 Other assets 35,410 35,410 Less accumulated amortization (23,606) ---------- --------- Net other assets 11,804 35,410 ---------- --------- $ 506,461 $ 163,082 ========== ========= LIABILITIES AND STOCKHOLDERS'/DIVISION EQUITY - --------------------------------------------- Current liabilities: Accounts payable $ 3,000 - Amount due officer/shareholder 5,000 - ---------- ---------- Total current liabilities 8,000 - Stockholders'/division equity: Preferred Sock - $0.01 par value, - - 5,000,000 shares authorized, none issued at June 30, 1996 and December 31, 1995 Common Stock - $.001 par value, 5,956 - 40,000,000 shares authorized, 5,955,528 issued at June 30, 1996 and none at December 31, 1995 Additional paid-in capital 674,076 - Accumulated (deficit) (181,571) - Advances from Medstone - 3,888,875 Divisional accumulated (deficit) - (3,725,793) ---------- ----------- Total stockholders'/division equity 498,461 163,082 ---------- ----------- $ 506,461 $ 163,082 ========== =========== Note: The Balance Sheet at December 31, 1995 has been derived from the audited statements at that date but does not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. See accompanying notes. 2 UROGEN CORP. (A Development-Stage Enterprise) CONDENSED STATEMENTS OF OPERATIONS ---------------------------------- UNAUDITED --------- Three Months Ended Six Months Ended July 1, 1991 ------------------------ ---------------------------- (inception) to June 30, June 30, June 30, June 30, June 30, 1996 1995 1996 1995 1996 ----------- ---------- -------------- ----------- --------------- Net laboratory sales $ - $ - $ - $ - $ 455,580 Costs and expenses: Cost of sales - - - - 821,878 Research and development 68,174 19,839 110,398 37,764 2,936,226 Selling - - - - 11,448 General and administrative 32,669 - 76,904 - 599,123 Interest income (4,827) - (5,731) - (5,731) --------- --------- ---------- ---------- ------------ Total costs and expenses 96,016 19,839 181,571 37,764 4,362,944 --------- --------- ---------- ---------- ------------ Net loss $ (96,016) $ (19,839) $ (181,571) $ (37,764) $ (3,907,364) ========= ========= ============= ========== ============ Net loss per share $ (.02) $ (.00) $ (.03) $ (.01) =========== ========= ============= ========== Number of shares used in 5,955,528 5,616,528 5,955,528 5,616,528 the computation of net =========== ========= ============= ========== loss per share See accompanying notes. 3 UROGEN CORP. (A Development-Stage Enterprise) CONDENSED STATEMENT OF STOCKHOLDERS'/DIVISION EQUITY ---------------------------------------------------- FOR THE PERIOD JULY 1, 1991 (INCEPTION) TO JUNE 30, 1996 --------------------------------------------------------- UNAUDITED --------- Common Stock ------------------ Additional Advances Divisional Number of paid-in Accumulated from Accumulated shares Amount Capital (Deficit) Medstone (Deficit) Total --------- ------ ---------- ------------ ------------ ------------- ------------- Advances from Medstone July 1, 1991 to December 31, 1994 - $ - $ - $ - $ 3,852,465 $ - $ 3,852,465 Net loss July 1, 1991 to December 31, 1994 - - - - - (3,651,153) (3,651,153) --------- ------ ---------- ----------- ----------- ------------ ------------ - - - - 3,852,465 (3,651,153) 201,312 Advances from Medstone January 1, 1995 to December 31, 1995 - - - - 36,410 - 36,410 Net loss January 1, 1995 to December 31, 1995 - - - - - (74,640) (74,640) --------- ------ ---------- ----------- ----------- ------------ ------------ - - - - 3,888,875 (3,725,793) 163,082 Distribution of stock dividend and net assets February 9, 1996 5,616,528 5,617 657,465 - (3,888,875) 3,725,793 500,000 --------- ------ ---------- ----------- ----------- ------------ ------------ 5,616,528 5,617 657,465 - - - 663,082 Distribution of Common Stock for services at $.05 per share - June 1996 339,000 339 16,611 - - - 16,950 Net loss January 1, 1996 to June 30, 1996 - - - (181,571) - - (181,571) --------- ------ ---------- ----------- ----------- ------------ ------------ Balance at June 30, 1996 5,955,528 $ 5,956 $ 674,076 $ (181,571) $ - $ - $ 498,461 ========= ======== ========= =========== =========== ============ =========== See accompanying notes. 4 UROGEN CORP. (A Development-Stage Enterprise) CONDENSED STATEMENTS OF CASH FLOWS ----------------------------------- UNAUDITED --------- Three Months Ended Six Months Ended July 1, 1991 -------------------------- ---------------------- (inception) to June 30, June 30, June 30, June 30, June 30, 1996 1995 1996 1995 1996 ------------ ---------- --------- --------- ------------ Net loss $(96,016) $(19,839) $(181,571) $ (37,764) $(3,907,364) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation 42,226 19,839 84,448 37,764 458,074 Amortization 11,803 - 23,606 - 23,606 Increase in amount due officer / shareholder - - 5,000 - 5,000 Increase in accounts payable 3,000 - 3,000 - 3,000 Non-cash distribution of Common Stock 16,950 - 16,950 - 16,950 Other, net - - - - (30,000) ------------ ---------- --------- --------- ------------ Net cash used in operating activities (22,037) - $ (48,567) - $(3,430,734) Cash flows from investing activities: Purchase of property and equipment - - - - (512,267) Disposal of property and equipment - - - - 11,969 ------------ ---------- --------- --------- ------------ Net cash used in investing activities - - - - (500,298) Cash flows from financing activities: Net advances from Medstone - - - - 3,883,465 Capital contribution of cash by Medstone - - 500,000 - 500,000 ------------ ---------- --------- --------- ------------ Net cash provided by financing activities - - 500,000 - 4,383,465 ------------ ---------- --------- --------- ------------ Net increase (decrease) in cash and equivalents (22,037) - 451,433 - 452,433 ------------ ---------- --------- --------- ------------ Cash and equivalents, beginning of period 474,470 - 1,000 - - ------------ ---------- --------- --------- ------------ Cash and equivalents, end of period $452,433 $ - $ 452,433 $ - $ 452,433 ============ ========== ========= ========= ============ See accompanying notes. 5 UROGEN CORP. (A Development-Stage Enterprise) NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS ------------------------------------------------- June 30, 1996 ------------- A. ORGANIZATION AND OPERATIONS OF THE COMPANY Urogen Corp. (the "Company"), a Delaware corporation, was incorporated on June 30, 1995, as a wholly-owned subsidiary of Medstone International, Inc. ("Medstone"). The Company was formed from the medical biology and small molecule pharmaceuticals divisions of Medstone to continue the effort, started in 1991, to develop pharmaceuticals to treat diseases in urology, with a particular interest in prostate cancer. Urogen operated as a division of Medstone from July 1, 1991 to December 29, 1995. B. DISTRIBUTION AND CAPITALIZATION On December 29, 1995, Medstone declared a dividend of all of the stock of Urogen Corp. to be distributed to all Medstone stockholders. Each stockholder of Medstone received, on February 9, 1996, one share of Urogen Common Stock for every one share of Medstone Common Stock held on the Record Date, December 29, 1995. The Distribution resulted in the receipt, by record holders of Medstone Common Stock, of all of Urogen's outstanding Common Stock. Upon completion of the Distribution, there were 5,616,528 shares of Urogen Common Stock outstanding. The Distribution occurred on February 9, 1996, on which date Medstone also contributed to the capital of Urogen Corp. $500,000 cash. For financial reporting purposes, the Distribution and contribution to capital have been considered effective as of January 1, 1996, and the operations of the business have been considered those of Urogen Corp. effective that date. Additionally, effective January 1, 1996, Medstone executed a forgiveness of all intercompany advances resulting from the prior divisional funding of operations between Medstone and Urogen. C. PER SHARE INFORMATION Net loss per share is based on the weighted average common shares outstanding. As of June 30, 1996, there are outstanding, options to purchase 1,160,000 shares of Urogen Common Stock. Additionally, there are 690,000 shares reserved and available for future grant under The 1995 Stock Plan. Such outstanding stock options have not been included in the computation of net loss per share as their effect would be antidilutive. 6 D. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation and Continued Existence ---------------------------------------------- The Company is in the development stage. From July 1, 1991 (inception) through June 30, 1996, the Company has incurred losses of $3,907,364. Recovery of the Company's assets is dependent upon future events, the outcome of which is indeterminable. Additionally, successful completion of the Company's development program and its transition, ultimately, to attaining profitable operations is dependent upon obtaining additional financing adequate to fulfill its research and development activities, and achieving a level of revenues adequate to support the Company's cost structure. There can be no assurance that the Company will be successful in these areas. In the opinion of the Company's management, the accompanying unaudited financial statements include all adjustments (which consist only of normal recurring adjustments) necessary for a fair presentation of its financial position as of June 30, 1996 and results of operations and cash flows for the periods presented. Although the Company believes that the disclosures in these financial statements are adequate to make the information presented not misleading, certain information and disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been condensed or omitted and should be read in conjunction with the Company's audited financial statements included in the Company's 1995 Annual Report on Form 10-K filed with the Securities and Exchange Commission. Results of operations for the three and six months ended June 30, 1996, are not necessarily indicative of results for the full year. Stock Options ------------- On January 1, 1996, the Company adopted Financial Accounting Standards Board Statement No. 123 "Accounting for Stock-based Compensation." As permitted by the Statement, the Company accounts for stock options per the requirements contained in APB Opinion No. 25, "Accounting for Stock Issued to Employees." Adoption of the new Standard had no impact on the Company's financial statements. 7 E. INCOME TAXES Prior to the Distribution, income taxes had been allocated to the Company on a "separate return" basis whereby such amounts are determined as if the Company were a separate taxable entity. However, the Company's net operating losses and research and development credits incurred through December 31, 1995, have been included in the consolidated tax returns of Medstone and have been fully utilized. As a result, the Company's available net operating losses and research and development credits to offset future taxable income are limited to amounts incurred during the six months ended June 30, 1996. The Company has established a valuation allowance to fully offset its deferred tax assets in accordance with Statements of Financial Accounting Standards No. 109, "Accounting for Income Taxes." Accordingly, no benefit for the Company's deferred tax assets has been recognized, as their realization is not assured. F. RELATED PARTY TRANSACTIONS During June 1996, the Company issued 339,000 shares of Common Stock valued at $.05 per share to a research organization in connection with the execution of an Affiliation Agreement. During 1996, the Company paid the research organization $9,000 cash for services. During 1996, the Company paid a shareholder/officer $20,000 cash for consulting services. As of June 30, 1996, the Company owes the research organization $3,000 and the shareholder/officer $5,000 for services. 8 Item 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND --------------------------------------------------------------- RESULTS OF OPERATIONS --------------------- GENERAL Urogen Corp. (the "Company") is a development-stage company which is primarily engaged in the development of pharmaceuticals to treat prostate cancer. The Company was incorporated in Delaware on June 30, 1995. It was inactive until January 1, 1996, at which date, the operations of the business, which previously operated as a division of Medstone International, Inc. ("Medstone") from July 1, 1991 through December 31, 1995, were transferred to the new company. The Company, a division of Medstone prior to January 1, 1996, had no independent operating history of its own and, to date, has generated an operating loss of $3,907,364. Accordingly, there can be no assurances that the Company will be able to generate sufficient revenue and cash flow to maintain its operations beyond the $452,433 existing cash balance. The Company must develop new products and raise substantial additional financing. PLAN OF OPERATION The Company expects that its capital resources will enable it to maintain its current and planned operations for approximately the next six to twelve months. Thereafter, the Company will need to raise substantial additional capital to fund its operations. In the next twelve months Urogen will be actively pursuing opportunities to develop new prostate cancer therapeutics and diagnostics. Depending on the Company's success in identifying promising opportunities in prostate cancer therapy, and if it is successful in attracting additional capital, Urogen could substantially increase its number of employees. However, it is the Company's current intention to use human resources on a part-time and consulting basis for the near-term, if at all possible. LIQUIDITY AND CAPITAL RESOURCES From inception on July 1, 1991, all of the Company's operations have been funded by Medstone, however, such funding was completed with the $500,000 capital contribution of cash on February 9, 1996. The Company has incurred net losses of $3,907,364 since its inception and has never been profitable during its existence. The Company expects to incur significant additional operating losses over the next several years as the Company's research and development efforts expand. The Company's ability to achieve profitability depends upon its ability, alone or with others, to successfully complete development of pharmaceutical products, obtain required regulatory approvals and manufacture and market its products. 9 The Company's operations to date have consumed substantial amounts of cash. The negative cash flow from operations is expected to continue and to accelerate in the foreseeable future. The development of the Company's products will require a commitment of substantial funds to conduct the costly and time-consuming research, preclinical and clinical testing necessary to bring such products to market and to establish manufacturing and marketing capabilities. The Company's future capital requirements will depend on many factors, including scientific progress in its research and development programs, the ability of the Company to establish collaborative arrangements with others for drug development, progress with preclinical and clinical trials, the time and costs involved in obtaining regulatory approvals and effective commercialization activities. The Company expects that its existing capital resources, including the $452,433 existing cash and equivalents, will enable the Company to maintain its current and planned operations for approximately the next six to twelve months. Thereafter, the Company will need to raise substantial additional capital to fund its operations. The Company intends to seek such additional funding either through collaborative arrangements or through public or private equity or debt financings. There can be no assurance that additional financing will be available on acceptable terms or at all. If additional funds are raised by issuing equity securities, further dilution to stockholders will result. If adequate funds are not available, the Company may be required to delay or reduce the scope of its operations or obtain funds through arrangements with collaborative partners or others that may require the Company to relinquish rights it may have acquired in the interim. RESULTS OF OPERATIONS For the three months ended June 30, 1996 and 1995, the Company had no operating revenues and net losses of $96,016 and $19,839, respectively. The increased loss for the period reflects primarily one-time costs to execute the Distribution and operate as a separate entity, a change in depreciation and amortization policies to expense recorded assets more rapidly based upon shorter expected useful lives and a one-time expense associated with the issuance of 339,000 shares of Common Stock in connection with the execution of an Affiliation Agreement with a research organization. For the six months ended June 30, 1996 and 1995, the Company had no operating revenues and net losses of $181,571 and $37,764, respectively. The increased loss for the period reflects primarily one-time costs to execute the Distribution and operate as a separate entity, a change in depreciation and amortization policies to expense recorded assets more rapidly based upon shorter expected useful lives and a one-time expense associated with the issuance of 339,000 shares of Common Stock in connection with the execution of an Affiliation Agreement with a research organization. 10 UROGEN CORP. (A Development-Stage Enterprise) PART II. OTHER INFORMATION --------------------------- ITEM 1. LEGAL PROCEEDINGS None. ITEM 2. CHANGES IN SECURITIES None. ITEM 3. DEFAULTS UPON SENIOR SECURITIES None. ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS None. ITEM 5. OTHER INFORMATION Market for Registrants Common Equity No market for the Company's shares of capital stock presently exists and no assurance can be given that any active trading market will develop or be sustained. None of the shares of capital stock of the Company issued in the Distribution or otherwise, or acquired through the exercise of stock options prior to December 31, 1997, may be transferred before December 31, 1997 unless such restriction is earlier terminated by the Company as to all such shares, except for the following transfers: (i) transfers by gift, will, bequest or the applicable laws of descent and distribution; (ii) non-sale distributions by partnerships, corporations or trusts to their partners, shareholders or beneficiaries; (iii) transfers to the Company; and (iv) transfers pursuant to qualified domestic relations order as defined by the Code or the rules thereunder. In the case of any such permitted transfers, the shares in the hands of the transferees will continue to be subject to the same transfer restriction. ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K There were no reports on Form 8-K filed with the Commission during the quarter ended June 30, 1996. 11 SIGNATURES Pursuant to the requirements of Section 13 or 15 (d) of Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, hereunto duly authorized. UROGEN CORP. ------------ A Delaware Corporation Date: August 9, 1996 /s/ PAUL D. QUADROS --------------------- Paul D. Quadros Chairman of the Board Chief Financial Officer Secretary (Principal financial and accounting officer) 12