1 ================================================================================ 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, 1998 OR [ ] Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the Period From _____ to _____ Commission File Number: 0-19986 CELL GENESYS, INC. (EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER) Delaware 94-3061375 (State or other jurisdiction of (I.R.S. employer identification number) incorporation or organization) 342 Lakeside Drive, Foster City, California 94404 (Address of principal executive offices and zip code) Registrant's telephone number, including area code: (650) 425-4400 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 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 August 1, 1998, the number of outstanding shares of the Registrant's Common Stock was 28,450,809. ================================================================================ 2 CELL GENESYS, INC. TABLE OF CONTENTS PAGE ---- PART I. FINANCIAL INFORMATION Item 1. Consolidated Financial Statements: a. Condensed Consolidated Balance Sheets - June 30, 1998 and December 31, 1997.................................................................3 b. Condensed Consolidated Statements of Operations - Three and Six Months Ended June 30, 1998 and 1997......................................................4 c. Condensed Consolidated Statements of Cash Flows -Six Months Ended June 30, 1998 and 1997............................................................5 d. Notes to Condensed Consolidated Financial Statements..............................6 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations.............................................................8 Item 3. Quantitative and Qualitative Disclosures about Market Risk...........................16 PART II. OTHER INFORMATION Item 4. Submission of Matters to a Vote of Security Holders..................................17 Item 6. Exhibits and Reports on Form 8-K.....................................................18 SIGNATURES....................................................................................18 2 3 PART I. FINANCIAL INFORMATION ITEM 1. CONSOLIDATED FINANCIAL STATEMENTS CELL GENESYS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands) JUNE 30, DECEMBER 31, 1998 1997 -------------------------- (Unaudited) ASSETS Current assets: Cash and cash equivalents........................... $ 2,446 $ 10,631 Short-term investments.............................. 65,263 78,185 Prepaid expenses and other current assets........... 3,264 2,943 -------------------------- Total current assets................................... 70,973 91,759 Property and equipment at cost, net.................... 12,568 13,815 Deposits and other assets, net......................... 1,211 1,313 -------------------------- $ 84,752 $ 106,887 ========================== LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable and other accrued liabilities...... $ 7,693 $ 8,405 Deferred revenue.................................... 2,186 5,993 Accrued acquisition related costs................... 1,044 1,648 Current portion of property and equipment financing......................................... 4,805 5,159 Contribution payable to related party............... 3,750 3,750 Convertible note payable............................ 15,000 15,000 -------------------------- Total current liabilities.............................. 34,478 39,955 Noncurrent portion of property and equipment financing........................................... 9,460 11,082 Redeemable convertible preferred stock................. 19,817 19,817 Minority interest in the equity of subsidiary.......... 17,225 17,392 Stockholders' equity: Common stock........................................ 28 28 Additional paid-in capital.......................... 200,848 199,495 Deferred compensation of subsidiary................. (1,470) (1,319) Accumulated deficit................................. (195,634) (179,563) -------------------------- Total stockholders' equity............................. 3,772 18,641 -------------------------- $ 84,752 $ 106,887 ========================== See accompanying notes 3 4 CELL GENESYS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) THREE MONTHS ENDED JUNE 30, SIX MONTHS ENDED JUNE 30, 1998 1997 1998 1997 --------------------------------------------------------- (In thousands, except per share data) Revenue under collaborative agreements........... $ 2,934 $ 3,992 $ 7,498 $ 11,896 Operating expenses: Research and development....................... 10,879 8,017 23,346 16,351 General and administrative .................... 2,230 2,930 5,214 5,066 Charge for purchased in-process technology..... -- 72,270 -- 72,270 Restructuring costs related to acquisition..... -- 6,576 -- 6,576 Charge for cross-license and settlement (includes $3,750 equity in losses of Xenotech joint venture associated with cross-license and settlement)............... -- -- -- 15,000 --------------------------------------------------------- Total operating expenses......................... 13,109 89,793 28,560 115,263 Interest income.................................. 1,030 1,055 2,255 2,119 Interest expense................................. (727) (783) (1,398) (1,071) --------------------------------------------------------- Net loss before minority interest................ (9,872) (85,529) (20,205) (102,319) Loss attributed to minority interest............. 1,546 -- 4,192 -- -- --------------------------------------------------------- Net loss......................................... $ (8,326) $ (85,529) $ (16,013) $ (102,319) ========================================================= Net loss per share............................... $ (0.29) $ (4.20) $ (0.57) $ (5.55) ========================================================= Shares used in computing net loss per share...... 28,335 20,348 28,273 18,447 ========================================================= See accompanying notes 4 5 CELL GENESYS, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) SIX MONTHS ENDED JUNE 30, 1998 1997 -------------------------- (In thousands) CASH FLOWS FROM OPERATING ACTIVITIES Net loss............................................. $ (16,013) $ (102,319) Adjustments to reconcile net loss to net cash used by operating activities: Depreciation and amortization...................... 2,507 2,356 Amortization of deferred compensation ............. 528 -- of subsidiary Minority interest in net loss of subsidiary........ (4,192) -- Equity in losses of Xenotech joint venture......... 118 133 Charge for purchased in-process technology......... -- 72,270 Restructuring charges.............................. -- 4,021 Charge for cross-license and settlement ........... -- 15,000 Changes to: Prepaid expenses and other assets.................. 433 (1,135) Accounts payable and other accrued ................ (2,696) (1,911) liabilities Accrued compensation and benefits.................. 518 (1,241) Deferred revenue from related parties.............. (3,807) (3,720) Accrued construction costs......................... 102 (2,053) Accrued legal expenses............................. 418 (1,323) Accrued acquisition related costs.................. (604) -- -------------------------- Net cash used in operating activities......... (22,688) (19,922) CASH FLOWS FROM INVESTING ACTIVITIES Purchases of short-term investments.................. (22,386) (23,287) Maturities of short-term investments................. 9,000 2,919 Sales of short-term investments...................... 26,255 24,948 Purchase of subsidiary, net of cash acquired ........ -- 2,842 Contributions to Xenotech joint venture ............. (8) (83) Capital expenditures................................. (151) (284) -------------------------- Net cash provided by investing activities..... 12,710 7,055 -------------------------- CASH FLOWS FROM FINANCING ACTIVITIES Proceeds from minority interest investment in subsidiary...................................... 3,944 -- Proceeds from issuance of common stock............... 759 288 Proceeds from property and equipment financing....... -- 4,546 Payments under property and equipment financing obligations.............................. (2,910) (1,768) -------------------------- Net cash provided by financing activities..... 1,793 3,066 -------------------------- Net decrease in cash and cash equivalents............... (8,185) (9,801) Cash and cash equivalents at beginning of period........ 10,631 20,935 -------------------------- Cash and cash equivalents at end of period.............. $ 2,446 $ 11,134 ========================== See accompanying notes 5 6 CELL GENESYS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES BASIS OF PRESENTATION The accompanying condensed consolidated financial statements at June 30, 1998 and for the three and six months ended June 30, 1998 and 1997 include the accounts of Cell Genesys, Inc., including its subsidiaries Abgenix, Inc. and, from May 30, 1997, the date of acquisition, Somatix Therapy Corporation (collectively, the "Company"). These statements are unaudited, but include all of the adjustments, consisting only of normal recurring adjustments, which the management of the Company considers necessary for a fair presentation of the Company's financial position at such dates and the operating results and cash flows of those periods. The results of the interim periods are not necessarily indicative of the results for the entire year. The balance sheet and accompanying notes at December 31, 1997 have been condensed from the audited financial statements included in the Company's filing on Form 10-K. The condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Company's Annual Report for the year ended December 31, 1997 included in its filing on Form 10-K. COMPREHENSIVE INCOME (LOSS) As of January 1, 1998, the Company adopted the provisions of SFAS No. 130, "Reporting Comprehensive Income" ("SFAS 130"). SFAS 130 establishes new rules for the reporting and display of comprehensive income and its components. Comprehensive income(loss) is comprised of net income(loss) and other comprehensive income(loss). The measurement and presentation of net income(loss) will not change. Other comprehensive income(loss) includes certain changes to stockholders' equity of the Company that are excluded from net income(loss). Specifically, SFAS 130 requires unrealized gains or losses on the Company's available-for-sale securities, which prior to adoption were reported separately in stockholders' equity, to be included in other comprehensive income (loss). Prior year financial statements will be reclassified to conform to the requirements of SFAS 130. Total comprehensive loss amounted to $8.3 million and $85.3 million for the three months ended June 30, 1998 and 1997, and $16.1 million and $102.2 million for the six months ended June 30, 1998 and 1997, respectively. 2. CHARGE FOR CROSS-LICENSE AND SETTLEMENT On March 27, 1997, the Company announced that, along with Abgenix, Xenotech, L.P. ("Xenotech", an equal joint venture of Abgenix and Japan Tobacco) and Japan Tobacco, it had signed a comprehensive patent cross-license and settlement agreement with GenPharm International, Inc. (a subsidiary of Medarex, Inc.) that resolved all related litigation and claims between the parties. The cross-license agreement includes a worldwide royalty free cross-license to all issued and related patent applications pertaining to the generation of fully human monoclonal antibody technologies in genetically modified strains of mice. The Company also obtained a license to certain technology in the field of gene therapy held by GenPharm. As consideration for the cross-license and settlement agreement, Cell Genesys issued a note due September 30, 1998 for $15.0 million, convertible into shares of Cell Genesys common stock, at $8.62 per share. Of this note, $3.75 million was contributed to, then paid by Xenotech. The entire amount of the note was recognized as expense by Abgenix in the first quarter of 1997 based on an independent valuation analysis of technology acquired. In addition, Japan Tobacco also made a cash payment to 6 7 2. CHARGE FOR CROSS-LICENSE AND SETTLEMENT (CONTINUED) GenPharm. During 1997, two patent milestones of $7.5 million each under the agreement were met. Xenotech recognized expense of $15.0 million, $7.5 million of which was paid in cash with the remainder to be paid in November 1998. During 1997, Abgenix recognized an expense of $7.5 million for its contribution due to Xenotech for its share of the patent milestone obligations, of which $3.75 million was paid in cash and $3.75 million is accrued at June 30, 1998. The balance of the patent milestone obligations is the responsibility of Japan Tobacco. No additional milestone payments will accrue under this agreement. 3. MINORITY INTEREST Minority interest in the equity of subsidiary represents the minority stockholders' proportionate share of the equity of Abgenix, Inc. (Abgenix). In December 1997, Abgenix issued 2,846,542 shares of Series B redeemable convertible preferred stock at $6.50 per share to the minority stockholders for net aggregate proceeds of $17.0 million (net of $1.5 million of issuance costs). In addition, at December 31, 1997, Abgenix held subscriptions for 421,143 shares of Series B redeemable convertible preferred stock. Proceeds of $2.7 million (net of $81,000 of issuance costs) from these subscriptions were received in January 1998. Also in January 1998, Abgenix issued 160,000 shares of Series C redeemable convertible preferred stock at $8.00 per share for net proceeds of $1.3 million. These shares were converted into common stock upon the completion of Abgenix's initial public offering (see footnote 4). At June 30, 1998 and December 31, 1997, the Company owned approximately 54% and 55%, respectively, of Abgenix. The Company attributed $4.2 million of the losses of Abgenix for the six months ended June 30, 1998 to the minority stockholders. 4. SUBSEQUENT EVENT Abgenix' initial public offering On July 2, 1998, Abgenix completed an initial public offering of 2,500,000 shares of common stock at $8.00 per share, resulting in gross proceeds of $20 million. In addition, $3 million was received from the exercise of the underwriter's overallotment of 375,000 shares. The combined transactions reduced Cell Genesys' percentage ownership of Abgenix from 54% to approximately 40%. From July 2, 1998 forward, Abgenix will be accounted for under the equity method. As a result of the initial public offering and the equity method of accounting, the Company's net assets were increased by approximately $23 million in July 1998. 7 8 ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Statements made in this Item other than statements of historical fact, including statements about the Company's and its subsidiary's clinical trials, research programs, product pipelines, current and potential corporate partnerships, licenses and intellectual property and anticipated operating results and cash expenditures are forward-looking statements within the meaning of section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. As such, they are subject to a number of uncertainties that could cause actual results to differ materially from the statements made, including risks associated with the success of research and product development programs, the issuance and validity of patents, the development and protection of proprietary technology, operating expense levels and the ability to establish and retain corporate partnerships. Reference is made to discussions about risks associated with product development programs, intellectual property and other risks which may affect the Company under "Risk Factors" below. The Company does not undertake any obligation to update forward-looking statements. The following should be read in conjunction the Company's Annual Report for the year ended December 31, 1997 included in its filing on Form 10-K. OVERVIEW Since its inception in April 1988, Cell Genesys has focused its research and product development efforts on human disease therapies which are based on innovative gene modification technologies. Cell Genesys' strategic objective is to develop and commercialize ex vivo and in vivo gene therapies to treat major, life-threatening diseases and disorders. Cell Genesys' AIDS gene therapy currently is in Phase II human clinical testing and is being developed through a worldwide collaboration with Hoechst Marion Roussel. Two types of cancer gene therapies, for which Cell Genesys currently has worldwide rights, are in Phase I/II human clinical testing for the treatment of colon cancer, lung cancer, melanoma and prostate cancer. Preclinical studies are being conducted by Cell Genesys for the treatment of other cancer indications as well as for hemophilia, cardiovascular disease and Parkinson's disease. Cell Genesys' assets outside of gene therapy include its licensing program in gene activation technology and its Abgenix subsidiary, which is focused on the development and commercialization of antibody therapies. During 1997 and the first half of 1998, Cell Genesys made extensive progress in its gene therapy programs. For the treatment of HIV infection, Phase II human clinical studies were expanded using T cell AIDS gene therapy, based on encouraging data from earlier clinical studies and widespread medical reports about the inability of current drug therapies to eradicate reservoirs of HIV, the AIDS-causing virus. For the treatment of cancer, Phase I/II human clinical studies were initiated testing T cell cancer gene therapy for colon cancer and testing the GVAX (TM) cancer vaccine for melanoma, lung cancer and prostate cancer. Work is also progressing on the Company's preclinical programs in the areas of Hemophilia, Cardiovascular disease and central nervous system disorders. In May 1997, Cell Genesys acquired Somatix Therapy Corporation ("Somatix"), establishing a leadership position in gene therapy. Product research and development programs of the two companies were highly complementary, with Cell Genesys focused on the treatment of AIDS and cancer, and Somatix focused on cancer, central nervous system diseases and other disorders. Technology research and development programs also were highly complementary, with synergies in the retroviral and adenoviral vector programs of both companies and with new adeno-associated viral and lentiviral vector programs contributed by Somatix. Integration of the two companies was completed by the end of 1997, including prioritizing the most promising programs and significantly reducing overall expenses of the combined businesses. With the combined portfolio of product opportunities, technologies and intellectual property, Cell Genesys believes it has substantially increased its ability to attract new corporate collaborations to advance product candidates through development and commercialization and also has expanded its opportunities to license additional therapeutic genes from other companies and research institutes needed to create new gene therapies. On July 2, 1998, Abgenix completed an initial public offering of 2,500,000 shares of common stock at $8.00 per share, resulting in gross proceeds of $20 million. In addition, $3 million was received from the exercise of the underwriter's overallotment of 375,000 shares. The combined transactions reduced Cell Genesys' percentage ownership of Abgenix from 54% to approximately 40%. From July 2, 1998 forward, Abgenix will be accounted for under the equity method. As a result of the initial public offering and the equity method of accounting, the Company's net assets were increased by approximately $23 million in July 1998. 8 9 The Company's net cash expenditures for 1998 in its gene therapy operations (excluding Abgenix, which will not be consolidated after July 2, 1998) are not expected to exceed approximately $25 million and the Company intends to manage toward this net cash expenditure target. The Company may from time to time evaluate opportunities to acquire or in-license other potential products and technologies. Expenses associated with in-licensing such products may constitute unbudgeted expenses. RESULTS OF OPERATIONS Revenue decreased to $2.9 million and $7.5 million for the three and six months ended June 30, 1998 from $4.0 million and $11.9 million for the three and six months ended June 30, 1997, respectively. In 1995, the Company entered into a collaboration agreement with Hoechst Marion Roussel, Inc. for Cell Genesys' AIDS gene therapy program. A portion of the decrease in revenue reflects the completion of the majority of the research under this program and the shift to focus solely on human clinical trials. Hoechst Marion Roussel is funding this clinical development program through 1998. In February 1997, Cell Genesys entered into an agreement to license the Company's gene activation technology to Hoechst Marion Roussel for erythropoietin (EPO) and a second undisclosed protein. The agreement provides for milestone payments and annual maintenance fees, in addition to royalties on future sales of these two potential gene-activated protein products. The Company recognized revenue of $2.0 million and $4.0 million for the six months ended June 30, 1998 and 1997, respectively, pursuant to the agreement. Decreased revenues resulting from Abgenix' joint venture ("Xenotech") with JT Immunotech in its human monoclonal antibody program, were offset by revenue recognized under collaborative agreements initiated with Pfizer, Inc., Schering-Plough Research Institute and Genentech, Inc. in 1998. Research and development expenses increased to $10.9 million and $23.3 million for the three and six months ended June 30, 1998 from $8.0 million and $16.4 million for the three and six months ended June 30, 1997, respectively. The increase reflects the costs of additional research staff transferred following the acquisition of Somatix and expanding clinical development activities for the Company's AIDS gene therapy and cancer gene therapy programs. The increase also reflects Abgenix' contract manufacturing costs related to its lead antibody product candidate. Research and development expenses generally represent approximately 80% of the Company's total operating expenses, excluding the effect of the non-recurring charge for the cross-license and settlement agreement and the acquisition of Somatix and related restructuring charges incurred in 1997. The Company expects that its research and development expenditures will continue to increase to support additional product development activities, particularly in the field of cancer, for which a number of trials commenced in 1997. The rate of increase depends on a number of factors including progress in research and development, especially clinical trials. General and administrative expenses decreased to $2.2 million from $2.9 million for the three months ended June 30, 1998 and 1997, respectively. The decrease resulted from an insurance reimbursement for litigation expenses previously incurred. For the six months ended June 30, 1998, general and administrative expenses increased to $5.2 million from $5.1 million for the same period in the prior year. The increase reflects growth in administrative staff and outside services required to support expanded research and development programs. The Company expects these expenses to increase as these programs expand. Purchased in-process technology costs and restructuring costs related to the acquisition of Somatix on May 30, 1997 totaling $78.9 million were incurred in 1997. The fair value of the net assets acquired in the acquisition including in-process technology were estimated based on independent valuations of the acquired net assets. Other costs related to the acquisition consist primarily of underwriting and other transaction related costs, employee severance payments, consolidation of facilities and the write down of the book value of certain fixed assets. In 1997, the Company recognized a $15 million non-recurring, non-cash charge related to the Company's cross-license and settlement agreement with GenPharm International, Inc. Interest income remained relatively constant at $1.0 million and $1.1 million for the three months ended June 30, 1998 and 1997, respectively, and increased slightly to $2.3 million from $2.1 million for the six months ended June 30, 1998 and 1997 respectively. Average cash balances were consistent for the six months ended June 30, 1998 and 1997. Interest expense remained constant at $727,000 and $783,000 for the three months ended June 30, 1998 and 1997, respectively, and increased to $1.4 million from $1.1 million for the six months ended June 30, 1998. The increase for the six months represents interest paid on the note payable to GenPharm. 9 10 Cell Genesys' net loss decreased to $8.3 million and $16.0 million for the three and six months ended June 30, 1998 from $85.5 million and $102.3 million for the three and six months ended June 30, 1997, respectively. This was primarily due to $78.9 million in non-recurring charges for the acquisition of Somatix and related costs recognized in the second quarter 1997 and the non-recurring $15.0 million charge related to the cross license and settlement agreement recognized in the first quarter 1997. In addition, the Company attributed $1.5 million and $4.2 million of the losses of Abgenix for the three and six month periods ended June 30, 1998 to the minority stockholders. Net loss, excluding non-recurring charges, are expected to continue and are likely to increase in future years as operating expenses rise, particularly as the Company incurs expenses related to manufacturing and later stage human testing of its potential products. LIQUIDITY AND CAPITAL RESOURCES Cell Genesys has financed its operations primarily through the sale of equity securities, funding under collaborative arrangements and equipment financing. From inception through June 30, 1998, the Company received $169.7 million in net proceeds from equity financings, $96.2 million under collaborative agreements and utilized $26.4 million of property and equipment financings. At June 30, 1998, Cell Genesys' cash, cash equivalents and short-term investments totaled $60 million, excluding Abgenix' cash, cash equivalents and short-term investments of $7.6 million. Cell Genesys's cash, cash equivalents and short-term investments totaled to $73.5 million, excluding Abgenix' cash, cash equivalents and short-term investments of $15.3 million at December 31, 1997. The decrease was primarily due to use of cash in operating activities. In July 1998, Abgenix completed its initial public offering resulting in gross proceeds of $23 million. On March 27, 1997, the Company announced that, along with Abgenix, Xenotech, L.P. ("Xenotech", an equal joint venture of Abgenix and Japan Tobacco) and Japan Tobacco, it had signed a comprehensive patent cross-license and settlement agreement with GenPharm International, Inc. that resolved all related litigation and claims between the parties. The cross-license agreement includes a worldwide royalty free cross-license to all issued and related patent applications pertaining to the generation of fully human monoclonal antibody technologies in genetically modified strains of mice. The Company also obtained a license to certain technology in the field of gene therapy held by GenPharm. As consideration for the cross-license and settlement agreement, Cell Genesys issued a note due September 30, 1998 for $15.0 million, convertible into shares of Cell Genesys common stock, at $8.62 per share. Of this note, $3.75 million was contributed to, then paid by Xenotech. The entire amount of the note was recognized as expense by Abgenix in the first quarter of 1997 based on an independent valuation analysis of technology acquired. In addition, Japan Tobacco also made a cash payment to GenPharm. During 1997, two patent milestones of $7.5 million each under the agreement were met. Xenotech recognized expense of $15.0 million, $7.5 million of which was paid in cash with the remainder to be paid in November 1998. During 1997, Abgenix recognized an expense of $7.5 million for its contribution due to Xenotech for its share of the patent milestone obligations, of which $3.75 million was paid in cash and $3.75 million is accrued at June 30, 1998. The balance of the patent milestone obligations is the responsibility of Japan Tobacco. No additional milestone payments will accrue under this agreement. Cell Genesys anticipates that net cash expenditures for its gene therapy operations (excluding Abgenix, which will not be consolidated after July 2, 1998) will not exceed $25 million in 1998. Revenues under the agreement with Hoechst Marion Roussel are expected to decrease in 1998 and have been prepaid by Hoechst Marion Roussel. In addition, the above referenced note payable to GenPharm will come due September 30, 1998 and, depending on the Cell Genesys stock price at that time, may require cash settlement at the option of the holder. Payment by Abgenix of the second milestone due GenPharm will also be due in 1998. The Company expects its cash requirements to increase significantly in the future. The Company's capital requirements depend on numerous factors, including: the progress of the Company's research and development programs; preclinical and clinical trials; clinical and commercial scale manufacturing requirements; the attraction and maintenance of collaborative partners; the acquisition of new products or technologies; and the cost of litigation, patent interference proceedings or other legal proceedings or their resolution. Cell Genesys believes that its available cash, cash equivalents and short-term investments at June 30, 1988, together with the payments to be received under the Company's collaborative arrangements and license agreements 10 11 and $2.2 million in equipment financing available for capital equipment purchases will be sufficient to meet the Company's operating expenses and capital requirements at least through 1999. Thereafter, the Company will require substantial additional funds. Because of the Company's significant long-term cash requirements, the Company regularly considers financing alternatives, including the private or public sale of equity by Cell Genesys and by its subsidiary Abgenix. Any such transaction may be dilutive to existing stockholders. RISK FACTORS Need for Substantial Additional Funds. The Company and its subsidiary, Abgenix, will require substantial additional funds to continue existing and planned preclinical and clinical trials and its research and development activities, and to establish manufacturing and marketing capabilities for any products it may develop. The Company expects that its existing capital resources, together with payments to be received under existing collaborative agreements and amounts available under existing equipment financing facilities, will enable the Company to maintain the Company's operations at least through 1999. Beyond such time, the Company and Abgenix will need to raise substantial additional capital to fund its operations. The Company's future capital requirements will depend on, and could increase as a result of, many factors, including, but not limited to, the continuation of the collaboration with Hoechst Marion Roussel, continued scientific progress in its research and development programs, the magnitude of such programs, the progress of preclinical and clinical testing, the time and costs involved in obtaining regulatory approvals, the costs involved in preparing, filing, prosecuting, maintaining, enforcing and defending patent claims, competing technological and market developments, changes in collaborative relationships, the terms of any additional collaborative arrangements into which the Company may enter, the Company's ability to establish research, development and commercialization arrangements pertaining to products other than those covered by existing collaborative arrangements, the cost of establishing manufacturing facilities, the cost of commercialization activities, and the demand for the Company's products if and when approved. There is no assurance that opportunities for in-licensing technologies or for third party collaborations will continue to be available to the Company on acceptable terms. A major portion of the Company's operating revenues are derived from a collaborative agreement with Hoechst Marion Roussel signed in October 1995. Under the terms of the agreement, Hoechst Marion Roussel has the ability to terminate its commitment at any time two years after its anniversary date. Hoechst Marion Roussel is funding clinical development for this program in 1998. There is no assurance that Hoechst Marion Roussel will continue the agreement or that the level of funding will not vary year to year. The Company's operating results would be adversely affected should Hoechst Marion Roussel decide not to continue funding under this arrangement. Cell Genesys expects to raise additional funds through additional equity or debt financings, collaborative relationships, or otherwise. Because of these long-term capital requirements, the Company and its subsidiary, Abgenix, may seek to access the public or private equity markets whenever conditions are favorable, even if it does not have an immediate need for additional capital at that time. In July 1998, Abgenix completed its initial public offering of its common stock for gross proceeds of $23 million. There can be no assurance that any such additional funding will be available to the Company, or, if available, that it will be on acceptable terms. If additional funds are raised by issuing equity securities, further dilution to stockholders may result. If adequate funds are not available, the Company may be required to delay, reduce the scope of, or eliminate one or more of its research, development and clinical activities or to seek to obtain funds through arrangements with collaborative partners or others that may require the Company to relinquish rights to certain of its technologies, product candidates or products that the Company would otherwise seek to develop or commercialize itself, any of which could have a material adverse effect on the Company's business, results of operations, financial condition or cash flow. Early Stage Of Development; No Developed Or Approved Products. Cell Genesys' potential gene therapy products are in research and development. No revenues have been generated from the sale of any of such products, nor are any such revenues expected for at least the next several years. The products currently under development by Cell Genesys will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval, prior to commercial use. There can be no assurance that Cell Genesys' research and development efforts will be successful or that any commercially successful products will ultimately be developed by Cell Genesys. Even if developed, these products may not receive regulatory approval or be successfully introduced and marketed at prices that would permit Cell Genesys to operate profitably. 11 12 Operating Loss And Accumulated Deficit. Cell Genesys has incurred net losses since its inception. At June 30, 1998, Cell Genesys' accumulated deficit was approximately $195.6 million and incurred net losses of $16.0 million for the six months ended June 30, 1998. Such losses have resulted principally from expenses incurred in its research and development programs, and to a lesser extent, from general and administrative expenses. In 1997, Cell Genesys incurred losses of $123.5 million, including $78.9 million related to the acquisition of Somatix and $22.5 million related to the Cross-License and Settlement Agreement with GenPharm. The Company expects to incur substantial losses for at least the next several years due primarily to the expansion of research and development programs, including preclinical studies, clinical trials and manufacturing. Cell Genesys expects that losses will fluctuate from quarter to quarter and that such fluctuations may be substantial. There can be no assurance that the Company will successfully develop, commercialize, manufacture or market its products or ever achieve or sustain product revenues or profitability. Technological Uncertainty. Gene therapy is a new technology, and existing preclinical and clinical data on the safety and efficacy of gene therapy are limited. Data relating to Cell Genesys' specific gene therapy approaches are even more limited. The Company's T cell gene therapy for cancer, GVAX (TM) cancer vaccine and AIDS gene therapy are currently being tested in Phase I/II and Phase II human clinical trials to determine their safety and efficacy. None of the other products or therapies under development are in human clinical trials. The results of preclinical studies do not predict safety or efficacy in humans. Possible side effects of gene therapy may be serious and life-threatening. There can be no assurance that unacceptable side effects will not be discovered during preclinical and clinical testing of Cell Genesys' potential products or thereafter. There are many reasons that potential products that appear promising at an early stage of research or development do not result in commercialization. Although Cell Genesys is testing proposed products or therapies in human clinical trials, there can be no assurance that Cell Genesys will be permitted to undertake human clinical trials for any of its other products or that the results of such testing will demonstrate safety or efficacy. Even if clinical trials are successful, there is no assurance that Cell Genesys will obtain regulatory approval for any indication, or that an approved product can be produced in commercial quantities at reasonable cost, or be successfully marketed. Patents And Trade Secrets. The patent positions of pharmaceutical and biotechnology firms, including Cell Genesys, are generally uncertain and involve complex legal and factual questions. While Cell Genesys is prosecuting patent applications, it cannot be certain whether any given application will result in the issuance of a patent or, if any patent is issued, whether it will provide significant proprietary protection or will be invalidated. Because patent applications in the United States are confidential until patents are issued and publication of discoveries in the scientific or patent literature tends to lag behind actual discoveries by several months, Cell Genesys cannot be certain that it was the first creator of inventions covered by pending patent applications or that it was the first to file patent applications for such inventions. The commercial success of the Company will also depend in part on not infringing the patents or proprietary rights of others and not breaching licenses granted to Cell Genesys. The Company will be required to obtain licenses to certain third party technology and genes necessary to conduct its business. Any failure by the Company to license at reasonable cost any technology or genes required to commercialize its technologies or products may have a material adverse effect on the Company's business, results of operations, financial condition or cash flow. Litigation, which could result in substantial cost to the Company, may also be necessary to enforce any patents issued to Cell Genesys, or to determine the scope and validity of other parties' proprietary rights. To determine the priority of inventions, interference proceedings are frequently declared by the United States Patent Office that could result in substantial costs to the Company and may result in an adverse decision as to the priority of Cell Genesys' inventions. Cell Genesys is currently involved in three separate interference proceedings with regard to: (i) gene activation technology, (ii) ex vivo gene therapy, and (iii) chimeric receptor technology. While the Company believes its position in each interference proceeding is strong, the outcome of each proceeding cannot be predicted, and an adverse result could have a material adverse effect on the Company's intellectual property position and its business. The Company may be involved in other interference proceedings in the future. Cell Genesys believes that there will continue to be significant litigation in the industry regarding patent and other intellectual property rights. Cell Genesys also relies on unpatented trade secrets and improvements, unpatented know-how and continuing technological innovation to develop and maintain its competitive position. No assurance can be given that 12 13 others will not independently develop substantially equivalent proprietary information and techniques, or otherwise gain access to the Company's trade secrets or disclose such technology, or that the Company can meaningfully protect its rights to its unpatented trade secrets. Cell Genesys requires its employees and consultants to execute a confidentiality agreement upon the commencement of an employment or consulting relationship with it. These agreements provide that all confidential information developed by or made known to an individual during the course of the employment or consulting relationship generally must be kept confidential. In the case of employees, the agreements provide that all inventions conceived by the individual while employed by Cell Genesys, relating to its business are the exclusive property of Cell Genesys. These agreements may not provide meaningful protection for the Company's trade secrets in the event of unauthorized use or disclosure of such information. Competition. Competition in the field of gene therapy from other biotechnology and pharmaceutical companies and from research and academic institutions is intense and expected to increase. There are numerous competitors working on products to treat each of the diseases for which Cell Genesys is seeking to develop therapeutic products. Some competitors are pursuing a product development strategy competitive with Cell Genesys, particularly with respect to the Company's human monoclonal antibody program. Certain of these competitive products are in substantially more advanced stages of product development and clinical trials. The Company's competitors may develop technologies and products that are more effective than those being developed by Cell Genesys, or that would render the Company's technology and products less competitive or obsolete. Many of these competitors have substantially greater financial resources and larger research and development staffs than Cell Genesys. In addition, many of these competitors may have significantly greater experience than Cell Genesys in developing products, in undertaking preclinical testing and human clinical trials of new pharmaceutical products, in obtaining United States Food and Drug Administration (the "FDA") and other regulatory approvals of products, and in manufacturing and marketing such products. Accordingly, Cell Genesys' competitors may succeed in obtaining patent protection, receiving FDA approval or commercializing products more rapidly than Cell Genesys. There can be no assurance that the Company will be able to obtain certain biological materials necessary to support its research, development or manufacturing of any of its planned therapies. If the Company is permitted to commence commercial sales of products, it will also be competing with respect to marketing capabilities and manufacturing efficiency, areas in which it has limited or no experience. It is anticipated that the Company will build additional clinical scale and commercial scale manufacturing facilities to the extent that contract facilities are not available in order to commercialize its products. It is also anticipated that the Company will secure funding for these and other product development activities through its partners and future potential partners. Cell Genesys also competes with universities and other research institutions in the development of products, technologies and processes. In many instances, Cell Genesys competes with other commercial entities in acquiring products or technology from universities. Cell Genesys expects that competition among products approved for sale will be based, among other things, on product efficacy, safety, reliability, availability, price, patent, position, and sales, marketing and distribution capabilities. Cell Genesys' competitive positions also depend upon its ability to attract and retain qualified personnel, obtain patent protection or otherwise develop proprietary products or processes and secure sufficient capital resources for the often substantial period between product conception and commercial sales. The levels of revenues and profitability of biotechnology and pharmaceutical companies such as the Company may be affected by the continuing efforts of governmental and third-party payers to contain or reduce the costs of health care through various means. In the United States there have been, and Cell Genesys expects that there will continue to be, a number of federal and state proposals to control health care costs. Cell Genesys cannot predict the effect health care reforms may have on its business, and no assurance can be given that any such reforms will not have a material adverse effect on the Company's business, results of operations, financial condition or cash flow. In the United States and elsewhere, sales of therapeutic products are dependent in part on the availability of reimbursements to the consumer from third party payers, such as government and private insurance plans. If the Company succeeds in bringing one or more products to the market, there can be no assurance that these products will be considered cost effective and that reimbursement to the consumer will be available or will be sufficient to allow the Company to sell its products on a competitive basis. 13 14 Volatility Of Stock Price. The market prices for securities of biopharmaceutical and biotechnology companies (including Cell Genesys) have historically been highly volatile, and the market has from time to time experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies. Factors such as fluctuations in Cell Genesys' operating results, announcements of technological innovations or new therapeutic products by Cell Genesys or its competitors, governmental regulation, developments in patent or other proprietary rights, public concern as to the safety of products developed by the Company or other biotechnology and pharmaceutical companies, and general market conditions may have a significant effect on the market price of the Cell Genesys' Common Stock. Government Regulation. Regulation by governmental authorities in the United States and foreign countries is a significant factor in the manufacture and marketing of Cell Genesys' proposed products and its research and development activities. All of Cell Genesys' products will require regulatory approval by governmental agencies prior to commercialization. In particular, human therapeutic products must undergo rigorous preclinical and clinical testing and other premarket approval procedures by the FDA and similar authorities in foreign countries. Since certain of Cell Genesys' potential products involve the application of new technologies, regulatory approvals may take longer than for products produced using more conventional methods. Various federal and, in some cases, state statutes and regulations also govern or influence the manufacturing, safety, labeling, storage, record keeping and marketing of such products. The lengthy process of seeking these approvals, and the subsequent compliance with applicable federal statutes and regulations, requires the expenditure of substantial resources. Any failure by Cell Genesys or its collaborators or licensees to obtain, or any delay in obtaining, regulatory approvals could adversely affect the marketing of any products developed by Cell Genesys, and its ability to receive product or royalty revenue. In responding to a new drug application, or a product license application, the FDA may grant marketing approvals, request additional information or further research, or deny the application if it determines that the application does not satisfy its regulatory approval criteria. Approvals may not be granted on a timely basis, if at all, or if granted may not cover all the clinical indications for which Cell Genesys is seeking approval or may contain significant limitations in the form of warnings, precautions or contraindications with respect to conditions of use. In addition to laws and regulations enforced by the FDA, Cell Genesys is also subject to regulation under the Occupational Safety and Health Act, the Environmental Protection Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act and other present and potential future federal, state or local laws and regulations. Cell Genesys' research and development involves the controlled use of hazardous materials, chemicals, viruses and various radioactive compounds. Although Cell Genesys believes its safety procedures for handling and disposing of such materials comply with the standards prescribed by state and federal regulations, the risk of accidental contamination or injury from these materials cannot be completely eliminated. In the event of such an accident, Cell Genesys could be held liable for any damages that result and any such liability could exceed the resources of the Company. The manufacturing facilities of Cell Genesys are subject to licensing requirements of the California Department of Health Services. While not subject to license by the FDA, such facilities are subject to inspection by the FDA as well as by the California Department of Health Services. A separate license from the FDA is required for commercial manufacture of any product. Failure to maintain such licenses or to meet the inspection criteria of the FDA and the California Department of Health Services would result in disruption to the manufacturing processes of the Company and would have a material adverse effect on the Company's business, results of operations, financial condition and cash flow. For marketing outside the United States, Cell Genesys is subject to foreign regulatory requirements governing human clinical trials and marketing approval for drugs and devices. The requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from country to country. Failure to comply with such regulatory requirements or obtain such approvals could impair the Company's ability to develop these markets and have a material adverse effect on the Company's business, results of operations, financial condition or cash flow. Commercialization; Lack of Marketing Experience. It is anticipated that the Company will rely on sales and marketing expertise of potential corporate partners for its initial products. Cell Genesys does not have any experience in sales, marketing or distribution of biopharmaceutical products. The decision to market future products directly or through corporate partners will be based on a number of factors including market size and concentration, the size and 14 15 expertise of the partner's sales force in a particular market and the Company's overall strategic objectives. Cell Genesys is currently engaged in various stages of discussions with potential partners. There can be no assurance that Cell Genesys will be able to establish such relationships, if at all, on acceptable terms and conditions. Product Liabilities And Insurance. Clinical trials or marketing of any of Cell Genesys' potential products may expose the Company to liability claims resulting from the use of such products. These claims might be made directly by consumers, health care providers or by others selling such products. Cell Genesys and Abgenix currently maintain product liability insurance with respect to each company's clinical trials. There can be no assurance that the Company will be able to maintain such insurance or, if maintained, that sufficient coverage can be acquired at a reasonable cost. An inability to maintain insurance at acceptable cost or at all could prevent or inhibit the clinical testing or commercialization of products developed by the Company. A product liability claim or recall could have a material adverse effect on the Company's business, results of operations, financial condition and cash flow. Hazardous Materials; Environmental Matters. Cell Genesys' research and development activities involve the controlled use of hazardous materials, chemicals, viruses and various radioactive compounds. Cell Genesys is subject to federal, state and local laws and regulations governing the use, manufacture, storage, handling and disposal of such materials and certain waste products. Although Cell Genesys believes that its safety procedures for handling and disposing of such materials comply with the standards prescribed by such laws and regulations, the risk of accidental contamination or injury from these materials cannot be completely eliminated. In the event of such an accident, the Company could be held liable for any damages that result and any such liability could exceed the resources of the Company. The Company may be required to incur significant costs to comply with environmental laws and regulations in the future. The Company's operations, business or assets may be materially adversely affected by current or future environmental laws or regulations. Reimbursement. In both domestic and foreign markets, sales of the Company's potential products will depend in part upon coverage and reimbursement from third-party payers, including health care organizations, government agencies, private health care insurers and other health care payers such as health maintenance organizations, self-insured employee plans and the Blue Cross/Blue Shield plans. There is considerable pressure to reduce the cost of drug products. In particular, reimbursement from government agencies and insurers and large health organizations may become more restricted in the future. Cell Genesys' potential products represent a new mode of therapy and, while the cost-benefit ratio of the products may be favorable, Cell Genesys expects that the costs associated with the Company's products will be substantial. There can be no assurance that the Company's proposed products, if successfully developed, will be considered cost-effective by third-party payers, that insurance coverage will be available or, if available, that such third-party payers' reimbursement policies will not adversely affect the Company's ability to sell its products on a profitable basis. In addition, there can be no assurance that insurance coverage will be provided by such third-party payers at all or without substantial delay or, if such coverage is provided, that the approved reimbursement will provide sufficient funds to enable the Company to become profitable. Uncertainty Of Pharmaceutical Pricing And Related Matters. The future revenues and profitability of and availability of capital for biotechnology companies may be materially adversely affected by the continuing efforts of governmental and third-party payers to contain or reduce the costs of healthcare through various means. For example, in certain foreign markets, pricing or profitability of prescription pharmaceuticals is subject to government control. In the United States, there have been, and Cell Genesys expects that there will continue to be, a number of federal and state proposals to implement similar government control. While Cell Genesys cannot predict whether any such legislative or regulatory proposals will be adopted, the announcement or adoption of such proposals could have a material adverse effect on the Company's business, results of operations, financial condition and cash flow. Dependence Upon Key Personnel And Collaborative Relationships. Cell Genesys' success is highly dependent on the retention of principal members of management and scientific staff and the recruitment of additional qualified personnel. The loss of key personnel or the failure to recruit necessary additional qualified personnel could have a material adverse effect on the Company's business, results of operations, financial condition or cash flow. There is intense competition from other companies, research and academic institutions and other organizations for qualified personnel in the areas of Cell Genesys' activities. There is no assurance that the Company will be able to continue to attract and retain the qualified personnel necessary for the development of its business. These activities are expected to require the addition of new personnel with expertise in the areas of clinical testing, manufacturing, marketing and distribution and the development of additional expertise by existing personnel. The failure to acquire 15 16 such personnel or develop such expertise could have a material adverse effect on the Company's business, results of operations, financial condition and cash flow. Cell Genesys has clinical trial arrangements with the National Institutes of Allergy and Infectious Diseases covering the initial proof-of-principle study for AIDS gene therapy being conducted in identical twin pairs now in Phase II testing. Cell Genesys also has clinical trial arrangements with the University of California, San Francisco, San Francisco General Hospital, the University of Colorado Health Sciences Center, Massachusetts General Hospital, the University of California, Los Angeles, ViRx, Inc. and the Aids Research Community Consortium covering Cell Genesys' patient-specific configuration of its AIDS gene therapy also now in Phase II testing. If these relationships were terminated, progress of clinical testing would be adversely affected. In addition, the Company has several clinical trial arrangements under its GVAX (TM) program, including with The Johns Hopkins University covering a Phase I clinical trial to treat prostate cancer patients and with the Dana Farber Cancer Institute covering two Phase I clinical trials to treat lung cancer and melanoma patients. In the event that any of these relationships are terminated, the completion and evaluation of clinical trials could be adversely affected. In addition, the Company has several clinical trial arrangements under its T cell gene therapy program for cancer, including with University of California, San Francisco, Stanford University and PRN Research, Inc. In the event that any of these relationships are terminated, the completion and evaluation of clinical trials could be adversely affected The Company will depend, in part, on the continued availability of outside scientific collaborators performing research. These relationships generally may be terminated at any time by the collaborator, typically by giving 30 days' notice. The Company's scientific collaborators are not employees of Cell Genesys. As a result, the Company has limited control over their activities and can expect that only limited amounts of their time will be dedicated to the Company's activities. The Company's agreements with these collaborators, as well as those with the Company's scientific consultants provide that any rights the Company obtains as a result of the research efforts of these individuals will be subject to the rights of the research institutions in such work. In addition, some of these collaborators have consulting or other advisory arrangements with other entities that may conflict with their obligations to the Company. For these reasons, there can be no assurance that inventions or processes discovered by the Company's scientific collaborators or consultants will become the property of the Company. Shares Eligible For Future Sale; Dilution. Substantially all of the Company's shares are eligible for sale in the public market. The issuance of common stock upon conversion of the Series B preferred stock and convertible note and upon exercise of the warrants, as well as future sales of such common stock or of shares of common stock by existing stockholders, or the perception that such sales could occur, could adversely affect the market price of the common stock. Conversion of the Series B preferred stock and the convertible note and exercise of the warrants for shares of common stock could adversely affect the market price of the common stock. In addition, investors could experience substantial dilution upon conversion of the Series B preferred stock into common stock as a result of either (i) a decline in the market price of the Company's common stock immediately prior to conversion, or (ii) an event triggering the antidilution rights of any outstanding shares of Series B preferred stock. IMPACT OF THE YEAR 2000 The Company has initiated modification of its information technology systems to recognize the year 2000 and has begun converting critical hardware and data processing systems. The Company expects the project to be substantially complete by early 1999. The Company does not expect this project to have a significant effect on operations, and the costs of modification are expected to be insignificant. In addition, the Company is evaluating significant vendors and other third parties which could have an effect on the Company's operations to ensure Year 2000 compliance. ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK Not Applicable. 16 17 PART II. OTHER INFORMATION ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS On June 3, 1998, in the annual stockholders' meeting, a quorum of stockholders of the Company approved the following proposals: (i.) Election of Directors. (ii.) Proposal to approve the adoption of the Cell Genesys' 1998 Incentive Stock Plan, to replace the 1989 Incentive Stock Plan, and reserve a total of 1,760,000 shares for issuance thereunder. (iii.) Proposal to ratify the appointment of Ernst & Young LLP as independent auditors of Cell Genesys for the fiscal year ending December 31, 1998. The following table shows the results of the voting on these matters. (i.) Director For Withheld -------- --- -------- David W. Carter 24,227,947 84,851 James M. Gower 24,231,258 84,851 Raju S. Kucherlapati 24,244,648 84,851 Joseph E. Maroun 25,904,909 84,851 John T. Potts 24,241,457 84,851 Stephen A. Sherwin 24,240,682 84,851 Eugene L. Step 24,239,657 84,851 Inder M. Verma 24,240,938 84,851 (ii.) For Against Abstain Broker Non-Vote --- ------- ------- --------------- 13,431,297 4,161,142 90,775 8,284,909 (iii.) For Against Abstain Broker Non-Vote --- ------- ------- --------------- 23,982,848 1,954,450 30,825 0 17 18 PART II. OTHER INFORMATION ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K a) Exhibits 27.1 Financial Data Schedule b) Reports on Form 8-K None. SIGNATURES Pursuant to the requirements of Section 13 or 15 (d) of the Securities Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized in Foster City, California, on August 14, 1998: CELL GENESYS, INC. By: /s/ Kathleen Serada Glaub -------------------------------------------- Kathleen Sereda Glaub, Senior Vice President and Chief Financial Officer (Principal Accounting and Financial Officer) Date: August 14, 1998 18 19 INDEX TO EXHIBITS Exhibit Number Description - ------- ----------- 27.1 Financial Data Schedule