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UNITED STATES
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, 2003

OR

[  ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ________to _________

Commission file number 0-19986

CELL GENESYS, INC.
(Exact name of Registrant as specified in its Charter)

 
Delaware
94-3061375
  (State or Other Jurisdiction of Incorporation or Organization) 
(IRS Employer Identification Number)

500 Forbes Blvd, South San Francisco, California   94080
(Address of Principal Executive Offices including Zip Code)

(650) 266-3000
(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 [  ]

    Indicate by check mark whether the Registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act). Yes [X] No [  ]

    As of July 31, 2003, the number of outstanding shares of the Registrant's Common Stock was 39,261,762.












CELL GENESYS, INC.
FORM 10-Q
TABLE OF CONTENTS

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements:

  1. Condensed Consolidated Balance Sheets -- June 30, 2003 and December 31, 2002

  2. Condensed Consolidated Statements of Operations -- Three and Six Months ended June 30, 2003 and 2002

  3. Condensed Consolidated Statements of Cash Flows -- Six Months ended June 30, 2003 and 2002

  4. Notes to Condensed Consolidated Financial Statements

Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations

Item 3. Quantitative and Qualitative Disclosure about Market Risks

Item 4. Controls and Procedures

PART II. OTHER INFORMATION

Item 1: Legal Proceedings

Item 4: Submission of Matters to a Vote of Security Holders

Item 6: Exhibits and Reports on Form 8-K

SIGNATURES








PART I -- FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS






CELL GENESYS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)



                                                             June 30,     December 31,
                                                               2003           2002
                                                           -------------  -------------
                                                            (Unaudited)     (Note 1)
                         ASSETS
Current assets:
   Cash and cash equivalents............................. $      28,836  $      39,072
   Short-term investments................................        42,646         60,555
   Current portion of restricted cash and investments....         3,358         16,166
   Receivable from Transkaryotic Therapies, Inc..........            --         15,000
   Investment in Abgenix, Inc. common stock..............        82,494         64,076
   Prepaid expenses and other current assets.............         2,211          1,340
                                                           -------------  -------------
 Total current assets....................................       159,545        196,209
Restricted cash and investments..........................        60,000         51,112
Property and equipment, net..............................       173,664        157,215
Deposits and other assets................................           799          1,312
                                                           -------------  -------------
                                                          $     394,008  $     405,848
                                                           =============  =============

          LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
   Accounts payable......................................         4,516          3,980
   Accrued compensation and benefits.....................         3,570          3,611
   Deferred revenue......................................         5,871          5,871
   Accrued facility exit costs...........................         7,777          6,178
   Other accrued liabilities.............................         4,342          6,870
   Income taxes payable..................................         9,945          4,219
   Deferred tax liability................................        30,489         23,147
   Current portion of debt financing.....................            --          8,889
   Current portion of capital leases.....................           699            286
                                                           -------------  -------------
 Total current liabilities...............................        67,209         63,051

Noncurrent portion of debt financing.....................        60,000         51,111
Noncurrent portion of capital leases.....................        52,711         52,906

Commitments
Redeemable convertible preferred stock...................         5,580          7,632

Stockholders' equity:
   Common stock..........................................            37             37
   Additional paid-in capital............................       289,366        286,548
   Accumulated other comprehensive income................        45,732         34,719
   Accumulated deficit...................................      (126,627)       (90,156)
                                                           -------------  -------------
 Total stockholders' equity..............................       208,508        231,148
                                                           -------------  -------------
                                                                394,008        405,848
                                                           =============  =============

See accompanying notes.







CELL GENESYS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share data) (Unaudited)


                                                              Three Months Ended            Six Months Ended
                                                                 June 30, 2003                June 30, 2003
                                                          --------------------------  --------------------------
                                                              2003          2002          2003          2002
                                                          ------------  ------------  ------------  ------------
Revenue ................................................ $         13  $     31,102  $      1,051  $     35,697


Operating expenses:
   Research and development.............................       22,578        17,800        43,636        34,363
   General and administrative ..........................        6,930         4,348        11,971         8,006
                                                          ------------  ------------  ------------  ------------
 Total operating expenses...............................       29,508        22,148        55,607        42,369
                                                          ------------  ------------  ------------  ------------
Income (loss) from operations...........................      (29,495)        8,954       (54,556)       (6,672)
Gain on sale of Abgenix, Inc. common stock..............        7,288            --         7,288            --
Interest and other income...............................        1,350         2,165         3,281         4,582
Interest expense........................................       (1,411)         (436)       (1,710)         (845)
                                                          ------------  ------------  ------------  ------------
Income (loss) before minority interest and income taxes.      (22,268)       10,683       (45,697)       (2,935)
Income (loss) attributed to minority interest...........           --          (175)           --            96
                                                          ------------  ------------  ------------  ------------
Income (loss) before income taxes.......................      (22,268)       10,508       (45,697)       (2,839)
Benefit (provision) for income taxes....................        3,172        (4,027)        9,226           502
                                                          ------------  ------------  ------------  ------------
Net income (loss)....................................... $    (19,096) $      6,481  $    (36,471) $     (2,337)
                                                          ============  ============  ============  ============

Basic net income (loss) per common share................ $      (0.51) $       0.18  $      (0.98) $      (0.07)
                                                          ============  ============  ============  ============
Diluted net income (loss) per common share.............. $      (0.51) $       0.17  $      (0.98) $      (0.07)
                                                          ============  ============  ============  ============
Weighted average shares of common stock
     outstanding - basic ...............................       37,193        35,645        37,060        35,635
                                                          ============  ============  ============  ============
Weighted average shares of common stock
     outstanding - diluted..............................       37,193        37,855        37,060        35,635
                                                          ============  ============  ============  ============

See accompanying notes.








CELL GENESYS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands) (unaudited)


                                                              Six Months Ended June 30,
                                                             --------------------------
                                                                 2003          2002
                                                             ------------  ------------
Cash flows from operating activities:
  Net loss................................................. $    (36,471) $     (2,337)
  Adjustments to reconcile net loss to net cash
   used in operating activities:
     Depreciation and amortization.........................        4,995         1,629
     Loss on disposal of property and equipment............          544            --
     Gain on sale of Abgenix, Inc. common stock............       (7,288)           --
     Non-employee stock-based compensation.................           81            --
  Changes to:
     Prepaid expenses and other assets.....................         (401)        8,508
     Receivable from Transkaryotic Therapies, Inc..........       15,000       (15,000)
     Accounts payable......................................          536         1,246
     Accrued compensation and benefits.....................          (41)         (129)
     Deferred revenue......................................           --         3,585
     Accrued facility exit costs...........................        1,599            --
     Other accrued liabilities.............................       (2,528)         (973)
     Minority interest in equity of subsidiary.............           --           (96)
     Income taxes payable..................................        5,726        (4,027)
                                                             ------------  ------------
  Net cash used in operating activities....................      (18,248)       (7,594)
                                                             ------------  ------------
Cash flows from investing activities:
  Purchases of short-term investments......................      (91,768)     (139,764)
  Maturities of short-term investments.....................        1,350            --
  Sales of short-term investments..........................      111,374        95,091
  Capital expenditures.....................................      (21,945)      (22,275)
  Proceeds from disposal of property and equipment.........           --           (71)
  Proceeds from sale of Abgenix common stock...............        8,098            --
                                                             ------------  ------------
  Net cash provided by (used in) investing activities......        7,109       (67,019)
                                                             ------------  ------------
Cash flows from financing activities:
  Proceeds from issuances of common stock..................          685           520
  Proceeds from capital leases.............................          237            --
  Payments under capital leases............................          (19)           --
                                                             ------------  ------------
  Net cash provided by financing activities................          903           520
                                                             ------------  ------------
Net decrease in cash and cash equivalents..................      (10,236)      (74,093)
Cash and cash equivalents at the beginning of the period...       39,072       143,055
                                                             ------------  ------------
Cash and cash equivalents at the end of the period......... $     28,836  $     68,962
                                                             ============  ============

See accompanying notes








Cell Genesys, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)

 

1. Organization and Summary of Significant Accounting Policies

Organization and basis of presentation

Cell Genesys, Inc. ("Cell Genesys" or "the Company") has focused its research and product development efforts on human disease therapies that are based on innovative gene modification technologies. The Company's objective is to develop and commercialize cancer vaccines, oncolytic virus therapies and gene therapies to treat cancer and other major, life-threatening diseases. Cell Genesys' current clinical programs include GVAX® cancer vaccines and oncolytic virus therapies.

The consolidated financial statements include the accounts of Cell Genesys and its majority-owned subsidiary. All significant intercompany balances and transactions have been eliminated.

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included. Operating results for the six-month period ended June 30, 2003 are not necessarily indicative of the results that may be expected for the year ending December 31, 2003.

The condensed consolidated balance sheet at December 31, 2002 has been derived from the audited consolidated 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 condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto included in the Company's Report on Form 10-K for the year ended December 31, 2002.

Revenue recognition

The Company's revenues are principally generated from research and licensing agreements with collaborators. Revenue under such collaboration agreements typically includes upfront payments, cost reimbursements and milestone payments.

Revenue under these agreements from non-refundable upfront license fees and other payments where the Company continues involvement throughout development is recognized ratably over the development period. The Company recognizes cost reimbursement revenue under collaborative agreements as the related research and development costs are incurred, as provided for under the terms of the agreements.

Incentive milestone payments under collaborative arrangements are recognized as revenue upon achievement of the incentive milestone events, which represent the culmination of the earnings process. Incentive milestone payments are triggered either by the results of our research efforts or by events external to Cell Genesys, such as regulatory approval to market a product or the achievement of specified sales levels by a marketing partner. As such, the incentive milestones are substantially at risk at the inception of the contract, and the amounts of the payments assigned thereto are commensurate with the milestone achieved. Upon the achievement of an incentive milestone event, the Company has no future performance obligations related to that payment.

Amounts received under license agreements relating to the Company's intellectual property are recognized as revenue upon execution of the technology licensing agreement, if the Company has no future performance obligations.

Deferred revenue represents the portion of upfront payments received that has not been earned.

Reclassifications

Certain prior period balances have been reclassified to conform with the current period presentation.

Stock-based compensation

In accordance with the provisions of Statement of Financial Accounting Standards No. 123, "Accounting for Stock-Based Compensation" ("SFAS 123"), the Company has elected to follow Accounting Principles Board Opinion No. 25, "Accounting for Stock Issued to Employees" ("APB 25") and related interpretations and to adopt the "disclosure only" alternative described in SFAS 123. Under APB 25, when the exercise price of the Company's employee stock options equals or exceeds the fair market value on the date of the grant or the fair value of the underlying stock on the date of the grant as determined by the Company's Board of Directors, no compensation expense is recognized.

The following table illustrates, pursuant to SFAS 123 and as amended by SFAS No. 148, the effect on net income (loss) and related net income (loss) per common share had compensation costs for stock-based employee compensation plans been determined based upon the fair value method prescribed under SFAS 123:

Three Months Ended
June 30,

Six Months Ended
June 30,

2003

2002

2003

2002

 

(in thousands, except share data)

 

 

 

 

 

Net income (loss)

$ (19,096)

$ 6,481

$ (36,471)

$ (2,337)

Deduct:

 

 

 

 

Stock-based employee compensation expense determined under SFAS 123

(4,255)

(3,977)

(8,454)

(7,313)

Pro forma net income (loss)

$ (23,351)

$ 2,504

$ (44,925)

$ (9,650)

 

 

 

 

 

Basic net income (loss) per common share, as reported

$ (0.51)

$ 0.18

$ (0.98)

$ (0.07)

Diluted net income (loss) per common share, as reported

$ (0.51)

$ 0.17

$ (0.98)

$ (0.07)

Basic pro forma net income (loss) per common share

$ (0.63)

$ 0.07

$ (1.21)

$ (0.27)

Diluted pro forma net income (loss) per common share

$ (0.63)

$ 0.07

$ (1.21)

$ (0.27)

Net income (loss) per share

Basic net income (loss) per common share is calculated using the weighted average number of shares of common stock outstanding during the period, less shares subject to repurchase. Diluted net income (loss) per share includes the impact of potentially dilutive securities. As the Company's potentially dilutive securities (stock options and redeemable convertible preferred stock) were anti-dilutive for the three months ended June 30, 2003 and the six months ended June 30, 2003 and 2002, they have been excluded from the computation of shares used in computing diluted net loss per common share for those periods. Diluted net income per share for the three months ended June 30, 2002 includes the effect of 2,210,000 potentially dilutive securities, consisting of stock options and convertible preferred stock.

Use of estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Actual results could differ from those estimates. Estimates in the financial statements include, but are not limited to, accrued but unbilled expenses for clinical trials, accrued facility exit costs, expenses for certain outside experts and consultants, useful lives of property and equipment, and other items.

Comprehensive income (loss)

Comprehensive income (loss) is comprised of net income (loss) and other comprehensive income (loss). Other comprehensive income (loss) includes certain changes to stockholders' equity of the Company that are excluded from net loss. Specifically, unrealized gains or losses on the Company's available-for-sale securities are included in other comprehensive income (loss), net of tax.

The following table presents the calculation of comprehensive income (loss):

 

Three Months Ended
June 30,

Six Months Ended
June 30,

 

2003

2002

2003

2002

 

(in thousands)

 

 

 

 

 

Net income (loss)

$ (19,096)

$ 6,481

$ (36,471)

$ (2,337)

Other comprehensive income (loss):

Increase (decrease) in unrealized gain on investments, net of tax

9,199

(47,552)

16,234

(127,467)

Less: reclassification adjustment for gains recognized in net loss, net of tax

(4,728)

(128)

(5,221)

(417)

Comprehensive income (loss)

$ (14,625)

$ (41,199)

$ (25,458)

$ (130,221)

Capitalization of interest expense

In connection with the construction of our manufacturing facility in Hayward, California, we have capitalized a portion of the interest expense related to our $60.0 million asset-backed debt facility. Capitalized interest is added to the cost of the underlying asset and is amortized over the useful life of that asset. Interest expense of $0.3 million and $0.6 million was capitalized in the three and six-month periods ended June 30, 2003, respectively. No interest was capitalized in the comparable quarters of 2002. As of June 30, 2003, interest expense totaling $1.3 million has been capitalized in connection with the construction of our manufacturing facility in Hayward, California.

Recent accounting pronouncements

i. Revenue arrangements with multiple deliverables

In November 2002, the Financial Accounting Standards Board (FASB) issued Emerging Issues Task Force ("EITF") Issue No. 00-21, "Revenue Arrangements with Multiple Deliverables." EITF 00-21 addresses certain aspects of the accounting by a company for arrangements under which it will perform multiple revenue-generating activities. The provisions of EITF 00-21 will apply to revenue arrangements entered into in fiscal periods beginning after June 15, 2003. The provisions of EITF 00-21 do not impact the accounting treatment of the Company's existing revenue arrangements. The Company believes that the adoption of EITF 00-21 will not result in a material change to its existing revenue recognition policy for prospective revenue arrangements and does not expect the adoption of EITF 00-21 to have a material impact on its consolidated financial statements.

ii. Consolidation of variable interest entities

In January 2003, the FASB issued Financial Interpretation No. 46, "Consolidation of Variable Interest Entities" (FIN 46). The consolidation requirements of FIN 46 apply immediately to variable interest entities created after January 31, 2003. The consolidation requirements apply to older entities in the first fiscal year or interim periods beginning after June 15, 2003. Certain of the disclosure requirements apply in all financial statements issued after January 31, 2003, regardless of when the variable interest entity was established. Based upon a preliminary assessment, Cell Genesys is not aware of any of its contractual arrangements or relationships that would be considered a variable interest in a variable interest entity. However, the implementation of FIN 46 is complex and will require the Company to perform a comprehensive review of its contractual arrangements in the third quarter of 2003.

iii. Accounting for certain financial instruments with characteristics of both liabilities and equity

In May 2003, the FASB issued Statement of Financial Accounting Standards No. 150, "Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity" (FAS 150). FAS 150 establishes standards on the classification and measurement of financial instruments with characteristics of both liabilities and equity. FAS 150 is effective for financial instruments entered into or modified after May 31, 2003. The Company is currently evaluating the impact that the adoption of FAS 150 will have on its consolidated financial statements.

2. Corporate Headquarter Facilities

Cell Genesys maintains its corporate headquarters in South San Francisco, California. In the fourth quarter of 2002, the Company recorded approximately $6.2 million of general and administrative expense for estimated lease exit costs associated with the Company's move of its corporate headquarters to South San Francisco, California in March 2003 and the related vacancy in Foster City, California. Based upon updated estimates of the rental market for comparable laboratory and office space, the Company revised its estimate of lease exit costs and recorded an additional $1.6 million of general and administrative expense in the second quarter of 2003. Lease exit costs will continue to be revised as necessary based on our ability to sublease the facilities and as market conditions change. Future rent payments related to the Company's Foster City location total $16.2 million through the expiration of the related leases in January 2006. The Company is actively pursuing sublease alternatives for its facilities in Foster City.

3. Redeemable Convertible Preferred Stock

During the three months ended June 30, 2003, 166 shares of the Company's Series B redeemable convertible preferred stock were converted into 278,264 shares of the Company's common stock at an average effective conversion price of $7.37 per share. The total market value of such common shares as of the date of conversion was approximately $2.1 million.

4. Property and Equipment Financing

In April 2003, the Company amended the terms of its $60.0 million asset-backed debt financing. Under the amendment, the quarterly principal payments have been replaced with a single balloon payment in 2008, and the interest rate was reduced from LIBOR (London Interbank Offering Rate) plus .750 percent to LIBOR plus .625 percent. The financing obligation remains secured by liquid financial instruments, including cash and marketable securities, which are classified as restricted cash and investments on the condensed consolidated balance sheet. Under the terms of the obligation the Company is required to meet various financial reporting covenants with which it remains in compliance. As a result of this amendment, the Company classified its short-term obligation under the original asset-backed debt financing as a noncurrent debt financing obligation on its June 30, 2003 condensed consolidated balance sheet.

5. Subsequent Event

On July 23, 2003, the Company announced a global alliance with Novartis AG for the development and commercialization of oncolytic virus therapies. Under the agreement, the Company acquired exclusive worldwide rights to the oncolytic virus therapy products and related intellectual property of Genetic Therapy, Inc. (GTI), an affiliate of Novartis, and received a signature payment of $28.5 million from Novartis. This payment is to be dedicated to the further development of certain oncolytic virus therapy products of the Company and those acquired from GTI. In exchange, the Company issued to Novartis 1,999,840 shares of Cell Genesys, Inc. common stock. The agreement also provides the basis for the sharing of future additional development costs and potential profits related to certain of the products on a worldwide basis.

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 us and our subsidiary's clinical trials, research programs, product pipelines, current and potential corporate partnerships, licenses and intellectual property, adequacy of capital reserves 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 technologies, the ability to raise capital, 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 us under "Other Factors Affecting Future Operations" below. We do not undertake any obligation to update forward-looking statements. The following should be read in conjunction with our condensed consolidated financial statements located elsewhere in this Quarterly Report on Form 10-Q and the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2002 and in other documents filed by us from time to time with the Securities and Exchange Commission.

Overview

Since its inception in April 1988, Cell Genesys has focused its research and product development efforts on human disease therapies that are based on innovative gene modification technologies. Our strategic objective is to develop and commercialize cancer vaccines, oncolytic virus therapies and gene therapies to treat cancer and other major, life-threatening diseases. Cell Genesys' current clinical programs include GVAX® cancer vaccines and oncolytic virus therapies. GVAX® cancer vaccines are in Phase 2 studies for prostate cancer, lung cancer, pancreatic cancer and leukemia and in Phase 1/2 studies for multiple myeloma. We expect to initiate Phase 3 trials for GVAX® prostate cancer vaccine and GVAX® lung cancer vaccine during the next year. Ongoing clinical programs evaluating our oncolytic virus therapies include a Phase 1/2 study of CG7870 plus radiation therapy for early-stage prostate cancer. In addition, Cell Genesys has preclinical oncolytic virus therapy programs as well as preclinical cancer gene therapy programs evaluating potential therapies for multiple types of cancer. Additionally, Cell Genesys has a majority-owned subsidiary, Ceregene, Inc., which is focused on gene therapies for neurological disorders, and continues to hold approximately 7.9 million shares of common stock of its former subsidiary, Abgenix, Inc. (NASDAQ: ABGX), which is focused on the development and commercialization of antibody therapies.

Second Quarter 2003 and Other Recent Highlights:

  • We reported interim data at the American Society of Clinical Oncology (ASCO) Annual Meeting from our second Phase 2 trial of GVAX® prostate cancer vaccine in patients with hormone-refractory metastatic prostate cancer. The study, which was designed to evaluate potential treatment regimens for Phase 3, demonstrated the safety and clinical activity of the vaccine as measured by three independent measurements of antitumor activity: (i) a collagen fragment assay which is a measure of the bone destruction that occurs when prostate cancer spreads to the bone, (ii) PSA (prostate-specific antigen), and (iii) prostate cancer-associated antibodies.
  • We reported initial data at the ASCO Annual Meeting from our Phase 1/2 trial for GVAX® cancer vaccine for multiple myeloma, a type of bone marrow cancer. Combination therapy with transplantation and GVAX® myeloma vaccine resulted in two complete responses, six partial responses, two patients with stable disease and one patient with progressive disease, with three remaining patients not yet able to be evaluated. Two of these patients, whose diseases had progressed after transplantation, demonstrated antitumor activity following GVAX® vaccination as measured by reductions in the myeloma-associated circulating protein. Treatment with GVAX® myeloma vaccine to date has been safe and well tolerated.
  • We announced a global alliance with Novartis AG (NYSE: NVS) for the development and commercialization of oncolytic virus therapies. Under the agreement, Cell Genesys acquired exclusive worldwide rights to the oncolytic virus therapy products and related intellectual property of Genetic Therapy, Inc. (GTI), an affiliate of Novartis, and received a signature payment of $28.5 million from Novartis. In the transaction, Cell Genesys issued to Novartis 1,999,840 shares of Cell Genesys common stock and, as a result, Novartis now holds approximately five percent of Cell Genesys' currently outstanding common stock.
  • We hired Carol C. Grundfest as our vice president, regulatory affairs and project management. Prior to joining Cell Genesys, Ms. Grundfest served as executive director of project management and strategic planning at Systemix, Inc. and GTI, Inc. (affiliates of Novartis AG). Ms. Grundfest also held senior regulatory positions with Roche Global Development and Syntex, and previously served as assistant vice president, R&D at the Pharmaceutical Research and Manufacturers of America.

Critical Accounting Policies

We consider certain accounting policies related to revenue recognition, lease accounting, use of estimates and income taxes to be critical policies. There have been no critical changes in our critical accounting policies during the three and six months ended June 30, 2003 as compared to what was previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2002 filed with the Securities and Exchange Commission on March 31, 2003.

Revenue recognition

Since our inception, a substantial portion of our revenues have been generated from research and licensing agreements with collaborators. Revenue under such collaboration agreements typically include upfront payments, cost reimbursements and milestone payments.

Revenue under these agreements from non-refundable upfront license fees and other payments where we continue involvement throughout development is recognized ratably over the development period. We recognize cost reimbursement revenue under collaborative agreements as the related research and development costs are incurred, as provided for under the terms of the agreements.

Incentive milestone payments under collaborative arrangements are recognized as revenue upon achievement of the incentive milestone events, which represent the culmination of the earnings process. Incentive milestone payments are triggered either by the results of our research efforts or by events external to Cell Genesys, such as regulatory approval to market a product or the achievement of specified sales levels by a marketing partner. As such, the incentive milestones are substantially at risk at the inception of the contract, and the amounts of the payments assigned thereto are commensurate with the milestone achieved. Upon the achievement of an incentive milestone event, we have no future performance obligations related to that payment.

Amounts received under license agreements relating to our intellectual property are recognized as revenue upon execution of the technology licensing agreement, if we have no future performance obligations.

Deferred revenue represents the portion of upfront payments received that has not been earned.

Lease Accounting

We record our obligations under facility operating lease agreements as rent expense. In the fourth quarter of 2002, we recorded approximately $6.2 million of general and administrative expense for estimated lease exit costs associated with the move of our corporate headquarters to South San Francisco, California in March 2003 and the related vacancy in Foster City, California. Based upon updated estimates of the rental market for comparable laboratory and office space, we revised our estimate of lease exit costs and recorded an additional $1.6 million of general and administrative expense in the second quarter of 2003. Lease exit costs will continue to be revised as necessary based on our ability to sublease the facilities and as market conditions change.

Use of estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates. Estimates in the financial statements include, but are not limited to, accrued but unbilled expenses for clinical trials, accrued facility exit costs, expenses for certain outside experts and consultants, useful lives of property and equipment, and other items.

Income taxes

Significant management judgment is required in developing our provision for income taxes, including the determination of deferred tax assets and liabilities and any valuation allowances that might be required against the deferred tax assets.  We record valuation allowances to reduce deferred tax assets to the amounts that are more likely than not to be realized.  We have considered anticipated future taxable income and ongoing prudent and feasible tax planning strategies in assessing the need for valuation allowances.  If we determine that we will be able to realize our deferred tax assets in the future in excess of our net deferred tax assets, adjustments to the deferred tax assets will increase income by reducing tax expense in the period that we make such determination.  Likewise, if we determine that we will not be able to realize all or part of our net deferred tax assets in the future, adjustments to the deferred tax assets will decrease income by increasing tax expense in the period that we make such determination.

Results of Operations

Revenues were $13,000 and $1.1 million for the three and six months ended June 30, 2003 compared with $31.1 million and $35.7 million for the corresponding periods in 2002. These decreases reflect the previously announced termination of a collaboration agreement for GVAX® lung cancer vaccine and the recognition of non-recurring license revenue in 2002.

We recorded a net loss of $19.1 million and $36.5 million for the three and six months ended June 30, 2003 compared to net income of $6.5 million and a net loss of $2.3 million for the corresponding periods in 2002. Losses are expected to continue and may increase in future years as operating expenses rise, particularly as we incur expenses related to manufacturing and advanced clinical trials of our potential products.

Our research and development expenses were $22.6 million and $43.6 million for the three and six months ended June 30, 2003 compared to $17.8 million and $34.3 million for the corresponding periods in 2002. These increases can be attributed primarily to our expanding clinical trials and other product development activities in both our GVAX® cancer vaccines and oncolytic virus therapy programs. We expect that our research and development expenditures and headcount will continue to increase in future years to support expanded, more advanced and more numerous clinical trials, additional manufacturing and office facilities and additional product development activities. The rate of increase depends on a number of factors, including progress in research and development and clinical trials.

General and administrative expenses were $6.9 million and $12.0 million for the three and six months ended June 30, 2003 compared to $4.3 million and $8.0 million for the corresponding periods in 2002. These increases resulted primarily from infrastructure expenses related to our manufacturing and corporate headquarters facilities and a $1.6 million charge related to our leased facilities in Foster City, California. Future spending for general and administrative costs is expected to continue to increase in order to support our growing infrastructure needs, particularly in the areas of manufacturing and other facilities.

We recorded a $7.3 million gain during the three months ended June 30, 2003 related to the sale of 800,000 shares of Abgenix, Inc. common stock. At June 30, 2003 we continued to hold approximately 7.9 million shares of Abgenix, Inc. common stock, which had a fair market value of approximately $82.5 million as of that date.

Interest and other income were $1.4 million and $3.3 million for the three and six months ended June 30, 2003 compared to $2.2 million and $4.6 million for the corresponding periods in 2002. These decreases were primarily due to lower average cash balances and lower interest rates during 2003 as compared to 2002. Interest expense was $1.4 million and $1.7 million for the three and six months ended June 30, 2003 compared to $0.4 million and $0.8 million for the corresponding periods in 2002. These increases relate primarily to our leased facility in South San Francisco, California, which we occupied in March 2003.

We recorded tax benefits of $3.2 million and $9.2 million for the three and six months ended June 30, 2003 compared to a tax provision of $4.0 million and a tax benefit of $0.5 million for the corresponding periods in 2002. These tax benefits relate to our ability to carry-back 2002 net operating losses to the 2000 tax year and our ability to utilize net operating losses based on the estimation of future taxable income, including taxable income which may result from the future sale of shares of our investment in Abgenix, Inc.

Liquidity and Capital Resources

At June 30, 2003, we had approximately $134.8 million in cash, cash equivalents and short-term investments, of which $63.4 million is classified as restricted cash primarily related to our outstanding debt financing. We have maintained our financial position through strategic management of our resources including our holdings in Abgenix, Inc. common stock and by relying on funding from various corporate collaborations and licensing agreements. Additionally, in February 2003, our shelf registration statement was declared effective by the Securities and Exchange Commission under the Securities Act of 1933, as amended, which allows us to offer up to $150 million of securities on short notice in one or more public offerings. However, there can be no assurance we will be able to issue such securities on acceptable terms, or at all.

Net cash used in operating activities was $18.2 million for the six months ended June 30, 2003 compared to $7.6 million for the corresponding period in 2002. This increase was due primarily to $34.1 million in increased net losses offset by the receipt of $15.0 million from a license agreement with Transkaryotic Therapies, Inc. Cash requirements for operating activities are expected to increase in future periods. The timing of these cash requirements may vary from period to period depending on our research and development activities, including our planned preclinical and clinical trials, obligations related to our existing manufacturing and headquarter facilities, and future requirements to establish manufacturing and marketing capabilities for any products that we may develop.

Net cash provided by investing activities was $7.1 million for the six months ended June 30, 2003 compared to cash used in investing activities of $67.0 million for the corresponding period in 2002. This trend reflects the conversion of short-term investments into cash to fund operating requirements in 2003, compared to the net investment of excess operating funds in 2002. Results for the 2003 period include $8.1 million in proceeds from the sale of 800,000 shares of Abgenix, Inc. common stock.

Capital expenditures were $21.9 million for the six months ended June 30, 2003 compared to $22.3 million for the corresponding period in 2002. Capital expenditures for both periods resulted primarily from the construction of our manufacturing facilities for our Phase 3 trials and future market launch in Hayward, California and leasehold improvements for our corporate headquarters in South San Francisco, California, to which we moved in March 2003. Final improvements to our corporate headquarters are expected to total approximately $3.0 million and are scheduled to be completed by the end of 2003, at which time all activities that currently remain at our Foster City location will be moved to South San Francisco. Cell Genesys currently has three manufacturing facilities located in Hayward and San Diego, California and Memphis, Tennessee. We have completed the construction necessary at our manufacturing facility for non patient-specific GVAXâ cancer vaccines located in Hayward, California for initiation of our first Phase 3 trial, and test manufacturing is currently underway at this facility. In addition, we have completed the construction of a new manufacturing facility in Memphis, Tennessee for the manufacture of patient-specific GVAXâ cancer vaccines for lung cancer. In 2002, we completed modifications of our GMP facility in San Diego, California for the manufacture of viral based products.

Cell Genesys has financed its operations primarily through the sale of equity securities, funding under collaborative arrangements, sales of Abgenix, Inc. common stock and secured financing. During the six months ended June 30, 2003, Cell Genesys received approximately $8.1 million in net proceeds from the sale of 800,000 shares of Abgenix, Inc. common stock. Our retained ownership of Abgenix, Inc. common stock represents a material portion of the total assets on our balance sheet. The common stock price of Abgenix, Inc. has proven to be highly volatile, which has a direct impact on our liquidity and capital resources.

In April 2003, we amended the terms of our $60 million asset- backed debt financing. Under the amendment, the quarterly principal payments have been replaced with a single balloon payment in 2008, and the interest rate was reduced from LIBOR (London Interbank Offering Rate) plus .750 percent to LIBOR plus .625 percent. The financing obligation remains secured by liquid financial instruments, including cash and marketable securities, which are classified as restricted cash and investments on our condensed consolidated balance sheet.

In connection with a gain on sale of Abgenix, Inc. common stock in 2000, we paid $41.5 million in federal and state income taxes. Since 2001 we have received $34.1 million in tax refunds from the carryback of losses. We have additional unutilized net operating loss ("NOL") carryforwards, although the future utilization of these NOL carryforwards is limited by IRS regulation Section 382, which imposes an annual limitation on taxable income that can be offset by NOLs following a change in control. For IRS purposes we experienced a change in control during our acquisition of Somatix in 1997. It is our current intention to minimize future tax liabilities on sales of Abgenix, Inc. common stock by offsetting gains against current operating losses and the NOL carryforwards allowed under Section 382. In addition, we have certain research and development tax credits that we may utilize to offset the tax effects of such gains. However, under some circumstances we may sell more Abgenix, Inc. common stock, and consequently recognize more gain, than we may be able to shelter from tax using these methods.

Future minimum payments under non-cancelable operating leases, capital leases and debt financing at June 30, 2003 were (in thousands):

 

Operating Leases *

Capital Leases

Debt Financing

Years ending December 31:

 

 

 

2003 (remaining portion)......

$ 5,461

$ 3,029

$ 571

2004..............

11,004

6,242

1,143

2005..............

11,362

6,402

1,143

2006..............

4,683

6,468

1,143

2007..............

2,354

6,543

1,143

2008 and beyond. ........

25,794

80,769

60,000

Total minimum payments........

$ 60,658

109,453

65,143

Less: Amount representing interest and
executory costs............

 

(56,043)

(5,143)

Present value of future debt payments...

 

53,410

60,000

Less: Current portion of future payments..

 

(699)

-

Noncurrent portion of future payments..

 

$ 52,711

$ 60,000

* Total operating lease commitments include rent payments for our Foster City location of $16.2 million, of which $7.8 million was accrued as of June 30, 2003 as part of the estimated facility exit costs associated with our move to the South San Francisco, California headquarters building in March 2003.

While we believe that our current liquidity position will be sufficient to meet our cash needs for at least the next year, we may entertain the possibility of raising additional capital to preserve our liquidity, depending on a number of conditions, including conditions in the capital markets. The sources of liquidity available to us include the sale of Abgenix, Inc. securities, asset-backed debt financing, and private or public placement of Cell Genesys equity securities, warrants, debt securities or depositary shares. We regularly consider the conditions of capital markets, dilution, stockholder value and tax consequences of each type of financing on stockholders. Certain of the financing options available to us may have negative consequences to stockholders such as dilution. Given the volatile nature of the capital markets, decisions to raise capital may require actions that would impose a negative consequence in order to reduce or minimize a more significant negative consequence to stockholders.

OTHER FACTORS AFFECTING FUTURE OPERATIONS

Investors should carefully consider the risks described below before making an investment decision. The risks described below are not the only ones facing our company. Additional risks not currently known to us or that we currently believe are immaterial may also impair our business operations. Our business could be harmed by any of these risks. The trading price of our common stock could decline due to any of these risks, and investors may lose all or part of their investment. In assessing these risks, investors should also refer to the other information contained or incorporated by reference in this Quarterly Report on Form 10-Q and our Annual Report on Form 10-K for the year ended December 31, 2002, including our consolidated financial statements and related notes.

Risks Related to Our Company

Our products are in developmental stage, are not approved for commercial sale and might not ever receive regulatory approval or become commercially viable.

All of our potential cancer vaccines, oncolytic virus therapies and cancer gene therapy products are in research and development. We have not generated any revenues from the sale of products. We do not expect to generate any revenues from product sales for at least the next several years. Our products currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval, prior to commercial use. Our research and development efforts may not be successful, and any of our future products may not be ultimately commercially successful. Even if developed, our products may not receive regulatory approval or be successfully introduced and marketed at prices that would permit us to operate profitably.

Our cancer vaccine, oncolytic virus therapies and cancer gene therapy programs must undergo exhaustive clinical testing and may not prove to be safe or effective. If any of our proposed products are delayed or fail, we may have to curtail our operations.

Our programs utilize new technologies. Existing preclinical and clinical data on the safety and efficacy of our programs are limited. Data relating to our specific gene therapy approaches are also limited. Our GVAX® cancer vaccines and oncolytic virus therapies are currently being tested in human clinical trials to determine their safety and efficacy. None of our other products or therapies under development are in human clinical trials. The results of preclinical studies do not necessarily predict safety or efficacy in humans. Serious and potentially life-threatening side effects may be discovered during preclinical and clinical testing of our 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 commercially successful products. Although we are testing some of our proposed products and therapies in human clinical trials, we cannot guarantee that we will be permitted to undertake human clinical trials for any of our other products or that adequate numbers of patients can be recruited for our clinical trials. Also, the results of this testing might not demonstrate the safety or efficacy of these products. Even if clinical trials are successful, we might not obtain regulatory approval for any indication. Finally, even if our products proceed successfully through clinical trials and receive regulatory approval, there is no guarantee that an approved product can be manufactured in commercial quantities at reasonable cost or that such a product will be successfully marketed.

We have not been profitable in our operations (absent the gains on sales of Abgenix, Inc. common stock and certain upfront or non- recurring license fees). We expect to continue to incur substantial losses and negative cash flow from operations and may not become profitable in the future.

We have incurred an accumulated deficit since our inception. At June 30, 2003, our accumulated deficit was approximately $126.6 million. Our accumulated deficit would be substantially higher absent the gains we have realized on sales of our Abgenix, Inc. common stock. For the six months ended June 30, 2003, we recorded a net loss of $36.5 million, notwithstanding a gain of $7.3 million on sales of our Abgenix, Inc. common stock. We expect to incur substantial operating losses for at least the next several years. This is due primarily to the expansion of research and development programs, clinical trials and manufacturing activities and, to a lesser extent, general and administrative expenses. We also have substantial lease obligations related to our new manufacturing and headquarter facilities impacting operating expenses. We expect that losses will fluctuate from quarter to quarter and that these fluctuations may be substantial. We cannot guarantee that we will successfully develop, manufacture, commercialize or market any products. We cannot guarantee that we will ever achieve or sustain product revenues or profitability.


We will need substantial additional funds to continue operations, and our ability to generate funds depends on many factors beyond our control.

We will need substantial funds for existing and planned preclinical and clinical trials, to continue research and development activities, for lease obligations related to our manufacturing and headquarter facilities, and to establish manufacturing and marketing capabilities for any products we may develop. At some point in the future, we will also need to raise additional capital just to fund our operations. Our future capital requirements will depend on, and could increase as a result of, many factors, such as:

  • the progress and scope of our internally funded research, development and commercialization activities;
  • our ability to establish new collaborations and the terms of those collaborations;
  • competing technological and market developments;
  • the time and cost of regulatory approval;
  • the extent to which we choose to commercialize our future products through our own sales and marketing capabilities;
  • the costs we incur in obtaining and enforcing patent and other proprietary rights or gaining the freedom to operate under the patents of others; and
  • our success in acquiring and integrating complementary products, technologies or businesses.

We plan to raise additional funds through collaborative business relationships, sales of some portion or all of our investment in Abgenix, Inc. common stock, additional equity or debt financings, or otherwise, but we may not be able to do any of the foregoing on favorable terms, or at all.

Because of our long-term capital requirements, we may seek to access the public or private debt and equity markets whenever conditions are favorable, even if we do not have an immediate need for additional capital at that time. Additional funding may not be available to us, and, if available, may not be on acceptable terms. If we raise additional funds by issuing equity securities, stockholders will incur immediate dilution. Opportunities for out- licensing technologies or for third-party collaborations may not be available to us on acceptable terms, or at all. If adequate funds are not available, we may be required to delay, reduce the scope of, or eliminate one or more of our research, development or clinical activities. Alternatively, we may need to seek funds through arrangements with collaborative partners or others that require us to relinquish rights to technologies or product candidates that we would otherwise seek to develop or commercialize ourselves. Either of these events could have a material adverse effect on our business, results of operations, financial condition or cash flow. Currently, we have no collaborative partners for the development of our GVAX® cancer vaccines. Certain of our oncolytic virus therapy products are being developed under our global strategic alliance with Novartis and Novartis has future commercialization rights for these products.

Our ability to manufacture our products is uncertain, which may delay or impair our ability to develop, test and commercialize our products.

We are building our own manufacturing facilities in compliance with FDA Good Manufacturing Practices regulatory requirements for the manufacture of products for clinical trials and to support the potential commercial launch of our product candidates. We are under significant lease obligations for each of our facilities. We may be unable to establish and maintain our manufacturing facilities within our planned time and budget, which could have a material adverse effect on our product development timelines. Our manufacturing facilities will be subject to ongoing, periodic inspection by the FDA and state agencies to ensure compliance with Good Manufacturing Practices. We also may encounter problems with the following:

  • achieving consistent production yield and costs;
  • meeting product release specifications;
  • quality control and assurance;
  • shortages of qualified manufacturing personnel;
  • shortages of raw materials;
  • shortages of key contractors; and
  • ongoing compliance with FDA and other regulations.

Developing advanced manufacturing techniques and process controls is required to fully utilize our expanded facilities. We may not be able to develop these techniques and process controls to manufacture our products effectively to meet demands of clinical testing and production.

If we are unable to manufacture our products for any reason, our options for outsourcing manufacturing are currently limited. We are unaware of available contract manufacturing facilities on a worldwide basis in which our product candidates can be manufactured under Good Manufacturing Practices regulations, a requirement for all pharmaceutical products. It would take a substantial period of time for a contract manufacturing facility that has not been producing our particular products to begin producing them under Good Manufacturing Practices regulations.

Our manufacturing facilities are subject to licensing requirements of the United States Drug Enforcement Administration (the DEA), the California Department of Health Services and the Tennessee Department of Commerce and Insurance, Board of Pharmacy, referred to as the Tennessee Board of Pharmacy. While not subject to license by the FDA, these facilities are subject to inspection by the FDA, as well as by the DEA, the California Department of Health Services and the Tennessee Board of Pharmacy. Failure to maintain these licenses or to meet the inspection criteria of the FDA, the DEA, the California Department of Health Services or the Tennessee Board of Pharmacy would disrupt our manufacturing processes and have a material adverse effect on our business, results of operations, financial condition and cash flow.

If our proposed products are not effectively protected by issued patents or if we are not otherwise able to protect our proprietary information, we will be more vulnerable to competitors, and our business could be adversely affected.

We rely heavily on the development and protection of our intellectual property portfolio. The patent positions of pharmaceutical and biotechnology firms, including Cell Genesys, are generally uncertain and involve complex legal and factual questions. As of June 30, 2003 we had approximately 360 patents issued or granted to Cell Genesys or available to us based on licensing arrangements and approximately 265 applications pending in the name of Cell Genesys or available to us based on licensing arrangements. Although we are prosecuting patent applications, we 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 and will not be invalidated. Also, patent applications in the United States are confidential until patents are issued. Publication of discoveries in scientific or patent literature tends to lag behind actual discoveries by several months. Accordingly, we cannot be sure that we were the first creator of inventions covered by pending patent applications or that we were the first to file patent applications for these inventions. In addition, to the extent we license our intellectual property to other parties, we may incur expenses as a result of contractual agreements in which we indemnify these licensing parties against losses incurred if our intellectual property infringes upon the rights of others.

Our intellectual property may be challenged by our competitors in the future, which may have a material adverse effect on our business, results of operations, financial condition and cash flow.

Our commercial success depends in part on not infringing the patents or proprietary rights of others and not breaching licensees granted to us. We are aware of competing intellectual property relating to both our programs in cancer vaccines and oncolytic virus therapies. While we currently believe we have freedom to operate in these areas, others may challenge our position in the future. We may be required to obtain licenses to third-party technologies or genes necessary in order to market our products. Any failure to license any technologies or genes required to commercialize our technologies or products at reasonable cost may have a material adverse effect on our business, results of operations, financial condition and cash flow.

We may have to engage in litigation, which could result in substantial cost, to enforce our patents or to determine the scope and validity of other parties' proprietary rights.

To determine the priority of inventions, the United States Patent and Trademark Office frequently declares interference proceedings. In Europe, patents can be revoked through opposition proceedings. These proceedings could result in an adverse decision as to the priority of our inventions.

We are currently involved in multiple interference and/or opposition proceedings with regard to:

  • gene activation technology; and
  • certain vector technologies.

We cannot predict the outcome of these proceedings. An adverse result could have a material adverse effect on our intellectual property position in these areas and on our business as a whole. We may be involved in other interference and/or opposition proceedings in the future. We believe that there will continue to be significant litigation in the industry regarding patent and other intellectual property rights.

Our competitive positions may be adversely affected by our limited ability to protect and control unpatented trade secrets, know-how and other technological innovation.

Our competitors may independently develop similar or better proprietary information and techniques and disclose them publicly. Also, others may gain access to our trade secrets, and we may not be able to meaningfully protect our rights to our unpatented trade secrets.

We require our employees and consultants to execute confidentiality agreements upon the commencement of employment or consulting relationships with us. 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 relating to our business conceived by the employee while employed by us are our exclusive property. These agreements may not provide meaningful protection for our trade secrets in the event of unauthorized use or disclosure of such information.

Our competitors may commercialize products more rapidly than we do, which may adversely affect our competitive position.

There are many companies pursuing programs for the treatment of cancer. Some of these competitors are large pharmaceutical companies, such as Aventis and GlaxoSmithKline, which have greater experience and resources than we do in developing products, in undertaking preclinical testing and human clinical trials of new pharmaceutical products, in obtaining FDA and other regulatory approvals of products, and in manufacturing and marketing new therapies. We are also competing with other biotechnology companies with similar experience and resources to ours, but who may have programs which are in a later stage of clinical testing than ours, such as Dendreon Corporation. Our competitive position and that of our competitors can vary based on the performance of products in clinical trials. In addition, our competitors may obtain patent protection or FDA approval and commercialize products more rapidly than we do, which may impact future sales of our products. We also may not have the access that some of our competitors have to biological materials necessary to support the research, development or manufacturing of planned therapies. If we are permitted by the FDA to commence commercial sales of products, we will also be competing with respect to marketing capabilities and manufacturing efficiency, areas in which we have limited or no experience. We expect that competition among products approved for sale will be based, among other things, on:

  • product efficacy;
  • price;
  • safety;
  • reliability;
  • availability;
  • patent protection; and
  • sales, marketing and distribution capabilities.

Our competitive position also depends upon our ability to attract and retain qualified personnel, develop proprietary products or processes, and secure sufficient funding for the often lengthy period between product conception and commercial sales.

To the extent we depend on strategic partners to sell, market or distribute our products, we will have reduced control over the success of the sales, marketing and distribution of our future products.

We have no experience in sales, marketing or distribution of biopharmaceutical products. We may in the future rely on sales and marketing expertise of potential corporate partners for our initial 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;
  • size and expertise of the partner's sales force in a particular market; and
  • our overall strategic objectives.

We may in the future be exposed to product liability claims, which could adversely affect our business, results of operation, financial condition and cash flow.

Clinical trials or marketing of any of our potential products may expose us to liability claims resulting from the use of our products. These claims might be made by consumers, health care providers or sellers of our products. We currently maintain product liability insurance with respect to each of our clinical trials. We may not be able to maintain insurance or obtain sufficient coverage at a reasonable cost, given the increasing cost of insurance in today's insurance market. An inability to maintain insurance at an acceptable cost, or at all, could prevent or inhibit the clinical testing or commercialization of our products or otherwise affect our financial condition. A claim, particularly resulting from a clinical trial, on any of our insurance policies or a product recall could have a material adverse effect on our business, results of operations, financial condition and cash flow.

 

Our business, financial condition and results of operations could suffer as a result of future strategic acquisitions and investments.

We may engage in future acquisitions or investments that could dilute our existing stockholders or cause us to incur contingent liabilities, debt or significant expense. From time to time, in the ordinary course of business, we may evaluate potential acquisitions or investments in related businesses, products or technologies. We may not be successful with any strategic acquisition or investment. Any future acquisition or investment could harm our business, financial condition and results of operations.

If we engage in future acquisitions, we may not be able to fully integrate the acquired companies and their intellectual property or personnel. Our attempts to do so may place additional burdens on our management and infrastructure. Future acquisitions will also subject us to a number of risks, including:

  • the loss of key personnel and business relationships;
  • difficulties associated with assimilating and integrating the new personnel and operations of the acquired companies;
  • the potential disruption of our ongoing business;
  • the expense associated with maintenance of diverse standards, controls, procedures, employees and clients;
  • the diversion of resources from the development of our own proprietary technology; and
  • our inability to generate revenue from acquired technology sufficient to offset associated acquisition and maintenance costs.

Our operations are vulnerable to interruption by fire, earthquake, power loss, telecommunications failure, terrorist activity and other events beyond our control, which could result in a material adverse effect on our business.

Our facilities in California have, in the past, been subject to electrical blackouts as a result of a shortage of available electrical power. Future blackouts could disrupt the operations of our facilities. In addition, we do not carry sufficient business interruption insurance to compensate us for actual losses from interruption of our business that may occur, and any losses or damages incurred by us could have a material adverse effect on our business.

We depend on our key technical and management personnel and clinical investigative sites to advance our technology, and the loss of these personnel or partners could impair the development of our products.

We rely and will continue to rely on our key management and scientific staff. The loss of key personnel or the failure to recruit necessary additional qualified personnel could have a material adverse effect on our business and results of operations. There is intense competition from other companies, research and academic institutions and other organizations for qualified personnel. We may not be able to continue to attract and retain the qualified personnel necessary for the development of our business. We will need to continue to recruit experts in the areas of clinical testing, manufacturing, marketing and distribution and to develop additional expertise in our existing personnel. If we do not succeed in recruiting necessary personnel or developing this expertise, our business could suffer significantly.

We have clinical trial agreements with a number of public and private medical institutions for the conduct of human clinical trials for our GVAX® cancer vaccine programs and oncolytic virus therapies. The early termination of any of these clinical trial agreements would hinder the progress of our clinical trial program. If any of these relationships are terminated, the clinical trials might not be completed and the results might not be evaluated.

Inventions or processes discovered by our outside scientific collaborators may not become our property, which may affect our competitive position.

We rely 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. These scientific collaborators are not our employees. As a result, we have limited control over their activities and can expect that only limited amounts of their time will be dedicated to our activities. Our agreements with these collaborators, as well as those with our scientific consultants, provide that any rights we obtain as a result of their research efforts will be subject to the rights of the research institutions for which they work. In addition, some of these collaborators have consulting or other advisory arrangements with other entities that may conflict with their obligations to us. For these reasons, inventions or processes discovered by our scientific collaborators or consultants may not become our property.

Our stock price is influenced by the market price of Abgenix, Inc. stock, which has been highly volatile.

Our retained ownership of Abgenix, Inc. common stock represents a material portion of the total assets on our balance sheet. The common stock price of Abgenix, Inc. has proven to be highly volatile. The value of our holdings of Abgenix, Inc. common stock was approximately $82.5 million at June 30, 2003. Movements in the price of Abgenix, Inc. common stock, up or down, may exert corresponding influences on the market price of our stock.

Our stock price has fluctuated in the past and is likely to continue to be volatile in the future.

The stock prices of biopharmaceutical and biotechnology companies (including Cell Genesys) have historically been highly volatile. Since January 1, 2001, our stock price has fluctuated between a high close price of $24.80 on December 6, 2001 and a low close price of $6.43 on March 18, 2003. The market has from time to time experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies. The following factors, among others, may affect our stock price:

  • fluctuations in our financial results;
  • announcements of technological innovations or new therapeutic products by us or our competitors;
  • announcements of changes in governmental regulation affecting us or our competitors;
  • announcements of regulatory approval or disapproval of our or our competitors' products;
  • announcements of new collaborative relationships by us or our competitors;
  • developments in patent or other proprietary rights affecting us or our competitors;
  • public concern as to the safety of products developed by us or other biotechnology and pharmaceutical companies;
  • general market conditions;
  • fluctuations in the price of Abgenix, Inc. common stock, as described above;
  • severe fluctuations in price and volume in the stock market in general (or in the trading of the stock of biopharmaceutical and biotechnology companies in particular) that are unrelated to our operating performance;
  • issuances of securities in equity, debt or other financings or issuances of common stock upon conversion of our Series B preferred stock, as described below;
  • sales of common stock by us or by existing stockholders; and
  • the perception that such issuances or sales could occur.

Our stockholders may be diluted by the conversion of outstanding Series B redeemable convertible preferred stock.

As of June 30, 2003, 499 shares of Series B redeemable convertible preferred stock, referred to as the Series B preferred, issued in January 2000 remained outstanding and were convertible into an aggregate of approximately 663,000 shares of common stock as of that date. The holders of the Series B preferred may choose at any time to convert their shares into common stock. Conversion of the Series B preferred would result in issuance of additional shares of common stock, diluting existing stockholders. The number of shares of common stock issuable upon conversion of the Series B preferred is determined by dividing the market value of the shares to be converted by the lower of:

  • a fixed conversion price of $14.53 per share (subject to antidilution provisions); or
  • the average of certain trading prices during the 10 trading days preceding such date of conversion.

The market value of the Series B preferred is based on the outstanding carrying value from the original issuance plus the deemed dividend earned over the holding period. As of June 30, 2003, the aggregate market value for all outstanding Series B preferred was approximately $5.9 million. The number of shares of common stock issuable upon conversion of the Series B preferred, and therefore the dilution of existing investors, would increase as a result of either an event triggering the antidilution rights of the Series B preferred or a decline in the market price of our common stock immediately prior to conversion of the Series B preferred.

During the three months ended June 30, 2003, 166 shares of the Company's Series B redeemable convertible preferred stock were converted into 278,264 shares of the Company's common stock at an average effective conversion price of $7.37 per share. The total market value of such common shares as of the date of conversion was approximately $2.1 million. In the event the holders of the remaining outstanding Series B preferred do not convert their shares, the shares will automatically be converted on January 18, 2005 according to the formula described above.

Our stockholders may be diluted by the exercise of outstanding stock options or other issuances of our common stock.

Substantially all shares of common stock for which our outstanding stock options are exercisable are, once they have been purchased, eligible for immediate sale in the public market. Issuance of common stock or the exercise of stock options would dilute existing investors.

We have adopted anti-takeover defenses that could make it difficult for another company to acquire control of us or limit the price investors might be willing to pay for our stock.

Certain provisions of our Certificate of Incorporation, Bylaws, and Delaware law could make it more difficult for a third party to acquire us, even if doing so would benefit our stockholders. These provisions include the adoption of a Stockholder Rights Plan, commonly known as a "poison pill." Under the Stockholder Rights Plan, we made a dividend distribution of one preferred share purchase right for each share of our common stock outstanding as of August 21, 1995 and each share of our common stock issued after that date. In July 2000, we made certain technical changes to amend the plan and extended the term of such plan until 2010. The rights are exercisable only if an acquirer purchases 15 percent or more of our common stock or announces a tender offer for 15 percent or more of our common stock. Upon exercise, holders other than the acquirer may purchase our stock at a discount. The Board of Directors may terminate the rights plan at any time or under certain circumstances redeem the rights. Because the rights may substantially dilute the stock ownership of a person or group attempting to take us over without the approval of the Board of Directors, the plan could make it more difficult for a third party to acquire us (or a significant percentage of our outstanding capital stock) without first negotiating with our Board of Directors regarding such acquisition. These provisions and certain provisions of the Delaware General Corporation Law may have the effect of deterring hostile takeovers or otherwise delaying or preventing changes in the control or management of Cell Genesys, including transactions in which our stockholders might otherwise receive a premium over the fair market value of our common stock.

Risks Related to Our Industry

In order for our products to be offered to the public, they must undergo extensive clinical testing and receive approval from the Food and Drug Administration, which could delay or prevent the commercialization of our products.

Human therapeutic products must undergo rigorous preclinical and clinical testing and other premarket approval procedures by the FDA and similar authorities in foreign countries. Preclinical tests include laboratory evaluation of potential products and animal studies to assess the potential safety and efficacy of the product and its formulations. Clinical trials involve the administration of the investigational new drug to healthy volunteers or to patients under the supervision of a qualified principal investigator. Clinical trials are conducted in accordance with FDA Good Clinical Practices under protocols that detail the objectives of the study, the parameters to be used to monitor safety and the efficacy criteria to be evaluated. The developer of the drug must provide information relating to the characterization of the product after administration to the patients participating in the clinical trials. This requires developing approved assays of the product to test before and after administration to the patient. The results of the preclinical testing and clinical testing, together with chemistry, manufacturing and controls information, are submitted to the FDA in the form of a new drug application for a pharmaceutical product, and in the form of a biologics license application for a biological product, requesting approval to commence commercial sales.

In responding to a new drug application or a biologics 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, and if granted may not cover all the clinical indications for which we are seeking approval. Also, an approval might contain significant limitations in the form of warnings, precautions or contraindications with respect to conditions of use.

We are subject to federal, state and local laws and regulations, and complying with these may cause us to incur significant costs.

We are subject to laws and regulations enforced by the FDA, the California Department of Health Services, the Tennessee Board of Pharmacy and other regulatory statutes including:

  • Occupational Safety and Health Act;
  • Environmental Protection Act;
  • Toxic Substances Control Act;
  • Resource Conservation and Recovery Act; and
  • other current and potential future federal, state or local laws and regulations.

In particular with respect to environmental laws, product development activities involve the use of hazardous materials, and we may incur significant costs as a result of the need to comply with these laws. Our research and development activities involve the controlled use of hazardous materials, chemicals, viruses and radioactive compounds. We are subject to federal, state and local laws and regulations governing the use, manufacture, storage, handling and disposal of these materials and waste products. Although we believe that our safety procedures for handling and disposing of these materials comply with the standards prescribed by applicable laws and regulations, we cannot completely eliminate the risk of contamination or injury, by accident or as the results of intentional acts of terrorists, from these materials. In the event of an accident, we could be held liable for any damages that result, and any resulting liability could exceed our resources. We may also be required to incur significant costs to comply with environmental laws and regulations in the future.

Failure to comply with foreign regulatory requirements governing human clinical trials and marketing approval for drugs and devices could prevent us from selling our products in foreign markets, which may adversely affect our operating results and financial condition.

For marketing outside the United States, the requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from country to country. Failure to comply with these regulatory requirements or obtain required approvals could impair our ability to develop these markets and have a material adverse effect on our results of operations and financial condition.

Our competitors may develop therapies for the diseases that we are targeting that are more advanced or more effective than ours, which could adversely affect our competitive position.

Competition in the field from other biotechnology and pharmaceutical companies and from research and academic institutions is intense and expected to increase. In many instances, we compete with other commercial entities in acquiring products or technology from universities. There are numerous competitors working on products to treat each of the diseases for which we are seeking to develop therapeutic products. Some competitors are pursuing a product development strategy competitive with ours, particularly with respect to our cancer vaccine and oncolytic virus therapy programs. Certain of these competitive products are in more advanced stages of product development and clinical trials. We compete with other clinical-stage companies and institutions for clinical study participants, which could reduce our ability to recruit participants for our clinical trials. Delay in recruiting clinical study participants could adversely affect our ability to bring a product to market prior to our competitors. Our competitors may develop technologies and products that are more effective than ours, or that would render our technology and products less competitive or obsolete.

Reimbursement from third-party payors may become more restricted in the future, which may reduce demand for our products.

Sales of our future products will be influenced by the willingness of third-party payors to provide reimbursement. In both domestic and foreign markets, sales of our potential products will depend in part upon coverage and reimbursement from third-party payors, including:

  • government agencies;
  • private health care insurers and other health care payors such as health maintenance organizations;
  • self-insured employee plans; and
  • Blue Cross/Blue Shield and similar plans.

There is considerable pressure to reduce the cost of biotechnology and pharmaceutical products. Reimbursement from government agencies, insurers and large health organizations may become more restricted in the future. Our potential products represent a new mode of therapy, and while the cost-benefit ratio of the products may be favorable, we expect that the costs associated with our products will be substantial. Our proposed products, if successfully developed, may not be considered cost-effective by third-party payors. Insurance coverage might not be provided by third-party payors at all or without substantial delay. Even if such coverage is provided, the approved reimbursement might not provide sufficient funds to enable us to become profitable.

The continuing efforts of governmental and third-party payors to contain or reduce the costs of healthcare may impair our future revenues and profitability.

The pricing of our future products may be influenced in part by government controls. 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 we expect that there will continue to be, a number of federal and state proposals to implement similar government control. While we cannot predict whether the government will adopt any such legislative or regulatory proposals, the announcement or adoption of these proposals could have a material adverse effect on our business, results of operations, financial condition and cash flow.

Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

In the normal course of business, the financial position of the Company is subject to a variety of risks, including market risk associated with interest rate movements. The Company regularly assesses these risks and has established policies and business practices to protect against these and other exposures. However, as mentioned under "Liquidity and Capital Resources" and the "Other Factors Affecting Future Operations" sections of the Company's Management Discussion and Analysis of Financial Condition and Results of Operations above, the Company is subject to risk associated with its retained ownership in Abgenix, Inc. common stock.

The Company has not entered into any financial instruments that would give rise to foreign currency exchange risk or commodity pricing risk. The Company has exposure related to the value of the number of shares of Abgenix, Inc. common stock it holds, which was approximately 7.9 million as of June 30, 2003.

The Company does not currently hold any derivative financial instruments nor has it entered into hedging transactions or activities.

The following table provides information about the Company's financial instruments that are sensitive to changes in interest rates. For investment securities and debt obligations, the table presents principal cash flows and related weighted-average interest rates by expected maturity dates. Additionally, the Company has assumed its available-for-sale securities, comprised of corporate notes and commercial paper, are similar enough to aggregate those securities for presentation purposes. The average interest rate was calculated using the weighted average fixed rates under all these instruments with Wells Fargo Bank, Sterling Capital Management, JP Morgan Chase H & Q, Fleet National Bank and General Electric Capital Corporation.

Interest Rate Sensitivity
Principal Amount by Expected Maturity
Average Interest Rate
(dollars in thousands)

  

2003

2004

2005

2006

2007

2008
Thereafter

Total

Fair Value
June 30, 2003

Total Investment Securities

$ 50,258

$ 22,134

$ 38,468

$ 4,101

$ 4,840

$ 100

$ 119,901

$ 120,922

Average Interest Rate

1.11%

2.26%

2.00%

2.58%

2.42%

3.14%

2.25%

 

 

 

 

 

 

 

 

 

 

Capital Leases, including Current Portion

$ 150

$ 317

$ 293

$ 162

$ 23

$ -

$ 945

$ 945

Average Interest Rate

7.12%

7.12%

7.08%

6.86%

5.90%

-

7.03%

 

 

 

 

 

 

 

 

 

 

Debt Financing, including Current Portion

$ -

$ -

$ -

$ -

$ -

$ 60,000

$ 60,000

$ 60,000

Average Interest Rate (1)

1.91%

1.91%

1.91%

1.91%

1.91%

1.91%

1.91%

 

(1) Interest rate based upon LIBOR rate index plus a spread of .625 percent, and can be reset on a quarterly or semi-annual basis.

Item 4. CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

An evaluation was performed under the supervision and with the participation of our management team, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered by this report. Based on that evaluation, our management, including our Chief Executive Officer and Chief Financial Officer, have concluded that our disclosure controls and procedures were effective as of June 30, 2003 to provide reasonable assurance that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in Securities and Exchange Commission rules and forms.

Changes in Internal Controls

There were no changes in our internal control over financial reporting that occurred during the quarter ended June 30, 2003, that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Part II. OTHER INFORMATION

Item 1. LEGAL PROCEEDINGS

None.

Item 4. SUBMISSION OF MATTERS TO VOTE OF SECURITY HOLDERS

On June 12, 2003 during the annual stockholders' meeting, a quorum of stockholders of the Company approved the following proposals:

    1. Election of Directors.
    2. Proposal to approve the amendment of the 1998 Incentive Stock Plan to increase the number of shares of common stock reserved for issuance thereunder by 500,000 shares and to prohibit future option repricings under that plan without the approval of the Company's stockholders.
    3. Proposal to ratify the appointment of Ernst & Young LLP as independent auditors for the 2003 fiscal year.

The following table shows the results of the voting on these matters.

(i)

Director

For

Withheld

 

 

David W. Carter

31,512,731

954,160

 

 

Nancy M. Crowell

32,109,390

357,501

 

 

James M. Gower

32,112,865

354,026

 

 

John T. Potts Jr., M.D.

31,511,074

955,817

 

 

Thomas E. Shenk, Ph. D.

32,178,311

288,580

 

 

Stephen A. Sherwin, M.D.

32,004,964

461,927

 

 

Eugene L. Step

31,445,958

1,020,933

 

 

Inder M. Verma, Ph.D.

32,108,270

358,621

 

 

 

 

 

 

 

 

 

 

Broker

(ii) Against Abstain

For

Against

Abstained

Non-Votes

119,980 33,155

27,737,066

3,297,368

1,432,456

0

 

 

 

 

 

 

 

 

 

Broker

 

For

Against

Abstained

Non-Votes

(iii)

31,865,961

568,465

32,465

0

 

 

 

 

 

 

 

Item 6. EXHIBITS AND REPORTS ON FORM 8-K

a) Exhibits

Exhibit Number

Description

10.1

Amendment No. 2 dated June 12, 2003 to the Credit Agreement between Cell Genesys and Fleet National Bank

10.2

Amended and Restated 1998 Incentive Stock Plan

10.3 *

Patent Assignment and License Agreement dated July 23, 2003 between Cell Genesys, Novartis AG and Genetic Therapy Inc.

10.4 *

Product Development and Option Agreement dated July 23, 2003 between Cell Genesys and Novartis Pharma AG

10.5

Standstill and Registration Rights Agreement dated July 23, 2003 between Cell Genesys, Novartis AG and Genetic Therapy, Inc.

12.1

Computation of Ratio of Earnings to Fixed Charges and Ratio of Earnings to Combined Fixed Charges and Preferred Stock Dividend Requirements

31.1

Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

32.1

Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished, not filed)

 

* Portions of this exhibit have been omitted pursuant to a request for confidential treatment filed with the Commission.

(1) Also filed in PDF as a courtesy

b) Reports on Form 8-K

On July 23, 2003 the Company filed a Form 8-K containing our press release announcing a global alliance between the Company and Novartis AG for the development and commercialization of oncolytic virus therapies.

On July 29, 2003 the Company filed a Form 8-K furnishing our press release announcing the Company's financial results for the three and six month periods ended June 30, 2003.








SIGNATURES

Pursuant to the requirements of Section 13 or 15 (d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized in South San Francisco, California, on August 14, 2003.

  CELL GENESYS, INC.
  (Registrant)

  By:  /s/ Matthew J. Pfeffer
 
  Matthew J. Pfeffer
Vice President and Chief Financial Officer
(Principal Financial and Accounting Officer)
Date: August 14, 2003