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 March 31, 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)
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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)
(Former name, former address and former fiscal year if changed
since last report)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes [X] No [ ]
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 April 30, 2003, the number of outstanding shares of the Registrant's Common Stock was 37,132,882.
CELL GENESYS, INC.
FORM 10-Q
TABLE OF CONTENTS
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements:
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
Item 3. Quantitative and Qualitative Disclosures about Market Risks
Item 4. Disclosure Controls and Procedures
PART II. OTHER INFORMATION
Item 1: Legal Proceedings
Item 6: Exhibits and Reports on Form 8-K
PART I -- FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
CELL GENESYS, INC.
March 31, December 31, 2003 2002 ------------- ------------- (Unaudited) (Note 1) ASSETS Current assets: Cash and cash equivalents.......................... $ 20,523 $ 39,072 Short-term investments............................. 57,732 60,555 Current portion of restricted cash and investments. 7,277 16,166 Receivable from Transkaryotic Therapies, Inc....... -- 15,000 Investment in Abgenix, Inc. common stock........... 75,640 64,076 Prepaid expenses and other current assets.......... 16,213 1,340 ------------- ------------ Total current assets................................. 177,385 196,209 Restricted cash and investments....................... 60,000 51,112 Property and equipment, net........................... 167,858 157,215 Deposits and other assets............................. 1,291 1,312 ------------- ----------- $ 406,534 $ 405,848 ============= =========== LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable................................... $ 2,699 $ 3,980 Accrued compensation and benefits.................. 2,506 3,611 Deferred revenue................................... 5,871 5,871 Accrued facility exit costs........................ 6,178 6,178 Other accrued liabilities.......................... 6,508 6,870 Income taxes payable............................... 13,265 4,219 Deferred tax liability............................. 27,506 23,147 Current portion of debt financing.................. -- 8,889 Current portion of capital leases.................. 5,687 5,608 ------------- ----------- Total current liabilities............................ 70,220 68,373 Noncurrent portion of debt financing.................. 60,000 51,111 Noncurrent portion of capital leases.................. 47,830 47,584 Commitments Redeemable convertible preferred stock................ 7,632 7,632 Stockholders' equity: Common stock....................................... 37 37 Additional paid-in capital......................... 287,085 286,548 Accumulated other comprehensive income............. 41,261 34,719 Accumulated deficit................................ (107,531) (90,156) ------------- ----------- Total stockholders' equity........................... 220,852 231,148 ------------- ----------- $ 406,534 $ 405,848 ============= ===========
See accompanying notes.
CELL GENESYS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(Unaudited)
Three Months Ended March 31, -------------------------- 2003 2002 ------------ ------------ Revenue ............................................ $ 1,038 $ 4,595 Operating expenses: Research and development......................... 21,058 16,563 General and administrative ...................... 5,041 3,658 ------------ ------------ Total operating expenses........................... 26,099 20,221 ------------ ------------ Loss from operations................................ (25,061) (15,626) Interest and other income........................... 1,931 2,417 Interest expense.................................... (299) (409) ------------ ------------ Loss before minority interest and income taxes...... (23,429) (13,618) Loss attributed to minority interest................ -- 271 ------------ ------------ Loss before income taxes............................ (23,429) (13,347) Benefit for income taxes............................ 6,054 4,529 ------------ ------------ Net loss............................................ $ (17,375) $ (8,818) ============ ============ Basic and diluted net loss per common share......... $ (0.47) $ (0.25) ============ ============ Weighted average shares of common stock outstanding - basic and diluted................ 36,926 35,625 ============ ============
See accompanying notes.
CELL GENESYS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
Three Months Ended March 31, -------------------------- 2003 2002 ------------ ------------ Cash flows from operating activities: Net loss.............................................. $ (17,375) $ (8,818) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization...................... 1,986 788 Changes to: Prepaid expenses and other assets.................. (14,852) 5,253 Receivable from Transkaryotic Therapies, Inc....... 15,000 -- Accounts payable................................... (1,281) 939 Accrued compensation and benefits.................. (1,105) (900) Deferred revenue................................... -- (1,909) Other accrued liabilities.......................... (362) (5,017) Minority interest in equity of subsidiary.......... -- (269) Income taxes payable............................... 9,046 (4,974) ---------- ---------- Net cash used in operating activities................. (8,943) (14,907) ---------- ---------- Cash flows from investing activities: Purchases of short-term investments................... (55,679) (83,841) Maturities of short-term investments.................. 1,350 -- Sales of short-term investments....................... 56,490 51,996 Capital expenditures.................................. (12,228) (12,312) ---------- ---------- Net cash used in investing activities................. (10,067) (44,157) ---------- ---------- Cash flows from financing activities: Proceeds from issuances of common stock............... 537 429 Payments under property and equipment financing obligations............................... (76) -- ---------- ---------- Net cash provided by financing activities............. 461 429 ---------- ---------- Net decrease in cash and cash equivalents............... (18,549) (58,635) Cash and cash equivalents at the beginning of the period 39,072 143,055 ---------- ---------- Cash and cash equivalents at the end of the period...... $ 20,523 $ 84,420 =========== ==========
See accompanying notes
CELL GENESYS, INC. 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 cancer gene therapies to treat multiple types of
cancers. 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 wholly-owned and majority- owned subsidiaries.
All significant inter-company 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 accruals)
considered necessary for a fair presentation have been included. Operating
results for the three-month period ended March 31, 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
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Revenue under these agreements from non-refundable upfront license fees and other payments where the Company continues involvement through 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 values 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 research 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 loss and related net 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 March 31, 2003 2002 ----------- ----------- (in thousands, except per share data) Net loss......................................... $ (17,375) $ (8,818) Deduct: Stock-based employee compensation expense determined under SFAS 123.................... (4,199) (3,336) Long-term Debt, including ----------- ----------- Pro forma net loss............................... $ (21,574) $ (12,154) =========== =========== Basic and diluted net loss per common share, as reported................................... $ (0.47) $ (0.25) Basic and diluted pro forma net loss per common share.................................. $ (0.58) $ (0.34)
Net loss per share
Basic net 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 loss per share includes the impact of potentially dilutive securities. As the Company's potentially dilutive securities (stock options, warrants, and redeemable convertible preferred stock) were anti-dilutive for the three months ended March 31, 2003 and 2002, they have been excluded from the computation of shares used in computing diluted net loss per common share for those periods.
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 in clinical trials, 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 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 March 31, 2003 2002 ----------- ----------- (in thousands) Net loss..................................... $ (17,375) $ (8,818) Other comprehensive income(loss): Incresae (decrease) in unrealized gain on investments, net of tax................. 7,033 (79,917) Less: reclassification adjustment for gains recognized in net loss, net of tax........ (493) (289) ----------- ----------- Comprehensive loss........................... $ (10,835) $ (89,024) =========== ===========
Recent accounting pronouncements
Exit or disposal activities
In June 2002, the FASB issued SFAS 146, "Accounting for Costs Associated with Exit or Disposal Activities," which addresses accounting for restructuring, discontinued operations, plant closing, or other exit or disposal activity. SFAS 146 requires companies to recognize costs associated with exit or disposal activities when they are incurred rather than at the date of a commitment to an exit or disposal plan. The Company adopted SFAS 146 on January 1, 2003 for prospective exit or disposal activities, and the adoption had no impact on our cash flows. In applying the provisions of SFAS 146 to lease exit or disposal costs that may arise prospectively, such costs will be recorded when the Company ceases to use the related facilities.
Revenue arrangements with multiple deliverables
In November 2002, the 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.
2. Corporate Headquarter Facilities
Cell Genesys maintains its corporate headquarters in South San Francisco, California. In the fourth quarter of 2002, the Company recorded a charge of approximately $6.2 million for 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. This charge was estimated based upon market conditions at that time and will be adjusted 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 $16.8 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. Subsequent Events
During April 2003, 101 shares of the Company's Series B redeemable convertible preferred stock were converted into 180,313 shares of the Company's common stock at an average effective conversion price of $6.50 per share. The total market value of such common shares as of the date of conversion was approximately $1.2 million. The transaction will be recorded on the Company's June 30, 2003 balance sheet as a reclassification from preferred stock to common stock and additional paid-in capital.
In April 2003, the Company amended the terms of its $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 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 March 31, 2003 condensed consolidated balance sheet.
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 subsidiaries' 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 biological therapies, including cancer vaccines, oncolytic virus therapies and cancer gene therapies, to treat multiple types of cancer. 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 evaluating potential therapies for bladder cancer, liver cancer and colon cancer, as well as preclinical cancer gene therapy programs evaluating potential therapies for multiple types of cancer. We plan to file an Investigational New Drug (IND) application for CG8840, an oncolytic virus therapy for the treatment of bladder cancer, during the next year. Additionally, Cell Genesys has a majority-owned subsidiary, Ceregene, Inc., which is focused on gene therapies for neurological disorders, and continues to hold approximately 8.7 million shares of common stock of its former subsidiary, Abgenix, Inc. (NASDAQ: ABGX), which is focused on the development and commercialization of antibody therapies.
First Quarter 2003 and Other Recent Highlights:
Critical Accounting Policies
We consider certain accounting policies related to revenue recognition, lease accounting, use of estimates and income taxes to be critical policies.
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 through 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 values 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 research 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 a charge of approximately $6.2 million for 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. This charge was estimated based upon market conditions at that time and will be adjusted 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 in clinical trials, 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 made 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 for the three months ended March 31, 2003 were $1.0 million compared with $4.6 million for the three months ended March 31, 2002,
a decrease reflecting the previously announced termination of a collaboration agreement for GVAX® lung cancer vaccine.Our research and development expenses were $21.1 million and $16.6 million for the three months ended March 31, 2003 and 2002, respectively. This increase can be attributed primarily to our expanding clinical trials and other product development activities in both its 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 $5.0 million and $3.7 million for the three months ended March 31, 2003 and 2002, respectively. This increase resulted primarily from infrastructure expenses related to our manufacturing and corporate headquarters facilities. 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.
Interest and other income were $1.9 million and $2.4 million for the three months ended March 31, 2003 and 2002, respectively. This decrease was primarily due to lower average cash balances and lower interest rates during the period. Interest expense was $0.3 million and $0.4 million for the three months ended March 31, 2003 and 2002, respectively. The interest expense incurred during the three months ended March 31, 2003 related primarily to our leased facility in South San Francisco, California. Interest expense for the three months ended March 31, 2002 related primarily to the $60 million asset- backed collateral debt financing completed in December 2001.
We
recorded a tax benefit of $6.1 million and $4.5 million for the three months ended March 31, 2003 and 2002, respectively. 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.The net loss for the three months ended March 31, 2003 was $17.4 million compared with $8.8 million for the three months ended March 31, 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.
Liquidity and Capital Resources
At March 31, 2003 we had approximately $145.5 million in cash, cash equivalents and short-term investments, of which $67.3 million is classified as restricted cash primarily related to our debt financing. We have maintained our financial position through strategic management of our resources including our holdings in Abgenix 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 were $8.9 million and $14.9 million for the three months ended March 31, 2003 and 2002, respectively. This decrease was due primarily to $8.6 million in increased net losses (as discussed above) offset by the receipt of $15 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.
Cell Genesys has financed its operations primarily through the sale of equity securities, funding under collaborative arrangements, sales of Abgenix common stock and secured financing. In 2002 and 2000, Cell Genesys received approximately $2.5 million and $243.9 million, respectively, in net proceeds from the sale of shares of Abgenix common stock. Cell Genesys did not sell any Abgenix stock in the first quarter of 2003.
In connection with the gain on sale of Abgenix 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 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 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 March 31, 2003 were (in thousands):
Operating Capital Debt Leases * Leases Financing ---------------------------------- Years ending December 31: 2003......................................... $ 8,039 $ 4,491 $ 1,035 2004......................................... 9,970 6,156 1,380 2005......................................... 10,278 6,369 1,380 2006......................................... 3,924 6,460 1,380 2007......................................... 1,877 6,511 61,380 2008 and beyond.............................. 15,698 89,286 -- --------- --------- --------- Total minimum payments (1)................... $ 49,786 $ 119,273 $ 66,555 ========= Less: Amount representing interest and executory costs. ($65,756) (6,555) ---------- --------- Present value of future debt payments.......... $ $53,517 $ 60,000 Less: Current portion of future payments....... ($5,687) -- Noncurrent portion of future payments.......... ---------- --------- $ $47,830 $ $60,000 ========== =========
(1) Total operating lease commitments include rent payments for the Company's Foster City facilities of which $6.2 million was accrued as of March 31, 2003 as part of the estimated facility exit co with our move to the South San Francisco, California headquarters in March 2003.
In April 2003 the Company amended the terms of its $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. 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 at March 31, 2003 as reflected above.
Capital expenditures for the three months ended March 31, 2003 were $12.2 million, relating primarily to 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. 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. Expenditures associated with the completion and validation of the two buildings comprising this facility is expected to total approximately $3.0 million in 2003. In addition, we have completed the construction of a new manufacturing facility in Memphis, Tennessee that will be devoted to the manufacture of patient-specific GVAXâ cancer vaccines for lung cancer. We expect to incur approximately $1.0 million of additional costs in 2003 associated with the validation of this facility. In 2002, we completed modifications of our GMP facility in San Diego, California, in preparation for the manufacture of viral based products. In March 2003, we moved our corporate headquarters to South San Francisco, California.
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 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 liquidity 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.
Gene therapy is a new technology. Existing preclinical and clinical data on the safety and efficacy of gene therapy 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 predict safety or efficacy in humans. Unacceptable side effects may be discovered during preclinical and clinical testing of our potential products or thereafter. Possible side effects of gene therapy may be serious and potentially life-threatening. 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 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 March 31, 2003, our accumulated deficit was approximately $107.5 million. Our accumulated deficit would be substantially higher absent the gains we have realized on sales of our Abgenix stock. For the quarter ended March 31, 2003, we recorded a net loss of $17.4 million. 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:
We plan to raise additional funds through collaborative relationships, sales of some portion or all of our investment in Abgenix, 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 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 continue to 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 and 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 or oncolytic virus therapy 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. Completion of these facilities could take longer than expected, and our inability to establish and maintain the facilities within our planned time and budget could materially affect 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:
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 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 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 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 March 31, 2003 we had approximately 353 patents issued or granted to Cell Genesys or available to us based on licensing arrangements and approximately 261 applications pending in the name off 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:
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 approximately 50 companies worldwide pursuing cancer programs with similar technology to ours. 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:
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:
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 our strategic acquisitions and investments.
In January 2001, we acquired the principal operating assets of Chiron Corporation's gene therapy business, a fully equipped and staffed manufacturing facility. Also in January 2001, we launched Ceregene, Inc., formed through the acquisition of Neurologic Gene Therapeutics, a private San Diego-based start-up company. Finally, in September 2001, we acquired Calydon, Inc., a private biotechnology company focused on the treatment of cancer using genetically engineered oncolytic virus therapies. We may not be able to fully integrate all these companies and their intellectual property or personnel. Our attempts to do so will place additional burdens on our management and infrastructure. These acquisitions will also subject us to a number of risks, including:
We may not be successful in overcoming these risks or any other problems encountered in connection with our acquisitions. Moreover, 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.
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 stock, which has been highly volatile.
Our retained ownership of Abgenix common stock represents a material portion of the total assets on our balance sheet. Abgenix stock price has proven to be highly volatile. The value of our holdings of Abgenix common stock was approximately $75.6 million at March 31, 2003. Movements in the price of Abgenix 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 April 30, 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 may affect our stock price:
Our stockholders may be diluted by the conversion of outstanding Series B redeemable convertible preferred stock.
As of March 31, 2003, 665 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 1.2 million 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:
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 March 31, 2003, the aggregate market value for all outstanding Series B preferred was approximately $7.7 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 April 2003, 101 shares of the Company's Series B redeemable convertible preferred stock were converted into 180,313 shares of the Company's common stock at an average effective conversion price of $6.50 per share. The total market value of such common shares as of the date of conversion was approximately $1.2 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 our shares of common stock for which our outstanding stock options are exercisable are, once they have been purchased, eligible for 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 Stockholders Rights Plan, stockholders of record on August 21, 1995 received one preferred share purchase right for each outstanding share of our common stock. 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:
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:
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 shares.
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 common stock it holds, which was approximately 8.7 million as of March 31, 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)
Fair Value 2008 March 31, 2003 2004 2005 2006 2007 Thereafter Total 2003 -------- ------- ------- ------- -------- ---------- -------- ---------- Total Investments Securities. $50,441 $44,505 $26,192 $4,831 $4,183 -- $130,152 $131,380 Average Interest Rate............... 1.38% 3.81% 2.74% 2.71% 2.18% -- 1.88% -- Long-term Debt, including Current Portion.... $ 181 $ 257 $ 230 $ 104 -- $60,000 $60,772 $60,772 Average Interest Rate............(1) 2.04% 2.04% 2.04% 2.04% -- 2.04% 2.04% --
(1) Interest rate based upon LIBOR rate index plus a spread of .75 percent, and can be reset on a quarte quarterly or semi-annual basis.
Item 4. DISCLOSURE CONTROLS AND PROCEDURES
(a) Evaluation of disclosure controls and procedures.
Our Chief Executive Officer and our Chief Financial Officer evaluated our "disclosure controls and procedures" (as defined in Rule 13a-14(c) of the Securities Exchange Act of 1934 (the "Exchange Act")) as of a date within 90 days before the filing date of this quarterly report. They concluded that, as of the evaluation date, our disclosure controls and procedures are effective to ensure that information we are required to disclose in reports that we file or submit under the Exchange Act is accurately recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission's rules and forms.
(b) Changes in internal controls
There have been no significant changes in our internal controls or in other factors that could significantly affect these controls subsequent to the above referenced evaluation. In addition there were no significant deficiencies or material weaknesses in our internal controls. Accordingly, no corrective actions were required or undertaken.
None
Item 6. Exhibits and Reports On Form 8-K
Exhibit Number |
Description |
12.1 |
Computation of Ratio of Earnings to Fixed Charges |
99.1 |
Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350 |
On April 28, 2003 the Company filed a Form 8-K containing our press release announcing the Company's financial results for the three-month period ended March 31, 2003.
SIGNATURES
Pursuant to the requirements of Section 13 or 15 (d) of the Securities Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized in Foster City, California, on May 15, 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: May 15, 2003 |
CERTIFICATIONS
I, Stephen A. Sherwin, certify that:
Dated: May 15, 2003
By: /s/ Stephen A. Sherwin,
M.D.
Name: Stephen A. Sherwin, M.D.
Title: Chief Executive Officer
I, Matthew J. Pfeffer, certify that:
Dated: May 15, 2003
By: /s/ Matthew J.
Pfeffer
Name: Matthew J. Pfeffer
Title: Chief Financial Officer