UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON D.C. 20549
| [X] |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
FOR THE PERIOD ENDED SEPTEMBER 30, 2002
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: 0-20859
GERON CORPORATION
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
| DELAWARE | 75-2287752 | |
| (STATE OR OTHER JURISDICTION OF INCORPORATION OR ORGANIZATION) |
(I.R.S. EMPLOYER IDENTIFICATION NO.) |
230 CONSTITUTION DRIVE, MENLO PARK, CA 94025
(ADDRESS, INCLUDING ZIP CODE, OF PRINCIPAL EXECUTIVE OFFICES)
REGISTRANTS TELEPHONE NUMBER, INCLUDING AREA CODE: (650) 473-7700
SECURITIES REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT: NONE
SECURITIES REGISTERED PURSUANT TO SECTION 12(g) OF THE ACT:
COMMON STOCK $0.001 PAR VALUE
(TITLE OF CLASS)
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 the number of shares outstanding of each of the issuers classes of common stock, as of the latest practicable date.
| Class: Common Stock $0.001 par value | Outstanding at October 29, 2002: | |
| 24,739,397 shares |
GERON CORPORATION
INDEX
| Page | ||||
| PART I. FINANCIAL INFORMATION | ||||
| Item 1: | Consolidated Financial Statements | 3 | ||
| Condensed Consolidated Balance Sheets as of September 30, 2002 and December 31, 2001 | 3 | |||
|
Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2002 and 2001 |
4 | |||
|
Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2002 and 2001 |
5 | |||
| Notes to Condensed Consolidated Financial Statements | 6 | |||
| Item 2: | Managements Discussion and Analysis of Financial Condition and Results of Operations | 9 | ||
| Item 3: | Quantitative and Qualitative Disclosures About Market Risk | 24 | ||
| Item 4: | Controls and Procedures | 25 | ||
| PART II. OTHER INFORMATION | ||||
| Item 1: | Legal Proceedings | 25 | ||
| Item 2: | Changes In Securities and Use of Proceeds | 25 | ||
| Item 3: | Defaults upon Senior Securities | 25 | ||
| Item 4: | Submission of Matters to a Vote of Security Holders | 25 | ||
| Item 5: | Other Information | 25 | ||
| Item 6: | Exhibits and Reports on Form 8-K | 25 | ||
| SIGNATURE | 26 | |||
| CERTIFICATIONS | 27 | |||
2
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
GERON CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS)
| SEPTEMBER 30, | DECEMBER 31, | |||||||||||
| 2002 | 2001 | |||||||||||
| (UNAUDITED) | (SEE NOTE 1) | |||||||||||
ASSETS |
||||||||||||
Current assets: |
||||||||||||
Cash and cash equivalents |
$ | 15,428 | $ | 18,773 | ||||||||
Restricted cash |
530 | 530 | ||||||||||
Short-term investments |
31,424 | 50,170 | ||||||||||
Interest and other receivables |
1,162 | 1,297 | ||||||||||
Notes receivable from related parties |
244 | 223 | ||||||||||
Other current assets |
2,353 | 703 | ||||||||||
Total current assets |
51,141 | 71,696 | ||||||||||
Long-term investments |
6,258 | 10,168 | ||||||||||
Equity investments in licensees |
314 | 699 | ||||||||||
Notes receivable from related parties |
356 | 292 | ||||||||||
Property and equipment, net |
2,788 | 3,587 | ||||||||||
Deposits and other assets |
254 | 241 | ||||||||||
Intangible assets |
7,400 | 9,548 | ||||||||||
| $ | 68,511 | $ | 96,231 | |||||||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||||||
Current liabilities: |
||||||||||||
Accounts payable |
$ | 847 | $ | 1,338 | ||||||||
Accrued compensation |
761 | 1,272 | ||||||||||
Accrued liabilities |
1,762 | 1,715 | ||||||||||
Current portion of deferred revenue |
567 | 767 | ||||||||||
Current portion of equipment loans |
528 | 825 | ||||||||||
Current portion of research funding obligation |
4,862 | 4,395 | ||||||||||
Total current liabilities |
9,327 | 10,312 | ||||||||||
Noncurrent portion of deferred revenue |
1,063 | 1,097 | ||||||||||
Noncurrent portion of equipment loans |
433 | 299 | ||||||||||
Noncurrent portion of research funding obligation |
4,544 | 6,686 | ||||||||||
Convertible debentures |
16,310 | 16,295 | ||||||||||
Commitments |
||||||||||||
Stockholders equity: |
||||||||||||
Common stock |
25 | 24 | ||||||||||
Additional paid-in-capital |
256,006 | 253,595 | ||||||||||
Deferred compensation |
(53 | ) | (234 | ) | ||||||||
Accumulated deficit |
(218,554 | ) | (191,875 | ) | ||||||||
Accumulated other comprehensive income (loss) |
(590 | ) | 32 | |||||||||
Total stockholders equity |
36,834 | 61,542 | ||||||||||
| $ | 68,511 | $ | 96,231 | |||||||||
See accompanying notes.
3
GERON CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS)
(UNAUDITED)
| THREE MONTHS ENDED | NINE MONTHS ENDED | |||||||||||||||||
| SEPTEMBER 30, | SEPTEMBER 30, | |||||||||||||||||
| 2002 | 2001 | 2002 | 2001 | |||||||||||||||
Revenues from collaborative agreements |
$ | 18 | $ | 515 | $ | 548 | $ | 2,765 | ||||||||||
License fees and royalties |
200 | 100 | 407 | 232 | ||||||||||||||
Total revenues |
218 | 615 | 955 | 2,997 | ||||||||||||||
Operating expenses: |
||||||||||||||||||
Research and development |
6,346 | 9,458 | 24,656 | 22,814 | ||||||||||||||
General and administrative |
1,314 | 1,641 | 4,363 | 6,918 | ||||||||||||||
Total operating expenses |
7,660 | 11,099 | 29,019 | 29,732 | ||||||||||||||
Loss from operations |
(7,442 | ) | (10,484 | ) | (28,064 | ) | (26,735 | ) | ||||||||||
Interest and other income |
434 | 1,616 | 1,970 | 4,866 | ||||||||||||||
Interest and other expense |
(188 | ) | (244 | ) | (585 | ) | (760 | ) | ||||||||||
Net loss |
$ | (7,196 | ) | $ | (9,112 | ) | $ | (26,679 | ) | $ | (22,629 | ) | ||||||
Basic and diluted net loss per share |
$ | (0.29 | ) | $ | (0.42 | ) | $ | (1.08 | ) | $ | (1.04 | ) | ||||||
Weighted average shares used in
computing basic and diluted net loss
per share |
24,737,635 | 21,905,598 | 24,634,161 | 21,832,266 | ||||||||||||||
See accompanying notes.
4
GERON CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
CHANGE IN CASH AND CASH EQUIVALENTS
(IN THOUSANDS)
(UNAUDITED)
| NINE MONTHS ENDED | ||||||||||
| SEPTEMBER 30, | ||||||||||
| 2002 | 2001 | |||||||||
Cash flows from operating activities: |
||||||||||
Net loss |
$ | (26,679 | ) | $ | (22,629 | ) | ||||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||||
Depreciation and amortization |
1,172 | 908 | ||||||||
Accretion and amortization on investments |
795 | 3 | ||||||||
Interest for convertible debentures |
15 | 94 | ||||||||
Issuance of redeemable common stock in exchange for acquired research
technology |
1,585 | | ||||||||
Stock-based compensation |
17 | 5,195 | ||||||||
Accretion of interest on research funding obligation |
367 | 368 | ||||||||
Deferred compensation |
181 | 206 | ||||||||
Loss on equity investments in licensees |
167 | 16 | ||||||||
Accrued research funding payments |
(2,044 | ) | (2,153 | ) | ||||||
Changes in assets and liabilities: |
||||||||||
Other current and noncurrent assets |
1,561 | 762 | ||||||||
Other current and noncurrent liabilities |
(1,576 | ) | 1,707 | |||||||
Translation adjustment |
(67 | ) | (136 | ) | ||||||
Net cash used in operating activities |
(24,506 | ) | (15,659 | ) | ||||||
Cash flows from investing activities: |
||||||||||
Capital expenditures |
(325 | ) | (927 | ) | ||||||
Purchases of securities available-for-sale |
(21,312 | ) | (35,453 | ) | ||||||
Proceeds from sales/calls of securities available-for-sale |
| 25,709 | ||||||||
Proceeds from maturities of securities available-for-sale |
42,776 | 27,040 | ||||||||
Net cash provided by investing activities |
21,139 | 16,369 | ||||||||
Cash flows from financing activities: |
||||||||||
Proceeds from equipment loans |
498 | 102 | ||||||||
Payments of obligations under equipment loans |
(661 | ) | (709 | ) | ||||||
Proceeds from issuance of common stock, net |
185 | 579 | ||||||||
Net cash provided by (used in) financing activities |
22 | (28 | ) | |||||||
Net (decrease) increase in cash and cash equivalents |
(3,345 | ) | 682 | |||||||
Cash and cash equivalents at the beginning of the period |
18,773 | 29,985 | ||||||||
Cash and cash equivalents at the end of the period |
$ | 15,428 | $ | 30,667 | ||||||
See accompanying notes.
5
GERON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2002
(UNAUDITED)
1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The terms GERON, the Company, we and us as used in this report refer to Geron Corporation. The accompanying condensed consolidated unaudited balance sheet as of September 30, 2002 and condensed consolidated statements of operations for the three and nine month periods ended September 30, 2002 and 2001 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 the management of Geron Corporation, all adjustments (consisting only of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the three and nine month periods ended September 30, 2002 are not necessarily indicative of the results that may be expected for the year ending December 31, 2002 or any other period. These financial statements and notes should be read in conjunction with the financial statements for the year ended December 31, 2001, included in the Companys Annual Report on Form 10-K. The accompanying condensed consolidated balance sheet as of December 31, 2001 has been derived from audited financial statements at that date.
Principles of Consolidation
The consolidated financial statements include the accounts of Geron Corporation and its wholly owned subsidiary, Geron Bio-Med Ltd., a United Kingdom company. Intercompany accounts and transactions have been eliminated. The financial statements of the Companys subsidiary outside the United States are measured using the local currency as the functional currency. Assets and liabilities of this subsidiary are translated at rates of exchange at the balance sheet date. The resultant translation adjustments are included in accumulated other comprehensive income (loss), a separate component of stockholders equity. Income and expense items are translated at average monthly rates of exchange.
Net Loss Per Share
Basic earnings (loss) per share is calculated using the weighted average number of common shares outstanding. Because the Company is in a net loss position, diluted earnings per share is also calculated using the weighted average number of common shares outstanding and excludes the effects of options, warrants and convertible securities which are antidilutive. Had the Company been in a net income position, diluted earnings per share would have included the shares used in the computation of basic net loss per share as well as an additional 1,307,175 and 1,658,209 shares for 2002 and 2001, respectively, related to outstanding options, warrants and convertible securities not included above (as determined using the treasury stock method at the estimated average market value).
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 financial statements and accompanying notes. Actual results could differ from those estimates.
Cash Equivalents and Marketable Debt Securities Available-For-Sale
The Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. The Company is subject to credit risk related to its cash equivalents and securities available-for-sale. The Company places its cash and cash equivalents in money market funds and commercial paper.
6
The Company classifies its marketable debt securities as available-for-sale. Available-for-sale securities are recorded at fair value with unrealized gains and losses reported in accumulated other comprehensive income (loss) in stockholders equity. Fair values for investment securities are based on quoted market prices, where available. If quoted market prices are not available, fair values are based on quoted market prices of comparable instruments. Realized gains and losses are included in interest and other income and are derived using the specific identification method for determining the cost of securities sold and have been immaterial to date. Declines in market value judged other-than-temporary result in a charge to interest income. Dividend and interest income are recognized when earned. The Companys investments include corporate notes in United States corporations with original maturities ranging from 7 to 18 months.
Revenue Recognition
Since the Companys inception, a substantial portion of its revenues has been generated from license and research agreements with collaborators. The Company recognizes revenue under these collaborative agreements as the related research and development costs are incurred. Milestone fees are recognized upon completion of specified milestones according to contract terms. Deferred revenue represents the portion of research payments received which have not been earned.
The Company also has several license, option and marketing agreements with various companies in fields such as diagnostics, research tools, agriculture, biologics production and cancer therapeutics. With each of these agreements, the Company receives nonrefundable license payments in cash or equity securities, option payments in cash or equity securities, royalties on future sales of products, or any combination of these items. Nonrefundable signing or license fees that are not dependent on future performance under these agreements are recognized as revenue when received and over the term of the arrangement if the Company has continuing performance obligations. Option payments are recognized as revenue over the period of the option agreement. Royalties are generally recognized upon receipt.
Restricted Cash
As of September 30, 2002 and 2001, the Company held $530,000 in a Certificate of Deposit as collateral on an unused line of credit.
Marketable and Non-Marketable Equity Investments in Licensees
Equity in nonpublic companies is carried at the lower of cost or net realizable value. Equity in public companies is carried at market value as of the balance sheet date. Unrealized gains and losses are included in accumulated other comprehensive income (loss), a separate component of stockholders equity. Realized gains or losses are included in interest and other income and are derived using the specific identification method. Statement of Financial Accounting Standards No. 115 (SFAS 115), Accounting for Certain Investments in Debt and Equity Securities, requires companies to determine whether a decline in fair value below the amortized cost basis is other than temporary. If a decline in fair value is determined to be other than temporary, SFAS 115 requires the carrying value of the debt or equity security to be written down to its fair value. No such writedowns were recorded for the three and nine months ended September 30, 2002 and 2001.
Depreciation and Amortization
The Company records property and equipment at cost and calculates depreciation using the straight-line method over the estimated useful lives of the assets, generally four years. Leasehold improvements are amortized over the remaining term of the lease.
Comprehensive Income (Loss)
Comprehensive income (loss) is comprised of net income (loss) and other comprehensive income (loss). Other comprehensive income (loss) includes certain changes in equity that are excluded from net income (loss). Specifically, net unrealized losses on our available-for-sale securities and equity investments in licensees of ($496,000) and cumulative translation adjustment of ($94,000) are included in accumulated other comprehensive income (loss).
7
Reclassifications
Certain reclassifications of prior year amounts have been made to conform to current year presentation, including common stock issued under purchase plan and accretion and amortization of investments.
Recent Accounting Pronouncements
In June 2002, the FASB issued Statement of Financial Accounting Standards No. 146 (SFAS 146), Accounting for Costs Associated with Exit or Disposal Activities. SFAS 146 addresses financial accounting and reporting for costs associated with exit or disposal activities and nullifies Emerging Issues Task Force Issue No. 94-3, Liability Recognition for Certain Employee Termination Benefits and Other Costs to Exit an Activity (including Certain Costs Incurred in a Restructuring). SFAS 146 is effective for exit or disposal activities initiated after December 31, 2002. Geron does not expect the adoption of SFAS 146 to have a material effect on its financial condition or results of operations.
2. RESTRUCTURING
In June 2002, Geron restructured its organization to focus available resources on its most advanced product development programs. In the process, Geron reduced its research staff by 33 employees and its support staff by 10 employees, a reduction of approximately 30% of Gerons work force in Menlo Park, California. Geron recorded a restructuring charge of $706,000 relating to employee severance benefits, of which $625,000 related to research and development expense and $81,000 related to general and administrative expense. At September 30, 2002, the remaining amount to be paid was $3,000. The Company expects to pay the remaining amount by December 31, 2002.
3. SEGMENT INFORMATION
Statement of Financial Accounting Standards No. 131, Disclosures about Segments of an Enterprise and Related Information (SFAS 131) establishes standards for reporting information regarding operating segments in annual financial statements and requires selected information for those segments to be presented in interim financial reports issued to stockholders. SFAS 131 also establishes standards for related disclosures about products and services and geographic areas. Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision making group, in making decisions how to allocate resources and assess performance. The Companys chief decision maker, as defined under SFAS 131, is the Chief Executive Officer. To date, the Company has viewed its operations as principally one segment, the development of therapeutic and diagnostic products for applications in oncology, drug discovery and regenerative medicine. As a result, the financial information disclosed herein materially represents all of the financial information related to the Companys principal operating segment.
4. CONSOLIDATED STATEMENT OF CASH FLOWS DATA
| NINE MONTHS | NINE MONTHS | |||||||
| ENDED | ENDED | |||||||
| (IN THOUSANDS) | SEPTEMBER 30, 2002 | SEPTEMBER 30, 2001 | ||||||
| (Unaudited) | (Unaudited) | |||||||
Supplemental Investing and Financing Activities: |
||||||||
Net unrealized gain (loss) on equity investments |
$ | (374 | ) | $ | (236 | ) | ||
Net unrealized gain (loss) on available-for-sale securities |
$ | (397 | ) | $ | 372 | |||
Shares issued for services |
$ | 624 | $ | | ||||
Deferred revenue receivable |
$ | 400 | $ | | ||||
8
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
OVERVIEW
This Form 10-Q contains forward-looking statements that involve risks and uncertainties. We use words such as anticipate, believe, plan, expect, future, intend and similar expressions to identify forward-looking statements. These statements appear throughout the Form 10-Q and are statements regarding our intent, belief, or current expectations, primarily with respect to our operations and related industry developments. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this Form 10-Q. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including the risks faced by us and described under the heading Risk Factors in the Companys Annual Report on Form 10-K for the fiscal year ended December 31, 2001, in the section of this Item 2 titled Additional Factors That May Affect Future Results, and elsewhere in this Form 10-Q.
The following discussion should be read in conjunction with the unaudited financial statements and notes thereto included in Part I, Item 1 of this Quarterly Report on Form 10-Q and with Managements Discussion and Analysis of Financial Condition and Results of Operations contained in the Companys Annual Report on Form 10-K for the fiscal year ended December 31, 2001.
We are a biopharmaceutical company focused on developing and commercializing therapeutic and diagnostic products for applications in oncology and regenerative medicine, and research tools for drug discovery. Our product development programs are based upon three patented core technologies: telomerase, human embryonic stem cells and nuclear transfer.
Our results of operations have fluctuated from period to period and may continue to fluctuate in the future based upon the timing and composition of funding under our various collaborative agreements, as well as the progress of our research and development efforts and variations in the level of expenses related to developmental efforts during any given period. Results of operations for any period may be unrelated to results of operations for any other period. In addition, historical results should not be viewed as indicative of future operating results. We are subject to risks common to companies in our industry and at our stage of development, including risks inherent in our research and development efforts, reliance upon our collaborative partners, enforcement of our patent and proprietary rights, need for future capital, potential competition and uncertainty of regulatory approvals or clearances. In order for a product to be commercialized based on our research, we and our collaborators must conduct preclinical tests and clinical trials, demonstrate the efficacy and safety of our product candidates, obtain regulatory approvals or clearances and enter into manufacturing, distribution and marketing arrangements, as well as obtain market acceptance. We do not expect to receive revenues or royalties based on therapeutic products for a period of years, if at all.
CRITICAL ACCOUNTING POLICIES
We consider certain accounting policies related to revenue recognition, consolidation and use of estimates to be critical policies.
Revenue Recognition
Since our inception, a substantial portion of our revenues has been generated from license and research agreements with collaborators. We recognize cost reimbursement revenue under these collaborative agreements as the related research and development costs are incurred. We recognize milestone fees upon completion of specified milestones according to contract terms. Deferred revenue represents the portion of research payments received which has not been earned.
We also have several license, option and marketing agreements with various companies in fields such as diagnostics, research tools, agriculture, biologics production and cancer therapeutics. With each of these agreements, we may receive nonrefundable license payments in cash or equity securities, option payments in cash or equity securities, royalties on future sales of products, or any combination of these items. We recognize nonrefundable signing or license fees that are not dependent on future performance under these
9
agreements as revenue when received or over the term of the arrangement if we have continuing performance obligations. We recognize option payments as revenue over the period of the option agreement. We generally recognize royalties as revenue upon receipt.
Consolidation
Our consolidated financial statements include the results of Geron in the United States and our wholly owned subsidiary, Geron Bio-Med Ltd., a United Kingdom company. Transactions and accounts between us and Geron Bio-Med have been eliminated. We translate the assets and liabilities of Geron Bio-Med from British pounds sterling into United States dollars using foreign exchange rates as of the balance sheet date. We translate the revenues and expenses of Geron Bio-Med using average monthly foreign exchange rates. Translation adjustments are included in the balance sheet under accumulated other comprehensive income (loss), a separate component of stockholders equity.
Use of Estimates
In preparing our consolidated financial statements to conform with accounting principles generally accepted in the United States, we make estimates and assumptions that affect the amounts reported in our financial statements and accompanying notes. These estimates include useful lives for fixed assets for depreciation calculations, estimated lives for license agreements related to deferred revenue and assumptions for valuing options and warrants. Actual results could differ from these estimates.
RESULTS OF OPERATIONS
Revenues
We recognized revenues from collaborative agreements of $18,000 and $548,000 for the three and nine months ended September 30, 2002, compared to $515,000 and $2.8 million for the comparable periods in 2001. Revenues recognized in 2002 reflected the final research support payment from our collaborative agreement with Kyowa Hakko and a consulting arrangement with Modex Therapeutiques. Revenues recognized in 2001 reflected final research support payments from our collaborative agreements with Pharmacia and Kyowa Hakko. Our agreement with Pharmacia terminated in January 2001. Kyowa Hakko selected GRN163, a telomerase inhibitor compound, for development in August 2001, which moved the project from the research phase to the development phase. Kyowa Hakko is not obligated to provide any further research funding in the future. We recognize revenue under collaborative agreements as we incur the related research and development costs.
We have entered into license and option agreements with various companies involved in fields such as diagnostics, research tools, agriculture, biologics production and cancer therapeutics. In each of these agreements, we have conveyed certain rights to our technologies. In connection with the agreements, we are entitled to receive license fees, option fees, milestone payments, royalties on future sales, or any combination in cash or equity securities. We recognized license and option fee revenues of $130,000 and $252,000 for the three and nine months ended September 30, 2002 as compared to $63,000 and $112,000 for the same periods in 2001 related to our various agreements. Also, we received royalties of $70,000 and $155,000 for the three and nine months ended September 30, 2002, compared to $37,000 and $120,000 for the comparable periods in 2001, on product sales of telomerase diagnostic kits to the research-use-only market and cell-based research products. License and royalty revenues are dependent upon additional agreements being signed and future product sales. We expect to recognize total revenue of $156,000 during the remainder of 2002, $532,000 in 2003, $205,000 in 2004, $127,000 in 2005 and $610,000 thereafter related to our existing deferred revenue. Current revenues may not be predictive of future results.
Research and Development Expenses
Research and development expenses were $6.3 million and $24.7 million for the three and nine months ended September 30, 2002, compared to $9.5 million and $22.8 million for the comparable periods in 2001. The overall decrease for the third quarter 2002 compared to the third quarter 2001 was primarily the result of a reduction in personnel-related costs of $1.0 million as a result of the restructuring in June 2002, a reduction in scientific consulting and contract research costs of $871,000, and the absence of $2.0 million in license fee payments, offset by an increase in scientific supply costs of $619,000. In August 2001, in connection with a
10
license agreement, Geron issued common stock and warrants to a research institution, which resulted in $2.0 million in license fee expense. The overall increase for the nine month period in 2002 compared to 2001 was primarily the result of an increase in scientific supply costs of $1.9 million. Overall, Geron expects research and development expense to increase in the future as a result of continued development of its telomerase inhibitor GRN163 and other potential products into clinical trials.
The scope and magnitude of future research and development expenses are difficult to predict at this time given the number of studies that will need to be conducted for any of our potential products. In general, biopharmaceutical development involves a series of steps beginning with identification of a potential target, generation of in-vitro (laboratory) data, proof of concept in animals and Phase 1, 2, and 3 clinical studies in humans each of which is typically more expensive than the previous step. Success in development therefore results in increasing expenditures. Our research and development expenses currently include costs for scientific personnel, supplies, equipment, consultants, patent filings and sponsored research at academic and research institutions. Future research and development expenses would also include costs related to clinical trials.
Currently, our lead oncology development product, GRN163, is in animal studies. Upon conclusive results from those animal studies, we expect to enter Phase 1 clinical studies for this product in 2003. Costs for materials necessary to produce GRN163 have been included in research and development expenses and account for approximately 55% of the increase in scientific supplies expense for 2002. Geron expects scientific supplies expense to increase in the future as more GRN163 is produced for animal studies and clinical studies.
We are currently supporting a Phase 1 clinical study at Duke University Medical Center for a telomerase therapeutic vaccine for patients with prostate cancer. The results of this study will be evaluated in 2003. Future clinical progress of this product will depend on the study results.
In the Regenerative Medicine area, we are testing cells of various types that were differentiated from human embryonic stem cells in animal models of disease, including neurons for the treatment of Parkinsons disease, oligodendrocytes for the treatment of spinal cord injury, and cardiomyocytes for the treatment of heart disease. In addition, we have established protocols to scalably culture human embryonic stem cells. Establishment of this method is necessary for the eventual scale-up and manufacture of differentiated cell types for treatment of various diseases. Costs for materials necessary for these studies and related research have been included in research and development expenses and account for approximately half of the increase in scientific supplies expense for 2002. Geron expects scientific supplies expense to be maintained at this level in 2003.
For a more complete discussion of the risks and uncertainties associated with completing development of potential products, see the section titled Because we or our collaborators must obtain regulatory approval to market our products in the United States and foreign jurisdictions, we cannot predict whether or when we will be permitted to commercialize our products in the section entitled Additional Factors That May Affect Future Results, and elsewhere in this Form 10-Q.
General and Administrative Expenses
General and administrative expenses were $1.3 million and $4.4 million for the three and nine months ended September 30, 2002, compared to $1.6 million and $6.9 million for the comparable periods in 2001. The decrease in general and administrative expenses for the three month period ending September 30, 2002, primarily reflects reduced personnel-related costs as a result of the restructuring in June 2002. In 2001, $2.4 million of stock-based compensation expense was recorded as a result of extending the exercise period of certain options to purchase common stock. In the three and nine months ended September 30, 2002, no such stock-based compensation expense was recorded.
Interest and Other Income
Interest income was $330,000 and $1.5 million for the three and nine months ended September 30, 2002, compared to $1.3 million and $4.2 million for the comparable periods in 2001. The decrease in interest income for 2002 compared to 2001 was primarily due to lower interest rates and decreasing cash and investment balances. Interest earned in the future will depend on future funding and prevailing interest rates.
11
We also received $80,000 and $439,000 in research payments under government grants for the three and nine months ended September 30, 2002, compared to $325,000 and $648,000 for the comparable periods in 2001.
Interest and Other Expense
Interest and other expense was $188,000 and $585,000 for the three and nine months ended September 30, 2002, compared to $244,000 and $760,000 for the comparable periods in 2001. The decrease in interest and other expense for 2002 compared to 2001 was primarily the result of lower interest expenses related to convertible debentures in 2002.
Net Loss
Net loss was $7.2 million and $26.7 million for the three and nine months ended September 30, 2002, compared to $9.1 million and $22.6 million for the comparable periods in 2001. The decrease in net loss for the three months ended September 30, 2002 was primarily due to lower operating expenses as a result of the restructuring in June 2002. The increase in net loss for the nine months ended 2002 compared to 2001 was primarily the result of decreased revenues from collaborative agreements and decreased interest income.