UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
[X] | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE | |
ACT OF 1934 |
FOR THE 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: 0-20859
GERON CORPORATION
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
DELAWARE (STATE OR OTHER JURISDICTION OF INCORPORATION OR ORGANIZATION) |
75-2287752 (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.
Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act). 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 April 25, 2003: | ||
29,600,417 shares |
GERON CORPORATION
INDEX
Page | |||||||
PART I. FINANCIAL INFORMATION |
|||||||
Item 1: | Condensed Consolidated Financial Statements |
3 | |||||
Condensed Consolidated Balance Sheets as of March 31, 2003 and December 31, 2002 |
3 | ||||||
Condensed Consolidated Statements of Operations for the three months ended March
31, 2003 and 2002 |
4 | ||||||
Condensed Consolidated Statements of Cash Flows for the three months ended March
31, 2003 and 2002 |
5 | ||||||
Notes to Condensed Consolidated Financial Statements |
6 | ||||||
Item 2: | Managements Discussion and Analysis of Financial Condition and Results of Operations |
12 | |||||
Item 3: | Quantitative and Qualitative Disclosures About Market Risk |
28 | |||||
Item 4: | Controls and Procedures |
28 | |||||
PART II. OTHER INFORMATION |
|||||||
Item 1: | Legal Proceedings |
29 | |||||
Item 2: | Changes In Securities and Use of Proceeds |
29 | |||||
Item 3: | Defaults upon Senior Securities |
29 | |||||
Item 4: | Submission of Matters to a Vote of Security Holders |
29 | |||||
Item 5: | Other Information |
29 | |||||
Item 6: | Exhibits and Reports on Form 8-K |
30 | |||||
SIGNATURE |
30 | ||||||
CERTIFICATIONS |
31 |
2
PART I. FINANCIAL INFORMATION
ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
GERON CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS)
MARCH 31, | DECEMBER 31, | |||||||||
2003 | 2002 | |||||||||
(UNAUDITED) | (SEE NOTE 1) | |||||||||
ASSETS |
||||||||||
Current assets: |
||||||||||
Cash and cash equivalents |
$ | 7,089 | $ | 4,604 | ||||||
Restricted cash |
530 | 530 | ||||||||
Marketable securities |
31,919 | 42,383 | ||||||||
Interest and other receivables |
354 | 704 | ||||||||
Notes receivable from related parties |
366 | 433 | ||||||||
Prepaid assets |
3,357 | 2,115 | ||||||||
Total current assets |
43,615 | 50,769 | ||||||||
Equity investments in licensees |
347 | 365 | ||||||||
Notes receivable from related parties |
175 | 162 | ||||||||
Property and equipment, net |
2,167 | 2,444 | ||||||||
Deposits and other assets |
240 | 245 | ||||||||
Intangible assets |
5,967 | 6,684 | ||||||||
$ | 52,511 | $ | 60,669 | |||||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||||
Current liabilities: |
||||||||||
Accounts payable |
$ | 1,797 | $ | 1,594 | ||||||
Accrued compensation |
329 | 789 | ||||||||
Accrued liabilities |
905 | 949 | ||||||||
Current portion of deferred revenue |
442 | 543 | ||||||||
Current portion of equipment loans |
281 | 367 | ||||||||
Current portion of research funding obligation |
4,742 | 5,141 | ||||||||
Total current liabilities |
8,496 | 9,383 | ||||||||
Noncurrent portion of deferred revenue |
1,002 | 1,030 | ||||||||
Noncurrent portion of equipment loans |
326 | 377 | ||||||||
Noncurrent portion of research funding obligation |
3,108 | 3,822 | ||||||||
Convertible debentures |
16,320 | 16,316 | ||||||||
Commitments Stockholders equity: |
||||||||||
Common stock |
25 | 25 | ||||||||
Additional paid-in-capital |
257,563 | 256,097 | ||||||||
Deferred compensation |
(173 | ) | (209 | ) | ||||||
Accumulated deficit |
(233,715 | ) | (225,783 | ) | ||||||
Accumulated other comprehensive loss |
(441 | ) | (389 | ) | ||||||
Total stockholders equity |
23,259 | 29,741 | ||||||||
$ | 52,511 | $ | 60,669 | |||||||
See accompanying notes.
3
GERON CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS)
(UNAUDITED)
THREE MONTHS ENDED | ||||||||||
MARCH 31, | ||||||||||
2003 | 2002 | |||||||||
Revenues from collaborative agreements |
$ | 36 | $ | 515 | ||||||
License fees and royalties |
226 | 111 | ||||||||
Total revenues |
262 | 626 | ||||||||
Operating expenses: |
||||||||||
Research and development |
6,964 | 10,164 | ||||||||
General and administrative |
1,342 | 1,596 | ||||||||
Total operating expenses |
8,306 | 11,760 | ||||||||
Loss from operations |
(8,044 | ) | (11,134 | ) | ||||||
Interest and other income |
276 | 871 | ||||||||
Interest and other expense |
(164 | ) | (212 | ) | ||||||
Net loss |
$ | (7,932 | ) | $ | (10,475 | ) | ||||
Basic and diluted net loss per share |
$ | (0.32 | ) | $ | (0.43 | ) | ||||
Weighted average shares used in
computing basic and diluted net loss per share |
24,935,574 | 24,490,391 | ||||||||
See accompanying notes.
4
GERON CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
CHANGE IN CASH AND CASH EQUIVALENTS
(IN THOUSANDS)
(UNAUDITED)
THREE MONTHS ENDED | |||||||||||
MARCH 31, | |||||||||||
2003 | 2002 | ||||||||||
Cash flows from operating activities: |
|||||||||||
Net loss |
$ | (7,932 | ) | $ | (10,475 | ) | |||||
Adjustments to reconcile net loss to net cash used in operating activities: |
|||||||||||
Depreciation and amortization |
312 | 378 | |||||||||
Accretion and amortization on investments |
221 | 285 | |||||||||
Interest for convertible debentures |
4 | 5 | |||||||||
Issuance of redeemable common stock in exchange for acquired research
technology |
| 1,585 | |||||||||
Accretion of interest on research funding obligation |
123 | 124 | |||||||||
Deferred compensation |
36 | 60 | |||||||||
Realized (gain)/loss on equity investments in licensees |
(2 | ) | 18 | ||||||||
Amortization of intangible assets, principally research related |
717 | 716 | |||||||||
Changes in assets and liabilities: |
|||||||||||
Other current and noncurrent assets |
(767 | ) | 164 | ||||||||
Other current and noncurrent liabilities |
968 | (2,006 | ) | ||||||||
Accrued research funding payments |
(1,236 | ) | (527 | ) | |||||||
Translation adjustment |
(5 | ) | (64 | ) | |||||||
Net cash used in operating activities |
(7,561 | ) | (9,737 | ) | |||||||
Cash flows from investing activities: |
|||||||||||
Capital expenditures |
(46 | ) | (259 | ) | |||||||
Purchases of marketable securities |
(3,726 | ) | | ||||||||
Proceeds from maturities of marketable securities |
13,954 | 11,000 | |||||||||
Net cash provided by investing activities |
10,182 | 10,741 | |||||||||
Cash flows from financing activities: |
|||||||||||
Payments of obligations under equipment loans |
(137 | ) | (222 | ) | |||||||
Proceeds from issuance of common stock, net |
1 | 54 | |||||||||
Net cash used in financing activities |
(136 | ) | (168 | ) | |||||||
Net increase in cash and cash equivalents |
2,485 | 836 | |||||||||
Cash and cash equivalents at the beginning of the period |
4,604 | 18,773 | |||||||||
Cash and cash equivalents at the end of the period |
$ | 7,089 | $ | 19,609 | |||||||
See accompanying notes.
5
GERON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2003
(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 March 31, 2003 and condensed consolidated statements of operations for the three month periods ended March 31, 2003 and 2002 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 month period ended March 31, 2003 are not necessarily indicative of the results that may be expected for the year ending December 31, 2003 or any other period. These financial statements and notes should be read in conjunction with the financial statements for the year ended December 31, 2002, included in the Companys Annual Report on Form 10-K. The accompanying condensed consolidated balance sheet as of December 31, 2002 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 based on weighted average shares outstanding and excludes any dilutive effects of options, warrants and convertible securities. Diluted earnings (loss) per share includes any dilutive effect of options, warrants and convertible securities.
A reconciliation of shares used in calculation of basic and diluted net loss per share follows:
Three Months Ended March 31, | ||||||||
2003 | 2002 | |||||||
(In thousands, except share and per | ||||||||
share amounts) | ||||||||
Net loss |
$ | (7,932 | ) | $ | (10,475 | ) | ||
Basic and Diluted Net Loss Per Share: |
||||||||
Basic and diluted net loss per common share |
$ | (0.32 | ) | $ | (0.43 | ) | ||
Weighted average shares of common stock
outstanding used in computing basic and
diluted net loss per common share |
24,935,574 | 24,490,391 | ||||||
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 26,733 shares and 611,003 shares for 2003 and 2002, respectively related to outstanding options, warrants and convertible
6
securities not included above (as determined using the treasury stock method at average market price during the period).
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.
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 5 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 March 31, 2003 and December 31, 2002, 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, Accounting for Certain Investments in Debt and Equity Securities, (SFAS 115) 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 months ended March 31, 2003 and 2002.
7
Derivative Financial Instruments
The Company retains a warrant to purchase common stock in a private company. In accordance with Statement of Financial Accounting Standards No. 133, Accounting for Derivative Instruments and Hedging Activities, as amended (SFAS 133), the Company accounts for the warrant as a derivative financial instrument. Accordingly, the warrant is recorded at fair value as of the balance sheet date based on the Black-Scholes valuation of such instruments in comparable companies and other indicators of the investments value. Any gains or losses in fair value are recorded in interest and other income. The Company does not use derivative financial instruments for trading or speculative purposes.
In connection with an equity payment agreement with a legal services firm, the Company issued 250,465 shares of common stock at $3.39 per share in exchange for the elimination of approximately $849,000 payable to the law firm. The Company has agreed to review the potential proceeds received from the sale of these shares 150 days after the effective date of the registration statement underlying the shares. Any shortfall will be payable to the law firm in cash. The Company accounts for this potential liability as a derivative financial instrument. Accordingly, in the event the closing price of the Companys common stock is less than the price initially received, the Company will record the fair value of such liability at the balance sheet date.
The Companys exposure to currency exchange fluctuation risk is insignificant. Geron Bio-Med, Ltd., the Companys international subsidiary, satisfies its financial obligations almost exclusively in its local currency. For 2003 there was an insignificant currency exchange impact from intercompany transactions. The Company does not engage in foreign currency hedging activities.
Intangible Asset and Research Funding Obligation
In May 1999, the Company completed the acquisition of Roslin Bio-Med Ltd., a privately held company formed by the Roslin Institute in Midlothian, Scotland. In connection with this acquisition, the Company formed a research collaboration with the Roslin Institute and committed approximately $20,000,000 in research funding over six years. Using an effective interest rate of 6%, this research funding obligation had a net present value of $17,200,000 and has been capitalized as an intangible asset that is being amortized as research and development expense over six years. Imputed interest is also being accreted to the value of the research funding obligation and is recognized as interest expense.
Research and Development Expenses
All research and development costs are expensed as incurred. The value of acquired in-process research and development is charged to expense on the date of acquisition. Research and development expenses include, but are not limited to, payroll and personnel expense, lab supplies, preclinical studies, raw materials to manufacture clinical trial drugs, manufacturing costs, sponsored research at other labs, consulting, legal fees and research-related overhead. Accrued liabilities for raw materials to manufacture clinical trial drugs, manufacturing costs, patent legal fees and sponsored research reimbursement fees are included in accrued liabilities and research and development expenses.
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.
Employee Stock Plans
As permitted by Statement of Financial Accounting Standards No. 123, Accounting for Stock-Based Compensation, (SFAS 123) the Company elected to continue to apply the provisions of Accounting Principle Board Opinion No. 25, Accounting for Stock Issued to Employees, (APB 25) and related interpretations in accounting for its employee stock option and stock purchase plans. The Company is generally not required under APB 25 and related interpretations to recognize compensation expense in connection with its employee stock option and stock purchase plans.
8
Pro forma information regarding net loss and net loss per share is required by SFAS 123 and has been determined as if the Company had accounted for its employee stock options under the fair value method prescribed by the SFAS 123. The fair value for these options was estimated at the date of grant using the Black-Scholes option pricing model with the following weighted average assumptions: risk-free interest rates ranging from 2.02% to 2.85% for the three months ended March 31, 2003 and 3.46% to 4.98% for the comparable period in 2002; a dividend yield of 0.0% for the three months ended March 31, 2003 and 2002; a volatility factor of the expected market price of the Companys common stock of 1.013 and 0.8807 as of March 31, 2003 and 2002, respectively ; and a weighted average expected life of the options of 4 years for the three months ended March 31, 2003 and 2002.
For purposes of pro forma disclosures, the estimated fair value of the options is amortized to expense over the vesting period of the options using the straight-line method. The Companys pro forma information follows:
Three Months Ended March 31, | ||||||||
2003 | 2002 | |||||||
(In thousands, except per share | ||||||||
amounts) | ||||||||
Net loss |
$ | (7,932 | ) | $ | (10,475 | ) | ||
Add back: |
||||||||
Deferred compensation expense |
| 60 | ||||||
Deduct: |
||||||||
Stock-based employee expense determined under
SFAS 123 |
(1,919 | ) | (2,557 | ) | ||||
Pro forma net loss |
$ | (9,851 | ) | $ | (12,972 | ) | ||
Basic and diluted net loss per share as reported |
$ | (0.32 | ) | $ | (0.43 | ) | ||
Basic and diluted pro forma net loss per share |
$ | (0.40 | ) | $ | (0.53 | ) | ||
The Black-Scholes option valuation model was developed for use in estimating the fair value of traded options that have no vesting restrictions and are fully transferable. In addition, option valuation models require the input of highly subjective assumptions including the expected stock price volatility. Because the Companys employee stock options and employee stock purchase plans have characteristics significantly different from those of traded options, and because changes in the subjective input assumptions can materially affect the fair market value estimate, in managements opinion, the existing models do not necessarily provide a reliable single measure of the fair value of its employee stock options, nor do they necessarily represent the effects of employee stock options on reported net income (loss) for future years.
Comprehensive Loss
Comprehensive loss is comprised of net loss and other comprehensive loss. Other comprehensive loss includes certain changes in equity that are excluded from net loss.
The components of accumulated other comprehensive loss are as follows:
March 31, | December 31, | |||||||
2003 | 2002 | |||||||
(In thousands) | ||||||||
Unrealized holding loss on
available-for-sale securities and marketable equity investments in licensees |
$ | (351 | ) | $ | (316 | ) | ||
Foreign currency translation adjustments |
(90 | ) | (73 | ) | ||||
$ | (441 | ) | $ | (389 | ) | |||
Reclassifications
Certain reclassifications of prior year amounts have been made to conform to current year presentation, including amortization of intangible assets, marketable securities and prepaid assets.
9
Status of Recent Accounting Pronouncements
In June 2002, the Financial Accounting Standards Board (FASB) issued Statement of Financial Accounting Standards No. 146, Accounting for Costs Associated with Exit or Disposal Activities (SFAS 146). SFAS 146 addresses financial accounting and reporting for costs associated with exit or disposal activities and supersedes 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) and requires that a liability for a cost associated with an exit or disposal activity be recognized and initially measure at fair value only when the liability is incurred rather than at the date of an entitys commitment to an exit plan. SFAS 146 further establishes fair value as the objective for initial measurement of the liability and that employee benefit arrangements requiring future service beyond a minimum retention period be recognized over the future service period. SFAS 146 is effective for exit or disposal activities initiated after December 31, 2002. The Company adopted this accounting principle on January 1, 2003.
In November 2002, the FASB issued Financial Interpretation No. 45, Guarantors Accounting and Disclosure requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others (FIN 45). The initial recognition and initial measurement provisions apply on a prospective basis to guarantees issued or modified after December 31, 2002, regardless of the guarantors fiscal year-end. The disclosure requirements in FIN 45 are effective for financial statements of interim or annual periods ending after December 15, 2002. The Company does not have any guarantees nor does it provide any guarantees for others. The adoption of FIN 45 has not had a material effect on the Companys financial condition or results of operations.
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. EITF 00-21 addresses when and how an arrangement involving multiple deliverables should be divided into separate units of accounting. EITF 00-21 provides guidance with respect to the effect of certain customer rights due to company nonperformance on the recognition of revenue allocated to delivered units of accounting. EITF 00-21 also addresses the impact on the measurement and/or allocation of arrangement consideration of customer cancellation provisions and consideration that varies as a result of future actions of the customer or the company. Finally, EITF 00-21 provides guidance with respect to the recognition of the cost of certain deliverables that are excluded from the revenue accounting arrangement. The provisions of EITF 00-21 will apply to revenue arrangements entered into in fiscal periods beginning after June 15, 2003. The Company is currently evaluating the impact that the adoption of EITF 00-21 will have on its financial position and results of operations.
In December 2002, the FASB issued Statement of Financial Accounting Standards No. 148, Accounting for Stock-Based Compensation (SFAS 148). SFAS 148 amends SFAS 123 to provide alternative methods of transition to SFAS 123s fair value method of accounting for stock-based compensation. SFAS 148 also amends the disclosure provisions of SFAS 123 and Accounting Principle Board Opinion No. 28, Interim Financial Reporting, (APB 28) to require disclosure in the summary of significant accounting policies the effect of stock-based employee compensation on reported net income and earnings per share in annual and interim financial statements. SFAS 148s amendment of the transition and annual disclosure requirements of SFAS 123 are effective for fiscal years ending after December 15, 2002, with earlier application permitted. SFAS 148s amendment of the disclosure requirements of APB 28 is effective for financial reports containing condensed consolidated financial statements for interim periods beginning after December 15, 2002. The Company has adopted the disclosure requirements of SFAS 148.
In January 2003, the FASB issued Financial Interpretation No. 46, Consolidation of Variable Interest Entities (FIN 46). The consolidation requirements of FIN 46 apply immediately to variable interest entities created after January 31, 2003. The consolidation requirements apply to older entities in the first fiscal year or interim periods beginning after June 15, 2003. Certain of the disclosure requirements apply in all financial statements issued after January 31, 2003, regardless of when the variable interest entity was established. The Company does not have variable interest entities and does not expect the adoption of FIN 46 to have a material effect on its financial position or results of operations.
2. RESTRUCTURING
In January 2003, Geron restructured its organization to focus available resources on its most advanced product development programs. In the process, Geron reduced its research staff by 29 employees and its support staff by 11 employees, a reduction of approximately 44% of Gerons work force in Menlo Park, California. The Company
10
recorded a restructuring charge of $507,000 for the three months ended March 31, 2003 for employee severance benefits, of which $342,000 related to research and development expense and $165,000 related to general and administrative expense. At March 31, 2003, the remaining amount to be paid was $19,000, of which $13,000 has been accrued. The Company expects to accrue and pay the remaining amount by June 30, 2003.
In connection with the restructuring, the Company also entered into employment agreements with its remaining executive officers and certain other employees, and adopted a Severance Plan applicable according to its terms to all remaining employees. The Company is currently accruing the retention bonus commitment required under the Severance Plan. The executive officer employment agreements and the Severance Plan are attached as exhibits to this quarterly report.
3. STOCK-BASED COMPENSATION
The Company occasionally grants common stock or warrants to purchase common stock to consultants and research institutions in exchange for services performed for the Company. In March 2003, in conjunction with a consulting services agreement, the Company issued a warrant to purchase 50,000 shares of the Companys common stock. The warrant is exercisable at any time through March 2013 at $3.00 per share. Using the Black-Scholes model, the value of the warrant was approximately $68,000, which is being amortized to consulting expense over the remaining eight-month term of the consulting agreement. In March 2003, in conjunction with legal services rendered for patent prosecution, the Company issued 250,465 shares of its common stock at $3.39 per share. In exchange for the shares, the Company eliminated the outstanding balance of approximately $849,000 payable to the law firm. See reference to derivative financial instrument in Note 1.
4. 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.
5. CONSOLIDATED STATEMENT OF CASH FLOWS DATA
THREE MONTHS | THREE MONTHS | |||||||
ENDED | ENDED | |||||||
(IN THOUSANDS) | MARCH 31, 2003 | MARCH 31, 2002 | ||||||
(Unaudited) | (Unaudited) | |||||||
Supplemental Operating, Investing and Financing
Activities: |
||||||||
Net unrealized gain (loss) on equity investments |
$ | (21 | ) | $ | (84 | ) | ||
Net unrealized gain (loss) on marketable securities |
$ | (14 | ) | $ | (299 | ) | ||
401(k) matching contribution |
$ | 548 | $ | | ||||
Shares or warrants issued for services |
$ | 917 | $ | |
6. SUBSEQUENT EVENT
In April 2003, the Company sold 4.4 million shares of Geron common stock to two investors at $4.60 per share resulting in net proceeds of approximately $19.0 million. The shares were offered through a prospectus supplement to the Companys effective universal shelf registration statement. The Company granted the investors warrants to purchase an additional 600,000 shares of Geron common stock at an exercise price of $6.34 per share. The warrants expire in April 2006.
11
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 Additional Factors that May Affect Future Results in the Companys Annual Report on Form 10-K for the fiscal year ended December 31, 2002, 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, 2002.
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
The preparation of financial statements and related disclosures in conformity with accounting principles generally accepted in the United States requires management to make judgments, assumptions and estimates that affect the amounts reported. Actual results could differ from these estimates. Note 1 of Notes to Condensed Consolidated Financial Statements describes the significant accounting policies used in the preparation of the consolidated financial statements. Certain of these significant accounting policies are considered to be critical accounting policies, as defined below.
A critical accounting policy is defined as one that is both material to the presentation of our financial statements and requires management to make difficult, subjective or complex judgments that could have a material effect on our financial condition and results of operations. Specifically, critical accounting estimates have the following attributes: 1) we are required to make assumptions about matters that are highly uncertain at the time of the estimate; and 2) different estimates we could reasonably have used, or changes in the estimate that are reasonably likely to occur, would have a material effect on our financial condition or results of operations.
Estimates and assumptions about future events and their effects cannot be determined with certainty. We base our estimates on historical experience and on various other assumptions believed to be applicable and reasonable under the circumstances. These estimates may change as new events occur, as additional information is obtained and as our operating environment changes. These changes have historically been minor and have been included in the consolidated financial statements as soon as they became known. Based on a critical assessment of our accounting
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policies and the underlying judgments and uncertainties affecting the application of those policies, management believes that our consolidated financial statements are fairly stated in accordance with accounting principles generally accepted in the United States, and present a meaningful presentation of our financial condition and results of operations.
We consider that the following are critical accounting 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 make estimates about the estimated lives for license agreements related to deferred revenue.
We also have several license, option and marketing agreements with various oncology, diagnostics, research tools, agriculture and biologics production companies. 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, milestone payments, or any combination of these items. We recognize nonrefundable signing or license fees that are not dependent on future performance under these agreements as revenue when received and 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 recognize milestone payments upon completion of specified milestones according to contract terms. We generally recognize royalties as revenue upon receipt.
We receive income from United States government grants that support our research efforts in defined research projects. These grants generally provide for reimbursement of approved costs incurred as defined in the various grants. We recognize income associated with these grants upon receipt of reimbursement and include it in interest and other income on the consolidated statements of operations.
Intangible Asset and Research Funding Obligation
In May 1999, we completed the acquisition of Roslin Bio-Med Ltd., a privately held company formed by the Roslin Institute in Midlothian, Scotland. In connection with this acquisition, we formed a research collaboration with the Roslin Institute and committed approximately $20.0 million in research funding over six years. Using an effective interest rate of 6%, this research funding obligation had a net present value of $17.2 million. We have capitalized this obligation as an intangible asset that is being amortized as research and development expense over six years. Imputed interest is also being accreted to the value of the research funding obligation and is recognized as interest expense. We made assumptions in the valuation of the intangible asset.
Research and Development Expenses
All research and development costs are expensed as incurred. The value of acquired in-process research and development is charged to expense on the date of acquisition. Research and development expenses include, but are not limited to, payroll and personnel expense, lab supplies, preclinical studies, raw materials to manufacture clinical trial drugs, manufacturing costs, sponsored research at other laboratories, consulting, legal fees and research-related overhead. Accrued liabilities for raw materials and manufacturing costs for preclinical and clinical testing, patent legal fees and sponsored research reimbursement fees are included in accrued liabilities and research and development expenses. We make assumptions regarding the timing and probability of costs incurred for research and development.
Employee Stock Plans
As permitted by SFAS 123, we have elected to continue to apply the provisions of APB 25 and related interpretations in accounting for our employee stock option and stock purchase plans. We are generally not required under APB 25 and related interpretations to recognize compensation expense in connection with our employee stock option and stock purchase plans. As required by SFAS 123, we present in the Notes to Condensed Consolidated Financial Statements, the pro forma effects on reported net income and earnings per share as if compensation
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expense had been recognized based on the fair value method of accounting prescribed by SFAS 123. We make assumptions in valuing options and warrants.
RESULTS OF OPERATIONS
Revenues
We recognized revenues from collaborative agreements of $36,000 for the three months ended March 31, 2003, compared to $515,000 for the comparable period in 2002. Revenues recognized in 2003 primarily relate to a consulting arrangement. Revenues in 2002 primarily represented research support payments from our collaborative agreement with Kyowa Hakko. Our collaboration with Kyowa Hakko has moved the project from the research phase to the development phase and 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 $186,000 for the three months ended March 31, 2003 as compared to $61,000 for the same period in 2002 related to our various agreements. Also, we received royalties of $40,000 for the three months ended March 31, 2003, compared to $50,000 for the comparable period in 2002, 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 $388,000 during the remainder of 2003, $215,000 in 2004, $137,000 in 2005, $137,000 in 2006 and $567,000 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 $7.0 million for the three months ended March 31, 2003, compared to $10.2 million for the comparable period in 2002. The overall decrease for the first quarter 2003 compared to the first quarter 2002 was the net result of reduced personnel-related costs of approximately $1.7 million associated with restructurings in June 2002 and January 2003 and reduced license fee expense of $2.5 million, partially offset by an increase in scientific supplies of approximately $1.0 million. Overall, we expect research and development expenses to remain constant in the future as we continue to reduce operating costs to absorb increases in expenses related to manufacturing and testing of GRN163, Gerons telomerase inhibitor drug.
In our oncology area, we have concentrated our resources on two areas: telomerase inhibitor drugs (especially GRN163) and telomerase therapeutic vaccines. Currently GRN163 is in animal toxicology studies to enable initiation of Phase 1 clinical trials. After we receive conclusive results from those animal studies later this year, we expect to file an IND. A Phase 1 clinical study is currently in progress at Duke University Medical Center for a telomerase therapeutic vaccine for patients with metastatic prostate cancer. In April 2003, we reported the preliminary results of the low-dose group in that Phase 1 study. The study results suggest the vaccinations were very well tolerated, without any adverse effects attributable to the treatment and resulted in the generation of an anti-telomerase immune response in almost all patients. The study is proceeding to enroll the high-dose group of patients. After the study is completed, we will evaluate its results. Future clinical progress of this product will depend on the study results.
In our regenerative medicine area, we have concentrated our resources on four specific cell types: hESC-derived neural cells for spinal cord injury and Parkinsons disease, hematopoietic cells for transplantation, cardiomyocytes for heart failure and pancreatic islet cells for diabetes. We are engaged in animal proof-of-concept testing for these cell types. If these tests are successful, we will continue clinical development of these products in accordance with Food and Drug Administration (FDA) guidelines.
Drug development in the U.S. is a process that includes multiple steps defined by the FDA under applicable statutes, regulations and guidance documents. After the preclinical research process of identifying, selecting and testing in animals a potential pharmaceutical compound, the clinical development process begins with the filing of an Initial Drug Application (IND). If successful, an IND allows opportunity for clinical study of the potential new medicine. Clinical development typically involves three phases of study: Phase 1, 2, and 3. The most significant
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costs associated with clinical development are the Phase 3 trials, which tend to be the longest and largest studies conducted during the drug development process. After the completion of a successful preclinical and clinical development program, a New Drug Application (NDA) must be filed with the FDA, which includes among other things very large amounts of preclinical and clinical data and results and manufacturing-related information necessary to support requested approval of the product. The NDA must be reviewed by the FDA.
According to industry statistics, it generally takes 10 to 15 years to research, develop and bring to market a new prescription medicine in the United States. In light of the steps and complexities involved, the successful development of our products is highly uncertain. Actual product timelines and costs are subject to enormous variability and are very difficult to predict, as our clinical development programs are updated and changed to reflect the most recent preclinical and clinical data and other relevant information. In addition, various statutes and regulations also govern or influence the manufacturing, safety reporting, labeling, storage, recordkeeping and marketing of each product. The lengthy process of seeking these regulatory reviews and approvals, and the subsequent compliance with applicable statutes and regulations, require the expenditure of substantial resources. Any failure by us to obtain, or any delay in obtaining, regulatory approvals could materially adversely affect our business. In responding to an NDA submission, the FDA may grant marketing approval, may request additional information, may deny the application if it determines that the application does not provide an adequate basis for approval, and may also refuse to review an application that has been submitted if it determines that the application does not provide an adequate basis for filing and review. We cannot assure you that any approval required by the FDA will be obtained on a timely basis, if at all.
For a more complete discussion of the risks and uncertainties associated with completing development of potential products, see the sub-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 and Entry into clinical trials with one or more products may not result in any commercially viable products in the section of Item 2 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 for the three months ended March 31, 2003, compared to $1.6 million for the comparable period in 2002. The decrease in general and administrative expenses for the three month period ending March 31, 2003, primarily reflects reduced personnel-related costs as a result of the restructurings in June 2002 and January 2003.
Interest and Other Income
Interest income was $249,000 for the three months ended March 31, 2003, compared to $712,000 for the comparable period in 2002. The decrease in interest income for 2003 compared to 2002 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.
We also received $27,000 in research payments under government grants for the three months ended March 31, 2003, compared to $159,000 for the comparable period in 2002.
Interest and Other Expense
Interest and other expense was $164,000 for the three months ended March 31, 2003, compared to $212,000 for the comparable period in 2002. The decrease in interest and other expense for 2003 compared to 2002 was primarily the result of lower interest expenses related to convertible debentures in 2003.
Net Loss
Net loss was $7.9 million for the three months ended March 31, 2003, compared to $10.5 million for the comparable period in 2002. The decrease in net loss for the three months ended March 31, 2003 was primarily due to lower operating expenses as a result of restructurings in June 2002 and January 2003.
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LIQUIDITY AND CAPITAL RESOURCES
Cash, restricted cash, cash equivalents and marketable securities at March 31, 2003 totaled $39.5 million compared to $47.5 million at December 31, 2002. The decrease in cash, cash equivalents and investments in 2003 was the result of the use of cash in operations. Our investment policy is to invest these funds in liquid, investment-grade securities, such as interest-bearing money market funds, commercial paper and municipal securities.
Net cash used in operations was $7.6 million for the three months ended March 31, 2003 compared to $9.7 million for the comparable period in 2002. The decrease was primarily due to decreased expenses as a result of restructurings in June 2002 and January 2003.
For the three months ended March 31, 2003, we have invested approximately $46,000 in property and equipment compared to $259,000 for the comparable 2002 period. For the three months ended March 31, 2003, no equipment was financed through equipment financing compared to $54,000 for the comparable 2002 period. As of March 31, 2003, we had approximately $607,000 outstanding under our current equipment financing arrangements and had approximately $1.1 million available for borrowing under our equipment financing arrangements. The drawdown period under the equipment financing arrangements will expire on September 30, 2003. We intend to renew the commitment for a new equipment financing facility in 2003 to further fund equipment purchases. If we are unable to renew the commitment or obtain other financing alternatives, then we will need to spend our own resources for equipment purchases.
As of December 31, 2002, our contractual obligations for the next five years, and thereafter are as follows:
Principal Payments Due by Period | |||||||||||||||||||||
Less Than | After 5 | ||||||||||||||||||||
Contractual Obligations (1) | Total | 1 Year | 1-3 Years | 4-5 Years | Years | ||||||||||||||||
(Amounts in thousands) | |||||||||||||||||||||
Convertible debentures (2) |
$ | 15,000 | $ | | $ | 15,000 | $ | | $ | | |||||||||||
Equipment loans |
744 | 367 | 377 | | | ||||||||||||||||
Operating leases |
2,032 | 1,096 | 936 | | | ||||||||||||||||
Research funding (3) |
10,687 | 3,187 | 7,133 | 367 | | ||||||||||||||||
Product manufacturing (4) |
1,750 | 1,750 | | | | ||||||||||||||||
Total contractual cash obligations |
$ | 30,213 | $ | 6,400 | $ | 23,446 | $ | 367 | $ | | |||||||||||
(1) | This table does not include any milestone payments under research collaborations or license agreements as the timing and likelihood of such payments are not known. | |
(2) | Our convertible debentures may be converted to common stock prior to their maturity date and therefore may not require use of our capital resources. | |
(3) | Research funding is comprised of sponsored research commitments at various academic laboratories around the world, including the Roslin Institute. | |
(4) | In July 2002, we entered into a manufacturing agreement to produce GMP-grade GRN163 for preclinical and clinical studies. |
In April 2003, we sold 4.4 million shares of Geron common stock to two investors at $4.60 per share resulting in net proceeds of approximately $19.0 million. The shares were offered through a prospectus supplement to our effective universal shelf registration statement. We granted the investors warrants to purchase an additional 600,000 shares of Geron common stock at an exercise price of $6.34 per share. The warrants expire in April 2006.
We estimate that our existing capital resources (including the financing completed in April 2003), interest income and equipment financing will be sufficient to fund our current and planned operations through June 30, 2005. Changes in our research and development plans or other changes affecting our operating expenses may result in the expenditure of available resources before such time, and in any event, we will need to raise substantial
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additional capital to fund our operations in the future. We intend to seek additional funding through strategic collaborations, public or private equity financings, capital lease transactions or other financing sources that may be available.
ADDITIONAL FACTORS THAT MAY AFFECT FUTURE RESULTS
Our business is subject to various risks, including those described below. You should carefully consider these risk factors, together with all of the other information included in this Form 10-Q. Any of these risks could materially adversely affect our business, operating results and financial condition.
Our business is at an early stage of development.
The science and technology of telomere biology and telomerase, human embryonic stem cells, and nuclear transfer are relatively new. Our business is at an early stage of development. Our ability to produce products that progress to and through clinical trials is subject to our ability to, among other things:
| continue to have success with our research and development efforts; | ||
| select therapeutic compounds for development; | ||
| obtain the required regulatory approvals; and | ||
| manufacture and market resulting products. |
When potential lead drug compounds or product candidates are identified through our research programs, they will require significant preclinical and clinical testing prior to regulatory approval in the United States and elsewhere. In addition, we will also need to determine whether any of these potential products can be manufactured in commercial quantities at an acceptable cost. Our efforts may not result in a product that can be marketed. Because of the significant scientific, regulatory and commercial milestones that must be reached for any of our development programs to be successful, any program may be abandoned, even after significant resources have been expended.
We have a history of losses and anticipate future losses; continued losses could impair our ability to sustain operations.
We have incurred operating losses every year since our operations began in 1990. As of March 31, 2003, our accumulated deficit was approximately $233.7 million. Losses have resulted principally from costs incurred in connection with our research and development activities and from general and administrative costs associated with our operations. We expect to incur additional operating losses as our development efforts and clinical testing activities are continued. Substantially all of our revenues to date have been research support payments under collaboration agreements. We may be unsuccessful in entering into any new corporate collaboration that results in revenues. Even if we are able to obtain new collaboration arrangements with third parties the revenues generated from these arrangements may not be sufficient alone to continue or expand our research or development activities and otherwise sustain our operations.
We are unable to estimate at this time the level of revenue to be received from the sale of diagnostic products and telomerase-immortalized cell lines, and do not currently expect to receive significant revenues from the sale of these products. Our ability to continue or expand our research activities and otherwise sustain our operations is dependent on our ability, alone or with others to, among other things, manufacture and market therapeutic products.
We may never receive material revenues from product sales or if we do receive revenues, such revenues may not be sufficient to continue or expand our research or development activities and otherwise sustain our operations.
We will need additional capital to conduct our operations and develop our products, and our ability to obtain the necessary funding is uncertain.
We will require substantial capital resources in order to conduct our operations and develop our products. While we estimate that our existing capital resources (including the financing completed in April 2003), interest income and equipment financing arrangements will be sufficient to fund our current and planned operations through
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June 30, 2005, we cannot guarantee that this will be the case. The timing and degree of any future capital requirements will depend on many factors, including:
| the accuracy of the assumptions underlying our estimates for our capital needs in 2003 and beyond; | ||
| continued scientific progress in our research and development programs; | ||
| the magnitude and scope of our research and development programs; | ||
| our ability to maintain and establish strategic arrangements for research, development, clinical testing, manufacturing and marketing; | ||
| our progress with preclinical and clinical trials; | ||
| the time and costs involved in obtaining regulatory approvals; | ||
| the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims; and | ||
| the potential for new technologies and products. |
We intend to acquire additional funding through strategic collaborations, public or private equity financings, capital lease transactions or other financing sources that may be available. Additional financing may not be available on acceptable terms, or at all. Additional equity financings could result in significant dilution to stockholders. Further, in the event that additional funds are obtained through arrangements with collaborative partners, these arrangements may require us to relinquish rights to some of our technologies, product candidates or products that we would otherwise seek to develop and commercialize ourselves. If sufficient capital is not available, we may be required to delay, reduce the scope of or eliminate one or more of our programs, any of which could have a material adverse effect on our business.
We may be unable to identify a safe and effective inhibitor of telomerase that can be developed into a commercially viable cancer treatment product, which would adversely impact our future business prospects.
As a result of our drug discovery efforts to date, we have identified compounds in laboratory studies that demonstrate potential for inhibiting telomerase in humans. We have selected one of these compounds, GRN163, as a lead compound for development as a telomerase inhibitor for cancer. Further research is required to determine if this compound can be fully developed as an efficacious, safe and commercially viable treatment for cancer.
This compound, and other compounds we have identified, may prove to have undesirable and unintended side effects or other characteristics adversely affecting its safety, efficacy or cost-effectiveness that would likely prevent or limit its commercial use. Accordingly, it may not be appropriate for us to proceed with clinical development, to obtain regulatory approval or to market a telomerase inhibitor for the treatment of cancer. If we abandon our research for cancer treatment for any of these reasons or for other reasons, our business prospects would be materially and adversely affected.
If our access to necessary tissue samples, information or licensed technologies is restricted, we will not be able to develop our business.
To continue the research and development of our therapeutic and diagnostic products, we need access to normal and diseased human and other tissue samples, other biological materials and related clinical and other information. We compete with many other companies for these materials and information. We may not be able to obtain or maintain access to these materials and information on acceptable terms, if at all. In addition, government regulation in the United States and foreign countries could result in restricted access to, or prohibiting the use of, human and other tissue samples. If we lose access to sufficient numbers or sources of tissue samples, or if tighter restrictions are imposed on our use of the information generated from tissue samples, our business will be materially harmed.
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Some of our competitors may develop technologies that are superior to or more cost-effective than ours, which may impact the commercial viability of our technologies and which may significantly damage our ability to sustain operations.
The pharmaceutical and biotechnology industries are intensely competitive. Other pharmaceutical and biotechnology companies and research organizations currently engage in or have in the past engaged in efforts related to the biological mechanisms that are the focus of our programs in oncology and regenerative medicine, including the study of telomeres, telomerase, human embryonic stem cells, and nuclear transfer. In addition, other products and therapies that could compete directly with the products that we are seeking to develop and market currently exist or are being developed by pharmaceutical and biopharmaceutical companies and by academic and other research organizations.
Many companies are also developing alternative therapies to treat cancer and, in this regard, are competitors of ours. Many of the pharmaceutical companies developing and marketing these competing products have significantly greater financial resources and expertise than we do in:
| research and development; | ||
| manufacturing; | ||
| preclinical and clinical testing; | ||
| obtaining regulatory approvals; and | ||
| marketing. |
Smaller companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. Academic institutions, government agencies and other public and private research organizations may also conduct research, seek patent protection and establish collaborative arrangements for research, clinical development and marketing of products similar to ours. These companies and institutions compete with us in recruiting and retaining qualified scientific and management personnel as well as in acquiring technologies complementary to our programs.
In addition to the above factors, we expect to face competition in the following areas:
| product efficacy and safety; | ||
| the timing and scope of regulatory consents; | ||
| availability of resources; | ||
| reimbursement coverage; | ||
| price; and | ||
| patent position, including potentially dominant patent positions of others. |
As a result of the foregoing, our competitors may develop more effective or more affordable products, or achieve earlier patent protection or product commercialization than we do. Most significantly, competitive products may render the products that we develop obsolete.
The ethical, legal and social implications of our research using embryonic stem cells and nuclear transfer could prevent us from developing or gaining acceptance for commercially viable products in this area.
Our programs in regenerative medicine may involve the use of human pluripotent stem cells that would be derived from human embryonic or fetal tissue. The use of human embryonic stem cells gives rise to ethical, legal and social issues regarding the appropriate use of these cells. In the event that our research related to human embryonic stem cells becomes the subject of adverse commentary or publicity, the market price for our common stock could be significantly harmed.
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Some groups have voiced opposition to our technology and practices. The concepts of cell regeneration, cell immortality, and nuclear transfer have stimulated significant debate in social and political arenas. We use human pluripotent stem cells derived through a process that uses as the starting material donated embryos created for in vitro fertilization procedures but no longer needed or suitable for that use. Many research institutions, including some of our scientific collaborators, have adopted policies regarding the ethical use of human embryonic tissue. These policies may have the effect of limiting the scope of research conducted using human embryonic stem cells, resulting in reduced scientific progress. In addition, the United States government and its agencies have in recent years refused to fund research which involves the use of human embryonic tissue. President Bush announced on August 9, 2001 that he would permit federal funding of research on human embryonic stem cells using the limited number of embryonic stem cell lines that had already been created, but relatively few federal grants have been made so far. The Presidents Council on Bioethics will monitor stem cell research, and the guidelines and regulations it recommends may include restrictions on the scope of research using human embryonic or fetal tissue. The Council issued a report in July 2002 that recommended that the federal government undertake a thorough-going review of present and projected practices of human embryo research, with the aim of establishing appropriate institutions to advise and shape federal policy in this arena. Our inability to conduct research using human embryonic stem cells due to such factors as government regulation or otherwise could have a material adverse effect on us.
Finally, we acquired Roslin Bio-Med to gain the rights to somatic cell nuclear transfer technology. We acquired exclusive rights to this technology for all areas except human reproductive cloning and certain other limited applications. Although we will not be pursuing human reproductive cloning, the use of nuclear transfer to produce embryonic stem cells (referred to as therapeutic cloning) could provide scientific insights that would help us advance our research. Government-imposed restrictions with respect to any or all of these practices could:
| harm our ability to establish critical partnerships and collaborations; | ||
| prompt government regulation of our technologies; | ||
| cause delays in our research and development; and | ||
| cause a decrease in the price of our stock. |
The U.S. Congress has recently considered legislation that would ban human therapeutic cloning as well as reproductive cloning. Such a bill has been passed by the House of Representatives, although not by the Senate, and many legislators reportedly favor such a ban. The July 2002 report of the Presidents Council on Bioethics recommended a four-year moratorium on therapeutic cloning. If human therapeutic cloning is restricted or banned, our ability to commercialize those applications could be significantly harmed. Also, if regulatory bodies were to ban nuclear transfer processes, our research using nuclear transfer technology could be canceled and our business could be significantly harmed.
Entry into clinical trials with one or more products may not result in any commercially viable products.
We do not expect to generate any significant revenues from product sales for a period of several years. We may never generate revenues from product sales or become profitable because of a variety of risks inherent in our business, including the following risks:
| clinical trials may not demonstrate the safety and efficacy of our products; | ||
| completion of clinical trials may be delayed, or costs of clinical trials may exceed anticipated amounts; | ||
| we may not be able to obtain regulatory approval of our products, or may experience delays in obtaining such approvals; | ||
| we may not be able to manufacture our drugs economically on a commercial scale; | ||
| we and our licensees may not be able to successfully market our products; | ||
| physicians may not prescribe our products, or patients may not accept such products; |
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| others may have proprietary rights which prevent us from marketing our products; and | ||
| competitors may sell similar, superior or lower-cost products. |
Impairment of our intellectual property rights may limit our ability to pursue the development of our intended technologies and products.
Protection of our proprietary technology is critically important to our business. Our success will depend in part on our ability to obtain and enforce our patents and maintain trade secrets, both in the United States and in other countries. The patent positions of pharmaceutical and biopharmaceutical companies, including ours, are highly uncertain and involve complex legal and technical questions. In particular, legal principles for biotechnology patents in the United States and in other countries are evolving, and the extent to which we will be able to obtain patent coverage to protect our technology, or enforce issued patents, is uncertain. Further, our patents may be challenged, invalidated or circumvented, and our patent rights may not provide proprietary protection or competitive advantages to us. In the event that we are unsuccessful in obtaining and enforcing patents, our business would be negatively impacted.
Publication of discoveries in scientific or patent literature tends to lag behind actual discoveries by at least several months and sometimes several years. Therefore, the persons or entities that we or our licensors name as inventors in our patents and patent applications may not have been the first to invent the inventions disclosed in the patent applications or patents, or file patent applications for these inventions. As a result, we may not be able to obtain patents for discoveries that we otherwise would consider patentable and that we consider to be extremely significant to our future success.
Where several parties seek patent protection for the same technology, the U.S. Patent Office may declare an interference proceeding in order to ascertain the party to which the patent should be issued. Patent interferences are typically complex, highly contested legal proceedings, subject to appeal. They are usually expensive and prolonged, and can cause significant delay in the issuance of patents. Moreover, parties that receive an adverse decision in an interference can lose important patent rights. Our pending patent applications, or our issued patents, may be drawn into interference proceedings which may delay or prevent the issuance of patents, or result in the loss of issued patent rights.
The interference process can also be used to challenge a patent that has been issued to another party. In 2001, the U.S. Patent Office granted our request for the declaration of an interference between one of our pending applications relating to nuclear transfer and an issued patent, held by the University of Massachusetts. We requested this interference in order to clarify our patent rights in nuclear transfer technology. In March 2002, a second interference was declared involving our patent application and a patent application held by Infigen Inc. Both of these interferences are now ongoing. Based on a review of publicly available information, we believe that the technology at issue in both of these interferences was invented first at the Roslin Institute and is encompassed within our nuclear transfer license. However, we do not have access to the other partys invention records, and, as in any legal proceeding, the outcome is uncertain.
Outside of the U.S., certain jurisdictions, such as Europe and Australia, permit oppositions to be filed against the granting of patents. Because our intent is to commercialize products internationally, securing both proprietary protection and freedom to operate outside of the U.S. is important to us. We are involved in both opposing the grant of patents to others through such opposition proceedings, and in defending against oppositions filed by others.
If interferences, oppositions or other challenges to our patent rights are not resolved promptly in our favor, our existing business relationships may be jeopardized and we could be delayed or prevented from entering into new collaborations or from commercializing certain products, which could materially harm our business.
Patent litigation may also be necessary to enforce patents issued or licensed to us or to determine the scope and validity of our proprietary rights or the proprietary rights of another. We may not be successful in any patent litigation. Patent litigation can be extremely expensive and time-consuming, even if the outcome is favorable to us. An adverse outcome in a patent litigation or any other proceeding in a court or patent office could subject our business to significant liabilities to other parties, require disputed rights to be licensed from other parties or require us to cease using the disputed technology.
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If we fail to meet our obligations under license agreements, we may face loss of our rights to key technologies on which our business depends.
Our business depends on our three core technology platforms, each of which is based in part on patents licensed from third parties. Those third-party license agreements impose obligations on us, such as payment obligations and obligations to diligently pursue development of commercial products under the licensed patents. If a licensor believes that we have failed to meet our obligations under a license agreement, the licensor could seek to limit or terminate our license rights, which would most likely lead to costly and time-consuming litigation. During the period of any such litigation our ability to carry out the development and commercialization of potential products could be significantly and negatively affected. If our license rights were ultimately lost, our ability to continue our business based on the affected technology platform would be severely affected.
We may be subject to litigation that will be costly to defend or pursue and uncertain in its outcome.
Our business may bring us into conflict with our licensees, licensors, or others with whom we have contractual or other business relationships, or with our competitors or others whose interests differ from ours. If we are unable to resolve those conflicts on terms that are satisfactory to all parties, we may become involved in litigation brought by or against us. That litigation is likely to be expensive and may require a significant amount of managements time and attention, at the expense of other aspects of our business. The outcome of litigation is always uncertain, and in some cases could include judgments against us that require us to pay damages, enjoin us from certain activities, or otherwise affect our legal or contractual rights, which could have a significant effect on our business.
We may be subject to infringement claims that are costly to defend, and which may limit our ability to use disputed technologies and prevent us from pursuing research and development or commercialization of potential products.
Our commercial success depends significantly on our ability to operate without infringing patents and the proprietary rights of others. Our technologies may infringe the patents or proprietary rights of others. In addition, we may become aware of discoveries and technology controlled by third parties that are advantageous to our research programs. In the event our technologies do infringe on the rights of others or we require the use of discoveries and technology controlled by third parties, we may be prevented from pursuing research, development or commercialization of potential products or may be required to obtain licenses to those patents or other proprietary rights or develop or obtain alternative technologies. We may not be able to obtain alternative technologies or any required license on commercially favorable terms, if at all. If we do not obtain the necessary licenses or alternative technologies, we may be delayed or prevented from pursuing the development of some potential products. Our failure to obtain alternative technologies or a license to any technology that we may require to develop or commercialize our products will significantly and negatively affect our business.
Much of the information and know-how that is critical to our business is not patentable and we may not be able to prevent others from obtaining this information and establishing competitive enterprises.
We sometimes rely on trade secrets to protect our proprietary technology, especially in circumstances in which patent protection is not believed to be appropriate or obtainable. We attempt to protect our proprietary technology in part by confidentiality agreements with our employees, consultants, collaborators and contractors. We cannot assure you that these agreements will not be breached, that we would have adequate remedies for any breach, or that our trade secrets will not otherwise become known or be independently discovered by competitors, any of which would harm our business significantly.
We depend on our collaborators to help us complete the process of developing and testing our products and our ability to develop and commercialize products may be impaired or delayed if our collaborative partnerships are unsuccessful.
Our strategy for the development, clinical testing and commercialization of our products requires entering into collaborations with corporate partners, licensors, licensees and others. We are dependent upon the subsequent success of these other parties in performing their respective responsibilities and the continued cooperation of our partners. Our collaborators may not cooperate with us or perform their obligations under our agreements with them. We cannot control the amount and timing of our collaborators resources that will be devoted to our research activities related to our collaborative agreements with them. Our collaborators may choose to pursue existing or alternative technologies in preference to those being developed in collaboration with us.
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Under agreements with collaborators, we rely significantly on them, among other activities, to:
| design and conduct advanced clinical trials in the event that we reach clinical trials; | ||
| fund research and development activities with us; | ||
| pay us fees upon the achievement of milestones; and | ||
| market with us any commercial products that result from our collaborations. |
The development and commercialization of potential products will be delayed if collaborators fail to conduct these activities in a timely manner or at all. In addition, our collaborators could terminate their agreements with us and we may not receive any development or milestone payments. If we do not achieve milestones set forth in the agreements, or if our collaborators breach or terminate their collaborative agreements with us, our business may be materially harmed.
Our reliance on the research activities of our non-employee scientific consultants and other research institutions, whose activities are not wholly within our control, may lead to delays in technological developments.
We rely extensively and have relationships with scientific consultants at academic and other institutions, some of whom conduct research at our request. These scientific consultants are not our employees and may have commitments to, or consulting or advisory contracts with, other entities that may limit their availability to us. We have limited control over the activities of these consultants and, except as otherwise required by our collaboration and consulting agreements, can expect only limited amounts of their time to be dedicated to our activities. If our scientific consultants are unable or refuse to contribute to the development of any of our potential discoveries, our ability to generate significant advances in our technologies will be significantly harmed.
In addition, we have formed research collaborations with many academic and other research institutions throughout the world, including the Roslin Institute. These research facilities may have commitments to other commercial and non-commercial entities. We have limited control over the operations of these laboratories and can expect only limited amounts of time to be dedicated to our research goals.
The loss of key personnel could slow our ability to conduct research and develop products.
Our future success depends to a significant extent on the skills, experience and efforts of our executive officers and key members of our scientific staff. Competition for personnel is intense and we may be unable to retain our current personnel or attract or assimilate other highly qualified management and scientific personnel in the future. The loss of any or all of these individuals could harm our business and might significantly delay or prevent the achievement of research, development or business objectives.
We also rely on consultants and advisors who assist us in formulating our research and development strategy. We face intense competition for qualified individuals from numerous pharmaceutical, biopharmaceutical and biotechnology companies, as well as academic and other research institutions. We may not be able to attract and retain these individuals on acceptable terms. Failure to do so would materially harm our business.
We may not be able to obtain or maintain sufficient insurance on commercially reasonable terms or with adequate coverage against potential liabilities in order to protect ourselves against product liability claims.
Our business exposes us to potential product liability risks that are inherent in the testing, manufacturing and marketing of human therapeutic and diagnostic products. We may become subject to product liability claims if the use of our products is alleged to have injured subjects or patients. This risk exists for products tested in human clinical trials as well as products that are sold commercially. We currently have no clinical trial liability insurance and we may not be able to obtain and maintain this type of insurance for any of our clinical trials. In addition, product liability insurance is becoming increasingly expensive. As a result, we may not be able to obtain or maintain product liability insurance in the future on acceptable terms or with adequate coverage against potential liabilities which could have a material adverse effect on us.
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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.
Federal, state and local governments in the United States and governments in other countries have significant regulations in place that govern many of our activities. The preclinical testing and clinical trials of the products that we develop ourselves or that our collaborators develop are subject to extensive government regulation and may prevent us from creating commercially viable products from our discoveries. In addition, the sale by us or our collaborators of any commercially viable product will be subject to government regulation from several standpoints, including the processes of:
| manufacturing; | ||
| advertising and promoting; | ||
| selling and marketing; | ||
| labeling; and | ||
| distributing. |
We may not obtain regulatory approval for the products we develop and our collaborators may not obtain regulatory approval for the products they develop. Regulatory approval may also entail limitations on the indicated uses of a proposed product. Because certain of our product candidates involve the application of new technologies and may be based upon a new therapeutic approach, such products may be subject to substantial additional review by various government regulatory authorities, and, as a result, we may obtain regulatory approvals for such products more slowly than for products based upon more conventional technologies. If, and to the extent that, we are unable to comply with these regulations, our ability to earn revenues will be materially and negatively impacted.
The regulatory process, particularly for biopharmaceutical products like ours, is uncertain, can take many years and requires the expenditure of substantial resources. Any product that we or our collaborative partners develop must receive all relevant regulatory agency approvals or clearances before it may be marketed in the United States or other countries. Generally, biological drugs and non-biological drugs are regulated more rigorously than medical devices. In particular, human pharmaceutical therapeutic products are subject to rigorous preclinical and clinical testing and other requirements by the Food and Drug Administration in the United States and similar health authorities in foreign countries. The regulatory process, which includes extensive preclinical testing and clinical trials of each product in order to establish its safety and efficacy, is uncertain, can take many years and requires the expenditure of substantial resources.
Data obtained from preclinical and clinical activities is susceptible to varying interpretations that could delay, limit or prevent regulatory agency approvals or clearances. In addition, delays or rejections may be encountered as a result of changes in regulatory agency policy during the period of product development and/or the period of review of any application for regulatory agency approval or clearance for a product. Delays in obtaining regulatory agency approvals or clearances could:
| significantly harm the marketing of any products that we or our collaborators develop; | ||
| impose costly procedures upon our activities or the activities of our collaborators; | ||
| diminish any competitive advantages that we or our collaborative partners may attain; or | ||
| adversely affect our ability to receive royalties and generate revenues and profits. |
Even if we commit the necessary time and resources, economic and otherwise, the required regulatory agency approvals or clearances may not be obtained for any products developed by or in collaboration with us. If regulatory agency approval or clearance for a new product is obtained, this approval or clearance may entail limitations on the indicated uses for which it may be marketed that could limit the potential commercial use of the product. Furthermore, approved products and their manufacturers are subject to continual review, and discovery of previously unknown problems with a product or its manufacturer may result in restrictions on the product or
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manufacturer, including withdrawal of the product from the market. Failure to comply with regulatory requirements can result in severe civil and criminal penalties, including but not limited to:
| recall or seizure of products; | ||
| injunction against manufacture, distribution, sales and marketing; and | ||
| criminal prosecution. |
The imposition of any of these penalties could significantly impair our business, financial condition and results of operations.
To be successful, our products must be accepted by the health care community, which can be very slow to adopt or unreceptive to new technologies and products.
Our products and those developed by our collaborative partners, if approved for marketing, may not achieve market acceptance since physicians, patients or the medical community in general may decide to not accept and utilize these products. The products that we are attempting to develop may represent substantial departures from established treatment methods and will compete with a number of traditional drugs and therapies manufactured and marketed by major pharmaceutical companies. The degree of market acceptance of any of our developed products will depend on a number of factors, including:
| our establishment and demonstration to the medical community of the clinical efficacy and safety of our product candidates; | ||
| our ability to create products that are superior to alternatives currently on the market; | ||
| our ability to establish in the medical community the potential advantage of our treatments over alternative treatment methods; and | ||
| reimbursement policies of government and third-party payors. |
If the health care community does not accept our products for any of the foregoing reasons, or for any other reason, our business would be materially harmed.
The reimbursement status of newly-approved health care products is uncertain and failure to obtain reimbursement approval could severely limit the use of our products.
Significant uncertainty exists as to the reimbursement status of newly approved health care products, including pharmaceuticals. If we fail to generate adequate third party reimbursement for the users of our potential products and treatments, then we may be unable to maintain price levels sufficient to realize an appropriate return on our investment in product development.
In both domestic and foreign markets, sales of our products, if any, will depend in part on the availability of reimbursement from third-party payors, examples of which include:
| government health administration authorities; | ||
| private health insurers; | ||
| health maintenance organizations; and | ||
| pharmacy benefit management companies. |
Both federal and state governments in the United States and foreign governments continue to propose and pass legislation designed to contain or reduce the cost of health care through various means. Legislation and regulations affecting the pricing of pharmaceuticals and other medical products may change or be adopted before any of our potential products are approved for marketing. Cost control initiatives could decrease the price that we receive for any product we may develop in the future. In addition, third-party payors are increasingly challenging the price and
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cost-effectiveness of medical products and services and any of our potential products and treatments may ultimately not be considered cost effective by these third parties. Any of these initiatives or developments could materially harm our business.
Our products are likely to be expensive to manufacture, and they may not be profitable if we are unable to significantly reduce the costs to manufacture them.
Both GRN163 and our hESC-based products are likely to be significantly more expensive to manufacture than most other drugs currently on the market today. Oligonucleotides are large molecules with complex chemistry, and the cost of manufacturing even a short oligonucleotide like GRN163 is considerably greater than the cost of making most small-molecule drugs. Our present manufacturing processes are conducted at a relatively small scale and are at an early stage of development. We hope to substantially reduce manufacturing costs by process improvements, as well as through scale increases. If we are not able to do so, however, and depending on the pricing of the product, the profit margin on GRN163 may be significantly less than that of most drugs on the market today. Similarly, we currently make differentiated cells from hESCs on a laboratory scale, at a high cost per unit of measure. The cell-based therapies we are developing based on hESCs will probably require large quantities of cells. We continue to develop processes to scale up production of the cells in a cost-effective way. If we cannot continue to improve our manufacturing processes, we may not be able to charge a high enough price for our cell therapy products, even if they are safe and effective, to make a profit. If we are unable to realize significant profits from our potential products, our business would be materially harmed.
Our activities involve hazardous materials and improper handling of these materials by our employees or agents could expose us to significant legal and financial penalties.
Our research and development activities involve the controlled use of hazardous materials, chemicals and various radioactive compounds. As a consequence, we are subject to numerous environmental and safety laws and regulations, including those governing laboratory procedures, exposure to blood-borne pathogens and the handling of biohazardous materials. We may be required to incur significant costs to comply with current or future environmental laws and regulations and may be adversely affected by the cost of compliance with these laws and regulations.
Although we believe that our safety procedures for using, handling, storing and disposing of hazardous materials comply with the standards prescribed by state and federal regulations, the risk of accidental contamination or injury from these materials cannot be eliminated. In the event of such an accident, state or federal authorities could curtail our use of these materials and we could be liable for any civil damages that result, the cost of which could be substantial. Further, any failure by us to control the use, disposal, removal or storage of, or to adequately restrict the discharge of, or assist in the cleanup of, hazardous chemicals or hazardous, infectious or toxic substances could subject us to significant liabilities, including joint and several liability under certain statutes, and any liability could exceed our resources and could have a material adverse effect on our business, financial condition and results of operations. Additionally, an accident could damage our research and manufacturing facilities and operations.
Additional federal, state and local laws and regulations affecting us may be adopted in the future. We may incur substantial costs to comply with these laws and regulations and substantial fines or penalties if we violate any of these laws or regulations.
Our stock price has historically been very volatile.
Stock prices and trading volumes for many biopharmaceutical companies fluctuate widely for a number of reasons, including factors which may be unrelated to their businesses or results of operations such as media coverage, legislation and regulatory measures and the activities of various interest groups or organizations. This market volatility, as well as general domestic or international economic, market and political conditions, could materially and adversely affect the market price of our common stock and the return on your investment.
Historically, our stock price has been extremely volatile. Between January 1998 and March 31, 2003, our stock has traded as high as $75.88 per share and as low as $1.41 per share. The significant market price fluctuations of our common stock are due to a variety of factors, including:
| depth of the market for the common stock; |
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| the experimental nature of our prospective products; | ||
| fluctuations in our operating results; | ||
| market conditions relating to the biopharmaceutical and pharmaceutical industries; | ||
any announcements of technological innovations, new commercial products or clinical progress or lack thereof by us, our collaborative partners or our competitors; or | |||
| announcements concerning regulatory developments, developments with respect to proprietary rights and our collaborations. |
In addition, the stock market is subject to other factors outside our control that can cause extreme price and volume fluctuations. Securities class action litigation has often been brought against companies, including many biotechnology companies, which then experience volatility in the market price of their securities. Litigation brought against us could result in substantial costs and a diversion of managements attention and resources, which could adversely affect our business.
The sale of a substantial number of shares may adversely affect the market price for our common stock.
Sales of substantial number of shares of our common stock in the public market could significantly and negatively affect the market price for our common stock. As of March 31, 2003, we had 25,169,881 shares of common stock outstanding. Of these shares, approximately 11,194,999 shares were issued (including shares issuable upon conversion or exercise of convertible notes or warrants) since December 1998 pursuant to private placements. Of these shares, approximately 9,833,463 shares have been registered pursuant to shelf registration statements and therefore may be resold (if not sold prior to the date hereof) in the public market and approximately 1,361,536 of the remaining shares may be resold pursuant to Rule 144 into the public markets. In April 2003, we issued 4,400,000 shares of common stock in connection with a financing. These shares were offered through a prospectus supplement to our effective universal shelf registration statement.
Our undesignated preferred stock may inhibit potential acquisition bids; this may adversely affect the market price for our common stock and the voting rights of the holders of common stock.
Our certificate of incorporation provides our Board of Directors with the authority to issue up to 3,000,000 shares of undesignated preferred stock and to determine the rights, preferences, privileges and restrictions of these shares without further vote or action by the stockholders. As of the date of this Form 10-Q, 50,000 shares of preferred stock have been designated Series A Junior Participating Preferred Stock and the Board of Directors still has authority to designate and issue up to 2,950,000 shares of preferred stock. The rights of the holders of common stock will be subject to, and may be adversely affected by, the rights of the holders of any preferred stock that may be issued in the future. The issuance of shares of preferred stock may delay or prevent a change in control transaction without further action by our stockholders. As a result, the market price of our common stock may be adversely affected. The issuance of preferred stock may also result in the loss of voting control by others.
Provisions in our share purchase rights plan, charter and bylaws, and provisions of Delaware law, may inhibit potential acquisition bids for us, which may prevent holders of our common stock from benefiting from what they believe may be the positive aspects of acquisitions and takeovers.
Our Board of Directors has adopted a share purchase rights plan, commonly referred to as a poison pill. This plan entitles existing stockholders to rights, including the right to purchase shares of common stock, in the event of an acquisition of 15% or more of our outstanding common stock. Our share purchase rights plan could prevent stockholders from profiting from an increase in the market value of their shares as a result of a change of control of Geron by delaying or preventing a change of control. In addition, our Board of Directors has the authority, without further action by our stockholders, to issue additional shares of common stock, to fix the rights and preferences of, and to issue authorized but undesignated shares of preferred stock.
In addition to our share purchase rights plan and the undesignated preferred stock, provisions of our charter documents and bylaws may make it substantially more difficult for a third party to acquire control of us and may prevent changes in our management, including provisions that:
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| prevent stockholders from taking actions by written consent; | ||
divide the Board of Directors into separate classes with terms of office that are structured to prevent all of the directors from being elected in any one year; and | |||
| set forth procedures for nominating directors and submitting proposals for consideration at stockholders meetings. |
Provisions of Delaware law may also inhibit potential acquisition bids for us or prevent us from engaging in business combinations. Either collectively or individually, these provisions may prevent holders of our common stock from benefiting from what they may believe are the positive aspects of acquisitions and takeovers, including the potential realization of a higher rate of return on their investment from these types of transactions.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
The following discussion about our market risk disclosures contains forward-looking statements. Actual results could differ materially from those projected in the forward-looking statements. We are exposed to market risk related to changes in interest rates and foreign currency exchange rates. We do not use derivative financial instruments for speculative or trading purposes.
Credit Risk. We place our cash, restricted cash, cash equivalents, and marketable securities with three financial institutions in the United States. Generally, these deposits may be redeemed upon demand and therefore, bear minimal risk. Deposits with banks may exceed the amount of insurance provided on such deposits. Financial instruments that potentially subject us to concentrations of credit risk consist primarily of marketable securities. Marketable securities consist of high-grade corporate bonds and U.S. government agency securities. Our investment policy, approved by our Board of Directors, limits the amount we may invest in any one type of investment, thereby reducing credit risk concentrations.
Interest Rate Sensitivity. The fair value of our cash equivalents and marketable securities at March 31, 2003 was $39.0 million. These investments include $7.1 million of cash equivalents which are due in less than 90 days, $12.8 million of short-term investments which are due in less than one year and $19.1 million in long-term investments which are due in 12 to 18 months. Our investment policy is to manage our marketable securities portfolio to preserve principal and liquidity while maximizing the return on the investment portfolio through the full investment of available funds. We diversify the marketable securities portfolio by investing in multiple types of investment grade securities. We primarily invest our marketable securities portfolio in short-term securities with at least an investment grade rating to minimize interest rate and credit risk as well as to provide for an immediate source of funds. Although changes in interest rates may affect the fair value of the marketable securities portfolio and cause unrealized gains or losses, such gains or losses would not be realized unless the investments are sold. Due to the nature of our investments, which are primarily corporate notes and money market funds, we have concluded that there is no material market risk exposure.
Foreign Currency Exchange Risk. Because we translate foreign currencies into United States dollars for reporting purposes, currency fluctuations can have an impact, though generally immaterial, on our results. We believe that our exposure to currency exchange fluctuation risk is insignificant primarily because our international subsidiary satisfies its financial obligations almost exclusively in its local currency. As of March 31, 2003, there was an immaterial currency exchange impact from our intercompany transactions. However, our financial obligations to the Roslin Institute are stated in British pounds sterling over the next three years. This obligation may become more expensive for us if the United States dollar becomes weaker against the British pounds sterling. As of March 31, 2003, we did not engage in foreign currency hedging activities.
ITEM 4. CONTROLS AND PROCEDURES
Based on their evaluation as of a date within 90 days of the filing date of this Quarterly Report on Form 10-Q, Gerons principal executive officer and principal financial officer have concluded that Gerons disclosure controls and procedures as defined in Rules 13a-14(c) and 15d-14(c) under the Securities Exchange Act of 1934 (the Exchange Act) are effective to ensure that information required to be disclosed by Geron in reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in Securities and Exchange Commission rules and forms.
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There were no significant changes in Gerons internal controls or in other factors that could significantly affect these controls subsequent to the date of their evaluation and up to the filing date of this Quarterly Report on Form 10-Q. We have not identified any significant deficiencies or material weaknesses, and therefore there were no corrective actions taken.
It should be noted that any system of controls, however well designed and operated, can provide only reasonable, and not absolute assurance that the objectives of the system are met. In addition, the design of any control system is based in part upon certain assumptions about the likelihood of future events. Because of these and other inherent limitations of control systems, there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions, regardless of how remote.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
None
ITEM 2. CHANGES IN SECURITIES AND USE OF PROCEEDS
Recent Sales of Unregistered Securities
In March 2003, in conjunction with a consulting services agreement, we issued a warrant to purchase 50,000 shares of common stock. The warrant is exercisable at any time through March 2013 at $3.00 per share. In exchange for the warrant, we will receive consulting services over the remaining eight month term of the consulting agreement. We have agreed to register the underlying shares of this warrant by the fifth anniversary of the issuance date.
On March 21, 2003, we issued 250,465 shares of common stock at $3.39 per share (the closing price of the Companys common stock on the Nasdaq National Market) to a law firm that has provided patent services to us. In exchange for the shares, we eliminated the outstanding balance of approximately $849,000 payable to the law firm. We registered the shares for resale under Form S-3.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None
ITEM 5. OTHER INFORMATION
None
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ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) EXHIBITS
Exhibit | ||
Number | Description | |
10.1 | Employment agreement between Registrant and Thomas Okarma, dated January 21, 2003. | |
10.2 | Employment agreement between Registrant and David Greenwood, dated January 21, 2003. | |
10.3 | Employment agreement between Registrant and David Earp, dated January 21, 2003. | |
10.4 | Employment agreement between Registrant and Calvin Harley, dated January 21, 2003. | |
10.5 | Employment agreement between Registrant and Melissa Kelly, dated January 21, 2003. | |
10.6 | Employment agreement between Registrant and Jane Lebkowski, dated January 21, 2003. | |
10.7 | Employment agreement between Registrant and William Stempel, dated January 21, 2003. | |
10.8 | Severance Plan, effective January 21, 2003. | |
99.1 | Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, dated April 30, 2003. | |
99.2 | Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, dated April 30, 2003. |
(b) REPORTS ON FORM 8-K
The Registrant filed a report on Form 8-K, dated January 22, 2003, announcing that a restructuring resulted in a reduction in its research staff by 29 employees and its support staff by 11 employees. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized.
GERON CORPORATION | ||||
By: | /s/ DAVID L. GREENWOOD | |||
David L. Greenwood | ||||
Senior Vice President, Corporate Development and | ||||
Chief Financial Officer | ||||
(Duly Authorized Signatory) |
Date: April 30, 2003
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GERON CORPORATION
SARBANES-OXLEY ACT SECTION 302(a) CERTIFICATION
I, Thomas B. Okarma, Chief Executive Officer of Geron Corporation, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Geron Corporation;
2. Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;
3. Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;
4. The registrants other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have:
a) designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared; | |||
b) evaluated the effectiveness of the registrants disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the Evaluation Date); and | |||
c) presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date; |
5. The registrants other certifying officers and I have disclosed, based on our most recent evaluation, to the registrants auditors and the audit committee of registrants board of directors (or persons performing the equivalent function):
a) all significant deficiencies in the design or operation of internal controls which could adversely affect the registrants ability to record, process, summarize and report financial data and have identified for the registrants auditors any material weaknesses in internal controls; and | |||
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal controls; and |
6. The registrants other certifying officers and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses.
Date: April 30, 2003
/s/ THOMAS B. OKARMA
Thomas B. Okarma
President and Chief Executive Officer
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GERON CORPORATION
SARBANES-OXLEY ACT SECTION 302(a) CERTIFICATION
I, David L. Greenwood, Chief Financial Officer of Geron Corporation, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Geron Corporation;
2. Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;
3. Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;
4. The registrants other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have:
a) designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared; | |||
b) evaluated the effectiveness of the registrants disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the Evaluation Date); and | |||
c) presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date; |
5. The registrants other certifying officers and I have disclosed, based on our most recent evaluation, to the registrants auditors and the audit committee of registrants board of directors (or persons performing the equivalent function):
a) all significant deficiencies in the design or operation of internal controls which could adversely affect the registrants ability to record, process, summarize and report financial data and have identified for the registrants auditors any material weaknesses in internal controls; and | |||
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal controls; and |
6. The registrants other certifying officers and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses.
Date: April 30, 2003
/s/ DAVID L. GREENWOOD
David L. Greenwood
Senior Vice President, Corporate Development
and Chief Financial Officer
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EXHIBIT INDEX
Exhibit | ||
Number | Description | |
10.1 | Employment agreement between Registrant and Thomas Okarma, dated January 21, 2003. | |
10.2 | Employment agreement between Registrant and David Greenwood, dated January 21, 2003. | |
10.3 | Employment agreement between Registrant and David Earp, dated January 21, 2003. | |
10.4 | Employment agreement between Registrant and Calvin Harley, dated January 21, 2003. | |
10.5 | Employment agreement between Registrant and Melissa Kelly, dated January 21, 2003. | |
10.6 | Employment agreement between Registrant and Jane Lebkowski, dated January 21, 2003. | |
10.7 | Employment agreement between Registrant and William Stempel, dated January 21, 2003. | |
10.8 | Severance Plan, effective January 21, 2003. | |
99.1 | Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, dated April 30, 2003. | |
99.2 | Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, dated April 30, 2003. |
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