UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
FORM 10-Q
| þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE PERIOD ENDED MARCH 31, 2005
OR
| o 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.
Yes þ No o
Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).
Yes þ No o
Indicate the number of shares outstanding of each of the issuers classes of common stock, as of the latest practicable date.
| Class: | Outstanding at April 22, 2005: | |
| Common Stock, $0.001 par value | 55,435,581 shares |
GERON CORPORATION
INDEX
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| 36 | ||||||||
| 36 | ||||||||
| 36 | ||||||||
| 37 | ||||||||
| EXHIBIT 10.1 | ||||||||
| EXHIBIT 10.2 | ||||||||
| EXHIBIT 10.3 | ||||||||
| EXHIBIT 31.1 | ||||||||
| EXHIBIT 31.2 | ||||||||
| EXHIBIT 32.1 | ||||||||
| EXHIBIT 32.2 | ||||||||
PART I. FINANCIAL INFORMATION
ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
GERON CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS)
| MARCH 31, | DECEMBER 31, | |||||||
| 2005 | 2004 | |||||||
| (UNAUDITED) | (SEE NOTE 1) | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 7,530 | $ | 9,846 | ||||
Restricted cash |
530 | 530 | ||||||
Marketable securities |
116,955 | 110,118 | ||||||
Interest and other receivables |
1,638 | 1,550 | ||||||
Notes receivable from related parties |
143 | 147 | ||||||
Prepaid assets |
2,681 | 2,586 | ||||||
Total current assets |
129,477 | 124,777 | ||||||
Prepaid assets |
2,822 | 3,212 | ||||||
Equity investments in licensees and joint venture |
484 | 489 | ||||||
Property and equipment, net |
1,975 | 2,089 | ||||||
Deposits and other assets |
170 | 175 | ||||||
Intangible assets |
942 | 1,131 | ||||||
| $ | 135,870 | $ | 131,873 | |||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 1,388 | $ | 2,535 | ||||
Accrued compensation |
572 | 2,024 | ||||||
Accrued liabilities |
580 | 822 | ||||||
Current portion of deferred revenue |
472 | 477 | ||||||
Current portion of equipment loans |
129 | 146 | ||||||
Current portion of research funding obligation |
2,001 | 2,454 | ||||||
Total current liabilities |
5,142 | 8,458 | ||||||
Noncurrent portion of deferred revenue |
665 | 707 | ||||||
Noncurrent portion of equipment loans |
28 | 55 | ||||||
Noncurrent portion of research funding obligation |
295 | 590 | ||||||
Commitments |
||||||||
Stockholders equity: |
||||||||
Common stock |
54 | 52 | ||||||
Additional paid-in capital |
476,554 | 458,965 | ||||||
Deferred compensation |
(207 | ) | (260 | ) | ||||
Accumulated deficit |
(345,759 | ) | (336,071 | ) | ||||
Accumulated other comprehensive loss |
(902 | ) | (623 | ) | ||||
Total stockholders equity |
129,740 | 122,063 | ||||||
| $ | 135,870 | $ | 131,873 | |||||
See accompanying notes.
3
GERON CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
| THREE MONTHS ENDED | ||||||||
| MARCH 31, | ||||||||
| 2005 | 2004 | |||||||
License fees and royalties |
$ | 59 | $ | 248 | ||||
Operating expenses: |
||||||||
Research and development |
6,473 | 5,718 | ||||||
Acquired in-process research technology |
| 45,150 | ||||||
General and administrative |
3,949 | 1,391 | ||||||
Total operating expenses |
10,422 | 52,259 | ||||||
Loss from operations |
(10,363 | ) | (52,011 | ) | ||||
Interest and other income |
847 | 498 | ||||||
Interest and other expense |
(172 | ) | (170 | ) | ||||
Net loss |
$ | (9,688 | ) | $ | (51,683 | ) | ||
Basic and diluted net loss per share |
$ | (0.18 | ) | $ | (1.28 | ) | ||
Weighted average shares used in computing
basic and diluted net loss per share |
54,175,184 | 40,449,815 | ||||||
See accompanying notes.
4
GERON CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
| THREE MONTHS ENDED | ||||||||
| MARCH 31, | ||||||||
| 2005 | 2004 | |||||||
Cash flows from operating activities: |
||||||||
Net loss |
$ | (9,688 | ) | $ | (51,683 | ) | ||
Adjustments to reconcile net loss to net cash used in operating
activities: |
||||||||
Depreciation and amortization |
240 | 251 | ||||||
Accretion and amortization on investments |
584 | 944 | ||||||
Issuance of common stock in exchange for acquired research
technology |
| 45,150 | ||||||
Issuance of common stock and warrants in exchange for services |
2,725 | 100 | ||||||
Accretion of interest on research funding obligation |
123 | 123 | ||||||
Amortization of deferred compensation |
53 | 34 | ||||||
Realized gain on equity investments in licensees |
(3 | ) | (18 | ) | ||||
Amortization of intangible assets, principally research related |
189 | 716 | ||||||
Changes in assets and liabilities: |
||||||||
Other current and noncurrent assets |
204 | (2,942 | ) | |||||
Other current and noncurrent liabilities |
(1,085 | ) | (1,768 | ) | ||||
Accrued research funding obligation |
(871 | ) | (896 | ) | ||||
Translation adjustment |
(27 | ) | 2 | |||||
Net cash used in operating activities |
(7,556 | ) | (9,987 | ) | ||||
Cash flows from investing activities: |
||||||||
Capital expenditures |
(126 | ) | (125 | ) | ||||
Purchases of marketable securities |
(32,010 | ) | (12,232 | ) | ||||
Proceeds from sale of equity investment in licensee |
| 201 | ||||||
Proceeds from maturities of marketable securities |
24,357 | 15,200 | ||||||
Net cash (used in)/provided by investing activities |
(7,779 | ) | 3,044 | |||||
Cash flows from financing activities: |
||||||||
Payments of obligations under equipment loans |
(44 | ) | (51 | ) | ||||
Proceeds from issuances of common stock, net of issuance costs |
563 | 700 | ||||||
Proceeds from exercise of warrants |
12,500 | | ||||||
Net cash provided by financing activities |
13,019 | 649 | ||||||
Net decrease in cash and cash equivalents |
(2,316 | ) | (6,294 | ) | ||||
Cash and cash equivalents at the beginning of the period |
9,846 | 12,823 | ||||||
Cash and cash equivalents at the end of the period |
$ | 7,530 | $ | 6,529 | ||||
See accompanying notes.
5
GERON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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, 2005 and condensed consolidated statements of operations for the three months ended March 31, 2005 and 2004 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 U.S. 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, 2005 are not necessarily indicative of the results that may be expected for the year ending December 31, 2005 or any other period. These financial statements and notes should be read in conjunction with the financial statements for the year ended December 31, 2004, included in the Companys Annual Report on Form 10-K. The accompanying condensed consolidated balance sheet as of December 31, 2004 has been derived from audited financial statements at that date.
Principles of Consolidation
The consolidated financial statements include the accounts of Geron Corporation and our one wholly-owned subsidiary, Geron Bio-Med Ltd., a United Kingdom company. We have eliminated intercompany accounts and transactions. We measure the financial statements of Geron Bio-Med using the local currency as the functional currency. We translate the assets and liabilities of this subsidiary at rates of exchange at the balance sheet date. We translate income and expense items at average monthly rates of exchange. The resultant translation adjustments are included in accumulated other comprehensive income (loss), a separate component of stockholders equity.
FASB Interpretation No. 46-R (FIN 46R), Consolidation of Variable Interest Entities, an Interpretation of ARB No. 51, as amended, provides guidance on the identification, classification and accounting of variable interest entities. We have variable interests in VIEs through marketable and non-marketable equity investments in various companies with whom we have executed licensing agreements. In accordance with FIN 46R, we have concluded that we are not the primary beneficiary in any of these VIEs and therefore have not consolidated such entities in our consolidated financial statements.
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 would include any dilutive effect of options, warrants and other convertible securities.
6
A reconciliation of shares used in calculation of basic and diluted net loss per share follows:
| Three Months Ended | ||||||||
| March 31, 2005 | March 31, 2004 | |||||||
| (In thousands, except per share amounts) | ||||||||
Net loss |
$ | (9,688 | ) | $ | (51,683 | ) | ||
Basic and diluted net loss per common share |
$ | (0.18 | ) | $ | (1.28 | ) | ||
Weighted average shares of common stock
outstanding used in computing basic and
diluted net loss per common share |
54,175,184 | 40,449,815 | ||||||
Because we are 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 common stock equivalents consisting of options and warrants which are all antidilutive. Had we been in a net income position, diluted earnings per share would have included the shares used in the computation of basic net loss per share as well as an additional 1,454,626 shares and 2,110,180 shares for 2005 and 2004, respectively related to common stock equivalents 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 U.S. generally accepted accounting principles 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
We consider all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. We are subject to credit risk related to our cash equivalents and available-for-sale securities. We place our cash and cash equivalents in money market funds and commercial paper. Our investments include corporate notes in United States corporations and asset-backed securities with original maturities ranging from four to 24 months.
We classify our marketable debt securities as available-for-sale. We record available-for-sale securities 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. 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 insignificant to date. We recognize an impairment charge when the declines in the fair values of our available-for-sale securities below the amortized cost basis are judged to be other-than-temporary. We consider various factors in determining whether to recognize an impairment charge, including the length of time and extent to which the fair value has been less than our cost basis, the financial condition and near-term prospects of the security issuer, and our intent and ability to hold the investment for a period of time sufficient to allow for any anticipated recovery in market value. Declines in market value judged other-than-temporary result in a charge to interest and other income. No impairment charges were recorded for our available-for-sale securities for the three months ended March 31, 2005 and 2004. Dividend and interest income are recognized when earned.
Revenue Recognition
We recognize revenue related to license and research agreements with collaborators, royalties, milestone payments and government grants. Our revenue arrangements with multiple deliverables are divided into separate units of accounting if certain criteria are met, including whether the delivered item has stand-alone value to the end user and whether there is objective and reliable evidence of the fair value of the undelivered items. The consideration we receive is allocated among the separate units based on their respective fair
7
values, and the applicable revenue recognition criteria are considered separately for each of the separate units.
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 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. 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 we have continuing performance obligations. Option payments are recognized as revenue over the period of the option agreement. Milestone payments are recognized upon completion of specified milestones according to contract terms. Royalties are generally recognized upon receipt.
In prior years, a substantial portion of our revenues had been generated from license and research agreements with collaborators. We recognized revenue under those collaborative agreements as the related research and development costs were incurred. Deferred revenue represented the portion of research payments received which had not been earned. Milestone fees were recognized upon completion of specified milestones according to contract terms.
Through March 31, 2004, we received funding from United States government grants that supported our research efforts in defined research projects. Those grants generally provided for reimbursement of approved costs incurred as defined in the various grants. Funding associated with those grants was recognized as revenue upon receipt of reimbursement and was included in interest and other income.
Restricted Cash
As of March 31, 2005 and December 31, 2004, we held $530,000 in a Certificate of Deposit as collateral on an unused line of credit.
Marketable and Non-Marketable Equity Investments in Licensees and Joint Venture
Investments in non-marketable nonpublic companies are carried at the lower of cost or net realizable value. Investments in marketable equity securities are carried at the market value as of the balance sheet date. For marketable equity securities, unrealized gains and losses are reported in accumulated other comprehensive income (loss) in stockholders equity. Realized gains or losses are included in interest and other income and are derived using the specific identification method.
We monitor our equity investments in licensees for impairment on a quarterly basis and make appropriate reductions in carrying values when such impairments are determined to be other-than-temporary. Impairment charges are included in interest and other income. Factors used in determining an impairment include, but are not limited to, the current business environment including competition and uncertainty of financial condition; going concern considerations such as the rate at which the investee company utilizes cash, and the investee companys ability to obtain additional private financing to fulfill its stated business plan; the need for changes to the investee companys existing business model due to changing business environments and its ability to successfully implement necessary changes; and the general progress toward product development, including clinical trial results. If an investment is determined to be impaired, a determination is made as to whether such impairment is other-than-temporary. We did not recognize any impairment charges for the three months ended March 31, 2005 and 2004 related to other-than-temporary declines in fair values of our non-marketable equity investments. As of March 31, 2005 and 2004, the carrying values of our equity investments in non-marketable nonpublic companies, including our joint venture, were $463,000 and $199,000, respectively.
8
Derivative Financial Instruments
We own 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), we account 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. We do not use derivative financial instruments for trading or speculative purposes.
Our exposure to currency exchange fluctuation risk is insignificant. Geron Bio-Med, Ltd., our international subsidiary, satisfies its financial obligations almost exclusively in its local currency. For the three months ended March 31, 2005 and 2004, there was an insignificant currency exchange impact from intercompany transactions. We do not engage in foreign currency hedging activities.
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 $20,000,000 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 at the acquisition date and was capitalized as an intangible asset that was being amortized as research and development expense over the six year funding period. In December 2004, we extended the research funding period from June 30, 2005 to June 30, 2006 and we adjusted the amortization period of the intangible asset to coincide with the extended research period. No additional funding was committed. Imputed interest is also being accreted to the value of the research funding obligation and is recognized as interest expense. The remaining obligation as of March 31, 2005 was $2,296,000.
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 and research-related overhead. Accrued liabilities for raw materials to manufacture clinical trial drugs, manufacturing costs and sponsored research reimbursement fees are included in accrued liabilities and research and development expenses.
Depreciation and Amortization
We record property and equipment at cost and calculate depreciation using the straight-line method over the estimated useful lives of the assets, generally four years. Leasehold improvements are amortized over the shorter of the estimated useful life or remaining term of the lease.
Employee Stock Plans
As permitted by SFAS No. 123, Accounting for Stock-Based Compensation, (SFAS 123), as amended by SFAS No. 148, Accounting for Stock-Based Compensation -Transition and Disclosures (SFAS 148), we elected to continue to apply the provisions of APB Opinion No. 25, Accounting for Stock Issued to Employees, (APB Opinion 25) and related interpretations in accounting for our employee stock option and stock purchase plans. We are generally not required under APB Opinion 25 and related interpretations to recognize compensation expense in connection with our employee stock option and stock purchase plans.
To comply with SFAS 148, we are presenting the following table to illustrate the effect on our net loss and loss per share as if we had applied the fair value recognition provisions of SFAS 123, as amended, to
9
options granted under our stock-based employee compensation plans. For purposes of this pro forma disclosure, the estimated value of the options is amortized to expense using the straight-line method over the options vesting period:
| Three Months Ended March 31, | ||||||||
| 2005 | 2004 | |||||||
| (In thousands, except per share amounts) | ||||||||
Net loss |
$ | (9,688 | ) | $ | (51,683 | ) | ||
Deduct: |
||||||||
Stock-based employee expense determined
under SFAS 123 |
(1,040 | ) | (1,480 | ) | ||||
Pro forma net loss |
$ | (10,728 | ) | $ | (53,163 | ) | ||
Basic and diluted net loss per share as reported |
$ | (0.18 | ) | $ | (1.28 | ) | ||
Basic and diluted pro forma net loss per share |
$ | (0.20 | ) | $ | (1.31 | ) | ||
The fair value of options granted for the three months ended March 31, 2005 and 2004 has been estimated at the date of grant using the Black Scholes option-pricing model with the following assumptions:
| Three Months Ended March 31, | ||||
| 2005 | 2004 | |||
Dividend yield |
None | None | ||
Expected volatility range |
0.893 | 0.992 | ||
Risk-free interest rate range |
3.48% to 4.08% | 2.37% to 2.95% | ||
Expected life |
4 yrs | 4 yrs | ||
The fair value of employees purchase rights has been estimated using the Black Scholes option-pricing model with the following assumptions:
| Three Months Ended March 31, | ||||||||
| 2005 | 2004 | |||||||
Dividend yield |
None | None | ||||||
Expected volatility range |
0.617 | 0.580 | ||||||
Risk-free interest rate range |
3.10 | % | 1.59 | % | ||||
Expected life |
6 mos | 6 mos | ||||||
The Black Scholes option-pricing 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 our 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 our opinion, the existing models do not necessarily provide a reliable single measure of the fair value of our employee stock options, nor do they necessarily represent the effects of employee stock options on reported net income (loss) for future years.
See Recent Accounting Pronouncements for a discussion of SFAS 123R.
Comprehensive Loss
Comprehensive loss is comprised of net loss and other comprehensive loss. Other comprehensive loss includes certain changes in stockholders equity which are excluded from net loss.
10
The components of accumulated other comprehensive loss are as follows:
| March 31, | December 31, | |||||||
| 2005 | 2004 | |||||||
| (In thousands) | ||||||||
Unrealized holding loss on
available-for-sale securities and
marketable equity investments |
$ | (745 | ) | $ | (493 | ) | ||
Foreign currency translation adjustments |
(157 | ) | (130 | ) | ||||
| $ | (902 | ) | $ | (623 | ) | |||
Recent Accounting Pronouncements
In December 2004, the FASB issued SFAS No. 123 (revised 2004), Share-Based Payment (SFAS 123R). SFAS 123R requires the compensation cost relating to stock-based payment transactions be recognized in financial statements. That cost will be measured based on the fair value of the equity or liability instruments issued on the grant date of such instruments, and will be recognized over the period during which an individual is required to provide service in exchange for the award (typically the vesting period). SFAS 123R covers a wide range of stock-based compensation arrangements including stock options, restricted stock plans, performance-based awards, stock appreciation rights, and employee stock purchase plans. SFAS 123R replaces SFAS 123 and supersedes APB Opinion 25. In April 2005, the Securities and Exchange Commission delayed the effective date of SFAS 123R to the first interim or annual reporting period of the Companys first fiscal year beginning on or after June 15, 2005. Early adoption will be permitted in periods in which financial statements have not yet been issued. We expect to adopt SFAS 123R on January 1, 2006.
SFAS 123R permits public companies to adopt its requirement using one of two methods: 1) A modified prospective method in which compensation cost is recognized beginning with the effective date (a) based on the requirements of SFAS 123R for all share-based payments granted after the effective date and (b) based on the requirements of SFAS 123 for all awards granted to employees prior to the effective date of SFAS 123R that remain unvested on the effective date; or 2) A modified retrospective method which includes the requirements of the modified prospective method described above, but also permits entities to restate based on the amounts previously recognized under SFAS 123 for purposes of pro forma disclosures either (a) all prior periods presented or (b) to the start of the fiscal year in which SFAS 123R is adopted. The Company plans to adopt SFAS 123R using the modified prospective method.
As permitted by SFAS 123, we currently account for share-based payments to employees using APB Opinion 25s intrinsic value method and, as such, generally recognize no compensation cost for employee stock options which have exercise prices equal to the fair market value of the underlying common stock at the date of granting the option. Accordingly, the adoption of SFAS 123Rs fair value method will have a significant impact on our result of operations, although it will have no impact on our overall financial position. The impact of adoption of SFAS 123R cannot be predicted at this time because it will depend on levels of share-based payments granted in the future. However, had we adopted SFAS 123R in prior periods, the impact of that standard would have approximated the impact of SFAS 123 as described in the disclosure of pro forma net loss and loss per share in Note 1 to our condensed consolidated financial statements. SFAS 123R also requires the benefits of tax deductions in excess of recognized compensation cost to be reported as a financing cash flow, rather than as an operating cash flow as required under current literature. It is unlikely that we will have near term benefits from tax deductions. This requirement will reduce net operating cash flows and increase net financing cash flows in periods after adoption. We cannot estimate what those amounts will be in the future (because they depend on, among other things, when employees exercise stock options, and whether we will be in a taxable position). At this time, there would be no tax impact related to the prior periods since we are in a net loss position.
11
2. ISSUANCES OF COMMON STOCK
In January 2005, we received cash proceeds of $12,500,000 upon the exercise of warrants to purchase 2,049,180 shares of common stock. The warrants were issued to institutional investors in connection with the financing announced in November 2004 and had an expiration date of January 11, 2005.
In January 2005, we awarded 148,137 shares of common stock to employees in lieu of cash for 2004 year-end performance bonuses. The shares were granted from the 2002 Equity Incentive Plan. Compensation expense related to this award was included in accrued compensation as of December 31, 2004.
3. JOINT VENTURE AGREEMENT
On March 1, 2005, we and the Biotechnology Research Corporation Limited (BRC), a company incorporated under the laws of Hong Kong, entered into a Joint Venture Agreement (JVA) to establish a joint venture in Hong Kong called TA Therapeutics, Limited (TAT). Geron and BRC each will own 50% of TAT. TAT will conduct research and develop products that utilize telomerase activator drugs to restore the functional capacity of cells in various organ systems that have been impacted by senescence, injury, or chronic disease.
Pursuant to the JVA, we will contribute scientific leadership, development expertise, intellectual property, and capital to TAT. BRC will provide scientific leadership, a research team, capital, and laboratory facilities. Geron and BRC each have agreed to contribute financially to fund the operations of TAT. BRC has agreed to an initial capital contribution of $6,000,000, payable in six equal quarterly payments. Three months after BRC has fully paid this amount, we will contribute $2,000,000, payable in two equal quarterly payments. Operations for TAT began April 1, 2005.
In accordance with the equity method of accounting, we will increase (decrease) the carrying value of our investment in the joint venture by a proportionate share of TATs earnings (losses). Any increases (decreases) will be reflected separately in our condensed consolidated statements of operations as equity in losses or income in the joint venture. We will suspend applying the equity method when our investment in and net advances to TAT is reduced to zero and when our proportionate share of TATs losses exceeds the carrying amount of the investment and our committed funding amount. If TAT subsequently reports net income, we will resume applying the equity method only after our share of that net income equals the share of net losses not recognized during the period the equity method was suspended. The initial investment in TAT reflects our initial payment for our share of equity in TAT of $12,000. Cash contributions made by us in the future will be recorded as additional investments when such amounts are actually paid. No value has been recognized for the intellectual property contribution as it represented a nonmonetary transaction and there was no net book value associated with these intangible assets at the execution of this arrangement.
In April 2005, we issued a warrant to purchase 470,000 shares of Geron common stock to a consultant in payment for consulting services associated with the formation of the joint venture. The warrant is immediately exercisable at an exercise price of $3.75 per share for a period of 10 years from the date of issuance. The fair value of the warrant of $2,562,000 was determined using the Black Scholes option-pricing model and was recognized as general and administrative expense during the quarter ended March 31, 2005 commensurate with the period the consulting services were rendered.
12
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. Our chief decision maker, as defined under SFAS 131, is the Chief Executive Officer. To date, we have viewed our operations as principally one segment, the discovery and development of therapeutic and diagnostic products for oncology and human embryonic stem cell therapies. As a result, the financial information disclosed herein materially represents all of the financial information related to our principal operating segment.
5. CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS DATA
| Three Months Ended | ||||||||
| March 31, | ||||||||
| (In Thousands) | 2005 | 2004 | ||||||
| (Unaudited) | ||||||||
Supplemental Operating, Investing and Financing Activities: |
||||||||
Net unrealized loss on equity investments in licensees |
$ | (20 | ) | $ | (3 | ) | ||
Net unrealized gain (loss) on marketable securities |
$ | (232 | ) | $ | 158 | |||
Shares issued for 401(k) matching contribution and retention bonus |
$ | 1,803 | $ | 978 | ||||
Shares or warrants issued for services |
$ | | $ | 4,695 | ||||
6. SUBSEQUENT EVENTS
In April 2005, we entered into a Formation and Shareholders Agreement (FSA) and Contribution and License Agreement (CLA) with Exeter Life Sciences, Inc. to form stART Licensing, Inc.(stART). stART will manage and license a broad portfolio of intellectual property rights related to animal reproductive technologies. We and Exeter own 49.9% and 50.1% of stART, respectively.
Pursuant to the CLA, we granted a worldwide, exclusive, non-transferable license, with the right to sublicense, to our patent rights to nuclear transfer technology for use in animal cloning. These patent rights include patents originally licensed from the Roslin Institute in Edinburgh, Scotland in conjunction with Gerons 1999 acquisition of Roslin BioMed, as well as patents covering technology arising from subsequent animal cloning work that we funded at the Roslin Institute. Geron has retained all rights to nuclear transfer technology for use in human cells. Exeter granted a worldwide, exclusive, non-transferable license, with the right to sublicense, to its patent rights for the use of the Roslin nuclear transfer technology for the production of proteins in milk of animals, as well as rights to other cloning technologies, including chromatin transfer, a technology developed at the University of Massachusetts.
Pursuant to the FSA, Exeter will provide initial operating capital and other management services for stART. Exeter will make an initial capital contribution, of which an amount is immediately payable to stART and the remainder will be provided from time to time, but in any event within 24 months following the execution of the FSA. Geron has no financial obligations to provide operating capital for stART and we received an upfront payment in cash of $4,000,000 from stART upon the execution of the FSA in consideration of the technology we contributed in excess of the value of the equity we received in stART. Geron is also entitled to receive payment upon achievement of a certain future milestone.
In April 2005, we sold 740,741 shares of Geron common stock to investors at a price of $5.40 per share for total gross proceeds of $4,000,000. The shares were offered through a prospectus supplement to an effective universal registration statement. In connection with the sale, we also issued warrants to purchase 370,370 shares at $7.95 per share. The warrants are immediately exercisable for a period of five years from
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the date of issuance. The fair value of the warrants of $1,610,000 was determined using the Black Scholes option-pricing model and was recognized as an issuance cost resulting in offsetting entries to additional paid-in capital. The purchased shares and the shares underlying the warrant are subject to a two year lock-up which prohibits the sale or other disposition of these shares over the two year lock up period.
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, 2004, 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 condensed 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, 2004.
Geron is a biopharmaceutical company developing and commercializing three groups of products: i) therapeutic products for oncology that target telomerase; ii) pharmaceuticals that activate telomerase in tissues impacted by senescence, injury or degenerative disease; and iii) cell-based therapies derived from its human embryonic stem cell platform for applications in multiple chronic diseases.
Our results of operations have fluctuated from period to period and may continue to fluctuate in the future, 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 AND ESTIMATES
We believe that there have been no significant changes in our critical accounting policies and estimates during the three months ended March 31, 2005 as compared to the critical accounting policies and estimates disclosed in our Annual Report on Form 10-K for the year ended December 31, 2004 as filed with the Securities and Exchange Commission on February 24, 2005.
Our condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these financial statements requires management to make
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estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses. Note 1 of Notes to Condensed Consolidated Financial Statements describes the significant accounting policies used in the preparation of the condensed 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 condensed consolidated financial statements as soon as they became known. Based on a critical assessment of our accounting policies and the underlying judgments and uncertainties affecting the application of those policies, management believes that our condensed 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 believe the following critical accounting policies reflect our more significant estimates and assumptions used in the preparation of our condensed consolidated financial statements:
Revenue Recognition
Since our inception, a substantial portion or our revenues has been generated from research and licensing agreements with collaborators. Revenue under such collaboration agreements typically includes upfront signing or license fees, cost reimbursements, milestone payments and royalties on future product sales.
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 estimate the projected future life of license agreements over which we recognize revenue. Our estimates are based on historical experience and general industry practice. Revisions in the estimated lives have the effect of increasing or decreasing license fee revenue in the period of revision. As of March 31, 2005, no revisions to the estimated future lives of license agreements have been made and we do not expect revisions in the future.
In the past, we recognized cost reimbursement revenue under those collaborative agreements as the related research and development costs were incurred. Deferred revenue represented the portion of research payments received which had not been earned. We recognized milestone fees upon completion of specified milestones according to contract terms.
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
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six years. Using an effective interest rate of 6%, this research funding obligation had a net present value of $17.2 million at the acquisition date and was capitalized as an intangible asset that was being amortized as research and development expense over the six year funding period. In December 2004, we extended the research funding period from June 30, 2005 to June 30, 2006 and we adjusted the amortization period of the intangible asset to coincide with the extended research period. No additional funding was committed. Imputed interest is being accreted to the value of the research funding obligation and is recognized as interest expense.
At the time of acquisition, we estimated the effective interest rate and have been evaluating the spending rate under the collaboration as compared to the contractual funding period. Revisions in the effective interest rate or amortization period would have the effect of increasing or decreasing research and development expense as well as the balance of intangible assets and research funding obligation on the balance sheet. As of March 31, 2005, no revisions to the effective interest rate have been made and we do not expect revisions in the future. Further adjustments to the amortization period may occur as we near the end of the extended research period and evaluate our continuing research support.
Valuation of Equity Instruments
As permitted by SFAS No. 123, Accounting for Stock-Based Compensation, (SFAS 123), as amended by SFAS No. 148, Accounting for Stock-Based Compensation -Transition and Disclosures (SFAS 148), we elected to continue to apply the provisions of APB Opinion 25, Accounting for Stock Issued to Employees, (APB Opinion 25) and related interpretations in accounting for our employee stock option and stock purchase plans. We are generally not required under APB Opinion 25 and related interpretations to recognize compensation expense in connection with our employee stock option and stock purchase plans. To comply with SFAS 148, we presented in Note 1 to condensed consolidated financial statements, the pro forma effect on our net loss and loss per share as if we had applied the fair value recognition provisions of SFAS 123, as amended, to options granted to employees under our stock-based employee compensation plans.
In valuing our options using the Black Scholes option-pricing model, we make assumptions about risk-free interest rates, dividend yields, volatility and weighted average expected lives of the options. Risk-free interest rates are derived from United States zero-coupon treasury strip yields as of the option grant date. Dividend yields are based on our historical dividend payments, which have been zero to date. Volatility is derived from the historical volatility of our common stock as traded on Nasdaq. The weighted average expected lives of the options is based on historical experience of option exercises and the average vesting option schedule. Each year, we have consistently applied the same methodology when deriving these assumptions. Revisions of any of these assumptions would increase or decrease the value of the option and increase or decrease the pro forma effect on reported net income (loss) and earnings (loss) per share if compensation expense had been recognized based on the fair value method. As of March 31, 2005, no revisions to the methods used in arriving at the assumptions used in the Black Scholes option-pricing model have been made and revisions may occur in the future with the adoption of SFAS 123R.
In valuing our warrants using the Black Scholes option-pricing model, we make assumptions about risk-free interest rates, dividend yields, volatility and weighted average expected lives of the warrants. Risk-free interest rates are derived from United States zero-coupon treasury strip yields as of the warrant issue date. Dividend yields are based on our historical dividend payments, which have been zero to date. Volatility is derived from the historical volatility of our common stock as traded on Nasdaq. The weighted average expected lives of the warrants is based on the term of the warrants. Upon issuance of a warrant to consultants or collaborators, we recognize an expense in our condensed consolidated statements of operations. Upon issuance of warrants in connection with an equity financing, we recognize issuance costs with an offset to additional paid-in capital in our condensed consolidated balance sheets. Each year, we have consistently applied the same methodology when deriving these assumptions. Revisions of any of these assumptions would increase or decrease the value of the warrant and increase or decrease the expense or issuance cost recognized upon issuance of the warrant. As of March 31, 2005, no revisions to the assumptions used in the Black Scholes option-pricing model have been made and revisions may occur in the future with the adoption of SFAS 123R.
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RESULTS OF OPERATIONS
Revenues
We have entered into license and option agreements with companies involved with oncology, diagnostics, research tools, agriculture and biologics production. In each of these agreements, we have granted certain rights to our technologies. In connection with the agreements, we are entitled to receive license fees, option fees, milestone payments and royalties on future sales, or any combination thereof. We recognized license and option fee revenues of $47,000 for the three months ended March 31, 2005 compared to $241,000 for the comparable 2004 period related to our various agreements. The decrease in revenue recognition was due to the full amortization of deferred revenue in 2004 for certain license or option agreements prior to the quarter ended March 31, 2005. Also, we received royalties of $12,000 for the three months ended March 31, 2005, compared to $7,000 for the comparable 2004 period on product sales of telomerase detection and telomere measurement kits to the research-use-only market, cell-based research products and agricultural products. License and royalty revenues are dependent upon additional agreements being signed and future product sales. We expect to recognize revenue of $430,000 for the remainder of 2005, $165,000 in 2006, $137,000 in 2007, $119,000 in 2008 and $286,000 thereafter related to our existing deferred revenue. Current revenues may not be predictive of future revenues.
Research and Development Expenses
Research and development expenses were $6.5 million for the three months ended March 31, 2005, compared to $5.7 million for the comparable 2004 period. The overall increase in 2005 compared to 2004 was primarily due to an increase of $614,000 for increased personnel related expenses and $494,000 for clinical consulting and sponsored research at other academic laboratories. Overall, we expect research and development expenses to increase in the next year as we incur expenses related to manufacturing and testing of our telomerase inhibitor compounds, continue clinical trials of our telomerase cancer vaccine and continue development of our human embryonic stem cell (hESC) programs.
Our research and development activities can be divided into two major categories of related programs, oncology and hESC therapies. The oncology programs focus on treating or diagnosing cancer by targeting or detecting the presence of telomerase, either inhibiting activity of the telomerase enzyme, diagnosing cancer by detecting the presence of telomerase, or using telomerase as a target for therapeutic vaccines. Our core knowledge base in telomerase and telomere biology supports all these approaches, and our scientists may contribute to any or all of these programs in a given period. For our telomerase inhibition program, we are targeting completion of the preclinical animal toxicology and efficacy studies by early 2005, after which we expect to prepare and file an IND application on GRN163L. A therapeutic vaccine targeting telomerase in patients with metastatic prostate cancer is currently in investigator-sponsored Phase 1-2 clinical studies at Duke University Medical Center. Study results have shown no treatment-related adverse effects to date and a positive specific immune responses to telomerase. We are conducting additional small Phase 1-2 trials, also at Duke, in order to optimize the vaccination process. We have also transferred the vaccine manufacturing process in-house for further optimization. At the conclusion of these activities, and assuming continued success, we plan to file an IND for a Phase 2 clinical study for the telomerase therapeutic vaccine.
Our hESC therapy programs focus on treating injuries and degenerative diseases with cell therapies based on cells derived from hESCs. A core of knowledge of hESC biology, as well as a significant continuing effort in deriving, g