Document_and_Entity_Informatio
Document and Entity Information | 3 Months Ended | |
Mar. 31, 2015 | Apr. 30, 2015 | |
Document and Entity Information | ||
Entity Registrant Name | GERON CORP | |
Entity Central Index Key | 886744 | |
Document Type | 10-Q | |
Document Period End Date | 31-Mar-15 | |
Amendment Flag | FALSE | |
Current Fiscal Year End Date | -19 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 158,087,513 | |
Document Fiscal Year Focus | 2015 | |
Document Fiscal Period Focus | Q1 |
CONDENSED_BALANCE_SHEETS
CONDENSED BALANCE SHEETS (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
In Thousands, unless otherwise specified | ||
Current assets: | ||
Cash and cash equivalents | $10,182 | $42,796 |
Restricted cash | 266 | 266 |
Marketable securities | 135,655 | 108,645 |
Interest and other receivables | 1,190 | 963 |
Prepaid assets | 604 | 736 |
Total current assets | 147,897 | 153,406 |
Noncurrent marketable securities | 17,739 | 18,932 |
Property and equipment, net | 171 | 173 |
Total assets | 165,807 | 172,511 |
Current liabilities: | ||
Accounts payable | 1,180 | 1,033 |
Accrued compensation and benefits | 2,135 | 4,213 |
Accrued collaboration charges | 626 | |
Accrued restructuring charges | 316 | |
Accrued liabilities | 1,375 | 1,537 |
Deferred revenue | 35,000 | 35,000 |
Fair value of derivatives | 16 | |
Total current liabilities | 40,632 | 41,799 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Common stock | 158 | 157 |
Additional paid-in capital | 1,062,782 | 1,059,072 |
Accumulated deficit | -937,748 | -928,433 |
Accumulated other comprehensive loss | -17 | -84 |
Total stockholders' equity | 125,175 | 130,712 |
Total liabilities and stockholders' equity | $165,807 | $172,511 |
CONDENSED_STATEMENTS_OF_OPERAT
CONDENSED STATEMENTS OF OPERATIONS (USD $) | 3 Months Ended | |
In Thousands, except Share data, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Revenues: | ||
License fees and royalties | $537 | $474 |
Operating expenses: | ||
Research and development | 4,987 | 5,211 |
Restructuring charges | 406 | |
General and administrative | 4,600 | 3,994 |
Total operating expenses | 9,993 | 9,205 |
Loss from operations | -9,456 | -8,731 |
Unrealized gain on derivatives | 16 | 224 |
Interest and other income | 149 | 83 |
Interest and other expense | -24 | -16 |
Net loss | ($9,315) | ($8,440) |
Basic and diluted net loss per share (in dollars per share) | ($0.06) | ($0.06) |
Shares used in computing basic and diluted net loss per share (in shares) | 157,547,568 | 143,465,818 |
CONDENSED_STATEMENTS_OF_COMPRE
CONDENSED STATEMENTS OF COMPREHENSIVE LOSS (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
CONDENSED STATEMENTS OF COMPREHENSIVE LOSS | ||
Net loss | ($9,315) | ($8,440) |
Net unrealized gain (loss) on marketable securities | 67 | -76 |
Comprehensive loss | ($9,248) | ($8,516) |
CONDENSED_STATEMENTS_OF_CASH_F
CONDENSED STATEMENTS OF CASH FLOWS CHANGE IN CASH AND CASH EQUIVALENTS (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Cash flows from operating activities: | ||
Net loss | ($9,315) | ($8,440) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 9 | 15 |
Accretion and amortization on investments, net | 629 | 606 |
Stock-based compensation for services by non-employees | 67 | 65 |
Stock-based compensation for employees and directors | 2,013 | 1,641 |
Amortization related to 401(k) contributions | 154 | 12 |
Unrealized gain on derivatives | -16 | -224 |
Changes in assets and liabilities: | ||
Other current and noncurrent assets | -95 | -646 |
Other current liabilities | -1,151 | -2,534 |
Net cash used in operating activities | -7,705 | -9,505 |
Cash flows from investing activities: | ||
Purchases of property and equipment | -7 | |
Purchases of marketable securities | -78,869 | -107,144 |
Proceeds from maturities of marketable securities | 52,490 | 17,363 |
Net cash used in investing activities | -26,386 | -89,781 |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock, net of issuance costs | 1,477 | 97,620 |
Net cash provided by financing activities | 1,477 | 97,620 |
Net decrease in cash and cash equivalents | -32,614 | -1,666 |
Cash and cash equivalents at the beginning of the period | 42,796 | 12,990 |
Cash and cash equivalents at the end of the period | $10,182 | $11,324 |
SUMMARY_OF_SIGNIFICANT_ACCOUNT
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||||||||
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||||||||
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 unaudited condensed financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. generally accepted accounting principles, or GAAP, for complete financial statements. In the opinion of management of Geron, all adjustments (consisting only of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the three month period ending March 31, 2015 are not necessarily indicative of the results that may be expected for the year ending December 31, 2015 or any other period. These financial statements and notes should be read in conjunction with the financial statements for each of the three years ended December 31, 2014, included in the Company’s Annual Report on Form 10-K. The accompanying condensed balance sheet as of December 31, 2014 has been derived from audited financial statements at that date. | ||||||||
Net Loss Per Share | ||||||||
Basic earnings (loss) per share is calculated based on the weighted average number of shares of common stock outstanding during the period. Diluted earnings (loss) per share is calculated based on the weighted average number of shares of common stock and potential dilutive securities outstanding during the period. Potential dilutive securities primarily consist of outstanding stock options, restricted stock awards and warrants to purchase common stock and are determined using the treasury stock method at an average market price during the period. | ||||||||
Because we are in a net loss position, diluted loss per share excludes the effects of potential dilutive securities. 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 4,122,123 and 5,596,655 shares for the three months ended March 31, 2015 and 2014, respectively, related to outstanding stock options, restricted stock awards and warrants (as determined using the treasury stock method at the estimated average market value). | ||||||||
Use of Estimates | ||||||||
The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires us to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On a regular basis, management evaluates these estimates and assumptions. Actual results could differ from those estimates. | ||||||||
Fair Value of Financial Instruments | ||||||||
Cash Equivalents and Marketable Securities | ||||||||
We consider all highly liquid investments 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 marketable securities. We place our cash and cash equivalents in money market funds and cash operating accounts. Our marketable securities include U.S. government-sponsored enterprise securities, commercial paper and corporate notes with original maturities ranging from four to 20 months. | ||||||||
We classify our marketable 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. 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. Dividend and interest income are recognized when earned and included in interest and other income in our condensed statements of operations. We recognize a charge when the declines in the fair values below the amortized cost basis of our available-for-sale securities are judged to be other-than-temporary. We consider various factors in determining whether to recognize an other-than-temporary charge, including whether we intend to sell the security or whether it is more likely than not that we would be required to sell the security before recovery of the amortized cost basis. Declines in market value associated with credit losses judged as other-than-temporary result in a charge to interest and other income. Other-than-temporary charges not related to credit losses are included in accumulated other comprehensive income (loss) in stockholders’ equity. We have not recorded any other-than-temporary impairment charges on our available-for-sale securities for the three months ended March 31, 2015 and 2014. See Note 2 on Fair Value Measurements. | ||||||||
Fair Value of Derivatives | ||||||||
For non-employee options classified as liabilities, the fair value of these instruments is recorded on the condensed balance sheet at inception and adjusted to fair value at each financial reporting date. The change in fair value of the non-employee options is recorded in the condensed statements of operations as unrealized gain (loss) on derivatives. Fair value of non-employee options is estimated using the Black Scholes option-pricing model. The non-employee options continue to be reported as a liability until such time as the instruments are exercised or expire or are otherwise modified to remove the provisions which require this treatment, at which time these instruments are marked to fair value and reclassified from liabilities to stockholders’ equity. As of March 31, 2015, all non-employee options classified as liabilities expired unexercised. For non-employee options classified as permanent equity, the fair value of the non-employee options is recorded in stockholders’ equity as of their respective vesting dates and no further adjustments are made. See Note 2 on Fair Value Measurements. | ||||||||
Revenue Recognition | ||||||||
In general, we recognize revenue for each unit of accounting when all of the following criteria have been met: (a) persuasive evidence of an arrangement exists, (b) delivery has occurred or services have been rendered, (c) the seller’s price to the buyer is fixed or determinable, and (d) collectability is reasonably assured. Amounts received prior to satisfying these revenue recognition criteria are recorded as deferred revenue. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as current deferred revenue. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as noncurrent deferred revenue. | ||||||||
License and/or Collaboration Agreements | ||||||||
In addition to the exclusive collaboration and license agreement, or Collaboration Agreement, that we entered into with Janssen Biotech, Inc., or Janssen, in November 2014 (which is more fully described in Note 3 on Collaboration and License Agreement), we have entered into several license or collaboration agreements with various oncology, diagnostics, research tools and biologics production companies. Economic terms in these agreements may include non-refundable license payments in cash or equity securities, option payments in cash or equity securities, cost reimbursements, cost-sharing arrangements, milestone payments, royalties on future sales of products, or any combination of these items. In applying the appropriate revenue recognition guidance related to these agreements, we first assess whether the arrangement contains multiple elements. In this evaluation, we consider: (1) the deliverables included in the arrangement and (2) whether the individual deliverables represent separate units of accounting or whether they must be accounted for as a combined unit of accounting. This evaluation involves subjective determinations and requires us to make judgments about the individual deliverables and whether such deliverables are separable from the other aspects of the contractual relationship. Deliverables are considered separate units of accounting provided that: (i) the delivered item(s) has value to the customer on a standalone basis, and (ii) if the arrangement includes a general right of return relative to the delivered item(s), delivery or performance of the undelivered item(s) is considered probable and substantially in our control. In assessing whether an item has standalone value, we consider factors such as the research, manufacturing and commercialization capabilities of the collaboration partner and the availability of the associated expertise in the general marketplace. In addition, we consider whether the collaboration partner can use the other deliverable(s) for their intended purpose without the receipt of the remaining element(s), whether the value of the deliverable is dependent on the undelivered item(s) and whether there are other vendors that can provide the undelivered element(s). | ||||||||
Arrangement consideration that is fixed or determinable is allocated among the separate units of accounting using the relative selling price method. We then apply the applicable revenue recognition criteria noted above to each of the separate units of accounting in determining the appropriate period and pattern of recognition. We determine how to allocate arrangement consideration to identified units of accounting based on the selling price hierarchy provided under relevant accounting guidance. The estimated fair value of deliverables under the arrangement may be derived using a best estimate of selling price if vendor-specific-objective evidence and third-party evidence are not available. | ||||||||
Upfront non-refundable signing, license or non-exclusive option fees are recognized as revenue: (i) when rights to use the intellectual property, related to a license that has standalone value from the other deliverables to be provided under the agreement, have been delivered or (ii) over the term of the agreement if we have continuing performance obligations as the arrangement would be accounted for as a single unit of accounting. When payments are received in equity securities, we do not recognize any revenue unless such securities are determined to be realizable in cash. | ||||||||
At the inception of an arrangement that includes milestone payments, we assess whether each milestone is substantive and at risk to both parties on the basis of the contingent nature of the milestone. This evaluation includes an assessment of whether: (i) the consideration is commensurate with either the performance to achieve the milestone or the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the performance to achieve the milestone, (ii) the consideration relates solely to past performance and (iii) the consideration is reasonable relative to all of the deliverables and payment terms within the arrangement. We consider various factors such as the scientific, clinical, regulatory, commercial and other risks that must be overcome to achieve the respective milestone and the level of effort and investment required to achieve the respective milestone in making this assessment. There is considerable judgment involved in determining whether a milestone satisfies all of the criteria required to conclude that a milestone is substantive. Milestone payments for milestones that are considered substantive would be recognized as revenue in their entirety upon successful accomplishment of the milestone, assuming all other revenue recognition criteria are met. Milestone payments for milestones that are not considered substantive would be recognized as revenue over the remaining period of performance, assuming all other revenue recognition criteria are met. | ||||||||
Royalties are recognized as earned in accordance with contract terms when royalties from licensees can be reasonably estimated and collectability is reasonably assured. If royalties cannot be reasonably estimated or collectability of a royalty amount is not reasonably assured, royalties are recognized as revenue when the cash is received. Revenue from commercial milestone payments is accounted for as royalties and recorded as revenue upon achievement of the milestone, assuming all other revenue recognition criteria are met. | ||||||||
Cost-sharing expenses are recorded as earned or owed based on the performance requirements by both parties under the respective contracts. For arrangements in which we and our collaboration partner in the agreement are exposed to significant risks and rewards depending on the commercial success of the activity, we recognize payments between the parties on a net basis and record such amounts as a reduction or addition to research and development expense. For arrangements in which we have agreed to perform certain research and development services for our collaboration partner and are not exposed to significant risks and rewards depending on the commercial success of the activity, we recognize the respective cost reimbursements as revenue under the collaborative agreement as the related research and development services are rendered. | ||||||||
Restricted Cash | ||||||||
Restricted cash consists of funds maintained in a separate certificate of deposit account for credit card purchases. | ||||||||
Research and Development Expenses | ||||||||
Research and development expenses consist of expenses incurred in identifying, developing and testing product candidates resulting from our independent efforts as well as efforts associated with collaborations. These expenses include, but are not limited to, in-process research and development acquired in an asset acquisition and deemed to have no alternative future use, payroll and personnel expense, lab supplies, preclinical studies, clinical trials, including support for investigator-sponsored clinical trials, raw materials to manufacture clinical trial drugs, manufacturing costs for research and clinical trial materials, sponsored research at other labs, consulting, costs to maintain technology licenses, our proportionate share of research and development costs under cost-sharing arrangements with collaborators and research-related overhead. Research and development costs are expensed as incurred, including payments made under our license agreements. | ||||||||
Clinical Trial Costs | ||||||||
A significant component of our research and development expenses has historically been clinical trial costs. Substantial portions of our preclinical studies and all of our clinical trials have been performed by third-party contract research organizations, or CROs, and other vendors. We accrue expenses for preclinical studies performed by our vendors based on certain estimates over the term of the service period and adjust our estimates as required. We accrue expenses for our clinical trial activities performed by CROs based upon the estimated amount of work completed on each study. For our clinical trial expenses, the significant factors used in estimating accruals include the number of patients enrolled, the number of active clinical sites and the duration for which the patients have been enrolled in the study. Pass through costs from CROs include, but are not limited to, regulatory expenses, investigator fees, lab fees, travel costs and other miscellaneous costs, including shipping and printing fees. We accrue pass through costs based on estimates of the amount of work completed for the clinical trial. We monitor patient enrollment levels and related activities to the extent possible through internal reviews, review of contractual terms and correspondence with CROs. We base our estimates on the best information available at the time. However, additional information may become available to us which would allow us to make a more accurate estimate in future periods. In this event, we may be required to record adjustments to research and development expenses in future periods when the actual level of activity becomes more certain. | ||||||||
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. | ||||||||
Stock-Based Compensation | ||||||||
We recognize stock-based compensation expense on a straight-line basis over the requisite service period, which is generally the vesting period. The following table summarizes the stock-based compensation expense included in operating expenses on our condensed statements of operations related to stock options, restricted stock awards and employee stock purchases for the three months ended March 31, 2015 and 2014 which was allocated as follows: | ||||||||
Three Months Ended March 31, | ||||||||
(In thousands) | 2015 | 2014 | ||||||
Research and development | $ | 622 | $ | 589 | ||||
Restructuring charges | 90 | — | ||||||
General and administrative | 1,301 | 1,052 | ||||||
Stock-based compensation expense included in operating expenses | $ | 2,013 | $ | 1,641 | ||||
In connection with a restructuring we announced in March 2015, the post-termination exercise period for certain stock options previously granted to employees affected by the restructuring was extended from 90 days to one year from their respective termination dates, subject to each employee’s continuous service until his/her specified termination date. The incremental value associated with these stock option modifications is being recognized as non-cash stock-based compensation expense over each employee’s remaining service period with the Company and recorded as restructuring charges on our condensed statements of operations as reflected in the table above. See Note 4 on Restructuring for a further discussion of the March 2015 restructuring. | ||||||||
As stock-based compensation expense recognized in our condensed statements of operations for the three months ended March 31, 2015 and 2014 is based on awards ultimately expected to vest, it has been reduced for estimated forfeitures, but at a minimum, reflects the grant-date fair value of those awards that actually vested in the period. Forfeitures have been estimated at the time of grant based on historical data and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. | ||||||||
Stock Options | ||||||||
We grant options with service-based vesting under our equity plans to employees, non-employee directors and consultants. The vesting period for employee options is generally four years. The fair value of options granted during the three months ended March 31, 2015 and 2014 has been estimated at the date of grant using the Black Scholes option-pricing model with the following assumptions: | ||||||||
Three Months Ended March 31, | ||||||||
2015 | 2014 | |||||||
Dividend yield | 0% | 0% | ||||||
Expected volatility | 0.884 | 0.922 | ||||||
Risk-free interest rate range | 1.70% | 1.64% to 1.92% | ||||||
Expected term | 5.5 yrs | 5.5 yrs | ||||||
Employee Stock Purchase Plan | ||||||||
The fair value of employees’ purchase rights during the three months ended March 31, 2015 and 2014 has been estimated using the Black Scholes option-pricing model with the following assumptions: | ||||||||
Three Months Ended March 31, | ||||||||
2015 | 2014 | |||||||
Dividend yield | 0% | 0% | ||||||
Expected volatility range | 0.721 to 1.392 | 0.835 to 1.062 | ||||||
Risk-free interest rate range | 0.11% to 0.25% | 0.09% to 0.15% | ||||||
Expected term range | 6 – 12 mos | 6 – 12 mos | ||||||
Dividend yield is based on historical cash dividend payments. The expected volatility is based on historical volatilities of our stock since traded options on Geron stock do not correspond to option terms and the trading volume of options is limited. The risk-free interest rate is based on the U.S. Zero Coupon Treasury Strip Yields for the expected term in effect on the date of grant for an award. The expected term of options is derived from actual historical exercise and post-vesting cancellation data and represents the period of time that options granted are expected to be outstanding. The expected term of employees’ purchase rights is equal to the purchase period. | ||||||||
Restricted Stock Awards | ||||||||
We have granted restricted stock awards to employees and non-employee directors with service-based vesting schedules that generally vest annually over four years. The fair value for service-based restricted stock awards is determined using the fair value of our common stock on the date of grant. The fair value is amortized as stock-based compensation expense over the requisite service period of the award, which is generally the vesting period, on a straight-line basis and is reduced for estimated forfeitures, as applicable. | ||||||||
Non-Employee Stock-Based Awards | ||||||||
For our non-employee stock-based awards, the measurement date on which the fair value of the stock-based award is calculated is equal to the earlier of: (i) the date at which a commitment for performance by the counterparty to earn the equity instrument is reached or (ii) the date at which the counterparty’s performance is complete. We recognize stock-based compensation expense for the fair value of the vested portion of non-employee awards in our condensed statements of operations. | ||||||||
Recent Accounting Pronouncements | ||||||||
In January 2015, the Financial Accounting Standards Board, or FASB, issued Accounting Standard Update No. 2015-01, Income Statement - Extraordinary and Unusual Items (Subtopic 225-20): Simplifying Income Statement Presentation by Eliminating the Concept of Extraordinary Items, or ASU 2015-01. ASU 2015-01 eliminates the concept of an extraordinary item from GAAP. As a result, an entity will no longer be required to segregate extraordinary items from the results of ordinary operations to separately present an extraordinary item on its income statement, net of tax, after income from continuing operations or to disclose income taxes and earnings-per-share data applicable to an extraordinary item. However, ASU 2015-01 will still retain the presentation and disclosure guidance for items that are unusual in nature and occur infrequently. ASU 2015-01 becomes effective for annual periods, and interim periods within those annual periods, beginning on or after December 15, 2015. Early adoption is permitted. The adoption of ASU 2015-01 is not expected to have a material impact on our financial statements. | ||||||||
FAIR_VALUE_MEASUREMENTS
FAIR VALUE MEASUREMENTS | 3 Months Ended | ||||||||||||||||||||||
Mar. 31, 2015 | |||||||||||||||||||||||
FAIR VALUE MEASUREMENTS | |||||||||||||||||||||||
FAIR VALUE MEASUREMENTS | |||||||||||||||||||||||
2. FAIR VALUE MEASUREMENTS | |||||||||||||||||||||||
We categorize financial instruments recorded at fair value on our condensed balance sheets based upon the level of judgment associated with inputs used to measure their fair value. The categories are as follows: | |||||||||||||||||||||||
Level 1 | — | Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date. An active market for an asset or liability is a market in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis. | |||||||||||||||||||||
Level 2 | — | Inputs (other than quoted market prices included in Level 1) are either directly or indirectly observable for the asset or liability through correlation with market data at the measurement date and for the duration of the instrument’s anticipated life. | |||||||||||||||||||||
Level 3 | — | Inputs reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model. | |||||||||||||||||||||
A financial instrument’s categorization within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. Below is a description of the valuation methodologies used for financial instruments measured at fair value on our condensed balance sheets, including the category for such financial instruments. | |||||||||||||||||||||||
Cash Equivalents and Marketable Securities | |||||||||||||||||||||||
Certificates of deposit and money market funds are categorized as Level 1 within the fair value hierarchy as their fair values are based on quoted prices available in active markets. U.S. government-sponsored enterprise securities, commercial paper and corporate notes are categorized as Level 2 within the fair value hierarchy as their fair values are estimated by using pricing models, quoted prices of securities with similar characteristics or discounted cash flows. | |||||||||||||||||||||||
Cash equivalents, restricted cash and marketable securities by security type at March 31, 2015 were as follows: | |||||||||||||||||||||||
Gross | Gross | ||||||||||||||||||||||
Amortized | Unrealized | Unrealized | Estimated | ||||||||||||||||||||
(In thousands) | Cost | Gains | Losses | Fair Value | |||||||||||||||||||
Included in cash and cash equivalents: | |||||||||||||||||||||||
Money market funds | $ | 7,231 | $ | — | $ | — | $ | 7,231 | |||||||||||||||
Restricted cash: | |||||||||||||||||||||||
Certificate of deposit | $ | 266 | $ | — | $ | — | $ | 266 | |||||||||||||||
Marketable securities: | |||||||||||||||||||||||
Government-sponsored enterprise securities (due in less than 1 year) | $ | 401 | $ | — | $ | (1 | ) | $ | 400 | ||||||||||||||
Government-sponsored enterprise securities (due in 1 to 2 years) | 5,806 | — | (1 | ) | 5,805 | ||||||||||||||||||
Commercial paper (due in less than 1 year) | 28,963 | 33 | — | 28,996 | |||||||||||||||||||
Corporate notes (due in less than 1 year) | 106,305 | 10 | (56 | ) | 106,259 | ||||||||||||||||||
Corporate notes (due in 1 to 2 years) | 11,936 | 2 | (4 | ) | 11,934 | ||||||||||||||||||
$ | 153,411 | $ | 45 | $ | (62 | ) | $ | 153,394 | |||||||||||||||
Cash equivalents, restricted cash and marketable securities by security type at December 31, 2014 were as follows: | |||||||||||||||||||||||
Gross | Gross | ||||||||||||||||||||||
Amortized | Unrealized | Unrealized | Estimated | ||||||||||||||||||||
(In thousands) | Cost | Gains | Losses | Fair Value | |||||||||||||||||||
Included in cash and cash equivalents: | |||||||||||||||||||||||
Money market funds | $ | 40,342 | $ | — | $ | — | $ | 40,342 | |||||||||||||||
Restricted cash: | |||||||||||||||||||||||
Certificate of deposit | $ | 266 | $ | — | $ | — | $ | 266 | |||||||||||||||
Marketable securities: | |||||||||||||||||||||||
Government-sponsored enterprise securities (due in less than 1 year) | $ | 401 | $ | — | $ | (1 | ) | $ | 400 | ||||||||||||||
Government-sponsored enterprise securities (due in 1 to 2 years) | 6,556 | — | (7 | ) | 6,549 | ||||||||||||||||||
Commercial paper (due in less than 1 year) | 10,985 | 14 | — | 10,999 | |||||||||||||||||||
Corporate notes (due in less than 1 year) | 97,307 | 2 | (63 | ) | 97,246 | ||||||||||||||||||
Corporate notes (due in l to 2 years) | 12,412 | — | (29 | ) | 12,383 | ||||||||||||||||||
$ | 127,661 | $ | 16 | $ | (100 | ) | $ | 127,577 | |||||||||||||||
Marketable securities with unrealized losses at March 31, 2015 and December 31, 2014 were as follows: | |||||||||||||||||||||||
Less Than 12 Months | 12 Months or Greater | Total | |||||||||||||||||||||
Gross | Gross | Gross | |||||||||||||||||||||
Estimated | Unrealized | Estimated | Unrealized | Estimated | Unrealized | ||||||||||||||||||
(In thousands) | Fair Value | Losses | Fair Value | Losses | Fair Value | Losses | |||||||||||||||||
As of March 31, 2015: | |||||||||||||||||||||||
Government-sponsored enterprise securities (due in less than 1 year) | $ | 400 | $ | (1 | ) | $ | — | $ | — | $ | 400 | $ | (1 | ) | |||||||||
Government-sponsored enterprise securities (due in 1 to 2 years) | 5,805 | (1 | ) | — | — | 5,805 | (1 | ) | |||||||||||||||
Corporate notes (due in less than 1 year) | 80,083 | (56 | ) | — | — | 80,083 | (56 | ) | |||||||||||||||
Corporate notes (due in 1 to 2 years) | 6,012 | (4 | ) | — | — | 6,012 | (4 | ) | |||||||||||||||
$ | 92,300 | $ | (62 | ) | $ | — | $ | — | $ | 92,300 | $ | (62 | ) | ||||||||||
As of December 31, 2014: | |||||||||||||||||||||||
Government-sponsored enterprise securities (due in less than 1 year) | $ | 400 | $ | (1 | ) | $ | — | $ | — | $ | 400 | $ | (1 | ) | |||||||||
Government-sponsored enterprise securities (due in 1 to 2 years) | 5,549 | (7 | ) | — | — | 5,549 | (7 | ) | |||||||||||||||
Corporate notes (due in less than 1 year) | 92,989 | (63 | ) | — | — | 92,989 | (63 | ) | |||||||||||||||
Corporate notes (due in 1 to 2 years) | 12,383 | (29 | ) | — | — | 12,383 | (29 | ) | |||||||||||||||
$ | 111,321 | $ | (100 | ) | $ | — | $ | — | $ | 111,321 | $ | (100 | ) | ||||||||||
The gross unrealized losses related to government-sponsored enterprise securities and corporate notes as of March 31, 2015 and December 31, 2014 were due to changes in interest rates. We determined that the gross unrealized losses on our marketable securities as of March 31, 2015 and December 31, 2014 were temporary in nature. We review our investments quarterly to identify and evaluate whether any investments have indications of possible impairment. Factors considered in determining whether a loss is temporary include the length of time and extent to which the fair value has been less than the amortized cost basis and whether we intend to sell the security or whether it is more likely than not that we would be required to sell the security before recovery of the amortized cost basis. We currently do not intend to sell these securities before recovery of their amortized cost basis. | |||||||||||||||||||||||
Derivatives | |||||||||||||||||||||||
Non-employee options are normally traded less actively, have trade activity that is one way, and/or are traded in less-developed markets and are therefore valued based upon models with significant unobservable market parameters, resulting in Level 3 categorization. | |||||||||||||||||||||||
Options held by non-employees whose performance obligations are complete are classified as derivative liabilities on our condensed balance sheets. These options are marked to fair value at each reporting period, and upon the exercise of these options, the instruments are marked to fair value and reclassified from derivative liabilities to stockholders’ equity. As of December 31, 2014, non-employee options to purchase 284,600 shares of our common stock at an exercise price of $6.39 per share with a fair value of $16,000 were outstanding and classified as derivative liabilities. On March 31, 2015, these non-employee options expired unexercised. Accordingly, we have not reclassified any derivative liabilities to stockholders’ equity for any non-employee option exercises during the three months ended March 31, 2015. | |||||||||||||||||||||||
Fair Value on a Recurring Basis | |||||||||||||||||||||||
The following table presents information about our financial instruments that are measured at fair value on a recurring basis as of March 31, 2015 and indicates the fair value category assigned. | |||||||||||||||||||||||
Fair Value Measurements at Reporting Date Using | |||||||||||||||||||||||
Quoted Prices in | Significant | ||||||||||||||||||||||
Active Markets | Other | Significant | |||||||||||||||||||||
for Identical | Observable | Unobservable | |||||||||||||||||||||
Assets | Inputs | Inputs | |||||||||||||||||||||
(In thousands) | Level 1 | Level 2 | Level 3 | Total | |||||||||||||||||||
Assets: | |||||||||||||||||||||||
Money market funds(1) | $ | 7,231 | $ | — | $ | — | $ | 7,231 | |||||||||||||||
Government-sponsored enterprise securities(2)(3) | — | 6,205 | — | 6,205 | |||||||||||||||||||
Commercial paper(2) | — | 28,996 | — | 28,996 | |||||||||||||||||||
Corporate notes(2)(3) | — | 118,193 | — | 118,193 | |||||||||||||||||||
Total | $ | 7,231 | $ | 153,394 | $ | — | $ | 160,625 | |||||||||||||||
The following table presents information about our financial instruments that are measured at fair value on a recurring basis as of December 31, 2014 and indicates the fair value category assigned. | |||||||||||||||||||||||
Fair Value Measurements at Reporting Date Using | |||||||||||||||||||||||
Quoted Prices in | Significant | ||||||||||||||||||||||
Active Markets | Other | Significant | |||||||||||||||||||||
for Identical | Observable | Unobservable | |||||||||||||||||||||
Assets / Liabilities | Inputs | Inputs | |||||||||||||||||||||
(In thousands) | Level 1 | Level 2 | Level 3 | Total | |||||||||||||||||||
Assets: | |||||||||||||||||||||||
Money market funds(1) | $ | 40,342 | $ | — | $ | — | $ | 40,342 | |||||||||||||||
Government-sponsored enterprise securities(2)(3) | — | 6,949 | — | 6,949 | |||||||||||||||||||
Commercial paper(2) | — | 10,999 | — | 10,999 | |||||||||||||||||||
Corporate notes(2)(3) | — | 109,629 | — | 109,629 | |||||||||||||||||||
Total | $ | 40,342 | $ | 127,577 | $ | — | $ | 167,919 | |||||||||||||||
Liabilities: | |||||||||||||||||||||||
Derivatives(4) | $ | — | $ | — | $ | 16 | $ | 16 | |||||||||||||||
-1 | Included in cash and cash equivalents on our condensed balance sheets. | ||||||||||||||||||||||
-2 | Included in current portion of marketable securities on our condensed balance sheets. | ||||||||||||||||||||||
-3 | Included in noncurrent portion of marketable securities on our condensed balance sheets. | ||||||||||||||||||||||
-4 | Included in fair value of derivatives on our condensed balance sheets. | ||||||||||||||||||||||
Changes in Level 3 Recurring Fair Value Measurements | |||||||||||||||||||||||
The table below includes a rollforward of the balance sheet amounts for the three months ended March 31, 2015, including the change in fair value, for financial instruments in the Level 3 category. When a determination is made to classify a financial instrument within Level 3, the determination is based upon the significance of the unobservable parameters to the overall fair value measurement. However, Level 3 financial instruments typically include, in addition to the unobservable components, observable components (that is, components that are actively quoted and can be validated to external sources). Accordingly, the gain in the table below includes changes in fair value due in part to observable factors that are part of the methodology. As of March 31, 2015, all non-employee options classified as derivative liabilities within the Level 3 fair value category expired unexercised. | |||||||||||||||||||||||
Fair Value Measurements Using Significant Unobservable Inputs (Level 3) | |||||||||||||||||||||||
Three Months Ended March 31, 2015 | |||||||||||||||||||||||
Change in | |||||||||||||||||||||||
Unrealized Gain | |||||||||||||||||||||||
Total | Related to | ||||||||||||||||||||||
Unrealized | Transfers | Financial | |||||||||||||||||||||
Fair Value at | Gain | Purchases | In and/or | Fair Value at | Instruments | ||||||||||||||||||
December 31, | Included in | and | Sales and | Out of | March 31, | Held at | |||||||||||||||||
(In thousands) | 2014 | Earnings(1) | Issuances | Settlements | Level 3 | 2015 | March 31, 2015 | ||||||||||||||||
Derivative liabilities | $ | 16 | $ | (16 | ) | $ | — | $ | — | $ | — | $ | — | $ | — | ||||||||
-1 | Reported as unrealized gain on derivatives in our condensed statements of operations. | ||||||||||||||||||||||
COLLABORATION_AND_LICENSE_AGRE
COLLABORATION AND LICENSE AGREEMENT | 3 Months Ended |
Mar. 31, 2015 | |
COLLABORATION AND LICENSE AGREEMENT | |
COLLABORATION AND LICENSE AGREEMENT | |
3. COLLABORATION AND LICENSE AGREEMENT | |
In November 2014, we and Janssen entered into the Collaboration Agreement to develop and commercialize imetelstat worldwide for oncology, including hematologic myeloid malignancies, and all other human therapeutic uses. Under the Collaboration Agreement, we granted to Janssen exclusive worldwide rights to develop and commercialize imetelstat for all indications, and Janssen is responsible for the development, manufacturing and commercialization of, and seeking regulatory approval for, imetelstat worldwide. Upon the early termination of the waiting periods under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, the Collaboration Agreement became effective on December 15, 2014. Upon the effectiveness of the Collaboration Agreement, we received $35,000,000 from Janssen as an upfront payment, which has been classified as deferred revenue on our condensed balance sheets as of March 31, 2015 and December 31, 2014. | |
Under the Collaboration Agreement, development of imetelstat will initially proceed under a mutually agreed joint clinical development plan, or CDP, which includes two agreed upon Phase 2 studies to be pursued initially and conducted by Janssen, one in myelofibrosis, or the Initial Phase 2 MF Study, and one in myelodysplastic syndrome, or the Initial Phase 2 MDS Study. Development costs for the Initial Phase 2 MF Study and the Initial Phase 2 MDS Study will be shared between us and Janssen on a 50/50 basis. Additionally, under the terms of the Collaboration Agreement, we remain responsible for prosecuting, at Janssen’s direction, the patents licensed to Janssen at the time we entered into the Collaboration Agreement, with costs shared between us and Janssen on a 50/50 basis. The cost sharing arrangement with Janssen began in 2015. As of March 31, 2015, accrued collaboration charges of $626,000 on our condensed balance sheet represent the net amount owed to Janssen for our proportionate share of research and development costs incurred under the imetelstat collaboration during the three months ended March 31, 2015. | |
Following the protocol-specified primary analysis of the Initial Phase 2 MF Study or after a certain time period after the initiation of the first Phase 3 MF study, Janssen must notify us whether it elects to maintain its license rights and continue to advance the development of imetelstat in any indication. In the event that the Initial Phase 2 MF Study has been terminated early or suspended, Janssen must instead notify us of its election by the date that is the later of 24 months from the initiation of the planned Initial Phase 2 MDS Study or 24 months from the termination of the planned Initial Phase 2 MF Study or commencement of the suspension period, as applicable. | |
In the event that Janssen elects to continue to maintain its license rights and advance the development of imetelstat in any indication within the applicable timeframe set forth in the Collaboration Agreement (such election, the Continuation Election), we then would have an option, or the U.S. Opt-In Rights, to share further U.S. development and promotion costs in exchange for higher tiered royalty rates and higher future development and regulatory milestone payments if imetelstat is successfully developed and approved. If we exercise the U.S. Opt-In Rights, then we and Janssen would share U.S. development and promotion costs on a 20/80 basis (Geron 20%, Janssen 80%), we would receive a $65,000,000 milestone payment, or the Continuation Fee, at the time of the Continuation Election, and would be eligible to receive additional potential payments of up to $470,000,000 in development and regulatory milestones, up to $350,000,000 in sales milestones, and tiered royalties ranging from a mid-teens up to low twenties percentage rate on worldwide net sales of imetelstat in any countries where regulatory exclusivity exists or there are valid claims under the patent rights exclusively licensed to Janssen. In addition, if we exercise the U.S. Opt-In Rights, we then would also have a separate option, or the Co-Promotion Option, to provide 20% of the U.S. selling effort with sales force personnel, in lieu of funding 20% of U.S. promotion costs, upon regulatory approval and commercial launch of imetelstat in the United States. Such co-promotion would be conducted under a Janssen prepared promotion plan, and in accordance with a co-promotion agreement to be agreed by the parties at the time of our exercise of the Co-Promotion Option. We would be responsible for all costs associated with establishing and maintaining a sales force in any conduct of such co-promotion. All product sales would be booked by Janssen. If we do not exercise the U.S. Opt-In Rights, then all further development and promotion costs beyond the Initial Phase 2 MF Study or Initial Phase 2 MDS Study would be borne by Janssen, we would receive the $65,000,000 Continuation Fee at the time of the Continuation Election plus a $70,000,000 payment, or the Full U.S. Rights Fee, for Janssen’s retention of full U.S. rights to imetelstat, and would be eligible to receive additional potential payments of up to $415,000,000 in development and regulatory milestones, up to $350,000,000 in sales milestones, and tiered royalties ranging from a double-digit up to mid-teens percentage rate on worldwide net sales of imetelstat in any countries where regulatory exclusivity exists or there are valid claims under the patent rights exclusively licensed to Janssen. | |
Under the terms of the Collaboration Agreement, we and Janssen created a joint governance structure, including joint development and steering committees and working groups, to oversee and manage worldwide regulatory, development and manufacturing work under the joint CDP and promotional activities (assuming we exercises the U.S. Opt-In Rights) for imetelstat, with Janssen responsible for the operational implementation of those activities. In addition, either of the parties may propose to the joint development committee imetelstat development for any new indications not then provided for in the joint CDP and if the parties agree such development should be conducted outside of the joint CDP, each of Geron and Janssen would be entitled to independently undertake such development at its own cost, subject to the other party’s obligation to provide reimbursement for its specified portion of the costs plus a premium for such independent development following marketing approval of imetelstat in such newly proposed indication as a result of such independent development. In the event that we do not exercise the U.S. Opt-In Rights following Janssen’s Continuation Election, the joint governance structure under the Collaboration Agreement would be dissolved, a joint oversight committee would monitor the progress of the collaboration, and we would have no further rights to conduct any independent imetelstat development. | |
After a Continuation Election by Janssen, the Collaboration Agreement would remain in effect until the expiration of the last-to-expire patent or the royalty obligations on sales of imetelstat cease, unless terminated earlier. If Janssen does not effect a Continuation Election, then the Collaboration Agreement would terminate and all rights to the imetelstat program would revert to us. Janssen may terminate the Collaboration Agreement at any time for convenience and due to a safety-related concern. If a notice of termination from Janssen occurs, we would be entitled to certain continued operational support and cost-sharing under various circumstances and all rights to the imetelstat program would revert to us. | |
The terms of the Collaboration Agreement contain multiple deliverables, which include at inception: (i) exclusive worldwide rights to develop and commercialize imetelstat for all indications, (ii) transfer of know-how and intellectual property, including our obligation to procure supply for manufacturing imetelstat for up to nine months after the effective date of the Collaboration Agreement, (iii) participation on the joint steering committees and working groups and (iv) potential participation in selling imetelstat in the United States, if approved for commercial sale. We concluded the license for exclusive worldwide rights to develop and commercialize imetelstat has standalone value to Janssen based on the technical and financial resources of Janssen, including Janssen’s drug development experience, sizeable employee base with specific experience in hematologic malignancies, and sufficient capital to independently develop imetelstat on a global basis. Since Janssen has final decision-making authority in the event a unanimous decision cannot be reached by the joint steering committees, we determined our participation on the joint steering committees does not represent a non-contingent deliverable under the Collaboration Agreement. In addition, we determined our potential participation in selling imetelstat in the United States does not represent a non-contingent deliverable because such participation is uncertain and dependent on the drug being approved for commercial sale, which is not within our control. Accordingly, we have determined delivery of the license rights granted by us to Janssen, together with our performance of the technology transfer-related activities, represents the sole non-contingent deliverable under the Collaboration Agreement. Therefore, we have accounted for our delivery of the license rights and our performance of the technology transfer-related activities as a single unit of accounting. We currently expect completion of the technology transfer-related activities to occur by September 30, 2015 at which point we expect to fully recognize the $35,000,000 upfront payment from Janssen as license fee revenue on our condensed statement of operations. As a result, we have not recognized any revenue related to the Collaboration Agreement for the three months ended March 31, 2015. | |
We have determined that each of the additional potential milestone payments to us under the Collaboration Agreement, including: (i) the Continuation Fee at the time of the Continuation Election, (ii) the Full U.S. Rights Fee if we do not exercise the U.S. Opt-In Rights and (iii) payments based on the achievement of certain development, regulatory or commercial milestones, represent substantive milestones. Consequently, we will recognize revenue for these payments in their entirety upon successful accomplishment of the respective milestone. Royalties on future product sales of imetelstat, if successfully commercialized under the Collaboration Agreement, will be recognized as revenue when earned. | |
RESTRUCTURING
RESTRUCTURING | 3 Months Ended | ||||
Mar. 31, 2015 | |||||
RESTRUCTURING | |||||
RESTRUCTURING | |||||
4. RESTRUCTURING | |||||
In light of projected reduced operational demands as a result of the Collaboration Agreement with Janssen, on March 3, 2015, we announced an organizational resizing to reduce our workforce from 39 to 21 positions. We expect the majority of the reduction in our workforce to be completed by the end of the second quarter of 2015. In connection with this restructuring, we expect to record aggregate restructuring charges of approximately $1,748,000 related to one-time termination benefits which will be recognized on a pro-rata basis commencing from the date of announcement over the specified remaining service periods for the employees affected by the restructuring. For the three months ended March 31, 2015, we recognized $406,000 in restructuring charges for the pro-rata portion of the one-time termination benefits, which included $90,000 of non-cash stock-based compensation expense relating to the extension of the post-termination exercise period for certain stock options previously granted to employees affected by the restructuring from 90 days to one year from their respective termination dates. The majority of the remaining projected restructuring charges is expected to be recorded during the second quarter of 2015. We may incur other charges associated with this restructuring. Such charges, if any, will be recorded as they are determined. We expect this restructuring to be completed in 2015 and result in aggregate cash expenditures of approximately $1,377,000, the majority of which is expected to be paid in 2015. As of March 31, 2015, we have not made any payments in connection with this restructuring. | |||||
The components relating to the restructuring, including the outstanding restructuring liability which is included in accrued restructuring charges on our condensed balance sheet as of March 31, 2015, are summarized in the following table: | |||||
(In thousands) | Employee Severance | ||||
and Other Benefits | |||||
Beginning accrual balance as of December 31, 2014 | $ | — | |||
Restructuring charges | 406 | ||||
Adjustments or non-cash credits, including non-cash stock-based compensation expense | (90 | ) | |||
Ending accrual balance as of March 31, 2015 | $ | 316 | |||
COMMITMENTS_AND_CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 3 Months Ended |
Mar. 31, 2015 | |
COMMITMENTS AND CONTINGENCIES. | |
COMMITMENTS AND CONTINGENCIES | |
5. COMMITMENTS AND CONTINGENCIES | |
Purported Securities and Derivative Lawsuits | |
On March 14, 2014, a purported securities class action lawsuit was commenced in the United States District Court for the Northern District of California, or the California District Court, naming as defendants us and certain of our officers. The lawsuit alleges violations of the Securities Exchange Act of 1934 in connection with allegedly false and misleading statements made by us related to our Phase 2 trial of imetelstat in patients with essential thrombocythemia, or ET, or polycythemia vera, or PV. The plaintiff alleges, among other things, that we failed to disclose facts related to the occurrence of persistent low-grade liver function test, or LFT, abnormalities observed in our Phase 2 trial of imetelstat in ET or PV patients and the potential risk of chronic liver injury following long-term exposure to imetelstat. The plaintiff seeks damages and an award of reasonable costs and expenses, including attorneys’ fees. On March 28, 2014, a second purported securities class action lawsuit was commenced in the California District Court, and on June 6, 2014, a third purported securities lawsuit, not styled as a class action, was commenced in the United States District Court for the Southern District of Mississippi, or the Mississippi District Court, naming as defendants us and certain of our officers. These lawsuits, which are based on the same factual background as the purported securities class action lawsuit that commenced on March 14, 2014, also allege violations of the Securities Exchange Act of 1934 and seek damages and an award of reasonable costs and expenses, including attorneys’ fees. On June 30, 2014, the California District Court consolidated both of the purported class actions filed in the California District Court and appointed a lead plaintiff and lead counsel to represent the purported class. On July 21, 2014, the California District Court ordered the lead plaintiff to file its consolidated amended complaint, which was filed on September 19, 2014. On August 11, 2014, we filed a motion to transfer the purported securities lawsuit filed in the Mississippi District Court to the California District Court. On November 4, 2014, the Mississippi District Court granted our motion and transferred the case to the California District Court, which was thereafter consolidated with the class actions. On November 18, 2014, we filed a motion with the California District Court to dismiss the consolidated amended complaint. The plaintiff’s opposition to our motion to dismiss was filed on January 20, 2015, and we filed our reply in support of our motion to dismiss on February 25, 2015. A hearing on the motion to dismiss the consolidated amended complaint occurred on April 10, 2015. At the hearing, the California District Court granted our motion to dismiss with respect to some of the allegedly false and misleading statements made by us and denied our motion to dismiss with respect to other allegedly false and misleading statements made by us. | |
On April 21, 2014, a stockholder purporting to act on our behalf filed a derivative lawsuit in the Superior Court of California for the County of San Mateo against certain of our officers and directors. The lawsuit alleges breaches of fiduciary duties by the defendants and other violations of law. In general, the lawsuit alleges that the defendants caused or allowed the dissemination of allegedly false and misleading statements related to our Phase 2 trial of imetelstat in patients with ET or PV. The plaintiff is seeking unspecified monetary damages and other relief, including reforms and improvements to our corporate governance and internal procedures. It is possible that additional derivative lawsuits will be filed with respect to these same or other matters and also naming our officers and directors as defendants. Proceedings in the derivative lawsuit are pending further developments in the purported securities class action lawsuit. We intend to vigorously defend against the claims alleged and to seek dismissal of the lawsuit. | |
For a further discussion of these ongoing lawsuits, refer to the section entitled “Legal Proceedings” in Part II, Item 1 of this Form 10-Q. These lawsuits and any other related lawsuits are subject to inherent uncertainties, and the actual defense and disposition costs will depend upon many unknown factors. The outcome of these lawsuits is necessarily uncertain. We could be forced to expend significant resources in the defense against these and any other related lawsuits and we may not prevail. We currently are not able to estimate the possible cost to us from these lawsuits, as they are currently at an early stage, and we cannot be certain how long it may take to resolve these lawsuits or the possible amount of any damages that we may be required to pay. Such amounts could be material to our financial statements even if we prevail in the defense against these lawsuits. We have not established any reserves for any potential liability relating to these lawsuits. It is possible that we could, in the future, incur judgments or enter into settlements of claims for monetary damages. | |
STOCKHOLDERS_EQUITY
STOCKHOLDERS' EQUITY | 3 Months Ended |
Mar. 31, 2015 | |
STOCKHOLDERS' EQUITY | |
STOCKHOLDERS' EQUITY | |
6. STOCKHOLDERS’ EQUITY | |
On March 31, 2015, warrants to purchase 235,000 shares of our common stock were exercised at an exercise price of $3.75 per share. We received cash proceeds of approximately $881,000 from the exercise of these warrants. | |
SEGMENT_INFORMATION
SEGMENT INFORMATION | 3 Months Ended |
Mar. 31, 2015 | |
SEGMENT INFORMATION | |
SEGMENT INFORMATION | |
7. SEGMENT INFORMATION | |
Our executive management team represents our chief decision maker. We view our operations as one segment, the development of therapeutic products for oncology. As a result, the financial information disclosed herein materially represents all of the financial information related to our principal operating segment. | |
CONDENSED_STATEMENTS_OF_CASH_F1
CONDENSED STATEMENTS OF CASH FLOWS DATA | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
CONDENSED STATEMENTS OF CASH FLOWS DATA | ||||||||
CONDENSED STATEMENTS OF CASH FLOWS DATA | ||||||||
8. CONDENSED STATEMENTS OF CASH FLOWS DATA | ||||||||
Supplemental schedule of non-cash operating and investing activities: | ||||||||
Three Months Ended March 31, | ||||||||
(In thousands) | 2015 | 2014 | ||||||
Supplemental Operating Activities: | ||||||||
Issuance of common stock for 401(k) matching contributions | $ | — | $ | 313 | ||||
Reclassification of deposits to other current assets | — | 4 | ||||||
Supplemental Investing Activities: | ||||||||
Net unrealized gain (loss) on marketable securities | 67 | (76 | ) | |||||
SUMMARY_OF_SIGNIFICANT_ACCOUNT1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||||||||
Basis of Presentation | ||||||||
Basis of Presentation | ||||||||
The terms “Geron”, the “Company”, “we” and “us” as used in this report refer to Geron Corporation. The accompanying unaudited condensed financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. generally accepted accounting principles, or GAAP, for complete financial statements. In the opinion of management of Geron, all adjustments (consisting only of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the three month period ending March 31, 2015 are not necessarily indicative of the results that may be expected for the year ending December 31, 2015 or any other period. These financial statements and notes should be read in conjunction with the financial statements for each of the three years ended December 31, 2014, included in the Company’s Annual Report on Form 10-K. The accompanying condensed balance sheet as of December 31, 2014 has been derived from audited financial statements at that date. | ||||||||
Net Loss Per Share | ||||||||
Net Loss Per Share | ||||||||
Basic earnings (loss) per share is calculated based on the weighted average number of shares of common stock outstanding during the period. Diluted earnings (loss) per share is calculated based on the weighted average number of shares of common stock and potential dilutive securities outstanding during the period. Potential dilutive securities primarily consist of outstanding stock options, restricted stock awards and warrants to purchase common stock and are determined using the treasury stock method at an average market price during the period. | ||||||||
Because we are in a net loss position, diluted loss per share excludes the effects of potential dilutive securities. 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 4,122,123 and 5,596,655 shares for the three months ended March 31, 2015 and 2014, respectively, related to outstanding stock options, restricted stock awards and warrants (as determined using the treasury stock method at the estimated average market value). | ||||||||
Use of Estimates | ||||||||
Use of Estimates | ||||||||
The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires us to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On a regular basis, management evaluates these estimates and assumptions. Actual results could differ from those estimates. | ||||||||
Fair Value of Financial Instruments | ||||||||
Fair Value of Financial Instruments | ||||||||
Cash Equivalents and Marketable Securities | ||||||||
We consider all highly liquid investments 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 marketable securities. We place our cash and cash equivalents in money market funds and cash operating accounts. Our marketable securities include U.S. government-sponsored enterprise securities, commercial paper and corporate notes with original maturities ranging from four to 20 months. | ||||||||
We classify our marketable 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. 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. Dividend and interest income are recognized when earned and included in interest and other income in our condensed statements of operations. We recognize a charge when the declines in the fair values below the amortized cost basis of our available-for-sale securities are judged to be other-than-temporary. We consider various factors in determining whether to recognize an other-than-temporary charge, including whether we intend to sell the security or whether it is more likely than not that we would be required to sell the security before recovery of the amortized cost basis. Declines in market value associated with credit losses judged as other-than-temporary result in a charge to interest and other income. Other-than-temporary charges not related to credit losses are included in accumulated other comprehensive income (loss) in stockholders’ equity. We have not recorded any other-than-temporary impairment charges on our available-for-sale securities for the three months ended March 31, 2015 and 2014. See Note 2 on Fair Value Measurements. | ||||||||
Fair Value of Derivatives | ||||||||
For non-employee options classified as liabilities, the fair value of these instruments is recorded on the condensed balance sheet at inception and adjusted to fair value at each financial reporting date. The change in fair value of the non-employee options is recorded in the condensed statements of operations as unrealized gain (loss) on derivatives. Fair value of non-employee options is estimated using the Black Scholes option-pricing model. The non-employee options continue to be reported as a liability until such time as the instruments are exercised or expire or are otherwise modified to remove the provisions which require this treatment, at which time these instruments are marked to fair value and reclassified from liabilities to stockholders’ equity. As of March 31, 2015, all non-employee options classified as liabilities expired unexercised. For non-employee options classified as permanent equity, the fair value of the non-employee options is recorded in stockholders’ equity as of their respective vesting dates and no further adjustments are made. See Note 2 on Fair Value Measurements. | ||||||||
Revenue Recognition | ||||||||
Revenue Recognition | ||||||||
In general, we recognize revenue for each unit of accounting when all of the following criteria have been met: (a) persuasive evidence of an arrangement exists, (b) delivery has occurred or services have been rendered, (c) the seller’s price to the buyer is fixed or determinable, and (d) collectability is reasonably assured. Amounts received prior to satisfying these revenue recognition criteria are recorded as deferred revenue. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as current deferred revenue. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as noncurrent deferred revenue. | ||||||||
License and/or Collaboration Agreements | ||||||||
In addition to the exclusive collaboration and license agreement, or Collaboration Agreement, that we entered into with Janssen Biotech, Inc., or Janssen, in November 2014 (which is more fully described in Note 3 on Collaboration and License Agreement), we have entered into several license or collaboration agreements with various oncology, diagnostics, research tools and biologics production companies. Economic terms in these agreements may include non-refundable license payments in cash or equity securities, option payments in cash or equity securities, cost reimbursements, cost-sharing arrangements, milestone payments, royalties on future sales of products, or any combination of these items. In applying the appropriate revenue recognition guidance related to these agreements, we first assess whether the arrangement contains multiple elements. In this evaluation, we consider: (1) the deliverables included in the arrangement and (2) whether the individual deliverables represent separate units of accounting or whether they must be accounted for as a combined unit of accounting. This evaluation involves subjective determinations and requires us to make judgments about the individual deliverables and whether such deliverables are separable from the other aspects of the contractual relationship. Deliverables are considered separate units of accounting provided that: (i) the delivered item(s) has value to the customer on a standalone basis, and (ii) if the arrangement includes a general right of return relative to the delivered item(s), delivery or performance of the undelivered item(s) is considered probable and substantially in our control. In assessing whether an item has standalone value, we consider factors such as the research, manufacturing and commercialization capabilities of the collaboration partner and the availability of the associated expertise in the general marketplace. In addition, we consider whether the collaboration partner can use the other deliverable(s) for their intended purpose without the receipt of the remaining element(s), whether the value of the deliverable is dependent on the undelivered item(s) and whether there are other vendors that can provide the undelivered element(s). | ||||||||
Arrangement consideration that is fixed or determinable is allocated among the separate units of accounting using the relative selling price method. We then apply the applicable revenue recognition criteria noted above to each of the separate units of accounting in determining the appropriate period and pattern of recognition. We determine how to allocate arrangement consideration to identified units of accounting based on the selling price hierarchy provided under relevant accounting guidance. The estimated fair value of deliverables under the arrangement may be derived using a best estimate of selling price if vendor-specific-objective evidence and third-party evidence are not available. | ||||||||
Upfront non-refundable signing, license or non-exclusive option fees are recognized as revenue: (i) when rights to use the intellectual property, related to a license that has standalone value from the other deliverables to be provided under the agreement, have been delivered or (ii) over the term of the agreement if we have continuing performance obligations as the arrangement would be accounted for as a single unit of accounting. When payments are received in equity securities, we do not recognize any revenue unless such securities are determined to be realizable in cash. | ||||||||
At the inception of an arrangement that includes milestone payments, we assess whether each milestone is substantive and at risk to both parties on the basis of the contingent nature of the milestone. This evaluation includes an assessment of whether: (i) the consideration is commensurate with either the performance to achieve the milestone or the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the performance to achieve the milestone, (ii) the consideration relates solely to past performance and (iii) the consideration is reasonable relative to all of the deliverables and payment terms within the arrangement. We consider various factors such as the scientific, clinical, regulatory, commercial and other risks that must be overcome to achieve the respective milestone and the level of effort and investment required to achieve the respective milestone in making this assessment. There is considerable judgment involved in determining whether a milestone satisfies all of the criteria required to conclude that a milestone is substantive. Milestone payments for milestones that are considered substantive would be recognized as revenue in their entirety upon successful accomplishment of the milestone, assuming all other revenue recognition criteria are met. Milestone payments for milestones that are not considered substantive would be recognized as revenue over the remaining period of performance, assuming all other revenue recognition criteria are met. | ||||||||
Royalties are recognized as earned in accordance with contract terms when royalties from licensees can be reasonably estimated and collectability is reasonably assured. If royalties cannot be reasonably estimated or collectability of a royalty amount is not reasonably assured, royalties are recognized as revenue when the cash is received. Revenue from commercial milestone payments is accounted for as royalties and recorded as revenue upon achievement of the milestone, assuming all other revenue recognition criteria are met. | ||||||||
Cost-sharing expenses are recorded as earned or owed based on the performance requirements by both parties under the respective contracts. For arrangements in which we and our collaboration partner in the agreement are exposed to significant risks and rewards depending on the commercial success of the activity, we recognize payments between the parties on a net basis and record such amounts as a reduction or addition to research and development expense. For arrangements in which we have agreed to perform certain research and development services for our collaboration partner and are not exposed to significant risks and rewards depending on the commercial success of the activity, we recognize the respective cost reimbursements as revenue under the collaborative agreement as the related research and development services are rendered. | ||||||||
Restricted Cash | ||||||||
Restricted Cash | ||||||||
Restricted cash consists of funds maintained in a separate certificate of deposit account for credit card purchases. | ||||||||
Research and Development Expenses | ||||||||
Research and Development Expenses | ||||||||
Research and development expenses consist of expenses incurred in identifying, developing and testing product candidates resulting from our independent efforts as well as efforts associated with collaborations. These expenses include, but are not limited to, in-process research and development acquired in an asset acquisition and deemed to have no alternative future use, payroll and personnel expense, lab supplies, preclinical studies, clinical trials, including support for investigator-sponsored clinical trials, raw materials to manufacture clinical trial drugs, manufacturing costs for research and clinical trial materials, sponsored research at other labs, consulting, costs to maintain technology licenses, our proportionate share of research and development costs under cost-sharing arrangements with collaborators and research-related overhead. Research and development costs are expensed as incurred, including payments made under our license agreements. | ||||||||
Clinical Trial Costs | ||||||||
A significant component of our research and development expenses has historically been clinical trial costs. Substantial portions of our preclinical studies and all of our clinical trials have been performed by third-party contract research organizations, or CROs, and other vendors. We accrue expenses for preclinical studies performed by our vendors based on certain estimates over the term of the service period and adjust our estimates as required. We accrue expenses for our clinical trial activities performed by CROs based upon the estimated amount of work completed on each study. For our clinical trial expenses, the significant factors used in estimating accruals include the number of patients enrolled, the number of active clinical sites and the duration for which the patients have been enrolled in the study. Pass through costs from CROs include, but are not limited to, regulatory expenses, investigator fees, lab fees, travel costs and other miscellaneous costs, including shipping and printing fees. We accrue pass through costs based on estimates of the amount of work completed for the clinical trial. We monitor patient enrollment levels and related activities to the extent possible through internal reviews, review of contractual terms and correspondence with CROs. We base our estimates on the best information available at the time. However, additional information may become available to us which would allow us to make a more accurate estimate in future periods. In this event, we may be required to record adjustments to research and development expenses in future periods when the actual level of activity becomes more certain. | ||||||||
Depreciation and Amortization | ||||||||
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. | ||||||||
Stock-Based Compensation | ||||||||
Stock-Based Compensation | ||||||||
We recognize stock-based compensation expense on a straight-line basis over the requisite service period, which is generally the vesting period. The following table summarizes the stock-based compensation expense included in operating expenses on our condensed statements of operations related to stock options, restricted stock awards and employee stock purchases for the three months ended March 31, 2015 and 2014 which was allocated as follows: | ||||||||
Three Months Ended March 31, | ||||||||
(In thousands) | 2015 | 2014 | ||||||
Research and development | $ | 622 | $ | 589 | ||||
Restructuring charges | 90 | — | ||||||
General and administrative | 1,301 | 1,052 | ||||||
Stock-based compensation expense included in operating expenses | $ | 2,013 | $ | 1,641 | ||||
In connection with a restructuring we announced in March 2015, the post-termination exercise period for certain stock options previously granted to employees affected by the restructuring was extended from 90 days to one year from their respective termination dates, subject to each employee’s continuous service until his/her specified termination date. The incremental value associated with these stock option modifications is being recognized as non-cash stock-based compensation expense over each employee’s remaining service period with the Company and recorded as restructuring charges on our condensed statements of operations as reflected in the table above. See Note 4 on Restructuring for a further discussion of the March 2015 restructuring. | ||||||||
As stock-based compensation expense recognized in our condensed statements of operations for the three months ended March 31, 2015 and 2014 is based on awards ultimately expected to vest, it has been reduced for estimated forfeitures, but at a minimum, reflects the grant-date fair value of those awards that actually vested in the period. Forfeitures have been estimated at the time of grant based on historical data and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. | ||||||||
Stock Options | ||||||||
We grant options with service-based vesting under our equity plans to employees, non-employee directors and consultants. The vesting period for employee options is generally four years. The fair value of options granted during the three months ended March 31, 2015 and 2014 has been estimated at the date of grant using the Black Scholes option-pricing model with the following assumptions: | ||||||||
Three Months Ended March 31, | ||||||||
2015 | 2014 | |||||||
Dividend yield | 0% | 0% | ||||||
Expected volatility | 0.884 | 0.922 | ||||||
Risk-free interest rate range | 1.70% | 1.64% to 1.92% | ||||||
Expected term | 5.5 yrs | 5.5 yrs | ||||||
Employee Stock Purchase Plan | ||||||||
The fair value of employees’ purchase rights during the three months ended March 31, 2015 and 2014 has been estimated using the Black Scholes option-pricing model with the following assumptions: | ||||||||
Three Months Ended March 31, | ||||||||
2015 | 2014 | |||||||
Dividend yield | 0% | 0% | ||||||
Expected volatility range | 0.721 to 1.392 | 0.835 to 1.062 | ||||||
Risk-free interest rate range | 0.11% to 0.25% | 0.09% to 0.15% | ||||||
Expected term range | 6 – 12 mos | 6 – 12 mos | ||||||
Dividend yield is based on historical cash dividend payments. The expected volatility is based on historical volatilities of our stock since traded options on Geron stock do not correspond to option terms and the trading volume of options is limited. The risk-free interest rate is based on the U.S. Zero Coupon Treasury Strip Yields for the expected term in effect on the date of grant for an award. The expected term of options is derived from actual historical exercise and post-vesting cancellation data and represents the period of time that options granted are expected to be outstanding. The expected term of employees’ purchase rights is equal to the purchase period. | ||||||||
Restricted Stock Awards | ||||||||
We have granted restricted stock awards to employees and non-employee directors with service-based vesting schedules that generally vest annually over four years. The fair value for service-based restricted stock awards is determined using the fair value of our common stock on the date of grant. The fair value is amortized as stock-based compensation expense over the requisite service period of the award, which is generally the vesting period, on a straight-line basis and is reduced for estimated forfeitures, as applicable. | ||||||||
Non-Employee Stock-Based Awards | ||||||||
For our non-employee stock-based awards, the measurement date on which the fair value of the stock-based award is calculated is equal to the earlier of: (i) the date at which a commitment for performance by the counterparty to earn the equity instrument is reached or (ii) the date at which the counterparty’s performance is complete. We recognize stock-based compensation expense for the fair value of the vested portion of non-employee awards in our condensed statements of operations. | ||||||||
Recent Accounting Pronouncements | ||||||||
Recent Accounting Pronouncements | ||||||||
In January 2015, the Financial Accounting Standards Board, or FASB, issued Accounting Standard Update No. 2015-01, Income Statement - Extraordinary and Unusual Items (Subtopic 225-20): Simplifying Income Statement Presentation by Eliminating the Concept of Extraordinary Items, or ASU 2015-01. ASU 2015-01 eliminates the concept of an extraordinary item from GAAP. As a result, an entity will no longer be required to segregate extraordinary items from the results of ordinary operations to separately present an extraordinary item on its income statement, net of tax, after income from continuing operations or to disclose income taxes and earnings-per-share data applicable to an extraordinary item. However, ASU 2015-01 will still retain the presentation and disclosure guidance for items that are unusual in nature and occur infrequently. ASU 2015-01 becomes effective for annual periods, and interim periods within those annual periods, beginning on or after December 15, 2015. Early adoption is permitted. The adoption of ASU 2015-01 is not expected to have a material impact on our financial statements. | ||||||||
SUMMARY_OF_SIGNIFICANT_ACCOUNT2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||||||||
Summary of allocation of stock-based compensation expense included in operating expenses on condensed statements of operations related to share-based payment awards | Three Months Ended March 31, | |||||||
(In thousands) | 2015 | 2014 | ||||||
Research and development | $ | 622 | $ | 589 | ||||
Restructuring charges | 90 | — | ||||||
General and administrative | 1,301 | 1,052 | ||||||
Stock-based compensation expense included in operating expenses | $ | 2,013 | $ | 1,641 | ||||
Schedule of assumptions used to estimate the fair value of stock options granted | Three Months Ended March 31, | |||||||
2015 | 2014 | |||||||
Dividend yield | 0% | 0% | ||||||
Expected volatility | 0.884 | 0.922 | ||||||
Risk-free interest rate range | 1.70% | 1.64% to 1.92% | ||||||
Expected term | 5.5 yrs | 5.5 yrs | ||||||
Schedule of assumptions used to estimate the fair value of employee stock purchases under the Purchase Plans | Three Months Ended March 31, | |||||||
2015 | 2014 | |||||||
Dividend yield | 0% | 0% | ||||||
Expected volatility range | 0.721 to 1.392 | 0.835 to 1.062 | ||||||
Risk-free interest rate range | 0.11% to 0.25% | 0.09% to 0.15% | ||||||
Expected term range | 6 – 12 mos | 6 – 12 mos | ||||||
FAIR_VALUE_MEASUREMENTS_Tables
FAIR VALUE MEASUREMENTS (Tables) | 3 Months Ended | ||||||||||||||||||||||
Mar. 31, 2015 | |||||||||||||||||||||||
FAIR VALUE MEASUREMENTS | |||||||||||||||||||||||
Schedule of cash equivalents, restricted cash and marketable securities by security type | |||||||||||||||||||||||
Cash equivalents, restricted cash and marketable securities by security type at March 31, 2015 were as follows: | |||||||||||||||||||||||
Gross | Gross | ||||||||||||||||||||||
Amortized | Unrealized | Unrealized | Estimated | ||||||||||||||||||||
(In thousands) | Cost | Gains | Losses | Fair Value | |||||||||||||||||||
Included in cash and cash equivalents: | |||||||||||||||||||||||
Money market funds | $ | 7,231 | $ | — | $ | — | $ | 7,231 | |||||||||||||||
Restricted cash: | |||||||||||||||||||||||
Certificate of deposit | $ | 266 | $ | — | $ | — | $ | 266 | |||||||||||||||
Marketable securities: | |||||||||||||||||||||||
Government-sponsored enterprise securities (due in less than 1 year) | $ | 401 | $ | — | $ | (1 | ) | $ | 400 | ||||||||||||||
Government-sponsored enterprise securities (due in 1 to 2 years) | 5,806 | — | (1 | ) | 5,805 | ||||||||||||||||||
Commercial paper (due in less than 1 year) | 28,963 | 33 | — | 28,996 | |||||||||||||||||||
Corporate notes (due in less than 1 year) | 106,305 | 10 | (56 | ) | 106,259 | ||||||||||||||||||
Corporate notes (due in 1 to 2 years) | 11,936 | 2 | (4 | ) | 11,934 | ||||||||||||||||||
$ | 153,411 | $ | 45 | $ | (62 | ) | $ | 153,394 | |||||||||||||||
Cash equivalents, restricted cash and marketable securities by security type at December 31, 2014 were as follows: | |||||||||||||||||||||||
Gross | Gross | ||||||||||||||||||||||
Amortized | Unrealized | Unrealized | Estimated | ||||||||||||||||||||
(In thousands) | Cost | Gains | Losses | Fair Value | |||||||||||||||||||
Included in cash and cash equivalents: | |||||||||||||||||||||||
Money market funds | $ | 40,342 | $ | — | $ | — | $ | 40,342 | |||||||||||||||
Restricted cash: | |||||||||||||||||||||||
Certificate of deposit | $ | 266 | $ | — | $ | — | $ | 266 | |||||||||||||||
Marketable securities: | |||||||||||||||||||||||
Government-sponsored enterprise securities (due in less than 1 year) | $ | 401 | $ | — | $ | (1 | ) | $ | 400 | ||||||||||||||
Government-sponsored enterprise securities (due in 1 to 2 years) | 6,556 | — | (7 | ) | 6,549 | ||||||||||||||||||
Commercial paper (due in less than 1 year) | 10,985 | 14 | — | 10,999 | |||||||||||||||||||
Corporate notes (due in less than 1 year) | 97,307 | 2 | (63 | ) | 97,246 | ||||||||||||||||||
Corporate notes (due in l to 2 years) | 12,412 | — | (29 | ) | 12,383 | ||||||||||||||||||
$ | 127,661 | $ | 16 | $ | (100 | ) | $ | 127,577 | |||||||||||||||
Schedule of marketable securities with unrealized losses | |||||||||||||||||||||||
Less Than 12 Months | 12 Months or Greater | Total | |||||||||||||||||||||
Gross | Gross | Gross | |||||||||||||||||||||
Estimated | Unrealized | Estimated | Unrealized | Estimated | Unrealized | ||||||||||||||||||
(In thousands) | Fair Value | Losses | Fair Value | Losses | Fair Value | Losses | |||||||||||||||||
As of March 31, 2015: | |||||||||||||||||||||||
Government-sponsored enterprise securities (due in less than 1 year) | $ | 400 | $ | (1 | ) | $ | — | $ | — | $ | 400 | $ | (1 | ) | |||||||||
Government-sponsored enterprise securities (due in 1 to 2 years) | 5,805 | (1 | ) | — | — | 5,805 | (1 | ) | |||||||||||||||
Corporate notes (due in less than 1 year) | 80,083 | (56 | ) | — | — | 80,083 | (56 | ) | |||||||||||||||
Corporate notes (due in 1 to 2 years) | 6,012 | (4 | ) | — | — | 6,012 | (4 | ) | |||||||||||||||
$ | 92,300 | $ | (62 | ) | $ | — | $ | — | $ | 92,300 | $ | (62 | ) | ||||||||||
As of December 31, 2014: | |||||||||||||||||||||||
Government-sponsored enterprise securities (due in less than 1 year) | $ | 400 | $ | (1 | ) | $ | — | $ | — | $ | 400 | $ | (1 | ) | |||||||||
Government-sponsored enterprise securities (due in 1 to 2 years) | 5,549 | (7 | ) | — | — | 5,549 | (7 | ) | |||||||||||||||
Corporate notes (due in less than 1 year) | 92,989 | (63 | ) | — | — | 92,989 | (63 | ) | |||||||||||||||
Corporate notes (due in 1 to 2 years) | 12,383 | (29 | ) | — | — | 12,383 | (29 | ) | |||||||||||||||
$ | 111,321 | $ | (100 | ) | $ | — | $ | — | $ | 111,321 | $ | (100 | ) | ||||||||||
Schedule of financial instruments measured at fair value on recurring basis | |||||||||||||||||||||||
The following table presents information about our financial instruments that are measured at fair value on a recurring basis as of March 31, 2015 and indicates the fair value category assigned. | |||||||||||||||||||||||
Fair Value Measurements at Reporting Date Using | |||||||||||||||||||||||
Quoted Prices in | Significant | ||||||||||||||||||||||
Active Markets | Other | Significant | |||||||||||||||||||||
for Identical | Observable | Unobservable | |||||||||||||||||||||
Assets | Inputs | Inputs | |||||||||||||||||||||
(In thousands) | Level 1 | Level 2 | Level 3 | Total | |||||||||||||||||||
Assets: | |||||||||||||||||||||||
Money market funds(1) | $ | 7,231 | $ | — | $ | — | $ | 7,231 | |||||||||||||||
Government-sponsored enterprise securities(2)(3) | — | 6,205 | — | 6,205 | |||||||||||||||||||
Commercial paper(2) | — | 28,996 | — | 28,996 | |||||||||||||||||||
Corporate notes(2)(3) | — | 118,193 | — | 118,193 | |||||||||||||||||||
Total | $ | 7,231 | $ | 153,394 | $ | — | $ | 160,625 | |||||||||||||||
The following table presents information about our financial instruments that are measured at fair value on a recurring basis as of December 31, 2014 and indicates the fair value category assigned. | |||||||||||||||||||||||
Fair Value Measurements at Reporting Date Using | |||||||||||||||||||||||
Quoted Prices in | Significant | ||||||||||||||||||||||
Active Markets | Other | Significant | |||||||||||||||||||||
for Identical | Observable | Unobservable | |||||||||||||||||||||
Assets / Liabilities | Inputs | Inputs | |||||||||||||||||||||
(In thousands) | Level 1 | Level 2 | Level 3 | Total | |||||||||||||||||||
Assets: | |||||||||||||||||||||||
Money market funds(1) | $ | 40,342 | $ | — | $ | — | $ | 40,342 | |||||||||||||||
Government-sponsored enterprise securities(2)(3) | — | 6,949 | — | 6,949 | |||||||||||||||||||
Commercial paper(2) | — | 10,999 | — | 10,999 | |||||||||||||||||||
Corporate notes(2)(3) | — | 109,629 | — | 109,629 | |||||||||||||||||||
Total | $ | 40,342 | $ | 127,577 | $ | — | $ | 167,919 | |||||||||||||||
Liabilities: | |||||||||||||||||||||||
Derivatives(4) | $ | — | $ | — | $ | 16 | $ | 16 | |||||||||||||||
-1 | Included in cash and cash equivalents on our condensed balance sheets. | ||||||||||||||||||||||
-2 | Included in current portion of marketable securities on our condensed balance sheets. | ||||||||||||||||||||||
-3 | Included in noncurrent portion of marketable securities on our condensed balance sheets. | ||||||||||||||||||||||
-4 | Included in fair value of derivatives on our condensed balance sheets. | ||||||||||||||||||||||
Schedule of rollforward of the balance sheet amounts for financial instruments in Level 3 category | |||||||||||||||||||||||
Fair Value Measurements Using Significant Unobservable Inputs (Level 3) | |||||||||||||||||||||||
Three Months Ended March 31, 2015 | |||||||||||||||||||||||
Change in | |||||||||||||||||||||||
Unrealized Gain | |||||||||||||||||||||||
Total | Related to | ||||||||||||||||||||||
Unrealized | Transfers | Financial | |||||||||||||||||||||
Fair Value at | Gain | Purchases | In and/or | Fair Value at | Instruments | ||||||||||||||||||
December 31, | Included in | and | Sales and | Out of | March 31, | Held at | |||||||||||||||||
(In thousands) | 2014 | Earnings(1) | Issuances | Settlements | Level 3 | 2015 | March 31, 2015 | ||||||||||||||||
Derivative liabilities | $ | 16 | $ | (16 | ) | $ | — | $ | — | $ | — | $ | — | $ | — | ||||||||
-1 | Reported as unrealized gain on derivatives in our condensed statements of operations. | ||||||||||||||||||||||
RESTRUCTURING_Tables
RESTRUCTURING (Tables) | 3 Months Ended | ||||
Mar. 31, 2015 | |||||
RESTRUCTURING | |||||
Summary of components of restructuring liability | (In thousands) | Employee Severance | |||
and Other Benefits | |||||
Beginning accrual balance as of December 31, 2014 | $ | — | |||
Restructuring charges | 406 | ||||
Adjustments or non-cash credits, including non-cash stock-based compensation expense | (90 | ) | |||
Ending accrual balance as of March 31, 2015 | $ | 316 | |||
CONDENSED_STATEMENTS_OF_CASH_F2
CONDENSED STATEMENTS OF CASH FLOWS DATA (Tables) | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
CONDENSED STATEMENTS OF CASH FLOWS DATA | ||||||||
Supplemental schedule of non-cash operating and investing activities | Three Months Ended March 31, | |||||||
(In thousands) | 2015 | 2014 | ||||||
Supplemental Operating Activities: | ||||||||
Issuance of common stock for 401(k) matching contributions | $ | — | $ | 313 | ||||
Reclassification of deposits to other current assets | — | 4 | ||||||
Supplemental Investing Activities: | ||||||||
Net unrealized gain (loss) on marketable securities | 67 | (76 | ) | |||||
SUMMARY_OF_SIGNIFICANT_ACCOUNT3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Net Loss Per Share | ||
Potential dilutive securities excluded from diluted earnings (loss) per share calculation (in shares) | 4,122,123 | 5,596,655 |
Depreciation and Amortization | ||
Estimated useful lives of assets | 4 years | |
Minimum | ||
Marketable securities | ||
Original maturity period of marketable securities | 4 months | |
Maximum | ||
Marketable securities | ||
Original maturity period of marketable securities | 20 months |
SUMMARY_OF_SIGNIFICANT_ACCOUNT4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 3) (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Stock-Based Compensation Expense | ||
Stock-based compensation expense included in operating expenses | $2,013 | $1,641 |
Research and development | ||
Stock-Based Compensation Expense | ||
Stock-based compensation expense included in operating expenses | 622 | 589 |
Restructuring charges | ||
Stock-Based Compensation Expense | ||
Stock-based compensation expense included in operating expenses | 90 | |
General and administrative | ||
Stock-Based Compensation Expense | ||
Stock-based compensation expense included in operating expenses | $1,301 | $1,052 |
SUMMARY_OF_SIGNIFICANT_ACCOUNT5
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 4) | 0 Months Ended | 3 Months Ended | |
Mar. 03, 2015 | Mar. 31, 2015 | Mar. 31, 2014 | |
March 2015 Restructuring | |||
Stock-Based Compensation | |||
Original exercise period for vested outstanding awards after termination | 90 days | ||
Modified exercise period for vested outstanding awards after termination | 1 year | ||
Employee Stock Purchase Plan | |||
Assumptions used to estimate fair value of awards | |||
Dividend yield (as a percent) | 0.00% | 0.00% | |
Expected volatility range, minimum (as a percent) | 72.10% | 83.50% | |
Expected volatility range, maximum (as a percent) | 139.20% | 106.20% | |
Risk-free interest rate range, minimum (as a percent) | 0.11% | 0.09% | |
Risk-free interest rate range, maximum (as a percent) | 0.25% | 0.15% | |
Employee Stock Purchase Plan | Minimum | |||
Assumptions used to estimate fair value of awards | |||
Expected term | 6 months | 6 months | |
Employee Stock Purchase Plan | Maximum | |||
Assumptions used to estimate fair value of awards | |||
Expected term | 12 months | 12 months | |
Service-based restricted stock awards | |||
Stock-Based Compensation | |||
Vesting period of awards | 4 years | ||
Stock options | |||
Stock-Based Compensation | |||
Vesting period of awards | 4 years | ||
Assumptions used to estimate fair value of awards | |||
Dividend yield (as a percent) | 0.00% | 0.00% | |
Expected volatility (as a percent) | 88.40% | 92.20% | |
Risk-free interest rate (as a percent) | 1.70% | ||
Risk-free interest rate range, minimum (as a percent) | 1.64% | ||
Risk-free interest rate range, maximum (as a percent) | 1.92% | ||
Expected term | 5 years 6 months | 5 years 6 months |
FAIR_VALUE_MEASUREMENTS_Detail
FAIR VALUE MEASUREMENTS (Details) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
In Thousands, unless otherwise specified | ||
Included in cash and cash equivalents | ||
Amortized Cost | $7,231 | $40,342 |
Estimated Fair Value | 7,231 | 40,342 |
Restricted cash | ||
Amortized Cost | 266 | 266 |
Estimated Fair Value | 266 | 266 |
Marketable securities | ||
Amortized Cost | 153,411 | 127,661 |
Gross Unrealized Gains | 45 | 16 |
Gross Unrealized Losses | -62 | -100 |
Estimated Fair Value | 153,394 | 127,577 |
Money market funds | ||
Included in cash and cash equivalents | ||
Amortized Cost | 7,231 | 40,342 |
Estimated Fair Value | 7,231 | 40,342 |
Certificates of deposit | ||
Restricted cash | ||
Amortized Cost | 266 | 266 |
Estimated Fair Value | 266 | 266 |
Government-sponsored enterprise securities (due in less than 1 year) | ||
Marketable securities | ||
Amortized Cost | 401 | 401 |
Gross Unrealized Losses | -1 | -1 |
Estimated Fair Value | 400 | 400 |
Government-sponsored enterprise securities (due in 1 to 2 years) | ||
Marketable securities | ||
Amortized Cost | 5,806 | 6,556 |
Gross Unrealized Losses | -1 | -7 |
Estimated Fair Value | 5,805 | 6,549 |
Commercial paper (due in less than 1 year) | ||
Marketable securities | ||
Amortized Cost | 28,963 | 10,985 |
Gross Unrealized Gains | 33 | 14 |
Estimated Fair Value | 28,996 | 10,999 |
Corporate notes (due in less than 1 year) | ||
Marketable securities | ||
Amortized Cost | 106,305 | 97,307 |
Gross Unrealized Gains | 10 | 2 |
Gross Unrealized Losses | -56 | -63 |
Estimated Fair Value | 106,259 | 97,246 |
Corporate notes (due in 1 to 2 years) | ||
Marketable securities | ||
Amortized Cost | 11,936 | 12,412 |
Gross Unrealized Gains | 2 | |
Gross Unrealized Losses | -4 | -29 |
Estimated Fair Value | $11,934 | $12,383 |
FAIR_VALUE_MEASUREMENTS_Detail1
FAIR VALUE MEASUREMENTS (Details 2) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
In Thousands, unless otherwise specified | ||
Marketable securities with unrealized losses | ||
Less Than 12 Months - Estimated Fair Value | $92,300 | $111,321 |
Less Than 12 Months - Gross Unrealized Losses | -62 | -100 |
Total - Estimated Fair Value | 92,300 | 111,321 |
Total - Gross Unrealized Losses | -62 | -100 |
Government-sponsored enterprise securities (due in less than 1 year) | ||
Marketable securities with unrealized losses | ||
Less Than 12 Months - Estimated Fair Value | 400 | 400 |
Less Than 12 Months - Gross Unrealized Losses | -1 | -1 |
Total - Estimated Fair Value | 400 | 400 |
Total - Gross Unrealized Losses | -1 | -1 |
Government-sponsored enterprise securities (due in 1 to 2 years) | ||
Marketable securities with unrealized losses | ||
Less Than 12 Months - Estimated Fair Value | 5,805 | 5,549 |
Less Than 12 Months - Gross Unrealized Losses | -1 | -7 |
Total - Estimated Fair Value | 5,805 | 5,549 |
Total - Gross Unrealized Losses | -1 | -7 |
Corporate notes (due in less than 1 year) | ||
Marketable securities with unrealized losses | ||
Less Than 12 Months - Estimated Fair Value | 80,083 | 92,989 |
Less Than 12 Months - Gross Unrealized Losses | -56 | -63 |
Total - Estimated Fair Value | 80,083 | 92,989 |
Total - Gross Unrealized Losses | -56 | -63 |
Corporate notes (due in 1 to 2 years) | ||
Marketable securities with unrealized losses | ||
Less Than 12 Months - Estimated Fair Value | 6,012 | 12,383 |
Less Than 12 Months - Gross Unrealized Losses | -4 | -29 |
Total - Estimated Fair Value | 6,012 | 12,383 |
Total - Gross Unrealized Losses | ($4) | ($29) |
FAIR_VALUE_MEASUREMENTS_Detail2
FAIR VALUE MEASUREMENTS (Details 3) (USD $) | Dec. 31, 2014 |
Derivatives | |
Fair Value | $16,000 |
Non-employee options | |
Derivatives | |
Number of Shares | 284,600 |
Exercise Price (in dollars per share) | $6.39 |
Fair Value | $16,000 |
FAIR_VALUE_MEASUREMENTS_Detail3
FAIR VALUE MEASUREMENTS (Details 4) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
Liabilities | ||
Derivatives | $16,000 | |
Recurring basis | Level 1 | ||
Assets | ||
Total | 7,231,000 | 40,342,000 |
Recurring basis | Level 1 | Money market funds | ||
Assets | ||
Total | 7,231,000 | 40,342,000 |
Recurring basis | Level 2 | ||
Assets | ||
Total | 153,394,000 | 127,577,000 |
Recurring basis | Level 2 | Government-sponsored enterprise securities | ||
Assets | ||
Total | 6,205,000 | 6,949,000 |
Recurring basis | Level 2 | Commercial paper | ||
Assets | ||
Total | 28,996,000 | 10,999,000 |
Recurring basis | Level 2 | Corporate notes | ||
Assets | ||
Total | 118,193,000 | 109,629,000 |
Recurring basis | Level 3 | ||
Liabilities | ||
Derivatives | 16,000 | |
Recurring basis | Total | ||
Assets | ||
Total | 160,625,000 | 167,919,000 |
Liabilities | ||
Derivatives | 16,000 | |
Recurring basis | Total | Money market funds | ||
Assets | ||
Total | 7,231,000 | 40,342,000 |
Recurring basis | Total | Government-sponsored enterprise securities | ||
Assets | ||
Total | 6,205,000 | 6,949,000 |
Recurring basis | Total | Commercial paper | ||
Assets | ||
Total | 28,996,000 | 10,999,000 |
Recurring basis | Total | Corporate notes | ||
Assets | ||
Total | $118,193,000 | $109,629,000 |
FAIR_VALUE_MEASUREMENTS_Detail4
FAIR VALUE MEASUREMENTS (Details 5) (USD $) | 3 Months Ended | |
Mar. 31, 2015 | Dec. 31, 2014 | |
Changes in Level 3 Recurring Fair Value Measurements | ||
Fair value of derivative liabilities at the beginning of the period | $16,000 | |
Fair value of derivative liabilities at the end of the period | 16,000 | |
Derivative liabilities | ||
Changes in Level 3 Recurring Fair Value Measurements | ||
Fair value of derivative liabilities at the beginning of the period | 16,000 | |
Total Unrealized Gain Included in Earnings | ($16,000) |
COLLABORATION_AND_LICENSE_AGRE1
COLLABORATION AND LICENSE AGREEMENT (Details) (USD $) | 0 Months Ended | ||
Dec. 15, 2014 | Mar. 31, 2015 | Dec. 31, 2014 | |
item | |||
LICENSE AGREEMENTS | |||
Amount expected to be recognized as revenue | $35,000,000 | $35,000,000 | |
Accrued collaboration charges | 626,000 | ||
Expected Revenue | |||
LICENSE AGREEMENTS | |||
Amount expected to be recognized as revenue | 35,000,000 | ||
License agreements | Janssen Biotech | Initial Period | |||
LICENSE AGREEMENTS | |||
Upfront payment received | 35,000,000 | ||
Number of agreed upon studies | 2 | ||
Percentage of costs to be paid by Geron | 50.00% | ||
Percentage of costs to be paid by Janssen | 50.00% | ||
Notification period | 24 months | ||
Maximum period Geron is obligated to procure supply for manufacturing imetelstat under collaboration agreement | 9 months | ||
License agreements | Janssen Biotech | U.S. Opt-In Rights exercised | |||
LICENSE AGREEMENTS | |||
Percentage of costs to be paid by Geron | 20.00% | ||
Percentage of costs to be paid by Janssen | 80.00% | ||
Continuation Election milestone payment | 65,000,000 | ||
Aggregate maximum total payments for development and regulatory milestones under collaboration agreement | 470,000,000 | ||
Aggregate maximum total of payments for sales milestones under collaboration agreement | 350,000,000 | ||
Tiered royalties percentage, low end of the range | mid-teens | ||
Tiered royalties percentage, high end of the range | low twenties | ||
U.S. selling effort percentage | 20.00% | ||
License agreements | Janssen Biotech | U.S. Opt-In Rights not exercised | |||
LICENSE AGREEMENTS | |||
Continuation Election milestone payment | 65,000,000 | ||
Full U.S. Rights fee | 70,000,000 | ||
Aggregate maximum total payments for development and regulatory milestones under collaboration agreement | 415,000,000 | ||
Aggregate maximum total of payments for sales milestones under collaboration agreement | $350,000,000 | ||
Tiered royalties percentage, low end of the range | double-digit | ||
Tiered royalties percentage, high end of the range | mid-teens | ||
License agreements | Janssen Biotech | Collaborative Arrangement IP Exclusively Licensed | |||
LICENSE AGREEMENTS | |||
Percentage of costs to be paid by Geron | 50.00% | ||
Percentage of costs to be paid by Janssen | 50.00% |
RESTRUCTURING_Details
RESTRUCTURING (Details) (USD $) | 3 Months Ended | 0 Months Ended |
Mar. 31, 2015 | Mar. 03, 2015 | |
RESTRUCTURING | ||
Restructuring charges | $406,000 | |
Outstanding restructuring liability | ||
Restructuring Charges. | 406,000 | |
Accrual balance at the end of the period | 316,000 | |
Employee Severance And Other Benefits | ||
RESTRUCTURING | ||
Restructuring charges | 406,000 | |
Stock-based compensation expense related to extension of the post-termination exercise period | -90,000 | |
Outstanding restructuring liability | ||
Restructuring Charges. | 406,000 | |
Stock-based compensation expense related to extension of the post-termination exercise period | -90,000 | |
Accrual balance at the end of the period | 316,000 | |
March 2015 Restructuring | ||
RESTRUCTURING | ||
Number of positions before restructuring | 39 | |
Number of positions after restructuring | 21 | |
Original exercise period for vested outstanding awards after termination | 90 days | |
Modified exercise period for vested outstanding awards after termination | 1 year | |
Aggregate estimated restructuring charges | 1,748,000 | |
Expected cash payments | 1,377,000 | |
March 2015 Restructuring | One-time termination benefits | ||
RESTRUCTURING | ||
Restructuring charges | 406,000 | |
Stock-based compensation expense related to extension of the post-termination exercise period | 90,000 | |
Outstanding restructuring liability | ||
Restructuring Charges. | 406,000 | |
Stock-based compensation expense related to extension of the post-termination exercise period | $90,000 |
STOCKHOLDERS_EQUITY_Details
STOCKHOLDERS' EQUITY (Details) (USD $) | 0 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2015 | |
STOCKHOLDERS' EQUITY | ||
Number of warrants exercised | 235,000 | |
Exercise price of warrants issued (in dollars per share) | $3.75 | |
Proceeds from exercise of warrants | $881,000 |
SEGMENT_INFORMATION_Details
SEGMENT INFORMATION (Details) | 3 Months Ended |
Mar. 31, 2015 | |
item | |
SEGMENT INFORMATION | |
Number of operating segments | 1 |
CONDENSED_STATEMENTS_OF_CASH_F3
CONDENSED STATEMENTS OF CASH FLOWS DATA (Details) (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Supplemental Operating Activities: | ||
Issuance of common stock for 401(k) matching contributions | $313 | |
Reclassification of deposits to other current assets | 4 | |
Supplemental Investing Activities: | ||
Net unrealized gain (loss) on marketable securities | $67 | ($76) |