Document and Entity Information (USD $)
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9 Months Ended | ||
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Sep. 30, 2011
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Nov. 03, 2011
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Jun. 30, 2010
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Document and Entity Information [Abstract] | |||
Entity Registrant Name | GTX INC /DE/ | ||
Entity Central Index Key | 0001260990 | ||
Document Type | 10-Q | ||
Document Period End Date | Sep. 30, 2011 | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2011 | ||
Document Fiscal Period Focus | Q3 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Public Float | $ 56,844,168 | ||
Entity Common Stock, Shares Outstanding | 62,790,223 |
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- Definition
If the value is true, then the document as an amendment to previously-filed/accepted document. No definition available.
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- Definition
End date of current fiscal year in the format --MM-DD. No definition available.
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- Definition
This is focus fiscal period of the document report. For a first quarter 2006 quarterly report, which may also provide financial information from prior periods, the first fiscal quarter should be given as the fiscal period focus. Values: FY, Q1, Q2, Q3, Q4, H1, H2, M9, T1, T2, T3, M8, CY. No definition available.
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- Definition
This is focus fiscal year of the document report in CCYY format. For a 2006 annual report, which may also provide financial information from prior periods, fiscal 2006 should be given as the fiscal year focus. Example: 2006. No definition available.
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- Definition
The end date of the period reflected on the cover page if a periodic report. For all other reports and registration statements containing historical data, it is the date up through which that historical data is presented. If there is no historical data in the report, use the filing date. The format of the date is CCYY-MM-DD. No definition available.
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- Definition
The type of document being provided (such as 10-K, 10-Q, N-1A, etc). The document type is limited to the same value as the supporting SEC submission type, minus any "/A" suffix. The acceptable values are as follows: S-1, S-3, S-4, S-11, F-1, F-3, F-4, F-9, F-10, 6-K, 8-K, 10, 10-K, 10-Q, 20-F, 40-F, N-1A, 485BPOS, 497, NCSR, N-CSR, N-CSRS, N-Q, 10-KT, 10-QT, 20-FT, POS AM and Other. No definition available.
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- Definition
A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition
Indicate number of shares outstanding of each of registrant's classes of common stock, as of latest practicable date. Where multiple classes exist define each class by adding class of stock items such as Common Class A [Member], Common Class B [Member] onto the Instrument [Domain] of the Entity Listings, Instrument No definition available.
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- Definition
Indicate "Yes" or "No" whether registrants (1) have filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that registrants were required to file such reports), and (2) have been subject to such filing requirements for the past 90 days. This information should be based on the registrant's current or most recent filing containing the related disclosure. No definition available.
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- Definition
Indicate whether the registrant is one of the following: (1) Large Accelerated Filer, (2) Accelerated Filer, (3) Non-accelerated Filer, or (4) Smaller Reporting Company. Definitions of these categories are stated in Rule 12b-2 of the Exchange Act. This information should be based on the registrant's current or most recent filing containing the related disclosure. No definition available.
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- Definition
State aggregate market value of voting and non-voting common equity held by non-affiliates computed by reference to price at which the common equity was last sold, or average bid and asked price of such common equity, as of the last business day of registrant's most recently completed second fiscal quarter. The public float should be reported on the cover page of the registrants form 10K. No definition available.
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- Definition
The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition
Indicate "Yes" or "No" if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. No definition available.
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- Definition
Indicate "Yes" or "No" if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Is used on Form Type: 10-K, 10-Q, 8-K, 20-F, 6-K, 10-K/A, 10-Q/A, 20-F/A, 6-K/A, N-CSR, N-Q, N-1A. No definition available.
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- Details
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- Definition
Carrying value as of the balance sheet date of liabilities incurred (and for which invoices have typically been received) and payable to vendors for goods and services received that are used in an entity's business. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer). Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition
Amount due from customers or clients, within one year of the balance sheet date (or the normal operating cycle, whichever is longer), for goods or services (including trade receivables) that have been delivered or sold in the normal course of business, reduced to the estimated net realizable fair value by an allowance established by the entity of the amount it deems uncertain of collection. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition
Carrying value as of the balance sheet date of obligations incurred and payable, pertaining to costs that are statutory in nature, are incurred on contractual obligations, or accumulate over time and for which invoices have not yet been received or will not be rendered. Examples include taxes, interest, rent and utilities. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer). Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition
Value received from shareholders in common stock-related transactions that are in excess of par value or stated value and amounts received from other stock-related transactions. Includes only common stock transactions (excludes preferred stock transactions). May be called contributed capital, capital in excess of par, capital surplus, or paid-in capital. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition
Sum of the carrying amounts as of the balance sheet date of all assets that are recognized. Assets are probable future economic benefits obtained or controlled by an entity as a result of past transactions or events. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition
Sum of the carrying amounts as of the balance sheet date of all assets that are expected to be realized in cash, sold, or consumed within one year (or the normal operating cycle, if longer). Assets are probable future economic benefits obtained or controlled by an entity as a result of past transactions or events. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Details
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- Definition
Includes currency on hand as well as demand deposits with banks or financial institutions. It also includes other kinds of accounts that have the general characteristics of demand deposits in that the Entity may deposit additional funds at any time and also effectively may withdraw funds at any time without prior notice or penalty. Cash equivalents, excluding items classified as marketable securities, include short-term, highly liquid investments that are both readily convertible to known amounts of cash, and so near their maturity that they present minimal risk of changes in value because of changes in interest rates. Generally, only investments with original maturities of three months or less qualify under that definition. Original maturity means original maturity to the entity holding the investment. For example, both a three-month US Treasury bill and a three-year Treasury note purchased three months from maturity qualify as cash equivalents. However, a Treasury note purchased three years ago does not become a cash equivalent when its remaining maturity is three months. Compensating balance arrangements that do not legally restrict the withdrawal or usage of cash amounts may be reported as Cash and Cash Equivalents, while legally restricted deposits held as compensating balances against borrowing arrangements, contracts entered into with others, or company statements of intention with regard to particular deposits are not generally reported as cash and cash equivalents. Includes cash and cash equivalents associated with the entity's continuing operations. Excludes cash and cash equivalents associated with the disposal group (and discontinued operation). Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition
Represents the caption on the face of the balance sheet to indicate that the entity has entered into (1) purchase or supply arrangements that will require expending a portion of its resources to meet the terms thereof, and (2) is exposed to potential losses or, less frequently, gains, arising from (a) possible claims against a company's resources due to future performance under contract terms, and (b) possible losses or likely gains from uncertainties that will ultimately be resolved when one or more future events that are deemed likely to occur do occur or fail to occur. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition
Aggregate par or stated value of issued nonredeemable common stock (or common stock redeemable solely at the option of the issuer). This item includes treasury stock repurchased by the entity. Note: elements for number of nonredeemable common shares, par value and other disclosure concepts are in another section within stockholders' equity. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition
The carrying amount of consideration received or receivable as of the balance sheet date on potential earnings that were not recognized as revenue in conformity with GAAP, and which are expected to be recognized as such within one year or the normal operating cycle, if longer, including sales, license fees, and royalties, but excluding interest income. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition
The noncurrent portion of deferred revenue amount as of balance sheet date. Deferred revenue is a liability related to a revenue producing activity for which revenue has not yet been recognized, and is not expected to be recognized in the next twelve months. Generally, an entity records deferred revenue when it receives consideration from a customer before achieving certain criteria that must be met for revenue to be recognized in conformity with GAAP. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition
The aggregate sum of gross carrying value of a major finite-lived intangible asset class, less accumulated amortization and any impairment charges. A major class is composed of intangible assets that can be grouped together because they are similar, either by their nature or by their use in the operations of a company. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition
This item represents investments in debt securities which are categorized as held-to-maturity and that have scheduled maturities within one year of the balance sheet date or the normal operating cycle, whichever is longer; such investments are measured at amortized cost (carrying value). The held-to-maturity category is for those securities that the Entity has the positive intent and ability to hold until maturity. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition
Carrying amount (lower of cost or market) as of the balance sheet date of inventories less all valuation and other allowances. Excludes noncurrent inventory balances (expected to remain on hand past one year or one operating cycle, if longer). Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition
Total of all Liabilities and Stockholders' Equity items (or Partners' Capital, as applicable), including the portion of equity attributable to noncontrolling interests, if any. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition
Total obligations incurred as part of normal operations that are expected to be paid during the following twelve months or within one business cycle, if longer. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Details
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- Definition
Aggregate carrying amount, as of the balance sheet date, of noncurrent obligations not separately disclosed in the balance sheet. Noncurrent liabilities are expected to be paid after one year (or the normal operating cycle, if longer). Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition
The total of the amounts paid in advance for capitalized costs that will be expensed with the passage of time or the occurrence of a triggering event, and will be charged against earnings within one year or the normal operating cycle, if longer, and the aggregate carrying amount of current assets, as of the balance sheet date, not separately presented elsewhere in the balance sheet. Current assets are expected to be realized or consumed within one year (or the normal operating cycle, if longer). Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition
Tangible assets that are held by an entity for use in the production or supply of goods and services, for rental to others, or for administrative purposes and that are expected to provide economic benefit for more than one year; net of accumulated depreciation. Examples include land, buildings, machinery and equipment, and other types of furniture and equipment including, but not limited to, office equipment, furniture and fixtures, and computer equipment and software. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition
The cumulative amount of the reporting entity's undistributed earnings or deficit. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition
Total of all stockholders' equity (deficit) items, net of receivables from officers, directors, owners, and affiliates of the entity which are attributable to the parent. The amount of the economic entity's stockholders' equity attributable to the parent excludes the amount of stockholders' equity which is allocable to that ownership interest in subsidiary equity which is not attributable to the parent (noncontrolling interest, minority interest). This excludes temporary equity and is sometimes called permanent equity. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Details
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Condensed Balance Sheets (Parenthetical) (USD $)
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Sep. 30, 2011
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Dec. 31, 2010
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Stockholders' equity: | ||
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 120,000,000 | 60,000,000 |
Common stock, shares issued | 62,790,223 | 51,719,187 |
Common stock, shares outstanding | 62,790,223 | 51,719,187 |
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- Definition
Face amount or stated value of common stock per share; generally not indicative of the fair market value per share. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition
The maximum number of common shares permitted to be issued by an entity's charter and bylaws. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition
Total number of common shares of an entity that have been sold or granted to shareholders (includes common shares that were issued, repurchased and remain in the treasury). These shares represent capital invested by the firm's shareholders and owners, and may be all or only a portion of the number of shares authorized. Shares issued include shares outstanding and shares held in the treasury. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition
Total number of shares of common stock held by shareholders. May be all or portion of the number of common shares authorized. These shares represent the ownership interest of the common shareholders. Shares outstanding equals shares issued minus shares held in treasury and other adjustments, if any. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Details
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Condensed Statements of Operations (unaudited) (USD $)
In Thousands, except Share data, unless otherwise specified |
3 Months Ended | 9 Months Ended | ||
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Sep. 30, 2011
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Sep. 30, 2010
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Sep. 30, 2011
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Sep. 30, 2010
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Revenues: | ||||
Product sales, net | $ 2,029 | $ 960 | $ 4,903 | $ 2,358 |
Collaboration revenue | 336 | 8,066 | 56,450 | |
Total revenues | 2,029 | 1,296 | 12,969 | 58,808 |
Costs and expenses: | ||||
Cost of product sales | 311 | 216 | 780 | 501 |
Research and development expenses | 8,181 | 5,593 | 23,075 | 22,720 |
General and administrative expenses | 2,904 | 4,066 | 12,058 | 12,900 |
Total costs and expenses | 11,396 | 9,875 | 35,913 | 36,121 |
(Loss) income from operations | (9,367) | (8,579) | (22,944) | 22,687 |
Other income, net | 23 | 4 | 332 | 136 |
Net (loss) income | $ (9,344) | $ (8,575) | $ (22,612) | $ 22,823 |
Net (loss) income per share: | ||||
Basic and diluted | $ (0.15) | $ (0.24) | $ (0.41) | $ 0.63 |
Weighted average shares used in computing net (loss) income per share: | ||||
Basic and diluted | 62,778,575 | 36,424,971 | 55,529,320 | 36,422,273 |
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- Definition
Basic and diluted weighted average number of shares. No definition available.
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- Definition
Collaboration revenue consists of non-refundable upfront payments, license fees, reimbursements for research and development activities, and milestone payments associated with the Company's collaboration and license agreements. Collaboration revenue is recognized based on the performance requirements of the specific agreements. No definition available.
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X | ||||||||||
- Definition
Total costs related to goods produced and sold during the reporting period. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition
Total costs of sales and operating expenses for the period. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Details
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- Details
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- Definition
The amount of net income or loss for the period per each share in instances when basic and diluted earnings per share are the same amount and reported as a single line item on the face of the financial statements. Basic earnings per share is the amount of net income or loss for the period per each share of common stock or unit outstanding during the reporting period. Diluted earnings per share includes the amount of net income or loss for the period available to each share of common stock or common unit outstanding during the reporting period and to each share or unit that would have been outstanding assuming the issuance of common shares or units for all dilutive potential common shares or units outstanding during the reporting period. No definition available.
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X | ||||||||||
- Definition
The portion of profit or loss for the period, net of income taxes, which is attributable to the parent. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition
The net result for the period of deducting operating expenses from operating revenues. No definition available.
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X | ||||||||||
- Definition
The net amount of other income and expense amounts, the components of which are not separately disclosed on the income statement, resulting from ancillary business-related activities (that is, excluding major activities considered part of the normal operations of the business) also known as other nonoperating income (expense) recognized for the period. Such amounts may include: (a) dividends, (b) interest on securities, (c) net gains or losses on securities, (d) unusual costs, (e) gains or losses on foreign exchange transactions, and (f) miscellaneous other income and expense items. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition
The costs incurred in a planned search or critical investigation aimed at discovery of new knowledge with the hope that such knowledge will be useful in developing a new product or service, a new process or technique, or in bringing about a significant improvement to an existing product or process; or to translate research findings or other knowledge into a plan or design for a new product or process or for a significant improvement to an existing product or process whether intended for sale or the entity's use, during the reporting period charged to research and development projects, excluding in-process research and development acquired in a business combination consummated during the period. Excludes software research and development, which has a separate concept. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition
Aggregate revenue recognized during the period (derived from goods sold, services rendered, insurance premiums, or other activities that constitute an entity's earning process). For financial services companies, also includes investment and interest income, and sales and trading gains. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Details
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X | ||||||||||
- Definition
Aggregate revenue during the period from the sale of goods in the normal course of business, after deducting returns, allowances and discounts. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition
The aggregate total costs related to selling a firm's product and services, as well as all other general and administrative expenses. Direct selling expenses (for example, credit, warranty, and advertising) are expenses that can be directly linked to the sale of specific products. Indirect selling expenses are expenses that cannot be directly linked to the sale of specific products, for example telephone expenses, Internet, and postal charges. General and administrative expenses include salaries of non-sales personnel, rent, utilities, communication, etc. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Details
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X | ||||||||||
- Definition
Fees earned by non-employee directors under the Company's Directors' Deferred Compensation Plan which will be paid out in the form of Company common stock. No definition available.
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X | ||||||||||
- Definition
Payments on capital lease and financed equipment obligations No definition available.
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- Details
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X | ||||||||||
- Definition
Includes currency on hand as well as demand deposits with banks or financial institutions. It also includes other kinds of accounts that have the general characteristics of demand deposits in that the Entity may deposit additional funds at any time and also effectively may withdraw funds at any time without prior notice or penalty. Cash equivalents, excluding items classified as marketable securities, include short-term, highly liquid investments that are both readily convertible to known amounts of cash, and so near their maturity that they present minimal risk of changes in value because of changes in interest rates. Generally, only investments with original maturities of three months or less qualify under that definition. Original maturity means original maturity to the entity holding the investment. For example, both a three-month US Treasury bill and a three-year Treasury note purchased three months from maturity qualify as cash equivalents. However, a Treasury note purchased three years ago does not become a cash equivalent when its remaining maturity is three months. Compensating balance arrangements that do not legally restrict the withdrawal or usage of cash amounts may be reported as Cash and Cash Equivalents, while legally restricted deposits held as compensating balances against borrowing arrangements, contracts entered into with others, or company statements of intention with regard to particular deposits are not generally reported as cash and cash equivalents. Includes cash and cash equivalents associated with the entity's continuing operations. Excludes cash and cash equivalents associated with the disposal group (and discontinued operation). Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition
The increase (decrease) during the reporting period in cash and cash equivalents. While for technical reasons this element has no balance attribute, the default assumption is a debit balance consistent with its label. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition
The aggregate expense recognized in the current period that allocates the cost of tangible assets, intangible assets, or depleting assets to periods that benefit from use of the assets. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition
The amount of impairment loss recognized in the period resulting from the write-down of the carrying amount of a finite-lived intangible asset to fair value. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition
The increase (decrease) during the reporting period in the aggregate amount of liabilities incurred (and for which invoices have typically been received) and payable to vendors for goods and services received that are used in an entity's business. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition
The increase (decrease) during the reporting period in amount due within one year (or one business cycle) from customers for the credit sale of goods and services. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition
The increase (decrease) during the reporting period in the aggregate amount of expenses incurred but not yet paid. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition
The increase (decrease) during the reporting period in the aggregate value of all inventory held by the reporting entity, associated with underlying transactions that are classified as operating activities. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Details
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X | ||||||||||
- Definition
The increase (decrease) during the reporting period in the value of prepaid expenses and other assets not separately disclosed in the statement of cash flows, for example, deferred expenses, intangible assets,or income taxes. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition
The net cash inflow or outflow from financing activity for the period. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Details
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X | ||||||||||
- Definition
The net cash inflow or outflow from investing activity. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Details
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X | ||||||||||
- Definition
The net cash from (used in) all of the entity's operating activities, including those of discontinued operations, of the reporting entity. Operating activities generally involve producing and delivering goods and providing services. Operating activity cash flows include transactions, adjustments, and changes in value that are not defined as investing or financing activities. While for technical reasons this element has no balance attribute, the default assumption is a debit balance consistent with its label. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Details
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X | ||||||||||
- Definition
The portion of profit or loss for the period, net of income taxes, which is attributable to the parent. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition
The cash outflow from purchases of available-for-sale securities and held-to-maturity securities. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition
The cash outflow associated with the acquisition of long-lived, physical assets that are used in the normal conduct of business to produce goods and services and not intended for resale; includes cash outflows to pay for construction of self-constructed assets. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition
The cash inflow from the additional capital contribution to the entity. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition
The cash inflow associated with the maturity, prepayments and calls (requests for early payments) of debt securities designated as held-to-maturity. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition
The cash inflow associated with the amount received from holders exercising their stock options. This item inherently excludes any excess tax benefit, which the entity may have realized and reported separately. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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X | ||||||||||
- Definition
The amount of previously reported deferred or unearned revenue that was recognized as revenue during the period. For cash flows, this element primarily pertains to amortization of deferred credits on long-term arrangements. As a noncash item, it is deducted from net income when calculating cash provided by or used in operations using the indirect method. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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- Definition
The aggregate amount of noncash, equity-based employee remuneration. This may include the value of stock or unit options, amortization of restricted stock or units, and adjustment for officers' compensation. As noncash, this element is an add back when calculating net cash generated by operating activities using the indirect method. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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Business and Basis of Presentation
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9 Months Ended |
---|---|
Sep. 30, 2011
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|
Business and Basis of Presentation [Abstract] | |
Business and Basis of Presentation |
1. Business and Basis of Presentation
Business
GTx, Inc. (“GTx” or the “Company”), a Delaware corporation incorporated on September 24, 1997
and headquartered in Memphis, Tennessee, is a biopharmaceutical company dedicated to the discovery,
development and commercialization of small molecules that selectively target hormone pathways for
the treatment of cancer, cancer supportive care, and other serious medical conditions.
The Company is developing selective androgen receptor modulators (“SARMs”), including
OstarineTM (GTx-024). SARMs are a new class of drugs with the potential to prevent and
treat muscle wasting in patients with cancer and other musculoskeletal wasting or muscle loss
conditions, including chronic sarcopenia (age related muscle loss). The Company has commenced two
pivotal Phase III clinical trials evaluating OstarineTM for the prevention and treatment
of muscle wasting in patients with non-small cell lung cancer.
Additionally, the Company is developing CapesarisTM (GTx-758), an oral nonsteriodal
selective estrogen receptor alpha agonist. The Company is developing CapesarisTM for
first line and second line hormonal treatment of advanced prostate cancer. With respect to first
line hormonal therapy, the Company has completed enrollment in a Phase II maintenance dose finding clinical trial and
has initiated a Phase II loading dose finding clinical trial evaluating CapesarisTM in
men with advanced prostate cancer. The Company will also initiate a second line hormonal therapy
Phase II clinical trial evaluating CapesarisTM in men with castration resistant prostate
cancer.
The Company markets FARESTON® (toremifene citrate) 60 mg tablets, approved for the
treatment of advanced metastatic breast cancer in postmenopausal women, in the United States. The
Company previously determined to discontinue its toremifene 80 mg and toremifene 20 mg development
programs.
Basis of Presentation
The accompanying unaudited condensed financial statements reflect, in the opinion of
management, all adjustments (consisting of normal recurring adjustments) necessary for a fair
presentation of GTx’s financial position, results of operations and cash flows for each period
presented in accordance with accounting principles generally accepted in the United States for
interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation
S-X. Accordingly, information and footnote disclosures normally included in financial statements
prepared in accordance with accounting principles generally accepted in the United States have been
condensed or omitted from the accompanying condensed financial statements. These interim condensed
financial statements should be read in conjunction with the audited financial statements and
related notes thereto, which are included in the Company’s Annual Report on Form 10-K for the year
ended December 31, 2010. Operating results for the three months and nine months ended September
30, 2011 are not necessarily indicative of the results that may be expected for the entire fiscal
year ending December 31, 2011.
Use of Estimates
The preparation of condensed financial statements in conformity with accounting principles
generally accepted in the United States requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities, the disclosure of contingent assets and
liabilities at the date of the condensed financial statements, and the reported amounts of revenues
and expenses during the reporting period. Actual amounts and results could differ from those
estimates.
Revenue Recognition
The Company recognizes revenue from product sales of FARESTON® less deductions for
estimated sales discounts and sales returns. Revenue from product sales is recognized when
persuasive evidence of an arrangement exists, title passes, the price is fixed or determinable, and
collectability is reasonably assured. The Company accounts for rebates to certain governmental
agencies as a reduction of product sales. The Company allows customers to return product within a
specified time period prior to and subsequent to the product’s labeled expiration date. The
Company estimates an accrual for product returns, which is recorded as a reduction of product
sales, based on factors which include historical product returns and estimated product in the
distribution channel which is expected to exceed its expiration date. At September 30, 2011 and
December 31, 2010, the Company’s accrual for product returns was $978 and $802, respectively.
Collaboration revenue consisted of non-refundable upfront payments, license fees,
reimbursements for research and development activities, and milestone payments associated with the
Company’s former collaboration and license agreements. Revenues from the Company’s prior
collaboration and license agreements were recognized based on the performance requirements of the
specific agreements. The Company analyzed agreements with multiple element arrangements to
determine whether the deliverables under the agreement, including license and performance
obligations such as joint steering committee participation and research and development activities,
could have been separated or whether all of the deliverables must have been accounted for as a
single unit of accounting. Revenues from milestone payments for which the Company had no
continuing performance obligations were recognized upon achievement of the performance milestone,
as defined in the related agreement, provided the milestone was substantive and a culmination of
the earnings process had occurred. Due to the termination of the Company’s license and
collaboration agreement with Ipsen Biopharm Limited (“Ipsen”) in March 2011, the Company recognized
collaboration revenue of $8,066 in the first quarter of 2011 as the Company has no further
performance obligations.
Research and Development Expenses
Research and development expenses include, but are not limited to, the Company’s expenses for
personnel, supplies, and facilities associated with research activities, screening and
identification of product candidates, formulation and synthesis activities, manufacturing,
preclinical studies, toxicology studies, clinical trials, regulatory affairs activities, quality
assurance activities and license fees. The Company expenses these costs in the period in which
they are incurred. The Company estimates its liabilities for research and development expenses in
order to match the recognition of expenses to the period in which the actual services are received.
As such, accrued liabilities related to third party research and development activities are
recognized based upon the Company’s estimate of services received and degree of completion of the
services in accordance with the specific third party contract.
Cash, Cash Equivalents and Short-term Investments
The Company considers highly liquid investments with initial maturities of three months or
less to be cash equivalents.
At September 30, 2011 and December 31, 2010, short-term investments consisted of certificates
of deposit with original maturities of greater than three months and less than one year. As the
Company has the positive intent and ability to hold the certificates of deposit until maturity,
these investments have been classified as held to maturity investments and are stated at cost,
which approximates fair value.
Impairment of Long-Lived Assets
The Company reviews long-lived assets for impairment whenever events or changes in facts and
circumstances are present, both internally and externally, that may indicate impairment of
long-lived assets held for use. An impairment loss is recognized when estimated future cash flows
are less than the carrying amount. The cash flow estimates are based on management’s best
estimates, using appropriate and customary assumptions and projections at the time.
Based upon the Company’s decision to discontinue toremifene 80 mg development and after
analyzing future cash flows and estimates of fair market value from a market participant
perspective, the Company determined that its toremifene 80 mg intangible asset was impaired and
recorded an impairment charge of $1,598 during the three months ended March 31, 2011. The impaired
intangible asset consisted of the unamortized portion of capitalized license fees paid to Orion
Corporation (“Orion”) related to the Company’s toremifene 80 mg program. This license fee was paid
under the amended and restated license and supply agreement for the Company’s exclusive license
from Orion to develop and commercialize toremifene-based products.
The impairment charge was included in research and development expenses in the condensed
statement of operations for the nine months ended September 30, 2011.
Income Taxes
The Company accounts for deferred taxes by recognition of deferred tax assets and liabilities
for the expected future tax consequences of events that have been included in the financial
statements or tax returns. Under this method, deferred tax assets and liabilities are determined
based on the difference between the financial statement and tax basis of assets and liabilities
using enacted tax rates in effect for the year in which the differences are expected to reverse. A
valuation allowance is provided when it is more likely than not that some portion or all of the
deferred tax assets will not be realized. Accordingly, at September 30, 2011 and December 31,
2010, net of the valuation allowance, the net deferred tax assets were reduced to zero. Income
taxes are described more fully in Note 9 to the Company’s financial statements included in the
Company’s Annual Report on Form 10-K for the year ended December 31, 2010.
Other Income, net
Other income, net consists of interest earned on the Company’s cash, cash equivalents and
short-term investments, interest expense, foreign currency transaction gains and losses, and other
non-operating income or expense.
Subsequent Events
The Company has evaluated all events or transactions that occurred after September 30, 2011 up
through the date the condensed financial statements were issued. There were no material
recognizable or nonrecognizable subsequent events during the period evaluated.
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The entire disclosure for the general note to the financial statements for the reporting entity which may include, descriptions of the basis of presentation, business description, significant accounting policies, consolidations, reclassifications, new pronouncements not yet adopted and changes in accounting principles. No definition available.
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Share-Based Compensation
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Share-Based Compensation |
2. Share-Based Compensation
Share-based payments include stock option grants under the Company’s stock option and equity
incentive plans and deferred compensation arrangements for the Company’s non-employee directors.
The Company recognizes compensation expense for its share-based payments based on the fair value of
the awards over the period during which an employee or non-employee director is required to provide
service in exchange for the award. The Company’s share-based compensation plans are described more
fully in Note 3 to the Company’s financial statements included in the Company’s Annual Report on
Form 10-K for the year ended December 31, 2010.
The following table summarizes share-based compensation expense included within the condensed
statements of operations for the three and nine months ended September 30, 2011 and 2010:
Share-based compensation expense recorded as general and administrative expense for both of
the three months ended September 30, 2011 and 2010 included share-based compensation expense
related to deferred compensation arrangements for the Company’s non-employee directors of $45.
Share-based compensation expense related to deferred compensation arrangements for the Company’s
non-employee directors of $141 was included in share-based compensation expense recorded as general
and administrative expenses for both of the nine months ended September 30, 2011 and 2010.
The fair value of options granted was estimated using the following assumptions for the
periods presented:
The following is a summary of stock option transactions for all of the Company’s stock
option and equity incentive plans since the Company’s most recent fiscal year end:
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The entire disclosure for compensation-related costs for equity-based compensation, which may include disclosure of policies, compensation plan details, allocation of equity compensation, incentive distributions, equity-based arrangements to obtain goods and services, deferred compensation arrangements, employee stock ownership plan details and employee stock purchase plan details. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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Basic and Diluted Net (Loss) Income Per Share
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Sep. 30, 2011
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Earnings Per Share [Abstract] | |
Basic and Diluted Net (Loss) Income Per Share |
3. Basic and Diluted Net (Loss) Income Per Share
Basic and diluted net (loss) income per share attributable to common stockholders is
calculated based on the weighted average number of common shares outstanding during the period.
Diluted net (loss) income per share also gives effect to the dilutive potential of common stock
consisting of stock options.
Weighted average options outstanding to purchase shares of common stock of 5,113,943 and
4,515,006 for the three months ended September 30, 2011 and 2010, respectively, and 5,455,700 and
4,501,002 for the nine months ended September 30, 2011 and 2010, respectively, were excluded from
the calculations of diluted net (loss) income per share as inclusion of the options would have had
an anti-dilutive effect on the net (loss) income per share for the periods.
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The entire disclosure for earnings per share. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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Common Stock
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Common Stock [Abstract] | |
Common Stock |
4. Common Stock
On May 6, 2011, the Company filed a Certificate of Amendment to the Company’s Restated
Certificate of Incorporation with the Secretary of State of the State of Delaware to increase the
number of authorized shares of the Company’s common stock, par value $0.001 per share, from
60,000,000 shares to 120,000,000 shares. The foregoing amendment was approved by the Company’s
stockholders at the Company’s 2011 Annual Meeting of Stockholders held on May 5, 2011.
On June 28, 2011, the Company completed an underwritten public offering of 10,000,000 shares
of its common stock at a price to the public of $4.75 per share. The Company also granted the
underwriters a 30-day option to purchase up to an additional 1,500,000 shares of common stock to
cover over-allotments, if any. The underwriters exercised this option and purchased an additional
1,023,000 shares of the Company’s common stock on June 28, 2011 at a price of $4.75 per share. Net
cash proceeds from the public offering were approximately $49,000 after deducting the underwriting
discount and offering expenses.
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The entire disclosure for shareholders' equity, comprised of portions attributable to the parent entity and noncontrolling interest, if any, including other comprehensive income (as applicable). Including, but not limited to: (1) balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings; (2) accumulated balance for each classification of other comprehensive income and total amount of comprehensive income; (3) amount and nature of changes in separate accounts, including the number of shares authorized and outstanding, number of shares issued upon exercise and conversion, and for other comprehensive income, the adjustments for reclassifications to net income; (4) rights and privileges of each class of stock authorized; (5) basis of treasury stock, if other than cost, and amounts paid and accounting treatment for treasury stock purchased significantly in excess of market; (6) dividends paid or payable per share and in the aggregate for each class of stock for each period presented; (7) dividend restrictions and accumulated preferred dividends in arrears (in aggregate and per share amount); (8) retained earnings appropriations or restrictions, such as dividend restrictions; (9) impact of change in accounting principle, initial adoption of new accounting principle and correction of an error in previously issued financial statements; (10) shares held in trust for Employee Stock Ownership Plan (ESOP); (11) deferred compensation related to issuance of capital stock; (12) note received for issuance of stock; (13) unamortized discount on shares; (14) description, terms, and number of warrants or rights outstanding; (15) shares under subscription and subscription receivables, effective date of new retained earnings after quasi-reorganization and deficit eliminated by quasi-reorganization and, for a period of at least ten years after the effective date, the point in time from which the new retained dates; and (16) retroactive effective of subsequent change in capital structure. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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Collaboration and License Agreements
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Collaboration and License Agreements [Abstract] | |
Collaboration and License Agreements |
5. Collaboration and License Agreements
University of Tennessee Research Foundation License Agreements
The Company and the University of Tennessee Research Foundation (“UTRF”) are parties to a
consolidated, amended and restated license agreement (the “SARM License Agreement”) pursuant to
which the Company was granted exclusive worldwide rights in all existing SARM technologies owned or
controlled by UTRF, and certain improvements thereto, and exclusive rights to certain future SARM
technology that may be developed by certain scientists at the University of Tennessee or
subsequently licensed to UTRF under certain existing inter-institutional agreements with The Ohio
State University. Under the SARM License Agreement, the Company is obligated to pay UTRF annual
license maintenance fees, low single-digit royalties on net sales of products and mid single-digit
royalties on sublicense revenues.
Additionally, the Company and UTRF previously entered into an amended and restated license
agreement (the “SERM License Agreement”) pursuant to which the Company was granted exclusive
worldwide rights to UTRF’s method of use patents relating to SERMs, including toremifene for
chemoprevention of prostate cancer. In light of the Company’s decision to discontinue further
clinical development of toremifene 20 mg, the Company exercised its right to terminate the SERM
License Agreement with UTRF during the first quarter of 2011.
Ipsen Collaboration and License Agreement
In September 2006, the Company entered into a collaboration and license agreement with Ipsen
(the “Ipsen Collaboration Agreement”) pursuant to which the Company granted Ipsen exclusive rights
in the European Union, Switzerland, Norway, Iceland, Lichtenstein, and the Commonwealth of
Independent States (the “European Territory”) to develop and commercialize toremifene in all
indications which the Company has licensed from Orion, which include all indications in humans
except the treatment and prevention of breast cancer outside of the United States.
In accordance with the terms of the Ipsen Collaboration Agreement, Ipsen paid the Company
€23,000 as a license fee and expense reimbursement. In February 2008, the Company earned a
milestone of €1,000 (approximately $1,482) with the achievement of the primary endpoint in the
Company’s completed pivotal Phase III clinical trial evaluating toremifene 80 mg to reduce
fractures in men with prostate cancer on ADT. This amount was recognized as collaboration revenue
in the first quarter of 2008. Under the Ipsen Collaboration Agreement, the Company recorded
deferred revenue of $29,330 related to the Ipsen upfront license fee and expense reimbursement
which was being amortized into revenue on a straight-line basis over the estimated ten year
development period for toremifene in the European Territory.
In March 2011, the Company reacquired full rights to its toremifene program following the
termination by the Company and Ipsen of the collaboration and license agreement, as amended (the
“Amended Ipsen Collaboration Agreement”). During the first quarter of 2011, the Company recognized
as collaboration revenue all of the remaining $8,066 unamortized revenue that was deferred as of
December 31, 2010. This amount is included in collaboration revenue in the condensed statement of
operations for the nine months ended September 30, 2011. The Company recognized as collaboration
revenue $336 and $1,595 for the three months and nine months ended September 30, 2010,
respectively, from the amortization of the Ipsen deferred revenue.
Merck & Co., Inc. Collaboration and License Agreement
In December 2007, GTx and Merck & Co., Inc. (“Merck”) entered into a global exclusive license
and collaboration agreement (the “Merck Collaboration Agreement”) governing the Company’s and
Merck’s joint research, development and commercialization of SARM compounds and related SARM
products for all potential indications of interest. In March 2010, the Company reacquired full
rights to its SARM program, including OstarineTM, following the termination by the
Company and Merck of the Merck Collaboration Agreement.
Under the Merck Collaboration Agreement, the Company granted Merck an exclusive worldwide
license under its SARM-related patents and know-how. The Company conducted preclinical research of
SARM compounds and products, and Merck was primarily responsible under the terms of the agreement
for conducting and funding development and commercialization of products developed under the Merck
Collaboration Agreement. Merck paid the Company an upfront licensing fee of $40,000 and purchased
approximately $30,000 of the Company’s common stock. In addition, Merck paid the Company $15,000
in cost reimbursements for research and development activities in equal annual installments over a
three year period.
The Company deferred the recognition of the upfront licensing fee of $40,000 and the $10,800
in equity premium received that represented the difference between the purchase price and the
closing price of the Company’s common stock on the date the stock was purchased by Merck. These
payments were being recognized as collaboration revenue over the period of the Company’s
performance obligation, which the Company estimated to be ten years. The $5,000 of cost
reimbursements received in both December 2008 and December 2009 were being recognized as
collaboration revenue over the remaining period of the Company’s performance obligation. In March
2010, the Company reacquired full rights to the Company’s SARM program following the termination by
the Company and Merck of the Merck Collaboration Agreement. In the first quarter of 2010, the
Company recognized as collaboration revenue all of the remaining $49,856 unamortized revenue that
was deferred as of December 31, 2009, as well as the final $5,000 research and development
activities cost reimbursement due under the terms of the Merck Collaboration Agreement in December
2010 for which the Company had no further performance obligation. These amounts are included in
collaboration revenue in the condensed statement of operations for the nine months ended September
30, 2010.
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The entire disclosure for collaborative arrangements in which the entity is a participant, including a) information about the nature and purpose of such arrangements; b) its rights and obligations thereunder; c) the accounting policy for collaborative arrangements; and d) the income statement classification and amounts attributable to transactions arising from the collaborative arrangement between participants. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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