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Document and Entity Information
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9 Months Ended | |
|---|---|---|
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Sep. 30, 2011
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Oct. 27, 2011
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| Document Information [Line Items] | ||
| Document Type | 10-Q | |
| Amendment Flag | false | |
| Document Period End Date | Sep. 30, 2011 | |
| Document Fiscal Year Focus | 2011 | |
| Document Fiscal Period Focus | Q3 | |
| Trading Symbol | ACUR | |
| Entity Registrant Name | ACURA PHARMACEUTICALS, INC | |
| Entity Central Index Key | 0000786947 | |
| Current Fiscal Year End Date | --12-31 | |
| Entity Filer Category | Non-accelerated Filer | |
| Entity Common Stock, Shares Outstanding | 45,318,693 |
| X | ||||||||||
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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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| X | ||||||||||
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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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| X | ||||||||||
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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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- Details
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| X | ||||||||||
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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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| X | ||||||||||
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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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| X | ||||||||||
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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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| X | ||||||||||
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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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| X | ||||||||||
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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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| X | ||||||||||
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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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| X | ||||||||||
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- Definition
Trading symbol of an instrument as listed on an exchange. No definition available.
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CONSOLIDATED BALANCE SHEETS (USD $)
In Thousands, unless otherwise specified |
Sep. 30, 2011
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Dec. 31, 2010
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|---|---|---|
| Current assets | ||
| Cash and cash equivalents | $ 37,660 | $ 24,045 |
| Collaboration revenue receivable | 126 | |
| Prepaid expenses and other current assets | 426 | 270 |
| Total current assets | 38,086 | 24,441 |
| Property, plant and equipment, net | 1,002 | 1,052 |
| Total assets | 39,088 | 25,493 |
| Current liabilities | ||
| Accounts payable | 45 | |
| Accrued expenses | 966 | 686 |
| Income taxes payable | 105 | |
| Deferred program fee revenue | 466 | |
| Total current liabilities | 1,116 | 1,152 |
| Commitments and contingencies (Note 9) | ||
| Stockholders' equity | ||
| Common stock - $.01 par value; 100,000 shares authorized; 45,316 and 43,894 shares issued and outstanding at September 30, 2011 and December 31, 2010 | 453 | 439 |
| Additional paid-in capital | 361,416 | 359,830 |
| Accumulated deficit | (323,897) | (335,928) |
| Total stockholders' equity | 37,972 | 24,341 |
| Total liabilities and stockholders' equity | $ 39,088 | $ 25,493 |
| X | ||||||||||
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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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| X | ||||||||||
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- Definition
Carrying amount as of the balance sheet date of the unpaid sum of the known and estimated amounts payable to satisfy all currently due domestic and foreign income tax obligations. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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| X | ||||||||||
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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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| X | ||||||||||
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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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| X | ||||||||||
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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 | ||||||||||
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- 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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| X | ||||||||||
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- Details
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| X | ||||||||||
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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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| X | ||||||||||
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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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| X | ||||||||||
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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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| X | ||||||||||
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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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| X | ||||||||||
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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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| X | ||||||||||
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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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| X | ||||||||||
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- Details
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| X | ||||||||||
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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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| X | ||||||||||
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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 | ||||||||||
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- Definition
The total amount due to the entity within one year of the balance sheet date (or one operating cycle, if longer) from outside sources, including trade accounts receivable, notes and loans receivable, as well as any other types of receivables, net of allowances established for the purpose of reducing such receivables to an amount that approximates their net realizable value. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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| X | ||||||||||
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- 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 | ||||||||||
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- 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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| X | ||||||||||
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- Details
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CONSOLIDATED BALANCE SHEETS (Parenthetical) (USD $)
In Thousands, except Per Share data, unless otherwise specified |
Sep. 30, 2011
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Dec. 31, 2010
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|---|---|---|
| Common stock, par value | $ 0.01 | $ 0.01 |
| Common stock, shares authorized | 100,000 | 100,000 |
| Common stock, shares issued | 45,316 | 43,894 |
| Common stock, shares outstanding | 45,316 | 43,894 |
| X | ||||||||||
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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 | ||||||||||
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- 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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| X | ||||||||||
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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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| X | ||||||||||
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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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CONSOLIDATED STATEMENTS OF OPERATIONS (USD $)
In Thousands, except Per 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 | ||||
| Program fee revenue | $ 233 | $ 466 | $ 855 | |
| Milestone revenue | 20,000 | |||
| Collaboration revenue | 59 | 2,097 | ||
| Total revenues | 292 | 20,466 | 2,952 | |
| Operating expenses | ||||
| Research and development | 962 | 1,142 | 3,245 | 5,714 |
| Marketing, general and administrative | 1,185 | 1,716 | 4,840 | 7,025 |
| Total operating expenses | 2,147 | 2,858 | 8,085 | 12,739 |
| Income (loss) from operations | (2,147) | (2,566) | 12,381 | (9,787) |
| Other (expense) income, net | 6 | 15 | (9) | 17 |
| Income (loss) before income tax | (2,141) | (2,551) | 12,372 | (9,770) |
| Income tax expense | 2 | 341 | 10 | |
| Net income (loss) | $ (2,141) | $ (2,553) | $ 12,031 | $ (9,780) |
| Income (loss) per share | ||||
| Basic | $ (0.05) | $ (0.05) | $ 0.25 | $ (0.21) |
| Diluted | $ (0.05) | $ (0.05) | $ 0.25 | $ (0.21) |
| Weighted average shares | ||||
| Basic | 47,802 | 47,100 | 47,392 | 46,992 |
| Diluted | 47,802 | 47,100 | 47,627 | 46,992 |
| X | ||||||||||
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- Definition
Program fee revenue No definition available.
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| X | ||||||||||
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- 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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| X | ||||||||||
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- Details
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| X | ||||||||||
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- Definition
The amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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| X | ||||||||||
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- Definition
The amount of net income (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. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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| X | ||||||||||
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- Definition
Sum of operating profit and nonoperating income or expense before Income or Loss from equity method investments, income taxes, extraordinary items, and noncontrolling interest. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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| X | ||||||||||
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- Definition
The sum of the current income tax expense or benefit and the deferred income tax expense or benefit pertaining to continuing operations. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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| X | ||||||||||
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- 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 | ||||||||||
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- Definition
The net result for the period of deducting operating expenses from operating revenues. No definition available.
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| X | ||||||||||
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- 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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| X | ||||||||||
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- Definition
Repayment received or receivable for expenses incurred on behalf of a client or customer, other than those reimbursements received by landlords from tenants. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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| X | ||||||||||
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- Definition
The aggregate costs incurred (1) 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 (2) 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, including the costs of developing computer software up to the point in time of achieving technological feasibility, and costs allocated in accounting for a business combination to in-process projects deemed to have no alternative future use. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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| X | ||||||||||
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- Definition
The amount of consideration recognized during the period for the milestone or milestones. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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| X | ||||||||||
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- 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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| X | ||||||||||
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- Details
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| X | ||||||||||
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- 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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| X | ||||||||||
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- Definition
The average number of shares or units issued and outstanding that are used in calculating diluted EPS or earnings per unit (EPU), determined based on the timing of issuance of shares or units in the period. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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| X | ||||||||||
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- Definition
Number of [basic] shares or units, after adjustment for contingently issuable shares or units and other shares or units not deemed outstanding, determined by relating the portion of time within a reporting period that common shares or units have been outstanding to the total time in that period. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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| X | ||||||||||
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- Details
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CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY (USD $)
In Thousands |
Total
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Common Stock
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Additional Paid - in Capital
|
Accumulated Deficit
|
|---|---|---|---|---|
| Beginning Balance at Dec. 31, 2010 | $ 24,341 | $ 439 | $ 359,830 | $ (335,928) |
| Beginning Balance (in shares) at Dec. 31, 2010 | 43,894 | |||
| Net income | 12,031 | 12,031 | ||
| Share-based compensation | 2,133 | 2,133 | ||
| Distribution of common stock pursuant to restricted stock unit award plan (in shares) | 540 | |||
| Distribution of common stock pursuant to restricted stock unit award plan | (948) | 5 | (953) | |
| Issuance of common stock pursuant to exercise of stock options (in shares) | 546 | |||
| Issuance of common stock pursuant to exercise of stock options | (661) | 6 | (667) | |
| Issuance of common stock pursuant to exercise of common stock warrants (in shares) | 336 | |||
| Issuance of common stock pursuant to exercise of common stock warrants | 1,076 | 3 | 1,073 | |
| Ending Balance at Sep. 30, 2011 | $ 37,972 | $ 453 | $ 361,416 | $ (323,897) |
| Ending Balance (in shares) at Sep. 30, 2011 | 45,316 |
| X | ||||||||||
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- Definition
Number of shares issued during the period as a result of the exercise of warrants. No definition available.
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| X | ||||||||||
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- Definition
Value stock issued during the period as a result of the exercise of warrants. No definition available.
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| X | ||||||||||
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- Definition
This element represents the amount of recognized equity-based compensation during the period, that is, the amount recognized as expense in the income statement (or as asset if compensation is capitalized). Alternate captions include the words "stock-based compensation". Reference 1: http://www.xbrl.org/2003/role/presentationRef
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| X | ||||||||||
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- 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 | ||||||||||
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- Definition
Number of shares issued and outstanding as of the balance sheet date. No definition available.
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| X | ||||||||||
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- 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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| X | ||||||||||
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- Definition
Number of shares issued during the period related to Restricted Stock Awards, net of any shares forfeited. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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| X | ||||||||||
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- Definition
Number of share options (or share units) exercised during the current period. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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| X | ||||||||||
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- Definition
Value of stock related to Restricted Stock Awards issued during the period, net of the stock value of such awards forfeited. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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| X | ||||||||||
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- Definition
Value stock issued during the period as a result of the exercise of stock options. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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| X | ||||||||||
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- Details
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| X | ||||||||||
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- Details
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| X | ||||||||||
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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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| X | ||||||||||
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- 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 | ||||||||||
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- Definition
The amount of expense recognized in the current period that reflects the allocation of the cost of tangible assets over the assets' useful lives. Includes production and non-production related depreciation. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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| X | ||||||||||
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- Definition
The difference between the sale price or salvage price and the book value of a property, plant, and equipment asset that was sold or retired during the reporting period. This element refers to the gain (loss). Reference 1: http://www.xbrl.org/2003/role/presentationRef
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| X | ||||||||||
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- Definition
The amount of cash paid during the current period to foreign, federal, state, and local authorities as taxes on income. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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| X | ||||||||||
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- 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 | ||||||||||
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- Definition
The increase (decrease) during the period in the amount due for taxes based on the reporting entity's earnings or attributable to the entity's income earning process (business presence) within a given jurisdiction. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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| X | ||||||||||
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- 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 | ||||||||||
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- Definition
The increase (decrease) during the reporting period, excluding the portion taken into income, in the liability reflecting revenue yet to be earned for which cash or other forms of consideration was received or recorded as a receivable. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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| X | ||||||||||
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- Details
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| X | ||||||||||
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- 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 | ||||||||||
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- Definition
The increase (decrease) during the reporting period in the total amount due within one year (or one operating cycle) from all parties, associated with underlying transactions that are classified as operating activities. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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| X | ||||||||||
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- Definition
The amount of cash paid for interest during the period. 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 | ||||||||||
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- Details
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| X | ||||||||||
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- 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 | ||||||||||
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- 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 paid by the company to cover an employee's income tax withholding obligation as part of a net-share settlement of a share-based award. No definition available.
|
| 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 | ||||||||||
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- Definition
The cash inflow from other equity not otherwise defined in the taxonomy. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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| X | ||||||||||
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- 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 | ||||||||||
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- Definition
The cash inflow associated with the amount received from holders exercising their stock warrants. No definition available.
|
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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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|
CONSOLIDATED STATEMENTS OF CASH FLOWS (Parenthetical) (USD $)
In Thousands, except Per Share data, unless otherwise specified |
9 Months Ended | ||
|---|---|---|---|
|
Sep. 30, 2011
Stock Option
|
Sep. 30, 2011
Restricted Stock Units (RSUs)
|
Sep. 30, 2010
Warrant
|
|
| Supplemental Disclosure of Noncash Financing Activities: | |||
| Equity based employee compensation granted | 923 | 735 | 64 |
| Issuance of common stock for cashless exercise of warrants, exercise price per share | $ 1.29 | ||
| Common Stock issued upon exercise | 377 | 446 | 14 |
| Common stock withheld | 547 | 289 | |
| Minimum statutory withholding payroll taxes withheld | $ 877 | $ 953 | |
| X | ||||||||||
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- Definition
Common Stock Issued, Shares No definition available.
|
| X | ||||||||||
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- Definition
Common stock issued upon exercise of warrant, price per share No definition available.
|
| X | ||||||||||
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- Definition
Common Stock Withheld , Shares No definition available.
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| X | ||||||||||
|
- Definition
Equity Based Employee Compensation Granted, Shares No definition available.
|
| X | ||||||||||
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- Definition
Supplemental Tax Withholding No definition available.
|
| X | ||||||||||
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- Details
|
|
BASIS OF PRESENTATION
|
9 Months Ended |
|---|---|
|
Sep. 30, 2011
|
|
| BASIS OF PRESENTATION |
NOTE 1 BASIS OF PRESENTATION
Acura
Pharmaceuticals, Inc., a New York corporation, and its subsidiary
(the “Company”, “We”, or “Our”)
is a specialty pharmaceutical company engaged in research,
development and commercialization of products intended to address
medication abuse and misuse, utilizing its proprietary
Aversion® and Impede™ technologies.
The
accompanying unaudited consolidated financial statements of the
Company were prepared in accordance with generally accepted
accounting principles for interim financial information and
instructions to Form 10-Q and Rule 10-01 of Regulation
S-X. Accordingly, these financial statements do not
include all of the information and footnotes required by accounting
principles generally accepted in the United States of America for
complete financial statements. In the opinion of
management, all adjustments considered necessary to present fairly
the Company’s financial position, results of operations and
cash flows have been made. The results of operations for
the nine months ended September 30, 2011 are not necessarily
indicative of results expected for the full year ending December
31, 2011. These unaudited consolidated financial
statements should be read in conjunction with the audited
consolidated financial statements and footnotes thereto for the
year ended December 31, 2010 included in the Company's Annual
Report on Form 10-K filed with the Securities and Exchange
Commission. The 2010 year-end consolidated balance sheet presented
in this Report was derived from the Company’s 2010 year-end
audited consolidated financial statements, but does not include all
disclosures required by generally accepted accounting principles.
Amounts presented in the financial statements and footnotes are
rounded to the nearest thousands, except per share data and par
values.
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| X | ||||||||||
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- Definition
The entire disclosure for organization, consolidation and basis of presentation of financial statements disclosure. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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RESEARCH AND DEVELOPMENT
|
9 Months Ended |
|---|---|
|
Sep. 30, 2011
|
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| RESEARCH AND DEVELOPMENT |
NOTE 2 RESEARCH AND DEVELOPMENT
Research
and Development (“R&D”) expenses include
internal R&D activities, external Contract Research
Organization (“CRO”) services and their clinical
research sites, and other activities. Internal R&D
activity expenses include facility overhead, equipment and facility
maintenance and repairs, laboratory supplies, pre-clinical
laboratory experiments, depreciation, salaries, benefits, and
share-based compensation expenses. CRO activity expenses include
preclinical laboratory experiments and clinical trial studies.
Other activity expenses include regulatory consulting, and
regulatory legal counsel. Internal R&D activities and other
activity expenses are charged to operations as incurred. We
make payments to the CRO's based on agreed upon terms and may
include payments in advance of a study starting date. We review and
accrue CRO expenses and clinical trial study expenses based on
services performed and rely on estimates of those costs applicable
to the stage of completion of a study as provided by the CRO.
Accrued CRO costs are subject to revisions as such studies
progress to completion. Revisions are charged to expense in the
period in which the facts that give rise to the revision become
known.
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- Definition
Research And Development Disclosure [Text Block] No definition available.
|
|
REVENUE RECOGNITION AND DEFERRED PROGRAM FEE REVENUE
|
9 Months Ended |
|---|---|
|
Sep. 30, 2011
|
|
| REVENUE RECOGNITION AND DEFERRED PROGRAM FEE REVENUE |
NOTE 3 REVENUE RECOGNITION AND DEFERRED PROGRAM FEE
REVENUE
We
recognize revenue when there is persuasive evidence that an
agreement exists, performance specified in the agreement has
occurred, the price is fixed and determinable, and collection is
reasonably assured. In connection with our License, Development,
and Commercialization Agreement dated October 30, 2007 (the
“Pfizer Agreement”) with King Pharmaceuticals Research
and Development, Inc. (“King”), a subsidiary of Pfizer,
Inc. (“Pfizer”), we recognize program fee revenue,
collaboration revenue and milestone revenue.
Program
fee revenue is derived from amortized upfront payments, such as the
$30.0 million upfront payment under the Pfizer Agreement received
in December 2007, and license fees, such as the $3.0 million option
exercise fee paid to us in each of May and December 2008 upon the
exercise of Pfizer’s option to license a third and fourth
opioid analgesic product candidate under the Pfizer Agreement. We
have assigned an equal portion of the $30.0 million upfront payment
to each of three product candidates identified in the Pfizer
Agreement and recognize the upfront payment as program fee revenue
ratably over our estimate of the development period for each
identified product candidate. The recognition of the program
fee revenue for two of the three product candidates was completed
by June 2008. During the second quarter 2011, we recognized the
remaining program fee revenue which was assigned to the third
product candidate under the Pfizer Agreement.
Collaboration
revenue was derived from reimbursement of R&D expenses, which
was invoiced quarterly in arrears, and was recognized when costs
were incurred pursuant to the Pfizer Agreement. The R&D
service that was provided to Pfizer under the Pfizer Agreement was
priced at fair value based upon the reimbursement of expenses
incurred pursuant to the Pfizer Agreement. We did not incur
reimbursable R&D expenses during the nine months ended
September 30, 2011 and we do not expect to incur any reimbursable
R&D expenses for Pfizer in the future under the Pfizer
Agreement.
Milestone
revenue is contingent upon the achievement of certain pre-defined
events in the Pfizer Agreement. Milestone payments received under
the Pfizer Agreement are recognized as revenue upon achievement of
the “at risk” milestone events. Milestone payments are
triggered either by the results of our R&D efforts or by events
external to us, such as regulatory approval to market a product. As
such, the milestones were substantially at risk at the inception of
the Pfizer Agreement and the amounts of the revenue correspond to
the milestone payments set forth in the Pfizer
Agreement. In addition, upon the achievement of a
milestone event, we have no future performance obligations related
to that milestone. Milestone revenue is non-refundable and
non-creditable upon payment. On June 30, 2011, we
received a $20.0 million milestone payment from Pfizer as a result
of the FDA approval of Oxecta® (oxycodone HCI, USP) Tablets
CII. The trademark Oxecta® is owned by Pfizer or
its affiliates.
|
| X | ||||||||||
|
- Definition
Operating Revenue Disclosure [Text Block] No definition available.
|
|
INCOME TAXES
|
9 Months Ended |
|---|---|
|
Sep. 30, 2011
|
|
| INCOME TAXES |
NOTE 4 INCOME TAXES
The
Company accounts for income taxes under the liability method. Under
this method, deferred income tax assets and liabilities are
determined based on differences between financial reporting and
income tax basis of assets and liabilities and are accounted for
using the enacted income tax rates and laws that will be in effect
when the differences are expected to reverse. Additionally, net
operating loss (“NOL”) and tax credit carryforwards are
reported as deferred income tax assets. The realization
of deferred income tax assets is dependent upon future earnings. A
valuation allowance is required against deferred income tax assets
if, based on the weight of available evidence, it is more likely
than not that some or all of the deferred income tax assets may not
be realized. During June 2011, we decreased our valuation allowance
on our deferred income tax assets by $5.0 million. We recorded a
benefit from income taxes of $5.0 million against our current nine
month period income tax provision. At September 30, 2011 we
continue to maintain a full valuation on our remaining deferred
income tax assets due to uncertainties with respect to future
utilization of them. If in the future it is determined
that additional amounts of our deferred income tax assets would
likely be realized, the valuation allowance would be reduced in the
period in which such determination is made and an additional
benefit from income taxes in such period would be
recognized.
|
| X | ||||||||||
|
- Definition
The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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|
ACCRUED EXPENSES
|
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2011
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| ACCRUED EXPENSES |
NOTE 5 ACCRUED EXPENSES
Accrued
expenses are summarized as follows:
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| X | ||||||||||
|
- Definition
The entire disclosure for accounts payable and accrued liabilities at the end of the reporting period. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
|
SHARE-BASED COMPENSATION
|
9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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|
Sep. 30, 2011
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| SHARE-BASED COMPENSATION |
NOTE 6 SHARE-BASED COMPENSATION
The Company has share-based compensation plans
including stock options and restricted stock units
(“RSUs”) for its employees and
directors. The Company accounts for compensation cost
related to share-based payments based on fair value of the stock
options and RSUs when awarded to an employee or
director. The value of the portion of the award that is
ultimately expected to vest is recognized as expense in the
relevant accounting periods in the Company’s consolidated
financial statement. The Company uses the straight line
amortization method for calculating share-based compensation
expense. The Company determines the estimated fair value of
share-based stock option awards using the Black-Scholes option
pricing model. Option valuation models require the input of
assumptions including the expected volatility of the market price
of the Company’s common stock, risk-free interest rate and
expected dividend yields. The Company uses historical public market
closing price volatility and does not consider implied volatility
because there are no options traded in its stock. The risk –
free interest rate assumption is based on observed interest rates
appropriate for the estimated term of the employee stock options.
The dividend yield assumption is based on the Company’s
history and current expectation of dividend payouts on common
stock. The expected term of the award represents the period that
the employees and directors are expected to hold the award before
exercise and issuance using historical exercise activity. The
Company’s accounting for share-based compensation for RSUs is
also based on the fair-value method. The fair value of the RSUs is
based on the closing market price of the Company’s common
stock on the date of the RSU award.
Our
non-cash share-based compensation expense comprises the
following:
Stock Option Award Plans
At
September 30, 2011, the Company has stock options issued and
outstanding under three stock option plans. The
Company’s 1995 Stock Option Plan and 1998 Stock Option Plan
have each expired but stock options awarded under such plans remain
outstanding under the terms of those plans. The Company’s
2008 Stock Option Plan remains in effect. Under each of the 1998
Stock Option Plan and the 2008 Stock Option Plan, only one-fourth
of vested non-incentive stock options (“NonISO”) may be
exercised during each of calendar years 2011, 2012, 2013 and
2014.
Exercise
of NonISOs by employees may require the Company to make minimum
statutory withholding tax (“withholding tax”) payments
for such employee on any gain on such shares at the time of
exercise. The employee is responsible for providing
sufficient funds to the Company to make such withholding tax
payments. However, under the Company’s stock
option plans, the employee may elect to take a partial distribution
of the exercised NonISO shares and have the Company retain the
balance of the exercised shares in satisfaction of the
employee’s withholding tax payments. In such
event, the Company becomes obligated to directly pay the
withholding taxes of such employee and will retain a sufficient
number of exercised shares such that the fair market value of the
retained shares will offset the employee’s withholding taxes.
The Company has not reflected this obligation as a liability in its
consolidated financial statements as the withholding tax payments
are contingent upon the timing and number of NonISOs exercised by
employees and the closing market price of our common stock at the
time of exercise. Such withholding tax will be paid and charged
against additional paid in capital as the NonISOs are
exercised. During the nine months ended September 30,
2011, 0.23 million NonISOs shares were withheld by the Company upon
our employees’ election to satisfy $0.9 million of
withholding taxes relating to their stock option exercises during
such time period.
As
of September 30, 2011 the Company had $0.9 million of unrecognized
share-based compensation expense from stock option grants, which
will be recognized in our consolidated financial statements over
their remaining vesting periods. Under the stock option plans, if a
change in control occurs, an acceleration of unvested shares will
occur and any remaining unrecognized share-based compensation
expense will be recognized in our consolidated financial
statements.
Our stock option award activity during the nine
months ended September 30, 2011 and 2010 is as
follows:
Assumptions
used in the Black-Scholes model to determine fair value for the
stock option awards granted during the nine months ended September
30, 2011 and 2010 were:
Restricted Stock Unit Award Plan
The
Company has RSUs issued and outstanding under a Restricted Stock
Unit Award Plan (“2005 RSU Plan”) for its employees and
directors. A RSU represents the contingent obligation of the
Company to deliver a share of its common stock to the holders of a
vested RSU on a specified distribution date. For the
2005 RSU Plan, absent a change of control, one-fourth of vested
shares of common stock underlying an RSU award will be distributed
on January 1 of each of 2011, 2012, 2013 and 2014. Distribution of
RSU shares to employees may require the Company to make minimum
statutory withholding tax (“withholding tax”) payments
for such employee on any gain on such shares at the time of
distribution. The employee is responsible for providing
sufficient funds to the Company to make such withholding tax
payments. However, under the 2005 RSU Plan, the employee
may elect to take a partial distribution of shares and have the
Company retain the balance of the share distribution in
satisfaction of the withholding tax payments. In such
event, the Company becomes obligated to directly pay the
withholding taxes of such employee and will retain a sufficient
number of shares such that the fair market value of the retained
shares will offset the employee’s withholding
taxes. The Company has not reflected this obligation as
a liability in its consolidated financial statements as the
withholding tax payments are contingent upon the timing and number
of RSU shares distributed to employees and the closing market price
of our common stock at the time of distribution. Such withholding
taxes will be paid and charged against additional paid-in capital
as the RSU shares are distributed. On January 1, 2011, 0.54 million
vested shares were distributed to our employees and 0.29 million
shares were withheld by the Company upon our employees’
election to exchange RSUs in satisfaction of $1.0 million
withholding tax obligations relating to RSU distributions on such
date.
A
summary of the RSU Plan as of September 30, 2011 and 2010 and for
the nine months then ended consisted of the following:
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| X | ||||||||||
|
- Definition
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
|
|
COMMON STOCK WARRANTS
|
9 Months Ended |
|---|---|
|
Sep. 30, 2011
|
|
| COMMON STOCK WARRANTS |
NOTE 7 COMMON STOCK WARRANTS
At
September 30, 2011, the Company had common stock warrants
outstanding exercisable for 1.9 million shares of common stock at
an exercise price of $3.40 per share with an expiration date of
August 2014. Warrants exercisable for 0.34 million shares of common
stock were exercised during the nine months ended September 30,
2011.
|
| X | ||||||||||
|
- Definition
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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|
EARNINGS (LOSS) PER SHARE
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| EARNINGS (LOSS) PER SHARE |
NOTE 8 EARNINGS (LOSS) PER SHARE
The
computation of basic earnings (loss) per share of common stock is
based on the sum of the weighted average number of outstanding
common shares and vested RSUs during the period. Computation of
diluted earnings (loss) per share is based on the sum of the common
shares and vested RSUs used in the basic earnings (loss)
computation, adjusted for the effect of other potentially dilutive
securities.
(1)
Number of shares issuable represents those securities which were
either i) nonvested at period end or ii) were vested but
antidilutive. The number of shares is based on maximum number of
shares issuable on exercise at period end. Such amounts have not
been adjusted for the treasury stock method or weighted average
outstanding calculations as required if the securities were
dilutive.
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- Definition
The entire disclosure for earnings per share. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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COMMITMENTS AND CONTINGENCIES
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9 Months Ended |
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Sep. 30, 2011
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| COMMITMENTS AND CONTINGENCIES |
NOTE 9 COMMITMENTS AND CONTINGENCIES
Securities Class Action and Derivative Litigation
A
lawsuit captioned Bang v. Acura
Pharmaceuticals, et al, was filed on September 10, 2010 in
the United States District Court for the Northern District of
Illinois, Eastern Division (Case 1:10-cv-05757) against us and
certain of our current and former officers seeking unspecified
damages on behalf of a putative class of persons who purchased our
common stock between February 21, 2006 and April 22, 2010. The
complaint alleged that certain Company officers made false or
misleading statements, or failed to disclose material facts in
order to make statements not misleading, relating to our
Acurox®
with Niacin Tablet product candidate, resulting in violations of
Section 10(b) of the Securities Exchange Act of 1934 (the
“Exchange Act”), Rule 10b-5 under the Exchange Act and
Section 20(a) of the Exchange Act. The complaint further
alleges that such false or misleading statements or omissions had
the effect of artificially inflating the price of our common stock.
On March 14, 2011, an amended complaint was filed in this
lawsuit. The amended complaint asserts the same claims as the
initial complaint based upon the same alleged false or misleading
statements, and has added three of our current directors as
defendants. The Court has changed the caption of this case to
In re Acura
Pharmaceuticals, Inc. Securities Litigation. We filed a
motion to dismiss this case on May 13, 2011. We believe that the
allegations in the complaint are without merit and intend to
vigorously defend the litigation
On
October 25, 2010, Kiley Hill, a purported stockholder of the
Company filed a shareholder derivative action in the Circuit Court
of Cook County, Illinois, Chancery Division captioned Hill v. Acura
Pharmaceuticals et al. (Case No. 2010-CH-46380), against our
directors and certain of our executive officers, generally relating
to the same events that are the subject of the class action
litigation described above. The complaint purports to be brought on
our behalf and names us as a nominal defendant. The complaint seeks
unspecified damages from the individual defendants for breaches of
fiduciary duty, abuse of control, gross mismanagement, contribution
and indemnification, waste of corporate assets and unjust
enrichment for actions occurring from at least February 21, 2006
through April 22, 2010. Substantively similar complaints
captioned Hagan
v. Acura Pharmaceuticals et al. (Case No. 2010-CH-46621) and
Newell v.
Reddick et al (Case No. 2010-CH-46873) were filed in the
Circuit Court of Cook County, Illinois, Chancery Division, by other
purported stockholders of the Company on October 27, 2010 and
October 28, 2010, respectively. We have agreed to a temporary stay
of these derivative actions.
Reglan®/Metoclopramide
Litigation
Halsey
Drug Company, as predecessor to us, has been named along with
numerous other companies as a defendant in cases filed in three
separate state coordinated litigations pending in Pennsylvania, New
Jersey and California, respectively captioned In re:
Reglan®/Metoclopramide Mass Tort Litigation, Philadelphia
County Court of Common Pleas, January Term, 2010, No. 01997; In re:
Reglan® Litigation, Superior Court of New Jersey, Law
Division, Atlantic County, Case No. 289, Master Docket No.
ATL-L-3865-10; and Reglan®/Metoclopramide Cases, Superior
Court of California, San Francisco County, Judicial Council
Coordination Proceeding No. 4631, Superior Court No.:
CJC-10-004631. In this product liability litigation against
numerous pharmaceutical product manufacturers and distributors,
including us, plaintiffs claim injuries from their use of the
Reglan brand of metoclopramide and generic metoclopramide. In
the Pennsylvania state court mass tort proceeding, over 200
lawsuits have been filed against us and Halsey Drug Company
alleging that plaintiffs developed neurological disorders as a
result of their use of the Reglan brand and/or generic
metoclopramide. Plaintiffs have filed approximately 150
lawsuits against us, but have served less than 50 individual
lawsuits upon us in the New Jersey action. In the
California action, we were not served with any complaints until the
Spring of 2011 when a single complaint including over 400
plaintiffs was served. Earlier this year, over 70 plaintiffs
filed Reglan litigation in the Circuit Court of St. Clair County,
Illinois entitled Agresta v. Walgreens et
al., in which we, together with numerous generic and brand
drug companies, are a named defendant. However, none of
these Illinois state court complaints have been served on
us.
In
the lawsuits filed to date, plaintiffs have not confirmed they
ingested any of the generic metoclopramide manufactured by
us. We discontinued manufacture and distribution of generic
metoclopramide more than 15 years ago. In addition, we
believe the June 23, 2011 decision by the U.S. Supreme Court in
PLIVA v. Mensing
(“ Mensing decision”) holding that state tort
law failure to warn claims against generic drug companies are
pre-empted by the 1984 Hatch-Waxman Act Amendments and federal drug
regulations will assist us in favorably resolving these
cases. In Philadelphia and New Jersey, Generic
Defendants, including Acura, have filed dispositive motions based
on the Mensing decision, which we expect will be ruled upon by the
respective Courts in the 4th quarter of 2011. A similar
motion will be filed in the near future in the California
proceedings. We believe these claims are without merit
and intend to vigorously defend these actions.
Statutory Minimum Withholding Tax Obligations
Under
our stock option plans and our 2005 RSU plan, our employees may
elect to have shares withheld upon exercise of options and upon the
exchange of RSUs in satisfaction of the statutory minimum
withholding tax obligations of such employees relating to such
option exercises or RSU exchanges. On January 1, 2011, certain of
our employees elected to have 0.29 million common shares withheld
by the Company upon the exchange of their RSUs in satisfaction of
their combined $1.0 million withholding tax
obligations. In addition, during the nine months ended
September 30, 2011, employees exercising stock options elected to
have 0.22 million common shares withheld by the Company in
satisfaction of their combined $0.8 million withholding tax
obligations.
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| X | ||||||||||
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- Definition
The entire disclosure for commitments and contingencies. Reference 1: http://www.xbrl.org/2003/role/presentationRef
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