Document And Entity Information
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6 Months Ended | |
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Jun. 30, 2013
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Jul. 29, 2013
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Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2013 | |
Document Fiscal Year Focus | 2013 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | acur | |
Entity Common Stock, Shares Outstanding | 46,495,646 | |
Entity Registrant Name | ACURA PHARMACEUTICALS, INC | |
Entity Central Index Key | 0000786947 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer |
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CONSOLIDATED BALANCE SHEETS (Parenthetical) (USD $)
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Jun. 30, 2013
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Dec. 31, 2012
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Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 100,000 | 100,000 |
Common stock, shares issued | 46,496 | 45,867 |
Common stock, shares outstanding | 46,496 | 45,867 |
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CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPRENESIVE INCOME (LOSS) (USD $)
In Thousands, except Share data, unless otherwise specified |
3 Months Ended | 6 Months Ended | ||
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Jun. 30, 2013
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Jun. 30, 2012
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Jun. 30, 2013
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Jun. 30, 2012
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Revenues: | ||||
Royalty revenue | $ 1 | $ 0 | $ 5 | $ 0 |
Total revenues | 1 | 0 | 5 | 0 |
Operating expenses: | ||||
Research and development | 805 | 919 | 2,831 | 1,822 |
Selling, general and administrative | 2,336 | 1,270 | 4,558 | 2,711 |
Total operating expenses | 3,141 | 2,189 | 7,389 | 4,533 |
Operating loss | (3,140) | (2,189) | (7,384) | (4,533) |
Non-operating income: | ||||
Investment income | 71 | 11 | 81 | 22 |
Gain (loss) on sales of marketable securities | (7) | 0 | 9 | 0 |
Other income (expense) | 0 | (1) | 0 | (1) |
Total other income | 64 | 10 | 90 | 21 |
Loss before income taxes | (3,076) | (2,179) | (7,294) | (4,512) |
Provision for income taxes | 0 | 0 | 0 | 0 |
Net loss | (3,076) | (2,179) | (7,294) | (4,512) |
Other comprehensive income (loss): | ||||
Unrealized gains (losses) on securities | (131) | 0 | (79) | 0 |
Total other comprehensive income (loss) | (131) | 0 | (79) | 0 |
Comprehensive income (loss) | $ (3,207) | $ (2,179) | $ (7,373) | $ (4,512) |
Income (loss) per share: | ||||
Basic | $ (0.07) | $ (0.05) | $ (0.16) | $ (0.10) |
Diluted | $ (0.07) | $ (0.05) | $ (0.16) | $ (0.10) |
Weighted average shares outstanding: | ||||
Basic | 47,228 | 47,521 | 47,215 | 47,519 |
Diluted | 47,228 | 47,521 | 47,215 | 47,519 |
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CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Parenthetical) (USD $)
In Thousands, unless otherwise specified |
6 Months Ended | |
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Jun. 30, 2013
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Jun. 30, 2012
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Net offering costs | $ 8 | $ 0 |
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CONSOLIDATED STATEMENTS OF CASH FLOWS (Parenthetical) (USD $)
In Thousands, unless otherwise specified |
6 Months Ended | |
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Jun. 30, 2013
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Jun. 30, 2012
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Supplemental Disclosure of Noncash Financing Activities: | ||
Equity based employee compensation granted | 7 | 17 |
Common stock withheld in exercise costs in shares | 3 | 7 |
Common stock withheld in exercise costs | $ 9 | $ 22 |
Withholding of exercise cost in shares | 1 | 3 |
Minimum statutory withholding payroll taxes withheld | 4 | 12 |
Common Stock issued upon exercise | 3 | 7 |
Restricted Stock Unit
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Supplemental Disclosure of Noncash Financing Activities: | ||
Equity based employee compensation granted | 829 | 829 |
Common stock withheld in exercise costs in shares | 3 | 2 |
Common stock withheld in exercise costs | 7 | 7 |
Withholding of exercise cost in shares | 321 | 296 |
Minimum statutory withholding payroll taxes withheld | $ 712 | $ 1,034 |
Common Stock issued upon exercise | 505 | 531 |
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DESCRIPTION OF BUSINESS AND PRESENTATION
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6 Months Ended |
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Jun. 30, 2013
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Description Of Business Disclosure [Abstract] | |
DESCRIPTION OF BUSINESS AND PRESENTATION | NOTE 1 DESCRIPTION OF BUSINESS AND PRESENTATION Acura Pharmaceuticals, Inc., a New York corporation, and its subsidiary (the “Company”, “We”, or “Our”) is a specialty pharmaceutical company engaged in the research, development and commercialization of technologies and products intended to address medication abuse and misuse. We have discovered and developed two proprietary technologies. Our Aversion® Technology is a mixture of inactive ingredients incorporated into pharmaceutical tablets and capsules intended to address some common methods of product tampering associated with opioid abuse. Pfizer Inc.’s Oxecta® (oxycodone HCl) tablets, CII is the first approved and marketed product utilizing Aversion and is commercialized under a license agreement we have with a subsidiary of Pfizer. We have also developed our Impede® Technology which is a combination of inactive ingredients that are intended to prevent the extraction of pseudoephedrine from tablets and disrupt the direct conversion of pseudoephedrine from tablets into methamphetamine. In late December 2012 we launched in the United States, Nexafed® (pseudoephedrine HC1) tablets formulated with our Impede Technology. 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 three and six months ended June 30, 2013 are not necessarily indicative of results expected for the full year ending December 31, 2013. 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, 2012 included in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission. The 2012 year-end consolidated balance sheet presented in this Report was derived from the Company’s 2012 year-end audited consolidated financial statements, but does not include all disclosures required by generally accepted accounting principles. |
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RESEARCH AND DEVELOPMENT ACTIVITIES
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6 Months Ended |
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Jun. 30, 2013
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Research and Development Activities [Abstract] | |
RESEARCH AND DEVELOPMENT ACTIVITIES | NOTE 2 - RESEARCH AND DEVELOPMENT ACTIVITIES 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. We had $5 thousand accrued for CRO and clinical trial study expenses at June 30, 2013. We had no accrued costs at December 31, 2012. |
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REVENUE RECOGNITION
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6 Months Ended |
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Jun. 30, 2013
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Revenue Recognition [Abstract] | |
REVENUE RECOGNITION | NOTE 3 - REVENUE RECOGNITION Revenue is generally realized or realizable and earned when there is persuasive evidence an arrangement exists, delivery has occurred or services rendered, the price is fixed and determinable, and collection is reasonably assured. The Company records revenue from its Nexafed product sales when the price is fixed and determinable at the date of sale, title and risk of ownership have been transferred to the customer, and returns can be reasonably estimated. Nexafed was launched in mid-December 2012. The Company sells Nexafed in the United States to wholesale pharmaceutical distributors and as well as directly to chain drug stores. Nexafed is sold subject to the right of return for a period of up to twelve months after the product expiration. Nexafed currently has a shelf life of twenty-four months from the date of manufacture. Given the limited sales history of Nexafed, the Company currently cannot reliably estimate expected returns of the product at the time of shipment. Accordingly, the Company has deferred recognition of revenue on $61 thousand of product shipments of Nexafed since its launch until the right of return no longer exists or adequate history and information is available to estimate product returns. We are a party to a License, Development, and Commercialization Agreement dated October 30, 2007 with King Pharmaceuticals Research and Development, Inc., now a subsidiary of Pfizer Inc. (the “Pfizer Agreement”). Commencing in February 2013, we began earning royalties based on net sales of Oxecta by Pfizer. Such royalties are paid to us within 45 days after the end of each calendar quarter. We have recorded royalties of approximately $5 thousand for the six month period ended June 30, 2013 on Oxecta’s net sales of approximately $100 thousand. Shipping and Handling Costs The Company records shipping and handling costs in selling expenses. The costs recorded to selling expenses from the shipments of Nexafed during the six month period ended June 30, 2013 were not material. |
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LICENSE, DEVELOPMENT, AND COMMERCIALIZATION AGREEMENT
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6 Months Ended |
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Jun. 30, 2013
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Research and Development Disclosure [Abstract] | |
LICENSE, DEVELOPMENT, AND COMMERCIALIZATION AGREEMENT | NOTE 4 - LICENSE, DEVELOPMENT, AND COMMERCIALIZATION AGREEMENT On October 30, 2007, we and King Pharmaceuticals Research and Development, Inc., now a wholly-owned subsidiary of Pfizer, entered into the Pfizer Agreement to develop and commercialize in the United States, Canada and Mexico, or the Pfizer Territories, certain opioid analgesic products utilizing our proprietary Aversion Technology. Oxecta was approved on June 17, 2011 and sales of Oxecta by Pfizer commenced February 2012. On September 24, 2012, we entered into a letter agreement with Pfizer which amended the Pfizer Agreement and provided for the termination of Pfizer’s license to our Aversion® Technology used in the three development-stage products licensed to Pfizer and for the transfer of these products back to us. These development-stage products were hydrocodone bitartrate/acetaminophen tablets, oxycodone HCl/acetaminophen tablets and an undisclosed opioid. Pursuant to the Pfizer Agreement, we and Pfizer formed a joint steering committee to oversee development and commercialization strategies for Oxecta. Pfizer is responsible, at its own expense, for all regulatory, manufacturing and commercialization activities for Oxecta in all Pfizer Territories. Subject to the Pfizer Agreement, Pfizer will have final decision making authority with respect to all regulatory and commercialization activities for Oxecta. We can receive a one-time $50 million sales milestone payment upon the first attainment of $750 million in net sales of Oxecta across all Pfizer Territories. In addition, for Oxecta sales occurring on and following February 2, 2013 (the one year anniversary of the first commercial sale of Oxecta), Pfizer will pay us a royalty at one of six rates ranging from 5% to 25% based on the level of annual net sales for Oxecta across all Pfizer Territories, with the highest applicable royalty rate applied to such annual sales. Pfizer’s royalty payment obligations for Oxecta expire on a country-by-country basis upon the later of (i) the expiration of the last valid patent claim covering Oxecta in such country, or (ii) 15 years from the first commercial sale of Oxecta in such country. No minimum annual fees are payable by either party under the Pfizer Agreement. If Pfizer, after consultation with us, enters into a license agreement with a third party to avoid or settle such third party’s allegations or claims regarding freedom to operate against Oxecta, Pfizer may deduct 50% of any royalties or other license payments it pays to such third party under such license, provided that the royalties payable to us are no less than 80% of the royalties otherwise due to us under the Pfizer Agreement. The Pfizer Agreement expires upon the expiration of Pfizer’s royalty payment and other payment obligations under the Pfizer Agreement. Pfizer may terminate the Pfizer Agreement in its entirety at any time by written notice to us. We may terminate the Pfizer Agreement in its entirety if Pfizer commences any interference or opposition proceeding challenging the validity or enforceability of any of our patent rights licensed to Pfizer under the Pfizer Agreement. Either party has the right to terminate the Pfizer Agreement on a country-by-country basis if the other party is in material breach of its obligations under the Pfizer Agreement relating to such country, and to terminate the Agreement in its entirety in the event the other party makes an assignment for the benefit of creditors, files a petition in bankruptcy or otherwise seeks relief under applicable bankruptcy laws, in each case subject to applicable cure periods. In the event of termination, no payments are due except those royalties and milestones that have accrued prior to termination under the Pfizer Agreement and all licenses under the Pfizer Agreement are terminated. For all Acura terminations and termination by Pfizer where we are not in breach, the Pfizer Agreement provides for the transition of development and marketing of the licensed products from Pfizer to us, including the conveyance by Pfizer to us of the trademarks and all regulatory filings and approvals solely used in connection with the commercialization of such licensed products and, in certain cases, for Pfizer’s supply of such licensed products for a transitional period at Pfizer’s cost plus a mark-up. Paragraph IV ANDA Litigation On or about September 17, 2012, we believe the FDA internally changed the status of Oxecta to be considered a Reference Listed Drug, or RLD. An RLD is the standard to which all generic versions must be shown to be bioequivalent and a drug company seeking approval to market a generic equivalent must refer to the RLD. By designating Oxecta as an RLD, the FDA was allowed to accept ANDAs referencing Oxecta. On September 20, 2012, we announced that we had received a Paragraph IV Certification Notice under 21 U.S.C. 355(j) (a Paragraph IV Notice) from a generic sponsor seeking FDA approval to market a generic version of Oxecta. Since such date, we have received similar Paragraph IV Notices from four other generic pharmaceutical companies. The Paragraph IV Notices refer to our U.S. Patent Numbers 7,201,920, 7,510,726 and 7,981,439, which cover our Aversion Technology and Oxecta and are listed in the FDA Orange Book. The Paragraph IV Notices state that each generic sponsor believes that such patents are invalid, unenforceable or not infringed. Pfizer, Acura’s licensee for Oxecta, has advised us that they will not exercise their first right under the Pfizer Agreement to control the enforcement of the ANDA litigation against the generic sponsors. As a result, on October 31, 2012, we initiated suit against each of Watson Laboratories, Inc. Florida (“Watson”), Par Pharmaceutical, Inc. (“Par”), Impax Laboratories, Inc. (“Impax”), and Sandoz Inc. (“Sandoz”), and on April 29, 2013 we initiated suit against Ranbaxy Pharmaceuticals, Inc., each in the United States District Court for the District of Delaware alleging infringement of our U.S. Patent No. 7,510,726. The commencement of such litigation prohibits the FDA from granting approval of the filed ANDAs until the earliest of 30 months from the date Acura received notice of the first Paragraph IV certification, or the conclusion of litigation. The litigation is in its early stages. If any subsequent infringement suit is initiated in Delaware, it is likely that the suit would be consolidated with the current action. On January 2, 2013, the court granted our motion to dismiss the suit against Watson on the grounds that Watson had amended its ANDA from a Paragraph IV certification to Paragraph III, which indicated its intent not to market its product in advance of our patents expiring. During the course of the litigation, Acura has executed a covenant not to sue Par on Acura’s 7,201,920 and 7,981,439 patents based on the products described in its ANDAs. On April 2, 2013, the USPTO issued U.S. Patent No. 8,409,616 with claims directed at our Aversion Technology. This patent was listed in FDA’s Orange Book on April 22, 2013 which will require all of the Paragraph IV ANDA filers to decide whether to amend their Paragraph IV certifications to include this newly issued patent. Par, Ranbaxy and Impax have certified Paragraph IV against the ‘616 patent asserting that the ‘616 patent is either invalid or unenforceable or that their generic product will not infringe the claims of the patent. Litigation is inherently uncertain and we cannot predict the outcome of these infringement actions. If any of these generic companies prevails in its respective lawsuit and is able to obtain FDA approval of its product, it may be able to launch its generic version of Oxecta prior to the expiration of our patents in 2025. Additionally, it is possible that other generic manufacturers may also seek to launch a generic version of Oxecta and challenge our patents. Any determination in these infringement actions that our patents covering our Aversion Technology and Oxecta are invalid or unenforceable, in whole or in part, or that the products covered by generic sponsors’ ANDAs do not infringe our patents, could materially adversely affect the Company’s operations and financial condition. |
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INCOME TAXES
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6 Months Ended |
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Jun. 30, 2013
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Income Tax Disclosure [Abstract] | |
INCOME TAXES | NOTE 5 - 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 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. At both June 30, 2013 and December 31, 2012, all our remaining net deferred income tax assets were offset by a valuation allowance due to uncertainties with respect to future utilization of net operating loss (“NOL”) carryforwards. 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. Our NOL carryforwards will expire in varying amounts between 2013 and 2031 if not used, and those expirations will cause fluctuations in our valuation allowances. |
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INVESTMENTS IN MARKETABLE SECURITIES
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Investments Marketable Securities [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
INVESTMENTS IN MARKETABLE SECURITIES | NOTE 6 INVESTMENTS IN MARKETABLE SECURITIES Investments in marketable securities consisted of the following:
The Company’s marketable securities are classified as available-for-sale and are recorded at fair value based on quoted market prices or net asset value using the specific identification method. The purchase cost of corporate bonds may include a purchase price premium or discount which will be amortized or accreted against earned interest income to the maturity date of the bond. Our investments are classified as current in the Company’s Consolidated Balance Sheet as they may be sold within one year in response to changes in market prices or interest rates, to realign our investment concentrations or to meet our working capital needs. The following tables provide a summary of the fair value and unrealized gains (losses) related to the Company’s available-for-sale securities (in millions):
Fair Value Measurement Fair value is the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants. Fair values determined based on Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities. Fair values determined based on Level 2 inputs utilize observable quoted prices for similar assets and liabilities in active markets and observable quoted prices for identical or similar assets in markets that are not very active. Fair values determined based on Level 3 inputs utilize unobservable inputs and include valuations of assets or liabilities for which there is little, if any, market activity. A financial asset or liability’s classification within the above hierarchy is determined based on the lowest level input that is significant to the fair value measurement. We had no liabilities at June 30, 2013 meeting fair value measurement. Our assets measured at fair value or disclosed at fair value on a recurring basis as at June 30, 2013 and December 31, 2012 consisted of the following (in millions):
Accumulated Other Comprehensive Income (Loss) Unrealized gains or losses on marketable securities are recorded in accumulated other comprehensive income (loss). Accumulated other comprehensive income (loss) on marketable securities consisted of cumulative unrealized losses of $89 thousand and $40 thousand at June 30, 2013 and December 31, 2012 respectively. Comprehensive Income (Loss) Comprehensive income (loss) includes all changes in equity during a period except those that resulted from investments by or distributions to the Company’s stockholders. Other comprehensive income (loss) refers to revenues, expenses, gains and losses that, under GAAP, are included in comprehensive income (loss), but excluded from net income (loss) as these amounts are recorded directly as an adjustment to stockholders’ equity. Acura’s other comprehensive income (loss) is composed of unrealized gains (losses) on certain holdings of marketable securities, net of any realized gains (losses) included in net income (loss). |
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INVENTORIES
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Jun. 30, 2013
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Inventory Disclosure [Abstract] | |
INVENTORIES | NOTE 7 INVENTORIES Inventories consist of finished goods held for sale and distribution on our Nexafed product. Inventories are stated at the lower of cost (first-in, first-out method) or market (net realizable value). The Company writes down inventories to net realizable value based on forecasted demand and market conditions, which may differ from actual results. Our gross inventory is valued at $0.8 million and $0.2 million at June 30, 2013 and December 31, 2012, respectively. During the second quarter of 2013 we established an inventory reserve of $0.4 million which results in a net reported inventory value of $0.4 million at June 30, 2013. We did not have an inventory reserve at December 31, 2012. The cost of sales on $61 thousand of product shipments of Nexafed since its launch date is excluded from the value of the June 30, 2013 inventory and is reported in the Balance Sheet account as a deferred asset until the right of return no longer exists or adequate history and information is available to estimate product returns on the product shipments. Purchases of active pharmaceutical ingredients and raw materials required for our development and clinical trial manufacture of product candidates utilizing our Aversion or Impede Technologies are expensed as incurred. |
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ACCRUED EXPENSES
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ACCRUED EXPENSES | NOTE 8 - ACCRUED EXPENSES Accrued expenses consisted of the following (in thousands):
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SHARE-BASED COMPENSATION
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Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
SHARE-BASED COMPENSATION | NOTE 9 - SHARE-BASED COMPENSATION We have three share-based compensation plans covering stock options and Restricted Stock Units (“RSU”) for our employees and directors. We measure our compensation cost related to share-based payment transactions based on fair value of the equity or liability instrument issued. For purposes of estimating the fair value of each stock option unit on the date of grant, we utilize the Black-Scholes option-pricing model. The Black-Scholes option valuation model was developed for use in estimating the fair value of traded options, which have no vesting restrictions and are fully transferable. In addition, option valuation models require the input of highly subjective assumptions including the expected volatility factor of the market price of our common stock (as determined by reviewing our historical public market closing prices). Our accounting for share-based compensation for RSUs is based on the fair-value method. The fair value of the RSUs is the market price of our common stock on the date of grant, less its exercise cost. Our share-based compensation expense recognized in the Company’s results of operations for the period is shown below (in thousands):
Stock Option Award Plans At June 30, 2013, the Company has stock options issued and outstanding under three stock option plans. The Company’s 1995 and 1998 Stock Option Plans have 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. Absent a change in control, the balance of the vested non-incentive stock options (“NonISO”) granted under the 1998 and 2008 stock option plans may be exercised in equal amounts during each of calendar years 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 six months ended June 30, 2013, 14 thousand NonISOs were exercised by our employees. Our employees elected to have 4 thousand shares withheld in satisfaction of $14 thousand for both the exercise costs and the withholding tax obligations resulting in the net issuance of 10 thousand common shares to them. During the six months ended June 30, 2012, 23 thousand NonISOs were exercised by our employees. Our employees elected to have 10 thousand shares withheld in satisfaction of $34 thousand for both the exercise costs and the withholding tax obligations which resulted in the net issuance of 13 thousand common shares to them. As of June 30, 2013 the Company had $1.0 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 of the option grants over the next 1.4 years. Under the provisions of 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 six months ended June 30, 2013 and 2012 is shown below:
Assumptions used in the Black-Scholes model to determine fair value for the stock option awards granted during the period are show below:
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. An 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. To date, 75% of RSU awards under the 2005 RSU Plan have been distributed. Absent a change of control, the balance of the RSU awards will be distributed on January 1, 2014. Distribution of RSU shares to employees may require the Company to make minimum statutory withholding tax payments for such employees 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 each January 1st of 2013, 2012 and 2011, 0.83 million RSUs were distributed to our employees and directors. Our employees made elections to withhold 0.32 million shares in satisfaction of $0.71 million withholding tax obligations resulted in the net issuance of 0.50 million shares in January 2013. Our employees made elections to withhold 0.30 million shares in satisfaction of $1.0 million withholding tax obligations resulted in the net issuance of 0.53 million shares in January 2012. A summary of the RSU Plan as of June 30, 2013 and 2012 and for the six months then ended consisted of the following (in thousands):
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EQUITY FINANCING
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Jun. 30, 2013
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Equity [Abstract] | |
EQUITY FINANCING | NOTE 10 EQUITY FINANCING Our universal shelf registration statement on Form S-3 was declared effective by the Securities and Exchange Commission (“SEC”) on March 15, 2013. On April 18, 2013, we filed a prospectus supplement with the SEC pursuant to which we may sell shares of our common stock from time to time in “at the market” offerings and certain other transactions, having sales proceeds of up to $13 million. During the three months ended June 30, 2013, we sold approximately 114 thousand shares of our common stock under a Sales Agreement with MLV & Co., our sales agent, through an “at the market” offering, for gross proceeds of approximately $0.25 million. Transaction costs were approximately $8 thousand. The net proceeds of approximately $0.24 million will be used for general corporate purposes, which may include working capital, capital expenditures, research, development and marketing expenditures, clinical trial expenditures, acquisitions of new technologies, and possible investments in or acquisitions of, complementary businesses or technologies. |
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COMMON STOCK WARRANTS
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Jun. 30, 2013
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Stockholders Equity Note [Abstract] | |
COMMON STOCK WARRANTS | NOTE 11 - COMMON STOCK WARRANTS The Company has outstanding common stock purchase warrants at June 30, 2013 exercisable for 1.9 million shares of common stock, all of which contain a cashless exercise feature. These warrants have an exercise price of $3.40 per share and expiration date of August 2014. |
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EARNINGS PER SHARE ("EPS")
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EARNINGS PER SHARE ("EPS") | NOTE 12 - EARNINGS PER SHARE (“EPS”) Basic EPS is computed by dividing net income or loss by the weighted average common shares outstanding during a period, including shares weighted related to vested RSUs. Diluted EPS is based on the treasury stock method and computed based on the same number of shares used in the basic share calculation and includes the effect from potential issuance of common stock, such as shares issuable pursuant to the exercise of stock options and stock warrants, assuming the exercise of all in-the-money stock options and warrants. These common stock equivalents are excluded from the computation where their inclusion would be anti-dilutive. No such adjustments were made for either 2013 or 2012 as the Company reported a net loss for the three month and six month periods, and including the effects of these common stock equivalents in the diluted EPS calculation would have been antidilutive. A reconciliation of the numerators and denominators of basic and diluted EPS for the period is as follows (in thousands):
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COMMITMENTS AND CONTINGENCIES
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Jun. 30, 2013
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Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | NOTE 13 - COMMITMENTS AND CONTINGENCIES Facility Lease The Company leases administrative office space in Palatine, Illinois under a lease expiring March 31, 2014 for approximately $25 thousand annually. 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. To date, Acura has not been served with any metoclopramide lawsuits in jurisdictions other than Philadelphia, New Jersey and California state courts. 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. We have consistently maintained the position that these claims are without merit and intend to vigorously defend these actions. In New Jersey, Generic Defendants, including Acura, filed dispositive motions based on the Mensing decision, which the Court granted with a limited exception. In June 2012, the New Jersey trial court dismissed Acura with prejudice. In Philadelphia, and California, Generic Defendants, including Acura, also filed dispositive motions based on the Mensing decision. On November 18, 2011, the Philadelphia trial court denied Generic Defendants’ dispositive motion. In December 2011, the Generic Defendants appealed this ruling. On April 13, 2012, all trial court proceedings were stayed pending decisions by the Pennsylvania appellate courts. On November 28, 2012, the Pennsylvania Superior Court heard the appellate oral argument. A decision on this appeal should be issued later in 2013. This appeal process eventually could result in dismissal of all of the Philadelphia cases against all generic defendants including Acura, although there can be no assurance in this regard. Legal fees related to this matter are currently covered by our insurance carrier. In California, the trial court issued an April 17, 2012 ruling (confirmed in a May 25, 2012 Order) denying Generic Defendants’ dispositive preemption motions. The Generics Defendants’ appeals from this order were denied by the California appellate courts. Therefore, plaintiffs are now permitted to proceed with their lawsuits including state law claims based on (1) failing to communicate warnings to physicians through “Dear Doctor” letters; (2) failure to update labeling to adopt brand labeling changes; and (3) failure to withdraw generic products from the market. Despite its refusal to grant the demurrer or motion to strike, the California trial court acknowledged the preemptive effect of Mensing so that any claim “that would render the generic defendants in violation of federal law if they are found responsible under a state law cause of action, would not be permissible.” Nonetheless, plaintiffs have not confirmed they ingested any of the generic metoclopramide manufactured by us. Therefore, we expect the number of plaintiffs with possible claims to be reduced voluntarily or by motion practice. Action will be taken in an effort to dismiss Acura from these cases, although there can be no assurance in this regard. As any potential loss is neither probable nor estimable, we have not accrued for any potential loss related to this matter as of June 30, 2013 and we are presently unable to determine if any potential loss would be covered by our insurance carrier. Legal fees related to this matter are currently covered by our insurance carrier. Financial Advisor Agreement In connection with our August 2007 Unit Offering, we are obligated to pay a fee to our then financial advisor upon each exercise of the warrants issued in the Unit Offering, in proportion to the number of warrants exercised. The amount of the fee assuming 100% exercise of the remaining 1.9 million warrants is $0.38 million. We have not reflected this obligation as a liability in our consolidated financial statements as the payment is contingent upon the timing and exercise of the warrants by each of the warrant holders. Such fee, if any, will be paid to the financial advisor and be offset against the equity proceeds as the warrants are exercised. |
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INVESTMENTS IN MARKETABLE SECURITIES (Tables)
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Jun. 30, 2013
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Investments Marketable Securities [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Marketable securities | Investments in marketable securities consisted of the following:
|
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Available-for-sale Securities, Continuous Unrealized Loss Position, Fair Value | The following tables provide a summary of the fair value and unrealized gains (losses) related to the Company’s available-for-sale securities (in millions):
|
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Fair Value, Assets Measured on Recurring Basis | Our assets measured at fair value or disclosed at fair value on a recurring basis as at June 30, 2013 and December 31, 2012 consisted of the following (in millions):
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
ACCRUED EXPENSES (Tables)
|
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2013
|
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Payables and Accruals [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accrued expenses | Accrued expenses consisted of the following (in thousands):
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
SHARE-BASED COMPENSATION (Tables)
|
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2013
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Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-Based Compensation Expense Recognized | Our share-based compensation expense recognized in the Company’s results of operations for the period is shown below (in thousands):
|
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Schedule of Share-based Compensation, Stock Options, Activity | Our stock option award activity during the six months ended June 30, 2013 and 2012 is shown below:
|
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Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions | Assumptions used in the Black-Scholes model to determine fair value for the stock option awards granted during the period are show below:
|
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Schedule of Share-based Compensation, Restricted Stock Units Award Activity | A summary of the RSU Plan as of June 30, 2013 and 2012 and for the six months then ended consisted of the following (in thousands):
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
EARNINGS PER SHARE ("EPS") (Tables)
|
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2013
|
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Earnings Per Share [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reconciliation of Numerators and Denominators of Basic and Diluted EPS | A reconciliation of the numerators and denominators of basic and diluted EPS for the period is as follows (in thousands):
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
Research and Development Activities - Additional Information (Detail) (USD $)
In Thousands, unless otherwise specified |
Jun. 30, 2013
|
Dec. 31, 2012
|
---|---|---|
Research and Development Assets Acquired Other than Through Business Combination [Line Items] | ||
Accrued research and development expense current | $ 5 | $ 0 |
X | ||||||||||
- Definition
Accrued research and development expense current. No definition available.
|
X | ||||||||||
- Details
|
Revenue Recognition - Additional Information (Detail) (USD $)
In Thousands, unless otherwise specified |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2013
|
Jun. 30, 2012
|
Jun. 30, 2013
|
Jun. 30, 2012
|
|
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Recognition of revenue, deferred | $ 61 | $ 61 | ||
Payment of royalty maximum contractual term | 45 days | |||
Royalty revenue | 1 | 0 | 5 | 0 |
Sales revenue services net | $ 100 |
X | ||||||||||
- Definition
Payment of Royalty Maximum Contractual Term. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
License Development and Commercialization Agreement - Additional Information (Detail)
|
6 Months Ended |
---|---|
Jun. 30, 2013
|
|
License Development and Commercialization Agreement [Line Items] | |
Research and development contingent consideration payment, sales milestone payment ,description | One-time $50 million sales milestone payment upon the first attainment of $750 million in net sales of Oxecta across all Pfizer Territories. |
Percentage of royalty deducted to settle third party claim | 50.00% |
Percentage of royalty of royalty , payable minimum | 80.00% |
Royalty payment obligation expiration description | 15 years from the first commercial sale of Oxecta in such country. |
Patents expiration year | 2025 |
Minimum
|
|
License Development and Commercialization Agreement [Line Items] | |
Percentage of royalty | 5.00% |
Maximum
|
|
License Development and Commercialization Agreement [Line Items] | |
Percentage of royalty | 25.00% |
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
Patents Expiration Year. No definition available.
|
X | ||||||||||
- Definition
Percentage Of Royalty No definition available.
|
X | ||||||||||
- Definition
Percentage Of Royalty Deduct To Settle Third Party Claim No definition available.
|
X | ||||||||||
- Definition
Percentage Of Royalty Of Royalty Payable Minimum No definition available.
|
X | ||||||||||
- Definition
Research and Development Contingent Consideration Payment Sales Milestone Payment Description No definition available.
|
X | ||||||||||
- Definition
Royalty Payment Obligation Expiration Description. No definition available.
|
Income Taxes - Additional Information (Detail)
|
6 Months Ended |
---|---|
Jun. 30, 2013
|
|
Maximum
|
|
Income Tax Disclosure [Line Items] | |
NOL expiration year | 2031 |
Minimum
|
|
Income Tax Disclosure [Line Items] | |
NOL expiration year | 2013 |
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
Operating Loss Carry Forwards Expiration Year No definition available.
|
Summary of Investment in Marketable Securities (Detail) (USD $)
In Millions, unless otherwise specified |
Jun. 30, 2013
|
Dec. 31, 2012
|
---|---|---|
Marketable securities: | ||
Corporate bonds maturing within 1 year | $ 2.3 | $ 1.2 |
Corporate bonds maturing after 1 through 4 years | 8.8 | 6.3 |
Total marketable securities | 18.9 | 19.9 |
Exchange-traded funds
|
||
Marketable securities: | ||
Total marketable securities | 5.8 | 4.4 |
Pooled investment fund
|
||
Marketable securities: | ||
Total marketable securities | $ 2.0 | $ 8.0 |
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
Available for Sale Securities Continuous Unrealized Loss Position Fair Value (Detail) (USD $)
In Millions, unless otherwise specified |
6 Months Ended | 12 Months Ended |
---|---|---|
Jun. 30, 2013
|
Dec. 31, 2012
|
|
Available For Sale Securities Continuous Unrealized Loss Position Fair Value [Line Items] | ||
Cost | $ 19.0 | $ 20.0 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (0.1) | (0.1) |
Fair Value | 18.9 | 19.9 |
Corporate Bonds
|
||
Available For Sale Securities Continuous Unrealized Loss Position Fair Value [Line Items] | ||
Cost | 11.2 | 7.6 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (0.1) | (0.1) |
Fair Value | 11.1 | 7.5 |
Pooled investment fund
|
||
Available For Sale Securities Continuous Unrealized Loss Position Fair Value [Line Items] | ||
Cost | 2.0 | 8.0 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 2.0 | 8.0 |
Exchange-traded funds
|
||
Available For Sale Securities Continuous Unrealized Loss Position Fair Value [Line Items] | ||
Cost | 5.8 | 4.4 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | $ 5.8 | $ 4.4 |
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
Assets Measured at Fair Value or Disclosed at Fair Value on Recurring Basis (Detail) (USD $)
In Millions, unless otherwise specified |
Jun. 30, 2013
|
Dec. 31, 2012
|
---|---|---|
Assets | ||
Total marketable securities | $ 18.9 | $ 19.9 |
Corporate bonds
|
||
Assets | ||
Total marketable securities | 11.1 | 7.5 |
Pooled investment fund
|
||
Assets | ||
Total marketable securities | 2.0 | 8.0 |
Exchange-traded funds
|
||
Assets | ||
Total marketable securities | 5.8 | 4.4 |
Fair Value, Inputs, Level 1
|
||
Assets | ||
Total marketable securities | 16.9 | 11.9 |
Fair Value, Inputs, Level 1 | Corporate bonds
|
||
Assets | ||
Total marketable securities | 11.1 | 7.5 |
Fair Value, Inputs, Level 1 | Pooled investment fund
|
||
Assets | ||
Total marketable securities | 0 | 0 |
Fair Value, Inputs, Level 1 | Exchange-traded funds
|
||
Assets | ||
Total marketable securities | 5.8 | 4.4 |
Fair Value, Inputs, Level 2
|
||
Assets | ||
Total marketable securities | 2.0 | 8.0 |
Fair Value, Inputs, Level 2 | Corporate bonds
|
||
Assets | ||
Total marketable securities | 0 | 0 |
Fair Value, Inputs, Level 2 | Pooled investment fund
|
||
Assets | ||
Total marketable securities | 2.0 | 8.0 |
Fair Value, Inputs, Level 2 | Exchange-traded funds
|
||
Assets | ||
Total marketable securities | 0 | 0 |
Fair Value, Inputs, Level 3
|
||
Assets | ||
Total marketable securities | 0 | 0 |
Fair Value, Inputs, Level 3 | Corporate bonds
|
||
Assets | ||
Total marketable securities | 0 | 0 |
Fair Value, Inputs, Level 3 | Pooled investment fund
|
||
Assets | ||
Total marketable securities | 0 | 0 |
Fair Value, Inputs, Level 3 | Exchange-traded funds
|
||
Assets | ||
Total marketable securities | $ 0 | $ 0 |
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
Investment In Marketable Securities - Additional Information (Detail) (USD $)
In Thousands, unless otherwise specified |
3 Months Ended | 6 Months Ended | 12 Months Ended | ||
---|---|---|---|---|---|
Jun. 30, 2013
|
Jun. 30, 2012
|
Jun. 30, 2013
|
Jun. 30, 2012
|
Dec. 31, 2012
|
|
Investment In Marketable Securities [Line Items] | |||||
Unrealized gains (losses) on securities | $ (131) | $ 0 | $ (79) | $ 0 | $ 40 |
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
Inventories - Additional Information (Detail) (USD $)
|
6 Months Ended | |
---|---|---|
Jun. 30, 2013
|
Dec. 31, 2012
|
|
Inventory [Line Items] | ||
FIFO inventory amount | $ 800,000 | $ 200,000 |
Cost of sales | 61,000 | |
Inventory Valuation Reserves | 400,000 | |
Inventory, Net, Total | $ 400,000 |
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
Accrued Expenses (Detail) (USD $)
In Thousands, unless otherwise specified |
Jun. 30, 2013
|
Dec. 31, 2012
|
---|---|---|
Accounts Payable and Accrued Liabilities [Line Items] | ||
Payroll, payroll taxes, bonus and benefits | $ 145 | $ 55 |
Professional services | 309 | 216 |
Franchise taxes | 11 | 5 |
Property taxes | 19 | 20 |
Contract manufacturing services | 72 | 21 |
Clinical and regulatory services | 5 | 21 |
Other fees and services | 114 | 75 |
Total | $ 675 | $ 413 |
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
Accrued Other Professional Fees, Current No definition available.
|
X | ||||||||||
- Definition
Manufacturing services costs. No definition available.
|
X | ||||||||||
- Definition
Other Accrued Taxes Current No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
Recognition of Share-Based Compensation Expense (Detail) (USD $)
In Thousands, unless otherwise specified |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2013
|
Jun. 30, 2012
|
Jun. 30, 2013
|
Jun. 30, 2012
|
|
Share based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation | $ 315 | $ 424 | $ 630 | $ 848 |
Research and development | Stock options
|
||||
Share based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation | 81 | 91 | 162 | 182 |
General and administrative | Stock options
|
||||
Share based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation | $ 234 | $ 333 | $ 468 | $ 666 |
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Details
|
Stock Option Award Activity (Detail) (Stock Option Plan, USD $)
In Thousands, except Per Share data, unless otherwise specified |
6 Months Ended | |
---|---|---|
Jun. 30, 2013
|
Jun. 30, 2012
|
|
Stock Option Plan
|
||
Share based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of Options Outstanding, beginning | 3,296 | 3,556 |
Number of Options, Granted | 75 | 105 |
Number of Options, Exercised | (14) | (23) |
Number of Options, Forfeited or expired | (15) | (703) |
Number of Options Outstanding, ending | 3,342 | 2,935 |
Number of Options exercisable | 2,970 | 2,507 |
Weighted Average Exercise Price, beginning | $ 5.50 | $ 6.41 |
Weighted Average Exercise Price, Granted | $ 2.32 | $ 3.48 |
Weighted Average Exercise Price, Exercised | $ 1.30 | $ 1.30 |
Weighted Average Exercise Price, Forfeited or expired | $ 2.32 | $ 8.44 |
Weighted Average Exercise Price, ending | $ 5.46 | $ 5.86 |
Weighted Average Exercise Price, Options exercisable | $ 5.80 | $ 6.26 |
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
Assumptions Used in Black-Scholes Model to Determine Fair Value for Stock Option Awards Granted (Detail) (USD $)
|
6 Months Ended | |
---|---|---|
Jun. 30, 2013
|
Jun. 30, 2012
|
|
Share based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Dividend yield | 0.00% | 0.00% |
Average risk-free interest rate | 1.86% | 1.97% |
Average volatility | 114.00% | 114.00% |
Expected forfeitures | 0.00% | 0.00% |
Expected holding period | 10 years | 10 years |
Weighted average grant date fair value | $ 2.17 | $ 3.25 |
X | ||||||||||
- Definition
Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumption Expected Forfeitures. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
Summary of RSU Plan (Detail)
In Thousands, unless otherwise specified |
6 Months Ended | |
---|---|---|
Jun. 30, 2013
|
Jun. 30, 2012
|
|
Restricted Stock Units
|
||
Share based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Outstanding, beginning | 1,658 | 2,487 |
Granted | 0 | 0 |
Distributed | (829) | (829) |
Vested | 0 | 0 |
Forfeited or expired | 0 | 0 |
Outstanding, ending | 829 | 1,658 |
Vested Restricted Stock Units (RSUs)
|
||
Share based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Outstanding, beginning | 1,658 | 2,487 |
Granted | 0 | 0 |
Distributed | (829) | (829) |
Vested | 0 | 0 |
Forfeited or expired | 0 | 0 |
Outstanding, ending | 829 | 1,658 |
X | ||||||||||
- Definition
Share Based Compensation Arrangement By Share Based Payment Award Equity Instrument Other Than Options Distributed In Period No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
Number Of Stock Incentive Plans. No definition available.
|
X | ||||||||||
- Definition
Share Based Compensation Arrangement By Share Based Payment Award Equity Instruments Other Than Option Awards Distributed Percentage. No definition available.
|
X | ||||||||||
- Definition
Share Based Compensation Arrangement By Share Based Payment Award Equity Instruments Other Than Options Distributed In Period. No definition available.
|
X | ||||||||||
- Definition
Stock Issued During Period Shares Stock Options Exercised Net Of Shares For Tax Withholdings No definition available.
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- Definition
Taxes withheld on issuance of stock-based awards. No definition available.
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Equity Financing - Additional Information (Detail) (USD $)
Share data in Thousands, unless otherwise specified |
6 Months Ended | 3 Months Ended | |
---|---|---|---|
Jun. 30, 2013
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Jun. 30, 2012
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Jun. 30, 2013
Agreement with Mlv And Co
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Equity Financing [Line Items] | |||
Proceeds from sale of common stock | $ 13,000,000 | ||
Sale of stock number shares issued | 114 | ||
Sale of stock, Consideration received on transaction | 250,000 | ||
Proceeds from “at the market” offering | 251,000 | 0 | |
Net offering costs | $ 8,000 | $ 0 |
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Proceeds From Issuance Of Common Stock Value Under Market Offerings No definition available.
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Proceeds From Market Offering Of Shares No definition available.
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- Definition
Sale Of Stock Number Shares Issued. No definition available.
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- Definition
No authoritative reference available. No definition available.
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- Definition
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Common Stock Warrants - Additional Information (Detail) (USD $)
In Millions, except Per Share data, unless otherwise specified |
Jun. 30, 2013
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Class of Warrant or Right [Line Items] | |
Common stock warrant exercisable outstanding, shares | 1.9 |
Common stock warrant exercise price | $ 3.40 |
Common stock Warrant expiration date | August 2014 |
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- Definition
Class of Warrant or Right, Expiration Date No definition available.
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- Definition
Exercise Price Of Warrants No definition available.
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- Details
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- Definition
No authoritative reference available. No definition available.
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Reconciliation of Numerators and Denominators of Basic and Diluted EPS (Detail) (USD $)
In Thousands, except Share data, unless otherwise specified |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2013
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Jun. 30, 2012
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Jun. 30, 2013
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Jun. 30, 2012
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EPS- basic and diluted | ||||
Numerator: net loss | $ (3,076) | $ (2,179) | $ (7,294) | $ (4,512) |
Denominator: | ||||
Common shares | 46,399 | 45,863 | 46,386 | 45,861 |
Vested RSUs | 829 | 1,658 | 829 | 1,658 |
Basic and diluted weighted average shares outstanding | 47,228 | 47,521 | 47,215 | 47,519 |
EPS - basic and diluted | $ (0.07) | $ (0.05) | $ (0.16) | $ (0.10) |
Total excluded common shares | 5,198 | 4,791 | 5,198 | 4,791 |
Stock options
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Denominator: | ||||
Total excluded common shares | 3,342 | 2,935 | 3,342 | 2,935 |
Common stock warrants
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Denominator: | ||||
Total excluded common shares | 1,856 | 1,856 | 1,856 | 1,856 |
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No authoritative reference available. No definition available.
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- Details
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- Details
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Number of lawsuits filed No definition available.
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Number of lawsuits served. No definition available.
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Percentage Of Fee Assumed On Exercise Of warrants In Unit Offering No definition available.
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- Definition
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