Document And Entity Information
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Jun. 30, 2015
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Jul. 30, 2015
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Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2015 | |
Document Fiscal Year Focus | 2015 | |
Document Fiscal Period Focus | Q2 | |
Entity Registrant Name | ACURA PHARMACEUTICALS, INC | |
Entity Central Index Key | 0000786947 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Smaller Reporting Company | |
Trading Symbol | ACUR | |
Entity Common Stock, Shares Outstanding | 59,006,817 |
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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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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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Indicate number of shares or other units outstanding of each of registrant's classes of capital or common stock or other ownership interests, if and as stated on cover of related periodic report. Where multiple classes or units exist define each class/interest by adding class of stock items such as Common Class A [Member], Common Class B [Member] or Partnership Interest [Member] onto the Instrument [Domain] of the Entity Listings, Instrument. No definition available.
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Indicate whether the registrant is one of the following: (1) Large Accelerated Filer, (2) Accelerated Filer, (3) Non-accelerated Filer, (4) Smaller Reporting Company (Non-accelerated) or (5) Smaller Reporting Accelerated Filer. 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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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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CONSOLIDATED BALANCE SHEETS (Parenthetical) (USD $)
In Thousands, except Per Share data, unless otherwise specified |
Jun. 30, 2015
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Dec. 31, 2014
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Accounts receivable, net of allowances | $ 7 | $ 5 |
Finite-lived intangible assets accumulated amortization | 258 | 155 |
Long-term debt, net of debt discount | 251 | 281 |
Debt Instrument Issuance Cost | $ 128 | $ 162 |
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 100,000 | 100,000 |
Common stock, shares issued | 49,217 | 48,848 |
Common stock, shares outstanding | 49,217 | 48,848 |
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CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) (USD $)
In Thousands, except Per Share data, unless otherwise specified |
3 Months Ended | 6 Months Ended | ||
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Jun. 30, 2015
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Jun. 30, 2014
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Jun. 30, 2015
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Jun. 30, 2014
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Revenues: | ||||
Royalty revenue | $ 0 | $ 1 | $ 0 | $ 4 |
Product sales, net | 91 | 34 | 448 | 73 |
License fee revenue | 250 | 0 | 5,250 | 0 |
Total revenues, net | 341 | 35 | 5,698 | 77 |
Operating expenses: | ||||
Cost of sales (excluding inventory write-down) | 98 | 42 | 422 | 80 |
Inventory write-down (Note 7) | 47 | 68 | 307 | 201 |
Research and development | 511 | 1,281 | 1,475 | 2,719 |
Selling, marketing, general and administrative | 2,083 | 1,916 | 4,380 | 4,175 |
Total operating expenses | 2,739 | 3,307 | 6,584 | 7,175 |
Operating loss | (2,398) | (3,272) | (886) | (7,098) |
Non-Operating income (expense): | ||||
Investment income | 36 | 53 | 71 | 97 |
Interest expense (Note 9) | (301) | (302) | (609) | (603) |
Other expense | 0 | 0 | 0 | (5) |
Total other expense, net | (265) | (249) | (538) | (511) |
Loss before income taxes | (2,663) | (3,521) | (1,424) | (7,609) |
Provision for income taxes | 0 | 0 | 0 | 0 |
Net loss | (2,663) | (3,521) | (1,424) | (7,609) |
Other comprehensive (loss) income: | ||||
Unrealized (losses) gains on securities | (31) | 21 | 0 | 50 |
Total other comprehensive (loss) income | (31) | 21 | 0 | 50 |
Comprehensive loss | $ (2,694) | $ (3,500) | $ (1,424) | $ (7,559) |
Loss per share: | ||||
Basic | $ (0.05) | $ (0.07) | $ (0.03) | $ (0.16) |
Diluted | $ (0.05) | $ (0.07) | $ (0.03) | $ (0.16) |
Weighted average shares outstanding: | ||||
Basic | 49,233 | 48,848 | 49,101 | 48,846 |
Diluted | 49,233 | 48,848 | 49,101 | 48,846 |
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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, 2015
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Net offering costs | $ 8 |
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DESCRIPTION OF BUSINESS
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Jun. 30, 2015
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Description Of Business Disclosure [Abstract] | ||
DESCRIPTION OF BUSINESS | NOTE 1 - DESCRIPTION OF BUSINESS 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 three proprietary platform technologies which can be used to develop multiple products. 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. Oxaydo Tablets (formerly known as Oxecta®) (oxycodone HCl, CII), is the first approved product utilizing Aversion® in the United States. On January 7, 2015, we entered into a Collaboration and License Agreement with Egalet US, Inc. and Egalet Ltd., each a subsidiary of Egalet Corporation (collectively, “Egalet”) pursuant to which we exclusively licensed to Egalet worldwide rights to manufacture and commercialize Oxaydo. Oxaydo is currently approved by the FDA for marketing in the United States in 5mg and 7.5mg strengths. We are advised that Egalet plans to launch Oxaydo in the United States in the third quarter of 2015. We have also developed Impede® Technology which is a combination of inactive ingredients that prevent the extraction of pseudoephedrine from tablets and disrupt the direct conversion of pseudoephedrine from tablets into methamphetamine. We launched our first Impede Technology product, Nexafed®, into the United States market in December 2012 and our Nexafed Sinus Pressure + Pain product in the United States in February 2015. We have multiple pseudoephedrine products in development utilizing our Impede Technology. On June 15, 2015, we and Bayer Healthcare LLC (“Bayer”) entered into a License and Development Agreement to provide Bayer with an exclusive worldwide license to our Impede Technology for an undisclosed methamphetamine resistant pseudoephedrine containing product, and providing for our joint development of such product utilizing our Impede Technology for the U.S. market. Our third technology, Limitx, is designed to retard the release of active drug ingredients when an excess number of tablets are accidently or purposefully ingested. In August 2014, we were awarded a grant from the National Institute on Drug Abuse to advance early stage development of our Limitx technology. |
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ACCOUNTING PRONOUNCEMENTS
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6 Months Ended | |
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Jun. 30, 2015
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New Accounting Pronouncements and Changes in Accounting Principles [Abstract] | ||
ACCOUNTING PRONOUNCEMENTS | NOTE 2 ACCOUNTING PRONOUNCEMENTS Revenue from Contracts with Customers In May 2014, the FASB issued Accounting Standards Update (ASU) No. 2014-09, Revenue from Contracts with Customers (ASU 2014-09), which supersedes nearly all existing revenue recognition guidance under U.S. GAAP. The core principle of ASU 2014-09 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration to which an entity expects to be entitled for those goods or services. ASU 2014-09 defines a five step process to achieve this core principle and, in doing so, more judgment and estimates may be required within the revenue recognition process than are required under existing U.S. GAAP. The standard is effective for annual periods beginning after December 15, 2017, and interim periods therein, using either of the following transition methods: (i) a full retrospective approach reflecting the application of the standard in each prior reporting period with the option to elect certain practical expedients, or (ii) a retrospective approach with the cumulative effect of initially adopting ASU 2014-09 recognized at the date of adoption (which includes additional footnote disclosures). We are currently evaluating the impact of our pending adoption of ASU 2014-09 on our consolidated financial statements and have not yet determined the method by which we will adopt the standard in 2018. Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern In August 2014, the FASB issued Accounting Standards Update No. 2014-15, “Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern”, which will explicitly require management to assess an entity’s ability to continue as a going concern and to provide related footnote disclosures in certain circumstances. Currently, there is no guidance in GAAP about management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern or to provide related footnote disclosures. The amendments in this Update provide that guidance. In doing so, the amendments should reduce diversity in the timing and content of footnote disclosures. The amendments require management to assess an entity’s ability to continue as a going concern by incorporating and expanding upon certain principles that are currently in U.S. auditing standards. Specifically, the amendments (1) provide a definition of the term “substantial doubt”, (2) require an evaluation every reporting period including interim periods, (3) provide principles for considering the mitigating effect of management’s plans, (4) require certain disclosures when substantial doubt is alleviated as a result of consideration of management’s plans, (5) require an express statement and other disclosures when substantial doubt is not alleviated and (6) require an assessment for a period of one year after the date that the financial statements are issued (or available to be issued). The amendments in this update are effective for the first annual period ending after December 15, 2016, and for annual periods and interim periods thereafter. Early application is permitted. The Company is currently evaluating the impact of adopting this update on its financial statements. Presentation of Debt Issue Costs In April 2015, the FASB issued ASU No. 2015-03, "Interest - Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs." The amendments in this ASU require that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts. The recognition and measurement guidance for debt issuance costs are not affected by the amendments in this ASU. The amendments are effective for financial statements issued for fiscal years beginning after December 15, 2015. Early adoption of the amendments is permitted and the Company elected to adopt this guidance effective April 1, 2015. The Company adopted the guidance to implement the simplified presentation prescribed as the purpose of the amendment. The new guidance has been applied on a retrospective basis, wherein the consolidated balance sheets of December 31, 2014 have been retrospectively adjusted to reflect the effects of applying the new guidance. As a result of the change to the December 31, 2014 consolidated balance sheet, deferred debt issuance costs and long-term debt decreased and increased, respectively, by $162. After the retrospective application to December 31, 2014, subsequent amortization of the deferred debt issuance costs results in an increase to long-term debt. |
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LICENSE, DEVELOPMENT, AND COMMERCIALIZATION AGREEMENTS
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6 Months Ended | |
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Jun. 30, 2015
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Research and Development Disclosure [Abstract] | ||
LICENSE, DEVELOPMENT, AND COMMERCIALIZATION AGREEMENT | NOTE 3 - LICENSE, DEVELOPMENT, AND COMMERCIALIZATION AGREEMENTS Pfizer Agreement In October 2007, we entered into a License, Development and Commercialization Agreement, or the Pfizer Agreement, with King Pharmaceuticals Research and Development, Inc., now a subsidiary of Pfizer, to develop and commercialize in the United States, Canada and Mexico certain opioid analgesic products utilizing our Aversion Technology. Aversion Oxycodone was approved by the U.S. Food and Drug Administration, or FDA, on June 17, 2011 and sales of Aversion Oxycodone, under Pfizer’s brand name Oxecta, commenced in February 2012. For sales of Aversion Oxycodone occurring on and following February 2, 2013 (the one year anniversary of first commercial sale), Pfizer paid us a royalty of 5% of net sales of Aversion Oxycodone. On September 24, 2012, we entered into a letter agreement with Pfizer which provided for the termination of Pfizer’s license to our Aversion Technology used in three development-stage products licensed to Pfizer and for the return of these products to us. On April 9, 2014, we entered into a second letter agreement with Pfizer providing for the termination of the Pfizer Agreement and the return of Aversion Oxycodone to us effective April 9, 2014 in exchange for a one-time termination payment of $2.0 million. Pfizer’s royalty payment obligations relating to Aversion Oxycodone ceased effective April 9, 2014 and all royalty payments due to us have been received. Our termination payment of $2.0 million has been recorded on our financial statements as an intangible asset and is being amortized over the remaining useful life of the patent for Aversion Oxycodone. The recorded value of the intangible asset will be periodically assessed for impairment. We also purchased from Pfizer selected raw and packaging material inventories for $260 thousand relating to the Aversion Oxycodone product. During the quarter ended March 31, 2015, we recorded a 100% reserve against these inventories which is reflected in operating expense. Egalet Agreement On January 7, 2015, we and Egalet entered into a Collaboration and License Agreement (the “Egalet Agreement”) to commercialize Aversion Oxycodone under the tradename Oxaydo. Oxaydo is approved by the FDA for marketing in the United States in 5 mg and 7.5 mg strengths. Under the terms of the Egalet Agreement, we are transferring the approved NDA for Oxaydo to Egalet and Egalet is granted an exclusive license under our intellectual property rights for development and commercialization of Oxaydo worldwide (the “Territory”) in all strengths, subject to our right to co-promote Oxaydo in the United States. In accordance with the Egalet Agreement, we and Egalet have formed a joint steering committee to coordinate commercialization strategies and the development of product line extensions. Egalet will pay a significant portion of the expenses relating to (i) annual NDA PDUFA product fees, (ii) expenses of the FDA required post-marketing study for Oxaydo and (iii) expenses of clinical studies for product line extensions (additional strengths) of Oxaydo for the United States and will bear all of the expenses of development and regulatory approval of Oxaydo for sale outside the United States. Egalet is responsible for all manufacturing and commercialization activities in the Territory for Oxaydo. Subject to certain exceptions, Egalet will have final decision making authority with respect to all development and commercialization activities for Oxaydo, including pricing, subject to our co-promotion right. Egalet may develop Oxaydo for other countries and in additional strengths, in its discretion. Egalet paid us an upfront payment of $5 million upon signing of the Egalet Agreement and will pay us a $2.5 million milestone on the earlier to occur of (A) the launch of Oxaydo and (B) January 1, 2016. In addition, we will be entitled to a one-time $12.5 million milestone payment when worldwide Oxaydo net sales reach $150 million in a calendar year. We will receive from Egalet a stepped royalty at percentage rates ranging from mid-single digits to double-digits on net sales during a calendar year based on Oxaydo net sales during such year (excluding net sales resulting from our co-promotion efforts). In any calendar year in which net sales exceed a specified threshold, we will receive a double digit royalty on all Oxaydo net sales in that year (excluding net sales resulting from our co-promotion efforts). If we exercise our co-promotion rights, we will receive a share of the gross margin attributable to incremental Oxaydo net sales from our co-promotion activities. Egalet’s royalty payment obligations commence on the first commercial sale of Oxaydo and expire, on a country-by-country basis, upon the expiration of the last to expire valid patent claim covering Oxaydo in such country (or if there are no patent claims in such country, then upon the expiration of the last valid claim in the United States or the date when no valid and enforceable listable patent in the FDA’s Orange Book remains with respect to Oxaydo. Royalties will be reduced upon the entry of generic equivalents, as well for payments required to be made by Egalet to acquire intellectual property rights to commercialize Oxaydo, with an aggregate minimum floor. The Egalet Agreement expires upon the expiration of Egalet’s royalty payment obligations in all countries. Either party may terminate the Egalet Agreement in its entirety if the other party breaches a payment obligation, or otherwise materially breaches the Egalet Agreement, subject to applicable cure periods, or 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. We also may terminate the Egalet Agreement with respect to the U.S. and other countries if Egalet materially breaches its commercialization obligations. Egalet may terminate the Egalet Agreement for convenience on 120 days prior written notice, which termination may not occur prior to the second anniversary of Egalet’s launch of Oxaydo. Egalet also may terminate the Agreement prior to the launch of Oxaydo on 30 days prior written notice upon the occurrence of serious safety issues, regulatory restrictions and intellectual property issues, in each case involving Oxaydo. Termination does not affect a party’s rights accrued prior thereto, but there are no stated payments in connection with termination other than payments of obligations previously accrued. For all terminations (but not expiration), the Egalet Agreement provides for the transition of development and marketing of Oxaydo from Egalet to us, including the conveyance by Egalet to us of the trademarks and all regulatory filings and approvals relating to Oxaydo, and for Egalet’s supply of Oxaydo for a transition period. Paragraph IV ANDA Litigation and License Grants On or about September 17, 2012, the FDA began accepting ANDAs referencing Oxaydo. To date, we have received Paragraph IV Certification Notices under 21 U.S.C. 355(j) (a Paragraph IV Notice) from five separate generic sponsors of an ANDA for a generic drug listing Oxaydo as the reference listed drug. The Paragraph IV Notices state that each generic sponsor believes that our Aversion Technology patents listed in FDA’s Orange Book are invalid, unenforceable or not infringed. We initiated suit against each of Watson Laboratories, Inc. Florida (Watson), Par Pharmaceutical, Inc., Impax Laboratories, Inc., Sandoz Inc., and Ranbaxy, Inc., each in the United States District Court for the District of Delaware alleging infringement of our U.S. Patent No. 7,510,726 listed in the FDA’s Orange Book. We dismissed our suit against Watson on the grounds that Watson had amended its ANDA from a Paragraph IV Certification to a Paragraph Certification III, which indicated its intent not to market its generic Oxaydo product in advance of our patent expiry. We have entered into distinct Settlement Agreements with each of Par, Impax, Ranbaxy and Sandoz to settle our patent infringement actions. Par is the first filer of an ANDA for a generic Oxaydo product and is entitled to the 180-day first filer exclusivity under applicable law and FDA regulations. Par is entitled to launch its generic Oxaydo product in the U.S., through the grant of a non-exclusive, royalty-bearing license from us that would trigger on January 1, 2022. We currently have Orange Book patents that are due to expire between November 2023 and March 2025. In certain limited circumstances, our license to Par would become effective prior to January 1, 2022. Par is required to pay us royalties in the range of 10% to 15% of Par’s net profits from the sale of its generic Oxaydo product. Impax and Sandoz, are entitled to launch their generic Oxaydo product in the U.S., through the grant of a non-exclusive, royalty-free license from us that would trigger 180 days following the first sale of a generic Oxaydo® product in the U.S. by an entity that is entitled to the 180 day first-filer exclusivity under applicable law and FDA regulations (or if no entity is entitled to such 180 day exclusivity period, the date on which a generic Oxaydo® product is first sold in the U.S. or November 27, 2021, whichever date occurs first). In certain circumstances, our license to Impax and Sandoz would become effective prior to such time. In certain circumstances, Sandoz may be required to pay us a royalty on net profits of their generic Oxaydo product. We have entered into a Settlement Agreement with Ranbaxy Inc. to settle our patent infringement action pending in the United States District Court for the District of Delaware. The Settlement Agreement with Ranbaxy provides that Ranbaxy’s current generic of our Oxaydo product that is the subject of its ANDA filing does not infringe our Orange Book listed patents with the FDA. We have not provided Ranbaxy a license to our patents and we may re-commence patent infringement litigation against Ranbaxy if Ranbaxy changes the formulation of its current generic Oxaydo product. Notwithstanding the settlement of these prior infringement actions, it is possible that other generic manufacturers may also seek to launch a generic version of Oxaydo and challenge our patents. Any determination in such infringement actions that our patents covering our Aversion Technology and Oxaydo are invalid or unenforceable, in whole or in part, or that the products covered by generic sponsors’ ANDAs do not infringe our patents could have a material adverse effect on our operations and financial condition. Bayer Agreement On June 15, 2015, we and Bayer entered into a License and Development Agreement granting Bayer an exclusive worldwide license to our Impede Technology for use in an undisclosed methamphetamine resistant pseudoephedrine containing product (the “Bayer Licensed Product”) and providing for the joint development of such product utilizing our Impede Technology for the U.S. market. The Agreement also grants Bayer first right to negotiate a license to the Impede technology for certain other products. We and Bayer will form a joint development committee to coordinate development of the Bayer Licensed Product. We will be eligible to receive reimbursement of certain of our development costs, success-based development and regulatory milestones payments, and low mid-single digit royalties on net sales of the Bayer Licensed product in countries with patent coverage and a reduced royalty elsewhere. The term of the Agreement with respect to each country expires when royalties are no longer payable with respect to such country. After expiration of the term Bayer retains a license to sell the Bayer Licensed Product on a royalty free basis. Either party may terminate the Agreement in its entirety if the other party materially breaches the Agreement, subject to an applicable cure period, or 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. Bayer may terminate the Agreement immediately prior to completion of our development obligations or at any time upon six (6) months prior written notice thereafter. We may terminate the Agreement with respect to the U.S. if Bayer ceases or suspends development or commercialization of the Bayer Licensed Product for a certain period of time. Purdue Pharma The Company received a $250 thousand payment from Purdue Pharma L.P. in June 2015 relating to a December 2014 agreement to settle a patent interference action on U.S. Patent No. 8,101,630 issued to Acura. |
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REVENUE RECOGNITION
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REVENUE RECOGNITION | NOTE 4 - 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. We record revenue from our 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 and Nexafed Sinus Pressure + Pain was launched in February 2015. We sell our Nexafed products in the United States to wholesale pharmaceutical distributors as well as directly to chain drug stores. Our Nexafed products are sold subject to the right of return for a period of up to twelve months after the product expiration. The Nexafed products currently have a shelf life of twenty-four months from the date of manufacture. Given the limited sales history of our Nexafed products, we could not reliably estimate expected returns of the product at the time of shipment to certain customers and accordingly we had deferred revenue. During the first quarter ended March 31, 2015 we determined we had obtained sufficient sales returns history to reasonably estimate future returns. As a result of this change, we recorded a one-time adjustment in the first quarter ended March 31, 2015 to recognize revenue that had previously been deferred, resulting in additional net revenues of $314 thousand after recording an allowance for sales returns of $120 thousand, and cost of sales of $255 thousand. At June 30, 2015, we have a $195 thousand sales returns liability which will be reviewed against sales returns activity each quarter. Revenue is being recognized at the time the products are sold to a customer. Commencing in February 2013, we began earning royalties based on net sales of Aversion Oxycodone by Pfizer. We earned royalties of approximately $4 thousand for the six months ended June 30, 2014. The Pfizer Agreement was terminated effective April 9, 2014 and Pfizer’s royalty payment obligations ceased as of such date. All royalties owed to us have been received. Shipping and Handling Costs We record our shipping and handling costs in selling expenses. The amounts recorded to selling expenses from the shipments of Nexafed products during each of the six month periods ended June 30, 2015 and 2014 were not material. |
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RESEARCH AND DEVELOPMENT ACTIVITIES
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RESEARCH AND DEVELOPMENT ACTIVITIES | NOTE 5 - 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 did not have any accrued CRO costs and clinical trial study expenses at either June 30, 2015 or December 31, 2014. We did not have any prepaid CRO costs and clinical trial study expenses at either June 30, 2015 or December 31, 2014. |
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INVESTMENTS IN MARKETABLE SECURITIES
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INVESTMENTS IN MARKETABLE SECURITIES | NOTE 6 - INVESTMENTS IN MARKETABLE SECURITIES Investments in marketable securities consisted of the following (in millions):
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 Sheets 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. Our assets measured at fair value or disclosed at fair value on a recurring basis as at June 30, 2015 and December 31, 2014 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) at June 30, 2015 and December 31, 2014 consisted of unrealized losses on securities of $13 thousand. |
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INVENTORIES
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INVENTORIES | NOTE 7 INVENTORIES Inventories consist of both raw and packaging materials on our Oxaydo product and finished goods held for distribution and sale on our Nexafed products. During 2014, we purchased raw and packaging material inventories for $260 thousand from Pfizer on the Oxaydo product we reacquired from them. Inventories are stated at the lower of cost (first-in, first-out method) or market (net realizable value). We write down inventories to net realizable value based on forecasted demand and market conditions, which may differ from actual results. During the quarter ended March 31, 2015, we recorded a $260 thousand reserve against the raw and packaging material inventory on our Oxaydo product as Egalet will secure its own material requirements. During the quarter ended June 30, 2015, we applied the reserve against our packaging material inventory and we recorded a $47 thousand reserve against finished good inventory. We recorded finished good inventory reserves of $133 thousand and $68 thousand during each of the first and second quarters of 2014, respectively. We had recorded Nexafed deferred revenue of $0.35 million at December 31, 2014. The related cost of sales of $0.22 million at December 31, 2014 is reported in our balance sheet in the other current deferred assets account and excluded from the reported year end inventories. We recognize both the revenue and cost of sales on these Nexafed shipments once the right of return no longer exists or adequate history and information becomes available to estimate sales returns. During the first quarter ended March 31, 2015, we determined we had obtained sufficient sales returns history to reasonably estimate future returns. As a result of this change, we recorded a one-time adjustment in the first quarter ended March 31, 2015 to recognize revenue that had previously been deferred, resulting in additional net revenue of $314 thousand and cost of sales of $255 thousand. Revenue is being recognized at the time the products are sold to a customer. Our purchases of ingredients and other materials required in our development and clinical trial activities are expensed as incurred. Inventories are summarized as follows (in thousands):
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ACCRUED EXPENSES
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ACCRUED EXPENSES | NOTE 8 - ACCRUED EXPENSES Accrued expenses are summarized as follows (in thousands):
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DEBT
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DEBT | NOTE 9 DEBT On December 27, 2013, we entered into a Loan and Security Agreement (the “Loan Agreement”) with Oxford Finance LLC (“Oxford” or the “Lender”), for a term loan to the Company in the principal amount of $10.0 million (the “Term Loan”). The full principal amount of the Term Loan was funded on December 27, 2013. We are using the proceeds of the Loan Agreement for general working capital and to fund our business requirements. The Term Loan accrues interest at a fixed rate of 8.35% per annum (with a default rate of 13.35% per annum). The Company was required to make monthly interestonly payments until the April 1, 2015 (“Amortization Date”) and on the Amortization Date, the Company began to make payments of principal and accrued interest in equal monthly installments of $260 thousand sufficient to amortize the Term Loan through the maturity date of December 1, 2018. All unpaid principal and accrued and unpaid interest with respect to the Term Loan is due and payable in full on December 1, 2018. As of June 30, 2015 we have made $768 thousand in principal payments. As security for its obligations under the Loan Agreement, the Company granted Lender a security interest in substantially all of its existing and afteracquired assets, exclusive of its intellectual property assets. Pursuant to the Loan Agreement, the Company is not allowed to pledge its intellectual property assets to others. Upon the execution of the Loan Agreement, we issued to the Lender warrants to purchase an aggregate of up to 298 thousand shares of our common stock at an exercise price equal to $1.595 per share (the “Warrants”). We recorded $400 thousand as debt discount associated with the fair value of the Warrants and are amortizing it to interest expense over the term of the loan using the loan’s effective interest rate. The Warrants are immediately exercisable for cash or by net exercise and will expire December 27, 2020. On January 7, 2015, we and Oxford entered into an amendment to the Loan Agreement. Pursuant to the amendment, (i) the exercise price of the Warrants was lowered from $1.595 to $0.504 per share (the average closing price of our common stock on Nasdaq for the 10 trading days preceding the date of the amendment) and we recorded additional debt discount of $33 representing the fair value of the warrant modification, (ii) we agreed to maintain a $2.5 million cash reserve until such time as we have repaid $5.0 million in principal of the Term Loan, and (iii) the Lender consented to the terms of our Collaboration and License Agreement with Egalet relating to our Oxaydo product. The Company may voluntarily prepay the Term Loan in full, but not in part, and any prepayment is subject to a prepayment premium equal to 2% of the principal prepaid, if prepaid prior to December 27, 2015, and 1% of the principal prepaid if prepaid after December 27, 2015. In addition, at the maturity, termination or upon voluntary or mandatory prepayment of the Term Loan the Company must pay the Lender an additional one-time interest payment of $795 thousand. We will incur and accrue additional monthly interest expense over the term of the loan for this additional one-time interest payment using the loan’s effective cash interest rate. The Company was obligated to pay customary lender fees and expenses, including a one-time facility fee of $50 thousand and the Lender’s expenses in connection with the Loan Agreement. Combined with the Company’s own expenses and a $100 thousand consulting placement fee, the Company incurred $231 thousand in deferred debt issue costs. We are amortizing these costs, including debt modification additional costs, into interest expense over the term of the loan using the loan’s effective interest rate of 10.16%. The Loan Agreement contains customary representations and warranties and customary affirmative and negative covenants, including, among others, limits or restrictions on the Company’s ability to incur liens, incur indebtedness, pay dividends, redeem stock, and merge or consolidate and dispose of assets. In addition, it contains customary events of default that entitles the Lender to cause any or all of the Company’s indebtedness under the Loan Agreement to become immediately due and payable. The events of default (some of which are subject to applicable grace or cure periods), include, among other things, nonpayment defaults, covenant defaults, a material adverse change in the Company, bankruptcy and insolvency defaults and material judgment defaults. Our debt at June 30, 2015 is summarized below (in thousands):
Our interest expense during the three and six months ended June 30, 2015 and 2014 consisted of the following (in thousands):
The remaining annual principal payments on the debt as of June 30, 2015 is as follows (in thousands):
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EQUITY FINANCING
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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. We did not sell any shares of our common stock pursuant to our prospectus supplement during the year ended December 31, 2014. During the three and six months ended June 30, 2015, we sold approximately 270 thousand shares of our common stock for gross proceeds of approximately $0.23 million. Transaction costs were approximately $8 thousand. The net proceeds of approximately $0.22 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. In order to allow for the sale of our shares of common stock under our shelf registration statement pursuant to the Placement Agency Agreement and Securities Purchase Agreement described below, on June 30, 2015, we and MLV & Co., LLC, as sales agent, terminated the At Market Issuance Sales Agreement dated April 18, 2013, thereby terminating any further “at the market offerings” under our prospectus supplement filed with the SEC on April 18, 2013. On June 30, 2015, we entered into a Placement Agency Agreement (the “Placement Agency Agreement”) with Roth Capital Partners, LLC (“Roth”), pursuant to which we engaged Roth to act as sole placement agent in a registered direct offering (the “Offering”) of 9.79 million shares of our common stock, par value $.01. On June 30, 2015, we entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain institutional investors (the “Purchasers”), pursuant to which we agreed to sell 9.79 million shares of our common stock at a price of $0.78 per share to the Purchasers in the Offering, for gross proceeds to the Company of approximately $7.63 million, before expenses. The Offering was made pursuant to a prospectus supplement dated June 30, 2015 filed with the Securities and Exchange Commission in connection with a takedown from the Company’s shelf registration statement on Form S-3 (File No. 333-187075), which became effective on March 15, 2013, and the related base prospectus included in the Registration Statement, as supplemented by the prospectus supplement. The transactions contemplated by the Placement Agency Agreement and the Purchase Agreement closed on July 7, 2015. Pursuant to the terms of the Placement Agency Agreement, we paid Roth a cash placement fee equal to 6.5% of the gross proceeds in the Offering and reimbursed Roth $35 thousand for its expenses. We estimate that net proceeds from the Offering, after these and other legal expenses, will be approximately $7.0 million. |
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COMMON STOCK WARRANTS
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Stockholders Equity Note [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
COMMON STOCK WARRANTS | NOTE 11 - COMMON STOCK WARRANTS We have outstanding common stock purchase warrants (“warrants”) exercisable for 298 thousand shares of our common stock having an exercise price of $0.504 per share with an expiration date in December 2020. See Note 9 for a discussion of the reduction of the exercise price of the warrants to $0.504 per share. These warrants contain a cashless exercise feature. Our common stock warrant activity during the six months ended June 30, 2015 and 2014 is shown below:
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SHARE-BASED COMPENSATION
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Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
SHARE-BASED COMPENSATION | NOTE 12 - SHARE-BASED COMPENSATION Share-based Compensation We have three share-based compensation plans covering stock options and RSUs 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 comprised the following (in thousands):
Stock Option Award Plans We have one stock option plan in effect, and one stock option plan has expired by its terms, but pursuant to which stock options have been granted and remain outstanding. Our stock option award activity during the six months ended June 30, 2015 and 2014 is shown below:
No stock options were exercised during the six months ended June 30, 2015. During the six months ended June 30, 2014, a total of 31 thousand stock options were exercised by our employees. Of the total amount of these stock option exercises, 24 thousand of stock options were exercised under various cashless exercise features of the plan. Our employees elected to have 18 thousand shares withheld in satisfaction of $36 thousand for both the exercise costs and withholding tax obligations on those options, resulting in the net issuance of 13 thousand shares of common stock from all stock option exercises. Restricted Stock Unit Award Plans We have two Restricted Stock Unit Award Plans for our employees and non-employee directors, a 2005 Restricted Stock Unit Award Plan (the “2005 RSU Plan”) and a 2014 Restricted Stock Unit Award Plan (the “2014 RSU Plan”). Vesting of an RSU entitles the holder to receive a share of our common stock on a distribution date. The share-based compensation cost to be incurred on a granted RSU is the RSU’s fair value, which is the market price of our common stock on the date of grant, less its exercise cost. The compensation cost is amortized to expense over the vesting period of the RSU award. A summary of the grants under the RSU Plans consisted of the following (in thousands):
2005 Restricted Stock Unit Award Plan Under our 2005 RSU Plan, one-fourth of vested shares of common stock underlying RSU awards of 3.3 million shares will be distributed (after payment of exercise costs of $0.01 par value per share) on January 1 of each of years 2011 thru 2014. On January 1, 2014, 0.50 million shares were distributed to the holders while 0.33 million shares were withheld by the Company upon elections made to exchange RSUs in satisfaction of $0.5 million withholding tax obligations. All RSUs granted under the 2005 RSU Plan had been distributed effective January 1, 2014. 2014 Restricted Stock Unit Award Plan Our 2014 RSU Plan was approved by shareholders on May 1, 2014 and permits the grant of up to 2.0 million shares of our common stock pursuant to awards under the 2014 RSU Plan. As of June 30, 2015, 1.65 million shares are available for award under the 2014 RSU Plan. Information about the awards under the 2014 RSU Plan is as follows:
Information about the distribution of shares under the 2014 RSU Plan is as follows:
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INCOME TAXES
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Jun. 30, 2015
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Income Tax Disclosure [Abstract] | ||
INCOME TAXES | NOTE 13 INCOME TAXES We account 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, 2015 and December 31, 2014, 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. We have approximately $51.5 million federal income tax benefits at December 31, 2014 derived from $151.4 million Federal NOLs at the U.S. statutory tax rate of 34% and $2.9 million state NOLs, available to offset future taxable income, some of which have limitations for use as prescribed under IRC Section 382. Our Federal and state NOLs will expire in varying amounts between 2016 and 2034 if not used, and those expirations will cause fluctuations in our valuation allowances. As of December 31, 2014 we had federal research and development tax credits of approximately $1.1 million, which expire in the years 2024 through 2034. We also had approximately $0.3 million of Indiana state research and development tax credits, which expire in the years 2015 through 2017. |
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EARNINGS PER SHARE ("EPS")
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Earnings Per Share [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
EARNINGS PER SHARE ("EPS") | NOTE 14 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 Restricted Stock Units (“RSUs”) (see Note 12). 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. Common stock equivalents are excluded from the computation where their inclusion would be anti-dilutive. No such adjustments were made for 2015 and 2014 as the Company reported a net loss for the three and six month periods, and including the effects of common stock equivalents in the diluted EPS calculation would have been antidilutive. A reconciliation of the numerators and denominators of basic and diluted EPS consisted of the following:
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COMMITMENTS AND CONTINGENCIES
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Jun. 30, 2015
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Commitments and Contingencies Disclosure [Abstract] | ||
COMMITMENTS AND CONTINGENCIES | NOTE 15 COMMITMENTS AND CONTINGENCIES Purdue Pharma Complaint In April 2015, Purdue Pharma L.P., Purdue Pharmaceuticals L.P. and The P.F. Laboratories, Inc. (collectively, “Purdue”) commenced a patent infringement lawsuit against us and our Oxaydo product licensee Egalet US, Inc. and its parent Egalet Corporation in the United States District Court for the District of Delaware alleging our Oxaydo product infringes Purdue’s U.S. patent 8,389,007. The complaint seeks injunctive relief as well as awards of damages and attorneys’ fees. We deny the allegations in the complaint, believe they are without merit and are defending the action vigorously. 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 addition, Acura was served with a similar complaint by two individual plaintiffs in Nebraska federal court, which plaintiffs voluntarily dismissed in December 2014. In this product liability litigation against numerous pharmaceutical product manufacturers and distributors, including Acura, plaintiffs claim injuries from their use of the Reglan brand of metoclopramide and generic metoclopramide. In the Pennsylvania action, over 200 lawsuits have been filed against Acura and Halsey Drug Company alleging that plaintiffs developed neurological disorders as a result of their use of the Reglan brand and/or generic metoclopramide. In the New Jersey action, plaintiffs filed approximately 150 lawsuits against us, but served less than 50 individual lawsuits upon us. In the California action, there are 89 pending cases against us, with more than 445 individual plaintiffs. In the lawsuits filed to date, plaintiffs have not confirmed they ingested any of the generic metoclopramide manufactured by Acura. We discontinued manufacture and distribution of generic metoclopramide more than 18 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 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 all of the New Jersey cases pending against Acura with prejudice. It is possible that this ruling may eventually be appealed by plaintiffs at the conclusion of the litigation in the trial court. In Pennsylvania, and California, Generic Defendants, including Acura, also filed dispositive motions based on the Mensing decision. In Pennsylvania, on November 18, 2011, the trial court denied Generic Defendants’ dispositive preemption motions, without prejudice. In July 2013, the Pennsylvania Superior Court issued an adverse decision, and a subsequent appeal to the Pennsylvania Supreme Court was denied. On December 16, 2014, the Generic Defendants filed a Joint Petition for Certiorari with the United States Supreme Court captioned Teva Pharmaceuticals USA, Inc. et al. v. Dorothy Bentley, et al., No. 14-711 (U.S.) seeking reversal of the Pennsylvania state court decision. On April 27, 2015, the U.S. Supreme Court denied this Petition and this matter has been returned to the trial court for further proceedings. Pending a further court order, these proceedings are stayed. On July 16, 2015, the court has scheduled a conference to address lifting the stay and to confirm procedures for further litigation. To the extent, however, that plaintiffs intend to pursue these claims, Acura nonetheless remains optimistic that most, if not all, of these Philadelphia cases will eventually be dismissed against it based upon the favorable aspects of the Superior Court’s narrow preemption ruling and lack of product identification, although there can be no assurance in this regard. Legal fees related to this matter are currently covered by Acura’s insurance carrier. In California, the trial court entered a May 25, 2012 Order denying Generic Defendants’ dispositive preemption motions. The Generic Defendants’ appeals from this order were denied by the California appellate courts. In May 2014, the California Court denied a subsequent demurrer and motion to strike seeking dismissal of plaintiffs’ manufacturing defect and defective product claims to the extent that they are barred by federal preemption based upon the June 2013 Bartlett decision. Thus far, Acura and most Generic Defendants have not been required to file answers or other responsive pleadings in each individual case in which they are named defendants. However, the individual cases against Acura have been stayed pending further action by the trial court. Subject to further developments, plaintiffs may be permitted to proceed with these lawsuits against Acura including state law claims based on (1) failing to communicate warnings to physicians through “Dear Doctor” letters; and (2) failure to update labeling to adopt brand labeling changes. The California trial court also has 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.” To date, however, none of these plaintiffs have confirmed they ingested any of the generic metoclopramide manufactured by Acura. 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. Legal fees related to this matter are currently covered by our insurance carrier. As any potential loss is neither probable nor estimable, we have not accrued for any potential loss related to these matters as of June 30, 2015 and we are presently unable to determine if any potential loss would be covered by our insurance carrier. Facility Lease The Company leases administrative office space in Palatine, Illinois under a lease expiring March 31, 2016 for approximately $25 thousand annually. |
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INVESTMENTS IN MARKETABLE SECURITIES (Tables)
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Investments, Debt and Equity Securities [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Marketable securities | Investments in marketable securities consisted of the following (in millions):
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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, 2015 and December 31, 2014 consisted of the following (in millions):
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INVENTORIES (Tables)
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Inventory Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
INVENTORIES | Inventories are summarized as follows (in thousands):
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ACCRUED EXPENSES (Tables)
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Payables and Accruals [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
ACCRUED EXPENSES | Accrued expenses are summarized as follows (in thousands):
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DEBT (Tables)
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Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Debt | Our debt at June 30, 2015 is summarized below (in thousands):
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Schedule of Interest Expense | Our interest expense during the three and six months ended June 30, 2015 and 2014 consisted of the following (in thousands):
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule Of Long Term Debt Future Principal Payments Year | The remaining annual principal payments on the debt as of June 30, 2015 is as follows (in thousands):
|
X | ||||||||||
- Definition
Schedule of long term debt future principal payments year. No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
COMMON STOCK WARRANTS (Tables)
|
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2015
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stockholders Equity Note [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
COMMON STOCK WARRANTS | Our common stock warrant activity during the six months ended June 30, 2015 and 2014 is shown below:
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Details
|
SHARE-BASED COMPENSATION (Tables)
|
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2015
|
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Summary Of Information About Non Vested Stock Options Disclosure Abstract [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs | Our share-based compensation expense recognized in the Company’s results of operations comprised the following (in thousands):
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Share-based Compensation, Stock Options, Activity | Our stock option award activity during the six months ended June 30, 2015 and 2014 is shown below:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Share-based Compensation, Restricted Stock Units Award Activity | A summary of the grants under the RSU Plans 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.
|
EARNINGS PER SHARE ("EPS") (Tables)
|
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2015
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Earnings Per Share [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Earnings Per Share, Basic and Diluted | A reconciliation of the numerators and denominators of basic and diluted EPS consisted of the following:
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
Accounting Pronouncements - Additional Information (Detail) (USD $)
In Thousands, unless otherwise specified |
Jun. 30, 2015
|
Dec. 31, 2014
|
---|---|---|
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Debt Instrument Issuance Cost | $ 128 | $ 162 |
X | ||||||||||
- Definition
The amount of debt discount that was originally recognized at the issuance costs. No definition available.
|
X | ||||||||||
- Details
|
License, Development, and Commercialization Agreements - Additional Information (Detail) (USD $)
|
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Mar. 31, 2015
|
Jun. 30, 2015
|
Dec. 31, 2014
|
Sep. 24, 2012
|
|
License Development and Commercialization Agreement [Line Items] | ||||
Agreement Termination Notice Description | Egalet may terminate the Egalet Agreement for convenience on 120 days prior written notice, which termination may not occur prior to the second anniversary of Egalets launch of Oxaydo. Egalet also may terminate the Agreement prior to the launch of Oxaydo on 30 days prior written notice upon the occurrence of serious safety issues, regulatory restrictions and intellectual property issues, in each case involving Oxaydo | |||
Inventory, Raw Materials and Supplies, Gross | $ 126,000 | $ 260,000 | $ 260,000 | |
Percentage Of Inventory Allowance Reserve | 100.00% | |||
Licenses Revenue | 250,000 | |||
Settlement Agreement With Par
|
||||
License Development and Commercialization Agreement [Line Items] | ||||
Patents expiration year | expire between November 2023 and March 2025 | |||
Pfizer Agreement
|
||||
License Development and Commercialization Agreement [Line Items] | ||||
Percentage of royalty | 5.00% | |||
Payment for Termination | $ 2,000,000 | |||
Egalet Agreement
|
||||
License Development and Commercialization Agreement [Line Items] | ||||
Line of Credit Facility, Description | Egalet paid us an upfront payment of $5 million upon signing of the Egalet Agreement and will pay us a $2.5 million milestone on the earlier to occur of (A) the launch of Oxaydo and (B) January 1, 2016 | |||
Minimum Net Sales Reaching Description | one-time $12.5 million milestone payment when worldwide Oxaydo net sales reach $150 million in a calendar year | |||
Minimum | Settlement Agreement With Par
|
||||
License Development and Commercialization Agreement [Line Items] | ||||
Percentage of royalty | 10.00% | |||
Maximum | Settlement Agreement With Par
|
||||
License Development and Commercialization Agreement [Line Items] | ||||
Percentage of royalty | 15.00% |
X | ||||||||||
- Definition
Description of notice period of termination when the party breaches a payment obligation, or otherwise materially breaches the agreement. No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
Description of milestone payment to be made when worldwide net sales reached minimum level in a calendar year. No definition available.
|
X | ||||||||||
- Definition
Patents Expiration Year. No definition available.
|
X | ||||||||||
- Definition
Represents the amount of one-time termination payment under the agreement. No definition available.
|
X | ||||||||||
- Definition
The percentage of allowance reserve against inventory present at the reporting date when inventory is valued using different valuation methods. No definition available.
|
X | ||||||||||
- Definition
Percentage Of Royalty 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.
|
Revenue Recognition - Additional Information (Detail) (USD $)
In Thousands, unless otherwise specified |
3 Months Ended | 6 Months Ended | |||
---|---|---|---|---|---|
Jun. 30, 2015
|
Mar. 31, 2015
|
Jun. 30, 2014
|
Jun. 30, 2015
|
Jun. 30, 2014
|
|
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Deferred Sales Inducements, Additions | $ 255 | ||||
Deferred Revenue, Revenue Recognized | 314 | 314 | |||
Sales Returns Liability | 195 | 195 | |||
Royalty revenue | 0 | 1 | 0 | 4 | |
Allowance for Sales Returns [Member]
|
|||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Sales Returns and Allowances, Goods | 120 | ||||
Pfizer [Member]
|
|||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Royalty revenue | $ 4 |
X | ||||||||||
- Definition
Sales returns liability. 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.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
Research and Development Activities - Additional Information (Detail) (USD $)
|
Jun. 30, 2015
|
Dec. 31, 2014
|
---|---|---|
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Accrued Research And Development Expense Current | $ 0 | $ 0 |
Prepaid Research And Development Expense Current | $ 0 | $ 0 |
X | ||||||||||
- Definition
Accrued research and development expense current. No definition available.
|
X | ||||||||||
- Definition
Prepaid research and development expense current. No definition available.
|
X | ||||||||||
- Details
|
Summary of Investments in Marketable Securities (Detail) (USD $)
In Millions, unless otherwise specified |
Jun. 30, 2015
|
Dec. 31, 2014
|
---|---|---|
Marketable securities: | ||
Corporate bonds - maturing within 1 year | $ 3.0 | $ 3.5 |
Corporate bonds - maturing after 1 year and through March 2017 | 1.7 | 2.8 |
Total marketable securities | 9.7 | 11.3 |
Exchange-traded funds
|
||
Marketable securities: | ||
Total marketable securities | $ 5.0 | $ 5.0 |
X | ||||||||||
- Definition
air value of available-for-sale debt securities maturing in the second fiscal year through the third fiscal year following the latest fiscal year. Excludes interim and annual periods when interim periods are reported on a rolling approach, from latest balance sheet date. 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, 2015
|
Dec. 31, 2014
|
|
Available For Sale Securities Continuous Unrealized Loss Position Fair Value [Line Items] | ||
Cost | $ 9.7 | $ 11.3 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 9.7 | 11.3 |
Corporate Bonds
|
||
Available For Sale Securities Continuous Unrealized Loss Position Fair Value [Line Items] | ||
Cost | 4.7 | 6.3 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 4.7 | 6.3 |
Exchange-traded funds
|
||
Available For Sale Securities Continuous Unrealized Loss Position Fair Value [Line Items] | ||
Cost | 5.0 | 5.0 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | $ 5.0 | $ 5.0 |
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, 2015
|
Dec. 31, 2014
|
---|---|---|
Assets: | ||
Total marketable securities | $ 9.7 | $ 11.3 |
Corporate bonds
|
||
Assets: | ||
Total marketable securities | 4.7 | 6.3 |
Exchange-traded funds
|
||
Assets: | ||
Total marketable securities | 5.0 | 5.0 |
Fair Value, Inputs, Level 1
|
||
Assets: | ||
Total marketable securities | 5.0 | 5.0 |
Fair Value, Inputs, Level 1 | Corporate bonds
|
||
Assets: | ||
Total marketable securities | 0 | 0 |
Fair Value, Inputs, Level 1 | Exchange-traded funds
|
||
Assets: | ||
Total marketable securities | 5.0 | 5.0 |
Fair Value, Inputs, Level 2
|
||
Assets: | ||
Total marketable securities | 4.7 | 6.3 |
Fair Value, Inputs, Level 2 | Corporate bonds
|
||
Assets: | ||
Total marketable securities | 4.7 | 6.3 |
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 | Exchange-traded funds
|
||
Assets: | ||
Total marketable securities | $ 0 | $ 0 |
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
Investments In Marketable Securities - Additional Information (Detail) (USD $)
In Thousands, unless otherwise specified |
3 Months Ended | 6 Months Ended | 12 Months Ended | ||
---|---|---|---|---|---|
Jun. 30, 2015
|
Jun. 30, 2014
|
Jun. 30, 2015
|
Jun. 30, 2014
|
Dec. 31, 2014
|
|
Investment In Marketable Securities [Line Items] | |||||
Unrealized losses on securities | $ (31) | $ 21 | $ 0 | $ 50 | $ 13 |
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
Inventories (Detail) (USD $)
In Thousands, unless otherwise specified |
Jun. 30, 2015
|
Mar. 31, 2015
|
Dec. 31, 2014
|
Jun. 30, 2014
|
Mar. 31, 2014
|
Sep. 24, 2012
|
---|---|---|---|---|---|---|
Inventory [Line Items] | ||||||
Raw and packaging materials | $ 126 | $ 260 | $ 260 | |||
Finished goods | 264 | 44 | ||||
Total | 390 | 304 | ||||
Less: reserve for raw materials | (126) | (260) | 0 | |||
Less: reserve for finished goods | (47) | 0 | (68) | (133) | ||
Net | $ 217 | $ 304 |
X | ||||||||||
- Definition
Amount of valuation reserve for finished goods. No definition available.
|
X | ||||||||||
- Definition
It represents the reserve for raw materials. 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.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
Inventories - Additional Information (Detail) (USD $)
In Thousands, unless otherwise specified |
3 Months Ended | 6 Months Ended | 12 Months Ended | |||
---|---|---|---|---|---|---|
Mar. 31, 2015
|
Jun. 30, 2015
|
Dec. 31, 2014
|
Jun. 30, 2014
|
Mar. 31, 2014
|
Sep. 24, 2012
|
|
Inventory [Line Items] | ||||||
Inventory, Raw Materials and Supplies, Gross | $ 126 | $ 260 | $ 260 | |||
Inventory Reserve For Raw Materials | 260 | 126 | 0 | |||
Cost of Goods Sold | 255 | 220 | ||||
Deferred Revenue, Current | 0 | 353 | ||||
Deferred Revenue, Revenue Recognized | 314 | 314 | ||||
Inventory Reserve For Finished Goods | $ 47 | $ 0 | $ 68 | $ 133 |
X | ||||||||||
- Definition
Amount of valuation reserve for finished goods. No definition available.
|
X | ||||||||||
- Definition
It represents the reserve for raw materials. 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.
|
Accrued Expenses (Detail) (USD $)
In Thousands, unless otherwise specified |
Jun. 30, 2015
|
Dec. 31, 2014
|
---|---|---|
Accounts Payable and Accrued Liabilities [Line Items] | ||
Payroll, payroll taxes, and benefits | $ 165 | $ 94 |
Professional services | 436 | 253 |
Franchise taxes | 19 | 13 |
Property taxes | 15 | 15 |
Marketing and promotion | 150 | 61 |
Clinical, non-clinical and regulatory services | 24 | 83 |
Other fees and services | 54 | 49 |
Total | $ 863 | $ 568 |
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
Accrued Other Professional Fees, Current No definition available.
|
X | ||||||||||
- Definition
Marketing and promotion. 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.
|
X | ||||||||||
- Definition
It represents the additions made to debt instrument unamortized discount during the period. No definition available.
|
X | ||||||||||
- Definition
Class of warrant or right, expiration date. No definition available.
|
X | ||||||||||
- Definition
Debt consulting placement fee. No definition available.
|
X | ||||||||||
- Definition
Debt default long term debt percentage. No definition available.
|
X | ||||||||||
- Definition
This represents the debt instrument cash maintenance amount. No definition available.
|
X | ||||||||||
- Definition
Debt instrument prepayment percentage. 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 | ||||||||||
- 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
Additions to debt instrument issuance costs. No definition available.
|
X | ||||||||||
- Definition
It represents the additions made to debt instrument unamortized discount during the period. No definition available.
|
X | ||||||||||
- Definition
Amortization expense of debt instrument issuance costs. No definition available.
|
X | ||||||||||
- Details
|
X | ||||||||||
- Definition
This element refers our debt classifications. No definition available.
|
X | ||||||||||
- Definition
Debt instrument issuance costs. No definition available.
|
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 | ||||||||||
- Details
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
Interest Expense (Detail) (USD $)
In Thousands, unless otherwise specified |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2015
|
Jun. 30, 2014
|
Jun. 30, 2015
|
Jun. 30, 2014
|
|
Interest expense: | ||||
Term loan | $ 251 | $ 255 | $ 512 | $ 510 |
Debt discount | 33 | 30 | 63 | 59 |
Debt issue costs | 17 | 17 | 34 | 34 |
Total interest expense | $ 301 | $ 302 | $ 609 | $ 603 |
X | ||||||||||
- Definition
The debt discount related to interest expense during the period. 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.
|
Long-Term Debt (Detail) (USD $)
In Thousands, unless otherwise specified |
Jun. 30, 2015
|
Dec. 31, 2014
|
---|---|---|
Debt Instrument [Line Items] | ||
2015 | $ 1,185 | |
2016 | 2,522 | |
2017 | 2,741 | |
2018 | 2,979 | |
Total | $ 9,427 | $ 10,000 |
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.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
X | ||||||||||
- Definition
No authoritative reference available. No definition available.
|
Equity Financing - Additional Information (Detail) (USD $)
Share data in Thousands, except Per Share data, unless otherwise specified |
1 Months Ended | 3 Months Ended | 6 Months Ended | |||
---|---|---|---|---|---|---|
Apr. 18, 2013
|
Jun. 30, 2015
|
Jun. 30, 2015
Common Stock [Member]
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Jun. 30, 2015
Common Stock [Member]
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Jun. 30, 2015
Placement Agency Agreement [Member]
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Jun. 30, 2015
Securities Purchase Agreement [Member]
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Equity Financing [Line Items] | ||||||
Proceeds from sale of common stock | $ 13,000,000 | $ 230,000 | $ 230,000 | |||
Sale leaseback transaction, transaction costs, financing activities | 8,000 | |||||
Sale leaseback transaction, net proceeds, financing activities | 220,000 | |||||
Stock issued during period, shares, new issues | 270 | 270 | 9,790 | 9,790 | ||
Share price | $ 0.01 | $ 0.78 | ||||
Proceeds from issuance of private placement | 7,000,000 | 7,630,000 | ||||
Description for repayment of placement agent | paid Roth a cash placement fee equal to 6.5% of the gross proceeds in the Offering | |||||
Placement agency reimbursed for expenses | $ 35,000 |
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Description for repayment of placement agent. No definition available.
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Placement Agency reimbursed for expenses. No definition available.
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Common Stock Warrant Activity (Detail) (USD $)
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6 Months Ended | |
---|---|---|
Jun. 30, 2015
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Jun. 30, 2014
|
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Number of Shares | ||
Exercised | 0 | |
Warrant
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||
Number of Shares | ||
Number of Options Outstanding, beginning | 298,000 | 2,154,000 |
Issued | 0 | 0 |
Exercised | 0 | 0 |
Expired | 0 | 0 |
Number of Options Outstanding, ending | 298,000 | 2,154,000 |
Weighted Average Exercise Price | ||
Weighted Average Exercise Price, beginning | $ 1.60 | $ 3.15 |
Issued | $ 0 | $ 0 |
Exercised | $ 0 | $ 0 |
Expired | $ 0 | $ 0 |
Weighted Average Exercise Price, ending | $ 0.50 | $ 3.15 |
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Common Stock Warrants - Additional Information (Detail) (USD $)
In Thousands, except Per Share data, unless otherwise specified |
6 Months Ended |
---|---|
Jun. 30, 2015
|
|
Class of Warrant or Right [Line Items] | |
Common stock warrant exercisable outstanding, shares | 298 |
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.504 |
Warrant
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Class of Warrant or Right [Line Items] | |
Common stock warrant exercisable outstanding, shares | 298 |
Common stock Warrant expiration date | December 27, 2020 |
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 1.595 |
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Class of warrant or right, expiration date. No definition available.
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Share-Based Compensation - Additional Information (Detail) (USD $)
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6 Months Ended | 1 Months Ended | 6 Months Ended | 0 Months Ended | 1 Months Ended | 2 Months Ended | 12 Months Ended | 8 Months Ended | 0 Months Ended | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2015
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Jun. 30, 2015
Stock options
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Jun. 30, 2015
Option Plan [Member]
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Jan. 31, 2014
2005 Restricted Stock Unit Award Plan [Member]
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Jun. 30, 2015
2005 Restricted Stock Unit Award Plan [Member]
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Jun. 30, 2015
2014 Restricted Stock Unit Award Plan [Member]
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May 01, 2014
2014 Restricted Stock Unit Award Plan [Member]
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May 01, 2014
2014 Restricted Stock Unit Award Plan [Member]
Four Non Employee Directors [Member]
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Dec. 31, 2014
2014 Restricted Stock Unit Award Plan [Member]
Four Non Employee Directors [Member]
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Sep. 30, 2014
2014 Restricted Stock Unit Award Plan [Member]
Four Non Employee Directors [Member]
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Jun. 30, 2014
2014 Restricted Stock Unit Award Plan [Member]
Four Non Employee Directors [Member]
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Dec. 31, 2014
2014 Restricted Stock Unit Award Plan [Member]
Four Non Employee Directors [Member]
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Jan. 02, 2015
2014 Restricted Stock Unit Award Plan [Member]
Subsequent Event [Member]
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Jan. 02, 2015
2014 Restricted Stock Unit Award Plan [Member]
Subsequent Event [Member]
Settled In Cash [Member]
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Jan. 02, 2015
2014 Restricted Stock Unit Award Plan [Member]
Subsequent Event [Member]
Convertible Common Stock [Member]
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Jan. 02, 2015
2014 Restricted Stock Unit Award Plan [Member]
Subsequent Event [Member]
Four Non Employee Directors [Member]
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Employee Benefit Plans Disclosure [Line Items] | ||||||||||||||||
Withholding tax obligations | $ 36,000 | |||||||||||||||
Restricted Stock Units Sale Price | $ 0.01 | |||||||||||||||
Shares withheld upon elections made to exchange RSUs | 18,000 | 330,000 | ||||||||||||||
Restricted Stock Units Exchanged In Satisfaction Of Withholding Tax Obligations | 500,000 | |||||||||||||||
Number of vested shares distributed to holders | 500,000 | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 2,000,000 | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 37,000 | 51,500 | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 25.00% | 25.00% | 50.00% | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Description | stock, for up to 40% | stock, for up to 40% | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested in Period, Fair Value | 26,000 | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights | one-fourth of vested shares of common stock underlying RSU awards of 3.3 million shares will be distributed (after payment of exercise costs of $0.01 par value per share) on January 1 of each of years 2011 thru 2014. | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 0 | 31,000 | 24,000 | 129,000 | 30,000 | 99,000 | ||||||||||
Share Based Compensation Arrangement Share Based Payment Shares Reserved For Future Distribution | 18,000 | |||||||||||||||
Stock Issued During Period Shares Stock Options Exercised Net Of Shares For Tax Withholdings | 13,000 | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Shares Purchased for Award | 1,650,000 | |||||||||||||||
Deferred Compensation Arrangement with Individual, Recorded Liability | $ 49,000 |
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Restricted stock units exchanged in satisfaction of withholding tax obligations No definition available.
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Restricted stock units sale price No definition available.
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Number of share options reserved for future distribution to employees. No definition available.
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Stock issued during period shares stock options exercised net of shares for tax withholdings. No definition available.
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Taxes withheld on issuance of stock-based awards. No definition available.
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Recognition of Share-Based Compensation Expense (Detail) (USD $)
In Thousands, unless otherwise specified |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2015
|
Jun. 30, 2014
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Jun. 30, 2015
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Jun. 30, 2014
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Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Research and Development Expense, Total | $ 511 | $ 1,281 | $ 1,475 | $ 2,719 |
General and administrative expense | 112 | 201 | 233 | 342 |
Share Based Compensation Expense Recognized In Operations | 151 | 257 | 311 | 455 |
Stock options [Member]
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||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Research and Development Expense, Total | 39 | 56 | 78 | 113 |
General and administrative expense | 88 | 141 | 186 | 282 |
Restricted Stock units [Member]
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||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
General and administrative expense | $ 24 | $ 60 | $ 47 | $ 60 |
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Share based compensation expense recognized in operations. No definition available.
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Stock Option Award Activity (Detail) (USD $)
In Thousands, except Per Share data, unless otherwise specified |
6 Months Ended | |
---|---|---|
Jun. 30, 2015
|
Jun. 30, 2014
|
|
Share based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of Options, Exercised | 0 | |
Stock Option Plan
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||
Share based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of Options Outstanding, beginning | 4,556 | 3,738 |
Number of Options, Granted | 0 | 0 |
Number of Options, Exercised | 0 | (31) |
Number of Options, Forfeited or expired | (75) | 0 |
Number of Options Outstanding, ending | 4,481 | 3,707 |
Number of Options exercisable | 3,719 | 3,295 |
Weighted Average Exercise Price, beginning | $ 4.14 | $ 4.99 |
Weighted Average Exercise Price, Granted | $ 0 | $ 0 |
Weighted Average Exercise Price, Exercised | $ 0 | $ 1.3 |
Weighted Average Exercise Price, Forfeited or expired | $ 5.25 | $ 0 |
Weighted Average Exercise Price, ending | $ 4.13 | $ 5.02 |
Weighted Average Exercise Price, Options exercisable | $ 4.82 | $ 5.42 |
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Summary of RSU Plan (Detail)
In Thousands, unless otherwise specified |
6 Months Ended | |
---|---|---|
Jun. 30, 2015
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Jun. 30, 2014
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Restricted Stock Units
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||
Share based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Outstanding, beginning | 147 | 829 |
Granted | 206 | 147 |
Distributed | (129) | (829) |
Vested | 0 | 0 |
Forfeited or expired | 0 | 0 |
Outstanding, ending | 224 | 147 |
Vested Restricted Stock Units (RSUs)
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||
Share based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Outstanding, beginning | 147 | 829 |
Granted | 0 | 0 |
Distributed | (129) | (829) |
Vested | 103 | 74 |
Forfeited or expired | 0 | 0 |
Outstanding, ending | 121 | 74 |
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Share Based Compensation Arrangement By Share Based Payment Award Equity Instrument Other Than Options Distributed In Period No definition available.
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Income Taxes - Additional Information (Detail) (USD $)
In Millions, unless otherwise specified |
12 Months Ended | 6 Months Ended | 6 Months Ended | 12 Months Ended | |||
---|---|---|---|---|---|---|---|
Dec. 31, 2014
|
Jun. 30, 2015
Federal Research and Development
|
Dec. 31, 2014
Federal Research and Development
|
Jun. 30, 2015
Indiana State Research and Development
|
Dec. 31, 2014
Indiana State Research and Development
|
Dec. 31, 2014
Maximum
|
Dec. 31, 2014
Minimum
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Income Tax Disclosure [Line Items] | |||||||
Federal income tax benefits | $ 51.5 | ||||||
Federal NOLs | 151.4 | ||||||
U.S. statutory tax rate | 34.00% | ||||||
NOL expiration year | 2034 | 2016 | |||||
Research and development tax credits | 1.1 | 0.3 | |||||
Research and development expiration period | which expire in the years 2024 through 2034 | which expire in the years 2015 through 2017 | |||||
State income tax benefits | $ 2.9 |
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Deferred Tax Assets Tax Credit Carry forwards Research And Development Expiration Period No definition available.
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Operating Loss Carry Forwards Expiration Year No definition available.
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Reconciliation of Numerators and Denominators of Basic and Diluted EPS (Detail) (USD $)
In Thousands, except Per Share data, unless otherwise specified |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2015
|
Jun. 30, 2014
|
Jun. 30, 2015
|
Jun. 30, 2014
|
|
EPS - basic and diluted | ||||
Numerator: net loss | $ (2,663) | $ (3,521) | $ (1,424) | $ (7,609) |
Denominator: | ||||
Common shares | 49,163 | 48,848 | 49,055 | 48,846 |
Vested RSUs | 70 | 0 | 46 | 0 |
Basic and diluted weighted average shares outstanding | 49,233 | 48,848 | 49,101 | 48,846 |
EPS - basic and diluted | $ (0.05) | $ (0.07) | $ (0.03) | $ (0.16) |
Common shares issuable: | ||||
Total excluded common shares | 4,882 | 5,934 | 4,882 | 5,934 |
Stock options
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||||
Common shares issuable: | ||||
Total excluded common shares | 4,481 | 3,707 | 4,481 | 3,707 |
Nonvested RSUs member
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Common shares issuable: | ||||
Total excluded common shares | 103 | 73 | 103 | 73 |
Common stock warrants
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||||
Common shares issuable: | ||||
Total excluded common shares | 298 | 2,154 | 298 | 2,154 |
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Commitments and Contingencies - Additional Information (Detail) (USD $)
In Thousands, unless otherwise specified |
6 Months Ended |
---|---|
Jun. 30, 2015
|
|
Pennsylvania State
|
|
Commitments and Contingencies Disclosure [Line Items] | |
Number of lawsuits filed | 200 |
New Jersey State
|
|
Commitments and Contingencies Disclosure [Line Items] | |
Number of lawsuits filed | 150 |
Number of lawsuits served | 50 |
California State
|
|
Commitments and Contingencies Disclosure [Line Items] | |
Number of plaintiffs served in a single complaint | 445 |
Palatine Lllinois
|
|
Commitments and Contingencies Disclosure [Line Items] | |
Leases administrative office space | $ 25 |
Lease expiring date | March 31, 2016 |
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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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No authoritative reference available. No definition available.
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