Document_And_Entity_Informatio
Document And Entity Information | 3 Months Ended | |
Mar. 31, 2015 | Apr. 30, 2015 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | FALSE | |
Document Period End Date | 31-Mar-15 | |
Document Fiscal Year Focus | 2015 | |
Document Fiscal Period Focus | Q1 | |
Entity Registrant Name | ACURA PHARMACEUTICALS, INC | |
Entity Central Index Key | 786947 | |
Current Fiscal Year End Date | -19 | |
Entity Filer Category | Smaller Reporting Company | |
Trading Symbol | ACUR | |
Entity Common Stock, Shares Outstanding | 49,216,817 |
CONSOLIDATED_BALANCE_SHEETS
CONSOLIDATED BALANCE SHEETS (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
In Thousands, unless otherwise specified | ||
Current assets: | ||
Cash and cash equivalents | $3,821 | $774 |
Marketable securities (Note 6) | 10,387 | 11,322 |
Accounts receivable, net of allowances of $7 and $5 | 87 | 76 |
Accrued investment income | 63 | 66 |
Inventories, net (Note 7) | 282 | 304 |
Prepaid expenses and other current assets | 312 | 471 |
Other current deferred assets | 4 | 218 |
Total current assets | 14,956 | 13,231 |
Property, plant and equipment, net | 973 | 957 |
Deferred debt issuance costs, net of accumulated amortization of $86 and $69 (Note 9) | 145 | 162 |
Intangible asset, net of accumulated amortization of $207 and $155 (Note 3) | 1,793 | 1,845 |
Total assets | 17,867 | 16,195 |
Current liabilities: | ||
Accounts payable | 161 | 217 |
Accrued expenses (Note 8) | 987 | 568 |
Other current liabilities | 22 | 26 |
Accrued interest | 70 | 70 |
Sales returns liability | 153 | 0 |
Deferred revenue | 0 | 353 |
Current maturities of long-term debt (Note 9) | 2,369 | 1,758 |
Total current liabilities | 3,762 | 2,992 |
Long-term debt, net of discount of $283 and $281 (Note 9) | 7,348 | 7,961 |
Long-term portion of accrued interest | 241 | 190 |
Total liabilities | 11,351 | 11,143 |
Commitments and contingencies (Note 15) | ||
Stockholders' equity: | ||
Common stock: $.01 par value per share; 100,000 shares authorized, 48,947 and 48,848 shares issued and outstanding at 2015 and 2014, respectively | 489 | 488 |
Additional paid-in capital | 367,091 | 366,898 |
Accumulated deficit | -361,082 | -362,321 |
Accumulated other comprehensive income (loss) | 18 | -13 |
Total stockholders' equity | 6,516 | 5,052 |
Total liabilities and stockholders' equity | $17,867 | $16,195 |
CONSOLIDATED_BALANCE_SHEETS_Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
In Thousands, except Per Share data, unless otherwise specified | ||
Accounts receivable, net of allowances | $7 | $5 |
Accumulated amortization, deferred finance costs | 86 | 69 |
Finite-lived intangible assets accumulated amortization | 207 | 155 |
Long-term debt, net of debt discount | $283 | $281 |
Common stock, par value | $0.01 | $0.01 |
Common stock, shares authorized | 100,000 | 100,000 |
Common stock, shares issued | 48,947 | 48,848 |
Common stock, shares outstanding | 48,947 | 48,848 |
CONSOLIDATED_STATEMENTS_OF_OPE
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) (USD $) | 3 Months Ended | |
In Thousands, except Per Share data, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Revenues: | ||
Royalty revenue | $0 | $3 |
Product sales, net | 357 | 39 |
License fee revenue | 5,000 | 0 |
Total revenues, net | 5,357 | 42 |
Operating expenses: | ||
Cost of sales (excluding inventory write-down) | 324 | 38 |
Inventory write-down (Note 7) | 260 | 133 |
Research and development | 964 | 1,438 |
Selling, marketing, general and administrative | 2,297 | 2,259 |
Total operating expenses | 3,845 | 3,868 |
Operating income (loss) | 1,512 | -3,826 |
Non-Operating income (expense): | ||
Investment income | 35 | 44 |
Loss on sales of marketable securities | 0 | -5 |
Interest expense (Note 9) | -308 | -301 |
Total other expense, net | -273 | -262 |
Income (loss) before income taxes | 1,239 | -4,088 |
Provision for income taxes | 0 | 0 |
Net income (loss) | 1,239 | -4,088 |
Other comprehensive income: | ||
Unrealized gains on securities | 31 | 29 |
Total other comprehensive income | 31 | 29 |
Comprehensive income (loss) | $1,270 | ($4,059) |
Income (loss) per share: | ||
Basic | $0.03 | ($0.08) |
Diluted | $0.03 | ($0.08) |
Weighted average shares outstanding: | ||
Basic | 48,965 | 48,842 |
Diluted | 49,347 | 48,842 |
CONSOLIDATED_STATEMENTS_OF_STO
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (USD $) | Total | Common Stock | Additional paid-in capital | Accumulated deficit | Accumulated Other Comprehensive Income (Loss) |
In Thousands | |||||
Beginning Balance at Dec. 31, 2014 | $5,052 | $488 | $366,898 | ($362,321) | ($13) |
Beginning Balance (in shares) at Dec. 31, 2014 | 48,848 | ||||
Net income | 1,239 | 0 | 0 | 1,239 | 0 |
Other comprehensive income | 31 | 0 | 0 | 0 | 31 |
Share-based compensation | 160 | 0 | 160 | 0 | 0 |
Net distribution of common stock pursuant to restricted stock unit award plan (in shares) | 99 | ||||
Net distribution of common stock pursuant to restricted stock unit award plan | 1 | 1 | 0 | 0 | 0 |
Modification to warrants issued with promissory notes | 33 | 0 | 33 | 0 | 0 |
Ending Balance at Mar. 31, 2015 | $6,516 | $489 | $367,091 | ($361,082) | $18 |
Ending Balance (in shares) at Mar. 31, 2015 | 48,947 |
CONSOLIDATED_STATEMENTS_OF_CAS
CONSOLIDATED STATEMENTS OF CASH FLOWS (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Cash Flows from Operating Activities: | ||
Net income (loss) | $1,239 | ($4,088) |
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: | ||
Depreciation | 30 | 28 |
Provision to reduce inventory to net realizable value | 260 | 133 |
Provision for sales returns | 153 | 0 |
Share-based compensation | 160 | 198 |
Amortization of debt discount and deferred debt issue costs | 48 | 46 |
Amortization of bond premium in marketable securities | 41 | 76 |
Amortization of intangible asset | 52 | 0 |
Loss on sales of marketable securities | 0 | 5 |
Changes in assets and liabilities: | ||
Accounts receivable | -11 | 89 |
Accrued investment income | 3 | 18 |
Inventories | -238 | 24 |
Prepaid expenses and other current assets | 159 | -89 |
Other current deferred assets | 214 | 1 |
Other assets | 0 | -2 |
Accounts payable | -56 | 219 |
Accrued expenses | 419 | 313 |
Deferred revenue | -353 | 3 |
Accrued interest - current and long term | 51 | 46 |
Other current liabilities | -4 | 0 |
Net cash provided by (used in) operating activities | 2,167 | -2,980 |
Cash Flows from Investing Activities: | ||
Purchases of marketable securities | 0 | -1,110 |
Proceeds from sale and maturities of marketable securities | 925 | 1,170 |
Additions to property, plant and equipment | -46 | -34 |
Net cash provided by investing activities | 879 | 26 |
Cash Flows from Financing Activities: | ||
Proceeds from exercise of stock options | 0 | 8 |
Proceeds from distribution of restricted stock units | 1 | 1 |
Statutory minimum withholding taxes paid on the distribution of common stock pursuant to restricted stock unit plan and exercise of stock options | 0 | -529 |
Net cash provided by (used in) financing activities | 1 | -520 |
Net increase (decrease) in cash and cash equivalents | 3,047 | -3,474 |
Cash and cash equivalents at beginning of year | 774 | 12,340 |
Cash and cash equivalents at end of period | 3,821 | 8,866 |
Cash paid during the year for: | ||
Interest | 209 | 209 |
Income taxes | $0 | $0 |
CONSOLIDATED_STATEMENTS_OF_CAS1
CONSOLIDATED STATEMENTS OF CASH FLOWS (Parenthetical) (USD $) | 3 Months Ended | |
In Thousands, except Share data, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Supplemental Disclosure of Noncash Financing Activities: | ||
Common stock withheld in exercise costs in shares | ||
Class of Warrant or Right, Outstanding | 298,000 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights | $0.50 | |
Additions To Debt Instrument Unamortized Discount | $33 | |
Maximum [Member] | ||
Supplemental Disclosure of Noncash Financing Activities: | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $1.60 | |
Minimum [Member] | ||
Supplemental Disclosure of Noncash Financing Activities: | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $0.50 | |
Stock options | ||
Supplemental Disclosure of Noncash Financing Activities: | ||
Equity based employee compensation granted | 24,000 | |
Common stock withheld in exercise costs in shares | 16,000 | |
Common stock withheld in exercise costs | 32 | |
Withholding of exercise cost in shares | 2,000 | |
Minimum statutory withholding payroll taxes withheld | 4 | |
Common Stock issued upon exercise | 6,000 | |
Restricted Stock Unit | ||
Supplemental Disclosure of Noncash Financing Activities: | ||
Equity based employee compensation granted | 829,000 | |
Common stock withheld in exercise costs in shares | 4,000 | |
Common stock withheld in exercise costs | 7 | |
Withholding of exercise cost in shares | 315,000 | |
Minimum statutory withholding payroll taxes withheld | $525 | |
Common Stock issued upon exercise | 510,000 |
DESCRIPTION_OF_BUSINESS
DESCRIPTION OF BUSINESS | 3 Months Ended |
Mar. 31, 2015 | |
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. In August 2014, we were awarded a grant from the National Institute on Drug Abuse to advance early stage development of our third abuse deterrent technology, Limitx™. Limitx is designed to retard the release of active drug ingredients when too many tablets are accidently or purposefully ingested. | |
ACCOUNTING_PRONOUNCEMENTS
ACCOUNTING PRONOUNCEMENTS | 3 Months Ended |
Mar. 31, 2015 | |
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 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 for financial statements that have not been previously issued. The Company is currently evaluating the impact of the adoption of ASU 2015-03 on the Company's consolidated financial statements. | |
LICENSE_DEVELOPMENT_AND_COMMER
LICENSE, DEVELOPMENT, AND COMMERCIALIZATION AGREEMENTS | 3 Months Ended |
Mar. 31, 2015 | |
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, but in no event earlier than June 30, 2015. 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 | |
On or about September 17, 2012, we believe the FDA internally changed the status of Oxaydo (formerly known as Oxecta®) to be considered a Reference Listed Drug, or RLD. An RLD is the standard to which all generic versions must be shown to be bioequivalent and a drug company seeking approval to market a generic equivalent must refer to the RLD. By designating Oxaydo as an RLD, the FDA was allowed to accept ANDAs referencing Oxaydo. | |
On September 20, 2012, we announced that we had received a Paragraph IV Certification Notice under 21 U.S.C. 355(j) (a Paragraph IV Notice) from a generic sponsor of an ANDA for a generic drug listing Oxaydo as the reference listed drug. Since such date, we have received similar Paragraph IV Notices from four other generic pharmaceutical companies that have filed ANDAs listing Oxaydo as the reference drug. The Paragraph IV Notices refer to our U.S. Patent Numbers 7,201,920, 7,510,726 and 7,981,439, which cover our Aversion® Technology and Oxaydo. The Paragraph IV Notices state that each generic sponsor believes that such patents are invalid, unenforceable or not infringed. On October 31, 2012, we initiated suit against each of Watson Laboratories, Inc. – Florida (Watson), Par Pharmaceutical, Inc., Impax Laboratories, Inc. and Sandoz Inc., and on April 29, 2013 we initiated suit against 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. In January 2013, 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. | |
On October 9, 2013, we announced that we had entered into distinct Settlement Agreements with each of Par and Impax, to settle our patent infringement action pending against them in the United States District Court for the District of Delaware. 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. | |
Under the terms of the Settlement Agreement with Par, Par may 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. | |
Under the Settlement Agreement with Impax, Impax may launch its 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 would become effective prior to such time. | |
On May 8, 2014, we announced that we had 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 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. | |
On May 21, 2014, we announced that we had entered into a Settlement Agreement with Sandoz Inc. to settle our patent infringement action pending against Sandoz in the United States District Court for the District of Delaware. Under the Settlement Agreement, Sandoz may launch its generic to the Oxaydo product in the U.S., through the grant of a non-exclusive license from us that would trigger 180 days following the first sale of a generic to the 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 to the Oxaydo product is first sold in the U.S). In certain circumstances, our license to Sandoz would become effective prior to such time. Sandoz is not obligated to pay us a royalty if its current formulation of its generic to the Oxaydo product is approved by the FDA. In the event Sandoz changes or modifies the structure of its generic Oxaydo product, or materially changes or modifies the amounts or type of any excipient used in the Sandoz formulation disclosed in its ANDA filing with the FDA as of July 30, 2013, Sandoz is required to pay us a royalty based upon the Net Profits (as defined in the Settlement Agreement) derived from the net sales of such changed or modified Sandoz generic Oxaydo product in the United States. | |
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. | |
REVENUE_RECOGNITION
REVENUE RECOGNITION | 3 Months Ended |
Mar. 31, 2015 | |
Revenue Recognition [Abstract] | |
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. We sell Nexafed in the United States to wholesale pharmaceutical distributors as well as directly to chain drug stores. Nexafed is sold subject to the right of return for a period of up to twelve months after the product expiration. Nexafed currently has a shelf life of twenty-four months from the date of manufacture. Given the limited sales history of Nexafed, 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 March 31, 2015 we have a $153 thousand sales returns liability which will be reviewed against sales returns activity each quarter. Revenue will be recognized at the time the product is 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 $3 thousand for the three months ended March 31, 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 shipping and handling costs in selling expenses. The amounts recorded to selling expenses from the shipments of Nexafed during each of the three month periods ended March 31, 2015 and 2014 were not material. | |
RESEARCH_AND_DEVELOPMENT_ACTIV
RESEARCH AND DEVELOPMENT ACTIVITIES | 3 Months Ended |
Mar. 31, 2015 | |
Research and Development [Abstract] | |
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 March 31, 2015 or December 31, 2014. We did not have any prepaid CRO costs and clinical trial study expenses at either March 31, 2015 or December 31, 2014. | |
INVESTMENTS_IN_MARKETABLE_SECU
INVESTMENTS IN MARKETABLE SECURITIES | 3 Months Ended | |||||||||||||
Mar. 31, 2015 | ||||||||||||||
Investments, Debt and Equity Securities [Abstract] | ||||||||||||||
INVESTMENTS IN MARKETABLE SECURITIES | NOTE 6 - INVESTMENTS IN MARKETABLE SECURITIES | |||||||||||||
Investments in marketable securities consisted of the following: | ||||||||||||||
March 31, 2015 | December 31, 2014 | |||||||||||||
(in millions) | (in millions) | |||||||||||||
Marketable securities: | ||||||||||||||
Corporate bonds - maturing within 1 year | $ | 2.8 | $ | 3.5 | ||||||||||
Corporate bonds - maturing after 1 year and through March 2017 | 2.6 | 2.8 | ||||||||||||
Exchange-traded funds | 5 | 5 | ||||||||||||
Total marketable securities | $ | 10.4 | $ | 11.3 | ||||||||||
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: | ||||||||||||||
March 31, 2015 | ||||||||||||||
(in millions) | ||||||||||||||
Cost | Gross | Gross | Fair | |||||||||||
Unrealized | Unrealized | Value | ||||||||||||
Gains | Losses | |||||||||||||
Available-for-sale: | ||||||||||||||
Corporate bonds | $ | 5.4 | $ | - | $ | - | $ | 5.4 | ||||||
Exchange-traded funds | 5 | - | - | 5 | ||||||||||
Total - Current | $ | 10.4 | $ | - | $ | - | $ | 10.4 | ||||||
December 31, 2014 | ||||||||||||||
(in millions) | ||||||||||||||
Cost | Gross | Gross | Fair | |||||||||||
Unrealized | Unrealized | Value | ||||||||||||
Gains | Losses | |||||||||||||
Available-for-sale: | ||||||||||||||
Corporate bonds | $ | 6.3 | $ | - | $ | - | $ | 6.3 | ||||||
Exchange-traded funds | 5 | - | - | 5 | ||||||||||
Total - Current | $ | 11.3 | $ | - | $ | - | $ | 11.3 | ||||||
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 March 31, 2015 and December 31, 2014 consisted of the following: | ||||||||||||||
March 31, 2015 | ||||||||||||||
(in millions) | ||||||||||||||
Total | Level 1 | Level 2 | Level 3 | |||||||||||
Assets: | ||||||||||||||
Corporate bonds | 5.4 | - | 5.4 | - | ||||||||||
Exchange-traded funds | 5 | 5 | - | - | ||||||||||
Total | $ | 10.4 | $ | 5 | $ | 5.4 | $ | - | ||||||
December 31, 2014 | ||||||||||||||
(in millions) | ||||||||||||||
Total | Level 1 | Level 2 | Level 3 | |||||||||||
Assets: | ||||||||||||||
Corporate bonds | 6.3 | - | 6.3 | - | ||||||||||
Exchange-traded funds | 5 | $ | 5 | $ | - | $ | - | |||||||
Total | $ | 11.3 | 5 | 6.3 | - | |||||||||
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 March 31, 2015 consisted of unrealized gains on securities of $18 thousand. Accumulated other comprehensive income (loss) at December 31, 2014 consisted of unrealized losses on securities of $13 thousand. | ||||||||||||||
INVENTORIES
INVENTORIES | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
Inventory Disclosure [Abstract] | ||||||||
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 product. 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 Aversion Oxycodone product as our license partner will secure their own material requirements. During the quarter ended March 31, 2014, we increased our inventory reserves by $133 thousand against finished goods. | ||||||||
We have 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 will 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 will be recognized at the time the product is 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: | ||||||||
March 31, | December 31, | |||||||
2015 | 2014 | |||||||
(in thousands) | ||||||||
Raw and packaging materials | $ | 260 | $ | 260 | ||||
Finished goods | 282 | 44 | ||||||
Total | 542 | 304 | ||||||
Less: reserve for raw materials | -260 | (-) | ||||||
Net | $ | 282 | $ | 304 | ||||
ACCRUED_EXPENSES
ACCRUED EXPENSES | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
Payables and Accruals [Abstract] | ||||||||
ACCRUED EXPENSES | NOTE 8 - ACCRUED EXPENSES | |||||||
Accrued expenses are summarized as follows: | ||||||||
March 31, | December 31, | |||||||
2015 | 2014 | |||||||
(in thousands) | ||||||||
Payroll, payroll taxes, and benefits | $ | 146 | $ | 94 | ||||
Professional services | 195 | 253 | ||||||
Franchise taxes | 17 | 13 | ||||||
Property taxes | 17 | 15 | ||||||
Marketing and promotion | 251 | 61 | ||||||
Clinical, non-clinical and regulatory services | 241 | 83 | ||||||
Other fees and services | 120 | 49 | ||||||
Total | $ | 987 | $ | 568 | ||||
DEBT
DEBT | 3 Months Ended | ||||||||||
Mar. 31, 2015 | |||||||||||
Debt Disclosure [Abstract] | |||||||||||
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 is required to make monthly interest-only payments until the April 1, 2015 (“Amortization Date”) and starting on the Amortization Date, the Company is required 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 security for its obligations under the Loan Agreement, the Company granted Lender a security interest in substantially all of its existing and after-acquired 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 warrant previously issued to the Lender to purchase 298 thousand shares of our Common Stock 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. | |||||||||||
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, non-payment defaults, covenant defaults, a material adverse change in the Company, bankruptcy and insolvency defaults and material judgment defaults. | |||||||||||
Our debt at March 31, 2015 is summarized below (in thousands): | |||||||||||
Debt | Current | Long-term | Total | ||||||||
Balance at Dec 31, 2014 | $ | 1,758 | $ | 8,242 | $ | 10,000 | |||||
Principal payments | - | - | - | ||||||||
Classification | 611 | -611 | - | ||||||||
Balance at Mar 31, 2015 | $ | 2,369 | $ | 7,631 | $ | 10,000 | |||||
Debt Discount | Current | Long-term | Total | ||||||||
Balance at Dec 31, 2014 | $ | - | $ | -281 | $ | -281 | |||||
Additions | - | -33 | -33 | ||||||||
Amortization expense | - | 31 | 31 | ||||||||
Balance at Mar 31, 2015 | $ | - | $ | -283 | $ | -283 | |||||
Debt, net | $ | 2,369 | $ | 7,348 | $ | 9,717 | |||||
Our interest expense during the three month ended March 31, 2015 and 2014 consisted of the following: | |||||||||||
Three months Ended | |||||||||||
March 31, | |||||||||||
2015 | 2014 | ||||||||||
(in thousands) | |||||||||||
Interest expense: | |||||||||||
Secured Promissory notes | $ | 260 | $ | 254 | |||||||
Debt discount | 31 | 30 | |||||||||
Debt issue costs | 17 | 17 | |||||||||
Total interest expense | $ | 308 | $ | 301 | |||||||
The annual principal payments of the debt at March 31, 2015 are as follows: | |||||||||||
Annual | |||||||||||
Principal Payments | |||||||||||
(in thousands) | |||||||||||
2015 | $ | 1,758 | |||||||||
2016 | 2,522 | ||||||||||
2017 | 2,741 | ||||||||||
2018 | 2,979 | ||||||||||
Total | $ | 10,000 | |||||||||
EQUITY_FINANCING
EQUITY FINANCING | 3 Months Ended |
Mar. 31, 2015 | |
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 three month period ended March 31, 2015 or during the year ended December 31, 2014. As of March 31, 2015, we may sell shares of our common stock under the S-3 registration statement having gross sales proceeds of up to $7.9 million. Net proceeds of these transactions may be used for general corporate purposes, including working capital, capital expenditures, research, development and marketing expenditures and clinical trial expenditures. | |
COMMON_STOCK_WARRANTS
COMMON STOCK WARRANTS | 3 Months Ended | |||||||||||
Mar. 31, 2015 | ||||||||||||
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. In January 2015, the exercise price of these warrants was reduced from $1.595 to $0.504 per share. (see Note 9). These warrants contain a cashless exercise feature. Our common stock warrant activity during the three months ended March 31, 2015 and 2014 is shown below: | ||||||||||||
Three months Ended | ||||||||||||
March 31, | ||||||||||||
2015 | 2014 | |||||||||||
Number | Weighted | Number | Weighted | |||||||||
(000’s) | Average | (000’s) | Average | |||||||||
Exercise | Exercise | |||||||||||
Price | Price | |||||||||||
Outstanding, beginning | 298 | $ | 1.6 | 2,154 | $ | 3.15 | ||||||
Issued | - | - | - | - | ||||||||
Exercised | - | - | - | - | ||||||||
Expired | - | - | - | - | ||||||||
Outstanding, ending | 298 | $ | 0.5 | 2,154 | $ | 3.15 | ||||||
SHAREBASED_COMPENSATION
SHARE-BASED COMPENSATION | 3 Months Ended | |||||||||||||
Mar. 31, 2015 | ||||||||||||||
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: | ||||||||||||||
Three Months Ended | ||||||||||||||
March 31, | ||||||||||||||
2015 | 2014 | |||||||||||||
Research and development expense: | ||||||||||||||
Restricted stock units | $ | 39 | $ | 57 | ||||||||||
General and administrative expense: | ||||||||||||||
Stock options | 98 | 141 | ||||||||||||
Restricted stock units | 23 | - | ||||||||||||
Subtotal | 121 | 141 | ||||||||||||
Total | $ | 160 | $ | 198 | ||||||||||
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 three months ended March 31, 2015 and 2014 is shown below: | ||||||||||||||
Three months Ended | ||||||||||||||
March 31, | ||||||||||||||
2015 | 2014 | |||||||||||||
Number | Weighted | Number of | Weighted | |||||||||||
of | Average | Options | Average | |||||||||||
Options | Exercise | (000’s) | Exercise | |||||||||||
(000’s) | Price | Price | ||||||||||||
Outstanding, beginning | 4,556 | $ | 4.14 | 3,738 | $ | 4.99 | ||||||||
Granted | - | - | - | - | ||||||||||
Exercised | - | - | -31 | 1.3 | ||||||||||
Forfeited or expired | -75 | 5.25 | - | - | ||||||||||
Outstanding, ending | 4,481 | $ | 4.13 | 3,707 | $ | 5.02 | ||||||||
Options exercisable | 3,573 | $ | 5 | 3,189 | $ | 5.54 | ||||||||
During the three months ended March 31, 2014, a total of 31 thousand stock options were exercised by our employees. Of the total amount of 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: | ||||||||||||||
Three months Ended March 31, | ||||||||||||||
2015 | 2014 | |||||||||||||
(in thousands) | ||||||||||||||
Number of | Number of | Number of | Number of | |||||||||||
RSUs | Vested | RSUs | Vested | |||||||||||
RSUs | RSUs | |||||||||||||
Outstanding, beginning | 147 | 147 | 829 | 829 | ||||||||||
Granted | 206 | - | - | - | ||||||||||
Distributed | -129 | -129 | -829 | -829 | ||||||||||
Vested | - | 52 | - | - | ||||||||||
Forfeited or expired | - | - | - | - | ||||||||||
Outstanding, ending | 224 | 70 | - | - | ||||||||||
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 were 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 March 31, 2015, 1.65 million shares are available for award under the 2014 RSU Plan. | ||||||||||||||
Information about the RSU grants under the 2014 RSU Plan is as follows: | ||||||||||||||
· | On May 1, 2014, we awarded approximately 37 thousand RSUs to each of our 4 non-employee directors. Such RSU awards vested 50% on June 30, 2014 and 25% on each of September 30 and December 31, 2014. Such non-employee director awards allow for non-employee directors to receive payment in cash, instead of stock, for up to 40% of each RSU award. The RSU awards subject to cash settlement are recorded as a liability in the Company’s balance sheet. The liability was $26 thousand at December 31, 2014. Accordingly the vested portion of the awards containing the cash settlement feature are being marked-to-market each reporting period until they are distributed. Marked-to-market accounting can create fluctuations in our compensation expense including the need to record additional expense. RSU awards are generally distributed on the first business day of the year after vesting, but such distribution can be deferred until a later date at the election of the non-employee director. | |||||||||||||
· | On January 2, 2015, we awarded approximately 51.5 thousand RSUs to each of our 4 non-employee directors which also allow for them to receive payment in cash, instead of stock, for up to 40% of each RSU award. Such awards vest 25% at the end of each calendar quarter in 2015. The RSU awards subject to cash settlement are subject to marked-to market accounting and the liability recorded in the Company’s balance sheet was $22 thousand at March 31, 2015. Distributions of stock under the January 2, 2015 award cannot be deferred until a later date and the stock under such awards will be distributed on January 4, 2016. | |||||||||||||
Information about the distribution of shares under the 2014 RSU Plan is as follows: | ||||||||||||||
· | On January 2, 2015, 129 thousand RSUs from the May 1, 2014 award were distributed and 18 thousand RSUs were deferred until a future distribution date. Of the 129 thousand RSUs distributed, 99 thousand RSUs were distributed in common stock and 30 thousand RSUs were settled in cash. | |||||||||||||
INCOME_TAXES
INCOME TAXES | 3 Months Ended |
Mar. 31, 2015 | |
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 March 31, 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. | |
EARNINGS_PER_SHARE_EPS
EARNINGS PER SHARE ("EPS") | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
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 2014 as the Company reported a net loss for the three month period, and including the effects of common stock equivalents in the diluted EPS calculation would have been antidilutive. The Weighted-average common shares outstanding (diluted) computation is not impacted during any period where the exercise price of a stock option is greater than the average market price. There were 3.58 million non-dilutive equity awards outstanding for the three-months ended March 31, 2015 that are not included in the corresponding period Weighted-average common shares outstanding (diluted) computation. | ||||||||
A reconciliation of the numerators and denominators of basic and diluted EPS consisted of the following: | ||||||||
Three months Ended March 31, | ||||||||
2015 | 2014 | |||||||
(in thousands except per share | ||||||||
data) | ||||||||
EPS - basic | ||||||||
Numerator: net income (loss) | $ | 1,239 | $ | -4,088 | ||||
Denominator: | ||||||||
Common shares | 48,947 | 48,842 | ||||||
Vested RSUs | 18 | - | ||||||
Basic weighted average shares outstanding | 48,965 | 48,842 | ||||||
EPS - basic | $ | 0.03 | $ | -0.08 | ||||
EPS – assuming dilution | ||||||||
Numerator: net income (loss) | $ | 1,239 | $ | -4,088 | ||||
Denominator: | ||||||||
Common shares | 48,947 | 48,842 | ||||||
Vested RSUs | 170 | - | ||||||
Stock options | 167 | - | ||||||
Common stock warrants | 63 | - | ||||||
Diluted weighted average shares outstanding | 49,347 | 48,842 | ||||||
EPS - diluted | $ | 0.03 | $ | -0.08 | ||||
Excluded dilutive securities: | ||||||||
Common stock issuable: | ||||||||
Stock options | 3,580 | 3,707 | ||||||
Common stock warrants | - | 2,154 | ||||||
Total excluded potentially dilutive shares | 3,580 | 5,861 | ||||||
COMMITMENTS_AND_CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 3 Months Ended |
Mar. 31, 2015 | |
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 intend to defend 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 us, 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 us and Halsey Drug Company alleging that plaintiffs developed neurological disorders as a result of their use of the Reglan brand and/or generic metoclopramide. 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 99 pending cases against us, with more than 400 individual plaintiffs. | |
In the lawsuits filed to date, plaintiffs have not confirmed they ingested any of the generic metoclopramide manufactured by us. We discontinued manufacture and distribution of generic metoclopramide more than 19 years ago. In addition, we believe the June 23, 2011 decision by the U.S. Supreme Court in PLIVA v. Mensing (“Mensing decision”) holding that state tort law failure to warn claims against generic drug companies are pre-empted by the 1984 Hatch-Waxman Act Amendments and federal drug regulations will assist us in favorably resolving these cases. We have consistently maintained the position that these claims are without merit and intend to vigorously defend these actions. | |
In New Jersey, Generic Defendants, including Acura, filed dispositive motions based on the Mensing decision, which the Court granted with a limited exception. As of September 2012, the New Jersey trial court dismissed Acura with prejudice. 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. On appeal, the Pennsylvania Superior Court held in a July 29, 2013 decision that federal preemption applied, but that Mensing did not completely bar all claims and refused to dismiss these cases. On September 17, 2014, the Pennsylvania Supreme Court declined to hear a further appeal. On December 16, 2014, Generic Defendants filed a Petition for a Writ of Certiorari requesting that the United States Supreme Court agree to hear a further appeal on the grounds that federal preemption under Mensing should completely bar all of these claims. The Court is expected to issue its decision concerning acceptance or denial of this appeal by June 30, 2015. All trial court proceedings have been stayed pending resolution of this lengthy appeal process. To the extent that plaintiffs intend to pursue their claims in the future, if the appeal is denied, Acura nonetheless remains optimistic that most, if not all, of these Philadelphia cases will eventually be dismissed against us 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 our insurance carrier. | |
In California, the trial court entered a May 25, 2012 Order denying Generic Defendants’ dispositive preemption motions. The Generics Defendants’ appeals from this order were denied by the California appellate courts. Therefore, subject to further developments, plaintiffs may be permitted to proceed with these lawsuits 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. 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.” | |
In May 2014, the California Superior 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. More recently, on April 10, 2015, Judge Kramer ruled in plaintiffs’ favor on a jurisdictional waiver motion against PLIVA and Teva which could be applied in the future to other defendants. Thus far, Generic Defendants (including Acura) have not been required to file answers or other responsive pleadings in each individual case in which they are named defendants. Within the next few months, these cases also will be transferred to a new judge who will address a case management schedule for claims against Generic Defendants and possible selection of bellwether cases for focused discovery and trial. To date, however, none of these plaintiffs have confirmed they ingested any of the generic metoclopramide manufactured by us. Therefore, we expect the number of plaintiffs with possible claims to be reduced voluntarily or by motion practice. Action will be taken in an effort to dismiss Acura from these cases, although there can be no assurance in this regard. 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 March 31, 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. | |
INVESTMENTS_IN_MARKETABLE_SECU1
INVESTMENTS IN MARKETABLE SECURITIES (Tables) | 3 Months Ended | |||||||||||||
Mar. 31, 2015 | ||||||||||||||
Investments, Debt and Equity Securities [Abstract] | ||||||||||||||
Marketable securities | Investments in marketable securities consisted of the following: | |||||||||||||
March 31, 2015 | December 31, 2014 | |||||||||||||
(in millions) | (in millions) | |||||||||||||
Marketable securities: | ||||||||||||||
Corporate bonds - maturing within 1 year | $ | 2.8 | $ | 3.5 | ||||||||||
Corporate bonds - maturing after 1 year and through March 2017 | 2.6 | 2.8 | ||||||||||||
Exchange-traded funds | 5 | 5 | ||||||||||||
Total marketable securities | $ | 10.4 | $ | 11.3 | ||||||||||
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: | |||||||||||||
March 31, 2015 | ||||||||||||||
(in millions) | ||||||||||||||
Cost | Gross | Gross | Fair | |||||||||||
Unrealized | Unrealized | Value | ||||||||||||
Gains | Losses | |||||||||||||
Available-for-sale: | ||||||||||||||
Corporate bonds | $ | 5.4 | $ | - | $ | - | $ | 5.4 | ||||||
Exchange-traded funds | 5 | - | - | 5 | ||||||||||
Total - Current | $ | 10.4 | $ | - | $ | - | $ | 10.4 | ||||||
December 31, 2014 | ||||||||||||||
(in millions) | ||||||||||||||
Cost | Gross | Gross | Fair | |||||||||||
Unrealized | Unrealized | Value | ||||||||||||
Gains | Losses | |||||||||||||
Available-for-sale: | ||||||||||||||
Corporate bonds | $ | 6.3 | $ | - | $ | - | $ | 6.3 | ||||||
Exchange-traded funds | 5 | - | - | 5 | ||||||||||
Total - Current | $ | 11.3 | $ | - | $ | - | $ | 11.3 | ||||||
Fair Value, Assets Measured on Recurring Basis | Our assets measured at fair value or disclosed at fair value on a recurring basis as at March 31, 2015 and December 31, 2014 consisted of the following: | |||||||||||||
March 31, 2015 | ||||||||||||||
(in millions) | ||||||||||||||
Total | Level 1 | Level 2 | Level 3 | |||||||||||
Assets: | ||||||||||||||
Corporate bonds | 5.4 | - | 5.4 | - | ||||||||||
Exchange-traded funds | 5 | 5 | - | - | ||||||||||
Total | $ | 10.4 | $ | 5 | $ | 5.4 | $ | - | ||||||
December 31, 2014 | ||||||||||||||
(in millions) | ||||||||||||||
Total | Level 1 | Level 2 | Level 3 | |||||||||||
Assets: | ||||||||||||||
Corporate bonds | 6.3 | - | 6.3 | - | ||||||||||
Exchange-traded funds | 5 | $ | 5 | $ | - | $ | - | |||||||
Total | $ | 11.3 | 5 | 6.3 | - | |||||||||
INVENTORIES_Tables
INVENTORIES (Tables) | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
Inventory Disclosure [Abstract] | ||||||||
INVENTORIES | Inventories are summarized as follows: | |||||||
March 31, | December 31, | |||||||
2015 | 2014 | |||||||
(in thousands) | ||||||||
Raw and packaging materials | $ | 260 | $ | 260 | ||||
Finished goods | 282 | 44 | ||||||
Total | 542 | 304 | ||||||
Less: reserve for raw materials | -260 | (-) | ||||||
Net | $ | 282 | $ | 304 | ||||
ACCRUED_EXPENSES_Tables
ACCRUED EXPENSES (Tables) | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
Payables and Accruals [Abstract] | ||||||||
ACCRUED EXPENSES | Accrued expenses are summarized as follows: | |||||||
March 31, | December 31, | |||||||
2015 | 2014 | |||||||
(in thousands) | ||||||||
Payroll, payroll taxes, and benefits | $ | 146 | $ | 94 | ||||
Professional services | 195 | 253 | ||||||
Franchise taxes | 17 | 13 | ||||||
Property taxes | 17 | 15 | ||||||
Marketing and promotion | 251 | 61 | ||||||
Clinical, non-clinical and regulatory services | 241 | 83 | ||||||
Other fees and services | 120 | 49 | ||||||
Total | $ | 987 | $ | 568 | ||||
DEBT_Tables
DEBT (Tables) | 3 Months Ended | ||||||||||
Mar. 31, 2015 | |||||||||||
Debt Disclosure [Abstract] | |||||||||||
Schedule of Debt | Our debt at March 31, 2015 is summarized below (in thousands): | ||||||||||
Debt | Current | Long-term | Total | ||||||||
Balance at Dec 31, 2014 | $ | 1,758 | $ | 8,242 | $ | 10,000 | |||||
Principal payments | - | - | - | ||||||||
Classification | 611 | -611 | - | ||||||||
Balance at Mar 31, 2015 | $ | 2,369 | $ | 7,631 | $ | 10,000 | |||||
Debt Discount | Current | Long-term | Total | ||||||||
Balance at Dec 31, 2014 | $ | - | $ | -281 | $ | -281 | |||||
Additions | - | -33 | -33 | ||||||||
Amortization expense | - | 31 | 31 | ||||||||
Balance at Mar 31, 2015 | $ | - | $ | -283 | $ | -283 | |||||
Debt, net | $ | 2,369 | $ | 7,348 | $ | 9,717 | |||||
Schedule of Interest Expense | Our interest expense during the three month ended March 31, 2015 and 2014 consisted of the following: | ||||||||||
Three months Ended | |||||||||||
March 31, | |||||||||||
2015 | 2014 | ||||||||||
(in thousands) | |||||||||||
Interest expense: | |||||||||||
Secured Promissory notes | $ | 260 | $ | 254 | |||||||
Debt discount | 31 | 30 | |||||||||
Debt issue costs | 17 | 17 | |||||||||
Total interest expense | $ | 308 | $ | 301 | |||||||
Schedule Of Long Term Debt Future Principal Payments Year | The annual principal payments of the debt at March 31, 2015 are as follows: | ||||||||||
Annual | |||||||||||
Principal Payments | |||||||||||
(in thousands) | |||||||||||
2015 | $ | 1,758 | |||||||||
2016 | 2,522 | ||||||||||
2017 | 2,741 | ||||||||||
2018 | 2,979 | ||||||||||
Total | $ | 10,000 | |||||||||
COMMON_STOCK_WARRANTS_Tables
COMMON STOCK WARRANTS (Tables) | 3 Months Ended | |||||||||||
Mar. 31, 2015 | ||||||||||||
Stockholders Equity Note [Abstract] | ||||||||||||
COMMON STOCK WARRANTS | Our common stock warrant activity during the three months ended March 31, 2015 and 2014 is shown below: | |||||||||||
Three months Ended | ||||||||||||
March 31, | ||||||||||||
2015 | 2014 | |||||||||||
Number | Weighted | Number | Weighted | |||||||||
(000’s) | Average | (000’s) | Average | |||||||||
Exercise | Exercise | |||||||||||
Price | Price | |||||||||||
Outstanding, beginning | 298 | $ | 1.6 | 2,154 | $ | 3.15 | ||||||
Issued | - | - | - | - | ||||||||
Exercised | - | - | - | - | ||||||||
Expired | - | - | - | - | ||||||||
Outstanding, ending | 298 | $ | 0.5 | 2,154 | $ | 3.15 | ||||||
SHAREBASED_COMPENSATION_Tables
SHARE-BASED COMPENSATION (Tables) | 3 Months Ended | |||||||||||||
Mar. 31, 2015 | ||||||||||||||
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: | |||||||||||||
Three Months Ended | ||||||||||||||
March 31, | ||||||||||||||
2015 | 2014 | |||||||||||||
Research and development expense: | ||||||||||||||
Restricted stock units | $ | 39 | $ | 57 | ||||||||||
General and administrative expense: | ||||||||||||||
Stock options | 98 | 141 | ||||||||||||
Restricted stock units | 23 | - | ||||||||||||
Subtotal | 121 | 141 | ||||||||||||
Total | $ | 160 | $ | 198 | ||||||||||
Schedule of Share-based Compensation, Stock Options, Activity | Our stock option award activity during the three months ended March 31, 2015 and 2014 is shown below: | |||||||||||||
Three months Ended | ||||||||||||||
March 31, | ||||||||||||||
2015 | 2014 | |||||||||||||
Number | Weighted | Number of | Weighted | |||||||||||
of | Average | Options | Average | |||||||||||
Options | Exercise | (000’s) | Exercise | |||||||||||
(000’s) | Price | Price | ||||||||||||
Outstanding, beginning | 4,556 | $ | 4.14 | 3,738 | $ | 4.99 | ||||||||
Granted | - | - | - | - | ||||||||||
Exercised | - | - | -31 | 1.3 | ||||||||||
Forfeited or expired | -75 | 5.25 | - | - | ||||||||||
Outstanding, ending | 4,481 | $ | 4.13 | 3,707 | $ | 5.02 | ||||||||
Options exercisable | 3,573 | $ | 5 | 3,189 | $ | 5.54 | ||||||||
Schedule of Share-based Compensation, Restricted Stock Units Award Activity | A summary of the grants under the RSU Plans consisted of the following: | |||||||||||||
Three months Ended March 31, | ||||||||||||||
2015 | 2014 | |||||||||||||
(in thousands) | ||||||||||||||
Number of | Number of | Number of | Number of | |||||||||||
RSUs | Vested | RSUs | Vested | |||||||||||
RSUs | RSUs | |||||||||||||
Outstanding, beginning | 147 | 147 | 829 | 829 | ||||||||||
Granted | 206 | - | - | - | ||||||||||
Distributed | -129 | -129 | -829 | -829 | ||||||||||
Vested | - | 52 | - | - | ||||||||||
Forfeited or expired | - | - | - | - | ||||||||||
Outstanding, ending | 224 | 70 | - | - | ||||||||||
EARNINGS_PER_SHARE_EPS_Tables
EARNINGS PER SHARE ("EPS") (Tables) | 3 Months Ended | |||||||
Mar. 31, 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: | |||||||
Three months Ended March 31, | ||||||||
2015 | 2014 | |||||||
(in thousands except per share | ||||||||
data) | ||||||||
EPS - basic | ||||||||
Numerator: net income (loss) | $ | 1,239 | $ | -4,088 | ||||
Denominator: | ||||||||
Common shares | 48,947 | 48,842 | ||||||
Vested RSUs | 18 | - | ||||||
Basic weighted average shares outstanding | 48,965 | 48,842 | ||||||
EPS - basic | $ | 0.03 | $ | -0.08 | ||||
EPS – assuming dilution | ||||||||
Numerator: net income (loss) | $ | 1,239 | $ | -4,088 | ||||
Denominator: | ||||||||
Common shares | 48,947 | 48,842 | ||||||
Vested RSUs | 170 | - | ||||||
Stock options | 167 | - | ||||||
Common stock warrants | 63 | - | ||||||
Diluted weighted average shares outstanding | 49,347 | 48,842 | ||||||
EPS - diluted | $ | 0.03 | $ | -0.08 | ||||
Excluded dilutive securities: | ||||||||
Common stock issuable: | ||||||||
Stock options | 3,580 | 3,707 | ||||||
Common stock warrants | - | 2,154 | ||||||
Total excluded potentially dilutive shares | 3,580 | 5,861 | ||||||
Recovered_Sheet1
License, Development, and Commercialization Agreements - Additional Information (Detail) (USD $) | 3 Months Ended |
Mar. 31, 2015 | |
License Development and Commercialization Agreement [Line Items] | |
Inventory, Raw Materials and Supplies, Gross | 260,000 |
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, but in no event earlier than June 30, 2015 |
Minimum Net Sales Reaching Description | one-time $12.5 million milestone payment when worldwide Oxaydo net sales reach $150 million in a calendar year |
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 |
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% |
Revenue_Recognition_Additional
Revenue Recognition - Additional Information (Detail) (USD $) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Deferred Sales Inducements, Additions | $255,000 | $0 |
Royalty Revenue, Total | 0 | 3,000 |
Deferred Revenue, Revenue Recognized | 314,000 | |
Sales Returns Liability | 153,000 | |
Allowance for Sales Returns [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Sales Returns and Allowances, Goods | 120,000 | |
Pfizer [Member] | ||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||
Royalty Revenue, Total | $3,000 |
Recovered_Sheet2
Research and Development Activities - Additional Information (Detail) (USD $) | Mar. 31, 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 |
Summary_of_Investments_in_Mark
Summary of Investments in Marketable Securities (Detail) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
In Millions, unless otherwise specified | ||
Marketable securities: | ||
Corporate bonds - maturing within 1 year | $2.80 | $3.50 |
Corporate bonds - maturing after 1 year and through March 2017 | 2.6 | 2.8 |
Total marketable securities | 10.4 | 11.3 |
Exchange-traded funds | ||
Marketable securities: | ||
Total marketable securities | $5 | $5 |
Available_for_Sale_Securities_
Available for Sale Securities Continuous Unrealized Loss Position Fair Value (Detail) (USD $) | 3 Months Ended | 12 Months Ended |
In Millions, unless otherwise specified | Mar. 31, 2015 | Dec. 31, 2014 |
Available For Sale Securities Continuous Unrealized Loss Position Fair Value [Line Items] | ||
Cost | $10.40 | $11.30 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 10.4 | 11.3 |
Corporate Bonds | ||
Available For Sale Securities Continuous Unrealized Loss Position Fair Value [Line Items] | ||
Cost | 5.4 | 6.3 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 5.4 | 6.3 |
Exchange-traded funds | ||
Available For Sale Securities Continuous Unrealized Loss Position Fair Value [Line Items] | ||
Cost | 5 | 5 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | $5 | $5 |
Assets_Measured_at_Fair_Value_
Assets Measured at Fair Value or Disclosed at Fair Value on Recurring Basis (Detail) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
In Millions, unless otherwise specified | ||
Assets: | ||
Total marketable securities | $10.40 | $11.30 |
Corporate bonds | ||
Assets: | ||
Total marketable securities | 5.4 | 6.3 |
Exchange-traded funds | ||
Assets: | ||
Total marketable securities | 5 | 5 |
Fair Value, Inputs, Level 1 | ||
Assets: | ||
Total marketable securities | 5 | 5 |
Fair Value, Inputs, Level 1 | Corporate bonds | ||
Assets: | ||
Total marketable securities | 0 | |
Fair Value, Inputs, Level 1 | Exchange-traded funds | ||
Assets: | ||
Total marketable securities | 5 | 5 |
Fair Value, Inputs, Level 2 | ||
Assets: | ||
Total marketable securities | 5.4 | 6.3 |
Fair Value, Inputs, Level 2 | Corporate bonds | ||
Assets: | ||
Total marketable securities | 5.4 | 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 |
Recovered_Sheet3
Investments In Marketable Securities - Additional Information (Detail) (USD $) | 3 Months Ended | 12 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 | Dec. 31, 2014 |
Investment In Marketable Securities [Line Items] | |||
Unrealized gains on securities | $31 | $29 | $13 |
Schedule_of_Inventories_Detail
Schedule of Inventories (Detail) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
In Thousands, unless otherwise specified | ||
Inventory [Line Items] | ||
Raw and packaging materials | $260 | $260 |
Finished goods | 282 | 44 |
Total | 542 | 304 |
Less: reserve for raw materials | -260 | 0 |
Net | $282 | $304 |
Inventories_Additional_Informa
Inventories - Additional Information (Detail) (USD $) | 3 Months Ended | 12 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Dec. 31, 2014 | Mar. 31, 2014 |
Inventory [Line Items] | |||
Inventory, Raw Materials and Supplies, Gross | $260 | $260 | |
Inventory Reserve For Raw Materials | 260 | 0 | |
Cost of Goods Sold | 255 | 220 | |
Deferred Revenue, Current | 0 | 353 | |
Deferred Revenue, Revenue Recognized | 314 | ||
Inventory Reserve For Finished Goods | $133 |
Accrued_Expenses_Detail
Accrued Expenses (Detail) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
In Thousands, unless otherwise specified | ||
Accounts Payable and Accrued Liabilities [Line Items] | ||
Payroll, payroll taxes, and benefits | $146 | $94 |
Professional services | 195 | 253 |
Franchise taxes | 17 | 13 |
Property taxes | 17 | 15 |
Marketing and Promotion | 251 | 61 |
Clinical, non-clinical and regulatory services | 241 | 83 |
Other fees and services | 120 | 49 |
Total | $987 | $568 |
Debt_Additional_Information_De
Debt - Additional Information (Detail) (USD $) | 0 Months Ended | 3 Months Ended | |||
Share data in Thousands, except Per Share data, unless otherwise specified | Jan. 07, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 27, 2013 |
Debt Instrument [Line Items] | |||||
Debt instrument principal amount | $10,000,000 | ||||
Debt instrument, interest rate, stated percentage | 8.35% | ||||
Debt default long term debt percentage | 13.35% | ||||
Debt Instrument, Maturity Date | 1-Dec-18 | ||||
Debt instrument, fee amount | 50,000 | ||||
Debt consulting placement fee | 100,000 | ||||
Debt related commitment fees and debt issuance costs | 231,000 | ||||
Debt instrument unamortized discount | 283,000 | 281,000 | 400,000 | ||
Warrants to purchase common stock | 298 | 298 | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $1.60 | $0.50 | $1.60 | ||
Debt instrument Cash Maintenance | 2,500,000 | ||||
Repayments of Debt | 5,000,000 | ||||
Additions To Debt Instrument Unamortized Discount | 33,000 | ||||
Debt Instrument, Periodic Payment | 260,000 | ||||
Maximum [Member] | |||||
Debt Instrument [Line Items] | |||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $1.60 | ||||
Minimum [Member] | |||||
Debt Instrument [Line Items] | |||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $0.50 | $0.50 | |||
Warrant | |||||
Debt Instrument [Line Items] | |||||
Warrants to purchase common stock | 298 | ||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $1.60 | ||||
Warrants, expiry date | 27-Dec-20 | ||||
After December 27 2015 | |||||
Debt Instrument [Line Items] | |||||
Debt instrument prepayment percentage | 1.00% | ||||
First Revenue Event Occurs | |||||
Debt Instrument [Line Items] | |||||
Debt instrument periodic payment terms balloon payment to be paid | $795,000 | ||||
Prior To December 27 2015 | |||||
Debt Instrument [Line Items] | |||||
Debt instrument prepayment percentage | 2.00% |
Summary_of_Debt_Detail
Summary of Debt (Detail) (USD $) | 3 Months Ended | ||
In Thousands, unless otherwise specified | Mar. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 |
Debt | |||
Beginning of period | $10,000 | ||
Principal payments | 0 | ||
Classification | 0 | ||
End of period | 10,000 | ||
Debt Discount | |||
Beginning of period | 281 | 400 | |
Additions | 33 | ||
Amortization expense | 31 | ||
End of period | 283 | 400 | |
Debt, net | 7,348 | 7,961 | |
Long-term Debt [Member] | |||
Debt | |||
Beginning of period | 8,242 | ||
Principal payments | 0 | ||
Classification | -611 | ||
End of period | 7,631 | ||
Debt Discount | |||
Beginning of period | -281 | ||
Additions | -33 | ||
Amortization expense | 31 | ||
End of period | -283 | ||
Debt, net | 7,348 | ||
Short-term Debt [Member] | |||
Debt | |||
Beginning of period | 1,758 | ||
Principal payments | 0 | ||
Classification | 611 | ||
End of period | 2,369 | ||
Debt Discount | |||
Beginning of period | 0 | ||
Additions | 0 | ||
Amortization expense | 0 | ||
End of period | 0 | ||
Debt, net | $2,369 |
Interest_Expense_Detail
Interest Expense (Detail) (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Interest expense: | ||
Secured Promissory notes | $260 | $254 |
Debt discount | 31 | 30 |
Debt issue costs | 17 | 17 |
Total interest expense | $308 | $301 |
LongTerm_Debt_Detail
Long-Term Debt (Detail) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
In Thousands, unless otherwise specified | ||
Debt Instrument [Line Items] | ||
2015 | $1,758 | |
2016 | 2,522 | |
2017 | 2,741 | |
2018 | 2,979 | |
Total | $10,000 | $10,000 |
Equity_Financing_Additional_In
Equity Financing - Additional Information (Detail) (USD $) | 1 Months Ended | 3 Months Ended |
In Millions, unless otherwise specified | Apr. 18, 2013 | Mar. 31, 2015 |
Equity Financing [Line Items] | ||
Proceeds from sale of common stock | $13 | $7.90 |
Common_Stock_Warrant_Activity_
Common Stock Warrant Activity (Detail) (Warrant, USD $) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Warrant | ||
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 |
Common_Stock_Warrants_Addition
Common Stock Warrants - Additional Information (Detail) (USD $) | 3 Months Ended | ||
In Thousands, except Per Share data, unless otherwise specified | Mar. 31, 2015 | Jan. 07, 2015 | Dec. 31, 2014 |
Class of Warrant or Right [Line Items] | |||
Common stock warrant exercisable outstanding, shares | 298 | 298 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights | $0.50 | $1.60 | $1.60 |
Minimum [Member] | |||
Class of Warrant or Right [Line Items] | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $0.50 | $0.50 | |
Maximum [Member] | |||
Class of Warrant or Right [Line Items] | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $1.60 | ||
Warrant | |||
Class of Warrant or Right [Line Items] | |||
Common stock warrant exercisable outstanding, shares | 298 | ||
Common stock Warrant expiration date | 27-Dec-20 | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $1.60 |
ShareBased_Compensation_Additi
Share-Based Compensation - Additional Information (Detail) (USD $) | 3 Months Ended | 1 Months Ended | 0 Months Ended | 2 Months Ended | 3 Months Ended | 12 Months Ended | 8 Months Ended | 0 Months Ended | ||
Mar. 31, 2015 | Mar. 31, 2014 | Jan. 31, 2014 | 1-May-14 | Jun. 30, 2014 | Dec. 31, 2014 | Sep. 30, 2014 | Dec. 31, 2014 | Jan. 02, 2015 | Jan. 02, 2015 | |
Employee Benefit Plans Disclosure [Line Items] | ||||||||||
Restricted Stock Units Sale Price | 0.01 | |||||||||
Deferred Compensation Arrangement with Individual, Recorded Liability | 22,000 | 22,000 | ||||||||
Stock options | ||||||||||
Employee Benefit Plans Disclosure [Line Items] | ||||||||||
Withholding tax obligations | 36,000 | |||||||||
Shares withheld upon elections made to exchange RSUs | 18,000 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 31,000 | |||||||||
Option Plan [Member] | ||||||||||
Employee Benefit Plans Disclosure [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 24,000 | |||||||||
Stock Issued During Period Shares Stock Options Exercised Net Of Shares For Tax Withholdings | 13,000 | |||||||||
2005 Restricted Stock Unit Award Plan [Member] | ||||||||||
Employee Benefit Plans Disclosure [Line Items] | ||||||||||
Shares withheld upon elections made to exchange RSUs | 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, Award Vesting Rights | one-fourth of vested shares of common stock underlying RSU awards of 3.3 million shares were distributed (after payment of exercise costs of $0.01 par value per share) on January 1 of each of years 2011 thru 2014. | |||||||||
2014 Restricted Stock Unit Award Plan [Member] | ||||||||||
Employee Benefit Plans Disclosure [Line Items] | ||||||||||
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, Shares Purchased for Award | 1,650,000 | |||||||||
2014 Restricted Stock Unit Award Plan [Member] | Four Non Employee Directors [Member] | ||||||||||
Employee Benefit Plans Disclosure [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 37,000 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 50.00% | 25.00% | 25.00% | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Description | stock, for up to 40% | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested in Period, Fair Value | $26,000 | |||||||||
2014 Restricted Stock Unit Award Plan [Member] | Subsequent Event [Member] | ||||||||||
Employee Benefit Plans Disclosure [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 129,000 | |||||||||
Share Based Compensation Arrangement Share Based Payment Shares Reserved For Future Distribution | 18,000 | |||||||||
2014 Restricted Stock Unit Award Plan [Member] | Subsequent Event [Member] | Settled In Cash [Member] | ||||||||||
Employee Benefit Plans Disclosure [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 30,000 | |||||||||
2014 Restricted Stock Unit Award Plan [Member] | Subsequent Event [Member] | Convertible Common Stock [Member] | ||||||||||
Employee Benefit Plans Disclosure [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 99,000 | |||||||||
2014 Restricted Stock Unit Award Plan [Member] | Subsequent Event [Member] | Four Non Employee Directors [Member] | ||||||||||
Employee Benefit Plans Disclosure [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 51,500 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Description | stock, for up to 40% | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights | 25% |
Recognition_of_ShareBased_Comp
Recognition of Share-Based Compensation Expense (Detail) (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Research and Development Expense, Total | $964 | $1,438 |
Share Based Compensation Expense Recognized In Operations | 160 | 198 |
Subtotal [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Share Based Compensation Expense Recognized In Operations | 121 | 141 |
Research and Development Expense [Member] | Restricted Stock Units (RSUs) [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Research and Development Expense, Total | 39 | 57 |
General and Administrative Expense [Member] | Employee Stock Option [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
General and administrative expense | 98 | 141 |
General and Administrative Expense [Member] | Restricted Stock Units (RSUs) [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
General and administrative expense | $23 | $0 |
Stock_Option_Award_Activity_De
Stock Option Award Activity (Detail) (Stock Option Plan, USD $) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Stock Option Plan | ||
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 | 3,573 | 3,189 |
Weighted Average Exercise Price, beginning | $4.14 | $4.99 |
Weighted Average Exercise Price, Granted | $0 | $0 |
Weighted Average Exercise Price, Exercised | $0 | $1.30 |
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 | $5 | $5.54 |
Summary_of_RSU_Plan_Detail
Summary of RSU Plan (Detail) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Restricted Stock Units | ||
Share based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Outstanding, beginning | 147 | 829 |
Granted | 206 | 0 |
Distributed | -129 | -829 |
Vested | 0 | 0 |
Forfeited or expired | 0 | 0 |
Outstanding, ending | 224 | 0 |
Vested Restricted Stock Units (RSUs) | ||
Share based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Outstanding, beginning | 147 | 829 |
Granted | 0 | 0 |
Distributed | -129 | -829 |
Vested | 52 | 0 |
Forfeited or expired | 0 | 0 |
Outstanding, ending | 70 | 0 |
Income_Taxes_Additional_Inform
Income Taxes - Additional Information (Detail) (USD $) | 12 Months Ended | 3 Months Ended |
In Millions, unless otherwise specified | Dec. 31, 2014 | Mar. 31, 2015 |
Income Tax Disclosure [Line Items] | ||
Federal income tax benefits | $51.50 | |
Federal NOLs | 151.4 | |
U.S. statutory tax rate | 34.00% | |
State income tax benefits | 2.9 | |
Federal Research and Development | ||
Income Tax Disclosure [Line Items] | ||
Research and development tax credits | 1.1 | |
Research and development expiration period | which expire in the years 2024 through 2034 | |
Indiana State Research and Development | ||
Income Tax Disclosure [Line Items] | ||
Research and development tax credits | $0.30 | |
Research and development expiration period | which expire in the years 2015 through 2017 | |
Maximum | ||
Income Tax Disclosure [Line Items] | ||
NOL expiration year | 2034 | |
Minimum | ||
Income Tax Disclosure [Line Items] | ||
NOL expiration year | 2016 |
EARNINGS_PER_SHARE_EPS_Additio
EARNINGS PER SHARE ("EPS") - Additional Information (Detail) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share, Amount | 3,580 | 5,861 |
Reconciliation_of_Numerators_a
Reconciliation of Numerators and Denominators of Basic and Diluted EPS (Detail) (USD $) | 3 Months Ended | |
In Thousands, except Per Share data, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
EPS - basic | ||
Numerator: net income (loss) | $1,239 | ($4,088) |
Denominator: | ||
Common shares | 48,947 | 48,842 |
Vested RSUs | 18 | 0 |
Basic weighted average shares outstanding | 48,965 | 48,842 |
EPS - basic | $0.03 | ($0.08) |
EPS - assuming dilution | ||
Numerator: net income (loss) | $1,239 | ($4,088) |
Denominator: | ||
Common shares | 48,947 | 48,842 |
Vested RSUs | 170 | 0 |
Stock options | 167 | 0 |
Common stock warrants | 63 | 0 |
Diluted weighted average shares outstanding | 49,347 | 48,842 |
EPS - diluted | $0.03 | ($0.08) |
Common shares issuable: | ||
Total excluded common shares | 3,580 | 5,861 |
Stock options | ||
Common shares issuable: | ||
Total excluded common shares | 3,580 | 3,707 |
Common stock warrants | ||
Common shares issuable: | ||
Total excluded common shares | 0 | 2,154 |
Commitments_and_Contingencies_
Commitments and Contingencies - Additional Information (Detail) (USD $) | 3 Months Ended |
In Thousands, unless otherwise specified | Mar. 31, 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 | 400 |
Palatine Lllinois | |
Commitments and Contingencies Disclosure [Line Items] | |
Leases administrative office space | 25 |
Lease expiring date | 31-Mar-16 |