Document_And_Entity_Informatio
Document And Entity Information | 6 Months Ended | |
Jun. 30, 2014 | Jul. 30, 2014 | |
Document Information [Line Items] | ' | ' |
Document Type | '10-Q | ' |
Amendment Flag | 'false | ' |
Document Period End Date | 30-Jun-14 | ' |
Document Fiscal Year Focus | '2014 | ' |
Document Fiscal Period Focus | 'Q2 | ' |
Entity Registrant Name | 'ACURA PHARMACEUTICALS, INC | ' |
Entity Central Index Key | '0000786947 | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Entity Filer Category | 'Non-accelerated Filer | ' |
Trading Symbol | 'ACUR | ' |
Entity Common Stock, Shares Outstanding | ' | 48,847,982 |
CONSOLIDATED_BALANCE_SHEETS
CONSOLIDATED BALANCE SHEETS (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Current assets: | ' | ' |
Cash and cash equivalents | $3,541 | $12,340 |
Marketable securities | 13,820 | 13,733 |
Accounts receivable, net of allowances of $22 and $28 | 86 | 194 |
Accrued investment income | 102 | 120 |
Inventories, net | 445 | 251 |
Prepaid expenses and other current assets | 546 | 629 |
Other current deferred assets | 193 | 186 |
Total current assets | 18,733 | 27,453 |
Property, plant and equipment, net | 928 | 941 |
Deferred debt issuance costs | 196 | 231 |
Other assets | 3 | 5 |
Intangible asset | 2,000 | 0 |
Total assets | 21,860 | 28,630 |
Current liabilities: | ' | ' |
Accounts payable | 114 | 274 |
Accrued expenses (Note 7) | 1,444 | 541 |
Other current liabilities | 37 | 5 |
Deferred revenue | 307 | 287 |
Current maturities of long-term debt | 477 | 0 |
Total current liabilities | 2,379 | 1,107 |
Long-term debt, net of debt discount of $341 and $400 | 9,182 | 9,600 |
Total liabilities | 11,561 | 10,707 |
Commitments and contingencies (Note 13) | ' | ' |
Common stock: $.01 par value per shares; 100,000 shares authorized, 48,848 and 48,325 shares issued and outstanding at June 30, 2014 and December 31, 2013, respectively | 488 | 483 |
Additional paid-in capital | 366,463 | 366,533 |
Accumulated deficit | -356,721 | -349,112 |
Accumulated other comprehensive income (loss) | 69 | 19 |
Total stockholders’ equity | 10,299 | 17,923 |
Total liabilities and stockholders’ equity | $21,860 | $28,630 |
CONSOLIDATED_BALANCE_SHEETS_Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, except Per Share data, unless otherwise specified | ||
Common stock, par value | $0.01 | $0.01 |
Common stock, shares authorized | 100,000 | 100,000 |
Common stock, shares issued | 48,848 | 48,325 |
Common stock, shares outstanding | 48,848 | 48,325 |
Accounts receivable, net of allowances | $22 | $28 |
Long-term debt, net of debt discount | $341 | $400 |
CONSOLIDATED_STATEMENTS_OF_OPE
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) (USD $) | 3 Months Ended | 6 Months Ended | ||
In Thousands, except Per Share data, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 |
Revenues: | ' | ' | ' | ' |
Royalty revenue | $1 | $1 | $4 | $5 |
Product sales, net | 34 | 0 | 73 | 0 |
Total revenues, net | 35 | 1 | 77 | 5 |
Operating expenses: | ' | ' | ' | ' |
Cost of sales (excludes inventory write-down) | 42 | 0 | 80 | 0 |
Inventory write-down | 68 | 361 | 201 | 361 |
Research and development | 1,281 | 805 | 2,719 | 2,831 |
Selling, marketing, general and administrative | 1,916 | 1,975 | 4,175 | 4,197 |
Total operating expenses | 3,307 | 3,141 | 7,175 | 7,389 |
Operating loss | -3,272 | -3,140 | -7,098 | -7,384 |
Non-operating income (expense): | ' | ' | ' | ' |
Investment income | 53 | 71 | 97 | 81 |
(Loss) gain on sales of marketable securities | 0 | -7 | -5 | 9 |
Interest expense (Note 8) | -302 | 0 | -603 | 0 |
Total other income (expense) | -249 | 64 | -511 | 90 |
Loss before income taxes | -3,521 | -3,076 | -7,609 | -7,294 |
Provision for income taxes | 0 | 0 | 0 | 0 |
Net loss | -3,521 | -3,076 | -7,609 | -7,294 |
Other comprehensive income: | ' | ' | ' | ' |
Unrealized gains (losses) on securities | 21 | -131 | 50 | -79 |
Total other comprehensive income (expense) | 21 | -131 | 50 | -79 |
Comprehensive loss | ($3,500) | ($3,207) | ($7,559) | ($7,373) |
Loss per share: | ' | ' | ' | ' |
Basic | ($0.07) | ($0.07) | ($0.16) | ($0.16) |
Diluted | ($0.07) | ($0.07) | ($0.16) | ($0.16) |
Weighted average shares outstanding: | ' | ' | ' | ' |
Basic | 48,848 | 47,228 | 48,846 | 47,215 |
Diluted | 48,848 | 47,228 | 48,846 | 47,215 |
CONSOLIDATED_STATEMENTS_OF_STO
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (USD $) | Total | Cashless | Common Stock | Common Stock | Common Stock | Additional paid-in capital | Additional paid-in capital | Additional paid-in capital | Accumulated deficit | Accumulated deficit | Accumulated deficit | Accumulated Other Comprehensive Income (Loss) | Accumulated Other Comprehensive Income (Loss) | Accumulated Other Comprehensive Income (Loss) |
In Thousands | Cashless | Restricted Stock Units (RSUs) | Cashless | Restricted Stock Units (RSUs) | Cashless | Restricted Stock Units (RSUs) | Cashless | Restricted Stock Units (RSUs) | ||||||
Beginning Balance at Dec. 31, 2013 | $17,923 | ' | $483 | ' | ' | $366,533 | ' | ' | ($349,112) | ' | ' | $19 | ' | ' |
Beginning Balance (in shares) at Dec. 31, 2013 | ' | ' | 48,325 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Net loss | -7,609 | ' | 0 | ' | ' | 0 | ' | ' | -7,609 | ' | ' | 0 | ' | ' |
Other comprehensive income (loss) | 50 | ' | 0 | ' | ' | 0 | ' | ' | 0 | ' | ' | 50 | ' | ' |
Share-based compensation | 455 | ' | 0 | ' | ' | 455 | ' | ' | 0 | ' | ' | 0 | ' | ' |
Net distribution of common stock pursuant to restricted stock unit award plan (in shares) | ' | ' | 825 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Net distribution of common stock pursuant to restricted stock unit award plan | 1 | ' | 8 | ' | ' | -7 | ' | ' | 0 | ' | ' | 0 | ' | ' |
Common shares withheld for withholding taxes (in shares) | ' | ' | ' | -2 | -315 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Common shares withheld for withholding taxes | -525 | -4 | ' | 0 | -3 | ' | -4 | -522 | ' | 0 | 0 | ' | 0 | 0 |
Net issuance of common stock pursuant to cashless exercise of stock options (in shares) | ' | ' | 8 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Net issuance of common stock pursuant to cashless exercise of stock options | 0 | ' | 0 | ' | ' | 0 | ' | ' | 0 | ' | ' | 0 | ' | ' |
Issuance of common stock for exercise of stock options (in shares) | ' | ' | 7 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Issuance of common stock for exercise of stock options | 8 | ' | 0 | ' | ' | 8 | ' | ' | 0 | ' | ' | 0 | ' | ' |
Ending Balance at Jun. 30, 2014 | $10,299 | ' | $488 | ' | ' | $366,463 | ' | ' | ($356,721) | ' | ' | $69 | ' | ' |
Ending Balance (in shares) at Jun. 30, 2014 | ' | ' | 48,848 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
CONSOLIDATED_STATEMENTS_OF_CAS
CONSOLIDATED STATEMENTS OF CASH FLOWS (USD $) | 6 Months Ended | |
In Thousands, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 |
Cash Flows from Operating Activities: | ' | ' |
Net loss | ($7,609) | ($7,294) |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' |
Depreciation | 58 | 69 |
Provision to reduce inventory to net realizable value | 201 | 390 |
Share-based compensation | 455 | 630 |
Amortization of debt discount and deferred debt issue costs | 93 | 0 |
Amortization of bond premium in marketable securities | 138 | 0 |
Loss (gain) on sales of marketable securities | 5 | -9 |
Loss on disposal of property and equipment | 1 | 0 |
Changes in assets and liabilities | ' | ' |
Accounts receivable, net | 108 | -8 |
Accrued investment income | 18 | -91 |
Inventories | -394 | -532 |
Income taxes refundable | 0 | 43 |
Prepaid expenses and other current assets | 83 | -207 |
Other current deferred assets | -7 | -49 |
Other long-term assets | 3 | 3 |
Accounts payable | -160 | -666 |
Accrued expenses | 902 | 262 |
Other current liabilities | 32 | 0 |
Deferred revenue | 20 | 61 |
Net cash used in operating activities | -6,053 | -7,398 |
Cash Flows from Investing Activities: | ' | ' |
Purchases of marketable securities | -1,540 | -7,612 |
Proceeds from sale and maturities of marketable securities | 1,361 | 8,604 |
Additions to property, plant and equipment | -47 | -23 |
Acquisition of product rights | -2,000 | 0 |
Net cash (used in) provided by investing activities | -2,226 | 969 |
Cash Flows from Financing Activities: | ' | ' |
Proceeds from exercise of stock options | 8 | 9 |
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 | -529 | -716 |
Proceeds from “at-the-market†offering | 0 | 251 |
Offering transaction costs | 0 | -8 |
Net cash used in financing activities | -520 | -463 |
Net decreases in cash and cash equivalents | -8,799 | -6,892 |
Cash and cash equivalents at beginning of year | 12,340 | 7,476 |
Cash and cash equivalents at end of year | 3,541 | 584 |
Cash paid (refunded) during the year for: | ' | ' |
Interest | 348 | 0 |
Income taxes, net of refunds | $0 | ($43) |
CONSOLIDATED_STATEMENTS_OF_CAS1
CONSOLIDATED STATEMENTS OF CASH FLOWS (Parenthetical) (USD $) | 6 Months Ended | |
In Thousands, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 |
Stock options | ' | ' |
Supplemental Disclosure of Noncash Financing Activities: | ' | ' |
Equity based employee compensation granted | 24 | 7 |
Common stock withheld in exercise costs in shares | 16 | 3 |
Common stock withheld in exercise costs | $32 | $9 |
Withholding of exercise cost in shares | 2 | 1 |
Minimum statutory withholding payroll taxes withheld | 4 | 4 |
Common Stock issued upon exercise | 6 | 3 |
Restricted Stock Unit | ' | ' |
Supplemental Disclosure of Noncash Financing Activities: | ' | ' |
Equity based employee compensation granted | 829 | 829 |
Common stock withheld in exercise costs in shares | 4 | 3 |
Common stock withheld in exercise costs | 7 | 7 |
Withholding of exercise cost in shares | 315 | 321 |
Minimum statutory withholding payroll taxes withheld | $525 | $700 |
Common Stock issued upon exercise | 510 | 505 |
DESCRIPTION_OF_BUSINESS
DESCRIPTION OF BUSINESS | 6 Months Ended |
Jun. 30, 2014 | |
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 two proprietary technologies. Our oxycodone HCl tablets, CII formulated with Aversion® Technology, or Aversion® Oxycodone, is the first approved product utilizing Aversion®. Aversion Oxycodone was marketed by Pfizer Inc. under the brand name Oxecta® pursuant to our license agreement with Pfizer. Such license agreement was terminated effective April 9, 2014 and we have re-acquired all rights to Aversion Oxycodone. We have also developed our 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. In mid-December 2012 we launched in the United States Nexafed® (pseudoephedrine HC1) tablets formulated with our Impede Technology. | |
The accompanying unaudited consolidated financial statements of the Company were prepared in accordance with generally accepted accounting principles for interim financial information and instructions to Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, these financial statements do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for complete financial statements. In the opinion of management, all adjustments considered necessary to present fairly the Company’s financial position, results of operations and cash flows have been made. The results of operations for the three and six months ended June 30, 2014 are not necessarily indicative of results expected for the full year ending December 31, 2014. These unaudited consolidated financial statements should be read in conjunction with the audited consolidated financial statements and footnotes thereto for the year ended December 31, 2013 included in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission. The 2013 year-end consolidated balance sheet presented in this Report was derived from the Company’s 2013 year-end audited consolidated financial statements, but does not include all disclosures required by generally accepted accounting principles. | |
LICENSE_DEVELOPMENT_AND_COMMER
LICENSE, DEVELOPMENT, AND COMMERCIALIZATION AGREEMENT | 6 Months Ended |
Jun. 30, 2014 | |
Research and Development Disclosure [Abstract] | ' |
LICENSE, DEVELOPMENT, AND COMMERCIALIZATION AGREEMENT | ' |
NOTE 2 - LICENSE, DEVELOPMENT, AND COMMERCIALIZATION 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. The letter agreement further provides that (i) Pfizer will cease the development, marketing and sale of any product using our technologies effective April 9, 2014, (ii) Pfizer will retain its Oxecta® trademark, (iii) Pfizer will transfer to us of all studies, data, regulatory filings (including the NDA) and all other information relating to Aversion Oxycodone pursuant to a transition process described in the letter agreement, (iv) we will remit to Pfizer a one-time termination payment of $2.0 million, and (v) each party waives all claims against the other relating to the Pfizer Agreement. 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 will be periodically assessed on its recorded value for impairment. We plan to enter into a license agreement with another pharmaceutical company for the manufacture and sale of Aversion Oxycodone in the United States and possibly other territories, of which no assurance can be given. At the point of entering into a license agreement, the intangible asset will be amortized based on the projected cash flows expected over the remaining useful life of the patent. | |
Paragraph IV ANDA Litigation | |
On or about September 17, 2012, we believe the FDA internally changed the status of Aversion Oxycodone 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 Aversion Oxycodone as an RLD, the FDA was allowed to accept ANDAs referencing Aversion Oxycodone. | |
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 Aversion Oxycodone as the reference listed drug. Since such date, we have received similar Paragraph IV Notices from three other generic pharmaceutical companies that have filed ANDAs listing Aversion Oxycodone 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 Aversion Oxycodone. 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. The commencement of such litigation prohibits the FDA from granting approval of the filed ANDAs until the earliest of 30 months from the date the FDA accepted the application for filing, or the conclusion of litigation. 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 III Certification, which indicated its intent not to market its generic Aversion Oxycodone product in advance of our patent expiring. | |
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. In the suit, we alleged that a generic Aversion Oxycodone product for which each of Par and Impax is separately seeking approval to market in the United States pursuant to an ANDA filing with the FDA infringes a U.S. patent owned by us. Par is the first filer of an ANDA for a generic Aversion Oxycodone 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 Aversion Oxycodone 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 Aversion Oxycodone product. | |
Under the Settlement Agreement with Impax, Impax may launch its generic Aversion Oxycodone 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 Aversion Oxycodone 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 Aversion Oxycodone 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. In the suit, we alleged that a generic of our Aversion Oxycodone product for which Ranbaxy is seeking approval to market in the United States pursuant to an ANDA filed with the FDA infringes U.S. patents owned by us. The Settlement Agreement provides that Ranbaxy’s current generic of our Aversion Oxycodone 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 Aversion Oxycodone 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. In the suit, we alleged that a generic of our AVERSION® oxycodone product for which Sandoz is seeking approval to market in the United States pursuant to an ANDA filed with the FDA infringes a U.S. patent owned by us. Under the Settlement Agreement, Sandoz may launch its generic to the AVERSION® oxycodone 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 AVERSION® oxycodone 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 AVERSION® oxycodone 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 AVERSION® oxycodone product is approved by the FDA. In the event Sandoz changes or modifies the structure of its generic AVERSION® oxycodone 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 AVERSION® oxycodone product in the United States. | |
Litigation is inherently uncertain and we cannot predict the outcome of these infringement actions. It is possible that other generic manufacturers may also seek to launch a generic version of Aversion Oxycodone and challenge our patents. Any determination in such infringement actions that our patents covering our Aversion Technology and Aversion Oxycodone 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. | |
By designating Aversion Oxycodone as an RLD, we believe the FDA has acknowledged that Aversion Oxycodone contains unique properties and/or a unique label that is different from other FDA approved immediate-release oxycodone HCl tablets that do not contain abuse resistant characteristics. As required by the Food and Drug Administration Safety and Innovation Act of July 2012, the FDA published for comment draft guidance on the development of abuse-deterrent drug products in January 2013. We believe the ANDA applicants that refer to Aversion Oxycodone as an RLD will have to have substantially equivalent, if not identical, abuse deterrent characteristics to be considered by the FDA as therapeutically equivalent to Aversion Oxycodone. There can be no assurance, however, that FDA will rely on such guidance for ANDA applicants. | |
REVENUE_RECOGNITION
REVENUE RECOGNITION | 6 Months Ended |
Jun. 30, 2014 | |
Revenue Recognition [Abstract] | ' |
REVENUE RECOGNITION | ' |
NOTE 3 - REVENUE RECOGNITION | |
Revenue is generally realized or realizable and earned when there is persuasive evidence an arrangement exists, delivery has occurred or services rendered, the price is fixed and determinable, and collection is reasonably assured. We record revenue from its Nexafed product sales when the price is fixed and determinable at the date of sale, title and risk of ownership have been transferred to the customer, and returns can be reasonably estimated. | |
Nexafed was launched in mid-December 2012. 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 currently cannot reliably estimate expected returns of the product at the time of shipment to certain customers. Accordingly, at June 30, 2014 we had deferred the recognition of revenue on $0.3 million of Nexafed shipments to these customers until the right of return no longer exists or adequate history and information becomes available to estimate product returns. | |
Commencing in February 2013, we began earning royalties based on net sales of Aversion Oxycodone by Pfizer. We have earned royalties of approximately $4 thousand for the six months ended June 30, 2014. The Pfizer Agreement was terminated effective April 9, 2014 and Pfizer’s royalty payment obligations ceased as of such date. All royalties owed to us have been received. | |
Shipping and Handling Costs | |
We record 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 June 30, 2014 and 2013 were not material. | |
RESEARCH_AND_DEVELOPMENT_ACTIV
RESEARCH AND DEVELOPMENT ACTIVITIES | 6 Months Ended |
Jun. 30, 2014 | |
Research and Development [Abstract] | ' |
RESEARCH AND DEVELOPMENT ACTIVITIES | ' |
NOTE 4 - 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 expenses are subject to revisions as such studies progress to completion. Revisions are charged to expense in the period in which the facts that give rise to the revision become known. We had $0.1 million in accrued CRO expenses and clinical trial study and regulatory expenses at June 30, 2014. We did not have any of these accrued expenses at December 31, 2013. At December 31, 2013, we had $0.36 million of prepaid CRO costs and clinical trial study and regulatory expenses. We did not have any of these prepaid expenses at June 30, 2014. | |
INVESTMENTS_IN_MARKETABLE_SECU
INVESTMENTS IN MARKETABLE SECURITIES | 6 Months Ended | |||||||||||||
Jun. 30, 2014 | ||||||||||||||
Investments, Debt and Equity Securities [Abstract] | ' | |||||||||||||
INVESTMENTS IN MARKETABLE SECURITIES | ' | |||||||||||||
NOTE 5 - INVESTMENTS IN MARKETABLE SECURITIES | ||||||||||||||
Investments in marketable securities consisted of the following: | ||||||||||||||
June 30, 2014 | December 31, 2013 | |||||||||||||
(in millions) | (in millions) | |||||||||||||
Marketable securities: | ||||||||||||||
Corporate bonds — maturing within 1 year | $ | 3.3 | $ | 3.1 | ||||||||||
Corporate bonds — maturing after 1 through 4 years | 6.1 | 6.8 | ||||||||||||
Exchange-traded funds | 4.4 | 3.8 | ||||||||||||
Total marketable securities | $ | 13.8 | $ | 13.7 | ||||||||||
Our marketable securities are classified as available-for-sale and are recorded at fair value based on quoted market prices using the specific identification method. The purchase cost of corporate bonds may include a purchase price premium or discount which will be amortized or accreted against earned interest income to the maturity date of the bond. Our investments are classified as current in the Company’s Consolidated Balance Sheet as they may be sold within one year in response to changes in market prices or interest rates, to realign our investment concentrations or to meet our working capital needs. | ||||||||||||||
The following tables provide a summary of the fair value and unrealized gains (losses) related to our available-for-sale securities (in millions): | ||||||||||||||
June 30, 2014 | ||||||||||||||
(in millions) | ||||||||||||||
Cost | Gross | Gross | Fair | |||||||||||
Unrealized | Unrealized | Value | ||||||||||||
Gains | Losses | |||||||||||||
Available-for-sale: | ||||||||||||||
Corporate bonds | $ | 9.3 | $ | 0.1 | $ | - | $ | 9.4 | ||||||
Exchange-traded funds | 4.4 | - | - | 4.4 | ||||||||||
Total - Current | $ | 13.7 | $ | 0.1 | $ | - | $ | 13.8 | ||||||
December 31, 2013 | ||||||||||||||
(in millions) | ||||||||||||||
Cost | Gross | Gross | Fair | |||||||||||
Unrealized | Unrealized | Value | ||||||||||||
Gains | Losses | |||||||||||||
Available-for-sale: | ||||||||||||||
Corporate bonds | $ | 9.9 | $ | - | $ | - | $ | 9.9 | ||||||
Exchange-traded funds | 3.8 | - | - | 3.8 | ||||||||||
Total - Current | $ | 13.7 | $ | - | $ | - | $ | 13.7 | ||||||
Fair Value Measurement | ||||||||||||||
Fair value is the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants. Fair values determined based on Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities. Fair values determined based on Level 2 inputs utilize observable quoted prices for similar assets and liabilities in active markets and observable quoted prices for identical or similar assets in markets that are not very active. Fair values determined based on Level 3 inputs utilize unobservable inputs and include valuations of assets or liabilities for which there is little, if any, market activity. A financial asset or liability’s classification within the above hierarchy is determined based on the lowest level input that is significant to the fair value measurement. | ||||||||||||||
Our assets measured at fair value or disclosed at fair value on a recurring basis as at June 30, 2014 and December 31, 2013 consisted of the following (in millions): | ||||||||||||||
June 30, 2014 | ||||||||||||||
(in millions) | ||||||||||||||
Total | Level 1 | Level 2 | Level 3 | |||||||||||
Assets: | ||||||||||||||
Corporate bonds | $ | 9.4 | $ | 9.4 | $ | - | $ | - | ||||||
Exchange-traded funds | 4.4 | 4.4 | - | - | ||||||||||
Total | $ | 13.8 | $ | 13.8 | $ | - | $ | - | ||||||
December 31, 2013 | ||||||||||||||
(in millions) | ||||||||||||||
Total | Level 1 | Level 2 | Level 3 | |||||||||||
Assets: | ||||||||||||||
Corporate bonds | $ | 9.9 | $ | 9.9 | $ | - | $ | - | ||||||
Exchange-traded funds | 3.8 | 3.8 | - | - | ||||||||||
Total | $ | 13.7 | $ | 13.7 | $ | - | $ | - | ||||||
Accumulated Other Comprehensive Income (Loss) | ||||||||||||||
Unrealized gains or losses on marketable securities are recorded in accumulated other comprehensive income (loss). Accumulated other comprehensive income (loss) at June 30, 2014 consisted of unrealized gains on securities of $69 thousand. Accumulated other comprehensive income (loss) at December 31, 2013 consisted of unrealized gains on securities of $19 thousand. | ||||||||||||||
Comprehensive Income (Loss) | ||||||||||||||
Comprehensive income (loss) includes all changes in equity during a period except those that resulted from investments by or distributions to our stockholders. Other comprehensive income (loss) refers to revenues, expenses, gains and losses that, under GAAP, are included in comprehensive income (loss), but excluded from net income (loss) as these amounts are recorded directly as an adjustment to stockholders’ equity. Our other comprehensive income (loss) is composed of unrealized gains (losses) on certain holdings of marketable securities, net of any realized gains (losses) included in net income (loss). | ||||||||||||||
INVENTORIES
INVENTORIES | 6 Months Ended | |||||||
Jun. 30, 2014 | ||||||||
Inventory Disclosure [Abstract] | ' | |||||||
Inventory Disclosure | ' | |||||||
NOTE 6 – INVENTORIES | ||||||||
Inventories consist of both raw and packaging materials on our Aversion Oxycodone product and finished goods held for distribution and sale on our Nexafed product. 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. Our inventory reserve activity during the six months ended June 30, 2014 was to record a $0.2 million reserve expense and actual Nexafed inventory write-offs of $0.45 million. | ||||||||
The related cost of sales on deferred revenue of $0.3 million from Nexafed shipments is excluded from the value of the June 30, 2014 inventories and is reported in our balance sheet in the other current deferred assets account. We will recognize 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 product returns. | ||||||||
Our purchases of ingredients and other materials required in our development and clinical trial activities are expensed as incurred. | ||||||||
Inventories are summarized as follows: | ||||||||
June 30, | December 31, | |||||||
2014 | 2013 | |||||||
(in thousands) | ||||||||
Raw and packaging materials | $ | 260 | $ | - | ||||
Finished goods | 185 | 501 | ||||||
445 | 501 | |||||||
Less: inventory reserve for finished goods | (-) | -250 | ||||||
Total | $ | 445 | $ | 251 | ||||
ACCRUED_EXPENSES
ACCRUED EXPENSES | 6 Months Ended | |||||||
Jun. 30, 2014 | ||||||||
Payables and Accruals [Abstract] | ' | |||||||
ACCRUED EXPENSES | ' | |||||||
NOTE 7 - ACCRUED EXPENSES | ||||||||
Accrued expenses are summarized as follows: | ||||||||
June 30, | December 31, | |||||||
2014 | 2013 | |||||||
(in thousands) | ||||||||
Payroll, payroll taxes, bonus and benefits | $ | 219 | $ | 78 | ||||
Professional services | 214 | 293 | ||||||
Interest - current | 162 | - | ||||||
Franchise taxes | 8 | 1 | ||||||
Property taxes | 15 | 15 | ||||||
Contract manufacturing services | - | 14 | ||||||
Clinical and regulatory services | 175 | - | ||||||
Other | 651 | 140 | ||||||
Total | $ | 1,444 | $ | 541 | ||||
DEBT
DEBT | 6 Months Ended | |||||||||||||
Jun. 30, 2014 | ||||||||||||||
Debt Disclosure [Abstract] | ' | |||||||||||||
DEBT | ' | |||||||||||||
NOTE 8 – 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 us 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 may use the proceeds of the Loan Agreement for general working capital and to fund our business requirements. We estimate the fair value of our notes payable to be its carrying value due to its recent funding. | ||||||||||||||
The Term Loan accrues interest at a fixed rate of 8.35% per annum (with a default rate of 13.35% per annum). We are required to make monthly interest-only payments until the Amortization Date and starting on the Amortization Date, we are required to make payments of principal and accrued interest in equal monthly installments sufficient to amortize the Term Loan through the maturity date of December 1, 2018. The “Amortization Date” is April 1, 2015, but shall automatically become April 1, 2016 if we achieve 75% of our projected Nexafed cash receipts and 75% of our projected Aversion Oxycodone cash receipts for the fiscal year ending December 31, 2014 (collectively, the “First Revenue Event”). The Amortization Date will be further deferred until April 1, 2017 if the First Revenue Event occurs and in addition we achieve 75% of our projected Nexafed cash receipts and 75% of our projected Aversion Oxycodone cash receipts for the fiscal year ending December 31, 2015 (collectively, the “Second Revenue Event”). In view of the termination of the Pfizer Agreement in April 2014 and the return of Aversion Oxycodone to us, and the absence of sales of Aversion Oxycodone since such date pending the completion of a license agreement with another pharmaceutical company for the manufacture and sale of Aversion Oxycodone, we expect the Amortization Date of the Term Loan with Oxford will be April 1, 2015, at which date we will commence repayment of principal under the Term Loan. 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 our obligations under the Loan Agreement, we granted Lender a security interest in substantially all of our existing and after-acquired assets, exclusive of our intellectual property assets. Pursuant to the Loan Agreement, we are not allowed to pledge our intellectual property assets to others. | ||||||||||||||
We may voluntarily prepay the Term Loan in full, but not in part, and any prepayment is subject to a prepayment premium equal to 3% of the principal prepaid if prepaid on or prior to December 27, 2014, 2% of the principal prepaid, if prepaid after December 27, 2014 but on or 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 we must pay the Lender an additional one-time interest payment of (A) $795 thousand if the First Revenue Event does not occur, (B) $895 thousand if the First Revenue Event occurs but the Second Revenue Event does not occur, or (C) $995 thousand if both the First Revenue Event and the Second Revenue Event occur. 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 interest rate. | ||||||||||||||
We were 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 our own expenses and a $100 thousand consulting placement fee, we incurred $231 thousand in deferred debt issue costs. We will amortize those costs to non-operating 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 our 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 our 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. | ||||||||||||||
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 will amortize those costs 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. | ||||||||||||||
Our interest expense consisted of the following: | ||||||||||||||
Three months Ended | Six months Ended | |||||||||||||
June 30, | June 30, | |||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||
(in thousands) | ||||||||||||||
Interest expense: | ||||||||||||||
Secured Promissory notes | $ | 255 | $ | - | $ | 510 | $ | - | ||||||
Debt discount | 30 | - | 59 | - | ||||||||||
Debt issue costs | 17 | - | 34 | - | ||||||||||
Total interest expense | $ | 302 | $ | - | $ | 603 | $ | - | ||||||
The annual principal payments on the long-term debt at June 30, 2014 are as follows for each of the periods ending December 31: | ||||||||||||||
Annual | ||||||||||||||
Principal Payments | ||||||||||||||
(in thousands) | ||||||||||||||
2014 | $ | - | ||||||||||||
2015 | 1,758 | |||||||||||||
2016 | 2,522 | |||||||||||||
2017 | 2,741 | |||||||||||||
2018 | 2,979 | |||||||||||||
Thereafter | - | |||||||||||||
Total | $ | 10,000 | ||||||||||||
COMMON_STOCK_WARRANTS
COMMON STOCK WARRANTS | 6 Months Ended |
Jun. 30, 2014 | |
Stockholders Equity Note [Abstract] | ' |
COMMON STOCK WARRANTS | ' |
NOTE 9 - COMMON STOCK WARRANTS | |
We have common stock purchase warrants (“warrants”) exercisable for 1.9 million shares of our common stock with an exercise price of $3.40 per share and an expiration date in August 2014. In connection with the issuance of the $10.0 million secured promissory notes in December 2013, we issued warrants to acquire approximately 298 thousand shares of our common stock having an exercise price of $1.595 per share with an expiration date in December 2020. At June 30, 2014, we have total outstanding warrants exercisable for 2.2 million shares of our common stock having a weighted average exercise price of $3.15 per share. All of these warrants contain a cashless exercise feature. | |
SHAREBASED_COMPENSATION
SHARE-BASED COMPENSATION | 6 Months Ended | |||||||||||||
Jun. 30, 2014 | ||||||||||||||
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ' | |||||||||||||
SHARE-BASED COMPENSATION | ' | |||||||||||||
NOTE 10 - 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 | Six months Ended | |||||||||||||
June 30, | June 30, | |||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||
(in thousands) | ||||||||||||||
Stock options | ||||||||||||||
Research and development | $ | 56 | $ | 81 | $ | 113 | $ | 162 | ||||||
General and administrative | 141 | 234 | 282 | 468 | ||||||||||
Total | $ | 197 | $ | 315 | $ | 395 | $ | 630 | ||||||
RSUs | ||||||||||||||
General and administrative | $ | 92 | $ | - | $ | 92 | $ | - | ||||||
Combined | $ | 289 | $ | 315 | $ | 487 | $ | 630 | ||||||
Stock Option Award Plans | ||||||||||||||
We have one stock option plan in effect, and one stock option plan has expired by its terms, but pursuant to which stock options have been granted and remain outstanding. Our stock option award activity during the six months ended June 30, 2014 and 2013 is shown below: | ||||||||||||||
Six months Ended | ||||||||||||||
June 30, | ||||||||||||||
2014 | 2013 | |||||||||||||
Number | Weighted | Number | Weighted | |||||||||||
of | Average | of | Average | |||||||||||
Options | Exercise | Options | Exercise | |||||||||||
(000’s) | Price | (000’s) | Price | |||||||||||
Outstanding, beginning | 3,738 | $ | 4.99 | 3,296 | $ | 5.5 | ||||||||
Granted | - | - | 75 | 2.32 | ||||||||||
Exercised | -31 | 1.3 | -14 | 1.3 | ||||||||||
Forfeited or expired | - | - | -15 | 2.32 | ||||||||||
Outstanding, ending | 3,707 | $ | 5.02 | 3,342 | $ | 5.46 | ||||||||
Options exercisable | 3,295 | $ | 5.42 | 2,970 | $ | 5.8 | ||||||||
There were no stock option grants during the six month period ended June 30, 2014. The assumptions used in the Black-Scholes model to determine fair value for the stock option awards granted during the comparable period are shown below: | ||||||||||||||
Six months Ended June 30, 2013 | ||||||||||||||
Expected dividend yield | 0 | % | ||||||||||||
Risk-free interest rates | 1.86 | % | ||||||||||||
Average expected volatility | 114 | % | ||||||||||||
Expected term (years) | 10 | |||||||||||||
Weighted average grant date fair value | $ | 2.17 | ||||||||||||
During the six months ended June 30, 2014, 31 thousand NonISOs were exercised by our employees. Our employees elected to have 18 thousand shares withheld in satisfaction of $36 thousand for both the exercise costs and withholding tax obligations resulting in the net issuance of 13 thousand shares of common stock to them. During the six months ended June 30, 2013, 14 thousand NonISOs were exercised by our employees. Our employees elected to have 4 thousand shares withheld in satisfaction of $14 thousand for both the exercise costs and the withholding tax obligations resulting in the net issuance of 10 thousand common shares to them. | ||||||||||||||
Restricted Stock Unit Award Plan | ||||||||||||||
We have two Restricted Stock Unit Award Plans for our employees and non-employee directors. 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. | ||||||||||||||
Under our 2005 Restricted Stock Unit Award Plan (the “2005 RSU Plan”), one-fourth of vested shares of common stock underlying an RSU award were distributed (after payment of $0.01 par value per share) on January 1 of each of 2011 thru 2014. Effective January 1, 2014, all RSUs granted under the 2005 RSU Plan had been distributed. The distribution dates of January 1, 2013 and 2014 each consisting of 0.83 million shares and occurred as follows: | ||||||||||||||
· | On January 1, 2013, 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 $0.7 million withholding tax obligations; and | |||||||||||||
· | 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. | |||||||||||||
Our 2014 Restricted Stock Unit Award Plan (the “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. On May 1, 2014, we awarded 36,764 RSUs to each of our 4 non-employee directors. Such RSU awards vest 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 not material at June 30, 2014. Accordingly the vested portion of the awards containing the cash settlement feature will be 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. A summary of the grants under the 2005 RSU Plan and the 2014 RSU Plan as of June 30, 2014 and 2013 and for the six months then ended consisted of the following (in thousands): | ||||||||||||||
Six months Ended | ||||||||||||||
June 30, | ||||||||||||||
2014 | 2013 | |||||||||||||
Number | Number | Number | Number | |||||||||||
of RSUs | of Vested | of RSUs | of Vested | |||||||||||
RSUs | RSUs | |||||||||||||
(in thousands) | ||||||||||||||
Outstanding, beginning | 829 | 829 | 1,658 | 1,658 | ||||||||||
Granted | 147 | - | - | - | ||||||||||
Distributed | -829 | -829 | -829 | -829 | ||||||||||
Vested | - | 74 | - | - | ||||||||||
Forfeited or expired | - | - | - | - | ||||||||||
Outstanding, ending | 147 | 74 | 829 | 829 | ||||||||||
INCOME_TAXES
INCOME TAXES | 6 Months Ended |
Jun. 30, 2014 | |
Income Tax Disclosure [Abstract] | ' |
INCOME TAXES | ' |
NOTE 11 – INCOME TAXES | |
We account for income taxes under the liability method. Under this method, deferred income tax assets and liabilities are determined based on differences between financial reporting and income tax basis of assets and liabilities and are accounted for using the enacted income tax rates and laws that will be in effect when the differences are expected to reverse. Additionally, net operating loss and tax credit carryforwards are reported as deferred income tax assets. The realization of deferred income tax assets is dependent upon future earnings. A valuation allowance is required against deferred income tax assets if, based on the weight of available evidence, it is more likely than not that some or all of the deferred income tax assets may not be realized. At both June 30, 2014 and December 31, 2013, 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 $46.8 million federal income tax benefits at December 31, 2013 derived from $137.6 million Federal NOLs at the U.S. statutory tax rate of 34% and $2.8 million state NOLs, available to offset future taxable income, some of which have limitations for use as prescribed under IRC Section 382. Our NOL carryforwards will expire in varying amounts between 2014 and 2033 if not used, and those expirations will cause fluctuations in our valuation allowances. As of June 30, 2014 we had federal research and development tax credits of approximately $1.1 million, which expire in the years 2024 through 2033, and we had approximately $0.4 million of Indiana state research and development tax credits, which expire in the years 2014 through 2017. | |
EARNINGS_PER_SHARE_EPS
EARNINGS PER SHARE ("EPS") | 6 Months Ended | |||||||||||||
Jun. 30, 2014 | ||||||||||||||
Earnings Per Share [Abstract] | ' | |||||||||||||
EARNINGS PER SHARE ("EPS") | ' | |||||||||||||
NOTE 12 – EARNINGS PER SHARE (“EPS”) | ||||||||||||||
Basic EPS is computed by dividing net income or loss by the weighted average common shares outstanding during a period, including shares weighted related to vested RSUs. (See Note 10). 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 or 2013 as the Company reported a net loss for the three and six month periods, and including the effects of common stock equivalents in the diluted EPS calculation which would have been antidilutive. | ||||||||||||||
A reconciliation of the numerators and denominators of basic and diluted EPS consisted of the following: | ||||||||||||||
Three months Ended | Six months Ended | |||||||||||||
June 30, | June 30, | |||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||
EPS – basic and diluted | ||||||||||||||
Numerator: net loss | $ | -3,521 | $ | -3,076 | $ | -7,609 | $ | -7,294 | ||||||
Denominator: | ||||||||||||||
Common shares | 48,848 | 46,399 | 48,846 | 46,386 | ||||||||||
Vested RSUs | - | 829 | - | 829 | ||||||||||
Basic and diluted weighted average shares outstanding | 48,848 | 47,228 | 48,846 | 47,215 | ||||||||||
EPS – basic and diluted | $ | -0.07 | $ | -0.07 | $ | -0.16 | $ | -0.16 | ||||||
Excluded securities: | ||||||||||||||
Common shares issuable: | ||||||||||||||
Stock options | 3,707 | 3,342 | 3,707 | 3,342 | ||||||||||
Nonvested RSUs | 73 | - | 73 | - | ||||||||||
Common stock warrants | 2,154 | 1,856 | 2,154 | 1,856 | ||||||||||
Total excluded common shares | 5,934 | 5,198 | 5,934 | 5,198 | ||||||||||
COMMITMENTS_AND_CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 6 Months Ended |
Jun. 30, 2014 | |
Commitments and Contingencies Disclosure [Abstract] | ' |
COMMITMENTS AND CONTINGENCIES | ' |
NOTE 13 – COMMITMENTS AND CONTINGENCIES | |
Facility Lease | |
The Company leases administrative office space in Palatine, Illinois under a lease expiring March 31, 2015 for approximately $25 thousand annually. | |
Reglan®/Metoclopramide Litigation | |
Halsey Drug Company, as predecessor to us, has been named along with numerous other companies as a defendant in cases filed in three separate state coordinated litigations pending in Pennsylvania, New Jersey and California, respectively captioned In re: Reglan®/Metoclopramide Mass Tort Litigation, Philadelphia County Court of Common Pleas, January Term, 2010, No. 01997; In re: Reglan Litigation, Superior Court of New Jersey, Law Division, Atlantic County, Case No. 289, Master Docket No. ATL-L-3865-10; and Reglan/Metoclopramide Cases, Superior Court of California, San Francisco County, Judicial Council Coordination Proceeding No. 4631, Superior Court No.: CJC-10-004631. In addition, Acura was served with a similar complaint by two individual plaintiffs in Nebraska federal court. 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 89 pending cases against us, with more than 445 individual plaintiffs. | |
In the lawsuits filed to date, plaintiffs have not confirmed they ingested any of the generic metoclopramide manufactured by us. We discontinued manufacture and distribution of generic metoclopramide more than 18 years ago. In addition, we believe the June 23, 2011 decision by the U.S. Supreme Court in PLIVA v. Mensing (“Mensing decision”) holding that state tort law failure to warn claims against generic drug companies are pre-empted by the 1984 Hatch-Waxman Act Amendments and federal drug regulations will assist us in favorably resolving these cases. We have consistently maintained the position that these claims are without merit and intend to vigorously defend these actions. | |
In New Jersey, Generic Defendants, including Acura, filed dispositive motions based on the Mensing decision, which the Court granted with a limited exception. In June 2012, the New Jersey trial court dismissed Acura with prejudice. In Pennsylvania, and California, Generic Defendants, including Acura, also filed dispositive motions based on the Mensing decision. | |
In Pennsylvania, on November 18, 2011, trial court denied Generic Defendants’ dispositive motion. In December 2011, the Generic Defendants appealed this ruling. On April 13, 2012, all trial court proceedings were stayed pending decisions by the Pennsylvania appellate courts. An adverse decision by the Pennsylvania Superior Court was issued in July 2013. Further appeal proceedings are pending and a decision is expected later this year. This appeal process eventually could result in dismissal of all of the Philadelphia cases against all generic defendants including Acura, although there can be no assurance in this regard. Legal fees related to this matter are currently covered by our insurance carrier. | |
In California, the trial court 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.” Nonetheless, plaintiffs have not confirmed they ingested any of the generic metoclopramide manufactured by us. Therefore, we expect the number of plaintiffs with possible claims to be reduced voluntarily or by motion practice. Action will be taken in an effort to dismiss Acura from these cases, although there can be no assurance in this regard. Legal fees related to this matter are currently covered by our insurance carrier. | |
In Nebraska, the litigation against Acura has been stayed and plaintiffs have agreed to a final dismissal if there is no evidence of ingestion of generic metoclopramide manufactured by us. Legal fees related to this matter are currently covered by our insurance carrier. | |
As any potential loss is neither probable nor estimable, we have not accrued for any potential loss related to these matters as of June 30, 2014 and we are presently unable to determine if any potential loss would be covered by our insurance carrier. | |
Westport/Highland Complaint | |
On April 21, 2014, we obtained a copy of a Complaint filed by Westport Pharmaceuticals, LLC (“Westport”) and Highland Pharmaceuticals, LLC (“Highland”) in the U.S. District Court for the Eastern District of Missouri naming us as the defendant. To date, we have not been formally served with this Complaint. In the Complaint, each of Westport and Highland are commencing a declaratory judgment action seeking a declaration of non-infringement of our U.S. Patent No. 8,409,616 (“616 Patent”) by Westport’s Zephrex-D® (pseudoephedrine hydrochloride, 30mg) product, to enable Westport to continue to sell Zephrex-D and to allow retail distributors to continue to sell Zephrex-D , a competing product to Nexafed. We intend to vigorously defend our Company’s intellectual property. | |
Financial Advisor Agreement | |
In connection with our August 2007 Unit Offering, we are obligated to pay a fee to our then financial advisor upon each exercise of the warrants issued in the Unit Offering, in proportion to the number of warrants exercised. The amount of the fee assuming 100% exercise of the remaining 1.9 million warrants is $0.38 million. The expiration date of these warrants is in August 2014. We have not reflected this obligation as a liability in our consolidated financial statements as the payment is contingent upon the timing and exercise of the warrants by each of the warrant holders. Such fee, if any, will be paid to the financial advisor and be offset against the equity proceeds as the warrants are exercised. | |
INVESTMENTS_IN_MARKETABLE_SECU1
INVESTMENTS IN MARKETABLE SECURITIES (Tables) | 6 Months Ended | |||||||||||||
Jun. 30, 2014 | ||||||||||||||
Investments, Debt and Equity Securities [Abstract] | ' | |||||||||||||
Marketable securities | ' | |||||||||||||
Investments in marketable securities consisted of the following: | ||||||||||||||
June 30, 2014 | December 31, 2013 | |||||||||||||
(in millions) | (in millions) | |||||||||||||
Marketable securities: | ||||||||||||||
Corporate bonds — maturing within 1 year | $ | 3.3 | $ | 3.1 | ||||||||||
Corporate bonds — maturing after 1 through 4 years | 6.1 | 6.8 | ||||||||||||
Exchange-traded funds | 4.4 | 3.8 | ||||||||||||
Total marketable securities | $ | 13.8 | $ | 13.7 | ||||||||||
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 our available-for-sale securities (in millions): | ||||||||||||||
June 30, 2014 | ||||||||||||||
(in millions) | ||||||||||||||
Cost | Gross | Gross | Fair | |||||||||||
Unrealized | Unrealized | Value | ||||||||||||
Gains | Losses | |||||||||||||
Available-for-sale: | ||||||||||||||
Corporate bonds | $ | 9.3 | $ | 0.1 | $ | - | $ | 9.4 | ||||||
Exchange-traded funds | 4.4 | - | - | 4.4 | ||||||||||
Total - Current | $ | 13.7 | $ | 0.1 | $ | - | $ | 13.8 | ||||||
December 31, 2013 | ||||||||||||||
(in millions) | ||||||||||||||
Cost | Gross | Gross | Fair | |||||||||||
Unrealized | Unrealized | Value | ||||||||||||
Gains | Losses | |||||||||||||
Available-for-sale: | ||||||||||||||
Corporate bonds | $ | 9.9 | $ | - | $ | - | $ | 9.9 | ||||||
Exchange-traded funds | 3.8 | - | - | 3.8 | ||||||||||
Total - Current | $ | 13.7 | $ | - | $ | - | $ | 13.7 | ||||||
Fair Value, Assets Measured on Recurring Basis | ' | |||||||||||||
Our assets measured at fair value or disclosed at fair value on a recurring basis as at June 30, 2014 and December 31, 2013 consisted of the following (in millions): | ||||||||||||||
June 30, 2014 | ||||||||||||||
(in millions) | ||||||||||||||
Total | Level 1 | Level 2 | Level 3 | |||||||||||
Assets: | ||||||||||||||
Corporate bonds | $ | 9.4 | $ | 9.4 | $ | - | $ | - | ||||||
Exchange-traded funds | 4.4 | 4.4 | - | - | ||||||||||
Total | $ | 13.8 | $ | 13.8 | $ | - | $ | - | ||||||
December 31, 2013 | ||||||||||||||
(in millions) | ||||||||||||||
Total | Level 1 | Level 2 | Level 3 | |||||||||||
Assets: | ||||||||||||||
Corporate bonds | $ | 9.9 | $ | 9.9 | $ | - | $ | - | ||||||
Exchange-traded funds | 3.8 | 3.8 | - | - | ||||||||||
Total | $ | 13.7 | $ | 13.7 | $ | - | $ | - | ||||||
INVENTORIES_Tables
INVENTORIES (Tables) | 6 Months Ended | |||||||
Jun. 30, 2014 | ||||||||
Inventory Disclosure [Abstract] | ' | |||||||
INVENTORIES | ' | |||||||
Inventories are summarized as follows: | ||||||||
June 30, | December 31, | |||||||
2014 | 2013 | |||||||
(in thousands) | ||||||||
Raw and packaging materials | $ | 260 | $ | - | ||||
Finished goods | 185 | 501 | ||||||
445 | 501 | |||||||
Less: inventory reserve for finished goods | (-) | -250 | ||||||
Total | $ | 445 | $ | 251 | ||||
ACCRUED_EXPENSES_Tables
ACCRUED EXPENSES (Tables) | 6 Months Ended | |||||||
Jun. 30, 2014 | ||||||||
Payables and Accruals [Abstract] | ' | |||||||
ACCRUED EXPENSES | ' | |||||||
Accrued expenses are summarized as follows: | ||||||||
June 30, | December 31, | |||||||
2014 | 2013 | |||||||
(in thousands) | ||||||||
Payroll, payroll taxes, bonus and benefits | $ | 219 | $ | 78 | ||||
Professional services | 214 | 293 | ||||||
Interest - current | 162 | - | ||||||
Franchise taxes | 8 | 1 | ||||||
Property taxes | 15 | 15 | ||||||
Contract manufacturing services | - | 14 | ||||||
Clinical and regulatory services | 175 | - | ||||||
Other | 651 | 140 | ||||||
Total | $ | 1,444 | $ | 541 | ||||
DEBT_Tables
DEBT (Tables) | 6 Months Ended | |||||||||||||
Jun. 30, 2014 | ||||||||||||||
Debt Disclosure [Abstract] | ' | |||||||||||||
Schedule of Interest Expense | ' | |||||||||||||
Our interest expense consisted of the following: | ||||||||||||||
Three months Ended | Six months Ended | |||||||||||||
June 30, | June 30, | |||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||
(in thousands) | ||||||||||||||
Interest expense: | ||||||||||||||
Secured Promissory notes | $ | 255 | $ | - | $ | 510 | $ | - | ||||||
Debt discount | 30 | - | 59 | - | ||||||||||
Debt issue costs | 17 | - | 34 | - | ||||||||||
Total interest expense | $ | 302 | $ | - | $ | 603 | $ | - | ||||||
Schedule Of Long Term Debt Future Principal Payments Year | ' | |||||||||||||
The annual principal payments on the long-term debt at June 30, 2014 are as follows for each of the periods ending December 31: | ||||||||||||||
Annual | ||||||||||||||
Principal Payments | ||||||||||||||
(in thousands) | ||||||||||||||
2014 | $ | - | ||||||||||||
2015 | 1,758 | |||||||||||||
2016 | 2,522 | |||||||||||||
2017 | 2,741 | |||||||||||||
2018 | 2,979 | |||||||||||||
Thereafter | - | |||||||||||||
Total | $ | 10,000 | ||||||||||||
SHAREBASED_COMPENSATION_Tables
SHARE-BASED COMPENSATION (Tables) | 6 Months Ended | |||||||||||||
Jun. 30, 2014 | ||||||||||||||
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ' | |||||||||||||
Share-Based Compensation Expense Recognized | ' | |||||||||||||
Our share-based compensation expense recognized in the Company’s results of operations comprised the following: | ||||||||||||||
Three months Ended | Six months Ended | |||||||||||||
June 30, | June 30, | |||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||
(in thousands) | ||||||||||||||
Stock options | ||||||||||||||
Research and development | $ | 56 | $ | 81 | $ | 113 | $ | 162 | ||||||
General and administrative | 141 | 234 | 282 | 468 | ||||||||||
Total | $ | 197 | $ | 315 | $ | 395 | $ | 630 | ||||||
RSUs | ||||||||||||||
General and administrative | $ | 92 | $ | - | $ | 92 | $ | - | ||||||
Combined | $ | 289 | $ | 315 | $ | 487 | $ | 630 | ||||||
Schedule of Share-based Compensation, Stock Options, Activity | ' | |||||||||||||
Our stock option award activity during the six months ended June 30, 2014 and 2013 is shown below: | ||||||||||||||
Six months Ended | ||||||||||||||
June 30, | ||||||||||||||
2014 | 2013 | |||||||||||||
Number | Weighted | Number | Weighted | |||||||||||
of | Average | of | Average | |||||||||||
Options | Exercise | Options | Exercise | |||||||||||
(000’s) | Price | (000’s) | Price | |||||||||||
Outstanding, beginning | 3,738 | $ | 4.99 | 3,296 | $ | 5.5 | ||||||||
Granted | - | - | 75 | 2.32 | ||||||||||
Exercised | -31 | 1.3 | -14 | 1.3 | ||||||||||
Forfeited or expired | - | - | -15 | 2.32 | ||||||||||
Outstanding, ending | 3,707 | $ | 5.02 | 3,342 | $ | 5.46 | ||||||||
Options exercisable | 3,295 | $ | 5.42 | 2,970 | $ | 5.8 | ||||||||
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions | ' | |||||||||||||
The assumptions used in the Black-Scholes model to determine fair value for the stock option awards granted during the comparable period are shown below: | ||||||||||||||
Six months Ended June 30, 2013 | ||||||||||||||
Expected dividend yield | 0 | % | ||||||||||||
Risk-free interest rates | 1.86 | % | ||||||||||||
Average expected volatility | 114 | % | ||||||||||||
Expected term (years) | 10 | |||||||||||||
Weighted average grant date fair value | $ | 2.17 | ||||||||||||
Schedule of Share-based Compensation, Restricted Stock Units Award Activity | ' | |||||||||||||
A summary of the grants under the 2005 RSU Plan and the 2014 RSU Plan as of June 30, 2014 and 2013 and for the six months then ended consisted of the following (in thousands): | ||||||||||||||
Six months Ended | ||||||||||||||
June 30, | ||||||||||||||
2014 | 2013 | |||||||||||||
Number | Number | Number | Number | |||||||||||
of RSUs | of Vested | of RSUs | of Vested | |||||||||||
RSUs | RSUs | |||||||||||||
(in thousands) | ||||||||||||||
Outstanding, beginning | 829 | 829 | 1,658 | 1,658 | ||||||||||
Granted | 147 | - | - | - | ||||||||||
Distributed | -829 | -829 | -829 | -829 | ||||||||||
Vested | - | 74 | - | - | ||||||||||
Forfeited or expired | - | - | - | - | ||||||||||
Outstanding, ending | 147 | 74 | 829 | 829 | ||||||||||
EARNINGS_PER_SHARE_EPS_Tables
EARNINGS PER SHARE ("EPS") (Tables) | 6 Months Ended | |||||||||||||
Jun. 30, 2014 | ||||||||||||||
Earnings Per Share [Abstract] | ' | |||||||||||||
Reconciliation of Numerators and Denominators of Basic and Diluted EPS | ' | |||||||||||||
A reconciliation of the numerators and denominators of basic and diluted EPS consisted of the following: | ||||||||||||||
Three months Ended | Six months Ended | |||||||||||||
June 30, | June 30, | |||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||
EPS – basic and diluted | ||||||||||||||
Numerator: net loss | $ | -3,521 | $ | -3,076 | $ | -7,609 | $ | -7,294 | ||||||
Denominator: | ||||||||||||||
Common shares | 48,848 | 46,399 | 48,846 | 46,386 | ||||||||||
Vested RSUs | - | 829 | - | 829 | ||||||||||
Basic and diluted weighted average shares outstanding | 48,848 | 47,228 | 48,846 | 47,215 | ||||||||||
EPS – basic and diluted | $ | -0.07 | $ | -0.07 | $ | -0.16 | $ | -0.16 | ||||||
Excluded securities: | ||||||||||||||
Common shares issuable: | ||||||||||||||
Stock options | 3,707 | 3,342 | 3,707 | 3,342 | ||||||||||
Nonvested RSUs | 73 | - | 73 | - | ||||||||||
Common stock warrants | 2,154 | 1,856 | 2,154 | 1,856 | ||||||||||
Total excluded common shares | 5,934 | 5,198 | 5,934 | 5,198 | ||||||||||
Recovered_Sheet1
License Development and Commercialization Agreement - Additional Information (Detail) (USD $) | 6 Months Ended |
In Millions, unless otherwise specified | Jun. 30, 2014 |
License Development and Commercialization Agreement [Line Items] | ' |
Percentage of royalty | 5.00% |
Payment for Termination | $2 |
Pfizer Agreement [Member] | ' |
License Development and Commercialization Agreement [Line Items] | ' |
Payment for Termination | $2 |
Minimum | ' |
License Development and Commercialization Agreement [Line Items] | ' |
Patents expiration year | '2023 |
Minimum | Settlement Agreement With Par [Member] | ' |
License Development and Commercialization Agreement [Line Items] | ' |
Percentage of royalty | 10.00% |
Maximum | ' |
License Development and Commercialization Agreement [Line Items] | ' |
Patents expiration year | '2025 |
Maximum | Settlement Agreement With Par [Member] | ' |
License Development and Commercialization Agreement [Line Items] | ' |
Percentage of royalty | 15.00% |
Revenue_Recognition_Additional
Revenue Recognition - Additional Information (Detail) (USD $) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ' | ' | ' | ' |
Deferred Revenue, Current | $300,000 | ' | $300,000 | ' |
Royalty Revenue, Total | $1,000 | $1,000 | $4,000 | $5,000 |
Recovered_Sheet2
Research and Development Activities - Additional Information (Detail) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Millions, unless otherwise specified | ||
Research and Development Assets Acquired Other than Through Business Combination [Line Items] | ' | ' |
Accrued research and development expense current | $0.10 | $0 |
Prepaid research and development expense current | $0 | $0.36 |
Recovered_Sheet3
Investments In Marketable Securities - Additional Information (Detail) (USD $) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
In Thousands, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | Dec. 31, 2013 |
Investment In Marketable Securities [Line Items] | ' | ' | ' | ' | ' |
Unrealized gains on securities | $21 | ($131) | $50 | ($79) | $19 |
Summary_of_Investments_in_Mark
Summary of Investments in Marketable Securities (Detail) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Millions, unless otherwise specified | ||
Marketable securities: | ' | ' |
Corporate bonds — maturing within 1 year | $3.30 | $3.10 |
Corporate bonds — maturing after 1 through 4 years | 6.1 | 6.8 |
Total marketable securities | 13.8 | 13.7 |
Exchange-traded funds | ' | ' |
Marketable securities: | ' | ' |
Total marketable securities | $4.40 | $3.80 |
Available_for_Sale_Securities_
Available for Sale Securities Continuous Unrealized Loss Position Fair Value (Detail) (USD $) | 6 Months Ended | 12 Months Ended |
In Millions, unless otherwise specified | Jun. 30, 2014 | Dec. 31, 2013 |
Available For Sale Securities Continuous Unrealized Loss Position Fair Value [Line Items] | ' | ' |
Cost | $13.70 | $13.70 |
Gross Unrealized Gains | 0.1 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 13.8 | 13.7 |
Corporate Bonds | ' | ' |
Available For Sale Securities Continuous Unrealized Loss Position Fair Value [Line Items] | ' | ' |
Cost | 9.3 | 9.9 |
Gross Unrealized Gains | 0.1 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 9.4 | 9.9 |
Exchange-traded funds | ' | ' |
Available For Sale Securities Continuous Unrealized Loss Position Fair Value [Line Items] | ' | ' |
Cost | 4.4 | 3.8 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | $4.40 | $3.80 |
Assets_Measured_at_Fair_Value_
Assets Measured at Fair Value or Disclosed at Fair Value on Recurring Basis (Detail) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Millions, unless otherwise specified | ||
Assets | ' | ' |
Total marketable securities | $13.80 | $13.70 |
Corporate bonds | ' | ' |
Assets | ' | ' |
Total marketable securities | 9.4 | 9.9 |
Exchange-traded funds | ' | ' |
Assets | ' | ' |
Total marketable securities | 4.4 | 3.8 |
Fair Value, Inputs, Level 1 | ' | ' |
Assets | ' | ' |
Total marketable securities | 13.8 | 13.7 |
Fair Value, Inputs, Level 1 | Corporate bonds | ' | ' |
Assets | ' | ' |
Total marketable securities | 9.4 | 9.9 |
Fair Value, Inputs, Level 1 | Exchange-traded funds | ' | ' |
Assets | ' | ' |
Total marketable securities | 4.4 | 3.8 |
Fair Value, Inputs, Level 2 | ' | ' |
Assets | ' | ' |
Total marketable securities | 0 | 0 |
Fair Value, Inputs, Level 2 | Corporate bonds | ' | ' |
Assets | ' | ' |
Total marketable securities | 0 | 0 |
Fair Value, Inputs, Level 2 | Exchange-traded funds | ' | ' |
Assets | ' | ' |
Total marketable securities | 0 | 0 |
Fair Value, Inputs, Level 3 | ' | ' |
Assets | ' | ' |
Total marketable securities | 0 | 0 |
Fair Value, Inputs, Level 3 | Corporate bonds | ' | ' |
Assets | ' | ' |
Total marketable securities | 0 | 0 |
Fair Value, Inputs, Level 3 | Exchange-traded funds | ' | ' |
Assets | ' | ' |
Total marketable securities | $0 | $0 |
Inventories_Additional_Informa
Inventories - Additional Information (Detail) (USD $) | 6 Months Ended |
In Millions, unless otherwise specified | Jun. 30, 2014 |
Inventory [Line Items] | ' |
Cost of Goods Sold | $0.30 |
Increase in inventory reserve | 0.45 |
Inventory reserve expenses | $0.20 |
Schedule_of_Inventories_Detail
Schedule of Inventories (Details) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Inventory [Line Items] | ' | ' |
Raw and packaging materials | $260 | $0 |
Finished goods | 185 | 501 |
Inventory, Gross | 445 | 501 |
Less: inventory reserve for finished goods | ' | -250 |
Total | $445 | $251 |
Accrued_Expenses_Detail
Accrued Expenses (Detail) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Accounts Payable and Accrued Liabilities [Line Items] | ' | ' |
Payroll, payroll taxes, bonus and benefits | $219 | $78 |
Professional services | 214 | 293 |
Interest - current | 162 | 0 |
Franchise taxes | 8 | 1 |
Property taxes | 15 | 15 |
Contract manufacturing services | 0 | 14 |
Clinical and regulatory services | 175 | 0 |
Other | 651 | 140 |
Total | $1,444 | $541 |
Debt_Additional_Information_De
Debt - Additional Information (Detail) (USD $) | 6 Months Ended | ||
Share data in Thousands, except Per Share data, unless otherwise specified | Jun. 30, 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 First revenue event description | 'The Amortization Date is April 1, 2015, but shall automatically become April 1, 2016 if we achieve 75% of our projected Nexafed cash receipts and 75% of our projected Aversion Oxycodone cash receipts for the fiscal year ending December 31, 2014 (collectively, the First Revenue Event). | ' | ' |
Debt instrument second revenue event description | 'The Amortization Date will be further deferred until April 1, 2017 if the First Revenue Event occurs and in addition we achieve 75% of our projected Nexafed cash receipts and 75% of our projected Aversion Oxycodone cash receipts for the fiscal year ending December 31, 2015 (collectively, the Second Revenue Event). | ' | ' |
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 | 341,000 | 400,000 | ' |
Warrants to purchase common stock | 2,200 | ' | ' |
Class of Warrant or Right, Exercise Price of Warrants or Rights | $3.15 | ' | ' |
Warrant Two | ' | ' | ' |
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 | 'December 2020 | ' | ' |
Prior To December 27 2014 | ' | ' | ' |
Debt Instrument [Line Items] | ' | ' | ' |
Debt instrument prepayment percentage | 3.00% | ' | ' |
After December 27 2014 but on or prior to December 27, 2015 | ' | ' | ' |
Debt Instrument [Line Items] | ' | ' | ' |
Debt instrument prepayment percentage | 2.00% | ' | ' |
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 | ' | ' |
First Revenue Event OccursAnd Second Revenue Event Not Occurs | ' | ' | ' |
Debt Instrument [Line Items] | ' | ' | ' |
Debt instrument periodic payment terms balloon payment to be paid | 895,000 | ' | ' |
First Revenue Event And Second Revenue Event Occurs | ' | ' | ' |
Debt Instrument [Line Items] | ' | ' | ' |
Debt instrument periodic payment terms balloon payment to be paid | $995,000 | ' | ' |
Interest_Expense_Detail
Interest Expense (Detail) (USD $) | 3 Months Ended | 6 Months Ended | ||
In Thousands, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 |
Interest expense: | ' | ' | ' | ' |
Secured Promissory notes | $255 | $0 | $510 | $0 |
Debt discount | 30 | 0 | 59 | 0 |
Debt issue costs | 17 | 0 | 34 | 0 |
Total interest expense | $302 | $0 | $603 | $0 |
LongTerm_Debt_Detail
Long-Term Debt (Detail) (USD $) | Jun. 30, 2014 |
In Thousands, unless otherwise specified | |
Debt Instrument [Line Items] | ' |
2014 | $0 |
2015 | 1,758 |
2016 | 2,522 |
2017 | 2,741 |
2018 | 2,979 |
Thereafter | 0 |
Total | $10,000 |
Common_Stock_Warrants_Addition
Common Stock Warrants - Additional Information (Detail) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 | Jun. 30, 2014 | Jun. 30, 2014 |
In Millions, except Share data in Thousands, unless otherwise specified | Warrant One | Warrant Two | ||
Class of Warrant or Right [Line Items] | ' | ' | ' | ' |
Secured Debt | ' | $10 | ' | ' |
Common stock warrant exercisable outstanding, shares | 2,200 | ' | 1,900 | 298 |
Class of Warrant or Right, Exercise Price of Warrants or Rights | $3.15 | ' | $3.40 | $1.60 |
Common stock Warrant expiration date | ' | ' | 'August 2014 | 'December 2020 |
ShareBased_Compensation_Additi
Share-Based Compensation - Additional Information (Detail) (USD $) | 1 Months Ended | 6 Months Ended | 1 Months Ended | 6 Months Ended | 1 Months Ended | ||||||||
Jan. 31, 2014 | Jan. 31, 2013 | Jun. 30, 2014 | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | Jan. 31, 2014 | Jan. 31, 2013 | 31-May-14 | Jun. 30, 2014 | 31-May-14 | 31-May-14 | |
Stock options | Stock options | Option Plan | Option Plan | Restricted Stock Units (RSUs) | Restricted Stock Units (RSUs) | 2014 Restricted Stock Unit Award Plan | 2014 Restricted Stock Unit Award Plan | 2014 Restricted Stock Unit Award Plan | 2014 Restricted Stock Unit Award Plan | ||||
30-Sep-14 | 31-Dec-14 | ||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Shares withheld upon elections made to exchange RSUs | 830,000 | 830,000 | ' | 18,000 | 4,000 | ' | ' | 330,000 | 330,000 | ' | ' | ' | ' |
Number of Options, Exercised | ' | ' | ' | ' | ' | 31,000 | 14,000 | ' | ' | ' | ' | ' | ' |
Withholding tax obligations | ' | ' | ' | $36,000 | $14,000 | ' | ' | ' | ' | $2,000,000 | ' | ' | ' |
Options exercised to purchase common shares net of shares for tax withholdings | ' | ' | ' | ' | ' | 13,000 | 10,000 | ' | ' | ' | ' | ' | ' |
Restricted stock units sale price | ' | ' | $0.01 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of vested shares distributed to holders | ' | ' | ' | ' | ' | ' | ' | 500,000 | 500,000 | ' | ' | ' | ' |
Restricted stock units exchanged in satisfaction of withholding tax obligations | ' | ' | ' | ' | ' | ' | ' | $500,000 | $700,000 | ' | ' | ' | ' |
Share Based Compensation Arrangement By Share Based Payment Award Maximum Number Of Shares Per Non Employee Directors | ' | ' | ' | ' | ' | ' | ' | ' | ' | 36,764 | ' | ' | ' |
Share Based Compensation Number Of Non Employee Directors | ' | ' | ' | ' | ' | ' | ' | ' | ' | 4 | ' | ' | ' |
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 Award Vesting Rights Cash Percentage | ' | ' | ' | ' | ' | ' | ' | ' | ' | 40.00% | ' | ' | ' |
Recognition_of_ShareBased_Comp
Recognition of Share-Based Compensation Expense (Detail) (USD $) | 3 Months Ended | 6 Months Ended | ||
In Thousands, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 |
Share based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' |
Research and development | $1,281 | $805 | $2,719 | $2,831 |
Share based Compensation Expense recognized in Operations | 289 | 315 | 487 | 630 |
Stock options | ' | ' | ' | ' |
Share based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' |
Research and development | 56 | 81 | 113 | 162 |
General and administrative | 141 | 234 | 282 | 468 |
Share based Compensation Expense recognized in Operations | 197 | 315 | 395 | 630 |
Restricted Stock Units (RSUs) | ' | ' | ' | ' |
Share based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' |
General and administrative | $92 | $0 | $92 | $0 |
Stock_Option_Award_Activity_De
Stock Option Award Activity (Detail) (Stock Option Plan, USD $) | 6 Months Ended | |
In Thousands, except Per Share data, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 |
Stock Option Plan | ' | ' |
Share based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' |
Number of Options Outstanding, beginning | 3,738 | 3,296 |
Number of Options, Granted | 0 | 75 |
Number of Options, Exercised | -31 | -14 |
Number of Options, Forfeited or expired | 0 | -15 |
Number of Options Outstanding, ending | 3,707 | 3,342 |
Number of Options exercisable | 3,295 | 2,970 |
Weighted Average Exercise Price, beginning | $4.99 | $5.50 |
Weighted Average Exercise Price, Granted | $0 | $2.32 |
Weighted Average Exercise Price, Exercised | $1.30 | $1.30 |
Weighted Average Exercise Price, Forfeited or expired | $0 | $2.32 |
Weighted Average Exercise Price, ending | $5.02 | $5.46 |
Weighted Average Exercise Price, Options exercisable | $5.42 | $5.80 |
Assumptions_Used_in_BlackSchol
Assumptions Used in Black-Scholes Model to Determine Fair Value for Stock Option Awards Granted (Detail) (USD $) | 6 Months Ended |
Jun. 30, 2013 | |
Share based Compensation Arrangement by Share-based Payment Award [Line Items] | ' |
Expected dividend yield | 0.00% |
Risk-free interest rates | 1.86% |
Average expected volatility | 114.00% |
Expected term (years) | '10 years |
Weighted average grant date fair value | $2.17 |
Summary_of_RSU_Plan_Detail
Summary of RSU Plan (Detail) | 6 Months Ended | |
In Thousands, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 |
Restricted Stock Units | ' | ' |
Share based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' |
Outstanding, beginning | 829 | 1,658 |
Granted | 147 | 0 |
Distributed | -829 | -829 |
Vested | 0 | 0 |
Forfeited or expired | 0 | 0 |
Outstanding, ending | 147 | 829 |
Vested Restricted Stock Units (RSUs) | ' | ' |
Share based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' |
Outstanding, beginning | 829 | 1,658 |
Granted | 0 | 0 |
Distributed | -829 | -829 |
Vested | 74 | 0 |
Forfeited or expired | 0 | 0 |
Outstanding, ending | 74 | 829 |
Income_Taxes_Additional_Inform
Income Taxes - Additional Information (Detail) (USD $) | 12 Months Ended | 6 Months Ended | |||
In Millions, unless otherwise specified | Dec. 31, 2013 | Jun. 30, 2014 | Jun. 30, 2014 | Jun. 30, 2014 | Jun. 30, 2014 |
Federal Research and Development | Indiana State Research and Development | Maximum | Minimum | ||
Income Tax Disclosure [Line Items] | ' | ' | ' | ' | ' |
Federal income tax benefits | $46.80 | ' | ' | ' | ' |
Federal NOLs | 137.6 | ' | ' | ' | ' |
U.S. statutory tax rate | 34.00% | ' | ' | ' | ' |
NOL expiration year | ' | ' | ' | '2033 | '2014 |
Research and development tax credits | ' | 1.1 | 0.4 | ' | ' |
Research and development expiration period | ' | 'expire in the years 2024 through 2033 | 'expire in the years 2014 through 2017 | ' | ' |
State income tax benefits | $2.80 | ' | ' | ' | ' |
Reconciliation_of_Numerators_a
Reconciliation of Numerators and Denominators of Basic and Diluted EPS (Detail) (USD $) | 3 Months Ended | 6 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 |
EPS - basic and diluted | ' | ' | ' | ' |
Numerator: net loss | ($3,521) | ($3,076) | ($7,609) | ($7,294) |
Denominator: | ' | ' | ' | ' |
Common shares | 48,848 | 46,399 | 48,846 | 46,386 |
Vested RSUs | 0 | 829 | 0 | 829 |
Basic and diluted weighted average shares outstanding | 48,848 | 47,228 | 48,846 | 47,215 |
EPS - basic and diluted | ($0.07) | ($0.07) | ($0.16) | ($0.16) |
Common shares issuable: | ' | ' | ' | ' |
Total excluded common shares | 5,934 | 5,198 | 5,934 | 5,198 |
Stock options | ' | ' | ' | ' |
Common shares issuable: | ' | ' | ' | ' |
Total excluded common shares | 3,707 | 3,342 | 3,707 | 3,342 |
Common stock warrants | ' | ' | ' | ' |
Common shares issuable: | ' | ' | ' | ' |
Total excluded common shares | 2,154 | 1,856 | 2,154 | 1,856 |
Nonvested RSUs member | ' | ' | ' | ' |
Common shares issuable: | ' | ' | ' | ' |
Total excluded common shares | 73 | 0 | 73 | 0 |
Commitments_and_Contingencies_
Commitments and Contingencies - Additional Information (Detail) (USD $) | 6 Months Ended |
Share data in Thousands, unless otherwise specified | Jun. 30, 2014 |
Commitments and Contingencies Disclosure [Line Items] | ' |
Warrants Exercisable To Purchase Of Common Stock | 2,200 |
Financial Advisor | ' |
Commitments and Contingencies Disclosure [Line Items] | ' |
Warrants Exercisable To Purchase Of Common Stock | 1,900 |
Amount of warrants issued in unit offering | $380,000 |
Percentage of fee assumed on exercise of warrants in unit offering | 100.00% |
Investment warrants expiration date | 31-Aug-14 |
Pennsylvania State | ' |
Commitments and Contingencies Disclosure [Line Items] | ' |
Number of lawsuits filed | 200 |
New Jersey State | ' |
Commitments and Contingencies Disclosure [Line Items] | ' |
Number of lawsuits filed | 150 |
Number of lawsuits served | 50 |
California State | ' |
Commitments and Contingencies Disclosure [Line Items] | ' |
Number of plaintiffs served in a single complaint | 445 |
Palatine Lllinois | ' |
Commitments and Contingencies Disclosure [Line Items] | ' |
Leases administrative office space | $25,000 |
Lease expiring date | 'lease expiring March 31, 2015 |