Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Mar. 31, 2018 | Jun. 29, 2018 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2018 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q1 | |
Entity Registrant Name | ACURA PHARMACEUTICALS, INC | |
Entity Central Index Key | 786,947 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Smaller Reporting Company | |
Trading Symbol | ACUR | |
Entity Common Stock, Shares Outstanding | 21,033,528 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Assets: | ||
Cash and cash equivalents | $ 774 | $ 2,220 |
Royalty receivable | 192 | 71 |
Prepaid expenses and other current assets | 116 | 275 |
Total current assets | 1,082 | 2,566 |
Income tax receivable | 135 | 135 |
Property, plant and equipment, net (Note 6) | 659 | 679 |
Intangible asset, (net of accumulated amortization of $828 and $776) (Note 3) | 1,172 | 1,224 |
Total assets | 3,048 | 4,604 |
Liabilities: | ||
Accounts payable | 416 | 3 |
Accrued expenses (Note 7) | 817 | 939 |
Accrued interest | 745 | 700 |
Other current liabilities | 13 | 41 |
Sales returns liability | 254 | 254 |
Debt, (net of discounts) (Note 8) | 2,228 | 2,694 |
Total current liabilities | 4,473 | 4,631 |
Total liabilities | 4,473 | 4,631 |
Commitments and contingencies (Note 15) | ||
Stockholders’ deficit: | ||
Common stock - $.01 par value per share; 100,000 shares authorized, 21,034 and 20,796 shares issued and outstanding at March 31, 2018 and December 31, 2017, respectively | 210 | 208 |
Additional paid-in capital | 380,239 | 380,145 |
Accumulated deficit | (381,874) | (380,380) |
Total stockholders’ deficit | (1,425) | (27) |
Total liabilities and stockholders’ deficit | $ 3,048 | $ 4,604 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) shares in Thousands, $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Accumulated amortization, deferred finance costs | $ 828 | $ 776 |
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 100,000 | 100,000 |
Common stock, shares issued | 21,034 | 20,796 |
Common stock, shares outstanding | 21,034 | 20,796 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Revenues: | ||
License fee revenue | $ 0 | $ 2,500 |
Collaboration revenue | 0 | 36 |
Royalty revenue | 198 | 74 |
Product sales, net | 0 | 107 |
Total revenues, net | 198 | 2,717 |
Cost and expenses: | ||
Cost of sales | 0 | 128 |
Research and development | 650 | 711 |
Sales, marketing, general and administrative | 943 | 1,296 |
Total costs and expenses | 1,593 | 2,135 |
Operating (loss) income | (1,395) | 582 |
Interest expense, net (Note 8) | (99) | (177) |
(Loss) income before income taxes | (1,494) | 405 |
Provision for income taxes | 0 | 0 |
Net (loss) income | $ (1,494) | $ 405 |
Net (loss) income per share: | ||
Basic | $ (0.07) | $ 0.03 |
Diluted | $ (0.07) | $ 0.03 |
Weighted average shares outstanding: | ||
Basic | 21,034 | 11,907 |
Diluted | 21,034 | 12,083 |
CONSOLIDATED STATEMENT OF CHANG
CONSOLIDATED STATEMENT OF CHANGES IN ACCUMULATED STOCKHOLDERS' DEFICIT - 3 months ended Mar. 31, 2018 - USD ($) shares in Thousands, $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit |
Balance at Dec. 31, 2017 | $ (27) | $ 208 | $ 380,145 | $ (380,380) |
Balance (in shares) at Dec. 31, 2017 | 20,796 | |||
Net loss | (1,494) | $ 0 | 0 | (1,494) |
Non-cash share-based compensation | 62 | 0 | 62 | 0 |
Net distribution of common stock pursuant to restricted stock unit award plan | 34 | $ 2 | 32 | 0 |
Net distribution of common stock pursuant to restricted stock unit award plan (in shares) | 238 | |||
Balance at Mar. 31, 2018 | $ (1,425) | $ 210 | $ 380,239 | $ (381,874) |
Balance (in shares) at Mar. 31, 2018 | 21,034 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Cash Flows from Operating Activities: | ||
Net (loss) income | $ (1,494) | $ 405 |
Adjustments to reconcile net (loss) income to net cash (used in) provided by operating activities: | ||
Depreciation | 20 | 25 |
Provision for sales returns | 0 | 49 |
Non-cash share-based compensation | 62 | 117 |
Amortization of debt discount and deferred debt issue costs | 17 | 30 |
Amortization of intangible asset | 52 | 52 |
Change in assets and liabilities: | ||
Accounts receivable | 0 | 17 |
Collaboration revenue receivable | 0 | 43 |
Royalty receivable | (121) | (2) |
Inventory | 0 | 103 |
Prepaid expenses and other current assets | 159 | (33) |
Accounts payable | 413 | 132 |
Accrued expenses | (122) | 337 |
Accrued interest | 45 | 74 |
Other current liabilities | 4 | 0 |
Sales returns liability | 0 | (51) |
Net cash (used in) provided by operating activities | (965) | 1,298 |
Cash Flows from Investing Activities: | ||
Proceeds from transfer of equipment to licensee | 0 | 103 |
Proceeds from transfer of inventory to licensee | 0 | 206 |
Net cash provided by investing activities | 0 | 309 |
Cash Flows from Financing Activities: | ||
Proceeds from distribution of restricted stock units | 2 | 0 |
Principal payments on loan maturing December 1, 2018 | (483) | (445) |
Net cash (used in) financing activities | (481) | (445) |
Net (decrease) increase in cash, cash equivalents, and restricted cash | (1,446) | 1,162 |
Cash, cash equivalents, and restricted cash at beginning of period | 2,220 | 5,181 |
Cash, cash equivalents, and restricted cash at end of period | 774 | 6,343 |
Reconciliation of cash, cash equivalents, and restricted cash | ||
Cash and cash equivalents | 774 | 3,843 |
Restricted cash equivalents | 0 | 2,500 |
Total cash, cash equivalents and restricted cash show in the consolidated statements of cash flows | $ 2,220 | $ 5,181 |
OPERATIONS AND BASIS OF PRESENT
OPERATIONS AND BASIS OF PRESENTATION | 3 Months Ended |
Mar. 31, 2018 | |
Description Of Operation And Summary Of Significant Accounting Policies Disclosure [Abstract] | |
OPERATIONS AND BASIS OF PRESENTATION | Principal Operations Acura Pharmaceuticals, Inc., a New York corporation, and its subsidiary (the “Company”, “Acura”, “We”, “Us” 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 Limitx Technology is intended to address methods of product tampering associated with opioid abuse by retarding the release of active drug ingredients when too many tablets are accidently or purposefully ingested. Our Aversion® Technology is intended to address methods of product tampering associated with opioid abuse by incorporating gelling ingredients and irritants into tablets to discourage abuse by snorting and provide barriers to abuse by injection. Our Impede® Technology is directed at minimizing the extraction and conversion of pseudoephedrine into methamphetamine. · Our Limitx Technology is in development with the immediate-release hydrocodone bitartrate and acetaminophen as a lead Limitx product candidate due to its larger market size than our prior lead product and its known prevalence of oral excessive tablet abuse. · Our Aversion Technology has been licensed to Egalet Corporation for use in Oxaydo® Tablets (oxycodone HCl, CII), and is the first approved immediate-release oxycodone product in the United States with abuse deterrent labeling. Oxaydo is currently approved by the FDA for marketing in the United States in 5mg and 7.5mg strengths. (see Note 3). · Our Impede Technology is used in Nexafed® Tablets (30mg pseudoephedrine HCl) and Nexafed® Sinus Pressure + Pain Tablets (30/325mg pseudoephedrine HCl and acetaminophen). We have licensed to MainPointe Pharmaceuticals, LLC our Impede Technology in the United States and Canada to commercialize our Nexafed products. (see Note 3). Basis of Presentation and Substantial Doubt in Going Concern The accompanying unaudited consolidated financial statements of the Company have been prepared assuming the Company will continue as a going concern and in accordance with generally accepted accounting principles in the United States of America for interim financial information, the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not contain all disclosures required by generally accepted accounting principles. Reference should be made to the Company’s Annual Report on Form 10-K for the year ended December 31, 2017. In the opinion of the Company, all normal recurring adjustments have been made that are necessary to present fairly the results of operations for the interim periods. Operating results for the three month period ended March 31, 2018 are not necessarily indicative of the results that may be expected for the year ending December 31, 2018. The going concern basis of presentation assumes that we will continue in operation one year after the date these financial statements are issued and we will be able to realize our assets and discharge our liabilities and commitments in the normal course of business 0.8 3.4 382.0 0.7 1.4 1.5 We have suffered recurring losses from operations and have not generated positive cash flows from operations. 5.2 5.7 We anticipate operating losses to continue for the foreseeable future. We have a term loan with Oxford Finance LLC (“Oxford” or the “Lender”) and as of March 31, 2018 and June 28, 2018, the outstanding principal balance is $ 2.1 1.5 795 During the second quarter of 2018, we borrowed a total of $ 1.5 (see Notes 9 and 15). On June 7, 2018, we filed our 2017 financial statements as part of our annual report on Form 10-K. With the net proceeds of approximately $ 1.5 These factors, among others, raise substantial doubt about the Company's ability to continue as a going concern. We must seek sources to raise additional financing and seek to enter into license or collaboration agreements with third parties relating to our technologies. The Company is exploring a variety of capital raising and other transactions to provide additional funding to continue operations. These include potential private offerings of common stock to accredited and/or institutional investors and licensing transactions with pharmaceutical company partners for our proprietary technologies, including Limitx. We are actively seeking a licensing partner for our Limitx technology, with the objective of receiving an upfront license fee, development milestone payments and royalties on the net sales of products utilizing the Limitx technology, similar to the Egalet Agreement. We are also exploring licensing or selling select assets and intellectual property in an effort to raise capital and reduce operating expenses. Finally, the Company continues to evaluate the potential for a strategic transaction which may involve the Company being acquired in a merger or asset purchase transaction. No assurance can be given that we will be successful in completing any one or more of such transactions on acceptable terms, if at all, or if completed, that such transactions will provide payments to the Company sufficient to fund continued operations. In the absence of the Company’s completion of one or more of such transactions, there will be substantial doubt about the Company’s ability to continue as a going concern within one year after the date these financial statements are issued, and the Company will be required to scale back or terminate operations and/or seek protection under applicable bankruptcy laws. An extended delay or cessation of the Company’s continuing product development efforts will have a material adverse effect on the Company’s financial condition and results of operations. In view of the matters described above, management has concluded that substantial doubt exists with respect to the Company’s ability to continue as a going concern within one year after the date the financial statements are issued. The recoverability of a major portion of the recorded asset amounts shown in the Company’s accompanying balance sheets is dependent upon continued operations of the Company, which in turn is dependent upon the Company’s ability to meet its funding requirements on a continuous basis, to maintain existing financing and to succeed in its future operations. The Company’s financial statements do not include any adjustment relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company be unable to continue in existence. |
RECENT ACCOUNTING PRONOUNCEMENT
RECENT ACCOUNTING PRONOUNCEMENTS | 3 Months Ended |
Mar. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
RECENT ACCOUNTING PRONOUNCEMENTS | NOTE 2 RECENT ACCOUNTING PRONOUNCEMENTS New accounting standards which have been adopted on or before March 31, 2018 Revenue from Contracts with Customers The Company adopted Accounting Standards Codification Topic 606Revenue from Contracts with Customers, or Topic 606, on January 1, 2018, resulting in a change to its accounting policy for revenue recognition. The Company used the modified retrospective method and the cumulative effect of initially applying Topic 606 would be recognized as an adjustment to the opening accumulated deficit at January 1, 2018. Accordingly, comparative information has not been adjusted and continues to be reported under the previous accounting standards. Refer to Note 4 for additional information. Scope of Modification Accounting, Stock Based Compensation In May 2017, the FASB issued ASU No. 2017-09 which provides guidance as to how an entity should apply modified accounting in Topic 718 when changing the terms and conditions of its share-based payment awards. The guidance clarifies that modification accounting will be applied if the value, vesting conditions or classification of the award changes. The ASU is effective for annual reporting periods, including interim periods within those annual periods, beginning after December 15, 2017 but early adoption is permitted. The Company adopted this new standard on January 1, 2018 which did not have a material impact on the Company’s financial statements. Statement of Cash Flows - Classification of Certain Cash Receipts and Cash Payments In August 2016, the FASB issued ASU 2016-15 which clarifies existing guidance on how companies present and classify certain cash receipts and cash payments in the statement of cash flows by addressing specific cash flow issues in an effort to reduce diversity in practice, including guidance on debt prepayment or extinguishment costs and contingent consideration payments made after a business combination. This update is effective for annual reporting periods beginning after December 15, 2017, with early adoption permitted. The Company adopted this new standard on January 1, 2018 which did not have a material impact on the Company’s financial statements. Intra-Entity Transfers of Assets Other than Inventory In October 2016, the FASB issued ASU 2016-16, Intra-Entity Transfers of Assets Other Than Inventory New accounting standards which have not been adopted on or before March 31, 2018 Leases In February 2016, the FASB issued ASU 2016-02, Leases, which establishes a comprehensive new lease accounting model. The new standard will require most leases (with the exception of leases with terms of one year or less) to be recognized on the balance sheet as a lease liability with a corresponding right-of-use asset. Leases will be classified as an operating lease or a financing lease. Operating leases are expensed using the straight-line method whereas financing leases will be treated similarly to a capital lease under the current standard. The new standard will be effective for annual and interim periods, within those fiscal years, beginning after December 15, 2018 but early adoption is permitted. The new standard must be presented using the modified retrospective transition method existing at or entered into after the beginning of the earliest comparative period presented in the financial statements, but it does not require transition accounting for leases that expire prior to the date of initial application. Upon adoption, operating leases will be reported on the balance sheet as a gross-up of assets and liabilities. The Company is currently evaluating the impact that the standard will have on the financial statements and related footnote disclosures. |
LICENSE AND COLLABORATION AGREE
LICENSE AND COLLABORATION AGREEMENTS | 3 Months Ended |
Mar. 31, 2018 | |
License and Collaboration Agreements [Abstract] | |
LICENSE AND COLLABORATION AGREEMENTS | NOTE 3 LICENSE AND COLLABORATION AGREEMENTS The Company’s revenues are comprised of amounts earned under its license and collaboration agreements, royalties, and until March 2017 did previously include the Nexafed products’ net product sales. Revenue recognition occurs when a customer obtains control of promised goods or services in an amount that reflects the consideration the Company expects to receive in exchange for those goods or services based on a short-term credit arrangement. Egalet Agreement covering Oxaydo In April 2014, we terminated an agreement with Pfizer and the return to us of Aversion Oxycodone (formerly known as Oxecta®) and all Aversion product rights in exchange for a one-time termination payment of $ 2.0 2.0 9.7 208 208 In January 2015, we and Egalet US, Inc. and Egalet Ltd., each a subsidiary of Egalet Corporation, or collectively Egalet, entered into a Collaboration and License Agreement (the “Egalet Agreement”) to commercialize Aversion Oxycodone (formerly known as Oxecta®) under our 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 transferred the approved New Drug Application, or 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. Eaglet launched Oxaydo in the United States late in the third quarter of 2015. 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 is responsible for the fees and expenses relating to the Oxaydo NDA and product line extensions of Oxaydo, provided that Egalet will pay a substantial majority of the fees and expenses and we will pay for the remaining fees and expense 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. Egalet 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 a $ 5.0 2.5 one-time $12.5 million sales-based milestone payment when worldwide Oxaydo net sales reach $150 million in a calendar year. 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. 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. MainPointe Agreement covering Nexafed products In March 2017, we and MainPointe entered into the MainPointe Agreement, pursuant to which we granted MainPointe an exclusive license to our Impede technology to commercialize both of our Nexafed and Nexafed Sinus Pressure + Pain product (“Nexafed products”) in the U.S. and Canada. We also conveyed to MainPointe our existing inventory and equipment relating to our Nexafed products. MainPointe is responsible for all development, manufacturing and commercialization activities with respect to products covered by the Agreement. On signing the MainPointe Agreement, MainPointe paid us an upfront licensing fee of $ 2.5 7.5 MainPointe has the option to expand the licensed territory beyond the United States and Canada to the European Union (and the United Kingdom), Japan and South Korea for payments of $ 1.0 500 250 In addition, MainPointe has the option to add to the MainPointe Agreement certain additional products, or Option Products, containing PSE and utilizing the Impede technology for a fee of $500 thousand per product (for all product strengths). Such Option Products include the product candidate Loratadine with pseudoephedrine. If the territory has been expanded prior to the exercise of a product option, the option fee will be increased to $750 thousand per product. If the territory is expanded after the payment of the $500 thousand product option fee, a one-time $250 thousand fee will be due for each product. If a third party is interested in developing or licensing rights to an Option Product, MainPointe must exercise its option for that product or its option rights for such product will terminate. The MainPointe Agreement may be terminated by either party for a material breach of the other party, or by Acura if MainPointe challenges certain of its patents. Upon early termination of the MainPointe Agreement, MainPointe’s licenses to the Impede technology and all products will terminate. Upon termination, at Acura’s request the parties will use commercially reasonable efforts to transition the Nexafed® and Nexafed® Sinus Pressure + Pain products back to Acura. KemPharm Agreement Covering Certain Opioid Prodrugs In October 2016, we and KemPharm Inc. (”KemPharm”) entered into a worldwide License Agreement (the “KemPharm Agreement”) pursuant to which we licensed our Aversion® technology to KemPharm for its use in the development and commercialization of three products using 2 of KemPharm’s prodrug candidates. KemPharm has also been granted an option to extend the KemPharm Agreement to cover two additional prodrug candidates. KemPharm is responsible for all development, manufacturing and commercialization activities. Upon execution of the KemPharm Agreement, KemPharm paid us an upfront payment of $ 3.5 1.0 The KemPharm Agreement expires upon the expiration of KemPharm’s royalty payment obligations in all countries. Either party may terminate the KemPharm Agreement in its entirety if the other party materially breaches the KemPharm Agreement, subject to applicable cure periods. Acura or KemPharm may terminate the KemPharm Agreement with respect to the U.S. and other countries if the other party challenges the patents covering the licensed products. KemPharm may terminate the KemPharm Agreement for convenience on ninety (90) days prior written notice. 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 KemPharm Agreement provides for termination of our license grant to KemPharm. Terminated Bayer Agreement Covering Methamphetamine Resistant Pseudoephedrine-containing Product In June 2015, we and Bayer entered into a License and Development Agreement (the “Bayer Agreement”) granting Bayer an exclusive worldwide license to our Impede Technology for use in an undisclosed methamphetamine resistant pseudoephedrinecontaining product (the “Bayer Licensed Product”) and providing for the joint development of such product utilizing our Impede Technology for the U.S. market. In June 2017, we received Bayer’s notice of termination of the Bayer Agreement pursuant to its convenience termination right exercised prior to the Company’s completion of its product development obligations under the Bayer Agreement. We have received reimbursement of certain of our development costs under the Bayer Agreement. Following Bayer’s termination of the Bayer Agreement the Bayer Licensed Product is now subject to MainPointe’s option rights under the MainPointe Agreement. |
REVENUE FROM CONTRACTS WITH CUS
REVENUE FROM CONTRACTS WITH CUSTOMER | 3 Months Ended |
Mar. 31, 2018 | |
Revenue from Contract with Customer [Abstract] | |
REVENUE FROM CONTRACTS WITH CUSTOMER | NOTE 4 REVENUE FROM CONTRACTS WITH CUSTOMER Adoption of ASC Topic 606, Revenue from Contracts with Customers The Company adopted ASC Topic 606 on January 1, 2018 applying the modified retrospective method to all contracts that were not completed as of January 1, 2018. While the While the timing of future revenues under ASC Topic 606 may differ from the Company’s historical accounting practices under ASC Topic 605, the cumulative effect recorded through the Consolidated Statement of Stockholder’s Deficit was zero because there was no change in timing or measurement of revenues for open contracts at January 1, 2018. Under ASC 606, revenue is recognized when, or as, performance obligations under terms of a contract are satisfied, which occurs when control of the promised service is transferred to a customer. Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring services to a customer (“transaction price”). The Company will then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when, or as, the performance obligation is satisfied. When determining the transaction price of the contract, an adjustment is made if payment from a customer occurs either significantly before or significantly after performance, resulting in a significant financing component. None of the Company’s licenses and collaboration agreements contained a significant financing component at March 31, 2018. The Company’s existing license and collaboration agreements may contain a single performance obligation or may contain multiple performance obligations. Those which contain multiple performance obligations will require an allocation of the transaction price based on the estimated relative standalone selling prices of the promised services underlying each performance obligation. The Company’s existing license and collaboration agreements contain customer options for the license of additional products and territories. We determined the option’s standalone selling prices based on the option product’s potential market size in the option territory as compared to the currently licensed product and U.S. territory. Some of our existing license and collaboration agreements contain a license to the technology as well as licenses to tradenames or trademarks. The Company determined that the licenses to the tradenames or trademarks were immaterial in context of the contract. Net Product Sales Prior to the licensing the Nexafed products to MainPointe in March 2017, we sold our Nexafed products in the United States to wholesale pharmaceutical distributors as well as directly to chain drug stores. Our Nexafed products were sold subject to the right of return usually for a period of up to twelve months after the product expiration. Both products had an initial shelf life of twenty-four months from the date of manufacture, which shelf life had been extended to thirty-six months for Nexafed product supplied to us during 2016 from one of the Company’s contract manufacturers. We recognized revenue from our Nexafed products sales when the price was fixed and determinable at the date of sale, title and risk of ownership were transferred to the customer, and returns could be reasonably estimated, which generally occurred at the time of product shipment. ASC 606 did not change the practice under which the Company previously recognized the product revenue from sales of the Nexafed products, which was at the time the product was shipped to a customer. As a result of the Company’s license agreement with MainPointe completed in March 2017, the Company no longer sold the Nexafed products. There was a $ 0 Sales-based Milestones and Royalty Revenues The commercial sales-based milestones and sales royalties earned under the license and collaboration for Oxaydo and sales royalties earned under the license for the Nexafed products, are recorded in the period of the related sales by Egalet and MainPointe. Payments of sales-based milestones are generally due within 30 days after the end of a calendar year. Payments of royalties are generally due within 45 days after the end of a calendar quarter. License and Collaboration Agreement Revenues The achievement of milestones under the Company’s license and collaboration agreements will be recorded during the period the milestone’s achievement becomes probable, which may result in earlier recognition as compared to the previous accounting standards. The license fee of an option product or option territory under the Company’s license and collaboration agreements will be recorded when the option is exercised and any obligations on behalf of the Company, such as to transfer know-how, has been fulfilled, which may result in later recognition as compared to the previous accounting standards. Disaggregation of Total Revenues The Company has two licenses for currently marketed products containing its technologies; the Nexafed products containing the Impede Technology to MainPointe and Oxaydo containing the Aversion Technology to Egalet. All of the Company’s royalty revenues are earned from these two licenses and from the licensee’s sale of products in the U.S. Royalty revenues by licensee are summarized below: Three Months Ended Egalet $ 190 MainPointe 8 Royalty revenues $ 198 Contract Balance and Performance Obligations The Company’s reported contract assets and contract liability balances under the license and collaboration agreements at either March 31, 2018 or December 31, 2017 was $0.00. |
RESEARCH AND DEVELOPMENT ACTIVI
RESEARCH AND DEVELOPMENT ACTIVITIES | 3 Months Ended |
Mar. 31, 2018 | |
Research and Development [Abstract] | |
RESEARCH AND DEVELOPMENT ACTIVITIES | NOTE 5 RESEARCH AND DEVELOPMENT ACTIVITIES Research and Development (“R&D”) costs include internal R&D activities, external Contract Research Organization (“CRO”) services and their clinical research and investigative sites, and other activities. Internal R&D activity costs can include facility overhead, equipment and facility maintenance and repairs, laboratory supplies, pre-clinical laboratory experiments, formulation work, depreciation, salaries, benefits, insurance and share-based compensation expenses. CRO activity costs can include preclinical laboratory experiments and clinical trial studies. Other activity costs can include regulatory consulting, regulatory legal counsel, cost of acquiring, developing and manufacturing pre-clinical trial materials, costs of manufacturing scale-up, and cost sharing expenses under license agreements. Internal R&D costs and other activity costs are charged to expense as incurred. We make payments to CROs based on agreed upon terms and may include payments in advance of a study starting date. Payments in advance will be reflected in the financial statements as prepaid expenses. We review and charge to expense the amounts for CRO costs and clinical trial study costs 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 to us. The accrued CRO costs are subject to revisions by us as the study progresses towards completion. Revisions are charged to expense in the period in which the facts that give rise to the revision become known to us. We did not have any remaining obligations under cancelable arrangements, nor did we have any prepaid CRO costs or prepaid clinical trial study expenses at March 31, 2018 or December 31, 2017. |
PROPERTY, PLANT AND EQUIPMENT
PROPERTY, PLANT AND EQUIPMENT | 3 Months Ended |
Mar. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY, PLANT AND EQUIPMENT | NOTE 6 PROPERTY, PLANT AND EQUIPMENT March 31, December 31, 2018 2017 (in thousands) Building and improvements $ 1,273 $ 1,273 Scientific equipment 598 598 Computer hardware and software 107 107 Machinery and equipment 275 275 Land and improvements 162 162 Other personal property 70 70 Office equipment 27 27 Total 2,512 2,512 Less: accumulated depreciation (1,853) (1,833) Net property, plant and equipment $ 659 $ 679 We do not have leasehold improvements nor do we have capitalized leases. Costs of betterments are capitalized while maintenance costs and repair costs are charged to operations as incurred. When a depreciable asset is retired from service, the cost and accumulated depreciation will be removed from the respective accounts. |
ACCRUED EXPENSES
ACCRUED EXPENSES | 3 Months Ended |
Mar. 31, 2018 | |
Payables and Accruals [Abstract] | |
ACCRUED EXPENSES | NOTE 7 ACCRUED EXPENSES March 31, December 31, 2018 2017 (in thousands) Cost sharing expenses under license agreement $ 382 $ 328 Other fees and services 35 36 Payroll, payroll taxes and benefits 82 70 Professional services 190 149 Clinical, non-clinical and regulatory services 96 326 Property taxes 18 16 Franchise taxes 14 14 Total $ 817 $ 939 |
DEBT
DEBT | 3 Months Ended |
Mar. 31, 2018 | |
Debt Disclosure [Abstract] | |
DEBT | NOTE 8 DEBT Loan due December 1, 2018 In December 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 8.35 13.35 260 60 7.98 400 December 27, 2020 In January 2015, we and Oxford entered into an amendment to the Loan Agreement. Pursuant to the amendment, (i) the exercise price of the warrants was lowered from $ 7.98 2.52 33 2.5 5.0 In October 2016, we and Oxford entered into a second amendment to the Loan Agreement (the “Second Amendment”). Pursuant to the Second Amendment, (i) the requirement that we maintain a $ 2.5 5.0 2.5 6.0 3.0 4.0 2.5 In March 2017, we and Oxford entered into a third amendment to the Loan Agreement (the “Third Amendment”). Pursuant to the Third Amendment (i) we granted Oxford a lien on our intellectual property, (ii) Oxford provided a waiver of compliance with the Unqualified Audit Opinion Covenant in connection with our receipt of our auditor’s going concern opinion for our 2016 financial statements and (iii) Oxford consented to the terms of the MainPointe Agreement. Under the Loan Agreement, an audit opinion with an explanatory paragraph noting substantial doubt about the Company’s ability to continue in business is deemed to violate the Unqualified Audit Opinion Covenant. During the second quarter 2018, in connection with a $ 1.0 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 1 795 745 700 The Company was obligated to pay customary lender fees and expenses, including a one-time facility fee of $ 50 100 231 10.16 The Loan Agreement contains customary representations and warranties and customary affirmative and negative covenants, including, among others, limits or restrictions on the Company’s ability to incur liens, incur indebtedness, pay dividends, redeem stock, and merge or consolidate and dispose of assets. In addition, it contains customary events of default that entitles the Lender to cause any or all of the Company’s indebtedness under the Loan Agreement to become immediately due and payable. The events of default (some of which are subject to applicable grace or cure periods), include, among other things, non-payment defaults, covenant defaults (including breach of the Unqualified Audit Opinion Covenant), a material adverse change in the Company, bankruptcy and insolvency defaults and material judgment defaults. Current Long-term Total Loan Due December 1, 2018 Balance at Jan. 1, 2018 $ 2,740 $ - $ 2,740 Principal payments (483) - (483) Classification - - - Balance at Mar. 31, 2018 $ 2,257 $ - $ 2,257 Current Long-term Total Debt Discount Balance at Jan. 1, 2018 $ (32) $ - $ (32) Amortization expense 12 - 12 Classification - - - Balance at Mar. 31, 2018 $ (20) $ - $ (20) Current Long-term Total Deferred Debt Issuance Costs Balance at Jan. 1, 2018 $ (14) $ - $ (14) Amortization expense 5 - 5 Classification - - - Balance at Mar. 31, 2018 $ (9) $ - $ (9) Debt, net at Mar 31, 2018 $ 2,228 $ - $ 2,228 March 31, March 31, 2018 2017 (in thousands) Loan due December 1, 2018 Term loan $ 82 $ 148 Debt discount 12 20 Debt issue costs 5 10 Total interest expense $ 99 $ 178 Less: interest income - 1 Interest expense, net $ 99 $ 177 |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 3 Months Ended |
Mar. 31, 2018 | |
Related Party Transactions [Abstract] | |
RELATED PARTY TRANSACTIONS | NOTE 9 RELATED PARTY TRANSACTIONS In July 2017, we completed a $4.0 million private placement with John Schutte (sometimes referred to as the “Investor”), consisting of 8,912,655 0.4488 85 0.528 495 4.0 Investor is a principal of MainPointe, a Kentucky limited liability company. In March 2017, we granted MainPointe an exclusive license to our Impede technology to commercialize our Nexafed® and Nexafed® Sinus Pressure + Pain Products in the United States and Canada for an upfront licensing fee of $ 2.5 309 7.5 8 As part of the closing of the Transaction, the Company, Essex Woodlands Health Ventures V, L.P. (“Essex”) and Galen Partners III, L.P. (“Galen”) amended and restated the existing Voting Agreement including such parties to provide for the Investor to join as a party (as so amended, the “Second Amended and Restated Voting Agreement”). The Second Amended and Restated Voting Agreement provides that our Board of Directors shall remain comprised of no more than seven members (subject to certain exceptions), (i) one of whom is the Company’s Chief Executive Officer, (ii) three of whom are independent under Nasdaq standards, and (iii) one of whom shall be designated by each of Essex, Galen and Investor, and the parties to such agreement would vote for such persons. The right of each of Essex, Galen and Investor to designate one director to our Board will continue as long as he or it and their affiliates collectively hold at least 600,000 Once such shareholder no longer holds such securities, the additional forfeited seat would become a seat for an independent director to thereafter be nominated to the Board of Directors from time to time by the then current directors and as applicable, to be elected by the directors to fill the vacancy created by the forfeited seat or submitted to the vote of shareholders at the Company’s next annual meeting. During the second quarter of 2018, we borrowed $ 1.5 |
COMMON STOCK WARRANTS
COMMON STOCK WARRANTS | 3 Months Ended |
Mar. 31, 2018 | |
Stockholders Equity Note [Abstract] | |
COMMON STOCK WARRANTS | NOTE 10 COMMON STOCK WARRANTS March 31, 2018 2017 Number WAvg Number WAvg Outstanding, Jan. 1 1,842 $ 0.59 60 $ 2.52 Issued - - - - Exercised - - - - Expired - - - - Modification - - - - Outstanding, Mar. 31 1,842 $ 0.59 60 $ 2.52 In connection with the issuance of the $ 10.0 60 2.52 2.52 As part of our July 2017 private placement transaction with John Schutte, we issued warrants to purchase 1,782,531 0.528 495 4.0 |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 3 Months Ended |
Mar. 31, 2018 | |
Equity, Fair Value Disclosure [Abstract] | |
FAIR VALUE MEASUREMENTS | NOTE 11 FAIR VALUE MEASUREMENTS The Company’s financial instruments consist primarily of cash and cash equivalents, receivables from trade, royalties and collaboration, trade accounts payable, and our long-term debt. The carrying amounts of these financial instruments, other than our long-term debt, are representative of their respective fair values due to their relatively short maturities. |
SHARE-BASED COMPENSATION EXPENS
SHARE-BASED COMPENSATION EXPENSE | 3 Months Ended |
Mar. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
SHARE-BASED COMPENSATION EXPENSE | NOTE 12 SHARE-BASED COMPENSATION EXPENSE Share-based Compensation We have four 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. 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 market price of our common stock on the date of grant, less its exercise cost. Three Months Ended 2018 2017 Research and development expense: Stock options $ 13 $ 34 Restricted stock units 7 - Subtotal $ 20 $ 34 General and administrative expense: Stock options 34 53 Restricted stock units 22 30 Subtotal $ 56 $ 83 Total $ 76 $ 117 Stock Option Award Plans We maintain various stock option plans. Three Months Ended 2018 2017 Number of Weighted Number of Weighted Outstanding, Jan. 1 1,494 $ 12.33 1,397 $ 13.57 Granted - - - - Exercised - - (1) (0.92) Forfeited or expired (12) (32.50) - - Outstanding, Mar. 31 1,482 $ 12.17 1,396 $ 13.58 Options exercisable 1,235 $ 14.49 1,125 $ 16.52 Number of Weighted Outstanding, Jan. 1, 2018 270 $ 0.46 Granted - - Vested (23) 0.77 Forfeited - - Outstanding, Mar. 31, 2018 247 $ 0.43 We estimate the option’s fair value on the date of grant using the Black-Scholes option-pricing model. Black-Scholes utilizes assumptions related to expected term, forfeitures, volatility, the risk-free interest rate, the dividend yield (which is assumed to be zero, as we have not paid any cash dividends) and employee exercise behavior. Expected volatilities utilized in the Black-Scholes model are based on the historical volatility of our common stock price. The risk-free interest rate is derived from the U.S. Treasury yield curve in effect at the time of grant. The expected life of the grants is derived from historical exercise activity. The intrinsic value of the option awards which were vested and outstanding at each of March 31, 2018 and 2017 was $ 0 67 Restricted Stock Unit Award Plans We have two Restricted Stock Unit Award Plans for our employees and non-employee directors, a 2017 Restricted Stock Unit Award Plan (the “2017 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. Our non-employee director awards allow for non-employee directors to receive payment in cash, instead of stock, for up to 40 13 41 The compensation cost to be incurred on a granted RSU without a cash settlement option 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 and recorded to additional paid-in capital over the vesting period of the RSU award. Three months Ended March 31, 2018 2017 (in thousands) Number of Number of Number of Number of Outstanding, Jan. 1 462 262 91 91 Granted 267 - 238 - Distributed (262) (262) (67) (67) Vested - 66 - 59 Forfeited or expired - - - - Outstanding, Mar. 31 467 66 262 83 2017 Restricted Stock Unit Award Plan Our 2017 RSU Plan was approved by shareholders in November 2017 and permits the grant of up to 1.5 1.0 Information about the awards under the 2017 RSU Plan is as follows: · In December 2017, we awarded 200 100 · In January 2018, we awarded approximately 67 25 13 2014 Restricted Stock Unit Award Plan Our 2014 RSU Plan was approved by shareholders in May 2014 and permits the grant of up to 400 3 Information about the awards under the 2014 RSU Plan during 2017 and 2018 is as follows: · In January 2017, we awarded approximately 60 25 41 Information about the distribution of shares under the 2014 RSU Plan is as follows: · In January 2017, 1 66 1 22 67 49 18 · In January 2018, all outstanding 262 thousand RSUs from the 2014 RSU Plan were distributed. There are no outstanding awards which remain deferred until a future distribution date. Of the approximately 262 238 24 |
INCOME TAXES
INCOME TAXES | 3 Months Ended |
Mar. 31, 2018 | |
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. On December 22, 2017, the Tax Cuts and Jobs Act of 2017 (the “Act”) was signed into law making significant changes to the Internal Revenue Code. Changes include, but are not limited to, a corporate tax rate decrease from 35 21 Deferred tax assets reflect the tax effects of net operating losses (“NOLs”), tax credit carryovers, and temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. The most significant item of our deferred tax assets is derived from our Federal NOLs. We have approximately $ 169 168 1.0 150 20 2037 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, 2018 and December 31, 2017, all our remaining net deferred income tax assets were offset by a valuation allowance due to uncertainties with respect to future utilization of 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. |
NET LOSS PER SHARE
NET LOSS PER SHARE | 3 Months Ended |
Mar. 31, 2018 | |
Earnings Per Share [Abstract] | |
NET LOSS PER SHARE | NOTE 14 NET LOSS PER SHARE 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 2018 as the Company reported a net loss for the three month period, and including the effects of the common stock equivalents in the diluted EPS calculations 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 or common stock warrant is greater than the average market price. Three months Ended March 31, 2018 2017 (in thousands except per share data) EPS - basic Numerator: net (loss) income $ (1,494) $ 405 Denominator: Common shares 21,033 11,881 RSUs vested 1 26 Basic weighted average shares outstanding 21,034 11,907 EPS basic $ (0.07) $ 0.03 EPS assuming dilution Numerator: net (loss) income $ (1,494) $ 405 Denominator: Common shares 21,033 11,881 RSUs vested and nonvested 1 202 Stock options - - Common stock warrants - - Diluted weighted average shares outstanding 21,034 12,083 EPS diluted $ (0.07) $ 0.03 Excluded securities: Common stock issuable: Stock options vested and nonvested 1,482 1,396 Common stock warrants 1,842 60 RSUs nonvested 401 - Total excluded potentially dilutive shares 3,725 1,456 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 3 Months Ended |
Mar. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | NOTE 15 COMMITMENTS AND CONTINGENCIES Reglan ® /Metoclopramide Litigation Halsey Drug Company, as predecessor to us, was 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, we were served with a similar complaint by two individual plaintiffs in Nebraska federal court, which plaintiffs voluntarily dismissed in December 2014. In this product liability litigation against numerous pharmaceutical product manufacturers and distributors, including Acura, plaintiffs claim injuries from their use of the Reglan brand of metoclopramide and generic metoclopramide. In the 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 20 years ago. In addition, we believe the June 23, 2011 decision by the U.S. Supreme Court in PLIVA v. Mensing (“Mensing In New Jersey, Generic Defendants, including Acura, filed dispositive motions based on the Mensing In Pennsylvania, the trial court proceedings were stayed on January 12, 2017. On June 15, 2017, the Court entered an Order approving a stipulation which dismisses nearly all of the individual cases against us based upon lack of product identification without prejudice and provides for these cases to be dismissed finally, with prejudice, as of June 15, 2018. We expect that the Court will finally dismiss the Pennsylvania-based litigation against us with prejudice in 2018. Legal fees related to this matter are currently covered by our insurance carrier. In California, on May 24, 2016, the Court entered an Order approving a stipulation which stays the individual cases against us and provides for an agreed upon dismissal protocol for all cases where is a lack of product identification. On January 13, 2017, the Court also entered a general stay of this entire litigation. To date, none of these plaintiffs have confirmed they ingested any of the generic metoclopramide manufactured by us. Therefore, we expect that the lawsuits filed against us will be dismissed voluntarily with prejudice in 2018. 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, 2018 and we are presently unable to determine if any potential loss would be covered by our insurance carrier. DES Litigation On April 12, 2018, an action was commenced against the Company and over twenty-five other pharmaceutical manufacturers in New York State Supreme Court, New York County, captioned Cotto et al. v. Abbott Laboratories, Inc., et al 10.0 10.0 Purdue Pharma Settlement 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 No. 8,389,007 (the “ 007 patent”). In April 2016, Purdue commenced a second patent infringement lawsuit against us and Egalet in the United States District Court for the District of Delaware alleging our Oxaydo product infringes Purdue’s newly issued U.S. Patent No. 9,308,171 (the “171 Patent”). The actions regarding the 007 Patent and the 171 Patent are collectively referred to as the “Actions”. On April 6, 2016, we filed a petition for Inter Partes Review (the “IPR Review”) with the U.S. Patent and Trademark Office (“USPTO”) seeking to invalidate Purdue’s 007 Patent. On May 20, 2016, Purdue on behalf of themselves and certain affiliates, Egalet Corporation, on behalf of itself and its affiliates and we, on behalf of ourselves and our affiliates entered into a settlement agreement (the “Settlement Agreement”) to settle the Actions and the IPR Review. Under the Settlement Agreement the parties dismissed or withdrew the Actions, requested that the USPTO terminate the IPR Review and exchanged mutual releases. No payments were made under the Settlement Agreement. The Settlement Agreement also provides that Purdue will not, in the future, assert certain Purdue U.S. patents, including the 007 Patent, the 171 Patent and related technologies (the “Purdue Patents”) against any Acura Settlement Product or Egalet Settlement Product (except generally in an action or interference by Acura or Egalet challenging a Purdue Patent). Acura Settlement Products and Egalet Settlement Products are certain immediate-release and extended-release products, including Oxaydo. In addition, the Settlement Agreement provides that Purdue will not challenge, with certain exceptions, the Acura/Egalet Patents with respect to the Purdue Settlement Products (as defined below) and that Purdue provides Acura and/or Egalet certain waivers of non-patent marketing exclusivity with respect to Purdue Settlement Products. The Settlement Agreement also provides that Acura and Egalet will not, in the future, assert certain Acura and/or Egalet U.S. patents (the “Acura/Egalet Patents”), including Acura’s Aversion® Technology patents, against any Purdue Settlement Products (except generally in an action or interference by Purdue challenging an Acura/Egalet Patent). Purdue Settlement Products are certain immediate-release and extended-release products. In addition, the Settlement Agreement provides that Acura and Egalet will not challenge, with certain exceptions, the Purdue Patents with respect to the Acura Settlement Products and Egalet Settlement Products and that Acura and Egalet provide Purdue certain waivers of non-patent marketing exclusivity with respect to the Acura Settlement Products and Egalet Settlement Products. In addition, Purdue has certain rights to negotiate to exclusively distribute an authorized generic version of certain Egalet Settlement Products, including, in some circumstances, Oxaydo® and other products using Acura’s Aversion® Technology if licensed to Egalet. The Settlement Agreement specifically excludes our patents related to our Impede® and Limitx technologies from the scope of the Acura/Egalet Patents under the Settlement Agreement. In December 2014, the Company entered into an agreement with Purdue Pharma L.P. to settle a patent interference action regarding certain intellectual property held by Acura (U.S. Patent No. 8,101,630). The dispute centered upon the issue of which company has priority in developing the invention. The parties agreed to forgo protracted litigation and the uncertainties arising therefrom by entering an agreement whereby the Company conceded Purdue Pharma’s claim of priority in exchange for certain financial consideration to us including an immediate non-refundable payment of $ 500 250 Egalet Agreement covering Oxaydo On January 7, 2015, we and Egalet entered into a Collaboration and License Agreement (the “Egalet Agreement”) to commercialize Aversion Oxycodone (formerly known as Oxecta®) under our 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 transferred the approved New Drug Application, or 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. Eaglet launched Oxaydo in the United States late in the third quarter of 2015. 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 is responsible for the fees and expenses relating to the Oxaydo NDA and product line extensions of Oxaydo, provided that Egalet will pay a substantial majority of the expenses and we will pay for the remaining fees and 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. Egalet 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. At March 31, 2018 we have accrued approximately $ 382 Facility Lease The Company leases administrative office space in Palatine, Illinois on a month to month basis at the rate of approximately 2 |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 3 Months Ended |
Mar. 31, 2018 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 16 SUBSEQUENT EVENTS Loan Due January 2, 2020 During the second quarter 2018, we borrowed $ 1.5 2.0 January 2, 2020 Also, in connection with the loans, we and Oxford entered into a fourth amendment to the Oxford Loan Agreement. Pursuant to the fourth amendment, Oxford provided a waiver of compliance with the Unqualified Audit Opinion Covenant in connection with our receipt of our auditor’s opinion with a going concern explanatory paragraph for our 2017 financial statements and allowed us to deliver financial statements up |
REVENUE FROM CONTRACTS WITH C23
REVENUE FROM CONTRACTS WITH CUSTOMER (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Revenue from Contract with Customer [Abstract] | |
Disaggregation of Revenue | The Company has two licenses for currently marketed products containing its technologies; the Nexafed products containing the Impede Technology to MainPointe and Oxaydo containing the Aversion Technology to Egalet. All of the Company’s royalty revenues are earned from these two licenses and from the licensee’s sale of products in the U.S. Royalty revenues by licensee are summarized below: Three Months Ended Egalet $ 190 MainPointe 8 Royalty revenues $ 198 |
PROPERTY, PLANT AND EQUIPMENT (
PROPERTY, PLANT AND EQUIPMENT (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Property Plant and Equipment | Property, plant and equipment at March 31, 2018 and December 31, 2017 are summarized as follows: March 31, December 31, 2018 2017 (in thousands) Building and improvements $ 1,273 $ 1,273 Scientific equipment 598 598 Computer hardware and software 107 107 Machinery and equipment 275 275 Land and improvements 162 162 Other personal property 70 70 Office equipment 27 27 Total 2,512 2,512 Less: accumulated depreciation (1,853) (1,833) Net property, plant and equipment $ 659 $ 679 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Payables and Accruals [Abstract] | |
Accurued Expenses | Accrued expenses at March 31, 2018 and December 31, 2017 are summarized as follows: March 31, December 31, 2018 2017 (in thousands) Cost sharing expenses under license agreement $ 382 $ 328 Other fees and services 35 36 Payroll, payroll taxes and benefits 82 70 Professional services 190 149 Clinical, non-clinical and regulatory services 96 326 Property taxes 18 16 Franchise taxes 14 14 Total $ 817 $ 939 |
DEBT (Tables)
DEBT (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Debt Disclosure [Abstract] | |
Schedule of Debt | Our debt at March 31, 2018 is summarized below (in thousands): Current Long-term Total Loan Due December 1, 2018 Balance at Jan. 1, 2018 $ 2,740 $ - $ 2,740 Principal payments (483) - (483) Classification - - - Balance at Mar. 31, 2018 $ 2,257 $ - $ 2,257 Current Long-term Total Debt Discount Balance at Jan. 1, 2018 $ (32) $ - $ (32) Amortization expense 12 - 12 Classification - - - Balance at Mar. 31, 2018 $ (20) $ - $ (20) Current Long-term Total Deferred Debt Issuance Costs Balance at Jan. 1, 2018 $ (14) $ - $ (14) Amortization expense 5 - 5 Classification - - - Balance at Mar. 31, 2018 $ (9) $ - $ (9) Debt, net at Mar 31, 2018 $ 2,228 $ - $ 2,228 |
Schedule of Interest Expense | Our debt interest expense for the three months ended March 31, 2018 and 2017 consisted of the following: March 31, March 31, 2018 2017 (in thousands) Loan due December 1, 2018 Term loan $ 82 $ 148 Debt discount 12 20 Debt issue costs 5 10 Total interest expense $ 99 $ 178 Less: interest income - 1 Interest expense, net $ 99 $ 177 |
COMMON STOCK WARRANTS (Tables)
COMMON STOCK WARRANTS (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Stockholders Equity Note [Abstract] | |
Schedule Of Common Stock Warrant Activity | Our warrant activity for the three months ended March 31, 2018 and 2017 consisted of the following (in thousands except price data): March 31, 2018 2017 Number WAvg Number WAvg Outstanding, Jan. 1 1,842 $ 0.59 60 $ 2.52 Issued - - - - Exercised - - - - Expired - - - - Modification - - - - Outstanding, Mar. 31 1,842 $ 0.59 60 $ 2.52 |
SHARE-BASED COMPENSATION EXPE28
SHARE-BASED COMPENSATION EXPENSE (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
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 from all types of issued instruments comprised the following (in thousands): Three Months Ended 2018 2017 Research and development expense: Stock options $ 13 $ 34 Restricted stock units 7 - Subtotal $ 20 $ 34 General and administrative expense: Stock options 34 53 Restricted stock units 22 30 Subtotal $ 56 $ 83 Total $ 76 $ 117 |
Schedule of Share-based Compensation, Stock Options, Activity | A summary of our stock option plan activity during the three month periods ending March 31, 2018 and 2017 is shown below: Three Months Ended 2018 2017 Number of Weighted Number of Weighted Outstanding, Jan. 1 1,494 $ 12.33 1,397 $ 13.57 Granted - - - - Exercised - - (1) (0.92) Forfeited or expired (12) (32.50) - - Outstanding, Mar. 31 1,482 $ 12.17 1,396 $ 13.58 Options exercisable 1,235 $ 14.49 1,125 $ 16.52 |
Schedule of Nonvested Share Activity | The following table summarizes information about nonvested stock options outstanding at March 31, 2018 (in thousands except price data): Number of Weighted Outstanding, Jan. 1, 2018 270 $ 0.46 Granted - - Vested (23) 0.77 Forfeited - - Outstanding, Mar. 31, 2018 247 $ 0.43 |
Schedule of Share-based Compensation, Restricted Stock Units Award Activity | A summary of the grants under the RSU Plans as of March 31, 2018 and 2017, and for the three month period then ended consisted of the following (in thousands): Three months Ended March 31, 2018 2017 (in thousands) Number of Number of Number of Number of Outstanding, Jan. 1 462 262 91 91 Granted 267 - 238 - Distributed (262) (262) (67) (67) Vested - 66 - 59 Forfeited or expired - - - - Outstanding, Mar. 31 467 66 262 83 |
NET LOSS PER SHARE (Tables)
NET LOSS PER SHARE (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
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, 2018 2017 (in thousands except per share data) EPS - basic Numerator: net (loss) income $ (1,494) $ 405 Denominator: Common shares 21,033 11,881 RSUs vested 1 26 Basic weighted average shares outstanding 21,034 11,907 EPS basic $ (0.07) $ 0.03 EPS assuming dilution Numerator: net (loss) income $ (1,494) $ 405 Denominator: Common shares 21,033 11,881 RSUs vested and nonvested 1 202 Stock options - - Common stock warrants - - Diluted weighted average shares outstanding 21,034 12,083 EPS diluted $ (0.07) $ 0.03 Excluded securities: Common stock issuable: Stock options vested and nonvested 1,482 1,396 Common stock warrants 1,842 60 RSUs nonvested 401 - Total excluded potentially dilutive shares 3,725 1,456 |
OPERATIONS AND BASIS OF PRESE30
OPERATIONS AND BASIS OF PRESENTATION Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||
Jun. 30, 2018 | Mar. 31, 2018 | Mar. 31, 2017 | Dec. 31, 2017 | Jun. 28, 2018 | Dec. 31, 2013 | |
Cash, Cash Equivalent And Marketable Securities | $ 800 | |||||
Working Capital Deficit | 3,400 | |||||
Retained Earnings (Accumulated Deficit), Total | (381,874) | $ (380,380) | ||||
Operating Income (Loss), Total | (1,395) | $ 582 | 5,200 | |||
Net Income (Loss) Attributable to Parent, Total | (1,494) | $ 405 | ||||
Debt Instrument, Face Amount | $ 10,000 | |||||
Cash, Cash Equivalents, and Refundable Deposits | $ 700 | |||||
First Revenue Event Does Not Occurs [Member] | ||||||
Debt Instrument, Periodic Payment Terms, Balloon Payment to be Paid | 795 | |||||
Loan Agreement With Oxford [Member] | ||||||
Net Income (Loss) Attributable to Parent, Total | $ 5,700 | |||||
Long-term Line of Credit | $ 2,100 | $ 1,500 | ||||
Oxford Term Loan Agreement [Member] | Subsequent Event [Member] | ||||||
Proceeds from Issuance of Long-term Debt | $ 1,500 | |||||
Schutte Note [Member] | Subsequent Event [Member] | ||||||
Debt Instrument, Face Amount | $ 1,500 |
LICENSE AND COLLABORATION AGR31
LICENSE AND COLLABORATION AGREEMENTS - Additional Information (Detail) - USD ($) $ in Thousands | Oct. 09, 2015 | Mar. 31, 2017 | Mar. 16, 2017 | Oct. 31, 2016 | Apr. 30, 2014 | Mar. 31, 2018 | Mar. 31, 2017 |
License Development and Commercialization Agreement [Line Items] | |||||||
Agreement Termination Notice Description | Egalet may terminate the Egalet Agreement for convenience on 120 days prior written notice, which termination may not occur prior to the second anniversary of Egalets launch of Oxaydo. Termination does not affect a partys 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 Egalets supply of Oxaydo for a transition period. | ||||||
Amortization of Intangible Assets | $ 52 | $ 52 | |||||
License Agreement Option Products Description | In addition, MainPointe has the option to add to the MainPointe Agreement certain additional products, or Option Products, containing PSE and utilizing the Impede technology for a fee of $500 thousand per product (for all product strengths). Such Option Products include the product candidate Loratadine with pseudoephedrine. If the territory has been expanded prior to the exercise of a product option, the option fee will be increased to $750 thousand per product. If the territory is expanded after the payment of the $500 thousand product option fee, a one-time $250 thousand fee will be due for each product. If a third party is interested in developing or licensing rights to an Option Product, MainPointe must exercise its option for that product or its option rights for such product will terminate. | ||||||
Patents [Member] | |||||||
License Development and Commercialization Agreement [Line Items] | |||||||
Payment for Termination | $ 2,000 | ||||||
Egalet | |||||||
License Development and Commercialization Agreement [Line Items] | |||||||
Payment for Termination | $ 2,000 | ||||||
Minimum Net Sales Reaching Description | one-time $12.5 million sales-based milestone payment when worldwide Oxaydo net sales reach $150 million in a calendar year. | ||||||
Licenses Revenue | $ 5,000 | ||||||
Proceeds from Milestone Payment On Agreement | $ 2,500 | ||||||
Amortization of Intangible Assets | 208 | ||||||
Finite-Lived Intangible Asset, Useful Life | 9 years 8 months 12 days | ||||||
Finite-Lived Intangible Assets, Amortization Expense, Year Two | $ 208 | ||||||
Main Pointe Agreement [Member] | |||||||
License Development and Commercialization Agreement [Line Items] | |||||||
Proceeds from License Fees Received | $ 2,500 | $ 2,500 | |||||
Licensing Agreement, Royalty Percentage | 7.50% | 7.50% | |||||
Main Pointe Agreement [Member] | UNITED KINGDOM | |||||||
License Development and Commercialization Agreement [Line Items] | |||||||
Proceeds from License Fees Received | $ 1,000 | ||||||
Main Pointe Agreement [Member] | JAPAN | |||||||
License Development and Commercialization Agreement [Line Items] | |||||||
Proceeds from License Fees Received | 500 | ||||||
Main Pointe Agreement [Member] | South Korea [Member] | |||||||
License Development and Commercialization Agreement [Line Items] | |||||||
Proceeds from License Fees Received | $ 250 | ||||||
Kempharm Agreement [Member] | |||||||
License Development and Commercialization Agreement [Line Items] | |||||||
Proceeds from License Fees Received | $ 3,500 | ||||||
Kempharm Agreement [Member] | Minimum | |||||||
License Development and Commercialization Agreement [Line Items] | |||||||
Additional Upfront Payment Receivable | $ 1,000 |
REVENUE FROM CONTRACTS WITH C32
REVENUE FROM CONTRACTS WITH CUSTOMER (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Royalty revenues | $ 198 | $ 74 |
Egalet | ||
Royalty revenues | 190 | |
Main Pointe | ||
Royalty revenues | $ 8 |
REVENUE FROM CONTRACTS WITH C33
REVENUE FROM CONTRACTS WITH CUSTOMER (Details Textual) | 3 Months Ended |
Mar. 31, 2018USD ($) | |
Contract Balance and Performance Obligations,Description | The Companys reported contract assets and contract liability balances under the license and collaboration agreements at either March 31, 2018 or December 31, 2017 was $0.00. |
Product Sales [Member] | |
Cumulative Effect of New Accounting Principle in Period of Adoption | $ 0 |
PROPERTY, PLANT AND EQUIPMENT34
PROPERTY, PLANT AND EQUIPMENT (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Property, Plant and Equipment [Line Items] | ||
Total | $ 2,512 | $ 2,512 |
Less: accumulated depreciation | (1,853) | (1,833) |
Net property, plant and equipment | 659 | 679 |
Building and improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total | 1,273 | 1,273 |
Scientific equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total | 598 | 598 |
Computer hardware and software | ||
Property, Plant and Equipment [Line Items] | ||
Total | 107 | 107 |
Machinery and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total | 275 | 275 |
Land and improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total | 162 | 162 |
Other personal property | ||
Property, Plant and Equipment [Line Items] | ||
Total | 70 | 70 |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total | $ 27 | $ 27 |
ACCRUED EXPENSES (Detail)
ACCRUED EXPENSES (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Accounts Payable and Accrued Liabilities [Line Items] | ||
Cost sharing expenses under license agreement | $ 382 | $ 328 |
Other fees and services | 35 | 36 |
Payroll, payroll taxes and benefits | 82 | 70 |
Professional services | 190 | 149 |
Clinical, non-clinical and regulatory services | 96 | 326 |
Property taxes | 18 | 16 |
Franchise taxes | 14 | 14 |
Total | $ 817 | $ 939 |
DEBT - Summary of Debt (Detail)
DEBT - Summary of Debt (Detail) $ in Thousands | 3 Months Ended |
Mar. 31, 2018USD ($) | |
Current | |
Balance at Jan. 1, 2018 | $ 2,740 |
Principal payments | (483) |
Classification | 0 |
Balance at Mar. 31, 2018 | 2,257 |
Debt Discount | |
Balance at Jan. 1, 2018 | (32) |
Classification | 0 |
Amortization expense | 12 |
Balance at Mar. 31, 2018 | (20) |
Deferred Debt Issuance Costs | |
Balance at Jan. 1, 2018 | (14) |
Classification | 0 |
Amortization expense | 5 |
Balance at Mar. 31, 2018 | (9) |
Debt, net at Mar 31, 2018 | 2,228 |
Long-term [Member] | |
Current | |
Balance at Jan. 1, 2018 | 0 |
Principal payments | 0 |
Classification | 0 |
Balance at Mar. 31, 2018 | 0 |
Debt Discount | |
Balance at Jan. 1, 2018 | 0 |
Classification | 0 |
Amortization expense | 0 |
Balance at Mar. 31, 2018 | 0 |
Deferred Debt Issuance Costs | |
Balance at Jan. 1, 2018 | 0 |
Classification | 0 |
Amortization expense | 0 |
Balance at Mar. 31, 2018 | 0 |
Debt, net at Mar 31, 2018 | 0 |
Current [Member] | |
Current | |
Balance at Jan. 1, 2018 | 2,740 |
Principal payments | (483) |
Classification | 0 |
Balance at Mar. 31, 2018 | 2,257 |
Debt Discount | |
Balance at Jan. 1, 2018 | (32) |
Classification | 0 |
Amortization expense | 12 |
Balance at Mar. 31, 2018 | (20) |
Deferred Debt Issuance Costs | |
Balance at Jan. 1, 2018 | (14) |
Classification | 0 |
Amortization expense | 5 |
Balance at Mar. 31, 2018 | (9) |
Debt, net at Mar 31, 2018 | $ 2,228 |
DEBT - Interest Expense (Detail
DEBT - Interest Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Schedule Of Interest Expense [Line Items] | ||
Term loan | $ 82 | $ 148 |
Debt discount | 12 | 20 |
Debt issue costs | 5 | 10 |
Total interest expense | 99 | 178 |
Less: interest income | 0 | 1 |
Interest expense, net | $ 99 | $ 177 |
DEBT - Additional Information (
DEBT - Additional Information (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 1 Months Ended | 3 Months Ended | ||||||
Jul. 31, 2017 | Oct. 31, 2016 | Jan. 31, 2015 | Mar. 31, 2018 | Mar. 31, 2017 | Jun. 30, 2018 | Dec. 31, 2017 | Dec. 31, 2013 | |
Debt Instrument [Line Items] | ||||||||
Debt instrument principal amount | $ 10,000 | |||||||
Debt default long term debt percentage | 13.35% | |||||||
Debt instrument, fee amount | $ 50 | |||||||
Debt consulting placement fee | 100 | |||||||
Debt related commitment fees and debt issuance costs | 5 | $ 10 | ||||||
Debt instrument unamortized discount | 20 | $ 32 | ||||||
Debt instrument Cash Maintenance | $ 2,500 | |||||||
Repayments of Debt | 483 | 445 | ||||||
Debt Instrument, Periodic Payment | $ 260 | |||||||
Debt Instrument, Interest Rate, Effective Percentage | 10.16% | |||||||
Proceeds from Issuance or Sale of Equity | $ 6,000 | |||||||
Interest Payable, Current | $ 745 | 700 | ||||||
Proceeds from Issuance of Private Placement | $ 4,000 | |||||||
Restricted Cash and Cash Equivalents, Current | 0 | $ 2,500 | ||||||
Term Loan [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt related commitment fees and debt issuance costs | 231 | |||||||
Interest Payable, Current | 745 | $ 700 | ||||||
Schutte Note [Member] | Subsequent Event [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument principal amount | $ 1,000 | |||||||
Loan Agreement [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, interest rate, stated percentage | 8.35% | |||||||
Repayments of Debt | 5,000 | $ 5,000 | ||||||
Proceeds from Issuance or Sale of Equity | 2,500 | |||||||
Maximum [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 7.98 | |||||||
Minimum [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 2.52 | |||||||
Proceeds from Issuance or Sale of Equity | $ 3,000 | |||||||
Main Pointe Agreement [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Upfront Payments Received | 2,500 | |||||||
Oxford Term Loan Agreement [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Restricted Cash and Cash Equivalents, Current | $ 2,500 | |||||||
Warrant | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument unamortized discount | $ 400 | |||||||
Warrants to purchase common stock | 60 | |||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 2.52 | $ 2.52 | ||||||
Warrants, expiry date | December 27, 2020 | |||||||
Additions To Debt Instrument Unamortized Discount | $ 33 | |||||||
First Revenue Event Occurs | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument periodic payment terms balloon payment to be paid | $ 795 | |||||||
Prior To December 27 2015 | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument prepayment percentage | 1.00% |
RELATED PARTY TRANSACTIONS- Add
RELATED PARTY TRANSACTIONS- Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | ||||
Jul. 31, 2017 | Mar. 16, 2017 | Jun. 30, 2018 | Mar. 31, 2017 | Mar. 31, 2018 | Dec. 31, 2017 | |
Related Party Transaction [Line Items] | ||||||
Number of Common Stock Need to Hold to Designate As Director | 600,000 | |||||
Royalty Receivable | $ 192 | $ 71 | ||||
Schutte Note [Member] | Subsequent Event [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Proceeds from Issuance of Long-term Debt | $ 1,500 | |||||
Main Pointe Agreement [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Proceeds from License Fees Received | $ 2,500 | $ 2,500 | ||||
Asset Transferred, License Agreement | $ 309 | |||||
Licensing Agreement, Royalty Percentage | 7.50% | 7.50% | ||||
Royalty Receivable | 8 | |||||
Investor [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.528 | |||||
Investor [Member] | Private Placement [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Sale of Stock, Consideration Received on Transaction | $ 4,000 | |||||
Sale of Stock, Number of Shares Issued in Transaction | 8,912,655 | |||||
Sale of Stock, Price Per Share | $ 0.4488 | |||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.528 | |||||
Sale Of Stock Issue Price Description | 85 | |||||
Warrants Not Settleable in Cash, Fair Value Disclosure | $ 495 | |||||
Class Of Warrants Or Rights Expiry Period | 5 years |
COMMON STOCK WARRANTS - Schedul
COMMON STOCK WARRANTS - Schedule Of Common Stock Warrant Activity (Detail) - $ / shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Stock Option Plan [Member] | ||
Number of Options | ||
Number of Options Outstanding, beginning | 1,494 | 1,397 |
Number of Options, Issued | 0 | 0 |
Number of Options, Exercised | 0 | 1 |
Number of Options Outstanding, ending | 1,482 | 1,396 |
Weighted Average Exercise Price | ||
Weighted Average Exercise Price, beginning | $ 12.33 | $ 13.57 |
Weighted Average Exercise Price, Issued | 0 | 0 |
Weighted Average Exercise Price, Exercised | 0 | 0.92 |
Weighted Average Exercise Price, ending | $ 12.17 | $ 13.58 |
Warrant [Member] | ||
Number of Options | ||
Number of Options Outstanding, beginning | 1,842 | 60 |
Number of Options, Issued | 0 | 0 |
Number of Options, Exercised | 0 | 0 |
Number of Options, Expired | 0 | 0 |
Number of Options, Modification | 0 | 0 |
Number of Options Outstanding, ending | 1,842 | 60 |
Weighted Average Exercise Price | ||
Weighted Average Exercise Price, beginning | $ 0.59 | $ 2.52 |
Weighted Average Exercise Price, Issued | 0 | 0 |
Weighted Average Exercise Price, Exercised | 0 | 0 |
Weighted Average Exercise Price, Expired | 0 | 0 |
Weighted Average Exercise Price, Modification | 0 | 0 |
Weighted Average Exercise Price, ending | $ 0.59 | $ 2.52 |
COMMON STOCK WARRANTS - Additio
COMMON STOCK WARRANTS - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | |
Jul. 31, 2017 | Mar. 31, 2018 | Dec. 31, 2013 | |
Class of Warrant or Right [Line Items] | |||
Secured Debt | $ 10,000 | ||
Stock Issued During Period, Value, New Issues | $ 4,000 | ||
Investor [Member] | |||
Class of Warrant or Right [Line Items] | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.528 | ||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 1,782,531 | ||
Class of Warrant or Right, Term | 5 years | ||
Investor [Member] | Private Placement [Member] | |||
Class of Warrant or Right [Line Items] | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.528 | ||
Warrant | |||
Class of Warrant or Right [Line Items] | |||
Common stock warrant exercisable outstanding, shares | 60,000 | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 2.52 | $ 2.52 | |
Warrant | Private Placement [Member] | |||
Class of Warrant or Right [Line Items] | |||
Stock Issued During Period, Value, New Issues | $ 495 |
SHARE-BASED COMPENSATION EXPE42
SHARE-BASED COMPENSATION EXPENSE -Recognition of Share-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Research and development expense | $ 650 | $ 711 |
Total | 76 | 117 |
Research and Development Expense [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Research and development expense | 20 | 34 |
Research and Development Expense [Member] | Stock options [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Research and development expense | 13 | 34 |
Research and Development Expense [Member] | Restricted Stock units [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Research and development expense | 7 | 0 |
General and Administrative Expense [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
General and administrative expense | 56 | 83 |
General and Administrative Expense [Member] | Stock options [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
General and administrative expense | 34 | 53 |
General and Administrative Expense [Member] | Restricted Stock units [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
General and administrative expense | $ 22 | $ 30 |
SHARE-BASED COMPENSATION EXPE43
SHARE-BASED COMPENSATION EXPENSE - Stock Option Award Activity (Detail) - Stock Option Plan [Member] - $ / shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Share based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of Options Outstanding, beginning | 1,494 | 1,397 |
Number of Options, Granted | 0 | 0 |
Number of Options, Exercised | 0 | (1) |
Number of Options, Forfeited or expired | (12) | 0 |
Number of Options Outstanding, ending | 1,482 | 1,396 |
Number of Options exercisable | 1,235 | 1,125 |
Weighted Average Exercise Price, beginning | $ 12.33 | $ 13.57 |
Weighted Average Exercise Price, Granted | 0 | 0 |
Weighted Average Exercise Price, Exercised | 0 | (0.92) |
Weighted Average Exercise Price, Forfeited or expired | (32.50) | 0 |
Weighted Average Exercise Price, ending | 12.17 | 13.58 |
Weighted Average Exercise Price, Options exercisable | $ 14.49 | $ 16.52 |
SHARE-BASED COMPENSATION EXPE44
SHARE-BASED COMPENSATION EXPENSE - Summary of Information about Non Vested Stock Options (Detail) - Non Vested Stock Options [Member] shares in Thousands | 3 Months Ended |
Mar. 31, 2018$ / sharesshares | |
Summary Of Information About Non Vested Stock Options Disclosure [Line Items] | |
Outstanding, beginning | shares | 270 |
Granted | shares | 0 |
Vested | shares | (23) |
Forfeited | shares | 0 |
Outstanding, ending | shares | 247 |
Outstanding beginning, Weighted Average Fair Value | $ / shares | $ 0.46 |
Granted, Weighted Average Fair Value | $ / shares | 0 |
Vested, Weighted Average Fair Value | $ / shares | 0.77 |
Forfeited, Weighted Average Fair Value | $ / shares | 0 |
Outstanding ending, Weighted Average Fair Value | $ / shares | $ 0.43 |
SHARE-BASED COMPENSATION EXPE45
SHARE-BASED COMPENSATION EXPENSE - Summary of RSU Plan (Detail) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Restricted Stock Units [Member] | ||
Share based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Outstanding, beginning | 462 | 91 |
Granted | 267 | 238 |
Distributed | (262) | (67) |
Vested | 0 | 0 |
Forfeited or expired | 0 | 0 |
Outstanding, ending | 467 | 262 |
Vested Restricted Stock Units (RSUs) [Member] | ||
Share based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Outstanding, beginning | 262 | 91 |
Granted | 0 | 0 |
Distributed | (262) | (67) |
Vested | 66 | 59 |
Forfeited or expired | 0 | 0 |
Outstanding, ending | 66 | 83 |
SHARE-BASED COMPENSATION EXPE46
SHARE-BASED COMPENSATION EXPENSE- Additional Information (Detail) - USD ($) shares in Thousands, $ in Thousands | 1 Months Ended | 3 Months Ended | ||||||
Jan. 31, 2018 | Dec. 31, 2017 | Jan. 31, 2017 | Jan. 31, 2016 | May 31, 2014 | Mar. 31, 2018 | Nov. 30, 2017 | Mar. 31, 2017 | |
Employee Benefit Plans Disclosure [Line Items] | ||||||||
Aggregate intrinsic value of the option awards vested | $ 0 | $ 0 | ||||||
Unrecognized compensation cost on unvested option awards outstanding | $ 67 | |||||||
Director [Member] | ||||||||
Employee Benefit Plans Disclosure [Line Items] | ||||||||
Deferred Compensation Arrangement with Individual, Recorded Liability | $ 41 | |||||||
Share Based Compensation Non Employee Services Transaction cash Settlement Percentage | 40.00% | |||||||
2005 Restricted Stock Unit Award Plan [Member] | Director [Member] | ||||||||
Employee Benefit Plans Disclosure [Line Items] | ||||||||
Deferred Compensation Arrangement with Individual, Recorded Liability | $ 13 | |||||||
Restricted Stock Award Plan [Member] | ||||||||
Employee Benefit Plans Disclosure [Line Items] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 1,000 | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 60 | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 25.00% | 100.00% | 25.00% | |||||
Stock Issued During Period Shares Stock Options Exercised Net Of Shares For Tax Withholdings | 262 | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 1,500 | |||||||
Share-Based Compensation Arrangement By Share-Based Payment Award, Equity Instruments Other Than Options, Grants In Period | 67 | 200 | ||||||
Restricted Stock Award Plan [Member] | Settled In Cash [Member] | ||||||||
Employee Benefit Plans Disclosure [Line Items] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 18 | |||||||
Stock Issued During Period Shares Stock Options Exercised Net Of Shares For Tax Withholdings | 24 | |||||||
Restricted Stock Award Plan [Member] | Distributed In Common Stock [Member] | ||||||||
Employee Benefit Plans Disclosure [Line Items] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 67 | |||||||
Restricted Stock Award Plan [Member] | January 4, 2016 Award Distributed [Member] | ||||||||
Employee Benefit Plans Disclosure [Line Items] | ||||||||
Share Based Compensation Arrangement Share Based Payment Shares Reserved For Future Distribution | 66 | 1 | ||||||
Restricted Stock Award Plan [Member] | Convertible Common Stock [Member] | ||||||||
Employee Benefit Plans Disclosure [Line Items] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 49 | |||||||
Stock Issued During Period Shares Stock Options Exercised Net Of Shares For Tax Withholdings | 238 | |||||||
Restricted Stock 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 | 22 | |||||||
Deferred Compensation Arrangement with Individual, Recorded Liability | $ 41 | |||||||
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 | 400 | |||||||
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, Exercises in Period | 1 | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Shares Purchased for Award | 3 | |||||||
Deferred Compensation Arrangement with Individual, Recorded Liability | $ 13 | |||||||
Restricted Stock Unit Award Plan [Member] | ||||||||
Employee Benefit Plans Disclosure [Line Items] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Description | stock, for up to 40% |
INCOME TAXES - Additional Infor
INCOME TAXES - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Line Items] | |||
Federal NOLs | $ 169,000 | $ 168,000 | |
U.S. statutory tax rate | 35.00% | ||
State income tax benefits | $ 1,000 | ||
Operating Loss Carryforwards Expiration Term | 20 years | ||
Operating Loss Carry Forwards Expiration Year | 2,037 | ||
Tax Credit Carryforward, Amount | $ 150 | ||
Scenario, Plan [Member] | |||
Income Tax Disclosure [Line Items] | |||
U.S. statutory tax rate | 21.00% |
NET LOSS PER SHARE - Reconcilia
NET LOSS PER SHARE - Reconciliation of Numerators and Denominators of Basic and Diluted EPS (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
EPS - basic and diluted | ||
Numerator: net (loss) income | $ (1,494) | $ 405 |
Denominator: | ||
Common shares | 21,033 | 11,881 |
RSUs - vested | 1 | 26 |
Basic weighted average shares outstanding | 21,034 | 11,907 |
EPS - basic | $ (0.07) | $ 0.03 |
EPS - basic and diluted | ||
Numerator: net (loss) income | $ (1,494) | $ 405 |
Denominator: | ||
Common shares | 21,033 | 11,881 |
RSUs - vested and nonvested | 1 | 202 |
Diluted weighted average shares outstanding | 21,034 | 12,083 |
EPS - diluted | $ (0.07) | $ 0.03 |
Common stock issuable: | ||
Total excluded potentially dilutive shares | 3,725 | 1,456 |
Employee Stock Option [Member] | ||
Denominator: | ||
Stock options | 0 | 0 |
Common stock issuable: | ||
Total excluded potentially dilutive shares | 1,482 | 1,396 |
Warrant [Member] | ||
Denominator: | ||
Common stock warrants | 0 | 0 |
Common stock issuable: | ||
Total excluded potentially dilutive shares | 1,842 | 60 |
Restricted Stock Units (RSUs) [Member] | ||
Common stock issuable: | ||
Total excluded potentially dilutive shares | 401 | 0 |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - Additional Information (Detail) - USD ($) $ in Thousands | Apr. 12, 2018 | Jun. 30, 2015 | Mar. 31, 2018 | Dec. 31, 2014 |
Commitments and Contingencies Disclosure [Line Items] | ||||
Accrued Cost Sharing Expenses Clinical Studies | $ 382 | |||
Purdue Pharma [Member] | ||||
Commitments and Contingencies Disclosure [Line Items] | ||||
Litigation Settlement, Expense | $ 250 | $ 500 | ||
Palatine Illinois | ||||
Commitments and Contingencies Disclosure [Line Items] | ||||
Leases administrative office space | $ 2 | |||
Scenario, Forecast [Member] | ||||
Commitments and Contingencies Disclosure [Line Items] | ||||
Gain Contingency, Unrecorded Amount | $ 10,000 | |||
Loss Contingency, Damages Sought, Value | $ 10,000 |
SUBSEQUENT EVENTS - Additional
SUBSEQUENT EVENTS - Additional Information (Detail) - Subsequent Event [Member] - Schutte Note [Member] $ in Millions | 3 Months Ended |
Jun. 30, 2018USD ($) | |
Subsequent Event [Line Items] | |
Proceeds from Issuance of Long-term Debt | $ 1.5 |
Debt Instrument, Basis Spread on Variable Rate | 2.00% |
Debt Instrument, Maturity Date | Jan. 2, 2020 |