Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2018 | Nov. 26, 2018 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2018 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q3 | |
Entity Registrant Name | ACURA PHARMACEUTICALS, INC | |
Entity Central Index Key | 786,947 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Trading Symbol | ACUR | |
Entity Common Stock, Shares Outstanding | 21,033,528 | |
Entity Emerging Growth Company | false | |
Entity Small Business | true |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Assets: | ||
Cash and cash equivalents | $ 18 | $ 2,220 |
Royalty receivable | 108 | 71 |
Prepaid expenses and other current assets | 249 | 275 |
Refundable retainer deposits | 80 | 0 |
Total current assets | 455 | 2,566 |
Income tax receivable | 135 | 135 |
Property, plant and equipment, net (Note 6) | 623 | 679 |
Intangible asset, net of accumulated amortization of $931 and $776 (Note 3) | 1,069 | 1,224 |
Total assets | 2,282 | 4,604 |
Liabilities: | ||
Accounts payable | 781 | 3 |
Accrued expenses (Note 7) | 950 | 939 |
Accrued interest | 781 | 700 |
Other current liabilities | 15 | 41 |
Sales returns liability | 254 | 254 |
Debt, net of discounts (Note 8) | 1,016 | 2,694 |
Total current liabilities | 3,797 | 4,631 |
Accrued interest to related party | 39 | 0 |
Debt to related party, net of discounts | 2,115 | 0 |
Total liabilities | 5,951 | 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 September 30, 2018 and December 31, 2017, respectively | 210 | 208 |
Additional paid-in capital | 380,351 | 380,145 |
Accumulated deficit | (384,230) | (380,380) |
Total stockholders' deficit | (3,669) | (27) |
Total liabilities and stockholders' deficit | $ 2,282 | $ 4,604 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) shares in Thousands, $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Accumulated amortization, deferred finance costs | $ 931 | $ 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 | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Revenues: | ||||
License fee revenue | $ 0 | $ 0 | $ 0 | $ 2,500 |
Collaboration revenue | 0 | 0 | 0 | 59 |
Royalty revenue | 73 | 83 | 347 | 226 |
Product sales, net | 0 | 0 | 0 | 107 |
Total revenues, net | 73 | 83 | 347 | 2,892 |
Cost and expenses: | ||||
Cost of sales | 0 | 0 | 0 | 128 |
Research and development | 549 | 1,077 | 1,676 | 2,808 |
Selling, marketing, general and administrative | 543 | 1,068 | 2,332 | 3,427 |
Total cost and expenses | 1,092 | 2,145 | 4,008 | 6,363 |
Operating loss | (1,019) | (2,062) | (3,661) | (3,471) |
Interest expense, net (Note 8) | (76) | (138) | (189) | (473) |
Loss before income taxes | (1,095) | (2,200) | (3,850) | (3,944) |
Provision for income taxes | 0 | 0 | 0 | 0 |
Net loss | $ (1,095) | $ (2,200) | $ (3,850) | $ (3,944) |
Loss per share: | ||||
Basic | $ (0.05) | $ (0.12) | $ (0.18) | $ (0.27) |
Diluted | $ (0.05) | $ (0.12) | $ (0.18) | $ (0.27) |
Weighted average shares outstanding: | ||||
Basic | 21,168 | 16,686 | 21,101 | 14,147 |
Diluted | 21,168 | 16,686 | 21,101 | 14,147 |
CONSOLIDATED STATEMENT OF CHANG
CONSOLIDATED STATEMENT OF CHANGES IN ACCUMULATED STOCKHOLDERS' DEFICIT - 9 months ended Sep. 30, 2018 - USD ($) shares in Thousands, $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] |
Balance at Dec. 31, 2017 | $ (27) | $ 208 | $ 380,145 | $ (380,380) |
Balance (in shares) at Dec. 31, 2017 | 20,796 | |||
Net loss | (3,850) | $ 0 | 0 | (3,850) |
Non-cash share-based compensation | 174 | 0 | 174 | 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 Sep. 30, 2018 | $ (3,669) | $ 210 | $ 380,351 | $ (384,230) |
Balance (in shares) at Sep. 30, 2018 | 21,034 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Cash Flows from Operating Activities: | ||
Net loss | $ (3,850) | $ (3,944) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 56 | 68 |
Provision for sales returns | 0 | 49 |
Non-cash share-based compensation | 174 | 353 |
Capitalized debt discount | (103) | 0 |
Amortization of debt discount and deferred debt issue costs | 59 | 79 |
Amortization of intangible asset | 155 | 155 |
Gain on disposal of machinery & equipment | 0 | (3) |
Change in assets and liabilities: | ||
Trade accounts receivable | 0 | 23 |
Collaboration revenue receivable | 0 | 79 |
Royalty receivable | (37) | (15) |
Inventory | 0 | 103 |
Prepaid expenses and other current assets | 26 | (174) |
Refundable retainer deposits | (80) | 0 |
Accounts payable | 778 | 50 |
Accrued expenses | 11 | 187 |
Accrued interest | 120 | 135 |
Other current liabilities | 6 | 17 |
Sales returns liability | 0 | (50) |
Net cash used in operating activities | (2,685) | (2,888) |
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: | ||
Issuance of common stock | 0 | 4,000 |
Proceeds from distribution of restricted stock units | 2 | 0 |
Proceeds from loan maturing January 2, 2020 | 2,200 | 0 |
Principal payments on loan maturing December 1, 2018 | (1,719) | (1,815) |
Net cash provided by financing activities | 483 | 2,185 |
Net decrease in cash, cash equivalents, and restricted cash | (2,202) | (394) |
Cash, cash equivalents, and restricted cash at beginning of period | 2,220 | 5,181 |
Cash and cash equivalents at end of period | 18 | 4,787 |
Supplemental disclosure of cash flow information: | ||
Cash interest payments on loan maturing December 1, 2018 | 112 | 262 |
Cash | 18 | 2,284 |
Cash equivalents | 0 | 2,503 |
Total cash and cash equivalents cash show in the consolidated statements of cash flows | $ 18 | $ 4,787 |
CONSOLIDATED STATEMENTS OF CA_2
CONSOLIDATED STATEMENTS OF CASH FLOWS (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2018 | Jun. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Payments of Debt Issuance Costs | $ 29 | $ 74 | $ 0 | $ 103 | $ 0 |
Proceeds from Issuance of Long-term Debt | $ 700 | $ 1,500 | $ 2,200 | $ 0 |
OPERATIONS AND BASIS OF PRESENT
OPERATIONS AND BASIS OF PRESENTATION | 9 Months Ended |
Sep. 30, 2018 | |
Description Of Operation And Summary Of Significant Accounting Policies Disclosure [Abstract] | |
OPERATIONS AND BASIS OF PRESENTATION | NOTE 1 – 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 immediate-release tablets containing hydrocodone bitartrate and acetaminophen as the lead product candidate due to its large market size 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 nine month period ended September 30, 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 . As of September 30, 2018, we had cash and refundable retainer deposits of $98 thousand, working capital deficit of $3.3 million and an accumulated deficit of $384.2 million. We had a loss from operations of $3.7 million and a net loss of $3.9 million for the nine months ended September 30, 2018. We have suffered recurring losses from operations and have not generated positive cash flows from operations. We had a loss from operations of $5.2 million and a net loss of $5.7 million for the year ended December 31, 2017. We anticipate operating losses to continue for the foreseeable future. To date, we have borrowed a total of $4.15 million from John Schutte, a principal of MainPointe and our largest shareholder, including $150 thousand received on . As of November 26, 2018 we had cash of $150 thousand. With the net proceeds to the Company resulting from the loans from Mr. Schutte, we expect our cash will only be sufficient to fund operations into early December 2018. 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 | 9 Months Ended |
Sep. 30, 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 September 30, 2018 Revenue from Contracts with Customers The Company adopted Accounting Standards Codification Topic 606—Revenue 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. (See Note 4). 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 . ASU 2016-16 eliminates from Topic 740, Income Taxes, the recognition exception for intra-entity asset transfers other than inventory so that an entity’s financial statements reflect the current and deferred tax consequences of those intra-entity asset transfers when they occur. The new standard will be effective for annual and interim periods, within those fiscal years, 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. New accounting standards which have not been adopted on or before September 30, 2018 Fair Value Measurements In August 2018, the FASB issued ASU 2018-13 , Fair Value Measurement (Topic 820): Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement 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 | 9 Months Ended |
Sep. 30, 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 million. Our termination payment of $2.0 million has been recorded in our financial statements as an intangible asset and is being amortized over the remaining useful life of the patent covering Aversion Oxycodone, which was 9.7 years as of the date the agreement was terminated. We have recorded amortization expense of $155 thousand in each of the nine month periods ending September 30, 2018 and 2017. Annual amortization of the patent for its remaining life through 2021 is expected to approximate $208 thousand each year or $52 thousand per quarter. 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 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 million license fee upon signing of the Egalet Agreement and on October 9, 2015, paid us a $2.5 million milestone in connection with the first commercial sale of Oxaydo. We will be entitled to a one-time $12.5 million sales-based milestone payment when worldwide Oxaydo net sales reach $150 million in a calendar year. We are receiving from Egalet a stepped royalty at percentage rates ranging from mid-single digits to double-digits based on Oxaydo net sales during each calendar year (excluding net sales resulting from our co-promotion efforts). In any calendar year of the agreement in which net sales exceed a specified threshold, we will receive a double digit royalty on all Oxaydo net sales in that year (excluding net sales resulting from our co-promotion efforts). If we exercise our co-promotion rights, we will receive a share of the gross margin attributable to incremental Oxaydo net sales from our co-promotion activities. Egalet’s royalty payment obligations commence on the first commercial sale of Oxaydo and expire, on a country-by-country basis, upon the expiration of the last to expire valid patent claim covering Oxaydo in such country (or if there are no patent claims in such country, then upon the expiration of the last valid claim in the United States or the date when no valid and enforceable listable patent in the FDA’s Orange Book remains with respect to Oxaydo). Royalties will be reduced upon the entry of generic equivalents, as well as for payments required to be made by Egalet to acquire intellectual property rights to commercialize Oxaydo, with an aggregate minimum floor. The Egalet Agreement expires upon the expiration of Egalet’s royalty payment obligations in all countries. Either party may terminate the Egalet Agreement in its entirety if the other party breaches a payment obligation, or otherwise materially breaches the Egalet Agreement, subject to applicable cure periods, or in the event the other party makes an assignment for the benefit of creditors, files a petition in bankruptcy or otherwise seeks relief under applicable bankruptcy laws. We also may terminate the Egalet Agreement with respect to the U.S. and other countries if Egalet materially breaches its commercialization obligations. Egalet may terminate the Egalet Agreement for convenience on 120 days prior written notice, which termination may not occur prior to the second anniversary of Egalet’s launch of Oxaydo. 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. On October 31, 2018, Egalet issued a press release and filed a SEC Form 8-K announcing its filing for voluntary pre-arranged plan of reorganization under Chapter 11 of the United States Bankruptcy Code in the District of Delaware. As Egalet’s announcement is very recent, at this time it is uncertain as to the impact on our license agreement with them, but we do anticipate a delay in the Egalet’s payment of their third quarter 2018 royalty payment to us until the first quarter 2019, assuming no objections or changes to their Chapter 11 proceedings. Our royalty receivable is $80 thousand at September 30, 2018 and remains unreserved for collectability at this time as we monitor the proceedings. We have recognized royalty revenue under the Egalet license agreement of $70 thousand and $330 thousand for the three and nine month periods ending September 30, 2018. 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 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 million. The MainPointe Agreement also provides for our receipt of a 7.5% royalty on net sales of the licensed products. The royalty payment for each product will expire on a country-by-country basis when the Impede® patent rights for such country have expired or are no longer valid; provided that if no Impede patent right exists in a country, then the royalty term for that country will be the same as the royalty term for the United States. After the expiration of a royalty term for a country, MainPointe retains a royalty free license to our Impede® for products covered by the Agreement in such country. 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 million, $500 thousand and $250 thousand, respectively. 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 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® 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 million. If KemPharm exercises its option to use our Aversion with more than the two licensed prodrugs, then KemPharm will pay us up to $1.0 million for each additional prodrug license. In addition, we will receive from KemPharm a low single digit royalty on commercial sales by KemPharm of products developed using our Aversion under the KemPharm Agreement. KemPharm’s royalty payment obligations commence on the first commercial sale of a product using our Aversion and expire, on a country-by-country basis, upon the expiration of the last to expire patent claim of the Aversion covering a product in such country, at which time the license for the particular product and country becomes fully paid and royalty free. 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 pseudoephedrine–containing product (the “Bayer Licensed Product”) and providing for the joint development of such product utilizing our Impede Technology for the U.S. market. 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 CUSTOMERS | 9 Months Ended |
Sep. 30, 2018 | |
Revenue from Contract with Customer [Abstract] | |
REVENUE FROM CONTRACTS WITH CUSTOMERS | NOTE 4 – REVENUE FROM CONTRACTS WITH CUSTOMERS 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 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 September 30, 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 no impact from the recognition of revenue for Nexafed product sales under the adoption of ASC 606. 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 September 30, 2018 Nine months Ended September 30, 2018 (in thousands) Egalet $ 70 $ 330 MainPointe 3 17 Royalty revenues $ 73 $ 347 Contract Balance and Performance Obligations The Company’s reported contract assets and contract liability balances under the license and collaboration agreements at either September 30, 2018 or December 31, 2017 was $0 thousand. Contract assets may be reported in future periods under prepaid expenses or other current assets on the balance sheet. Contract liabilities may be reported in future periods consisting of deferred revenue as presented on the balance sheet. |
RESEARCH AND DEVELOPMENT ACTIVI
RESEARCH AND DEVELOPMENT ACTIVITIES | 9 Months Ended |
Sep. 30, 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 September 30, 2018 or December 31, 2017. |
PROPERTY, PLANT AND EQUIPMENT
PROPERTY, PLANT AND EQUIPMENT | 9 Months Ended |
Sep. 30, 2018 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY, PLANT AND EQUIPMENT | NOTE 6 – PROPERTY, PLANT AND EQUIPMENT Property, plant and equipment at September 30, 2018 and December 31, 2017 are summarized as follows: September 30, 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 (1,889 ) (1,833 ) Net property, plant and equipment $ 623 $ 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 | 9 Months Ended |
Sep. 30, 2018 | |
Payables and Accruals [Abstract] | |
ACCRUED EXPENSES | NOTE 7 - ACCRUED EXPENSES Accrued expenses at September 30, 2018 and December 31, 2017 are summarized as follows: September 30, December 31, 2018 2017 (in thousands) Cost sharing expenses under license agreement $ 443 $ 328 Other fees and services 32 36 Payroll, payroll taxes and benefits 53 70 Professional services 100 149 Financed insurance premiums 187 - Clinical, non-clinical and regulatory services 116 326 Property taxes 15 16 Franchise taxes 4 14 Total $ 950 $ 939 |
DEBT
DEBT | 9 Months Ended |
Sep. 30, 2018 | |
Debt Disclosure [Abstract] | |
DEBT | NOTE 8 – DEBT Fully Paid Loan due December 1, 2018 In December 2013, we entered into a Loan and Security Agreement (the “Oxford Loan Agreement”) with Oxford Finance LLC (“Oxford” or the “Lender”), for a term loan to the Company in the principal amount of $10.0 million (the “Term Loan”). On October 5, 2018 and we borrowed $1.8 million and $150 thousand, respectively from John Schutte. We used $1.5 million from the October 5, 2018 loan proceeds to fully pay-off the debt outstanding under the Oxford Loan Agreement. (See Note 16). All security interests of Oxford with respect to the Oxford Term Loan have been released. The Oxford Term Loan accrued interest at a fixed rate of 8.35% per annum (with a default rate of 13.35% per annum). The Company was required to make monthly interest−only payments until April 1, 2015 (“Amortization Date”) and on the Amortization Date, the Company began to make payments of principal and accrued interest in equal monthly installments of $260 thousand sufficient to amortize the Term Loan through the maturity date of December 1, 2018. All unpaid principal and accrued and unpaid interest with respect to the Term Loan is due and payable in full on December 1, 2018. As security for its obligations under the initial Oxford Loan Agreement (prior to the Third Amendment), the Company granted Lender a security interest in substantially all of its existing and after−acquired assets, exclusive of its intellectual property assets. Upon the execution of the Oxford Loan Agreement, we issued to the Lender warrants to purchase an aggregate of up to 60 thousand shares of our common stock at an exercise price equal to $7.98 per share (after adjustment for our one-for-five reverse stock split) (the “Warrants”). We recorded $400 thousand as debt discount associated with the relative fair value of the Warrants and are amortizing it to interest expense over the term of the loan using the loan’s effective interest rate. The Warrants are immediately exercisable for cash or by net exercise and will expire December 27, 2020. In January 2015, we and Oxford amended the Oxford Loan Agreement providing for the exercise price of the warrants to be lowered from $7.98 to $2.52 per share (the average closing price of our common stock on Nasdaq for the 10 trading days preceding the date of the amendment and after giving effect to our one-for-five reverse stock split) and we recorded additional debt discount of $33 thousand representing the fair value of the warrant modification. The Company was obligated to pay customary lender fees and expenses, including a one-time facility fee of $50 thousand and the Lender’s expenses in connection with the Oxford Loan Agreement. Combined with the Company’s own expenses and a $100 thousand consulting placement fee, the Company incurred $231 thousand in deferred debt issue costs. We are amortizing these costs, including debt modification additional costs, into interest expense over the term of the Term Loan using the loan’s effective interest rate of 10.16%. Loan due January 2, 2020 We borrowed $1.5 million and $0.7 million during the second and third quarters 2018, respectively, and have borrowed an aggregate $2.2 million as of September 30, 2018 from John Schutte, a related-party, and issued four promissory notes (the Schutte Notes), in that aggregate principal amount to him. The Schutte Notes bear interest at prime plus 2.0%, and mature on January 2, 2020, at which time all principal and interest is due, and are unsecured until all obligations to Oxford are satisfied at which time we are required to grant a security interest to Mr. Schutte in all of our assets. Because we believe the promissory notes’ rate of interest is below current market rates for us, we imputed interest on the below market rate element of the loans using the 10.16% interest rate under the Oxford Loan Agreement which has amounted to $103 thousand as of September 30, 2018. We recorded the $74 thousand and $29 thousand as a benefit to interest income in the three month periods ended June 30, 2018 and September 30, 2018, respectively, with a corresponding like amount as debt discount against the principal amount of the loan. The debt discount will be amortized to interest expense over the term on the loans. The events of default under the Schutte Notes are limited to bankruptcy defaults and failure to pay interest and principal when due on January 2, 2020. In addition, Mr. Schutte and Oxford entered into a subordination agreement, approved by us and our subsidiary, pursuant to which Mr. Schutte subordinated the Schutte Notes to our obligations to Oxford under the Oxford Loan Agreement. The Schutte Notes may be prepaid at any time in whole or in part, however while Oxford’s loan is outstanding such prepayment will require Oxford’s consent. On October 5, 2018 and we borrowed $1.8 million and $150 thousand, respectively from John Schutte. We used $1.5 million from the October 5, 2018 loan proceeds to fully pay-off the debt outstanding under the Oxford Loan Agreement and therefore, all our assets are pledged as collateral under the Schutte Notes, including our intellectual property. (See Note 16.) Our debt at September 30, 2018 is summarized below (in thousands): Debt Current Long-term Total Loan Due December 1, 2018 Balance at Jan. 1, 2018 $ 2,740 $ - $ 2,740 Principal payments (1,719 ) - (1,719 ) Balance at Sept. 30, 2018 $ 1,021 $ - $ 1,021 Loan Due January 2, 2020 Balance at Jan. 1, 2018 $ - $ - $ - Borrowings - 2,200 2,200 Balance at Sept. 30, 2018 $ - $ 2,200 $ 2,200 Debt Discount Current Long-term Total Balance at Jan. 1, 2018 $ (32 ) $ - $ (32 ) Additions - (103 ) (103 ) Amortization expense 28 18 46 Balance at Sept. 30, 2018 $ (4 ) $ (85 ) $ (89 ) Deferred Debt Issuance Costs Current Long-term Total Balance at Jan. 1, 2018 $ (14 ) $ - $ (14 ) Amortization expense 13 - 13 Balance at Sept. 30, 2018 $ (1 ) $ - $ (1 ) Debt, net at Sept. 30, 2018 $ 1,016 $ 2,115 $ 3,131 Our debt interest expense for the three and nine months ended September 30, 2018 and 2017 consisted of the following (in thousands): Three months Ended September 30, Nine months Ended September 30, Interest expense: 2018 2017 2018 2017 Term loan – due December 1, 2018 $ 49 $ 116 $ 194 $ 397 Term loans – due January 2, 2020 29 - 37 - Debt discount 22 15 46 52 Debt issue costs 3 8 13 27 Financed insurance 2 - 2 - Total interest expense $ 105 $ 139 $ 292 $ 476 Less: imputed interest income on related party loan (29 ) - (103 ) - Less: interest income - (1 ) - (3 ) Total interest expense, net $ 76 $ 138 $ 189 $ 473 |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 9 Months Ended |
Sep. 30, 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 units (“Units”) of the Company, at a price of $0.4488 per Unit (the “Transaction”). Each Unit consists of one share of Common Stock and a Warrant to purchase one fifth (0.2) of a share of Common Stock. The issue price of the Units was equal to 85% of the average last sale price of our Common Stock for the five trading days prior to completion of the Transaction. The Warrants are immediately exercisable at a price of $0.528 per share (which equals the average last sale price of the Company’s Common Stock for the five trading days prior to completion of the Transaction) and expire five years after issuance (subject to earlier expiration in event of certain acquisitions). We have assigned a relative fair value of $495 thousand to the warrants out of the total $4.0 million proceeds from the private placement transaction and have accounted these warrants as equity. The Transaction was completed through a private placement to an accredited investor and was exempt from registration pursuant to Section 4(2) of the Securities Act of 1933, as amended and/or Regulation D promulgated under the Securities Act of 1933. 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 million plus approximately $309 thousand for transferred inventory and equipment. The Company will receive a 7.5% royalty on sales of licensed products. MainPointe also has options to expand the territory and products covered for additional sums. Included in the reported revenue for the nine month period ending September 30, 2018 is $17 thousand of royalty revenue from MainPointe. (See Note 3). 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 shares of our Common Stock (including warrants exercisable for such shares). Immanuel Thangaraj is the designee of Essex. Galen has not designated a director and lost that right in December 2017 when it disposed of its shares. Investor has not designated a director as of the date of filing of this Report. 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 and third quarters of 2018, we borrowed $1.5 million and $0.7 million, respectively, from John Schutte and issued promissory notes aggregating $2.2 million principal amount to him. (See Note 8). On October 5, 2018 and we borrowed $1.8 million and $150 thousand, respectively from John Schutte. (See Note 16). |
COMMON STOCK WARRANTS
COMMON STOCK WARRANTS | 9 Months Ended |
Sep. 30, 2018 | |
Stockholders' Equity Note [Abstract] | |
COMMON STOCK WARRANTS | NOTE 10 - COMMON STOCK WARRANTS We had no activity in our warrants for either the nine months ended September 30, 2018 or 2017. Our warrants consisted of the following (in thousands except price data): September 30, 2018 2017 Number WAvg Exercise Price Number WAvg Exercise Price Outstanding, Jan. 1, 1,843 $ 0.59 60 $ 2.52 Issued - - 1,783 0.53 Exercised - - - - Expired - - - - Modification - - - - Outstanding, Sept. 30, 1,843 $ 0.59 1,843 $ 0.59 In connection with the issuance of the $10.0 million secured promissory notes in December 2013, we issued common stock purchase warrants (“warrants”) exercisable for 60 thousand shares of our common stock having an exercise price of $2.52 per share (after giving effect to our one-for-five reverse stock split) with an expiration date in December 2020. These warrants contain a cashless exercise feature. (See Note 8). As part of our July 2017 private placement transaction with John Schutte, we issued warrants to purchase 1,782,531 shares of our common stock. The Warrants are immediately exercisable at a price of $0.528 per share and expire five years after issuance. (See Note 9). We have assigned a relative fair value of $495 thousand to the warrants out of the total $4.0 million proceeds from the private placement transaction and have accounted these warrants as equity. |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 9 Months Ended |
Sep. 30, 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 debt. The carrying amounts of these financial instruments, other than our debt, are representative of their respective fair values due to their relatively short maturities. |
SHARE-BASED COMPENSATION EXPENS
SHARE-BASED COMPENSATION EXPENSE | 9 Months Ended |
Sep. 30, 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. Our total 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 September 30, Nine months Ended September 30, 2018 2017 2018 2017 Total Stock Compensation Research and development costs: Stock options $ 9 $ 38 $ 33 $ 106 Restricted stock units 7 - 21 - Subtotal $ 16 $ 38 $ 54 $ 106 General and administrative costs: Stock options $ 14 $ 52 $ 67 $ 158 Restricted stock units 18 35 69 119 Subtotal $ 32 $ 87 $ 136 $ 277 Total $ 48 $ 125 $ 190 $ 383 Included in the table’s reported totals for general and administrative costs is share-based compensation expense from the mark-to-market accounting of a portion of the RSUs granted to our directors is approximately $5 thousand benefit and $5 thousand for the three month periods ended September 30, 2018 and 2017, respectively and approximately $15 thousand and $30 thousand for the nine month periods ended September 30, 2018 and 2017, respectively. Stock Option Award Plans We maintain various stock option plans. A summary of our stock option plan activity during the nine month periods ending September 30, 2018 and 2017 is shown below (in thousands except price data): Nine months Ended September 30, 2018 2017 Number Weighted Average Exercise Price Number of Weighted Average Exercise Price Outstanding, Jan. 1, 1,494 $ 12.33 1,397 $ 13.57 Granted - - 185 0.31 Exercised - - (1 ) 0.92 Forfeited or expired (166 ) 1.77 (87 ) 6.48 Outstanding, Sept. 30, 1,328 $ 8.64 1,494 $ 12.33 Options exercisable 1,313 $ 8.73 1,176 $ 15.46 The following table summarizes information about nonvested stock options outstanding at September 30, 2018 (in thousands except price data): Number of Weighted Outstanding, Jan. 1, 2018 270 $ 0.46 Granted - - Vesting (251 ) 0.44 Forfeited (4 ) 0.41 Outstanding, Sept. 30, 2018 15 $ 0.77 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 September 30, 2018 and 2017 was $0 thousand. The total remaining unrecognized compensation cost on unvested option awards outstanding at September 30, 2018 was $12 thousand, and is expected to be recognized in operating expense in varying amounts over the 2 months remaining in the requisite service period. 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, at their election, to receive payment in cash, instead of stock, for up to 40% of each RSU award. The portion of the RSU awards subject to cash settlement are recorded as a liability in the Company’s balance sheet as they vest and are being marked-to-market each reporting period until they are distributed. The cash settlement liability for vested RSU awards was $15 thousand and $41 thousand at September 30, 2018 and December 31, 2017, respectively. 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. The total remaining unrecognized compensation cost on unvested RSU awards outstanding at September 30, 2018 was $11 thousand, and is expected to be recognized in operating expense over the two months remaining in the requisite service period. A summary of the award activity under the RSU Plans as of September 30, 2018 and 2017, and for each of the nine month periods then ended consisted of the following: Nine months Ended September 30, 2018 2017 (in thousands) Number Number of Number of Number of Outstanding, Jan. 1 462 262 91 91 Granted 267 - 238 - Distributed (262 ) (262 ) (67 ) (67 ) Vested - 200 - 178 Forfeited or expired (8 ) - - - Outstanding, Sept. 30 459 200 262 202 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 million shares of our common stock pursuant to awards under the 2017 RSU Plan. As of September 30, 2018, approximately 1.0 million shares are available for award under the 2017 RSU Plan. Information about the awards under the 2017 RSU Plan is as follows: · In December 2017, we awarded 200 thousand RSUs to our employees. Such RSU awards will vest 100% after one full year of service. Distributions of the vested RSU awards to the employees will be made in three equal installments on the first business day of each of January 2020, 2021, and 2022 or earlier upon a qualifying change of control. · In January 2018, we awarded approximately 67 thousand RSUs to each of our 4 non-employee directors which also allow for them to receive payment in cash, instead of stock, for up to 40% of each RSU award. Such awards vest 25% at the end of each calendar quarter in 2018. Settlement of this RSU award will occur on January 2, 2019, the first business day of the year after vesting. The portion of the RSU awards which are subject to cash settlement are also subject to marked-to market accounting and the liability recorded in the Company’s balance sheet as an estimate for such cash settlement was $15 thousand at September 30, 2018. 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 thousand shares of our common stock pursuant to awards under the 2014 RSU Plan. As of September 30, 2018, approximately 3 thousand shares are available for award under the 2014 RSU Plan. Information about the awards under the 2014 RSU Plan during 2017 and 2018 is as follows: · In January 2017, we awarded approximately 60 thousand RSUs to each of our 4 non-employee directors which also allow for them to receive payment in cash, instead of stock, for up to 40% of each RSU award. Such awards vest 25% at the end of each calendar quarter in 2017. The portion of the RSU awards which are subject to cash settlement are also subject to marked-to market accounting and the liability recorded in the Company’s balance sheet as an estimate for such cash settlement was $41 thousand at December 31, 2017. The RSU award was settled on January 2, 2018. Information about the distribution of shares under the 2014 RSU Plan is as follows: · In January 2017, 1 thousand RSUs from the May 2014 award and 66 thousand RSUs from the January 2016 award were distributed. There were 1 thousand RSUs from the May 1 2014 award and 22 thousand RSUs from the January 2016 award which remained deferred until a future distribution date, which occurred on January 1, 2018. Of the 67 thousand RSUs distributed, 49 thousand RSUs were settled in common stock and 18 thousand RSUs were settled in cash. · In January 2018, all outstanding 262 thousand RSUs from the 2014 RSU Plan were distributed. Of the approximately 262 thousand RSUs distributed, 238 thousand RSUs were settled in common stock and 24 thousand RSUs were settled in cash. |
INCOME TAXES
INCOME TAXES | 9 Months Ended |
Sep. 30, 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% to 21% effective for tax years beginning after December 31, 2017 and requiring adjustment to 2017 deferred taxes. 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 million gross Federal NOLs at September 30, 2018 (of which approximately $168 million were generated prior to 2018). Because we believe the ability for us to use the Federal NOLs generated prior to January 1, 2018 to offset future taxable income is severely limited, as prescribed under Internal Revenue Code (“IRC”) Section 382, we have estimated and recorded an amount for the likely limitation to our deferred tax asset. The amount we recorded thereby reduced the aggregate estimated benefit of the Federal NOLs generated prior to January 1, 2018 to approximately $1.0 million. We believe the gross Federal NOL benefit we generated prior to January 1, 2018 to offset future taxable income is less than $150 thousand annually. As prescribed under Internal Revenue Code, any unused Federal NOL benefit from the annual limitation can be accumulated and carried forward to the subsequent year and will expire if not used in accordance with the NOL carried forward term of 20 years or 2037, if generated before January 1, 2018 and Federal NOLs generated after December 31, 2017 can be carried forward indefinitely. Future common stock transactions may cause another qualifying event under IRC 382 which may further limit our utilization of our NOLs. 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 September 30, 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 | 9 Months Ended |
Sep. 30, 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 or 2017 as the Company reported a net loss for each of the nine month periods, 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. A reconciliation of the numerators and denominators of basic and diluted EPS consisted of the following (in thousands except per share data): Three months Ended September 30, Nine months Ended September 30, 2018 2017 2018 2017 EPS – basic and diluted Numerator: net loss $ (1,095 ) $ (2,200 ) $ (3,850 ) $ (3,944 ) Denominator (weighted): Common shares 21,034 16,544 21,033 14,103 Vested RSUs 134 142 68 44 Basic and diluted weighted average shares outstanding 21,168 16,686 21,101 14,147 EPS – basic and diluted $ (0.05 ) $ (0.12 ) $ (0.18 ) $ (0.27 ) Excluded securities (non-weighted): Common shares issuable: Stock options – vested and nonvested 1,328 1,494 1,328 1,494 Nonvested RSUs 259 60 259 60 Common stock purchase warrants 1,843 1,843 1,843 1,843 Total excluded common shares 3,430 3,397 3,430 3,397 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 9 Months Ended |
Sep. 30, 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 decision”) holding that state tort law failure to warn claims against generic drug companies are pre-empted by the 1984 Hatch-Waxman Act Amendments and federal drug regulations will assist us in favorably resolving these cases. In New Jersey, Generic Defendants, including Acura, filed dispositive motions based on the Mensing decision, which the Court granted with a limited exception. In June 2012, the New Jersey trial court dismissed all of the New Jersey cases pending against us with prejudice. 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 later 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 September 30, 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, as successor to Halsey Drug 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 (index 153339/2018). The Complaint contains seven causes of action, including negligence, strict liability, and breach of warranty, wrongful death, among others, in connection with the alleged exposure of the deceased plaintiff in utero to diethylstilbestrol (DES) in approximately 1956 as the result of the ingestion of the drug by her mother. The plaintiffs are the personal representative of the deceased and her two daughters, individually. The plaintiffs were unable to determine which of the defendants produced the DES used by the deceased, but regardless seeks to hold all defendants jointly and severally liable. The Complaint seeks $10.0 million in compensatory and $10.0 million in punitive damages on each of five counts and damages in an amount to be determined for wrongful death and additional punitive damages in an unstated amount. As any potential loss is neither probable nor estimable, we have not accrued for any potential loss related to these matters as of September 30, 2018. We are presently unable to determine if any potential loss would be covered by any of our insurance carriers. 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 thousand. In June 2015, the Company received an additional $250 thousand payment from Purdue Pharma relating to the December 2014 agreement. 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 September 30, 2018 we have accrued approximately $443 thousand of these potential cost sharing reimbursable expenses under the Egalet Agreement. Facility Lease The Company leases administrative office space in Palatine, Illinois on a month to month basis at the rate of approximately $2 thousand per month. |
SUBSEQUENT EVENT
SUBSEQUENT EVENT | 9 Months Ended |
Sep. 30, 2018 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENT | NOTE 16 – SUBSEQUENT EVENT Debt Restructure On October 5, 2018 we received a $1.8 million loan from John Schutte, and another $150 thousand loan on which combined with earlier $4.15 million in loans from Mr. Schutte. In connection the two loans $1.95 million, we issued two promissory notes, or the Schutte Notes, in each of that principal amount to him. The Schutte Notes bear interest at prime plus 2%, and mature on January 2, 2020, at which time all principal and interest is due. The terms of these notes are the same as the terms for the $2.2 million loans previously received from Mr. Schutte which are also represented by promissory notes (together with the Schutte Notes, the “Aggregate Schutte Notes”). Events of Default under the Aggregate Schutte Notes include bankruptcy events and failure to pay interest and principal when due. Using a portion of the proceeds from the $1.8 million Schutte loan, we made a lump sum payment of $1.5 million on October 5, 2018 to Oxford Finance to settle, in full, all remaining obligations of the Oxford Loan Agreement. Loans from Mr. Schutte provide that they be secured after our obligations to Oxford Finance have been satisfied in full. As a result of the termination of the Loan Agreement with Oxford Finance, we are now required to secure payment of the Aggregate Schutte Notes with a security interest in our assets and these Notes now become our senior secured debt. The Aggregate Schutte Notes may be prepaid in whole or part at any time. |
REVENUE FROM CONTRACTS WITH C_2
REVENUE FROM CONTRACTS WITH CUSTOMERS (Tables) | 9 Months Ended |
Sep. 30, 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 September 30, 2018 Nine months Ended September 30, 2018 (in thousands) Egalet $ 70 $ 330 MainPointe 3 17 Royalty revenues $ 73 $ 347 |
PROPERTY, PLANT AND EQUIPMENT (
PROPERTY, PLANT AND EQUIPMENT (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Property, Plant and Equipment [Abstract] | |
Property Plant and Equipment | Property, plant and equipment at September 30, 2018 and December 31, 2017 are summarized as follows: September 30, 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 (1,889 ) (1,833 ) Net property, plant and equipment $ 623 $ 679 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Payables and Accruals [Abstract] | |
Accurued Expenses | Accrued expenses at September 30, 2018 and December 31, 2017 are summarized as follows: September 30, December 31, 2018 2017 (in thousands) Cost sharing expenses under license agreement $ 443 $ 328 Other fees and services 32 36 Payroll, payroll taxes and benefits 53 70 Professional services 100 149 Financed insurance premiums 187 - Clinical, non-clinical and regulatory services 116 326 Property taxes 15 16 Franchise taxes 4 14 Total $ 950 $ 939 |
DEBT (Tables)
DEBT (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Debt Disclosure [Abstract] | |
Schedule of Debt | Our debt at September 30, 2018 is summarized below (in thousands): Debt Current Long-term Total Loan Due December 1, 2018 Balance at Jan. 1, 2018 $ 2,740 $ - $ 2,740 Principal payments (1,719 ) - (1,719 ) Balance at Sept. 30, 2018 $ 1,021 $ - $ 1,021 Loan Due January 2, 2020 Balance at Jan. 1, 2018 $ - $ - $ - Borrowings - 2,200 2,200 Balance at Sept. 30, 2018 $ - $ 2,200 $ 2,200 Debt Discount Current Long-term Total Balance at Jan. 1, 2018 $ (32 ) $ - $ (32 ) Additions - (103 ) (103 ) Amortization expense 28 18 46 Balance at Sept. 30, 2018 $ (4 ) $ (85 ) $ (89 ) Deferred Debt Issuance Costs Current Long-term Total Balance at Jan. 1, 2018 $ (14 ) $ - $ (14 ) Amortization expense 13 - 13 Balance at Sept. 30, 2018 $ (1 ) $ - $ (1 ) Debt, net at Sept. 30, 2018 $ 1,016 $ 2,115 $ 3,131 |
Schedule of Interest Expense | Our debt interest expense for the three and nine months ended September 30, 2018 and 2017 consisted of the following (in thousands): Three months Ended September 30, Nine months Ended September 30, Interest expense: 2018 2017 2018 2017 Term loan – due December 1, 2018 $ 49 $ 116 $ 194 $ 397 Term loans – due January 2, 2020 29 - 37 - Debt discount 22 15 46 52 Debt issue costs 3 8 13 27 Financed insurance 2 - 2 - Total interest expense $ 105 $ 139 $ 292 $ 476 Less: imputed interest income on related party loan (29 ) - (103 ) - Less: interest income - (1 ) - (3 ) Total interest expense, net $ 76 $ 138 $ 189 $ 473 |
COMMON STOCK WARRANTS (Tables)
COMMON STOCK WARRANTS (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Stockholders' Equity Note [Abstract] | |
Schedule Of Common Stock Warrant Activity | We had no activity in our warrants for either the nine months ended September 30, 2018 or 2017. Our warrants consisted of the following (in thousands except price data): September 30, 2018 2017 Number WAvg Exercise Price Number WAvg Exercise Price Outstanding, Jan. 1, 1,843 $ 0.59 60 $ 2.52 Issued - - 1,783 0.53 Exercised - - - - Expired - - - - Modification - - - - Outstanding, Sept. 30, 1,843 $ 0.59 1,843 $ 0.59 |
SHARE-BASED COMPENSATION EXPE_2
SHARE-BASED COMPENSATION EXPENSE (Tables) | 9 Months Ended |
Sep. 30, 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 total 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 September 30, Nine months Ended September 30, 2018 2017 2018 2017 Total Stock Compensation Research and development costs: Stock options $ 9 $ 38 $ 33 $ 106 Restricted stock units 7 - 21 - Subtotal $ 16 $ 38 $ 54 $ 106 General and administrative costs: Stock options $ 14 $ 52 $ 67 $ 158 Restricted stock units 18 35 69 119 Subtotal $ 32 $ 87 $ 136 $ 277 Total $ 48 $ 125 $ 190 $ 383 |
Schedule of Share-based Compensation, Stock Options, Activity | We maintain various stock option plans. A summary of our stock option plan activity during the nine month periods ending September 30, 2018 and 2017 is shown below (in thousands except price data): Nine months Ended September 30, 2018 2017 Number Weighted Average Exercise Price Number of Weighted Average Exercise Price Outstanding, Jan. 1, 1,494 $ 12.33 1,397 $ 13.57 Granted - - 185 0.31 Exercised - - (1 ) 0.92 Forfeited or expired (166 ) 1.77 (87 ) 6.48 Outstanding, Sept. 30, 1,328 $ 8.64 1,494 $ 12.33 Options exercisable 1,313 $ 8.73 1,176 $ 15.46 |
Schedule of Nonvested Share Activity | The following table summarizes information about nonvested stock options outstanding at September 30, 2018 (in thousands except price data): Number of Weighted Outstanding, Jan. 1, 2018 270 $ 0.46 Granted - - Vesting (251 ) 0.44 Forfeited (4 ) 0.41 Outstanding, Sept. 30, 2018 15 $ 0.77 |
Schedule of Share-based Compensation, Restricted Stock Units Award Activity | A summary of the award activity under the RSU Plans as of September 30, 2018 and 2017, and for each of the nine month periods then ended consisted of the following: Nine months Ended September 30, 2018 2017 (in thousands) Number Number of Number of Number of Outstanding, Jan. 1 462 262 91 91 Granted 267 - 238 - Distributed (262 ) (262 ) (67 ) (67 ) Vested - 200 - 178 Forfeited or expired (8 ) - - - Outstanding, Sept. 30 459 200 262 202 |
NET LOSS PER SHARE (Tables)
NET LOSS PER SHARE (Tables) | 9 Months Ended |
Sep. 30, 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 (in thousands except per share data): Three months Ended September 30, Nine months Ended September 30, 2018 2017 2018 2017 EPS – basic and diluted Numerator: net loss $ (1,095 ) $ (2,200 ) $ (3,850 ) $ (3,944 ) Denominator (weighted): Common shares 21,034 16,544 21,033 14,103 Vested RSUs 134 142 68 44 Basic and diluted weighted average shares outstanding 21,168 16,686 21,101 14,147 EPS – basic and diluted $ (0.05 ) $ (0.12 ) $ (0.18 ) $ (0.27 ) Excluded securities (non-weighted): Common shares issuable: Stock options – vested and nonvested 1,328 1,494 1,328 1,494 Nonvested RSUs 259 60 259 60 Common stock purchase warrants 1,843 1,843 1,843 1,843 Total excluded common shares 3,430 3,397 3,430 3,397 |
OPERATIONS AND BASIS OF PRESE_2
OPERATIONS AND BASIS OF PRESENTATION - Additional Information (Detail) - USD ($) $ in Thousands | Oct. 05, 2018 | Nov. 21, 2018 | Oct. 05, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | Nov. 26, 2018 |
Working Capital Deficit | $ 3,300 | $ 3,300 | ||||||||
Retained Earnings (Accumulated Deficit) | (384,230) | (384,230) | $ (380,380) | |||||||
Operating Income (Loss) | (1,019) | $ (2,062) | (3,661) | $ (3,471) | (5,200) | |||||
Net Income (Loss) Attributable to Parent, Total | (1,095) | (2,200) | (3,850) | (3,944) | ||||||
Proceeds from Issuance of Long-term Debt | 700 | $ 1,500 | 2,200 | 0 | ||||||
Cash, Cash Equivalents, and Refundable Deposits | 98,000 | 98,000 | ||||||||
Cash | $ 18 | $ 2,284 | $ 18 | $ 2,284 | ||||||
Loan Agreement With Oxford [Member] | ||||||||||
Net Income (Loss) Attributable to Parent, Total | $ (5,700) | |||||||||
Subsequent Event [Member] | ||||||||||
Proceeds from Issuance of Long-term Debt | $ 1,800 | $ 150 | $ 1,800 | |||||||
Cash | $ 150 | |||||||||
Schutte Note [Member] | Subsequent Event [Member] | ||||||||||
Proceeds from Issuance of Long-term Debt | $ 4,150 |
LICENSE AND COLLABORATION AGR_2
LICENSE AND COLLABORATION AGREEMENTS - Additional Information (Detail) - USD ($) $ in Thousands | Oct. 09, 2015 | Mar. 31, 2017 | Oct. 31, 2016 | Apr. 30, 2014 | Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 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 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. | ||||||||
Revenue from Contract with Customer, Including Assessed Tax | $ 73 | $ 347 | |||||||
Amortization of Intangible Assets | 155 | $ 155 | |||||||
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. | ||||||||
FiniteLived Intangible Assets Amortization Expense Quarter | 52 | 52 | |||||||
Revenue From Royalty | 73 | $ 83 | 347 | 226 | |||||
Royalty Receivable | 108 | $ 108 | $ 71 | ||||||
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. | ||||||||
Revenue from Contract with Customer, Including Assessed Tax | $ 5,000 | ||||||||
Proceeds from Milestone Payment On Agreement | $ 2,500 | ||||||||
Amortization of Intangible Assets | $ 155 | $ 155 | |||||||
Finite-Lived Intangible Asset, Useful Life | 9 years 8 months 12 days | ||||||||
Finite-Lived Intangible Assets, Amortization Expense, Year Two | 208 | 208 | |||||||
Revenue From Royalty | 70 | 330 | |||||||
Royalty Receivable | 80 | 80 | |||||||
Main Pointe Agreement [Member] | |||||||||
License Development and Commercialization Agreement [Line Items] | |||||||||
Proceeds from License Fees Received | $ 2,500 | ||||||||
Licensing Agreement, Royalty Percentage | 7.50% | ||||||||
Royalty Receivable | $ 17 | $ 17 | |||||||
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 C_3
REVENUE FROM CONTRACTS WITH CUSTOMERS (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2018 | Sep. 30, 2018 | |
Royalty revenues | $ 73 | $ 347 |
Egalet | ||
Royalty revenues | 70 | 330 |
MainPointe | ||
Royalty revenues | $ 3 | $ 17 |
REVENUE FROM CONTRACTS WITH C_4
REVENUE FROM CONTRACTS WITH CUSTOMERS - Additional Information (Detail) | 9 Months Ended |
Sep. 30, 2018 | |
Contract Balance and Performance Obligations,Description | The Company's reported contract assets and contract liability balances under the license and collaboration agreements at either September 30, 2018 or December 31, 2017 was $0 thousand. |
PROPERTY, PLANT AND EQUIPMENT_2
PROPERTY, PLANT AND EQUIPMENT (Detail) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Property, Plant and Equipment [Line Items] | ||
Total | $ 2,512 | $ 2,512 |
Less: accumulated depreciation | (1,889) | (1,833) |
Net property, plant and equipment | 623 | 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 | Sep. 30, 2018 | Dec. 31, 2017 |
Accounts Payable and Accrued Liabilities [Line Items] | ||
Cost sharing expenses under license agreement | $ 443 | $ 328 |
Other fees and services | 32 | 36 |
Payroll, payroll taxes and benefits | 53 | 70 |
Professional services | 100 | 149 |
Financed insurance premiums | 187 | 0 |
Clinical, non-clinical and regulatory services | 116 | 326 |
Property taxes | 15 | 16 |
Franchise taxes | 4 | 14 |
Total | $ 950 | $ 939 |
DEBT - Summary of Debt (Detail)
DEBT - Summary of Debt (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2018 | Jun. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Debt Discount | |||||
Balance at Jan. 1, 2018 | $ (32) | ||||
Capitalized debt discount | $ (29) | $ (74) | $ 0 | (103) | $ 0 |
Amortization expense | 46 | ||||
Balance at Sept. 30, 2018 | (89) | (89) | |||
Deferred Debt Issuance Costs | |||||
Balance at Jan. 1, 2018 | (14) | ||||
Amortization expense | 13 | ||||
Balance at Sept. 30, 2018 | (1) | (1) | |||
Debt, net at Sept. 30, 2018 | 3,131 | 3,131 | |||
Loan Due January 2, 2020 [member] | |||||
Current | |||||
Balance at Jan. 1, 2018 | 0 | ||||
Borrowings | 2,200 | ||||
Balance at Sept. 30, 2018 | 2,200 | 2,200 | |||
Loan Due December 1, 2018 [Member] | |||||
Current | |||||
Balance at Jan. 1, 2018 | 2,740 | ||||
Principal payments | (1,719) | ||||
Balance at Sept. 30, 2018 | 1,021 | 1,021 | |||
Long-term [Member] | |||||
Debt Discount | |||||
Balance at Jan. 1, 2018 | 0 | ||||
Capitalized debt discount | (103) | ||||
Amortization expense | 18 | ||||
Balance at Sept. 30, 2018 | (85) | (85) | |||
Deferred Debt Issuance Costs | |||||
Balance at Jan. 1, 2018 | 0 | ||||
Amortization expense | 0 | ||||
Balance at Sept. 30, 2018 | 0 | 0 | |||
Debt, net at Sept. 30, 2018 | 2,115 | 2,115 | |||
Long-term [Member] | Loan Due January 2, 2020 [member] | |||||
Current | |||||
Balance at Jan. 1, 2018 | 0 | ||||
Borrowings | 2,200 | ||||
Balance at Sept. 30, 2018 | 2,200 | 2,200 | |||
Long-term [Member] | Loan Due December 1, 2018 [Member] | |||||
Current | |||||
Balance at Jan. 1, 2018 | 0 | ||||
Principal payments | 0 | ||||
Balance at Sept. 30, 2018 | 0 | 0 | |||
Current [Member] | |||||
Debt Discount | |||||
Balance at Jan. 1, 2018 | (32) | ||||
Capitalized debt discount | 0 | ||||
Amortization expense | 28 | ||||
Balance at Sept. 30, 2018 | (4) | (4) | |||
Deferred Debt Issuance Costs | |||||
Balance at Jan. 1, 2018 | (14) | ||||
Amortization expense | 13 | ||||
Balance at Sept. 30, 2018 | (1) | (1) | |||
Debt, net at Sept. 30, 2018 | 1,016 | 1,016 | |||
Current [Member] | Loan Due January 2, 2020 [member] | |||||
Current | |||||
Balance at Jan. 1, 2018 | 0 | ||||
Borrowings | 0 | ||||
Balance at Sept. 30, 2018 | 0 | 0 | |||
Current [Member] | Loan Due December 1, 2018 [Member] | |||||
Current | |||||
Balance at Jan. 1, 2018 | 2,740 | ||||
Principal payments | (1,719) | ||||
Balance at Sept. 30, 2018 | $ 1,021 | $ 1,021 |
DEBT - Interest Expense (Detail
DEBT - Interest Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2018 | Jun. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Schedule Of Interest Expense [Line Items] | |||||
Term loan – due December 1, 2018 | $ 49 | $ 116 | $ 194 | $ 397 | |
Term loans – due January 2, 2020 | 29 | 0 | 37 | 0 | |
Debt discount | 22 | 15 | 46 | 52 | |
Debt issue costs | 3 | 8 | 13 | 27 | |
Financed insurance premiums | 2 | 0 | 2 | 0 | |
Total interest expense | 105 | 139 | 292 | 476 | |
Less: imputed interest income on related party loan | (29) | $ (74) | 0 | (103) | 0 |
Less: interest income | 0 | (1) | 0 | (3) | |
Total interest expense, net | $ 76 | $ 138 | $ 189 | $ 473 |
DEBT - Additional Information (
DEBT - Additional Information (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | Oct. 05, 2018 | Nov. 21, 2018 | Oct. 31, 2018 | Oct. 05, 2018 | Jan. 31, 2015 | Sep. 30, 2018 | Jun. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | Dec. 31, 2013 |
Debt Instrument [Line Items] | ||||||||||||
Debt instrument principal amount | $ 2,200 | $ 2,200 | $ 10,000 | |||||||||
Debt instrument, interest rate, stated percentage | 10.16% | 10.16% | 13.35% | |||||||||
Debt instrument, fee amount | $ 50 | $ 50 | ||||||||||
Debt consulting placement fee | 100 | |||||||||||
Debt related commitment fees and debt issuance costs | 3 | $ 8 | 13 | $ 27 | ||||||||
Debt instrument unamortized discount | $ 89 | 89 | $ 32 | |||||||||
Repayments of Debt | 1,719 | 1,815 | ||||||||||
Debt Instrument, Periodic Payment | $ 260 | |||||||||||
Debt Instrument, Interest Rate, Effective Percentage | 10.16% | 10.16% | ||||||||||
Debt Instrument, Description of Variable Rate Basis | at prime plus 2.0% | |||||||||||
Payments of Debt Issuance Costs | $ 29 | $ 74 | $ 0 | $ 103 | 0 | |||||||
Proceeds from Issuance of Long-term Debt | 700 | 1,500 | 2,200 | $ 0 | ||||||||
Subsequent Event [Member] | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Proceeds from Issuance of Long-term Debt | $ 1,800 | $ 150 | $ 1,800 | |||||||||
Debt Instrument, Maturity Date | Jan. 2, 2020 | |||||||||||
Term Loan [Member] | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Debt related commitment fees and debt issuance costs | 231 | |||||||||||
Schutte Note [Member] | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Debt instrument principal amount | 700 | 1,500 | $ 700 | |||||||||
Proceeds from Issuance of Long-term Debt | 4,150 | $ 4,150 | ||||||||||
Debt Instrument, Maturity Date | Jan. 2, 2020 | |||||||||||
Schutte Note [Member] | Subsequent Event [Member] | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Debt instrument principal amount | $ 1,950 | |||||||||||
Loan Agreement [Member] | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Debt instrument, interest rate, stated percentage | 8.35% | |||||||||||
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 | |||||||||||
Oxford Term Loan Agreement [Member] | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Debt instrument principal amount | 103 | $ 103 | ||||||||||
Oxford Term Loan Agreement [Member] | Subsequent Event [Member] | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Repayments of Debt | $ 1,500 | |||||||||||
Warrant | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Debt instrument unamortized discount | $ 400 | $ 400 | ||||||||||
Warrants to purchase common stock | 60 | 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 |
RELATED PARTY TRANSACTIONS- Add
RELATED PARTY TRANSACTIONS- Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | Oct. 05, 2018 | Nov. 21, 2018 | Oct. 05, 2018 | Jul. 31, 2017 | Mar. 31, 2017 | Sep. 30, 2018 | Jun. 30, 2018 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 |
Related Party Transaction [Line Items] | ||||||||||
Number of Common Stock Need to Hold to Designate As Director | 600,000 | |||||||||
Royalty Receivable | $ 108 | $ 108 | $ 71 | |||||||
Proceeds from Issuance of Long-term Debt | 700 | $ 1,500 | 2,200 | $ 0 | ||||||
Class Of Warrants Or Rights Expiry Period | 5 years | |||||||||
Debt Instrument, Repurchase Amount | 2,200 | 2,200 | ||||||||
Subsequent Event [Member] | ||||||||||
Related Party Transaction [Line Items] | ||||||||||
Proceeds from Issuance of Long-term Debt | $ 1,800 | $ 150 | $ 1,800 | |||||||
Main Pointe Agreement [Member] | ||||||||||
Related Party Transaction [Line Items] | ||||||||||
Proceeds from License Fees Received | $ 2,500 | |||||||||
Asset Transferred, License Agreement | $ 309 | |||||||||
Licensing Agreement, Royalty Percentage | 7.50% | |||||||||
Royalty Receivable | 17 | 17 | ||||||||
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 | $ 495 |
COMMON STOCK WARRANTS - Schedul
COMMON STOCK WARRANTS - Schedule Of Common Stock Warrant Activity (Detail) - Warrant [Member] - $ / shares shares in Thousands | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Number of Options | ||
Number of Options Outstanding, beginning | 1,843 | 60 |
Number of Options, Issued | 0 | 1,783 |
Number of Options, Exercised | 0 | 0 |
Number of Options, Expired | 0 | 0 |
Number of Options, Modification | 0 | 0 |
Number of Options Outstanding, ending | 1,843 | 1,843 |
Weighted Average Exercise Price | ||
Weighted Average Exercise Price, beginning | $ 0.59 | $ 2.52 |
Weighted Average Exercise Price, Issued | 0 | 0.53 |
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 | $ 0.59 |
COMMON STOCK WARRANTS - Additio
COMMON STOCK WARRANTS - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 9 Months Ended | |
Jul. 31, 2017 | Sep. 30, 2018 | Dec. 31, 2013 | |
Class of Warrant or Right [Line Items] | |||
Secured Debt | $ 10,000 | ||
Class of Warrant or Right, Term | 5 years | ||
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 | ||
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 | ||
Warrant | Private Placement [Member] | |||
Class of Warrant or Right [Line Items] | |||
Stock Issued During Period, Value, New Issues | $ 495 |
SHARE-BASED COMPENSATION EXPE_3
SHARE-BASED COMPENSATION EXPENSE -Recognition of Share-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Total Stock Compensation | ||||
Allocated Share-based Compensation Expense | $ 48 | $ 125 | $ 190 | $ 383 |
Research and Development Expense [Member] | ||||
Total Stock Compensation | ||||
Allocated Share-based Compensation Expense | 16 | 38 | 54 | 106 |
Research and Development Expense [Member] | Stock options [Member] | ||||
Total Stock Compensation | ||||
Allocated Share-based Compensation Expense | 9 | 38 | 33 | 106 |
Research and Development Expense [Member] | Restricted Stock units [Member] | ||||
Total Stock Compensation | ||||
Allocated Share-based Compensation Expense | 7 | 0 | 21 | 0 |
General and Administrative Expense [Member] | ||||
Total Stock Compensation | ||||
Allocated Share-based Compensation Expense | 32 | 87 | 136 | 277 |
General and Administrative Expense [Member] | Stock options [Member] | ||||
Total Stock Compensation | ||||
Allocated Share-based Compensation Expense | 14 | 52 | 67 | 158 |
General and Administrative Expense [Member] | Restricted Stock units [Member] | ||||
Total Stock Compensation | ||||
Allocated Share-based Compensation Expense | $ 18 | $ 35 | $ 69 | $ 119 |
SHARE-BASED COMPENSATION EXPE_4
SHARE-BASED COMPENSATION EXPENSE - Stock Option Award Activity (Detail) - Stock Option Plan [Member] - $ / shares shares in Thousands | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 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 | 185 |
Number of Options, Exercised | 0 | (1) |
Number of Options, Forfeited or expired | (166) | (87) |
Number of Options Outstanding, ending | 1,328 | 1,494 |
Number of Options exercisable | 1,313 | 1,176 |
Weighted Average Exercise Price, beginning | $ 12.33 | $ 13.57 |
Weighted Average Exercise Price, Granted | 0 | 0.31 |
Weighted Average Exercise Price, Exercised | 0 | 0.92 |
Weighted Average Exercise Price, Forfeited or expired | 1.77 | 6.48 |
Weighted Average Exercise Price, ending | 8.64 | 12.33 |
Weighted Average Exercise Price, Options exercisable | $ 8.73 | $ 15.46 |
SHARE-BASED COMPENSATION EXPE_5
SHARE-BASED COMPENSATION EXPENSE - Summary of Information about Non Vested Stock Options (Detail) - Non Vested Stock Options [Member] shares in Thousands | 9 Months Ended |
Sep. 30, 2018$ / sharesshares | |
Summary Of Information About Non Vested Stock Options Disclosure [Line Items] | |
Outstanding, beginning | shares | 270 |
Granted | shares | 0 |
Vesting | shares | (251) |
Forfeited | shares | (4) |
Outstanding, ending | shares | 15 |
Outstanding beginning, Weighted Average Fair Value | $ / shares | $ 0.46 |
Granted, Weighted Average Fair Value | $ / shares | 0 |
Vesting, Weighted Average Fair Value | $ / shares | 0.44 |
Forfeited, Weighted Average Fair Value | $ / shares | 0.41 |
Outstanding ending, Weighted Average Fair Value | $ / shares | $ 0.77 |
SHARE-BASED COMPENSATION EXPE_6
SHARE-BASED COMPENSATION EXPENSE - Summary of RSU Plan (Detail) - shares shares in Thousands | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 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 | (8) | 0 |
Outstanding, ending | 459 | 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 | 200 | 178 |
Forfeited or expired | 0 | 0 |
Outstanding, ending | 200 | 202 |
SHARE-BASED COMPENSATION EXPE_7
SHARE-BASED COMPENSATION EXPENSE- Additional Information (Detail) - USD ($) shares in Thousands, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||
Jan. 31, 2018 | Dec. 31, 2017 | Jan. 31, 2017 | May 31, 2014 | Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Nov. 30, 2017 | |
Employee Benefit Plans Disclosure [Line Items] | |||||||||
Aggregate intrinsic value of the option awards vested | $ 0 | $ 0 | $ 0 | $ 0 | |||||
Unrecognized compensation cost on unvested option awards outstanding | 12 | 12 | |||||||
Share Based Compensation Arrangement Share Based Payment Shares Reserved For Future Distribution | 1 | ||||||||
Allocated Share-based Compensation Expense | 48 | 125 | $ 190 | 383 | |||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 months | ||||||||
Restricted Stock Units (RSUs) [Member] | |||||||||
Employee Benefit Plans Disclosure [Line Items] | |||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Share-based Awards Other than Options | 11 | $ 11 | |||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 months | ||||||||
Restricted Stock Units (RSUs) [Member] | Four Non Employee Directors [Member] | |||||||||
Employee Benefit Plans Disclosure [Line Items] | |||||||||
Deferred Compensation Arrangement with Individual, Recorded Liability | 15 | $ 15 | |||||||
Restricted Stock Units (RSUs) [Member] | Director [Member] | |||||||||
Employee Benefit Plans Disclosure [Line Items] | |||||||||
Deferred Compensation Arrangement with Individual, Recorded Liability | $ 41 | 15 | 15 | ||||||
Restricted Stock Units (RSUs) [Member] | Director [Member] | General and Administrative Expense [Member] | |||||||||
Employee Benefit Plans Disclosure [Line Items] | |||||||||
Allocated Share-based Compensation Expense | $ 5 | $ 5 | $ 15 | $ 30 | |||||
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 | 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% | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Description | stock, for up to 40% | ||||||||
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 | ||||||||
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, Shares Purchased for Award | 3 |
INCOME TAXES - Additional Infor
INCOME TAXES - Additional Information (Detail) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 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 | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
EPS – basic and diluted | ||||
Numerator: net loss | $ (1,095) | $ (2,200) | $ (3,850) | $ (3,944) |
Denominator (weighted): | ||||
Common shares | 21,034 | 16,544 | 21,033 | 14,103 |
Vested RSUs | 134 | 142 | 68 | 44 |
Basic and diluted weighted average shares outstanding | 21,168 | 16,686 | 21,101 | 14,147 |
EPS – basic and diluted | $ (0.05) | $ (0.12) | $ (0.18) | $ (0.27) |
Common shares issuable: | ||||
Total excluded common shares | 3,430 | 3,397 | 3,430 | 3,397 |
Employee Stock Option [Member] | ||||
Common shares issuable: | ||||
Total excluded common shares | 1,328 | 1,494 | 1,328 | 1,494 |
Warrant [Member] | ||||
Common shares issuable: | ||||
Total excluded common shares | 1,843 | 1,843 | 1,843 | 1,843 |
Restricted Stock Units (RSUs) [Member] | ||||
Common shares issuable: | ||||
Total excluded common shares | 259 | 60 | 259 | 60 |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - Additional Information (Detail) - USD ($) $ in Thousands | Apr. 12, 2018 | Jun. 30, 2015 | Sep. 30, 2018 | Dec. 31, 2014 |
Commitments and Contingencies Disclosure [Line Items] | ||||
Accrued Cost Sharing Expenses Clinical Studies | $ 443 | |||
Gain Contingency, Unrecorded Amount | $ 10,000 | |||
Loss Contingency, Damages Sought, Value | $ 10,000 | |||
Purdue Pharma [Member] | ||||
Commitments and Contingencies Disclosure [Line Items] | ||||
Litigation Settlement, Expense | $ 250 | $ 500 | ||
Palatine Illinois | ||||
Commitments and Contingencies Disclosure [Line Items] | ||||
Litigation Settlement, Expense | $ 2 |
SUBSEQUENT EVENT - Additional I
SUBSEQUENT EVENT - Additional Information (Detail) - USD ($) $ in Thousands | Oct. 05, 2018 | Nov. 21, 2018 | Oct. 31, 2018 | Oct. 05, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2013 |
Subsequent Event [Line Items] | |||||||||
Proceeds from Issuance of Long-term Debt | $ 700 | $ 1,500 | $ 2,200 | $ 0 | |||||
Debt Instrument, Face Amount | 2,200 | $ 2,200 | $ 10,000 | ||||||
Repayments of Lines of Credit | $ 1,500 | ||||||||
Schutte Note [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Proceeds from Issuance of Long-term Debt | 4,150 | 4,150 | |||||||
Debt Instrument, Maturity Date | Jan. 2, 2020 | ||||||||
Debt Instrument, Face Amount | $ 700 | $ 1,500 | $ 700 | ||||||
Subsequent Event [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Proceeds from Issuance of Long-term Debt | 1,800 | $ 150 | $ 1,800 | ||||||
Debt Instrument, Basis Spread on Variable Rate | 2.00% | ||||||||
Debt Instrument, Maturity Date | Jan. 2, 2020 | ||||||||
Subsequent Event [Member] | Loan Agreement With Oxford [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Proceeds from Issuance of Long-term Debt | $ 1,800 | ||||||||
Subsequent Event [Member] | Schutte Note [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Debt Instrument, Face Amount | $ 1,950 |