Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2017 | Nov. 10, 2017 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2017 | |
Document Fiscal Year Focus | 2,017 | |
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 | Smaller Reporting Company | |
Trading Symbol | ACUR | |
Entity Common Stock, Shares Outstanding | 20,795,994 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Assets: | ||
Cash and cash equivalents | $ 4,787 | $ 2,681 |
Restricted cash equivalents (Note 10) | 0 | 2,500 |
Trade accounts receivable (net of allowances of $- and $7) | 0 | 23 |
Collaboration revenue receivable | 0 | 79 |
Royalty receivable | 65 | 50 |
Inventories (net of allowances of $- and $32) (Note 6) | 0 | 309 |
Prepaid expenses and other current assets | 442 | 268 |
Total current assets | 5,294 | 5,910 |
Property, plant and equipment, net (Note 7) | 699 | 867 |
Intangible asset, net of accumulated amortization of $724 and $569 (Note 3) | 1,276 | 1,431 |
Total assets | 7,269 | 8,208 |
Liabilities: | ||
Accounts payable | 127 | 77 |
Accrued expenses (Note 8) | 890 | 703 |
Accrued interest | 26 | 0 |
Other current liabilities | 36 | 27 |
Sales returns liability | 303 | 304 |
Debt - current (Note 10) | 2,917 | 2,376 |
Total current liabilities | 4,299 | 3,487 |
Debt - non-current portion, net of discounts (Note 10) | 702 | 2,979 |
Accrued interest - non-current portion (Note 10) | 668 | 559 |
Total liabilities | 5,669 | 7,025 |
Commitments and contingencies (Note 17) | ||
Stockholders' equity: | ||
Common stock - $.01 par value per share; 100,000 shares authorized, 20,796 and 11,834 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively | 208 | 118 |
Additional paid-in capital | 380,034 | 375,763 |
Accumulated deficit | (378,642) | (374,698) |
Total stockholders’ equity | 1,600 | 1,183 |
Total liabilities and stockholders’ equity | $ 7,269 | $ 8,208 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Accounts receivable, net of allowances | $ 0 | $ 7 |
Inventory Valuation Reserves | 0 | 32 |
Finite-lived intangible assets accumulated amortization | $ 724 | $ 569 |
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 100,000 | 100,000 |
Common stock, shares issued | 20,796 | 11,834 |
Common stock, shares outstanding | 20,796 | 11,834 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Revenues: | ||||
License fee revenue | $ 0 | $ 0 | $ 2,500 | $ 0 |
Collaboration revenue | 0 | 74 | 59 | 307 |
Royalty revenue | 83 | 39 | 226 | 86 |
Product sales, net | 0 | 105 | 107 | 306 |
Total revenues, net | 83 | 218 | 2,892 | 699 |
Cost and expenses: | ||||
Cost of sales (excluding inventory provisions) | 0 | 108 | 128 | 309 |
Inventory provisions | 0 | 0 | 0 | 26 |
Research and development | 1,077 | 841 | 2,808 | 3,258 |
Selling, marketing, general and administrative | 1,068 | 1,338 | 3,427 | 5,392 |
Total costs and expenses | 2,145 | 2,287 | 6,363 | 8,985 |
Operating loss | (2,062) | (2,069) | (3,471) | (8,286) |
Non-operating income (expense): | ||||
Interest and investment income | 1 | 11 | 3 | 59 |
Interest expense (Note 10) | (139) | (215) | (476) | (697) |
Other income (expense) | 0 | 23 | 0 | 2 |
Total other expense, net | (138) | (181) | (473) | (636) |
Loss before provision for income taxes | (2,200) | (2,250) | (3,944) | (8,922) |
Provision for income taxes | 0 | 0 | 0 | 0 |
Net loss | (2,200) | (2,250) | (3,944) | (8,922) |
Other comprehensive income: | ||||
Unrealized (losses) gains on securities | 0 | (26) | 0 | 65 |
Comprehensive loss | $ (2,200) | $ (2,276) | $ (3,944) | $ (8,857) |
Loss per share: | ||||
Basic | $ (0.12) | $ (0.19) | $ (0.27) | $ (0.75) |
Diluted | $ (0.12) | $ (0.19) | $ (0.27) | $ (0.75) |
Weighted average shares outstanding: | ||||
Basic | 16,686 | 11,880 | 14,147 | 11,858 |
Diluted | 16,686 | 11,880 | 14,147 | 11,858 |
CONSOLIDATED STATEMENT OF CHANG
CONSOLIDATED STATEMENT OF CHANGES IN ACCUMULATED STOCKHOLDERS' EQUITY - 9 months ended Sep. 30, 2017 - USD ($) shares in Thousands, $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit |
Balance at Dec. 31, 2016 | $ 1,183 | $ 118 | $ 375,763 | $ (374,698) |
Balance (in shares) at Dec. 31, 2016 | 11,834 | |||
Net loss | (3,944) | $ 0 | 0 | (3,944) |
Share-based compensation | 353 | 0 | 353 | 0 |
Issuance of shares and warrants under private placement | 4,000 | $ 89 | 3,911 | |
Issuance of shares and warrants under private placement (in shares) | 8,913 | |||
Net distribution of common stock pursuant to restricted stock unit award plan | 8 | $ 1 | 7 | 0 |
Net distribution of common stock pursuant to restricted stock unit award plan (in shares) | 49 | |||
Balance at Sep. 30, 2017 | $ 1,600 | $ 208 | $ 379,539 | $ (378,642) |
Balance (in shares) at Sep. 30, 2017 | 20,796 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Cash Flows from Operating Activities: | ||
Net loss | $ (3,944) | $ (8,922) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | ||
Depreciation | 68 | 104 |
Provision to reduce inventory to net realizable value | 0 | 26 |
Provision for sales returns | 49 | 83 |
Share-based compensation | 353 | 450 |
Amortization of debt discount and deferred debt issue costs | 79 | 113 |
Amortization of bond premium in marketable securities | 0 | 31 |
Amortization of intangible asset | 155 | 155 |
(Gain) loss on disposal of machinery and equipment | (3) | 2 |
(Gain) loss on sales of marketable securities | 0 | (2) |
Change in assets and liabilities: | ||
Trade accounts receivable, net | 23 | (24) |
Collaboration revenue receivable | 79 | (27) |
Royalty receivable | (15) | (30) |
Accrued investment income | 0 | 37 |
Inventories | 103 | (174) |
Prepaid expenses and other current assets | (174) | 4 |
Other assets | 0 | 175 |
Accounts payable | 50 | 293 |
Accrued expenses | 187 | 170 |
Accrued interest | 135 | 176 |
Other current liabilities | 17 | 17 |
Sales returns liability | (50) | 0 |
Net cash used in operating activities | (2,888) | (7,343) |
Cash Flows from Investing Activities: | ||
Proceeds from sales and maturities of marketable securities | 0 | 10,873 |
Proceeds from transfer of equipment to licensee | 103 | 0 |
Proceeds from transfer of inventory to licensee | 206 | 0 |
Capital expenditures | 0 | (72) |
Net cash provided by investing activities | 309 | 10,801 |
Cash Flows from Financing Activities: | ||
Principal payments on debt | (1,815) | (1,671) |
Issuance of common stock | 4,000 | 0 |
Net cash provided by (used in) financing activities | 2,185 | (1,671) |
Net (decrease) increase in cash, cash equivalents, and restricted cash | (394) | 1,787 |
Cash, cash equivalents, and restricted cash at beginning of period | 5,181 | 2,485 |
Cash, cash equivalents, and restricted cash at end of period | 4,787 | 4,272 |
Cash paid during the year for: | ||
Interest on term loan with Oxford Finance LLC | 262 | 407 |
Income taxes | 0 | 0 |
Reconciliation of cash, cash equivalents, and restricted cash | ||
Cash and cash equivalents | 4,787 | 1,772 |
Restricted cash equivalents | 0 | 2,500 |
Total cash, cash equivalents and restricted cash shown in the consolidated statements of cash flows | $ 5,181 | $ 2,485 |
OPERATIONS AND BASIS OF PRESENT
OPERATIONS AND BASIS OF PRESENTATION | 9 Months Ended |
Sep. 30, 2017 | |
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”, “We”, or “Our”) is a specialty pharmaceutical company engaged in the research and development of technologies and products intended to address medication abuse and misuse. We have discovered and developed three proprietary platform technologies which can be used to develop multiple products. Our Aversion® and Limitx Technologies are intended to address methods of product tampering associated with opioid abuse while our Impede® Technology is directed at minimizing the extraction and conversion of pseudoephedrine into methamphetamine. · Our Limitx Technology, is designed to retard the release of active drug ingredients when too many tablets are accidently or purposefully ingested by neutralizing stomach acid with buffer ingredients but deliver efficacious amounts of drug when taken as a single tablet with a nominal buffer dose. We have completed two clinical studies of various product formulations utilizing immediate-release hydromorphone HCl and one clinical study using immediate-release hydrocodone bitartrate and acetaminophen. We plan to conduct another dose ranging study for immediate-release hydrocodone bitartrate and acetaminophen to commence in the fourth quarter of 2017, with topline results expected in the first quarter of 2018. The FDA has designated the development program for immediate-release hydromorphone HCl as Fast Track, which is designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. However, we intend to advance immediate-release hydrocodone bitartrate and acetaminophen as a lead Limitx product candidate due to its larger market size and its known prevalence of oral excessive tablet abuse. · Our Aversion Technology incorporates gelling ingredients and irritants into tablets to discourage abuse by snorting and provide barriers to abuse by injection. Aversion is used in Oxaydo® Tablets (oxycodone HCl, CII), and is the first approved immediate-release oxycodone product in the United States with abuse deterrent labeling. On January 7, 2015, we entered into a Collaboration and License Agreement with Egalet US, Inc. and Egalet Ltd., each a subsidiary of Egalet Corporation (collectively, “Egalet”) pursuant to which we exclusively licensed to Egalet worldwide rights to manufacture and commercialize Oxaydo®. Oxaydo is currently approved by the FDA for marketing in the United States in 5mg and 7.5mg strengths. Egalet launched Oxaydo in the United States late in the third quarter of 2015. (see Note 3). · Our Impede Technology is a proprietary mixture of inactive ingredients that prevents the extraction of pseudoephedrine, or PSE, from tablets using known extraction methods and disrupts the direct conversion of PSE from tablets into methamphetamine. Impede is used in Nexafed® Tablets (30mg pseudoephedrine HCl) and Nexafed® Sinus Pressure + Pain Tablets (30/325mg pseudoephedrine HCl and acetaminophen), and those Nexafed products were launched by us into the United States market in December 2012 and February 2015, respectively. We have multiple PSE products in development utilizing our Impede Technology. On March 16, 2017, we and MainPointe Pharmaceuticals, LLC (“MainPointe”) entered into a License, Commercialization and Option Agreement (“MainPointe Agreement”) pursuant to which we granted MainPointe an exclusive license to our Impede technology in the United States and Canada to commercialize our Nexafed products. The MainPointe Agreement also grants MainPointe the option to expand the licensed territory to the European Union, Japan and South Korea and to add additional pseudoephedrine-containing products utilizing our Impede Technology. (see Note 3). MainPointe is controlled by John Schutte, who became our largest shareholder pursuant to a private placement transaction completed in July 2017. Basis of Presentation and 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, 2016. In the opinion of the Company, all normal recurring adjustments have been made that are necessary to present fairly the results of operations for the interim periods. Operating results for the three and nine month periods ended September 30, 2017 are not necessarily indicative of the results that may be expected for the year ending December 31, 2017. The going concern basis of presentation assumes that we will continue in operation for the next twelve months and will be able to realize our assets and discharge our liabilities and commitments in the normal course of business and does not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from our inability to continue as a going concern. 4.8 1.0 378.6 3.5 3.9 e have suffered annual losses from operations and have not generated or have generated limited annual positive cash flows from operations. We expect our Our term loan agreement with Oxford contains customary affirmative and negative covenants. One such covenant is that the Company must submit on an annual basis to Oxford, within 120 days after the end of its fiscal year, audited consolidated financial statements, together with an unqualified audit opinion from an independent registered public accounting firm, or the Unqualified Audit Opinion Covenant. Per the term loan agreement an audit opinion with an explanatory paragraph noting substantial doubt about the Company’s ability to continue in business (the “going concern opinion”) is deemed to violate the Unqualified Audit Opinion Covenant. Failure to comply with the Unqualified Audit Opinion Covenant is a breach of the term loan agreement and unless such covenant or breach is waived, Oxford would have the option of accelerating the debt under the term loan agreement and initiating enforcement collection actions, foreclosing on collateral (which includes most assets of the Company) and, among other things, preventing the Company from using any funds in its bank or securities accounts. On March 16, 2017, we and Oxford entered into a third amendment to the Loan Agreement, or the Third Amendment. Pursuant to the Third Amendment (i) we granted Oxford a lien on our intellectual property, (ii) Oxford provided a waiver of compliance with the Unqualified Audit Opinion Covenant in connection with our receipt of our auditor’s going concern opinion for our 2016 financial statements and (iii) Oxford consented to the terms of the MainPointe Agreement. There can be no assurance, however, that Oxford will grant a similar waiver of compliance with the Unqualified Audit Opinion Covenant in connection with our receipt of our auditor’s opinion relating to our 2017 financial statements. These factors, among others, raise substantial doubt about the Company's ability to continue as a going concern. To fund further operations and product development activities beyond April 2018, we must raise additional financing or enter into license or collaboration agreements with third parties relating to our technologies. The Company intends to explore 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 is evaluating 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 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, 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, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
RECENT ACCOUNTING PRONOUNCEMENTS | NOTE 2 RECENT ACCOUNTING PRONOUNCEMENTS Revenue from Contracts with Customers In May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2014-09, Revenue from Contracts with Customers The standard is effective for us on January 1, 2018, using either of the following transition methods: (i) a full retrospective approach reflecting the application of the standard in each prior reporting period with the option to elect certain practical expedients, or (ii) a modified retrospective approach with the cumulative accounting effect of initially adopting ASU 2014-09 to be recognized on January 1, 2018. We have determined the transition method we will utilize to adopt the standard for use in 2018 to be the modified retrospective approach. Under the modified retrospective method, we will recognize the cumulative effect of initially applying the new revenue standard as an adjustment to the opening balance of retained earnings account . The comparative information will not be restated and will continue to be reported under the accounting standards in effect for those periods. In order to evaluate the impact that the adoption of ASU 2014-09 will have on our consolidated financial statements and related disclosures, we have initiated a comprehensive review of revenues. We have identified four significant contracts that will need to be evaluated under the standard. We are reviewing these four contracts and agreements to identify significant performance obligations and other factors to determine what impact the adoption of the standard will have on our consolidated financial statements and related disclosures. We are reviewing our current accounting policies, procedures and controls with respect to these contracts and arrangements to determine what changes, if any, may be required by the adoption of ASU 2014-09.We expect to complete our evaluation prior to the filing of, and make disclosures in, the 2017 Form 10-K. Additional disclosures will be required to enable users to understand the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers. Inventories In July 2015, the FASB issued ASU No. 2015-11, which amended Accounting Standards Codification (“ASC”) Topic 330 Inventory. The amendment simplifies the measurement of inventory, applying to inventories for which cost is determined by methods other than last-in first-out (LIFO) and the retail inventory method (RIM), specifying that an entity should measure inventory at the lower of cost and net realizable value instead of at the lower of cost or market. The amendments in this ASU were effective for annual and interim periods, within those fiscal years, beginning after December 15, 2016. The Company adopted the guidance of the standard in the first quarter of 2017 which did not have a material impact on the Company’s consolidated financial statements. 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 consolidated financial statements and related footnote disclosures. Employee Share-Based Payments In March 2016, the FASB issued ASU 2016-09, Improvements to Employee Share-Based Payment Accounting Statement of Cash Flows In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments 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 Statement of Cash Flows - Restricted Cash In November 2016, the FASB issued ASU 2016-18, Statements of Cash Flows (Topic 230): Restricted Cash Compensation Stock Compensation In May 2017, the FASB issued ASU No. 2017-09, Compensation - Stock Compensation (ASC 718) - Scope of Modification Accounting. |
LICENSE, DEVELOPMENT, AND COMME
LICENSE, DEVELOPMENT, AND COMMERCIALIZATION AGREEMENTS | 9 Months Ended |
Sep. 30, 2017 | |
Research and Development Disclosure [Abstract] | |
LICENSE, DEVELOPMENT, AND COMMERCIALIZATION AGREEMENTS | NOTE 3 LICENSE, DEVELOPMENT, AND COMMERCIALIZATION AGREEMENTS MainPointe Agreement covering Nexafed Product Line On March 16, 2017, we and MainPointe entered into the MainPointe Agreement, pursuant to which we granted MainPointe an exclusive license to our Impede technology to commercialize our 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 $ 2.5 309 7.5 MainPointe has the option to expand the licensed territory beyond the United States and Canada to the European Union (and the United Kingdom), Japan and South Korea for payments of $ 1.0 500 250 The MainPointe Agreement may be terminated by either party for a material breach of the other party, or by Acura if MainPointe challenges certain of its patents. Upon early termination of the MainPointe Agreement, MainPointe’s licenses to the Impede technology and all products will terminate. Upon termination, at Acura’s request the parties will use commercially reasonable efforts to transition the Nexafed® and Nexafed® Sinus Pressure + Pain products back to Acura. KemPharm Agreement Covering Certain Opioid Prodrugs On October 13, 2016, we and KemPharm Inc. (”KemPharm”) entered into a worldwide License Agreement (the “KemPharm Agreement”) pursuant to which we licensed our Aversion® technology to KemPharm for its use in the development and commercialization of three products using 2 of KemPharm’s prodrug candidates. KemPharm has also been granted an option to extend the KemPharm Agreement to cover two additional prodrug candidates. KemPharm is responsible for all development, manufacturing and commercialization activities. Upon execution of the KemPharm Agreement, KemPharm paid us an upfront payment of $ 3.5 1.0 The KemPharm Agreement expires upon the expiration of KemPharm’s royalty payment obligations in all countries. Either party may terminate the KemPharm Agreement in its entirety if the other party materially breaches the KemPharm Agreement, subject to applicable cure periods. Acura or KemPharm may terminate the KemPharm Agreement with respect to the U.S. and other countries if the other party challenges the patents covering the licensed products. KemPharm may terminate the KemPharm Agreement for convenience on ninety (90) days prior written notice. Termination does not affect a party’s rights accrued prior thereto, but there are no stated payments in connection with termination other than payments of obligations previously accrued. For all terminations (but not expiration), the KemPharm Agreement provides for termination of our license grant to KemPharm. Egalet Agreement covering Oxaydo In April 2014, we terminated an agreement with Pfizer and the return to us of Aversion Oxycodone (formerly known as Oxecta®) and all Aversion product rights in exchange for a one-time termination payment of $ 2.0 2.0 9.7 52 155 208 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 fees and expenses and we will pay for the remaining fees and expense relating to (i) annual NDA PDUFA product fees, (ii) expenses of the FDA required post-marketing study for Oxaydo and (iii) expenses of clinical studies for product line extensions (additional strengths) of Oxaydo for the United States. Egalet will bear all of the expenses of development and regulatory approval of Oxaydo for sale outside the United States. Egalet is responsible for all manufacturing and commercialization activities in the Territory for Oxaydo. Subject to certain exceptions, Egalet will have final decision making authority with respect to all development and commercialization activities for Oxaydo, including pricing, subject to our co-promotion right. Egalet may develop Oxaydo for other countries and in additional strengths, in its discretion. Egalet paid us a $ 5.0 2.5 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. Terminated Bayer Agreement Covering Methamphetamine Resistant Pseudoephedrine-containing Product On June 15, 2015, we and Bayer entered into a License and Development Agreement (the “Bayer Agreement”) granting Bayer an exclusive worldwide license to our Impede Technology for use in an undisclosed methamphetamine resistant pseudoephedrinecontaining product (the “Bayer Licensed Product”) and providing for the joint development of such product utilizing our Impede Technology for the U.S. market. On June 28, 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 License Product is now subject to MainPointe’s option rights under the MainPointe Agreement. |
REVENUE RECOGNITION
REVENUE RECOGNITION | 9 Months Ended |
Sep. 30, 2017 | |
Revenue Recognition [Abstract] | |
REVENUE RECOGNITION | NOTE 4 - REVENUE RECOGNITION License Fee Revenue On signing the MainPointe Agreement in March 2017, MainPointe paid us an upfront licensing fee of $ 2.5 Milestone Revenue Milestone revenue is contingent upon the achievement of certain pre-defined events in the development agreements. Milestone payments are recognized as revenue upon achievement of the “at risk” milestone events, which represent the culmination of the earnings process related to that milestone. Milestone payments are triggered either by the results of our research and development efforts or by events external to us, such as regulatory approval to market a product. As such, the milestones are substantially at risk at the inception of an agreement, and the amounts of the payments assigned thereto are commensurate with the milestone achieved. In addition, upon the achievement of a milestone event, we have no future performance obligations related to that milestone payment. Each milestone payment is non-refundable and non-creditable when made and is recognized as revenue when received. Collaboration Revenue Collaboration revenue is derived from research and development services we provide from time to time and are recognized when those services are incurred pursuant to the agreements. The ongoing research and development services being provided under the collaboration are priced at fair value based upon the service’s hourly rates pursuant to the collaboration agreement. We did not have collaboration revenue for the three months ended September 30, 2017 and recognized $ 74 59 307 Royalty Revenue In connection with our Collaboration and License Agreement with Egalet to commercialize Oxaydo tablets we are receiving a stepped royalty at percentage rates ranging from mid-single digits to double-digits based on Oxaydo net sales during each calendar year over the term of the agreement (excluding net sales resulting from any co-promotion efforts by us). We recognize royalty revenue each calendar quarter based on net sales reported to us by Egalet in accordance with the agreement. We recognized royalty revenue of $ 78 39 213 86 In connection with our License, Commercialization and Option Agreement with MainPointe, which occurred on March 16, 2017, we are receiving a royalty of 7.5 5 13 Product Sales Nexafed was launched in mid-December 2012 and Nexafed Sinus Pressure + Pain was launched in February 2015. Prior to entering into the MainPointe Agreement, 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. Prior to entering into the MainPointe Agreement, we recognized revenue from our Nexafed product line 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. Shipping and Handling Costs We record shipping and handling costs in selling expenses. As of mid-March 2017 we no longer manufacture, distribute or sell the Nexafed product line as the Company granted MainPointe an exclusive license to our Impede technology to commercialize our Nexafed products in the U.S. and Canada. The amounts recorded to selling expenses from the shipments of the Nexafed product line during each of the nine month periods ended September 30, 2017 and 2016 were not material. |
RESEARCH AND DEVELOPMENT ACTIVI
RESEARCH AND DEVELOPMENT ACTIVITIES | 9 Months Ended |
Sep. 30, 2017 | |
Research and Development [Abstract] | |
RESEARCH AND DEVELOPMENT ACTIVITIES | NOTE 5 - RESEARCH AND DEVELOPMENT ACTIVITIES Research and Development (“R&D”) expenses include internal R&D activities, external Contract Research Organization (“CRO”) services and their clinical research sites, and other activities. Internal R&D activity expenses include facility overhead, equipment and facility maintenance and repairs, laboratory supplies, pre-clinical laboratory experiments, formulation work, depreciation, salaries, benefits, and share-based compensation expenses. CRO activity expenses include preclinical laboratory experiments and clinical trial studies. Other activity expenses include regulatory consulting, and regulatory legal counsel. Internal R&D activities and other activity expenses are charged to operations as incurred. We make payments to the CRO's based on agreed upon terms and may include payments in advance of a study starting date. We review and accrue CRO expenses and clinical trial study expenses based on services performed and rely on estimates of those costs applicable to the stage of completion of a study as provided by the CRO. Accrued CRO costs are subject to revisions as such studies progress to completion. Revisions are charged to expense in the period in which the facts that give rise to the revision become known. During 2015, we entered into a cancelable arrangement for contract manufacturing services on a project to integrate Impede 2.0 technology into our Nexafed 30mg tablet while moving supply to an alternate contract manufacturer. Approximately $ 50 |
INVENTORIES
INVENTORIES | 9 Months Ended |
Sep. 30, 2017 | |
Inventory Disclosure [Abstract] | |
INVENTORIES | NOTE 6 INVENTORIES We did not have inventories at September 30, 2017 as all our inventories were transferred to MainPointe under the MainPointe Agreement in March 2017. (See Note 3). Inventories at December 31, 2016 are stated at the lower of cost (first-in, first-out method) or net realizable value. We write down inventories to net realizable value based on forecasted demand and market conditions, which may differ from actual results. Our purchases of ingredients and other materials required in our development and clinical trial activities are expensed as incurred. December 31, (in thousands) Raw and packaging materials $ 98 Finished goods 243 Total 341 Less: reserve for finished goods (32) Net inventories $ 309 |
PROPERTY, PLANT AND EQUIPMENT
PROPERTY, PLANT AND EQUIPMENT | 9 Months Ended |
Sep. 30, 2017 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY, PLANT AND EQUIPMENT | NOTE 7 PROPERTY, PLANT AND EQUIPMENT Property, plant and equipment at September 30, 2017 and December 31, 2016 are summarized as follows: September 30, December 31, 2017 2016 (in thousands) Building and improvements $ 1,273 $ 1,273 Scientific equipment 598 598 Computer hardware and software 107 109 Machinery and equipment 275 568 Land and improvements 162 162 Other personal property 70 70 Office equipment 27 27 Total 2,512 2,807 Less: impairment reserve - (82) Less: accumulated depreciation (1,813) (1,858) Net property, plant and equipment $ 699 $ 867 The impairment reserve of $ 82 |
ACCRUED EXPENSES
ACCRUED EXPENSES | 9 Months Ended |
Sep. 30, 2017 | |
Payables and Accruals [Abstract] | |
ACCRUED EXPENSES | NOTE 8 - ACCRUED EXPENSES September 30, December 31, 2017 2016 (in thousands) Cost sharing expenses under license agreement $ 274 $ 150 Other fees and services 80 47 Payroll, payroll taxes and benefits 114 116 Professional services 157 232 Clinical, non-clinical and regulatory services 236 131 Marketing, advertising, and promotion - 10 Property taxes 15 16 Franchise taxes 14 1 Total $ 890 $ 703 |
EQUITY FINANCING
EQUITY FINANCING | 9 Months Ended |
Sep. 30, 2017 | |
Equity [Abstract] | |
EQUITY FINANCING | NOTE 9 EQUITY FINANCING On July 24, 2017, we completed a $ 4.0 8,912,655 0.4488 0.528 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 $ 2.5 425 7.5 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 between the 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. 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 |
DEBT
DEBT | 9 Months Ended |
Sep. 30, 2017 | |
Debt Disclosure [Abstract] | |
DEBT | NOTE 10 DEBT On December 27, 2013, we entered into a Loan and Security Agreement (the “Loan Agreement”) with Oxford Finance LLC (“Oxford” or the “Lender”), for a term loan to the Company in the principal amount of $ 10.0 8.35 13.35 - 260 December 1, 2018 - 60 400 December 27, 2020 On January 7, 2015, we and Oxford entered into an amendment to the Loan Agreement. Pursuant to the amendment, (i) the exercise price of the warrants was lowered from $ 7.98 2.52 33 2.5 5.0 On October 13, 2016, we and Oxford entered into a second amendment to the Loan Agreement (the “Second Amendment”). Pursuant to the Second Amendment, (i) the requirement that we maintain a $ 2.5 5.0 2.5 6.0 3.0 3.9 2.5 On March 16, 2017, we and Oxford entered into a third amendment to the Loan Agreement (the “Third Amendment”). Pursuant to the Third Amendment (i) we granted Oxford a lien on our intellectual property, (ii) Oxford provided a waiver of compliance with the Unqualified Audit Opinion Covenant in connection with our receipt of our auditor’s going concern opinion for our 2016 financial statements and (iii) Oxford consented to the terms of the MainPointe Agreement. Under the Loan Agreement, an audit opinion with an explanatory paragraph noting substantial doubt about the Company’s ability to continue in business is deemed to violate the Unqualified Audit Opinion Covenant. The Company may voluntarily prepay the Term Loan in full, but not in part, and any prepayment is subject to a prepayment premium equal to 1 795 668 559 The Company was obligated to pay customary lender fees and expenses, including a one-time facility fee of $ 50 100 231 10.16 The Loan Agreement contains customary representations and warranties and customary affirmative and negative covenants, including, among others, limits or restrictions on the Company’s ability to incur liens, incur indebtedness, pay dividends, redeem stock, and merge or consolidate and dispose of assets. In addition, it contains customary events of default that entitles the Lender to cause any or all of the Company’s indebtedness under the Loan Agreement to become immediately due and payable. The events of default (some of which are subject to applicable grace or cure periods), include, among other things, non-payment defaults, covenant defaults (including breach of the Unqualified Audit Opinion Covenant), a material adverse change in the Company, bankruptcy and insolvency defaults and material judgment defaults. Current Debt Current Long-term Total Balance at Jan. 1, 2017 $ 2,521 $ 2,979 $ 5,500 Principal payments (1,815) - (1,815) Classification 2,211 (2,211) - Balance at Sept. 30, 2017 $ 2,917 $ 768 $ 3,685 Debt Discount Current Long-term Total Balance at Jan. 1, 2017 $ (98) $ - $ (98) Classification 98 (98) - Amortization expense - 52 52 Balance at Sept. 30, 2017 $ - $ (46) $ (46) Deferred Debt Issuance Costs Current Long-term Total Balance at Jan. 1, 2017 $ (47) $ - $ (47) Classification 47 (47) - Amortization expense - 27 27 Balance at Sept. 30, 2017 $ - $ (20) $ (20) Current Debt, net at Sept. 30, 2017 $ 2,917 $ 702 $ 3,619 Three months Ended Nine months Ended Interest expense: 2017 2016 2017 2016 Term loan $ 116 $ 180 $ 397 $ 584 Debt discount 15 23 52 74 Debt issue costs 8 12 27 39 Total interest expense $ 139 $ 215 $ 476 $ 697 Remaining Annual Year (in thousands) 2017 $ 707 2018 2,978 Total $ 3,685 |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 9 Months Ended |
Sep. 30, 2017 | |
Equity, Fair Value Disclosure [Abstract] | |
FAIR VALUE MEASUREMENTS | NOTE 11 FAIR VALUE MEASUREMENTS The Company’s financial instruments consist primarily of cash and cash equivalents, receivables from trade, royalties and collaboration, trade accounts payable, and our long-term debt. The carrying amounts of these financial instruments, other than our long-term debt, are representative of their respective fair values due to their relatively short maturities. |
COMMON STOCK WARRANTS
COMMON STOCK WARRANTS | 9 Months Ended |
Sep. 30, 2017 | |
Stockholders Equity Note [Abstract] | |
COMMON STOCK WARRANTS | NOTE 12 - COMMON STOCK WARRANTS Nine months Ended 2017 2016 Number WAvg Number WAvg Outstanding, Jan. 1 60 $ 2.52 60 $ 2.52 Issued 1,783 0.53 - - Exercised - - - - Expired - - - - Modification - - - - Outstanding, Sept. 30 1,843 $ 0.59 60 $ 2.52 In connection with the issuance of the $ 10.0 60 2.52 2.52 As part of our July 2017 private placement transaction, we issued warrants to purchase 1,782,531 0.528 |
SHARE-BASED COMPENSATION
SHARE-BASED COMPENSATION | 9 Months Ended |
Sep. 30, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
SHARE-BASED COMPENSATION | NOTE 13 - SHARE-BASED COMPENSATION Share-based Compensation We have four share-based compensation plans covering stock options and RSUs for our employees and directors. We measure our compensation cost related to share-based payment transactions based on fair value of the equity or liability instrument issued. For purposes of estimating the fair value of each stock option unit on the date of grant, we utilize the Black-Scholes option-pricing model. Option valuation models require the input of highly subjective assumptions including the expected volatility factor of the market price of our common stock (as determined by reviewing our historical public market closing prices). Our accounting for share-based compensation for RSUs is based on the market price of our common stock on the date of grant, less its exercise cost. Three months Ended Nine months Ended 2017 2016 2017 2016 Research and development expense: Stock options $ 38 $ 43 $ 106 $ 128 Restricted stock units - - - - Subtotal $ 38 $ 43 $ 106 $ 128 General and administrative expense: Stock options $ 52 $ 77 $ 158 $ 232 Restricted stock units 30 30 89 90 Subtotal $ 82 $ 107 $ 247 $ 322 Total $ 120 $ 150 $ 353 $ 450 Stock Option Award Plans We maintain various stock option plans. Nine Months Ended 2017 2016 Number Weighted Number of Weighted Outstanding, Jan. 1 1,397 $ 13.57 1,198 $ 15.67 Granted 185 0.31 - - Exercised (1) (0.92) - - Forfeited or expired 87 6.48 - - Outstanding, Sept. 30 1,494 $ 12.33 1,198 $ 15.67 Options exercisable 1,176 $ 15.46 1,000 $ 18.37 Number of Weighted Outstanding, Jan. 1, 2017 335 $ 1.18 Granted 185 0.31 Vested (188) 1.36 Forfeited (14) 1.05 Outstanding, Sept. 30, 2017 318 $ 0.58 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. There was no intrinsic value of any option awards vested and outstanding at either September 30, 2017 or 2016. The total remaining unrecognized compensation cost on unvested option awards outstanding at September 30, 2017 was $ 174 Restricted Stock Unit Award Plan We have a Restricted Stock Unit Award Plan (the “2014 RSU Plan”) for our employees and non-employee directors. Vesting of an RSU entitles the holder to receive a share of our common stock on a distribution date. The share-based compensation cost to be incurred on a granted RSU is the RSU’s fair value, which is the market price of our common stock on the date of grant, less its exercise cost. The compensation cost is amortized to expense over the vesting period of the RSU award. Nine months Ended September 30, 2017 2016 (in thousands) Number Number of Number of Number of Outstanding, Jan. 1 91 91 45 45 Granted 238 - 88 - Distributed (67) (67) (42) (42) Vested - 178 - 66 Forfeited or expired - - - - Outstanding, Sept. 30 262 202 91 69 Our 2014 RSU Plan was approved by shareholders on May 1, 2014 and permits the grant of up to 400 3 Information about the awards under the 2014 RSU Plan is as follows: · On January 2, 2015, we awarded approximately 10 25 · On January 4, 2016, we awarded approximately 22 25 27 · On January 3, 2017, we awarded approximately 60 25 36 Information about the distribution of shares under the 2014 RSU Plan is as follows: · On January 4, 2016, 1 41 2 42 33 9 · On January 3, 2017, 1 66 1 22 67 49 18 |
INCOME TAXES
INCOME TAXES | 9 Months Ended |
Sep. 30, 2017 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | NOTE 14 INCOME TAXES We account for income taxes under the liability method. Under this method, deferred income tax assets and liabilities are determined based on differences between financial reporting and income tax basis of assets and liabilities and are accounted for using the enacted income tax rates and laws that will be in effect when the differences are expected to reverse. Additionally, net operating loss and tax credit carryforwards are reported as deferred income tax assets. The realization of deferred income tax assets is dependent upon future earnings. A valuation allowance is required against deferred income tax assets if, based on the weight of available evidence, it is more likely than not that some or all of the deferred income tax assets may not be realized. At both September 30, 2017 and December 31, 2016, all our remaining net deferred income tax assets were offset by a valuation allowance due to uncertainties with respect to future utilization of net operating loss (“NOL”) carryforwards. If in the future it is determined that additional amounts of our deferred income tax assets would likely be realized, the valuation allowance would be reduced in the period in which such determination is made and an additional benefit from income taxes in such period would be recognized. We have approximately $ 47.2 138.8 34 2.1 2017 2036 1.2 0.2 |
EARNINGS PER SHARE ("EPS")
EARNINGS PER SHARE ("EPS") | 9 Months Ended |
Sep. 30, 2017 | |
Earnings Per Share [Abstract] | |
EARNINGS PER SHARE ("EPS") | NOTE 15 EARNINGS PER SHARE (“EPS”) Basic EPS is computed by dividing net income or loss by the weighted average common shares outstanding during a period, including shares weighted related to vested Restricted Stock Units (“RSUs”) (see Note 13). 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, common stock purchase warrants and nonvested RSUs, assuming the exercise of all in-the-money stock securities. The weighted-average common shares outstanding computation for Diluted EPS is not impacted during any period where the exercise price of the security is greater than the period’s average market price of our common stock. Common stock equivalents are excluded from the Diluted EPS where their inclusion would be anti-dilutive. No such adjustments were made for either 2017 or 2016 as the Company reported a net loss for the three and nine month periods, and including the effects of the common stock equivalents in the Diluted EPS calculations would have been antidilutive. Three months Ended Nine months Ended 2017 2016 2017 2016 EPS basic and diluted Numerator: net loss $ (2,200) $ (2,250) $ (3,944) $ (8,922) Denominator (weighted): Common shares 18,544 11,834 14,103 11,833 Vested RSUs 142 46 44 25 Basic and diluted weighted average shares outstanding 16,686 11,880 14,147 11,858 EPS basic and diluted $ (0.12) $ (0.19) $ (0.27) $ (0.75) Excluded securities (non-weighted): Common shares issuable: Stock options 1,494 1,198 1,494 1,198 Nonvested RSUs 60 22 60 22 Common stock purchase warrants 1,843 60 1,843 60 Total excluded common shares 3,397 1,280 3,397 1,280 |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 9 Months Ended |
Sep. 30, 2017 | |
Related Party Transactions [Abstract] | |
RELATED PARTY TRANSACTIONS | NOTE 16 RELATED PARTY TRANSACTIONS On July 24, 2017, we completed a $ 4.0 8,912,655 0.4488 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 Nexafed® and Nexafed® Sinus Pressure + Pain in the United States and Canada for an upfront licensing fee of $ 2.5 425 7.5 5 13 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 between the 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. 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 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 9 Months Ended |
Sep. 30, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | NOTE 17 COMMITMENTS AND CONTINGENCIES Reglan ® /Metoclopramide Litigation Halsey Drug Company, as predecessor to Acura, has been named along with numerous other companies as a defendant in cases filed in three separate state coordinated litigations pending in Pennsylvania, New Jersey and California, respectively captioned In re: Reglan®/Metoclopramide Mass Tort Litigation, Philadelphia County Court of Common Pleas, January Term, 2010, No. 01997; In re: Reglan Litigation, Superior Court of New Jersey, Law Division, Atlantic County, Case No. 289, Master Docket No. ATL-L-3865-10; and Reglan/Metoclopramide Cases, Superior Court of California, San Francisco County, Judicial Council Coordination Proceeding No. 4631, Superior Court No.: CJC-10-004631. In addition, 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 Pennsylvania action, over 200 150 50 445 In the lawsuits filed to date, plaintiffs have not confirmed they ingested any of the generic metoclopramide manufactured by us. We discontinued manufacture and distribution of generic metoclopramide more than 19 years ago. In addition, we believe the June 23, 2011 decision by the U.S. Supreme Court in PLIVA v. Mensing (“Mensing In New Jersey, Generic Defendants, including Acura, filed dispositive motions based on the Mensing In Pennsylvania, and California, Generic Defendants, including us, also filed dispositive motions based on the Mensing In Pennsylvania, on November 18, 2011, the trial court denied Generic Defendants’ dispositive preemption motions, without prejudice. In July 2013, the Pennsylvania Superior Court issued an adverse decision, and a subsequent appeal to the Pennsylvania Supreme Court was denied. On December 16, 2014, the Generic Defendants filed a Joint Petition for Certiorari with the United States Supreme Court captioned Teva Pharmaceuticals USA, Inc. et al. v. Dorothy Bentley, et al. In California, the trial court entered a May 25, 2012 Order denying Generic Defendants’ dispositive preemption motions. The Generic Defendants’ appeals from this order were denied by the California appellate courts. In May 2014, the California Court denied a subsequent demurrer and motion to strike seeking dismissal of plaintiffs’ manufacturing defect and defective product claims to the extent that they are barred by federal preemption based upon the June 2013 Bartlett 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, 2017 and we are presently unable to determine if any potential loss would be covered by our insurance carrier. 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 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, 2017 and December 31, 2016, we have accrued approximately $ 274 150 Facility Lease The Company leases administrative office space in Palatine, Illinois on a month to month basis at the rate of approximately $ 2,000 |
INVENTORIES (Tables)
INVENTORIES (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories at December 31, 2016 are summarized as follows: December 31, (in thousands) Raw and packaging materials $ 98 Finished goods 243 Total 341 Less: reserve for finished goods (32) Net inventories $ 309 |
PROPERTY, PLANT AND EQUIPMENT (
PROPERTY, PLANT AND EQUIPMENT (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Property, Plant and Equipment [Abstract] | |
Property Plant and Equipment | Property, plant and equipment at September 30, 2017 and December 31, 2016 are summarized as follows: September 30, December 31, 2017 2016 (in thousands) Building and improvements $ 1,273 $ 1,273 Scientific equipment 598 598 Computer hardware and software 107 109 Machinery and equipment 275 568 Land and improvements 162 162 Other personal property 70 70 Office equipment 27 27 Total 2,512 2,807 Less: impairment reserve - (82) Less: accumulated depreciation (1,813) (1,858) Net property, plant and equipment $ 699 $ 867 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Payables and Accruals [Abstract] | |
Accurued Expenses | Accrued expenses at September 30, 2017 and December 31, 2016 are summarized as follows: September 30, December 31, 2017 2016 (in thousands) Cost sharing expenses under license agreement $ 274 $ 150 Other fees and services 80 47 Payroll, payroll taxes and benefits 114 116 Professional services 157 232 Clinical, non-clinical and regulatory services 236 131 Marketing, advertising, and promotion - 10 Property taxes 15 16 Franchise taxes 14 1 Total $ 890 $ 703 |
DEBT (Tables)
DEBT (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Debt Disclosure [Abstract] | |
Schedule of Debt | Our debt at September 30, 2017 is summarized below (in thousands): Current Debt Current Long-term Total Balance at Jan. 1, 2017 $ 2,521 $ 2,979 $ 5,500 Principal payments (1,815) - (1,815) Classification 2,211 (2,211) - Balance at Sept. 30, 2017 $ 2,917 $ 768 $ 3,685 Debt Discount Current Long-term Total Balance at Jan. 1, 2017 $ (98) $ - $ (98) Classification 98 (98) - Amortization expense - 52 52 Balance at Sept. 30, 2017 $ - $ (46) $ (46) Deferred Debt Issuance Costs Current Long-term Total Balance at Jan. 1, 2017 $ (47) $ - $ (47) Classification 47 (47) - Amortization expense - 27 27 Balance at Sept. 30, 2017 $ - $ (20) $ (20) Current Debt, net at Sept. 30, 2017 $ 2,917 $ 702 $ 3,619 |
Schedule of Interest Expense | Our interest expense for the three and nine months ended September 30, 2017 and 2016 consisted of the following (in thousands): Three months Ended Nine months Ended Interest expense: 2017 2016 2017 2016 Term loan $ 116 $ 180 $ 397 $ 584 Debt discount 15 23 52 74 Debt issue costs 8 12 27 39 Total interest expense $ 139 $ 215 $ 476 $ 697 |
Schedule Of Long Term Debt Future Principal Payments Year | The remaining annual principal payments of the debt outstanding at September 30, 2017 are as follows: Remaining Annual Year (in thousands) 2017 $ 707 2018 2,978 Total $ 3,685 |
COMMON STOCK WARRANTS (Tables)
COMMON STOCK WARRANTS (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Stockholders Equity Note [Abstract] | |
Schedule Of Common Stock Warrant Activity | At September 30, 2017 and 2016, we have outstanding common stock purchase warrants as follows (in thousands except price data): Nine months Ended 2017 2016 Number WAvg Number WAvg Outstanding, Jan. 1 60 $ 2.52 60 $ 2.52 Issued 1,783 0.53 - - Exercised - - - - Expired - - - - Modification - - - - Outstanding, Sept. 30 1,843 $ 0.59 60 $ 2.52 |
SHARE-BASED COMPENSATION (Table
SHARE-BASED COMPENSATION (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Summary Of Information About Non Vested Stock Options Disclosure Abstract [Abstract] | |
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs | Our non-cash 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 Nine months Ended 2017 2016 2017 2016 Research and development expense: Stock options $ 38 $ 43 $ 106 $ 128 Restricted stock units - - - - Subtotal $ 38 $ 43 $ 106 $ 128 General and administrative expense: Stock options $ 52 $ 77 $ 158 $ 232 Restricted stock units 30 30 89 90 Subtotal $ 82 $ 107 $ 247 $ 322 Total $ 120 $ 150 $ 353 $ 450 |
Schedule of Share-based Compensation, Stock Options, Activity | A summary of our stock option plan activity during the nine month periods ending September 30, 2017 and 2016 is shown below: Nine Months Ended 2017 2016 Number Weighted Number of Weighted Outstanding, Jan. 1 1,397 $ 13.57 1,198 $ 15.67 Granted 185 0.31 - - Exercised (1) (0.92) - - Forfeited or expired 87 6.48 - - Outstanding, Sept. 30 1,494 $ 12.33 1,198 $ 15.67 Options exercisable 1,176 $ 15.46 1,000 $ 18.37 |
Schedule of Nonvested Share Activity | The following table summarizes information about nonvested stock options outstanding at September 30, 2017 (in thousands except price data): Number of Weighted Outstanding, Jan. 1, 2017 335 $ 1.18 Granted 185 0.31 Vested (188) 1.36 Forfeited (14) 1.05 Outstanding, Sept. 30, 2017 318 $ 0.58 |
Schedule of Share-based Compensation, Restricted Stock Units Award Activity | A summary of the grants under the RSU Plans consisted of the following: Nine months Ended September 30, 2017 2016 (in thousands) Number Number of Number of Number of Outstanding, Jan. 1 91 91 45 45 Granted 238 - 88 - Distributed (67) (67) (42) (42) Vested - 178 - 66 Forfeited or expired - - - - Outstanding, Sept. 30 262 202 91 69 |
EARNINGS PER SHARE ("EPS") (Tab
EARNINGS PER SHARE ("EPS") (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
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 Nine months Ended 2017 2016 2017 2016 EPS basic and diluted Numerator: net loss $ (2,200) $ (2,250) $ (3,944) $ (8,922) Denominator (weighted): Common shares 18,544 11,834 14,103 11,833 Vested RSUs 142 46 44 25 Basic and diluted weighted average shares outstanding 16,686 11,880 14,147 11,858 EPS basic and diluted $ (0.12) $ (0.19) $ (0.27) $ (0.75) Excluded securities (non-weighted): Common shares issuable: Stock options 1,494 1,198 1,494 1,198 Nonvested RSUs 60 22 60 22 Common stock purchase warrants 1,843 60 1,843 60 Total excluded common shares 3,397 1,280 3,397 1,280 |
OPERATIONS AND BASIS OF PRESE31
OPERATIONS AND BASIS OF PRESENTATION Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 | |
Cash, Cash Equivalent And Marketable Securities | $ 4,800 | $ 4,800 | |||
Working Capital Deficit | 1,000 | 1,000 | |||
Retained Earnings (Accumulated Deficit), Total | (378,642) | (378,642) | $ (374,698) | ||
Operating Income (Loss), Total | (2,062) | $ (2,069) | (3,471) | $ (8,286) | |
Net Income (Loss) Attributable to Parent, Total | $ (2,200) | $ (2,250) | $ (3,944) | $ (8,922) |
LICENSE, DEVELOPMENT, AND COM32
LICENSE, DEVELOPMENT, AND COMMERCIALIZATION AGREEMENTS - Additional Information (Detail) - USD ($) $ in Thousands | Oct. 09, 2015 | Jul. 24, 2017 | Mar. 16, 2017 | Oct. 31, 2016 | Apr. 30, 2014 | Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 |
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. | ||||||||
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. | ||||||||
Patents [Member] | |||||||||
License Development and Commercialization Agreement [Line Items] | |||||||||
Payment for Termination | $ 2,000 | ||||||||
Egalet Agreement | |||||||||
License Development and Commercialization Agreement [Line Items] | |||||||||
Payment for Termination | $ 2,000 | ||||||||
Minimum Net Sales Reaching Description | one-time $12.5 million milestone payment when worldwide Oxaydo net sales reach $150 million in a calendar year. | ||||||||
Licenses Revenue | $ 5,000 | ||||||||
Proceeds from Milestone Payment On Agreement | $ 2,500 | ||||||||
Amortization of Intangible Assets | $ 52 | $ 52 | $ 155 | $ 155 | |||||
Finite-Lived Intangible Asset, Useful Life | 9 years 8 months 12 days | ||||||||
Finite-Lived Intangible Assets, Amortization Expense, Year Two | $ 208 | 208 | |||||||
Main Pointe Agreement [Member] | |||||||||
License Development and Commercialization Agreement [Line Items] | |||||||||
Proceeds from License Fees Received | $ 2,500 | $ 2,500 | $ 2,500 | ||||||
Asset Transferred, License Agreement | $ 425 | $ 309 | |||||||
Licensing Agreement, Royalty Percentage | 7.50% | 7.50% | |||||||
Main Pointe Agreement [Member] | UNITED KINGDOM | |||||||||
License Development and Commercialization Agreement [Line Items] | |||||||||
Proceeds from License Fees Received | $ 1,000 | ||||||||
Main Pointe Agreement [Member] | JAPAN | |||||||||
License Development and Commercialization Agreement [Line Items] | |||||||||
Proceeds from License Fees Received | 500 | ||||||||
Main Pointe Agreement [Member] | South Korea [Member] | |||||||||
License Development and Commercialization Agreement [Line Items] | |||||||||
Proceeds from License Fees Received | $ 250 | ||||||||
Kempharm Agreement [Member] | |||||||||
License Development and Commercialization Agreement [Line Items] | |||||||||
Proceeds from License Fees Received | $ 3,500 | ||||||||
Kempharm Agreement [Member] | Minimum | |||||||||
License Development and Commercialization Agreement [Line Items] | |||||||||
Additional Upfront Payment Receivable | $ 1,000 |
REVENUE RECOGNITION - Additiona
REVENUE RECOGNITION - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Jul. 24, 2017 | Mar. 16, 2017 | Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||
Other Revenue, Net | $ 0 | $ 74 | $ 59 | $ 307 | ||
Royalty Revenue, Total | 83 | 39 | 226 | 86 | ||
Egalet Agreement [Member] | ||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||
Royalty Revenue, Total | 78 | $ 39 | 213 | $ 86 | ||
Main Pointe Agreement [Member] | ||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||
Royalty Revenue, Total | $ 5 | 13 | ||||
Proceeds from License Fees Received | $ 2,500 | $ 2,500 | $ 2,500 | |||
Licensing Agreement, Royalty Percentage | 7.50% | 7.50% |
RESEARCH AND DEVELOPMENT ACTI34
RESEARCH AND DEVELOPMENT ACTIVITIES - Additional Information (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2016USD ($) | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |
Research and Development Arrangement, Contract to Perform for Others, Costs Incurred, Gross | $ 50 |
INVENTORIES - Schedule of Inven
INVENTORIES - Schedule of Inventories (Detail) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Inventory [Line Items] | ||
Raw and packaging materials | $ 98 | |
Finished goods | 243 | |
Total | 341 | |
Less: reserve for finished goods | $ 0 | (32) |
Net inventories | $ 0 | $ 309 |
PROPERTY, PLANT AND EQUIPMENT36
PROPERTY, PLANT AND EQUIPMENT (Detail) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 2,512 | $ 2,807 |
Less: impairment reserve | 0 | (82) |
Less: accumulated depreciation | (1,813) | (1,858) |
Net property, plant and equipment | 699 | 867 |
Building and improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 1,273 | 1,273 |
Scientific equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 598 | 598 |
Computer hardware and software | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 107 | 109 |
Machinery and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 275 | 568 |
Land and improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 162 | 162 |
Other personal property | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 70 | 70 |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 27 | $ 27 |
PROPERTY, PLANT AND EQUIPMENT -
PROPERTY, PLANT AND EQUIPMENT - Additional Information (Detail) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Property, Plant and Equipment [Line Items] | ||
Impairment Of Property, Plant and Equipment, Reserve | $ 0 | $ (82) |
ACCRUED EXPENSES (Detail)
ACCRUED EXPENSES (Detail) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Accounts Payable and Accrued Liabilities [Line Items] | ||
Cost sharing expenses under license agreement | $ 274 | $ 150 |
Other fees and services | 80 | 47 |
Payroll, payroll taxes and benefits | 114 | 116 |
Professional services | 157 | 232 |
Clinical, non-clinical and regulatory services | 236 | 131 |
Marketing, advertising, and promotion | 0 | 10 |
Property taxes | 15 | 16 |
Franchise taxes | 14 | 1 |
Total | $ 890 | $ 703 |
EQUITY FINANCING- Additional In
EQUITY FINANCING- Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | Jul. 24, 2017 | Jul. 24, 2017 | Mar. 16, 2017 | Sep. 30, 2017 | Dec. 31, 2013 |
Number of Common Stock Need to Hold to Designate As Director | 600,000 | 600,000 | |||
Stock Issued During Period, Value, New Issues | $ 4,000 | ||||
Warrant [Member] | |||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 2.52 | $ 2.52 | |||
Investor [Member] | |||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.528 | $ 0.528 | |||
Class of Warrant or Right, Term | 5 years | 5 years | |||
Private Placement [Member] | Warrant [Member] | |||||
Stock Issued During Period, Value, New Issues | $ 495 | ||||
Private Placement [Member] | Investor [Member] | |||||
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 | $ 0.4488 | |||
Sale of Stock, Description of 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. | ||||
Main Pointe Agreement [Member] | |||||
Proceeds from License Fees Received | $ 2,500 | $ 2,500 | $ 2,500 | ||
Asset Transferred, License Agreement | $ 425 | $ 425 | $ 309 | ||
Licensing Agreement, Royalty Percentage | 7.50% | 7.50% |
DEBT - Summary of Debt (Detail)
DEBT - Summary of Debt (Detail) $ in Thousands | 9 Months Ended |
Sep. 30, 2017USD ($) | |
Current Debt | |
Balance at Jan. 1, 2017 | $ 5,500 |
Principal payments | (1,815) |
Classification | 0 |
Balance at Sept. 30, 2017 | 3,685 |
Debt Discount | |
Balance at Jan. 1, 2017 | (98) |
Classification | 0 |
Amortization expense | 52 |
Balance at Sept. 30, 2017 | (46) |
Deferred Debt Issuance Costs | |
Balance at Jan. 1, 2017 | (47) |
Classification | 0 |
Amortization expense | 27 |
Balance at Sept. 30, 2017 | (20) |
Current Debt, net at Sept. 30, 2017 | 3,619 |
Long-term [Member] | |
Current Debt | |
Balance at Jan. 1, 2017 | 2,979 |
Principal payments | 0 |
Classification | (2,211) |
Balance at Sept. 30, 2017 | 768 |
Debt Discount | |
Balance at Jan. 1, 2017 | 0 |
Classification | (98) |
Amortization expense | 52 |
Balance at Sept. 30, 2017 | (46) |
Deferred Debt Issuance Costs | |
Balance at Jan. 1, 2017 | 0 |
Classification | (47) |
Amortization expense | 27 |
Balance at Sept. 30, 2017 | (20) |
Current Debt, net at Sept. 30, 2017 | 702 |
Current [Member] | |
Current Debt | |
Balance at Jan. 1, 2017 | 2,521 |
Principal payments | (1,815) |
Classification | 2,211 |
Balance at Sept. 30, 2017 | 2,917 |
Debt Discount | |
Balance at Jan. 1, 2017 | (98) |
Classification | 98 |
Amortization expense | 0 |
Balance at Sept. 30, 2017 | 0 |
Deferred Debt Issuance Costs | |
Balance at Jan. 1, 2017 | (47) |
Classification | 47 |
Amortization expense | 0 |
Balance at Sept. 30, 2017 | 0 |
Current Debt, net at Sept. 30, 2017 | $ 2,917 |
DEBT - Interest Expense (Detail
DEBT - Interest Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Schedule Of Interest Expense [Line Items] | ||||
Term loan | $ 116 | $ 180 | $ 397 | $ 584 |
Debt discount | 15 | 23 | 52 | 74 |
Debt issue costs | 8 | 12 | 27 | 39 |
Total interest expense | $ 139 | $ 215 | $ 476 | $ 697 |
DEBT - Long-Term Debt (Detail)
DEBT - Long-Term Debt (Detail) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Debt Instrument [Line Items] | ||
2,017 | $ 707 | |
2,018 | 2,978 | |
Total | $ 3,685 | $ 5,500 |
DEBT - Additional Information (
DEBT - Additional Information (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | Jan. 07, 2015 | Jul. 24, 2017 | Oct. 31, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 | Dec. 31, 2013 | Dec. 27, 2013 |
Debt Instrument [Line Items] | ||||||||||
Debt instrument principal amount | $ 10,000 | |||||||||
Debt default long term debt percentage | 13.35% | |||||||||
Debt Instrument, Maturity Date | Dec. 1, 2018 | |||||||||
Debt instrument, fee amount | $ 50 | $ 50 | ||||||||
Debt consulting placement fee | 100 | |||||||||
Debt related commitment fees and debt issuance costs | 8 | $ 12 | 27 | $ 39 | ||||||
Debt instrument unamortized discount | $ 46 | 46 | $ 98 | |||||||
Debt instrument Cash Maintenance | $ 2,500 | |||||||||
Repayments of Debt | 1,815 | 1,671 | ||||||||
Debt Instrument, Periodic Payment | $ 260 | |||||||||
Debt Instrument, Interest Rate, Effective Percentage | 10.16% | 10.16% | ||||||||
Proceeds from Issuance or Sale of Equity | $ 6,000 | |||||||||
Interest Payable, Current | $ 26 | $ 26 | 0 | |||||||
Proceeds from Issuance of Private Placement | $ 3,900 | |||||||||
Restricted Cash and Cash Equivalents, Current | 0 | $ 2,500 | 0 | $ 2,500 | 2,500 | |||||
Term Loan [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt related commitment fees and debt issuance costs | 231 | |||||||||
Interest Payable, Current | 668 | 668 | $ 559 | |||||||
Loan Agreement [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt instrument, interest rate, stated percentage | 8.35% | |||||||||
Repayments of Debt | $ 5,000 | 5,000 | ||||||||
Proceeds from Issuance or Sale of Equity | 2,500 | |||||||||
Maximum [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 7.98 | |||||||||
Minimum [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 2.52 | |||||||||
Proceeds from Issuance or Sale of Equity | $ 3,000 | |||||||||
Main Pointe Agreement [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Upfront Payments Received | 2,500 | |||||||||
Oxford Term Loan Agreement [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Restricted Cash and Cash Equivalents, Current | $ 2,500 | |||||||||
Warrant | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt instrument unamortized discount | $ 400 | $ 400 | ||||||||
Warrants to purchase common stock | 60 | 60 | ||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 2.52 | $ 2.52 | $ 2.52 | |||||||
Warrants, expiry date | December 27, 2020 | |||||||||
Additions To Debt Instrument Unamortized Discount | $ 33 | |||||||||
First Revenue Event Occurs | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt instrument periodic payment terms balloon payment to be paid | $ 795 | $ 795 | ||||||||
Prior To December 27 2015 | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt instrument prepayment percentage | 1.00% |
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, 2017 | Sep. 30, 2016 | |
Number of Options | ||
Number of Options Outstanding, beginning | 60 | 60 |
Number of Options, Issued | 1,783 | 0 |
Number of Options, Exercised | 0 | 0 |
Number of Options, Expired | 0 | 0 |
Number of Options, Modification | 0 | 0 |
Number of Options Outstanding, ending | 1,843 | 60 |
Weighted Average Exercise Price | ||
Weighted Average Exercise Price, beginning | $ 2.52 | $ 2.52 |
Weighted Average Exercise Price, Issued | 0.53 | 0 |
Weighted Average Exercise Price, Exercised | 0 | 0 |
Weighted Average Exercise Price, Expired | 0 | 0 |
Weighted Average Exercise Price, Modification | 0 | 0 |
Weighted Average Exercise Price, ending | $ 0.59 | $ 2.52 |
COMMON STOCK WARRANTS - Additio
COMMON STOCK WARRANTS - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | Jul. 24, 2017 | Jul. 24, 2017 | Sep. 30, 2017 | Dec. 31, 2013 |
Class of Warrant or Right [Line Items] | ||||
Secured Debt | $ 10,000 | |||
Stock Issued During Period, Value, New Issues | $ 4,000 | |||
Investor [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.528 | $ 0.528 | ||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 1,782,531 | 1,782,531 | ||
Class of Warrant or Right, Term | 5 years | 5 years | ||
Warrant | ||||
Class of Warrant or Right [Line Items] | ||||
Common stock warrant exercisable outstanding, shares | 60,000 | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 2.52 | $ 2.52 | ||
Warrant | Private Placement [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Stock Issued During Period, Value, New Issues | $ 495 |
SHARE-BASED COMPENSATION -Recog
SHARE-BASED COMPENSATION -Recognition of Share-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Research and development expense | $ 1,077 | $ 841 | $ 2,808 | $ 3,258 |
Total | 120 | 150 | 353 | 450 |
Research and Development Expense [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Research and development expense | 38 | 43 | 106 | 128 |
Research and Development Expense [Member] | Stock options [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Research and development expense | 38 | 43 | 106 | 128 |
Research and Development Expense [Member] | Restricted Stock units [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Research and development expense | 0 | 0 | 0 | 0 |
General and Administrative Expense [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
General and administrative expense | 82 | 107 | 247 | 322 |
General and Administrative Expense [Member] | Stock options [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
General and administrative expense | 52 | 77 | 158 | 232 |
General and Administrative Expense [Member] | Restricted Stock units [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
General and administrative expense | $ 30 | $ 30 | $ 89 | $ 90 |
SHARE-BASED COMPENSATION - Stoc
SHARE-BASED COMPENSATION - Stock Option Award Activity (Detail) - Stock Option Plan [Member] - $ / shares shares in Thousands | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Share based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of Options Outstanding, beginning | 1,397 | 1,198 |
Number of Options, Granted | 185 | 0 |
Number of Options, Exercised | (1) | 0 |
Number of Options, Forfeited or expired | 87 | 0 |
Number of Options Outstanding, ending | 1,494 | 1,198 |
Number of Options exercisable | 1,176 | 1,000 |
Weighted Average Exercise Price, beginning | $ 13.57 | $ 15.67 |
Weighted Average Exercise Price, Granted | 0.31 | 0 |
Weighted Average Exercise Price, Exercised | (0.92) | 0 |
Weighted Average Exercise Price, Forfeited or expired | 6.48 | 0 |
Weighted Average Exercise Price, ending | 12.33 | 15.67 |
Weighted Average Exercise Price, Options exercisable | $ 15.46 | $ 18.37 |
SHARE-BASED COMPENSATION - Summ
SHARE-BASED COMPENSATION - Summary of Information about Non Vested Stock Options (Detail) - Non Vested Stock Options [Member] shares in Thousands | 9 Months Ended |
Sep. 30, 2017$ / sharesshares | |
Summary Of Information About Non Vested Stock Options Disclosure [Line Items] | |
Outstanding, beginning | shares | 335 |
Granted | shares | 185 |
Vested | shares | (188) |
Forfeited | shares | (14) |
Outstanding, ending | shares | 318 |
Outstanding beginning, Weighted Average Fair Value | $ / shares | $ 1.18 |
Granted, Weighted Average Fair Value | $ / shares | 0.31 |
Vested, Weighted Average Fair Value | $ / shares | 1.36 |
Forfeited, Weighted Average Fair Value | $ / shares | 1.05 |
Outstanding ending, Weighted Average Fair Value | $ / shares | $ 0.58 |
SHARE-BASED COMPENSATION - Su49
SHARE-BASED COMPENSATION - Summary of RSU Plan (Detail) - shares shares in Thousands | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Restricted Stock Units [Member] | ||
Share based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Outstanding, beginning | 91 | 45 |
Granted | 238 | 88 |
Distributed | (67) | (42) |
Vested | 0 | 0 |
Forfeited or expired | 0 | 0 |
Outstanding, ending | 262 | 91 |
Vested Restricted Stock Units (RSUs) [Member] | ||
Share based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Outstanding, beginning | 91 | 45 |
Granted | 0 | 0 |
Distributed | (67) | (42) |
Vested | 178 | 66 |
Forfeited or expired | 0 | 0 |
Outstanding, ending | 202 | 69 |
SHARE-BASED COMPENSATION - Addi
SHARE-BASED COMPENSATION - Additional Information (Detail) - USD ($) shares in Thousands, $ in Thousands | Jan. 03, 2017 | Jan. 04, 2016 | Jan. 02, 2015 | May 01, 2014 | Sep. 30, 2017 | Dec. 31, 2016 |
Employee Benefit Plans Disclosure [Line Items] | ||||||
Unrecognized compensation cost on unvested option awards outstanding | $ 174 | |||||
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, Options, Grants in Period, Gross | 60 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 25.00% | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 1 | 1 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Shares Purchased for Award | 3 | |||||
2014 Restricted Stock Unit 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 | 9 | ||||
2014 Restricted Stock Unit 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 | 42 | ||||
2014 Restricted Stock Unit Award Plan [Member] | January 2, 2015 Award Distributed [Member] | ||||||
Employee Benefit Plans Disclosure [Line Items] | ||||||
Share Based Compensation Arrangement Share Based Payment Shares Reserved For Future Distribution | 41 | 2 | ||||
2014 Restricted Stock Unit Award Plan [Member] | January 4, 2016 Award Distributed [Member] | ||||||
Employee Benefit Plans Disclosure [Line Items] | ||||||
Share Based Compensation Arrangement Share Based Payment Shares Reserved For Future Distribution | 66 | 1 | ||||
2014 Restricted Stock Unit 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 | 33 | ||||
2014 Restricted Stock Unit Award Plan [Member] | Four Non Employee Directors [Member] | ||||||
Employee Benefit Plans Disclosure [Line Items] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 22 | 22 | 10 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 25.00% | 25.00% | ||||
Deferred Compensation Arrangement with Individual, Recorded Liability | $ 36 | $ 27 |
INCOME TAXES - Additional Infor
INCOME TAXES - Additional Information (Detail) $ in Millions | 12 Months Ended |
Dec. 31, 2016USD ($) | |
Income Tax Disclosure [Line Items] | |
Federal income tax benefits | $ 47.2 |
Federal NOLs | $ 138.8 |
U.S. statutory tax rate | 34.00% |
State income tax benefits | $ 2.1 |
Federal Research and Development | |
Income Tax Disclosure [Line Items] | |
Research and development tax credits | 1.2 |
Indiana State Research and Development | |
Income Tax Disclosure [Line Items] | |
Research and development tax credits | $ 0.2 |
Maximum | |
Income Tax Disclosure [Line Items] | |
NOL expiration year | 2,036 |
Minimum | |
Income Tax Disclosure [Line Items] | |
NOL expiration year | 2,017 |
EARNINGS PER SHARE ("EPS") - Re
EARNINGS PER SHARE ("EPS") - 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, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
EPS - basic and diluted | ||||
Numerator: net loss | $ (2,200) | $ (2,250) | $ (3,944) | $ (8,922) |
Denominator (weighted): | ||||
Common shares | 18,544 | 11,834 | 14,103 | 11,833 |
Vested RSUs | 142 | 46 | 44 | 25 |
Basic and diluted weighted average shares outstanding | 16,686 | 11,880 | 14,147 | 11,858 |
EPS - basic and diluted | $ (0.12) | $ (0.19) | $ (0.27) | $ (0.75) |
Common stock issuable: | ||||
Total excluded potentially dilutive shares | 3,397 | 1,280 | 3,397 | 1,280 |
Employee Stock Option [Member] | ||||
Common stock issuable: | ||||
Total excluded potentially dilutive shares | 1,494 | 1,198 | 1,494 | 1,198 |
Warrant [Member] | ||||
Common stock issuable: | ||||
Total excluded potentially dilutive shares | 1,843 | 60 | 1,843 | 60 |
Restricted Stock Units (RSUs) [Member] | ||||
Common stock issuable: | ||||
Total excluded potentially dilutive shares | 60 | 22 | 60 | 22 |
RELATED PARTY TRANSACTIONS- Add
RELATED PARTY TRANSACTIONS- Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 9 Months Ended | |
Jul. 24, 2017 | Mar. 16, 2017 | Sep. 30, 2017 | |
Related Party Transaction [Line Items] | |||
Number of Common Stock Need to Hold to Designate As Director | 600,000 | ||
Main Pointe Agreement [Member] | |||
Related Party Transaction [Line Items] | |||
Proceeds from License Fees Received | $ 2,500 | $ 2,500 | $ 2,500 |
Asset Transferred, License Agreement | $ 425 | $ 309 | |
Licensing Agreement, Royalty Percentage | 7.50% | 7.50% | |
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 |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - Additional Information (Detail) | 9 Months Ended | |
Sep. 30, 2017USD ($) | Dec. 31, 2016USD ($) | |
Commitments and Contingencies Disclosure [Line Items] | ||
Accrued Cost Sharing Expenses Clinical Studies | $ 274,000 | $ 150,000 |
Pennsylvania State | ||
Commitments and Contingencies Disclosure [Line Items] | ||
Number of lawsuits filed | 200 | |
New Jersey State | ||
Commitments and Contingencies Disclosure [Line Items] | ||
Number of lawsuits filed | 150 | |
Number of lawsuits served | 50 | |
California State | ||
Commitments and Contingencies Disclosure [Line Items] | ||
Number of plaintiffs served in a single complaint | 445 | |
Palatine Illinois | ||
Commitments and Contingencies Disclosure [Line Items] | ||
Leases administrative office space | $ 2,000 |