Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Mar. 31, 2017 | May 05, 2017 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2017 | |
Document Fiscal Year Focus | 2,017 | |
Document Fiscal Period Focus | Q1 | |
Entity Registrant Name | ACURA PHARMACEUTICALS, INC | |
Entity Central Index Key | 786,947 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Smaller Reporting Company | |
Trading Symbol | ACUR | |
Entity Common Stock, Shares Outstanding | 11,883,339 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2017 | Dec. 31, 2016 |
Assets | ||
Cash and cash equivalents | $ 3,843 | $ 2,681 |
Restricted cash equivalents (Note 9) | 2,500 | 2,500 |
Trade accounts receivable (net of allowances of $27 and $7) | 6 | 23 |
Collaboration revenue receivable | 36 | 79 |
Royalty receivable | 52 | 50 |
Inventories (net of allowances of $- and $32) (Note 6) | 0 | 309 |
Prepaid expenses and other current assets | 301 | 268 |
Total current assets | 6,738 | 5,910 |
Property, plant and equipment, net (Note 7) | 739 | 867 |
Intangible asset, net of accumulated amortization of $621 and $569 (Note 4) | 1,379 | 1,431 |
Total assets | 8,856 | 8,208 |
Liabilities: | ||
Accounts payable | 209 | 77 |
Accrued expenses (Note 8) | 1,040 | 703 |
Accrued interest | 35 | 0 |
Other current liabilities | 19 | 27 |
Sales returns liability | 302 | 304 |
Debt - current (Note 9) | 2,798 | 2,376 |
Total current liabilities | 4,403 | 3,487 |
Debt - non-current portion, net of discounts (Note 9) | 2,142 | 2,979 |
Accrued interest - non-current portion | 598 | 559 |
Total liabilities | 7,143 | 7,025 |
Commitments and contingencies (Note 14) | ||
Stockholders' equity: | ||
Common stock - $.01 par value per share; 100,000 shares authorized, 11,883 and 11,834 shares issued and outstanding at March 31, 2017 and December 31, 2016, respectively | 119 | 118 |
Additional paid-in capital | 375,887 | 375,763 |
Accumulated deficit | (374,293) | (374,698) |
Total stockholders' equity | 1,713 | 1,183 |
Total liabilities and stockholders' equity | $ 8,856 | $ 8,208 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) shares in Thousands, $ in Thousands | Mar. 31, 2017 | Dec. 31, 2016 |
Accounts receivable, net of allowances | $ 27 | $ 7 |
Finite-lived intangible assets accumulated amortization | $ 621 | $ 569 |
Common stock, par value | $ 0.01 | $ 10 |
Common stock, shares authorized | 100,000 | 100,000 |
Common stock, shares issued | 11,883 | 11,834 |
Common stock, shares outstanding | 11,883 | 11,834 |
Inventory Valuation Reserves | $ 0 | $ 32 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Revenues: | ||
License fee revenue | $ 2,500 | $ 0 |
Collaboration revenue | 36 | 100 |
Royalty revenue | 74 | 17 |
Product sales, net | 107 | 107 |
Total revenues, net | 2,717 | 224 |
Cost and expenses: | ||
Cost of sales | 128 | 102 |
Research and development | 711 | 1,014 |
Sales, marketing, general and administrative | 1,296 | 2,246 |
Total costs and expenses | 2,135 | 3,362 |
Operating income (loss) | 582 | (3,138) |
Non-Operating income (expense): | ||
Investment income | 1 | 27 |
Interest expense (Note 9) | (178) | (249) |
Other income | 0 | (24) |
Total other expense, net | (177) | (246) |
Income (loss) before provision for income taxes | 405 | (3,384) |
Provision for income taxes | 0 | 0 |
Net income (loss) | 405 | (3,384) |
Other comprehensive income: | ||
Unrealized gains on securities | 0 | 70 |
Comprehensive income (loss) | $ 405 | $ (3,314) |
Income (loss) per share: | ||
Basic | $ 0.03 | $ (0.28) |
Diluted | $ 0.03 | $ (0.28) |
Weighted average shares outstanding: | ||
Basic | 11,907 | 11,837 |
Diluted | 12,083 | 11,837 |
CONSOLIDATED STATEMENT OF STOCK
CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY - 3 months ended Mar. 31, 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 income | 405 | $ 0 | 0 | 405 |
Share-based compensation | 117 | 0 | 117 | 0 |
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 Mar. 31, 2017 | $ 1,713 | $ 119 | $ 375,887 | $ (374,293) |
Balance (in shares) at Mar. 31, 2017 | 11,883 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Cash Flows from Operating Activities: | ||
Net income (loss) | $ 405 | $ (3,384) |
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: | ||
Depreciation | 25 | 34 |
Provision for sales returns | 49 | 39 |
Share-based compensation | 117 | 150 |
Amortization of debt discount and deferred debt issue costs | 30 | 40 |
Amortization of bond premium in marketable securities | 0 | 19 |
Amortization of intangible asset | 52 | 52 |
Loss on sales of marketable securities | 0 | 24 |
Changes in assets and liabilities: | ||
Trade accounts receivable | 17 | (57) |
Collaboration revenue receivable | 43 | 0 |
Royalty receivable | (2) | 0 |
Accrued investment income | 0 | 12 |
Inventories | 103 | 74 |
Prepaid expenses and other current assets | (33) | 121 |
Accounts payable | 132 | 265 |
Accrued expenses | 337 | 591 |
Accrued interest | 74 | 99 |
Other current liabilities | 0 | 1 |
Sales returns liability | (51) | (2) |
Net cash provided by (used in) operating activities | 1,298 | (1,922) |
Cash Flows from Investing Activities: | ||
Proceeds from sales and maturities of marketable securities | 0 | 3,177 |
Proceeds from transfer of equipment to licensee | 103 | 0 |
Proceeds from transfer of inventory to licensee | 206 | 0 |
Capital expenditures | 0 | (49) |
Net cash provided by investing activities | 309 | 3,128 |
Cash Flows from Financing Activities: | ||
Principal payments on debt | (445) | (409) |
Net cash (used in) financing activities | (445) | (409) |
Net increase in cash, cash equivalents, and restricted cash | 1,162 | 797 |
Cash, cash equivalents, and restricted cash at beginning of period | 5,181 | 2,485 |
Cash, cash equivalents, and restricted cash at end of period | 6,343 | 3,282 |
Cash paid during the year for: | ||
Interest | 75 | 110 |
Income taxes | 0 | 0 |
Reconciliation of cash, cash equivalents, and restricted cash [Abstract] | ||
Cash and cash equivalents | 3,843 | 782 |
Restricted cash equivalents | 2,500 | 2,500 |
Total cash, cash equivalents and restricted cash show in the consolidated statements of cash flows | $ 6,343 | $ 3,282 |
OPERATIONS
OPERATIONS | 3 Months Ended |
Mar. 31, 2017 | |
Description Of Operation And Summary Of Significant Accounting Policies Disclosure [Abstract] | |
OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 1 OPERATIONS 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, development and commercialization of technologies and products intended to address medication abuse and misuse. We have discovered and developed three proprietary platform technologies which can be used to develop multiple products. Our Aversion® 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. · Oxaydo® Tablets (oxycodone HCl, CII), which utilizes the Aversion Technology, is the first and only 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 4). · Nexafed® Tablets (30mg pseudoephedrine) and Nexafed® Sinus Pressure + Pain Tablets (30/325mg pseudoephedrine and acetaminophen), utilizing the Impede Technology, were launched by us into the United States market in December 2012 and February 2015, respectively. We have multiple pseudoephedrine products in development utilizing our Impede Technology. On June 15, 2015, we and Bayer Healthcare LLC entered into a License and Development Agreement pursuant to which we granted Bayer an exclusive worldwide license to our Impede Technology for use in an undisclosed methamphetamine resistant pseudoephedrine containing product and providing for the joint development of such product using our Impede Technology for the U.S. market. 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 4). · Our third abuse deterrent technology, Limitx, is designed to retard the release of active drug ingredients when too many tablets are accidently or purposefully ingested. We have completed our first clinical study, Study AP-LTX-400, of our lead Limitx immediate release oral abuse deterrent drug candidate using the opioid hydromorphone HCI (LTX-04). Study AP-LTX-400, or Study 400, was a two cohort, open label, crossover design pharmacokinetic study in healthy adult subjects. The FDA has designated the development program for LTX-04 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. We are also developing an immediate-release hydrocodone bitartrate with acetaminophen product utilizing our Limitx Technology. Going Concern The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern in accordance with accounting principles generally accepted in the United States of America (“GAAP”). 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. At March 31, 2017, we had unrestricted cash and cash equivalents of $ 3.8 0.2 374.3 0.6 0.4 2.5 In addition to our $ 2.5 However, 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 mid-2017, 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 a registered public offering of the Company’s common stock, for which the Company filed a registration statement on Form S-1 with the SEC on February 3, 2017, and potential private offerings of common stock to institutional investors. The Company is also actively seeking a licensing partner for its 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 and Bayer Agreements. The Company is 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 financing requirements on a continuous basis, to maintain existing financing and to succeed in its future operations. The Company’s financial statements do not include any adjustment relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company be unable to continue in existence. |
RECENT ACCOUNTING PRONOUNCEMENT
RECENT ACCOUNTING PRONOUNCEMENTS | 3 Months Ended |
Mar. 31, 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 annual periods beginning after December 15, 2017, and interim periods therein, using either of the following transition methods: (i) a full retrospective approach reflecting the application of the standard in each prior reporting period with the option to elect certain practical expedients, or (ii) a retrospective approach with the cumulative effect of initially adopting ASU 2014-09 recognized at the date of adoption (which includes additional footnote disclosures). We are currently evaluating the impact of our pending adoption of ASU 2014-09 on our consolidated financial statements and related disclosures and have not yet determined the transition method we will utilize to adopt the standard for use in 2018. Inventories Leases In February 2016, the FASB issued ASU 2016-02, Leases, which will require most leases (with the exception of leases with terms of one year or less) to be recognized on the balance sheet as an asset and a lease liability. 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 method beginning with the earliest comparative period presented. The Company is currently evaluating the impact that the standard will have on the consolidated financial statements and related footnote disclosures, and has not yet determined what effect, if any, the impact of adoption will be. Employee Share-Based In March 2016, the FASB issued Accounting Standards Update (“ASU”) 2016-09, Improvements to Employee Share-Based Payment Accounting Intra-Entity Transfers of Assets Other Than Inventory In October 2016, the FASB issued Accounting Standards Update (“ASU”) 2016-16, Intra-Entity Transfers of Assets Other Than Inventory Statement of Cash Flows - Restricted Cash In November 2016, the FASB issued Accounting Standards Update (“ASU”) 2016-18, Statements of Cash Flows (Topic 230): Restricted Cash |
LICENSE, DEVELOPMENT, AND COMME
LICENSE, DEVELOPMENT, AND COMMERCIALIZATION AGREEMENTS | 3 Months Ended |
Mar. 31, 2017 | |
Research and Development Disclosure [Abstract] | |
LICENSE, DEVELOPMENT, AND COMMERCIALIZATION AGREEMENT | NOTE 3 LICENSE, DEVELOPMENT, AND COMMERCIALIZATION AGREEMENTS MainPointe Agreement 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 $ 2.5 309 117 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 $ 1 500 250 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 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. Bayer Agreement 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. The Bayer Agreement also grants Bayer first right to negotiate a license to the Impede Technology for certain other products. We and Bayer have formed a joint development committee to coordinate development of the Bayer Licensed Product. We are eligible to receive reimbursement of certain of our development costs, success-based development and regulatory milestones payments, and low mid-single digit royalties on net sales of the Bayer Licensed Product in countries with patent coverage and a reduced royalty elsewhere. The term of the Bayer Agreement with respect to each country expires when royalties are no longer payable with respect to such country. After expiration of the term Bayer retains a license to sell the Bayer Licensed Product on a royalty free basis. Either party may terminate the Bayer Agreement in its entirety if the other party materially breaches the Bayer Agreement, subject to an applicable cure period, 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. Bayer may terminate the Bayer Agreement immediately prior to completion of our development obligations or at any time upon six (6) months prior written notice thereafter. We may terminate the Bayer Agreement with respect to the U.S. if Bayer ceases or suspends development or commercialization of the Bayer Licensed Product for a certain period of time. Egalet Agreement 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 Pfizer Agreement In 2007, we entered into License, Development and Commercialization Agreement for Oxaydo (named Oxecta under a Pfizer trademark) and other Aversion opioid development products with King Pharmaceuticals Research and Development, Inc., which became a subsidiary of Pfizer in 2011 (the “Pfizer Agreement”). In April 2014, we entered into two letter agreements with Pfizer providing for the termination of the Pfizer Agreement and the return to us of Oxaydo and all Aversion product rights in exchange for a one-time termination payment of $2.0 million. Our termination payment of $ 2.0 9.7 52 207 |
REVENUE RECOGNITION
REVENUE RECOGNITION | 3 Months Ended |
Mar. 31, 2017 | |
Revenue Recognition [Abstract] | |
REVENUE RECOGNITION | NOTE 4 - REVENUE RECOGNITION License Fee Revenue On signing the MainPointe Agreement, 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, such as under our agreement with Bayer, 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 recognized $ 36 100 Royalty Revenue In connection with our Collaboration and License Agreement with Egalet to commercialize Oxaydo tablets we will receive 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 have recorded royalties of $ 72 17 In connection with our License, Commercialization and Option Agreement with MainPointe, which occurred on March 16, 2017, we will receive a royalty of 7.5 2 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. The amounts recorded to selling expenses from the shipments of the Nexafed product line during each of the three month periods ended March 31, 2017 and 2016 were not material. 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. |
RESEARCH AND DEVELOPMENT ACTIVI
RESEARCH AND DEVELOPMENT ACTIVITIES | 3 Months Ended |
Mar. 31, 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, 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 commercially available Nexafed 30mg tablet while moving supply to an alternate contract manufacturer. Approximately $ 50 0.1 and the final study reports are completed. |
INVENTORIES
INVENTORIES | 3 Months Ended |
Mar. 31, 2017 | |
Inventory Disclosure [Abstract] | |
INVENTORIES | NOTE 6 INVENTORIES Inventories 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, 2016 (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 | 3 Months Ended |
Mar. 31, 2017 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY, PLANT AND EQUIPMENT | NOTE 7 PROPERTY, PLANT AND EQUIPMENT March 31, December 31, 2017 2016 (in thousands) Building and improvements $ 1,273 $ 1,273 Scientific equipment 598 598 Computer hardware and software 109 109 Machinery and equipment 415 568 Land and improvements 162 162 Other personal property 70 70 Office equipment 27 27 Total 2,654 2,807 Less: impairment reserve (82) (82) Less: accumulated depreciation (1,833) (1,858) Net property, plant and equipment $ 739 $ 867 The impairment reserve of $ 82 |
ACCRUED EXPENSES
ACCRUED EXPENSES | 3 Months Ended |
Mar. 31, 2017 | |
Payables and Accruals [Abstract] | |
ACCRUED EXPENSES | NOTE 8 - ACCRUED EXPENSES March 31, December 31, 2017 2016 (in thousands) Cost sharing expenses under license agreement $ 269 $ 150 Advanced expense reimbursements under license agreements 209 - Other fees and services 51 47 Payroll, payroll taxes and benefits 173 116 Professional services 173 232 Clinical, non-clinical and regulatory services 136 131 Marketing, advertising, and promotion 5 10 Property taxes 18 16 Franchise taxes 6 1 Total $ 1,040 $ 703 |
DEBT
DEBT | 3 Months Ended |
Mar. 31, 2017 | |
Debt Disclosure [Abstract] | |
DEBT | NOTE 9 DEBT On December 27, 2013, we entered into a Loan and Security Agreement (the “Loan Agreement”) with Oxford Finance LLC (“Oxford” or the “Lender”), for a term loan to the Company in the principal amount of $ 10.0 8.35 13.35 260 December 1, 2018 60 7.98 400 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 6.0 3.0 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 1 795 598 559 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 Current Debt Current Long-term Total Balance at Jan. 1, 2017 $ 2,521 $ 2,979 $ 5,500 Principal payments (445) - (445) Classification 722 (722) - Balance at Mar. 31, 2017 $ 2,798 $ 2,257 $ 5,055 Debt Discount Current Long-term Total Balance at Jan. 1, 2017 $ - $ (98) $ (98) Amortization expense - 20 20 Classification - - - Balance at Mar. 31, 2017 $ - $ (78) $ (78) Deferred Debt Issuance Costs Current Long-term Total Balance at Jan. 1, 2017 $ - $ (47) $ (47) Amortization expense - 10 10 Classification - - - Balance at Mar. 31, 2017 $ - $ (37) $ (37) Current Debt, net at Mar 31, 2017 $ 2,798 $ 2,142 $ 4,940 March 31, March 31, 2017 2016 (in thousands) Term Loan $ 148 $ 209 Debt discount 20 26 Debt issue costs 10 14 Total interest expense $ 178 $ 249 Annual Principal Payments Year (in thousands) 2017 $ 2,077 2018 2,978 Total $ 5,055 |
COMMON STOCK WARRANTS
COMMON STOCK WARRANTS | 3 Months Ended |
Mar. 31, 2017 | |
Stockholders Equity Note [Abstract] | |
COMMON STOCK WARRANTS | NOTE 10 - COMMON STOCK WARRANTS At both March 31, 2017 and 2016, we have outstanding common stock purchase warrants (“warrants”) exercisable for 60 2.52 2.52 10.0 |
SHARE-BASED COMPENSATION
SHARE-BASED COMPENSATION | 3 Months Ended |
Mar. 31, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
SHARE-BASED COMPENSATION | NOTE 11 - 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. Our share-based compensation expense recognized in the Company’s results of operations from all types of issued instruments comprised the following (in thousands): Three Months Ended March 31, 2017 2016 Research and development expense: Stock options $ 34 $ 43 Restricted stock units - - Subtotal $ 34 $ 43 General and administrative expense: Stock options 53 77 Restricted stock units 30 30 Subtotal $ 83 $ 107 Total $ 117 $ 150 Stock Option Award Plans We maintain various stock option plans. Three Months Ended 2017 2016 Number Weighted Number Weighted Outstanding, Jan. 1 1,397 $ 13.57 1,198 $ 15.67 Granted - - -- Exercised (1) (0.92) -- Forfeited or expired - - -- Outstanding, Mar. 31 1,396 $ 13.58 1,198 $ 15.67 Options exercisable 1,125 $ 16.52 876 $ 20.64 Number of Weighted Outstanding, Jan. 1, 2017 335 $ 1.18 Granted - - Vested (64) 1.36 Forfeited - - Outstanding, Mar. 31, 2017 271 $ 1.14 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. Historically, the majority of our stock options have been held until their expiration date. 2016 Expected dividend yield 0.0 % Risk-free interest rates 2.3 % Average expected volatility 85 % Expected term (years) 10 Weighted average grant date fair value $ 0.77 The intrinsic value of the option awards which were vested and outstanding at March 31, 2017 and 2016 was $ 0 70 309 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. Three months Ended March 31, 2017 2016 (in thousands) Number Number of Number of Number of Outstanding, Jan. 1 91 91 45 Granted 238 - 88 - Distributed (67) (67) (42) (42) Vested - 59 - 22 Forfeited or expired - - - - Outstanding, Mar. 31 262 83 91 25 Our 2014 RSU Plan was approved by shareholders on May 1, 2014 and permits the grant of up to 400 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 19 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 | 3 Months Ended |
Mar. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | NOTE 12 INCOME TAXES We account for income taxes under the liability method. Under this method, deferred income tax assets and liabilities are determined based on differences between financial reporting and income tax basis of assets and liabilities and are accounted for using the enacted income tax rates and laws that will be in effect when the differences are expected to reverse. Additionally, net operating loss and tax credit carryforwards are reported as deferred income tax assets. The realization of deferred income tax assets is dependent upon future earnings. A valuation allowance is required against deferred income tax assets if, based on the weight of available evidence, it is more likely than not that some or all of the deferred income tax assets may not be realized. At both March 31, 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") | 3 Months Ended |
Mar. 31, 2017 | |
Earnings Per Share [Abstract] | |
EARNINGS PER SHARE ("EPS") | NOTE 13 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 11). Diluted EPS is based on the treasury stock method and computed based on the same number of shares used in the basic share calculation and includes the effect from potential issuance of common stock, such as shares issuable pursuant to the exercise of stock options and stock warrants, assuming the exercise of all in-the-money stock options and warrants. Common stock equivalents are excluded from the computation where their inclusion would be anti-dilutive. No such adjustments were made for 2016 as the Company reported a net loss for the three month period, and including the effects of the common stock equivalents in the diluted EPS calculations would have been antidilutive. The weighted-average common shares outstanding (diluted) computation is not impacted during any period where the exercise price of a stock option is greater than the average market price. Three months Ended March 31, 2017 2016 (in thousands except per share data) EPS - basic Numerator: net income (loss) $ 405 $ (3,384) Denominator: Common shares 11,881 11,832 Vested RSUs 26 5 Basic weighted average shares outstanding 11,907 11,837 EPS - basic $ 0.03 $ (0.28) EPS assuming dilution Numerator: net income (loss) $ 405 $ (3,384) Denominator: Common shares 11,881 11,832 RSUs 202 5 Stock options - - Common stock warrants - - Diluted weighted average shares outstanding 12,083 11,837 EPS - diluted $ 0.03 $ (0.28) Excluded securities: Common stock issuable: Stock options 1,396 1,198 Common stock warrants 60 60 RSUs - 66 Total excluded potentially dilutive shares 1,456 1,324 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 3 Months Ended |
Mar. 31, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | NOTE 14 COMMITMENTS AND CONTINGENCIES Reglan ® /Metoclopramide Litigation Halsey Drug Company, as predecessor to us, has been named along with numerous other companies as a defendant in cases filed in three separate state coordinated litigations pending in Pennsylvania, New Jersey and California, respectively captioned In re: Reglan®/Metoclopramide Mass Tort Litigation, Philadelphia County Court of Common Pleas, January Term, 2010, No. 01997; In re: Reglan Litigation, Superior Court of New Jersey, Law Division, Atlantic County, Case No. 289, Master Docket No. ATL-L-3865-10; and Reglan/Metoclopramide Cases, Superior Court of California, San Francisco County, Judicial Council Coordination Proceeding No. 4631, Superior Court No.: CJC-10-004631. In addition, 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. From July, 2015 to date, the court has taken procedural steps to narrow this litigation, including requests for plaintiffs to voluntarily discontinue cases, such as those filed against us, where there is no case-specific product identification. The trial court proceedings were stayed on January 12, 2017. We are in the process of obtaining voluntary dismissal without prejudice of all of the Pennsylvania cases pending against us. We expect that the Court will approve these dismissals during the second quarter of 2017 and should finally dismiss the Pennsylvania-based litigation against us with prejudice later this year. Legal fees related to this matter are currently covered by our insurance carrier. In California, the trial court entered a May 25, 2012 Order denying Generic Defendants’ dispositive preemption motions. The 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 March 31, 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. In December 2014, the Company entered into an agreement with Purdue Pharma L.P. to settle a patent interference action regarding certain intellectual property held by Acura (U.S. Patent No. 8,101,630). The dispute centered upon the issue of which company has priority in developing the invention. The parties agreed to forgo protracted litigation and the uncertainties arising therefrom by entering an agreement whereby the Company conceded Purdue Pharma’s claim of priority in exchange for certain financial consideration to us including an immediate non-refundable payment of $ 500 250 Egalet Agreement On January 7, 2015, we and Egalet entered into a Collaboration and License Agreement (the “Egalet Agreement”) to commercialize Aversion Oxycodone (formerly known as Oxecta®) under our tradename Oxaydo. Oxaydo is approved by the FDA for marketing in the United States in 5 mg and 7.5 mg strengths. Under the terms of the Egalet Agreement, we transferred the approved New Drug Application, or NDA, for Oxaydo to Egalet and Egalet is granted an exclusive license under our intellectual property rights for development and commercialization of Oxaydo worldwide (the “Territory”) in all strengths, subject to our right to co-promote Oxaydo in the United States. Eaglet launched Oxaydo in the United States late in the third quarter of 2015. In accordance with the Egalet Agreement, we and Egalet have formed a joint steering committee to coordinate commercialization strategies and the development of product line extensions. Egalet is responsible for the fees and expenses relating to the Oxaydo NDA and product line extensions of Oxaydo, provided that Egalet will pay a substantial majority of the expenses and we will pay for the remaining fees and expenses relating to (i) annual NDA PDUFA product fees, (ii) expenses of the FDA required post-marketing study for Oxaydo and (iii) expenses of clinical studies for product line extensions (additional strengths) of Oxaydo for the United States. Egalet will bear all of the expenses of development and regulatory approval of Oxaydo for sale outside the United States. Egalet is responsible for all manufacturing and commercialization activities in the Territory for Oxaydo. Subject to certain exceptions, Egalet will have final decision making authority with respect to all development and commercialization activities for Oxaydo, including pricing, subject to our co-promotion right. Egalet may develop Oxaydo for other countries and in additional strengths, in its discretion. At March 31, 2017 and December 31, 2016, we have accrued approximately $ 269 150 Facility Lease The Company leases administrative office space in Palatine, Illinois under a lease for $ 25 March 31, 2017 |
INVENTORIES (Tables)
INVENTORIES (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories at December 31, 2016 are summarized as follows: December 31, 2016 (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) | 3 Months Ended |
Mar. 31, 2017 | |
Property, Plant and Equipment [Abstract] | |
Property Plant and Equipment | Property, plant and equipment at March 31, 2017 and December 31, 2016 are summarized as follows: March 31, December 31, 2017 2016 (in thousands) Building and improvements $ 1,273 $ 1,273 Scientific equipment 598 598 Computer hardware and software 109 109 Machinery and equipment 415 568 Land and improvements 162 162 Other personal property 70 70 Office equipment 27 27 Total 2,654 2,807 Less: impairment reserve (82) (82) Less: accumulated depreciation (1,833) (1,858) Net property, plant and equipment $ 739 $ 867 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Payables and Accruals [Abstract] | |
Accurued Expenses | Accrued expenses at March 31, 2017 and December 31, 2016 are summarized as follows: March 31, December 31, 2017 2016 (in thousands) Cost sharing expenses under license agreement $ 269 $ 150 Advanced expense reimbursements under license agreements 209 - Other fees and services 51 47 Payroll, payroll taxes and benefits 173 116 Professional services 173 232 Clinical, non-clinical and regulatory services 136 131 Marketing, advertising, and promotion 5 10 Property taxes 18 16 Franchise taxes 6 1 Total $ 1,040 $ 703 |
DEBT (Tables)
DEBT (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Debt Disclosure [Abstract] | |
Schedule of Debt | Our debt at March 31, 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 (445) - (445) Classification 722 (722) - Balance at Mar. 31, 2017 $ 2,798 $ 2,257 $ 5,055 Debt Discount Current Long-term Total Balance at Jan. 1, 2017 $ - $ (98) $ (98) Amortization expense - 20 20 Classification - - - Balance at Mar. 31, 2017 $ - $ (78) $ (78) Deferred Debt Issuance Costs Current Long-term Total Balance at Jan. 1, 2017 $ - $ (47) $ (47) Amortization expense - 10 10 Classification - - - Balance at Mar. 31, 2017 $ - $ (37) $ (37) Current Debt, net at Mar 31, 2017 $ 2,798 $ 2,142 $ 4,940 |
Schedule of Interest Expense | Our interest expense for the three months ended March 31, 2017 and 2016 consisted of the following: March 31, March 31, 2017 2016 (in thousands) Term Loan $ 148 $ 209 Debt discount 20 26 Debt issue costs 10 14 Total interest expense $ 178 $ 249 |
Schedule Of Long Term Debt Future Principal Payments Year | The annual principal payments of the debt outstanding at March 31, 2017 are as follows: Annual Principal Payments Year (in thousands) 2017 $ 2,077 2018 2,978 Total $ 5,055 |
SHARE-BASED COMPENSATION (Table
SHARE-BASED COMPENSATION (Tables) | 3 Months Ended |
Mar. 31, 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 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 March 31, 2017 2016 Research and development expense: Stock options $ 34 $ 43 Restricted stock units - - Subtotal $ 34 $ 43 General and administrative expense: Stock options 53 77 Restricted stock units 30 30 Subtotal $ 83 $ 107 Total $ 117 $ 150 |
Schedule of Share-based Compensation, Stock Options, Activity | A summary of our stock option plan activity during the three month periods ending March 31, 2017 and 2016 is shown below: Three Months Ended 2017 2016 Number Weighted Number Weighted Outstanding, Jan. 1 1,397 $ 13.57 1,198 $ 15.67 Granted - - -- Exercised (1) (0.92) -- Forfeited or expired - - -- Outstanding, Mar. 31 1,396 $ 13.58 1,198 $ 15.67 Options exercisable 1,125 $ 16.52 876 $ 20.64 |
Schedule of Nonvested Share Activity | The following table summarizes information about nonvested stock options outstanding at March 31, 2017 (in thousands except price data): Number of Weighted Outstanding, Jan. 1, 2017 335 $ 1.18 Granted - - Vested (64) 1.36 Forfeited - - Outstanding, Mar. 31, 2017 271 $ 1.14 |
Schedule of fair value of the warrants | The assumptions used in the Black-Scholes model to determine fair value for the 2016 stock option grant were: 2016 Expected dividend yield 0.0 % Risk-free interest rates 2.3 % Average expected volatility 85 % Expected term (years) 10 Weighted average grant date fair value $ 0.77 |
Schedule of Share-based Compensation, Restricted Stock Units Award Activity | A summary of the grants under the RSU Plans consisted of the following: Three months Ended March 31, 2017 2016 (in thousands) Number Number of Number of Number of Outstanding, Jan. 1 91 91 45 Granted 238 - 88 - Distributed (67) (67) (42) (42) Vested - 59 - 22 Forfeited or expired - - - - Outstanding, Mar. 31 262 83 91 25 |
EARNINGS PER SHARE ("EPS") (Tab
EARNINGS PER SHARE ("EPS") (Tables) | 3 Months Ended |
Mar. 31, 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: Three months Ended March 31, 2017 2016 (in thousands except per share data) EPS - basic Numerator: net income (loss) $ 405 $ (3,384) Denominator: Common shares 11,881 11,832 Vested RSUs 26 5 Basic weighted average shares outstanding 11,907 11,837 EPS - basic $ 0.03 $ (0.28) EPS assuming dilution Numerator: net income (loss) $ 405 $ (3,384) Denominator: Common shares 11,881 11,832 RSUs 202 5 Stock options - - Common stock warrants - - Diluted weighted average shares outstanding 12,083 11,837 EPS - diluted $ 0.03 $ (0.28) Excluded securities: Common stock issuable: Stock options 1,396 1,198 Common stock warrants 60 60 RSUs - 66 Total excluded potentially dilutive shares 1,456 1,324 |
OPERATIONS Additional Informati
OPERATIONS Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2017 | Mar. 31, 2016 | Dec. 31, 2016 | |
Cash, Cash Equivalent And Marketable Securities | $ 3,800 | ||
Working Capital Deficit | 200 | ||
Retained Earnings (Accumulated Deficit), Total | (374,293) | $ (374,698) | |
Operating Income (Loss), Total | 582 | $ (3,138) | |
Net Income (Loss) Attributable to Parent, Total | 405 | $ (3,384) | |
Debt Instrument, Debt Default, Amount | 2,500 | ||
Oxford Term Loan Agreement [Member] | |||
Debt Instrument, Debt Default, Amount | $ 2,500 |
LICENSE, DEVELOPMENT, AND COM28
LICENSE, DEVELOPMENT, AND COMMERCIALIZATION AGREEMENTS - Additional Information (Detail) - USD ($) $ in Thousands | Oct. 09, 2015 | Mar. 16, 2017 | Oct. 31, 2016 | Mar. 31, 2017 | Mar. 31, 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 | $ 52 | $ 52 | |||
License Agreement Option Products Description | In addition, MainPointe has the option to add to the MainPointe Agreement certain additional products, or Option Products, containing pseudoephedrine (“PSE”) and utilizing the Impede technology for a fee of $500 thousand per product (for all product strengths). 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. | ||||
Pfizer Agreement | |||||
License Development and Commercialization Agreement [Line Items] | |||||
Payment for Termination | $ 2,000 | ||||
Finite-Lived Intangible Asset, Useful Life | 9 years 8 months 12 days | ||||
Finite-Lived Intangible Assets, Amortization Expense, Next Twelve Months | $ 207 | ||||
Finite-Lived Intangible Assets, Amortization Expense, Year Two | 207 | ||||
Finite-Lived Intangible Assets, Amortization Expense, Year Three | 207 | ||||
Finite-Lived Intangible Assets, Amortization Expense, Year Four | $ 207 | ||||
Egalet Agreement | |||||
License Development and Commercialization Agreement [Line Items] | |||||
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 | ||||
Main Pointe Agreement [Member] | |||||
License Development and Commercialization Agreement [Line Items] | |||||
Proceeds from License Fees Received | $ 2,500 | $ 2,500 | |||
Asset Transferred, License Agreement | $ 309 | ||||
Licensing Agreement, Royalty Percentage | 7.50% | 7.50% | |||
Main Pointe Agreement [Member] | Nexafed inventory [Member] | |||||
License Development and Commercialization Agreement [Line Items] | |||||
Proceeds from License Fees Received | $ 117 | ||||
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 | |
Mar. 16, 2017 | Mar. 31, 2017 | Mar. 31, 2016 | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Other Revenue, Net | $ 36 | $ 100 | |
Royalty Revenue, Total | 74 | $ 17 | |
Main Pointe Agreement [Member] | |||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||
Royalty Revenue, Total | 2 | ||
Proceeds from License Fees Received | $ 2,500 | $ 2,500 | |
Licensing Agreement, Royalty Percentage | 7.50% | 7.50% |
RESEARCH AND DEVELOPMENT ACTI30
RESEARCH AND DEVELOPMENT ACTIVITIES - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2017 | Dec. 31, 2016 | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Research and Development Arrangement, Contract to Perform for Others, Costs Incurred, Gross | $ 50 | $ 50 |
Professional and Contract Services Expense | $ 100 |
INVENTORIES - Schedule of Inven
INVENTORIES - Schedule of Inventories (Detail) - USD ($) $ in Thousands | Mar. 31, 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 EQUIPMENT32
PROPERTY, PLANT AND EQUIPMENT (Detail) - USD ($) $ in Thousands | Mar. 31, 2017 | Dec. 31, 2016 |
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 2,654 | $ 2,807 |
Less: impairment reserve | (82) | (82) |
Less: accumulated depreciation | (1,833) | (1,858) |
Net property, plant and equipment | 739 | 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 | 109 | 109 |
Machinery and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 415 | 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 | Mar. 31, 2017 | Dec. 31, 2016 |
Property, Plant and Equipment [Line Items] | ||
Impairment Of Property, Plant and Equipment, Reserve | $ (82) | $ (82) |
ACCRUED EXPENSES (Detail)
ACCRUED EXPENSES (Detail) - USD ($) $ in Thousands | Mar. 31, 2017 | Dec. 31, 2016 |
Accounts Payable and Accrued Liabilities [Line Items] | ||
Cost sharing expenses under license agreement | $ 269 | $ 150 |
Advanced expense reimbursements under license agreements | 209 | 0 |
Other fees and services | 51 | 47 |
Payroll, payroll taxes and benefits | 173 | 116 |
Professional services | 173 | 232 |
Clinical, non-clinical and regulatory services | 136 | 131 |
Marketing, advertising, and promotion | 5 | 10 |
Property taxes | 18 | 16 |
Franchise taxes | 6 | 1 |
Total | $ 1,040 | $ 703 |
DEBT - Summary of Debt (Detail)
DEBT - Summary of Debt (Detail) $ in Thousands | 3 Months Ended |
Mar. 31, 2017USD ($) | |
Current Debt | |
Balance at Jan. 1, 2017 | $ 5,500 |
Principal payments | (445) |
Classification | 0 |
Balance at Mar. 31, 2017 | 5,055 |
Debt Discount | |
Balance at Jan. 1, 2017 | (98) |
Amortization expense | 20 |
Classification | 0 |
Balance at Mar. 31, 2017 | (78) |
Deferred Debt Issuance Costs | |
Balance at Jan. 1, 2017 | (47) |
Amortization expense | 10 |
Classification | 0 |
Balance at Mar. 31, 2017 | (37) |
Current Debt, net at Mar 31, 2017 | 4,940 |
Long-term [Member] | |
Current Debt | |
Balance at Jan. 1, 2017 | 2,979 |
Principal payments | 0 |
Classification | (722) |
Balance at Mar. 31, 2017 | 2,257 |
Debt Discount | |
Balance at Jan. 1, 2017 | (98) |
Amortization expense | 20 |
Classification | 0 |
Balance at Mar. 31, 2017 | (78) |
Deferred Debt Issuance Costs | |
Balance at Jan. 1, 2017 | (47) |
Amortization expense | 10 |
Classification | 0 |
Balance at Mar. 31, 2017 | (37) |
Current Debt, net at Mar 31, 2017 | 2,142 |
Current [Member] | |
Current Debt | |
Balance at Jan. 1, 2017 | 2,521 |
Principal payments | (445) |
Classification | 722 |
Balance at Mar. 31, 2017 | 2,798 |
Debt Discount | |
Balance at Jan. 1, 2017 | 0 |
Amortization expense | 0 |
Classification | 0 |
Balance at Mar. 31, 2017 | 0 |
Deferred Debt Issuance Costs | |
Balance at Jan. 1, 2017 | 0 |
Amortization expense | 0 |
Classification | 0 |
Balance at Mar. 31, 2017 | 0 |
Current Debt, net at Mar 31, 2017 | $ 2,798 |
DEBT - Interest Expense (Detail
DEBT - Interest Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Schedule Of Interest Expense [Line Items] | ||
Term Loan | $ 148 | $ 209 |
Debt discount | 20 | 26 |
Debt issue costs | 10 | 14 |
Total interest expense | $ 178 | $ 249 |
DEBT - Long-Term Debt (Detail)
DEBT - Long-Term Debt (Detail) - USD ($) $ in Thousands | Mar. 31, 2017 | Dec. 31, 2016 |
Debt Instrument [Line Items] | ||
2,017 | $ 2,077 | |
2,018 | 2,978 | |
Total | $ 5,055 | $ 5,500 |
DEBT - Additional Information (
DEBT - Additional Information (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | Jan. 07, 2015 | Oct. 31, 2016 | Mar. 31, 2017 | Mar. 31, 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 | ||||||
Debt consulting placement fee | 100 | ||||||
Debt related commitment fees and debt issuance costs | 10 | $ 14 | |||||
Debt instrument unamortized discount | 78 | $ 98 | |||||
Debt instrument Cash Maintenance | $ 2,500 | ||||||
Repayments of Debt | 445 | $ 409 | |||||
Debt Instrument, Periodic Payment | $ 260 | ||||||
Debt Instrument, Interest Rate, Effective Percentage | 10.16% | ||||||
Proceeds from Issuance or Sale of Equity | $ 6,000 | ||||||
Interest Payable, Current | $ 35 | 0 | |||||
Term Loan [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt related commitment fees and debt issuance costs | 231 | ||||||
Interest Payable, Current | 598 | $ 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 | ||||||
Warrant | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument unamortized discount | $ 400 | ||||||
Warrants to purchase common stock | 60 | 60 | |||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 7.98 | $ 2.52 | $ 2.52 | ||||
Warrants, expiry date | December 27, 2020 | ||||||
Additions To Debt Instrument Unamortized Discount | $ 33 | ||||||
First Revenue Event Occurs | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument periodic payment terms balloon payment to be paid | $ 795 | ||||||
Prior To December 27 2015 | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument prepayment percentage | 1.00% |
COMMON STOCK WARRANTS - Additio
COMMON STOCK WARRANTS - Additional Information (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Millions | Mar. 31, 2017 | Mar. 31, 2016 | Dec. 31, 2013 |
Class of Warrant or Right [Line Items] | |||
Secured Debt | $ 10 | ||
Warrant | |||
Class of Warrant or Right [Line Items] | |||
Common stock warrant exercisable outstanding, shares | 60 | 60 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 7.98 | $ 2.52 | $ 2.52 |
SHARE-BASED COMPENSATION -Recog
SHARE-BASED COMPENSATION -Recognition of Share-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Research and development expense | $ 711 | $ 1,014 |
Total | 117 | 150 |
Research and Development Expense [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Research and development expense | 34 | 43 |
Research and Development Expense [Member] | Stock options [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Research and development expense | 34 | 43 |
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 |
General and Administrative Expense [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
General and administrative expense | 83 | 107 |
General and Administrative Expense [Member] | Stock options [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
General and administrative expense | 53 | 77 |
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 |
SHARE-BASED COMPENSATION - Stoc
SHARE-BASED COMPENSATION - Stock Option Award Activity (Detail) - Stock Option Plan [Member] - $ / shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 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 | 0 | |
Number of Options, Exercised | (1) | |
Number of Options, Forfeited or expired | 0 | |
Number of Options Outstanding, ending | 1,396 | 1,198 |
Number of Options exercisable | 1,125 | 876 |
Weighted Average Exercise Price, beginning | $ 13.57 | $ 15.67 |
Weighted Average Exercise Price, Granted | 0 | 0 |
Weighted Average Exercise Price, Exercised | (0.92) | 0 |
Weighted Average Exercise Price, Forfeited or expired | 0 | 0 |
Weighted Average Exercise Price, ending | 13.58 | 15.67 |
Weighted Average Exercise Price, Options exercisable | $ 16.52 | $ 20.64 |
SHARE-BASED COMPENSATION - Summ
SHARE-BASED COMPENSATION - Summary of Information about Non Vested Stock Options (Detail) shares in Thousands | 3 Months Ended |
Mar. 31, 2017$ / sharesshares | |
Summary Of Information About Non Vested Stock Options Disclosure [Line Items] | |
Outstanding, beginning | shares | 335 |
Granted | shares | 0 |
Vested | shares | (64) |
Forfeited | shares | 0 |
Outstanding, ending | shares | 271 |
Outstanding beginning, Weighted Average Fair Value | $ / shares | $ 1.18 |
Granted, Weighted Average Fair Value | $ / shares | 0 |
Vested, Weighted Average Fair Value | $ / shares | 1.36 |
Forfeited, Weighted Average Fair Value | $ / shares | 0 |
Outstanding ending, Weighted Average Fair Value | $ / shares | $ 1.14 |
SHARE-BASED COMPENSATION - Assu
SHARE-BASED COMPENSATION - Assumptions Used in Black-Scholes Model to Determine Fair Value for Stock Option Awards Granted (Detail) - Stock Option [Member] | 12 Months Ended |
Dec. 31, 2016$ / shares | |
Share based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Expected dividend yield | 0.00% |
Risk-free interest rates | 2.30% |
Average expected volatility | 85.00% |
Expected term (years) | 10 years |
Weighted average grant date fair value | $ 0.77 |
SHARE-BASED COMPENSATION - Su44
SHARE-BASED COMPENSATION - Summary of RSU Plan (Detail) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Share based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Outstanding, beginning | 335 | |
Granted | 0 | |
Vested | 64 | |
Forfeited or expired | 0 | |
Outstanding, ending | 271 | |
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 | 0 |
Granted | 0 | 0 |
Distributed | (67) | (42) |
Vested | 59 | 22 |
Forfeited or expired | 0 | 0 |
Outstanding, ending | 83 | 25 |
SHARE-BASED COMPENSATION - Addi
SHARE-BASED COMPENSATION - Additional Information (Detail) - USD ($) shares in Thousands, $ in Thousands | Jan. 03, 2017 | Jan. 04, 2016 | May 01, 2014 | Mar. 31, 2017 | Jan. 02, 2015 | Dec. 31, 2016 | Mar. 31, 2016 |
Employee Benefit Plans Disclosure [Line Items] | |||||||
Aggregate intrinsic value of the option awards vested | $ 0 | $ 70 | |||||
Unrecognized compensation cost on unvested option awards outstanding | $ 309 | ||||||
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, Exercises in Period | 1 | 1 | |||||
Share Based Compensation Arrangement Share Based Payment Shares Reserved For Future Distribution | 66 | 41 | 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] | 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 | 60 | 22 | 10 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 25.00% | 25.00% | 25.00% | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Description | stock, for up to 40% | stock, for up to 40% | stock, for up to 40% | ||||
Share Based Compensation Arrangement Share Based Payment Shares Reserved For Future Distribution | 2 | ||||||
Deferred Compensation Arrangement with Individual, Recorded Liability | $ 19 | $ 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 | |
Mar. 31, 2017 | Mar. 31, 2016 | |
EPS - basic | ||
Numerator: net income (loss) | $ 405 | $ (3,384) |
Denominator: | ||
Common shares | 11,881 | 11,832 |
Vested RSUs | 26 | 5 |
Basic weighted average shares outstanding | 11,907 | 11,837 |
EPS - basic | $ 0.03 | $ (0.28) |
EPS - assuming dilution | ||
Numerator: net income (loss) | $ 405 | $ (3,384) |
Denominator: | ||
Common shares | 11,881 | 11,832 |
RSUs | 202 | 5 |
Stock options | 0 | 0 |
Common stock warrants | 0 | 0 |
Diluted weighted average shares outstanding | 12,083 | 11,837 |
EPS - diluted | $ 0.03 | $ (0.28) |
Common stock issuable: | ||
Total excluded potentially dilutive shares | 1,456 | 1,324 |
Employee Stock Option [Member] | ||
Common stock issuable: | ||
Total excluded potentially dilutive shares | 1,396 | 1,198 |
Warrant [Member] | ||
Common stock issuable: | ||
Total excluded potentially dilutive shares | 60 | 60 |
Restricted Stock Units (RSUs) [Member] | ||
Common stock issuable: | ||
Total excluded potentially dilutive shares | 0 | 66 |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - Additional Information (Detail) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |
Jun. 30, 2015USD ($) | Mar. 31, 2017USD ($) | Dec. 31, 2014USD ($) | Dec. 31, 2016USD ($) | |
Commitments and Contingencies Disclosure [Line Items] | ||||
Accrued Cost Sharing Expenses Clinical Studies | $ 269 | $ 150 | ||
Purdue Pharma [Member] | ||||
Commitments and Contingencies Disclosure [Line Items] | ||||
Litigation Settlement, Expense | $ 250 | $ 500 | ||
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 | $ 25 | |||
Lease expiring date | March 31, 2017 |