Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2020 | Nov. 12, 2020 | |
Document And Entity Information | ||
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2020 | |
Entity Registrant Name | ACURA PHARMACEUTICALS, INC | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Trading Symbol | ACUR | |
Entity Common Stock, Shares Outstanding | 21,650,294 | |
Entity Central Index Key | 0000786947 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q3 | |
Current Fiscal Year End Date | --12-31 | |
Amendment Flag | false | |
Title of 12(b) Security | Common Stock, $0.01 par value | |
Security Exchange Name | NASDAQ |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Assets: | ||
Cash | $ 493 | $ 862 |
Royalty receivable | 6 | 82 |
Collaboration revenue receivable - related party | 115 | 78 |
License fee receivable - related party | 800 | 0 |
Prepaid expenses and other current assets | 209 | 122 |
Income tax receivable | 0 | 34 |
Total current assets | 1,623 | 1,178 |
Income tax receivable | 0 | 34 |
Property, plant and equipment, net (Note 6) | 498 | 540 |
Intangible asset, net (Note 3) | 78 | 810 |
Total assets | 2,199 | 2,562 |
Liabilities: | ||
Accounts payable | 284 | 237 |
Accrued expenses (Note 7) | 721 | 585 |
Loan under CARES Act | 164 | 0 |
Other current liabilities (Note 11) | 16 | 29 |
Sales returns liability (Note 4) | 0 | 223 |
Total current liabilities | 1,185 | 1,074 |
Convertible debt - related party (Note 8) | 6,000 | 6,000 |
Accrued interest - related party (Note 8) | 566 | 229 |
Loan under CARES Act | 105 | 0 |
Total liabilities | 7,856 | 7,303 |
Commitments and contingencies | ||
Stockholders' deficit: | ||
Common stock - $0.01 par value per share; 100,000 shares authorized, 21,650 and 21,300 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively | 216 | 213 |
Additional paid-in capital | 383,088 | 383,042 |
Accumulated deficit | (388,961) | (387,996) |
Total stockholders' deficit | (5,657) | (4,741) |
Total liabilities and stockholders' deficit | $ 2,199 | $ 2,562 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares shares in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
CONSOLIDATED BALANCE SHEETS | ||
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 100,000 | 100,000 |
Common stock, shares issued | 21,650 | 21,300 |
Common stock, shares outstanding | 21,650 | 21,300 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Revenues: | ||||
Royalties | $ 14 | $ 172 | $ 81 | $ 285 |
Collaboration- related party | 96 | 102 | 148 | 102 |
License fees - related party | 300 | 1,050 | 2,400 | 1,050 |
Product sales, net of allowance (Note 4) | 0 | 0 | 223 | 0 |
Total revenues | 410 | 1,324 | 2,852 | 1,437 |
Expenses: | ||||
Research and development | 519 | 465 | 1,351 | 1,040 |
General and administrative | 456 | 548 | 2,128 | 1,391 |
Total expenses | 975 | 1,013 | 3,479 | 2,431 |
Operating income (loss) | (565) | 311 | (627) | (994) |
Loss on debt extinguishment | 0 | 0 | 0 | (2,600) |
Interest expense - related party (Note 10) | (113) | (111) | (338) | (335) |
Income (loss) before provision for income taxes | (678) | 200 | (965) | (3,929) |
Provision for income taxes | 0 | 0 | 0 | 0 |
Net income (loss) | $ (678) | $ 200 | $ (965) | $ (3,929) |
Net income (loss) per share: | ||||
Basic | $ (0.02) | $ 0 | $ (0.03) | $ (0.16) |
Diluted | $ (0.02) | $ 0 | $ (0.03) | $ (0.16) |
Weighted average number of shares outstanding: | ||||
Basic | 32,336 | 31,593 | 32,304 | 25,023 |
Diluted | 32,336 | 31,593 | 32,304 | 25,023 |
CONSOLIDATED STATEMENT OF CHANG
CONSOLIDATED STATEMENT OF CHANGES IN ACCUMULATED STOCKHOLDERS' DEFICIT - USD ($) shares in Thousands, $ in Thousands | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total |
Balance at Dec. 31, 2018 | $ 210 | $ 380,395 | $ (384,222) | $ (3,617) |
Balance (in shares) at Dec. 31, 2018 | 21,034 | |||
Net income (loss) | (788) | (788) | ||
Net distribution of common stock pursuant to restricted stock unit award plan | $ 3 | 12 | 15 | |
Net distribution of common stock pursuant to restricted stock unit award plan (in shares) | 266 | |||
Non-cash share-based compensation | 29 | 29 | ||
Balance at Mar. 31, 2019 | $ 213 | 380,436 | (385,010) | (4,361) |
Balance (in shares) at Mar. 31, 2019 | 21,300 | |||
Balance at Dec. 31, 2018 | $ 210 | 380,395 | (384,222) | (3,617) |
Balance (in shares) at Dec. 31, 2018 | 21,034 | |||
Net income (loss) | (3,929) | |||
Debt premium from debt modification | 1,380 | |||
Issuance of warrant | 1,150 | |||
Balance at Sep. 30, 2019 | $ 213 | 383,021 | (388,151) | (4,917) |
Balance (in shares) at Sep. 30, 2019 | 21,300 | |||
Balance at Dec. 31, 2018 | $ 210 | 380,395 | (384,222) | (3,617) |
Balance (in shares) at Dec. 31, 2018 | 21,034 | |||
Net income (loss) | (3,800) | |||
Balance at Dec. 31, 2019 | $ 213 | 383,042 | (387,996) | (4,741) |
Balance (in shares) at Dec. 31, 2019 | 21,300 | |||
Balance at Mar. 31, 2019 | $ 213 | 380,436 | (385,010) | (4,361) |
Balance (in shares) at Mar. 31, 2019 | 21,300 | |||
Net income (loss) | (3,341) | (3,341) | ||
Non-cash share-based compensation | 29 | 29 | ||
Debt premium from debt modification | 1,382 | 1,382 | ||
Issuance of warrant | 1,145 | 1,145 | ||
Balance at Jun. 30, 2019 | $ 213 | 382,992 | (388,351) | (5,146) |
Balance (in shares) at Jun. 30, 2019 | 21,300 | |||
Net income (loss) | 200 | 200 | ||
Non-cash share-based compensation | 29 | 29 | ||
Balance at Sep. 30, 2019 | $ 213 | 383,021 | (388,151) | (4,917) |
Balance (in shares) at Sep. 30, 2019 | 21,300 | |||
Balance at Dec. 31, 2019 | $ 213 | 383,042 | (387,996) | (4,741) |
Balance (in shares) at Dec. 31, 2019 | 21,300 | |||
Net income (loss) | (595) | (595) | ||
Net distribution of common stock pursuant to restricted stock unit award plan | $ 3 | 19 | 22 | |
Net distribution of common stock pursuant to restricted stock unit award plan (in shares) | 350 | |||
Non-cash share-based compensation | 9 | 9 | ||
Balance at Mar. 31, 2020 | $ 216 | 383,070 | (388,591) | (5,305) |
Balance (in shares) at Mar. 31, 2020 | 21,650 | |||
Balance at Dec. 31, 2019 | $ 213 | 383,042 | (387,996) | (4,741) |
Balance (in shares) at Dec. 31, 2019 | 21,300 | |||
Net income (loss) | (965) | |||
Balance at Sep. 30, 2020 | $ 216 | 383,088 | (388,961) | (5,657) |
Balance (in shares) at Sep. 30, 2020 | 21,650 | |||
Balance at Mar. 31, 2020 | $ 216 | 383,070 | (388,591) | (5,305) |
Balance (in shares) at Mar. 31, 2020 | 21,650 | |||
Net income (loss) | 308 | 308 | ||
Non-cash share-based compensation | 9 | 9 | ||
Balance at Jun. 30, 2020 | $ 216 | 383,079 | (388,283) | (4,988) |
Balance (in shares) at Jun. 30, 2020 | 21,650 | |||
Net income (loss) | (678) | (678) | ||
Non-cash share-based compensation | 9 | 9 | ||
Balance at Sep. 30, 2020 | $ 216 | $ 383,088 | $ (388,961) | $ (5,657) |
Balance (in shares) at Sep. 30, 2020 | 21,650 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Cash Flows from Operating Activities: | ||
Net loss | $ (965) | $ (3,929) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 42 | 51 |
Non-cash share-based compensation | 27 | 87 |
Capitalized debt discount | 0 | (13) |
Amortization of debt discount and deferred debt issue costs | 0 | 66 |
Amortization of intangible asset | 64 | 155 |
Loss on debt extinguishment | 0 | 2,600 |
Impairment charge on intangible asset | 668 | 0 |
Loss on disposal of equipment | 0 | 1 |
Changes in operating assets and liabilities: | ||
Royalty receivable | 75 | (34) |
License fee receivable - related party | (800) | 0 |
Collaboration revenue receivable from related party | (37) | (10) |
Prepaid expenses and other current assets | (86) | (19) |
Income taxes refundable | 67 | 67 |
Accounts payable | 47 | (275) |
Accrued expenses | 136 | 89 |
Sales return liability | (223) | 0 |
Accrued interest on related party loans | 338 | 6 |
Other current liabilities | 8 | 18 |
Net cash used in operating activities | (639) | (1,140) |
Cash Flows from Financing Activities: | ||
Proceeds from distribution of restricted stock units | 3 | 14 |
Statutory minimum payroll withholding taxes paid on the distribution of shares pursuant to RSU award plan | (2) | 0 |
Proceeds from loan under CARES Act | 269 | 0 |
Proceeds from related party loans | 0 | 1,650 |
Net cash provided by financing activities | 270 | 1,664 |
Net increase (decrease) in cash | (369) | 524 |
Cash at beginning of period | 862 | 91 |
Cash at end of end of period | $ 493 | $ 615 |
CONSOLIDATED STATEMENTS OF CA_2
CONSOLIDATED STATEMENTS OF CASH FLOWS (Parenthetical) - USD ($) $ in Thousands | Jul. 02, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Jun. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Jun. 28, 2019 |
Related party loans made to Company | $ 5,000 | $ 5,000 | $ 5,000 | |||||
(Loss) gain on debt extinguishment (Note 7) | 0 | $ 0 | 0 | $ (2,600) | ||||
Common stock purchase warrant issued to the related party lender | $ 1,145 | 1,150 | ||||||
Excess fair value premium on the newly issued convertible debt | $ 1,382 | 1,380 | ||||||
Write-off of unamortized debt discount | 70 | |||||||
Accrued interest due on the related party loan rolled into principal under modifications | $ 566 | 274 | 566 | 274 | $ 229 | |||
Proceeds from related party loans | $ 725 | $ 0 | 1,650 | |||||
Interest Rate Below Market Reduction [Member] | ||||||||
Related party loans made to Company | $ 650 | 650 | ||||||
Imputed interest on the below market rate recorded as benefit to interest income | $ 13 |
OPERATIONS AND SUMMARY OF SIGNI
OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 30, 2020 | |
OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 1 – OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Principal Operations Acura Pharmaceuticals, Inc., a New York corporation, and its subsidiary (the “Company”, “Acura”, “We”, “Us” or “Our”) is an innovative drug delivery company engaged in the research, development and commercialization of technologies and products intended to address safe use of medications. We have discovered and developed three proprietary platform technologies which can be used to develop multiple products. Our Limitx™ Technology is intended to minimize the risks and side effects associated with overdose by retarding the release of active drug ingredients when too many tablets are accidently or purposefully ingested. Our Aversion® Technology is intended to address methods of product tampering associated with opioid abuse by incorporating gelling ingredients and irritants into tablets to discourage abuse by snorting and provide barriers to abuse by injection. Our Impede® Technology is directed at minimizing the extraction and conversion of pseudoephedrine tablets into methamphetamine. · Our Limitx Technology is in development with immediate-release tablets containing hydrocodone bitartrate and acetaminophen (also known as LTX-03) as the lead product candidate due to its large market size and its known prevalence of oral excessive tablet abuse and overdose. The technology is designed to retard the release of active opioid drug when too many tablets are accidentally 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. US commercialization rights to LTX-03 are licensed to Abuse Deterrent Pharma, LLC (See Note 3). · Our Aversion Technology has been licensed to Assertio Holdings Inc. or Assertio (formerly known as Zyla Life Sciences and previously as Egalet Corporation) for use in Oxaydo® Tablets (oxycodone HCl, CII), and is the first approved immediate-release oxycodone product in the United States with abuse deterrent labeling. Oxaydo is currently approved by the FDA for marketing in the United States in 5mg and 7.5mg strengths (See Note 3). · Our Impede Technology is used in Nexafed® Tablets (30mg pseudoephedrine HCl) and Nexafed® Sinus Pressure + Pain Tablets (30/325mg pseudoephedrine HCl and acetaminophen). We have licensed to MainPointe Pharmaceuticals, LLC (MainPointe), our Impede Technology in the United States and Canada to commercialize these Nexafed products (See Note 3). MainPointe subsequently assigned its interest in the license to Abuse Deterrent Pharma, LLC but continues to market the products. Basis of Presentation, Liquidity and Substantial Doubt in Going Concern The accompanying 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. The going concern basis of presentation assumes that we will continue in operation one year after the date these financial statements are issued and we will be able to realize our assets and discharge our liabilities and commitments in the normal course of business. As of September 30, 2020, we had cash of $0.5 million, working capital of $0.4 million and an accumulated deficit of $389 million. We had a loss from operations of $0.6 million and a net loss of $1.0 million for the nine months ended September 30, 2020, and had a loss from operations of $725 thousand and a net loss of $3.8 million for the year ended December 31, 2019. We have suffered recurring losses and have not generated positive cash flows from operations. We anticipate operating losses to continue for the foreseeable future. On June 28, 2019, we entered into a License, Development and Commercialization Agreement with Abuse Deterrent Pharma, LLC ("AD Pharma") which was amended in October 2020 (the "AD Pharma Agreement"). AD Pharma has the right to terminate the AD Pharma Agreement for "convenience on 30 days prior written notice". Under the AD Pharma Agreement, as amended, the required monthly license payments by AD Pharma will only continue until July 2021 if AD Pharma does not exercise their right to terminate the AD Pharma Agreement. To fund further operations, we must raise additional financing or enter into license or collaboration agreements with third parties relating to our technologies or explore a variety of capital raising and other transactions to provide additional funding. No assurance can be given that we will be successful in obtaining any such financing or in securing license or collaboration agreements with third parties on acceptable terms, if at all, or if secured, that such financing or license or collaboration agreements will provide payments to the Company sufficient to fund continued operations and the Company will be required to scale back or terminate operations and/or seek protection under applicable bankruptcy laws. 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. Should AD Pharma exercise their right to terminate the AD Pharma Agreement, we would need to raise additional financing or enter into license or collaboration agreements with third parties relating to our technologies. The Company's ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, financial markets in the United States and worldwide resulting from the ongoing COVID-19 pandemic. No assurance can be given that we will be successful in obtaining any such financing or in securing license or collaboration agreements with third parties on acceptable terms, if at all, or if secured, that such financing or license or collaboration agreements will provide payments to the Company sufficient to fund continued operations. In the absence of such financing or third-party license or collaboration agreements, 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. Also included in the AD Pharma Agreement, as amended, is the requirement that the NDA for LTX-03 now be accepted by the FDA by July 31, 2021 or AD Pharma has the option to terminate the AD Pharma Agreement and take ownership of the LIMITx intellectual property. Importantly, such failure to meet this date will be an event of default under their $6.0 million note to Acura. In view of the matters described above, management has concluded that substantial doubt exists with respect to the Company’s ability to continue as a going concern within one year after the date the financial statements are issued. The recoverability of a major portion of the recorded asset amounts shown in the Company’s accompanying consolidated 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. COVID-19 On January 30, 2020, the World Health Organization (“WHO”) announced a global health emergency because of a new strain of coronavirus originating in Wuhan, China (the “COVID-19 outbreak”) and the risks to the international community as the virus spreads globally beyond its point of origin. In March 2020, the WHO classified the COVID-19 outbreak as a pandemic (“coronavirus pandemic”), based on the rapid increase in exposure globally. The coronavirus pandemic is affecting the United States and global economies. If the outbreak continues to spread, it may affect the Company’s operations and those of third parties on which the Company relies, including causing disruptions in the supply of the Company’s product candidates and the conduct of current and planned preclinical and clinical studies and contract manufacturing operations. We may need to limit operations or implement limitations, and may experience limitations in employee resources. There are risks that it may be more difficult to contain if the outbreak reaches a larger population or broader geography, in which case the risks described herein could be elevated significantly. The extent to which the coronavirus impacts our results will depend on future developments, which are highly uncertain and cannot be predicted, including new information which may emerge concerning the severity of the coronavirus and the actions to contain the coronavirus or treat its impact, among others. Additionally, while the potential economic impact brought by, and the duration of, the coronavirus pandemic is difficult to assess or predict, the impact of the coronavirus on the global financial markets may reduce the Company’s ability to access capital, which could negatively impact the Company’s short-term and long-term liquidity and the Company’s ability to complete its preclinical studies on a timely basis, or at all. For example, as further discussed throughout the notes to financial statements, our contract manufacturer did delay the installation of the auxiliary manufacturing equipment needed for LTX-03 development for several weeks due to COVID-19 risk mitigation strategies implemented in New Jersey which was needed to further our NDA application submission for LTX-03. The ultimate impact of coronavirus is highly uncertain and subject to change. The Company does not yet know the full extent of further potential delays or impacts on its business, financing, preclinical and clinical trial activities, contract manufacturing operations or the global economy as a whole. However, these effects could have a material, adverse impact on the Company’s liquidity, capital resources, operations and business and those of the third parties on which we rely. |
RECENT ANNOUNCING STANDARDS
RECENT ANNOUNCING STANDARDS | 9 Months Ended |
Sep. 30, 2020 | |
RECENT ANNOUNCING STANDARDS | |
RECENT ANNOUNCING STANDARDS | NOTE 2 – RECENT ANNOUNCING STANDARDS New accounting standards which have been adopted Fair Value Measurements In August 2018, the FASB issued ASU 2018-13 , Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement . ASU 2018-13 eliminates certain disclosure requirements for fair value measurements for all entities, requires public entities to disclose certain new information and modifies some disclosure requirements. This standard is effective for fiscal years beginning after December 15, 2019, including interim reporting periods within those years, with early adoption permitted. The Company's adoption of ASU 2018-13 did not have a material impact on the financial statements and related footnote disclosures. |
LICENSE AND COLLABORATION AGREE
LICENSE AND COLLABORATION AGREEMENTS | 9 Months Ended |
Sep. 30, 2020 | |
LICENSE AND COLLABORATION AGREEMENTS | |
LICENSE AND COLLABORATION AGREEMENTS | NOTE 3 – LICENSE AND COLLABORATION AGREEMENTS The Company’s revenues are comprised of amounts earned under its license and collaboration agreements and royalties. Revenue recognition occurs when a customer obtains control of promised services in an amount that reflects the consideration the Company expects to receive in exchange for those services based on a short-term credit arrangement. AD Pharma Agreement covering LTX-03 On June 28, 2019 we entered into a License, Development and Commercialization Agreement which was amended on October 23, 2020 (“the AD Pharma Agreement”) with Abuse Deterrent Pharma, LLC (AD Pharma”, for the development and license of LTX-03 (hydrocodone bitartrate with acetaminophen) immediate-release tablets utilizing Acura’s patented LIMITx™. Acura will receive a monthly license payment of $350 thousand by AD Pharma from inception through April 2020 at which time the monthly payments are $200 thousand thereafter until the earlier of July 31, 2021 or FDA’s acceptance of a New Drug Application (“NDA”) for LTX-03. The first license payment was received July 2, 2019. AD Pharma will pay for and reimburse Acura for all outside development costs on LTX-03. If the NDA filing for LTX-03 is not accepted by the FDA by July 31, 2021, AD Pharma has the option to terminate the AD Pharma Agreement and take ownership of the Limitx intellectual property. Should AD Pharma choose not to exercise this option to terminate and the NDA for LTX-03 is subsequently accepted by the FDA, such option expires. AD Pharma does have the right to terminate the AD Pharma Agreement anytime for “convenience on 30 days prior written notice”. AD Pharma retains commercialization rights from which Acura will receive stepped royalties on sales and potential sales related milestones. AD Pharma also has a license to the Limitx patents for LTX-02 (oxycodone/acetaminophen) and LTX-09 (alprazolam) which are not subject to any development agreement or responsibilities by Acura. We had also previously granted authority to MainPointe Pharmaceuticals, LLC (MainPointe) to assign to AD Pharma the option and the right to add, as an Option Product to the Nexafed® Agreement, a Nexafed® 12-hour dosage (an extended-release pseudoephedrine hydrochloride product utilizing the IMPEDE® Technology in 120mg dosage strength, and the Option Product exercise price of $500 thousand was waived if the exercise of the option occurred by June 28, 2024 (five years from the effective date of the AD Pharma Agreement). Effective with the October 2020 amendment to the AD Pharma Agreement, this option and right was rescinded. On June 28, 2019 Mr. John Schutte assigned and transferred to AD Pharma his $6.0 million promissory note, the common stock purchase warrant for 10.0 million common shares, and the security agreement granting a security interest in all of the Company's assets. Mr. Schutte is our largest shareholder and directly owns approximately 45.7% of our common stock (after giving effect to the exercise of remaining common stock purchase warrants he holds). Mr. Schutte controls MainPointe and is the principal investor in AD Pharma. Assertio Agreement covering Oxaydo In April 2014, we terminated an agreement with Pfizer which resulted in the return to us of Aversion Oxycodone (formerly known as Oxecta®) and all Aversion product rights in exchange for a one-time termination payment of $2.0 million. Our termination payment of $2.0 million has been recorded in our financial statements as an intangible asset and is being amortized over the remaining useful life of the patent covering Aversion Oxycodone, which was 9.7 years as of the date the Pfizer agreement was terminated. The recoverability of the Aversion intangible asset is contingent upon future Assertio royalty revenues to us. We have recorded amortization expense of $64 thousand and $155 thousand in each of the nine month periods ending September 30, 2020 and 2019, respectively. During the first quarter 2020 a triggering event occurred with the decline in royalty cash flows from Assertio, and we performed an impairment test which indicated that the carrying value of the intangible asset was greater than the fair value. The impairment test resulted in a $668 thousand impairment charge against the intangible asset, which was determined using our estimate of discounted royalty cash flows remaining under our license agreement with Assertio, and recorded a like amount to general and administrative expense. Amortization of the patent for its remaining life is expected to approximate $6 thousand per quarter. The Aversion intangible asset is summarized as follows (in thousands): September 30, December 31, 2020 2019 Intangible asset – Aversion 2,000 2,000 Less: accumulated amortization (1,254) (1,190) Less: impairment charge (668) — Net $ 78 $ 810 In January 2015, we and Egalet US, Inc. and Egalet Ltd., each a subsidiary of Egalet Corporation (now known as Assertio Holdings Inc. and formerly known as Zyla Life Sciences), or collectively Assertio, entered into a Collaboration and License Agreement (the “Assertio Agreement”) to commercialize Aversion Oxycodone under our tradename Oxaydo. Oxaydo is approved by the FDA for marketing in the United States in 5 mg and 7.5 mg strengths. Under the terms of the Assertio Agreement, we transferred the approved New Drug Application, or NDA, for Oxaydo to Assertio and Assertio 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 Assertio Agreement Assertio is responsible for the fees and expenses relating to the product line extensions of Oxaydo, provided that Assertio 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. Assertio will bear all of the expenses of development and regulatory approval of Oxaydo for sale outside the United States. Assertio is responsible for all manufacturing and commercialization activities in the Territory for Oxaydo. Subject to certain exceptions, Assertio will have final decision making authority with respect to all development and commercialization activities for Oxaydo, including pricing, subject to our co-promotion right. Assertio may develop Oxaydo for other countries and in additional strengths, in its discretion. Assertio paid us a $5.0 million license fee upon signing of the Assertio Agreement and on October 9, 2015, paid us a $2.5 million milestone in connection with the first commercial sale of Oxaydo. We will be entitled to a one-time $12.5 million sales-based milestone payment when worldwide Oxaydo net sales reach $150 million in a calendar year. We are entitled to receive from Assertio a stepped royalty at percentage rates ranging from mid-single digits to double-digits based on Oxaydo net sales during each calendar year (excluding net sales resulting from our co-promotion efforts). In any calendar year of the agreement in which net sales exceed a specified threshold, we will receive a double digit royalty on all Oxaydo net sales in that year (excluding net sales resulting from our co-promotion efforts). If we exercise our co-promotion rights, we will receive a share of the gross margin attributable to incremental Oxaydo net sales from our co-promotion activities. Assertio’s royalty payment obligations commenced on the first commercial sale of Oxaydo and expire, on a country-by-country basis, upon the expiration of the last to expire valid patent claim covering Oxaydo in such country (or if there are no patent claims in such country, then upon the expiration of the last valid claim in the United States or the date when no valid and enforceable listable patent in the FDA’s Orange Book remains with respect to Oxaydo). Royalties will be reduced upon the entry of generic equivalents, as well as for payments required to be made by Assertio to acquire intellectual property rights to commercialize Oxaydo, with an aggregate minimum floor. The Assertio Agreement expires upon the expiration of Assertio’s royalty payment obligations in all countries. Either party may terminate the Assertio Agreement in its entirety if the other party breaches a payment obligation, or otherwise materially breaches the Assertio 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 Assertio Agreement with respect to the U.S. and other countries if Assertio materially breaches its commercialization obligations. Assertio may terminate the Assertio Agreement for convenience on 120 days prior written notice, which termination may not occur prior to the second anniversary of Assertio’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 Assertio Agreement provides for the transition of development and marketing of Oxaydo from Assertio to us, including the conveyance by Assertio to us of the trademarks and all regulatory filings and approvals relating to Oxaydo, and for Assertio’s supply of Oxaydo for a transition period. MainPointe Agreement covering Nexafed Products and assignment thereof to AD Pharma In March 2017, we and MainPointe entered into the MainPointe Agreement, pursuant to which we granted MainPointe an exclusive license to our Impede Technology to commercialize both of our Nexafed and Nexafed Sinus Pressure + Pain product (“Nexafed products”) in the U.S. and Canada. We also conveyed to MainPointe our existing inventory and equipment relating to our Nexafed products. MainPointe is responsible for all development, manufacturing and commercialization activities with respect to products covered by the Agreement. On signing the MainPointe Agreement, MainPointe paid us an upfront licensing fee of $2.5 million. The MainPointe Agreement also provides for our receipt of a 7.5% royalty on net sales of the licensed products. The royalty payment for each product will expire on a country-by-country basis when the Impede® patent rights for such country have expired or are no longer valid; provided that if no Impede patent right exists in a country, then the royalty term for that country will be the same as the royalty term for the United States. After the expiration of a royalty term for a country, MainPointe retains a royalty free license to our Impede® Technology for products covered by the Agreement in such country. MainPointe has the option to expand the licensed territory beyond the United States and Canada to the European Union (and the United Kingdom), Japan and South Korea for payments of $1.0 million, $500 thousand and $250 thousand, respectively. In addition, MainPointe has the option to add to the MainPointe Agreement certain additional products, or Option Products, containing PSE and utilizing the Impede Technology for a fee of $500 thousand per product (for all product strengths). Such Option Products include the product candidate Loratadine with pseudoephedrine. If the territory has been expanded prior to the exercise of a product option, the option fee will be increased to $750 thousand per product. If the territory is expanded after the payment of the $500 thousand product option fee, a one-time $250 thousand fee will be due for each product. If a third party is interested in developing or licensing rights to an Option Product, MainPointe must exercise its option for that product or its option rights for such product will terminate. On June 28, 2019, we granted authority to MainPointe to assign to AD Pharma the option and the right to add, as an Option Product to the Nexafed® Agreement, a Nexafed® 12-hour dosage (an extended-release pseudoephedrine hydrochloride product utilizing the IMPEDE® Technology in 120mg dosage strength and the Option Product exercise price of $500 thousand was waived if the exercise of the option occurred by June 28, 2024 (five years from the effective date of the AD Pharma Agreement). Effective with the October 2020 amendment to the AD Pharma Agreement, this option and right was rescinded. 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. On January 1, 2020, MainPointe assigned to AD Pharma, with Acura's consent, all of its right, title and interest in the MainPointe Agreement between MainPointe and Acura. KemPharm Agreement Covering Certain Opioid Prodrugs In October 2016, we and KemPharm Inc. (”KemPharm”) entered into a worldwide License Agreement (the “KemPharm Agreement”) pursuant to which we licensed our Aversion® Technology to KemPharm for its use in the development and commercialization of three products using 2 of KemPharm’s prodrug candidates. KemPharm has also been granted an option to extend the KemPharm Agreement to cover two additional prodrug candidates. KemPharm is responsible for all development, manufacturing and commercialization activities. Upon execution of the KemPharm Agreement, KemPharm paid us an upfront payment of $3.5 million. If KemPharm exercises its option to use our Aversion Technology with more than the two licensed prodrugs, then KemPharm will pay us up to $1.0 million for each additional prodrug license. In addition, we will receive from KemPharm a low single digit royalty on commercial sales by KemPharm of products developed using our Aversion Technology under the KemPharm Agreement. KemPharm’s royalty payment obligations commence on the first commercial sale of a product using our Aversion Technology and expire, on a country-by-country basis, upon the expiration of the last to expire patent claim of the Aversion Technology covering a product in such country, at which time the license for the particular product and country becomes fully paid and royalty free. The KemPharm Agreement expires upon the expiration of KemPharm’s royalty payment obligations in all countries. Either party may terminate the KemPharm Agreement in its entirety if the other party materially breaches the KemPharm Agreement, subject to applicable cure periods. Acura or KemPharm may terminate the KemPharm Agreement with respect to the U.S. and other countries if the other party challenges the patents covering the licensed products. KemPharm may terminate the KemPharm Agreement for convenience on ninety (90) days prior written notice. Termination does not affect a party’s rights accrued prior thereto, but there are no stated payments in connection with termination other than payments of obligations previously accrued. For all terminations (but not expiration), the KemPharm Agreement provides for termination of our license grant to KemPharm. |
REVENUE FROM CONTRACTS WITH CUS
REVENUE FROM CONTRACTS WITH CUSTOMERS | 9 Months Ended |
Sep. 30, 2020 | |
REVENUE FROM CONTRACTS WITH CUSTOMERS | |
REVENUE FROM CONTRACTS WITH CUSTOMERS | NOTE 4 – REVENUE FROM CONTRACTS WITH CUSTOMERS Revenue is recognized when, or as, performance obligations under terms of a contract are satisfied, which occurs when control of the promised service is transferred to a customer. Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring services to a customer (“transaction price”). The Company will then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when, or as, the performance obligation is satisfied. When determining the transaction price of the contract, an adjustment is made if payment from a customer occurs either significantly before or significantly after performance, resulting in a significant financing component. None of the Company’s licenses and collaboration agreements contained a significant financing component at either September 30, 2020 or December 31, 2019. The Company’s existing license and collaboration agreements may contain a single performance obligation or may contain multiple performance obligations. Those which contain multiple performance obligations will require an allocation of the transaction price based on the estimated relative standalone selling prices of the promised services underlying each performance obligation. The Company’s existing license and collaboration agreements contain customer options for the license of additional products and territories. We determined the option’s standalone selling prices based on the option product’s potential market size in the option territory as compared to the currently licensed product and U.S. territory. Some of our existing license and collaboration agreements contain a license to the technology as well as licenses to tradenames or trademarks. The Company determined that the licenses to the tradenames or trademarks were immaterial in context of the contract. Price adjustments are accounted for as variable consideration. Provisions for variable consideration are based on current assumptions, executed contracts, and historical data and are provided for in the period the related revenues are recorded. Sales-based Milestones and Royalty Revenues The commercial sales-based milestones and sales royalties earned under the license and collaboration for Oxaydo and sales royalties earned under the license for the Nexafed products, are recorded in the period of the related sales by Assertio and MainPointe. Payments of sales-based milestones are generally due within 30 days after the end of a calendar year. Payments of royalties are generally due within 45 days after the end of a calendar quarter. License and Collaboration Agreement Revenues The achievement of milestones under the Company’s license and collaboration agreements will be recorded as revenue during the period the milestone’s achievement becomes probable, which may result in earlier recognition as compared to the previous accounting standards. The license fee of an option product or option territory under the Company’s license and collaboration agreements will be recorded as revenue when the option is exercised and any obligations on behalf of the Company, such as to transfer know-how, has been fulfilled. The monthly license fee under the Company’s LTX-03 license and collaboration agreement will be recorded as revenue upon the fulfillment of the monthly development activities. The out-of-pocket development expenses under the license and collaboration agreements will be recorded as revenue upon the performance of the service or delivery of the material during the month. On June 28, 2019 we entered into an agreement with AD Pharma which was amended in October 2020 for the development and license of LTX-03 (hydrocodone bitartrate with acetaminophen) immediate-release tablets utilizing Acura’s patented LIMITx™ providing a monthly license payment of $350 thousand from AD Pharma to us for a period from inception up to April 2020 at which time the payment is $200 thousand per month through July 2021. The Company provided a price adjustment to AD Pharma in September 2020 when it was probable that the monthly license payments were being reduced from $350 thousand to $200 thousand. We have subsequently received the required monthly license payments for June thru October 2020 from AD Pharma. AD Pharma will pay directly for or reimburse Acura to the extent Acura pay’s for, all out-of-pocket development expenses. Product Sales, net of allowance Nexafed was launched in mid-December 2012 and Nexafed Sinus Pressure + Pain was launched in February 2015. Prior to entering into the MainPointe Agreement in March 2017, we sold our Nexafed products in the United States to wholesale pharmaceutical distributors as well as directly to chain drug stores. Our Nexafed products were sold subject to the right of return usually for a period of up to twelve months after the product expiration. During the second quarter 2020, we reviewed our product sales return allowance liability and recorded a $223 thousand favorable amount to product sales as we believe sufficient time has passed where the Nexafed product is no longer subject to right of return and we estimate no additional product will be returned and therefore, we no longer maintain a sales return allowance liability. Disaggregation of Total Revenues The Company has two license agreements for currently marketed products containing its technologies; the Oxaydo product containing the Aversion Technology has been licensed to Assertio and the Nexafed products containing the Impede Technology which have been licensed to MainPointe. The Company has a third license agreement having a product under development, LTX-03, containing its LIMITx™ technology to AD Pharma. We have recorded $0.3 million and $2.4 million of license fees for LTX-03 during the three and nine month periods ended September 30, 2020, respectively. On January 1, 2020, MainPointe assigned to AD Pharma, with Acura's consent, all of its right, title and interest in the MainPointe Agreement between MainPointe and Acura. All of the Company's royalty revenues are earned from these two license agreements by the licensee's sale of products in the United States. Royalty revenues by licensee are summarized below: Three months Ended Nine months Ended September 30, September 30, 2020 2019 2020 2019 Assertio (Oxaydo) $ 11 $ 171 $ 72 $ 269 MainPointe - related party (Nexafed) 3 1 9 16 Royalty revenues $ 14 $ 172 $ 81 $ 285 Contract Balance and Performance Obligations The Company had no contract assets and contract liability balances under the license and collaboration agreements at either September 30, 2020 or 2019. Contract assets may be reported in future periods under prepaid expenses or other current assets on the consolidated balance sheet. Contract liabilities may be reported in future periods consisting of deferred revenue as presented on the consolidated balance sheet. |
RESEARCH AND DEVELOPMENT
RESEARCH AND DEVELOPMENT | 9 Months Ended |
Sep. 30, 2020 | |
RESEARCH AND DEVELOPMENT | |
RESEARCH AND DEVELOPMENT | NOTE 5 – RESEARCH AND DEVELOPMENT Research and Development (“R&D”) costs include internal R&D activities, external Contract Research Organization (“CRO”) services and their clinical research and investigative sites, and other activities. Internal R&D activity costs can include facility overhead, equipment and facility maintenance and repairs, laboratory supplies, pre-clinical laboratory experiments, formulation work, depreciation, salaries, benefits, insurance and share-based compensation expenses. CRO activity costs can include preclinical laboratory experiments and clinical trial studies. Other activity costs can include regulatory consulting, regulatory legal counsel, cost of acquiring, developing and manufacturing pre-clinical trial materials, costs of manufacturing scale-up, and cost sharing expenses under license agreements. Internal R&D costs and other activity costs are charged to expense as incurred. We make payments to the CRO's based on agreed upon terms and may include payments in advance of a study starting date. Payments in advance will be reflected in the consolidated financial statements as prepaid expenses. We review and charge to expense accrued CRO costs and clinical trial study costs based on services performed and rely on estimates of those costs applicable to the stage of completion of a study as provided by the CRO. Our accrued CRO costs are subject to revisions as such studies progress towards completion. Revisions are charged to expense in the period in which the facts that give rise to the revision become known. We did not have prepaid CRO costs or prepaid clinical trial study expenses at September 30, 2020 and 2019. In connection with our development and scale-up of LTX-03 under the AD Pharma Agreement (See Note 3) we have entered into unbilled obligations under non-cancelable arrangements at September 30, 2020 aggregating $121 thousand. |
PROPERTY, PLANT AND EQUIPMENT
PROPERTY, PLANT AND EQUIPMENT | 9 Months Ended |
Sep. 30, 2020 | |
PROPERTY, PLANT AND EQUIPMENT | |
PROPERTY, PLANT AND EQUIPMENT | NOTE 6 – PROPERTY, PLANT AND EQUIPMENT Property, plant and equipment is summarized as follows (in thousands): September 30, December 31, 2020 2019 (in thousands) Building and improvements $ 1,273 $ 1,273 Scientific equipment 597 597 Computer hardware and software 106 106 Machinery and equipment 274 274 Land and improvements 162 162 Other personal property 70 70 Office equipment 27 27 Total 2,509 2,509 Less: accumulated depreciation (2,011) (1,969) Net property, plant and equipment $ 498 $ 540 We do not have leasehold improvements nor do we have capitalized leases. Costs of betterments are capitalized while maintenance costs and repair costs are charged to operations as incurred. When a depreciable asset is retired from service, the cost and accumulated depreciation will be removed from the respective accounts. Depreciation expense was $13 thousand and $17 thousand for each of the three month periods ended September 30, 2020 and 2019, respectively. Depreciation expense was $42 thousand and $51 thousand for each of the nine month periods ended September 30, 2020 and 2019, respectively. |
ACCRUED EXPENSES
ACCRUED EXPENSES | 9 Months Ended |
Sep. 30, 2020 | |
ACCRUED EXPENSES | |
ACCRUED EXPENSES | NOTE 7 – ACCRUED EXPENSES Accrued expenses are summarized as follows (in thousands): September 30, December 31, 2020 2019 (in thousands) Cost sharing expenses under license agreement $ 428 $ 363 Other fees and services 1 15 Payroll, payroll taxes and benefits 59 13 Professional services 150 151 Financed insurance policies 42 — Clinical, non-clinical and regulatory services 23 20 Property taxes 7 9 Franchise taxes 11 14 Total $ 721 $ 585 |
DEBT
DEBT | 9 Months Ended |
Sep. 30, 2020 | |
DEBT | |
DEBT | NOTE 8 – DEBT Related Party Convertible Loan At December 31, 2018, we had borrowed an aggregate of $4.350 million from Mr. Schutte, a related-party. From January 1, 2019 and through June 27, 2019, we borrowed additional amounts from Mr. Schutte for $650 thousand and issued various promissory notes to him with the same terms and conditions from the previous loans (the Schutte Notes). The Schutte Notes bear interest at prime plus 2.0%, and were to mature on January 2, 2020, at which time all principal and interest was to be due. The Schutte Notes were unsecured until all obligations to Oxford were satisfied at which time we were required to grant a security interest to Mr. Schutte in all of our assets, including our intellectual property. Because we believed the Schutte Notes’ rate of interest was below current market rates for us, we imputed interest on the below market rate element of the loans using the 10.16% interest rate under the Oxford Loan Agreement and this has aggregated to $172 thousand as of December 31, 2018. We recorded these benefits to interest income, with a corresponding like amount as debt discount against the principal amount of the loan. The debt discount will be amortized to interest expense over the term on the loans. At December 31, 2018, the unamortized debt discount balance was $126 thousand and the accrued interest balance was $110 thousand. We recorded a $13 thousand benefit to interest income during 2019 from the $650 thousand borrowings from Mr. Schutte. At June 27, 2019, the unamortized debt discount balance was $73 thousand and the accrued interest balance was $275 thousand. The events of default under the Schutte Notes are limited to bankruptcy defaults and failure to pay interest and principal when due on January 2, 2020. The Schutte Notes could be prepaid at any time in whole or in part. Included in the $4.350 million loan outstanding from Mr. Schutte as of December 31, 2018 was a borrowing of $1.8 million completed on October 5, 2018 of which we used $1.5 million to fully pay-off the debt outstanding under the Oxford Loan Agreement. All our assets are pledged as collateral under the Schutte Notes, including our intellectual property. On June 27, 2019 the aggregate amount of the loans made to the Company by Mr. Schutte aggregated $5.0 million. On June 28, 2019 we restructured the $5.0 million loan to borrow an additional $725 thousand from Mr. Schutte, which was received on July 2, 2019, bringing the aggregate principal of the loans and accrued interest to $6.0 million, and consolidated the loans into a single promissory note with a fixed interest rate of 7.5%, maturity date of July 1, 2023, granted principal and interest conversion rights into shares of our common stock at a price of $0.16 per share, issued a warrant for 10.0 million common shares having an exercise price of $0.01 per share, and granted a security interest in all of the Company’s assets, which includes our intellectual property. The principal amount of the loan is convertible into 37.5 million shares of our common stock. The loan restructuring was accounted for as debt extinguishment. We obtained a valuation of fair value on the modified loan and warrant and the method of accounting for the loan changes resulted in a $2.6 million loss on debt extinguishment. Of the loss on debt extinguishment, $1.145 million was allocated to the warrant, $1.382 million was related to the premium on the convertible loan, and $73 thousand was assignable to write-off of the original loan’s remaining unamortized debt discount. The $6.0 million promissory note, the common stock purchase warrant and the security agreement were all assigned and transferred by Mr. Schutte to AD Pharma on June 28, 2019. The accrued interest balance at September 30, 2020 and December 31, 2019 was $566 thousand and $229 thousand, respectively. The events of default under the $6.0 million note are limited to bankruptcy defaults, failure to pay interest and principal when due on July 1, 2023 or upon failure to meet certain timelines in the AD Pharma Agreement as defined in the loan agreement. The $6.0 million note may be prepaid at any time in whole or in part but only with the consent of the noteholder. Included in the amended AD Pharma Agreement entered into during October 2020, is the requirement that the NDA for LTX-03 now be accepted by the FDA by July 31, 2021, or AD Pharma has the option to terminate the AD Pharma Agreement and take ownership of the LIMITx intellectual property. Importantly, such failure to meet this date will be an event of default under their $6.0 million note to Acura. As the amendment to the AD Pharma Agreement extended the original NDA acceptance date of November 2020 to July 2021 providing additional development time, we have changed how we reflect the presentation of the $6.0 million note at September 30, 2020 from a current obligation to a non-current obligation. Our interest expense for the three and nine month months ended September 30, 2020 and 2019 consisted of the following: Three months Ended Nine months Ended September 30, September 30, Interest expense: 2020 2019 2020 2019 Related party term loans $ 113 $ 111 $ 338 $ 279 Debt discount — — — 66 Financed insurance premiums — — — 3 Total interest expense $ 113 $ 111 $ 338 $ 348 Less: imputed interest income on related party loan — — — (13) Total interest expense, net $ 113 $ 111 $ 338 $ 335 Paycheck Protection Program On April 13, 2020, the Company received a loan (the "Loan") from JP Morgan Chase Bank in the aggregate amount of $269 thousand, pursuant to the Paycheck Protection Program under Division A, Title I of the CARES Act, which was enacted March 27, 2020. The Loan, in the form of a promissory note, matures on April 8, 2022. Under the terms of the Paycheck Protection Program ("PPP"), certain amounts of the Loan may be forgiven if they are used for qualifying expenses as described in the CARES Act. No assurance is provided that forgiveness for any portion of the Loan will be obtained. To the extent that all or part of the Loan is not forgiven, the Company will be required to make payments, including interest accruing at an annual rate of 1.0% beginning on the date of disbursement. |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 9 Months Ended |
Sep. 30, 2020 | |
RELATED PARTY TRANSACTIONS | |
RELATED PARTY TRANSACTIONS | NOTE 9 – RELATED PARTY TRANSACTIONS Private Placement with Mr. John Schutte In July 2017, we completed a $4.0 million private placement with Mr. Schutte (sometimes referred to as the “Investor”), consisting of 8,912,655 units (“Units”) of the Company, at a price of $0.4488 per Unit (the “Transaction”). Each Unit consists of one share of common stock and a warrant to purchase one fifth (0.2) of a share of common stock. The issue price of the Units was equal to 85% of the average last sale price of our common stock for the five trading days prior to completion of the Transaction. The warrants are immediately exercisable for 1,782,532 common shares at a price of $0.528 per share (which equals the average last sale price of the Company’s common stock for the five trading days prior to completion of the Transaction) and expire five years after issuance (subject to earlier expiration in event of certain acquisitions). We have assigned a relative fair value of $495 thousand to the warrants out of the total $4.0 million proceeds from the private placement transaction and have accounted these warrants as equity. The Transaction was completed through a private placement to an accredited investor and was exempt from registration pursuant to Section 4(2) of the Securities Act of 1933, as amended and/or Regulation D promulgated under the Securities Act of 1933. MainPointe Pharmaceuticals LLC Investor is a principal of MainPointe Pharmaceuticals LLC, a Kentucky limited liability company (“MainPointe”). In March 2017, we granted MainPointe an exclusive license to our Impede Technology to commercialize our Nexafed® and Nexafed® Sinus Pressure + Pain Products in the United States and Canada for an upfront licensing fee of $2.5 million plus approximately $309 thousand for transferred inventory and equipment. The Company is receiving a 7.5% royalty on sales of licensed products. MainPointe also has options to expand the territory and products covered for additional sums. Included in the reported royalty revenue for the nine months ended 2020 and 2019 is $9 thousand and $16 thousand, respectively, of royalty revenue from MainPointe (See Note 3). On January 1, 2020, MainPointe assigned to AD Pharma, with Acura’s consent, all of its right, title and interest in the MainPointe Agreement between MainPointe and Acura. As part of the closing of the Transaction, the Company and Essex Woodlands Health Ventures V, L.P. (“Essex”) and Galen Partners III, L.P. (“Galen”) amended and restated the existing Voting Agreement including such parties to provide for the Investor to join as a party (as so amended, the “Second Amended and Restated Voting Agreement”). The Second Amended and Restated Voting Agreement provides that our Board of Directors shall remain comprised of no more than seven members (subject to certain exceptions), (i) one of whom is the Company’s Chief Executive Officer, (ii) three of whom are independent under Nasdaq standards, and (iii) one of whom shall be designated by each of Essex, Galen and Investor, and the parties to such agreement would vote for such persons. The right of each of Essex, Galen and Investor to designate one director to our Board will continue as long as he or it and their affiliates collectively hold at least 600,000 shares of our common stock (including warrants exercisable for such shares). Immanuel Thangaraj is the designee of Essex. Investor has not designated a director as of the date of filing of this Report. Galen had not designated a director and lost that right in December 2017 when it disposed of its shares of common stock in the Company. Once such shareholder no longer holds such securities, the additional forfeited seat would become a seat for an independent director to thereafter be nominated to the Board of Directors from time to time by the then current directors and as applicable, to be elected by the directors to fill the vacancy created by the forfeited seat or submitted to the vote of shareholders at the Company’s next annual meeting. An independent director has not been named to fill the seat forfeited by Galen. Loans with Mr. John Schutte During the period January 1, 2019 through June 27, 2019 we borrowed an aggregate of $650 thousand from Mr. John Schutte. On June 28, 2019 we borrowed an additional $725 thousand from Mr. Schutte, bringing the aggregate principal of the loans and accrued interest to $6.0 million, and consolidated the loans into a single promissory note with a fixed interest rate of 7.5%, maturity date of July 1, 2023, granted conversion rights of principal and interest into shares of our common stock at a price of $0.16 per share, issued a warrant for 10.0 million common shares having an exercise price of $0.01 per share, and granted a security interest in all of the Company’s assets, which includes our intellectual property. The principal amount of the note is convertible into 37.5 million shares of our common stock. The $6.0 million promissory note, the common stock purchase warrant and the security agreement were all assigned and transferred by Mr. Schutte to AD Pharma on June 28, 2019. AD Pharma Agreement covering LTX-03 On June 28, 2019, we entered into a License, Development and Commercialization Agreement which was amended in October 2020 (the "AD Pharma Agreement") with Abuse Deterrent Pharma, LLC (“AD Pharma”), a special purpose company representing a consortium of investors that will finance Acura’s operations and completion of development of LTX-03 (hydrocodone bitartrate with acetaminophen) immediate-release tablets utilizing Acura’s patented LIMITx™ technology which addresses the consequences of excess oral administration of opioid tablets, the most prevalent route of opioid overdose and abuse. The AD Pharma Agreement grants AD Pharma exclusive commercialization rights in the United States to LTX-03 as well as LTX-02 (oxycodone/acetaminophen) and LTX-09 (alprazolam). Financial arrangements include: · Monthly license payments to Acura by AD Pharma of $350 thousand from inception through April 2020 and $200 thousand thereafter until July 31, 2021 or FDA’s acceptance of a New Drug Application (“NDA”) for LTX-03; · Reimbursement by AP Pharma of Acura’s LTX-03 outside development expenses; and · Upon commercialization of the licensed products, Acura receives stepped royalties on sales and is eligible for certain sales related milestones AD Pharma may terminate the AD Pharma Agreement at any time. Additionally, if the NDA for LTX-03 is not accepted by the FDA by July 31, 2021, AD Pharma has the option to terminate the AD Pharma Agreement and take ownership of the intellectual property. Should AD Pharma choose not to exercise this option to terminate and the NDA for LTX-03 is subsequently accepted by the FDA, such option expires. We also granted authority to MainPointe Pharmaceuticals, LLC (MainPointe) to assign to AD Pharma the option and the right to add, as an Option Product to the Nexafed® Agreement, a Nexafed® 12-hour dosage (an extended-release pseudoephedrine hydrochloride product utilizing the IMPEDE® Technology in 120mg dosage strength), and the Option Product exercise price of $500 thousand was waived if the exercise of the option occurred by June 28, 2024 (five years from the effective date of the AD Pharma Agreement), however effective with the October 2020 amendment to the AD Pharma Agreement, this option and right was rescinded. 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. On January 1, 2020, MainPointe assigned to AD Pharma, with Acura’s consent, all of its right, title and interest in the MainPointe Agreement between MainPointe and Acura dated March 16, 2017. |
COMMON STOCK PURCHASE WARRANTS
COMMON STOCK PURCHASE WARRANTS | 9 Months Ended |
Sep. 30, 2020 | |
COMMON STOCK PURCHASE WARRANTS. | |
COMMON STOCK PURCHASE WARRANTS | NOTE 10 – COMMON STOCK PURCHASE WARRANTS Our warrant activity during the nine month periods ended September 30, 2020 and 2019 is shown below (in thousands except price data): December 31, 2020 2019 WAvg WAvg Exercise Exercise Number Price Number Price Outstanding, Jan. 1 11,842 $ 0.10 1,842 $ 0.59 Issued — — 10,000 0.01 Exercised — — — — Expired — — — — Modification — — — — Outstanding, Sept. 30 11,842 $ 0.10 11,842 $ 0.10 In connection with the issuance of the $10.0 million secured promissory notes in December 2013, we issued common stock purchase warrants (“warrants”) exercisable for 60 thousand shares of our common stock having an exercise price of $2.52 per share (after giving effect to our one-for-five reverse stock split) with an expiration date in December 2020. These warrants contain a cashless exercise feature (See Note 8). As part of our July 2017 private placement transaction with Mr. Schutte, we issued warrants to purchase 1,782,531 shares of our common stock. The warrants are immediately exercisable at a price of $0.528 per share and expire five years after issuance (See Note 9). We have assigned a relative fair value of $495 thousand to the warrants out of the total $4.0 million proceeds from the private placement transaction and have accounted for these warrants as equity. On June 28, 2019 as part of the changes made to the loan agreements we had with Mr. Schutte, each having an original due date of January 2, 2020, we issued to him a warrant to purchase 10.0 million shares of our common stock exercisable at a price of $0.01 per share and expire five years after issuance. We obtained a valuation of fair value on the warrant and $1.145 million was allocated to the warrant and accounted for as equity. (See Note 8 and Note 9). The warrant was assigned and transferred by Mr. Schutte to AD Pharma on June 28, 2019. |
SHARE-BASED COMPENSATION EXPENS
SHARE-BASED COMPENSATION EXPENSE | 9 Months Ended |
Sep. 30, 2020 | |
SHARE-BASED COMPENSATION EXPENSE | |
SHARE-BASED COMPENSATION EXPENSE | NOTE 11 – SHARE-BASED COMPENSATION EXPENSE We have several 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 classified instrument. 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 closing market price of our common stock on the date of grant. Our total share-based compensation expense recognized in the Company’s results of operations from non-cash and cash-portioned instruments issued to our employees and directors comprised the following (in thousands): Three months Ended Nine months Ended September 30, September 30, 2020 2019 2020 2019 (in thousands) Research and development costs: Stock options $ — $ 2 $ — $ 6 Restricted stock units — 3 — 11 Subtotal $ — $ 5 $ — $ 17 General and administrative costs: Stock options $ — $ 3 $ — $ 10 Restricted stock units 9 40 42 89 Subtotal 9 43 42 99 Total $ 9 $ 48 $ 42 $ 116 Stock Option Plans We maintain various stock option plans. A summary of our stock option plans as of September 30, 2020 and 2019 and for the nine months then ended consisted of the following (in thousands except exercise price): Nine Months ended September 30, 2020 2019 Weighted Weighted Number Average Average of Exercise Number of Exercise Options Price Options Price Outstanding, Jan. 1 1,356 $ 4.45 1,560 $ 7.38 Granted — — — — Exercised — — — — Forfeited — — — — Expired (12) 27.35 (182) 30.83 Outstanding, Sept. 30 1,344 $ 4.24 1,378 $ 4.44 Exercisable, Sept. 30 1,344 $ 4.24 1,155 $ 5.26 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. The intrinsic value contained in the stock option awards which are vested and outstanding at September 30, 2020 was $22 thousand. Restricted Stock Unit Award Plans We have two Restricted Stock Unit Award Plans for our employees and non-employee directors, a 2017 Restricted Stock Unit Award Plan (the “2017 RSU Plan”) and a 2014 Restricted Stock Unit Award Plan (the “2014 RSU Plan”). Vesting of an RSU entitles the holder to receive a share of our common stock on a distribution date. Our non-employee director awards allow for non-employee directors to receive payment in cash, instead of stock, for up to 40% of each RSU award. The portion of the RSU awards subject to cash settlement are being marked-to-market each reporting period until they are distributed and has been recorded as an other current liability in the Company’s consolidated balance sheet. The other current liability was $16 thousand and $29 thousand at September 30, 2020 and December 31, 2019, respectively. The compensation cost to be incurred on a granted RSU without a cash settlement option is the RSU’s fair value, which is the market price of our common stock on the date of grant, less its exercise cost. The compensation cost is amortized to expense and recorded to additional paid-in capital over the vesting period of the RSU award. A summary of the grants under the RSU Plans as of September 30, 2020 and 2019, and for the nine months then ended consisted of the following (in thousands): Nine Months Ended September 30, 2020 2019 Number of Number of Number Vested Number of Vested of RSUs RSUs RSUs RSUs Outstanding, Jan. 1 1,017 1,017 951 459 Granted 219 — 333 — Distributed (397) (397) (267) (267) Vested — 165 — 250 Forfeited — — — — Outstanding, Sept. 30 839 785 1,017 442 2017 Restricted Stock Unit Award Plan Our 2017 RSU Plan was approved by shareholders in November 2017 and permits the grant of up to 1.5 million shares of our common stock pursuant to awards under the 2017 RSU Plan. There are no shares available for award under the 2017 RSU Plan. Information about the awards under the 2017 RSU Plan is as follows: · In December 2017, we awarded 200 thousand RSUs to our employees. Such RSU awards vested 100% after one full year of service. Distributions of the vested RSU awards to the employees will be made in three equal installments on the first business day of each of January 2020, 2021, and 2022 or earlier upon a qualifying change of control. · In January 2018, we awarded approximately 67 thousand RSUs to each of our four non-employee directors which also allow for them to receive payment in cash, instead of stock, for up to 40% of each RSU award. Such awards vest 25% at the end of each calendar quarter in 2018. Settlement of this RSU award occurred on January 2, 2019, the first business day of the year after vesting. The portion of the RSU awards which are subject to cash settlement are also subject to marked-to market accounting having a liability recorded on the Company’s consolidated balance sheet with quarterly adjustments recorded to stock compensation expense in the general and administration operating category of our income statement. · In December 2018, we awarded 488 thousand RSUs to our employees. Such RSU awards vested 100% after one full year of service. Distributions of the vested RSU awards to the employees will be made in three equal installments on the first business day of each of January 2021, 2022, and 2023 or earlier upon a qualifying change of control. · In January 2019, we awarded approximately 83 thousand RSUs to each of our four non-employee directors which also allow for them to receive payment in cash, instead of stock, for up to 40% of each RSU award. Such awards vest 25% at the end of each calendar quarter in 2019. Settlement of this RSU award occurred on January 2, 2020, the first business day of the year after vesting. The portion of the RSU awards which were subject to cash settlement was also subject to marked-to market accounting having a liability recorded on the Company’s consolidated balance sheet with quarterly adjustments which were recorded to stock compensation expense in the general and administration operating category of our income statement. · In January 2020, we awarded approximately 55 thousand RSUs to each of our four non-employee directors which also allow for them to receive payment in cash, instead of stock, for up to 40% of each RSU award. Such awards vest 25% at the end of each calendar quarter in 2020. Settlement of this RSU award will occur on January 4, 2021, the first business day of the year after vesting. The portion of the RSU awards which are subject to cash settlement will also be subject to marked-to market accounting having a liability recorded on the Company’s consolidated balance sheet with quarterly adjustments recorded to stock compensation expense in the general and administration operating category of our income statement. Information about the distribution of shares under the 2017 RSU Plan is as follows: · In January 2019, 267 thousand RSUs were distributed to our non-employee directors from their January 2018 award and settled in common stock. · In January 2020, 333 thousand RSUs were distributed to our non-employee directors from their January 2019 award with 296 thousand RSUs settled in common stock, 4 thousand RSUs used to settle the purchase price and 33 thousand RSUs settled in cash. · In January 2020, 64 thousand RSUs were distributed to our current and former employees representing one third of their 2017 award with 54 thousand RSUs settled in common stock and 10 thousand RSUs used to settle the purchase price and employee withholding taxes. 2014 Restricted Stock Unit Award Plan Our 2014 RSU Plan was approved by shareholders in May 2014 and permits the grant of up to 400 thousand shares of our common stock pursuant to awards under the 2014 RSU Plan. There are no shares available for award under the 2014 RSU Plan. |
INCOME TAXES
INCOME TAXES | 9 Months Ended |
Sep. 30, 2020 | |
INCOME TAXES | |
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. Deferred tax assets reflect the tax effects of net operating losses (“NOLs”), tax credit carryovers, and temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. The most significant item of our deferred tax assets is derived from our Federal NOLs. We have approximately $167.8 million gross Federal NOLs at September 30, 2020 (of which approximately $160.2 million was generated prior to January 1, 2018). Because we believe the ability for us to use these NOLs generated prior to January 1, 2018 to offset any future taxable income is severely limited as prescribed under Internal Revenue Code (“IRC”) Section 382, we had estimated and recorded an amount for the likely limitation to our deferred tax asset in the fourth quarter of 2017, thereby reducing the aggregate estimated benefit of the Federal NOLs available to us of approximately $1.0 million at December 31, 2017. We believe the gross Federal NOL benefit we generated prior to January 1, 2018 to offset taxable income is less than $150 thousand annually. As prescribed under Internal Revenue Code, any unused Federal NOL benefit from the annual limitation can be accumulated and carried forward to the subsequent year and will expire if not used in accordance with the NOL carried forward term of 20 years or 2037, if generated before 2018 and Federal NOLs generated after 2017 can be carried forward indefinitely. Future common stock transactions, such as the exercise of common stock purchase warrants or the conversion of debt into common stock, may cause another qualifying event under IRC 382 which may further limit our utilization of our NOLs. The realization of deferred income tax assets is dependent upon future earnings, if any, and the timing and amount of which may be uncertain. 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, 2020 and December 31, 2019, all our remaining net deferred income tax assets were offset by a valuation allowance due to uncertainties with respect to future utilization of NOL carryforwards. If in the future it is determined that additional amounts of our deferred income tax assets would likely be realized, the valuation allowance would be reduced in the period in which such determination is made and an additional benefit from income taxes in such period would be recognized. |
NET EARNINGS (LOSS) PER SHARE
NET EARNINGS (LOSS) PER SHARE | 9 Months Ended |
Sep. 30, 2020 | |
NET EARNINGS (LOSS) PER SHARE | |
NET EARNINGS (LOSS) PER SHARE | NOTE 13 – NET EARNINGS (LOSS) PER SHARE Basic earnings (loss) per share (“EPS”) is computed by dividing net income or loss by the weighted average common shares outstanding during a period, including shares weighted related to both the vested Restricted Stock Units (“RSUs”) which settle in shares (See Note 11) and the common stock warrant exercisable for 10.0 million shares having an exercise price of $0.01 per share (See Note 10). Diluted EPS is based on the treasury stock method and computed based on the same number of shares used in the basic share calculation and includes the effect from potential issuance of common stock, such as shares issuable pursuant to the exercise of stock options, RSUs and stock warrants, assuming complete vesting and the exercise of all in-the-money stock options, RSUs and warrants. Common stock equivalents are excluded from the computation where their inclusion would be anti-dilutive. In any reporting period the Company had a net loss, including the effects of the common stock equivalents in the diluted EPS calculations for these periods would have been antidilutive. The weighted-average common share outstanding diluted computation is not impacted during any period where the exercise price of a stock option, RSU, common stock warrant or convertible loan is greater than the average market closing price of our common stock during such period. 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 September 30, September 30, 2020 2019 2020 2019 Earnings (loss) per share – basic Numerator: net income (loss) $ (678) $ 200 $ (965) $ (3,929) Denominator (weighted): Common shares 21,650 21,300 21,650 21,300 RSUs – vested 686 293 654 243 Common stock purchase warrants 10,000 10,000 10,000 3,480 Basic weighted average shares outstanding 32,336 31,593 32,304 25,023 Earnings (loss) per share – basic $ (0.02) $ 0.00 $ (0.03) $ (0.16) Earnings (loss) per share – diluted Numerator: net income (loss) $ (678) $ 200 $ (965) $ (3,929) Denominator (weighted): Common shares 21,650 21,300 21,650 21,300 RSUs 686 293 654 243 Stock options — — — 3,480 Common stock purchase warrants 10,000 10,000 10,000 — Diluted weighted average shares outstanding 32,336 31,593 32,304 25,023 Earnings (loss) per share – diluted $ (0.02) $ 0.00 $ (0.03) $ (0.16) Excluded securities (non-weighted): Common shares issuable: RSUs 121 542 121 542 Stock options 1,344 1,378 1,344 1,378 Common stock purchase warrants 1,842 1,842 1,842 1,842 Convertible loan 37,500 37,500 37,500 37,500 Total excluded potentially dilutive shares 40,807 41,262 40,807 41,262 |
SUBSEQUENT EVENT
SUBSEQUENT EVENT | 9 Months Ended |
Sep. 30, 2020 | |
SUBSEQUENT EVENT | |
SUBSEQUENT EVENT | NOTE 14 – SUBSEQUENT EVENT In October 2020, Acura and AD Pharma entered into an amendment to the AD Pharma Agreement which reduced the monthly license payments from $350 thousand to $200 thousand starting with the May 2020 payment and the requirement that the NDA for LTX-03 now be accepted by the FDA by July 31, 2021. This change has been reflected in the financial statements for the three and nine months ended September 30, 2020. We have subsequently received the required monthly license payments for June thru October 2020 from AD Pharma. |
LICENSE AND COLLABORATION AGR_2
LICENSE AND COLLABORATION AGREEMENTS (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
LICENSE AND COLLABORATION AGREEMENTS | |
Summary of Aversion intangible asset | The Aversion intangible asset is summarized as follows (in thousands): September 30, December 31, 2020 2019 Intangible asset – Aversion 2,000 2,000 Less: accumulated amortization (1,254) (1,190) Less: impairment charge (668) — Net $ 78 $ 810 |
REVENUE FROM CONTRACTS WITH C_2
REVENUE FROM CONTRACTS WITH CUSTOMERS (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
REVENUE FROM CONTRACTS WITH CUSTOMERS | |
Schedule of disaggregation of revenue | Royalty revenues by licensee are summarized below: Three months Ended Nine months Ended September 30, September 30, 2020 2019 2020 2019 Assertio (Oxaydo) $ 11 $ 171 $ 72 $ 269 MainPointe - related party (Nexafed) 3 1 9 16 Royalty revenues $ 14 $ 172 $ 81 $ 285 |
PROPERTY, PLANT AND EQUIPMENT (
PROPERTY, PLANT AND EQUIPMENT (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
PROPERTY, PLANT AND EQUIPMENT | |
Schedule of Property, Plant and equipment | Property, plant and equipment is summarized as follows (in thousands): September 30, December 31, 2020 2019 (in thousands) Building and improvements $ 1,273 $ 1,273 Scientific equipment 597 597 Computer hardware and software 106 106 Machinery and equipment 274 274 Land and improvements 162 162 Other personal property 70 70 Office equipment 27 27 Total 2,509 2,509 Less: accumulated depreciation (2,011) (1,969) Net property, plant and equipment $ 498 $ 540 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
ACCRUED EXPENSES | |
Schedule of Accrued expenses | Accrued expenses are summarized as follows (in thousands): September 30, December 31, 2020 2019 (in thousands) Cost sharing expenses under license agreement $ 428 $ 363 Other fees and services 1 15 Payroll, payroll taxes and benefits 59 13 Professional services 150 151 Financed insurance policies 42 — Clinical, non-clinical and regulatory services 23 20 Property taxes 7 9 Franchise taxes 11 14 Total $ 721 $ 585 |
DEBT (Tables)
DEBT (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
DEBT | |
Schedule of debt interest expense | Our interest expense for the three and nine month months ended September 30, 2020 and 2019 consisted of the following: Three months Ended Nine months Ended September 30, September 30, Interest expense: 2020 2019 2020 2019 Related party term loans $ 113 $ 111 $ 338 $ 279 Debt discount — — — 66 Financed insurance premiums — — — 3 Total interest expense $ 113 $ 111 $ 338 $ 348 Less: imputed interest income on related party loan — — — (13) Total interest expense, net $ 113 $ 111 $ 338 $ 335 |
COMMON STOCK PURCHASE WARRANTS
COMMON STOCK PURCHASE WARRANTS (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
COMMON STOCK PURCHASE WARRANTS. | |
Schedule Of Common Stock Warrant Activity | Our warrant activity during the nine month periods ended September 30, 2020 and 2019 is shown below (in thousands except price data): December 31, 2020 2019 WAvg WAvg Exercise Exercise Number Price Number Price Outstanding, Jan. 1 11,842 $ 0.10 1,842 $ 0.59 Issued — — 10,000 0.01 Exercised — — — — Expired — — — — Modification — — — — Outstanding, Sept. 30 11,842 $ 0.10 11,842 $ 0.10 |
SHARE-BASED COMPENSATION EXPE_2
SHARE-BASED COMPENSATION EXPENSE (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
SHARE-BASED COMPENSATION EXPENSE | |
Schedule of employee service share-based compensation, allocation of recognized period costs | Our total share-based compensation expense recognized in the Company’s results of operations from non-cash and cash-portioned instruments issued to our employees and directors comprised the following (in thousands): Three months Ended Nine months Ended September 30, September 30, 2020 2019 2020 2019 (in thousands) Research and development costs: Stock options $ — $ 2 $ — $ 6 Restricted stock units — 3 — 11 Subtotal $ — $ 5 $ — $ 17 General and administrative costs: Stock options $ — $ 3 $ — $ 10 Restricted stock units 9 40 42 89 Subtotal 9 43 42 99 Total $ 9 $ 48 $ 42 $ 116 |
Schedule of share-based compensation, stock option plan activity | A summary of our stock option plans as of September 30, 2020 and 2019 and for the nine months then ended consisted of the following (in thousands except exercise price): Nine Months ended September 30, 2020 2019 Weighted Weighted Number Average Average of Exercise Number of Exercise Options Price Options Price Outstanding, Jan. 1 1,356 $ 4.45 1,560 $ 7.38 Granted — — — — Exercised — — — — Forfeited — — — — Expired (12) 27.35 (182) 30.83 Outstanding, Sept. 30 1,344 $ 4.24 1,378 $ 4.44 Exercisable, Sept. 30 1,344 $ 4.24 1,155 $ 5.26 |
Schedule of grants under the RSU Plans | A summary of the grants under the RSU Plans as of September 30, 2020 and 2019, and for the nine months then ended consisted of the following (in thousands): Nine Months Ended September 30, 2020 2019 Number of Number of Number Vested Number of Vested of RSUs RSUs RSUs RSUs Outstanding, Jan. 1 1,017 1,017 951 459 Granted 219 — 333 — Distributed (397) (397) (267) (267) Vested — 165 — 250 Forfeited — — — — Outstanding, Sept. 30 839 785 1,017 442 |
NET EARNINGS (LOSS) PER SHARE (
NET EARNINGS (LOSS) PER SHARE (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
NET EARNINGS (LOSS) PER SHARE | |
Schedule of reconciliation of the numerators and denominators of basic and diluted EPS | 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 September 30, September 30, 2020 2019 2020 2019 Earnings (loss) per share – basic Numerator: net income (loss) $ (678) $ 200 $ (965) $ (3,929) Denominator (weighted): Common shares 21,650 21,300 21,650 21,300 RSUs – vested 686 293 654 243 Common stock purchase warrants 10,000 10,000 10,000 3,480 Basic weighted average shares outstanding 32,336 31,593 32,304 25,023 Earnings (loss) per share – basic $ (0.02) $ 0.00 $ (0.03) $ (0.16) Earnings (loss) per share – diluted Numerator: net income (loss) $ (678) $ 200 $ (965) $ (3,929) Denominator (weighted): Common shares 21,650 21,300 21,650 21,300 RSUs 686 293 654 243 Stock options — — — 3,480 Common stock purchase warrants 10,000 10,000 10,000 — Diluted weighted average shares outstanding 32,336 31,593 32,304 25,023 Earnings (loss) per share – diluted $ (0.02) $ 0.00 $ (0.03) $ (0.16) Excluded securities (non-weighted): Common shares issuable: RSUs 121 542 121 542 Stock options 1,344 1,378 1,344 1,378 Common stock purchase warrants 1,842 1,842 1,842 1,842 Convertible loan 37,500 37,500 37,500 37,500 Total excluded potentially dilutive shares 40,807 41,262 40,807 41,262 |
OPERATIONS AND SUMMARY OF SIG_2
OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||
Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||||||||||
Cash | $ (493,000) | $ (615,000) | $ (493,000) | $ (615,000) | $ (862,000) | $ (91,000) | ||||
Working Capital Deficit | 400,000 | 400,000 | ||||||||
Retained Earnings (Accumulated Deficit), Total | (388,961,000) | (388,961,000) | (387,996,000) | |||||||
Operating Income (Loss), Total | 565,000 | (311,000) | 627,000 | 994,000 | ||||||
Income (loss) from operation | 600,000 | 725,000 | ||||||||
Net loss | 678,000 | $ (308,000) | $ 595,000 | $ (200,000) | $ 3,341,000 | $ 788,000 | 965,000 | $ 3,929,000 | $ 3,800,000 | |
Aggregate principal of promissory notes and accrued interest | $ 6,000,000 | $ 6,000,000 |
LICENSE AND COLLABORATION AGR_3
LICENSE AND COLLABORATION AGREEMENTS - Intangible asset (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
LICENSE AND COLLABORATION AGREEMENTS | ||
Intangible asset - Aversion | $ 2,000 | $ 2,000 |
Less: accumulated amortization | (1,254) | (1,190) |
Less: impairment charge | (668) | |
Net | $ 78 | $ 810 |
LICENSE AND COLLABORATION AGR_4
LICENSE AND COLLABORATION AGREEMENTS (Details) - USD ($) $ in Thousands, shares in Millions | Jun. 28, 2019 | Oct. 09, 2015 | Oct. 31, 2020 | Mar. 31, 2017 | Oct. 31, 2016 | Apr. 30, 2014 | Mar. 31, 2020 | Sep. 30, 2020 | Sep. 30, 2019 | Apr. 30, 2020 | Jul. 31, 2021 |
License Development and Commercialization Agreement [Line Items] | |||||||||||
Payment for Termination | $ 2,000 | ||||||||||
Minimum Net Sales Reaching Description | one-time $12.5 million sales-based milestone payment when worldwide Oxaydo net sales reach $150 million in a calendar year | ||||||||||
Agreement Termination Notice Description | Assertio may terminate the Assertio Agreement for convenience on 120 days prior written notice, which termination may not occur prior to the second anniversary of Assertio'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 Assertio Agreement provides for the transition of development and marketing of Oxaydo from Assertio to us, including the conveyance by Assertio to us of the trademarks and all regulatory filings and approvals relating to Oxaydo, and for Assertio's supply of Oxaydo for a transition period | ||||||||||
Proceeds from Milestone Payment On Agreement | $ 2,500 | ||||||||||
Monthly license payment receivable | $ 5,000 | ||||||||||
Finite-Lived Intangible Asset, Useful Life | 9 years 8 months 12 days | ||||||||||
Aggregate principal of promissory notes and accrued interest | $ 6,000 | ||||||||||
Amortization of intangible asset | 64 | $ 155 | |||||||||
Impairment charge against the intangible asset | $ 668 | 668 | $ 0 | ||||||||
Expected amortization expense for patents per quarter. | $ 6 | ||||||||||
Patents | |||||||||||
License Development and Commercialization Agreement [Line Items] | |||||||||||
Payment for Termination | $ 2,000 | ||||||||||
Schutte | AD Pharma Agreement | |||||||||||
License Development and Commercialization Agreement [Line Items] | |||||||||||
Percentage of common stock held | 45.70% | ||||||||||
Abuse Deterrent Pharma, LLC | |||||||||||
License Development and Commercialization Agreement [Line Items] | |||||||||||
Monthly license payment receivable | $ 350 | ||||||||||
Abuse Deterrent Pharma, LLC | AD Pharma Agreement | |||||||||||
License Development and Commercialization Agreement [Line Items] | |||||||||||
Monthly license payment receivable | $ 350 | $ 200 | |||||||||
MainPointe Pharmaceuticals, LLC | AD Pharma Agreement | |||||||||||
License Development and Commercialization Agreement [Line Items] | |||||||||||
Waiver of exercise price if exercise of option occurs by certain date | $ 500 | ||||||||||
Period from effective date for exercise of option | 5 years | ||||||||||
Schutte | |||||||||||
License Development and Commercialization Agreement [Line Items] | |||||||||||
Aggregate principal of promissory notes and accrued interest | $ 6,000 | ||||||||||
Debt Conversion, Converted Instrument, Warrants or Options Issued | 10 | ||||||||||
Schutte | AD Pharma Agreement | |||||||||||
License Development and Commercialization Agreement [Line Items] | |||||||||||
Aggregate principal of promissory notes and accrued interest | $ 6,000 | ||||||||||
Debt Conversion, Converted Instrument, Warrants or Options Issued | 10 | ||||||||||
Subsequent event | AD Pharma Agreement | |||||||||||
License Development and Commercialization Agreement [Line Items] | |||||||||||
Monthly license payment receivable | $ 200 | ||||||||||
Subsequent event | Abuse Deterrent Pharma, LLC | AD Pharma Agreement | |||||||||||
License Development and Commercialization Agreement [Line Items] | |||||||||||
Monthly license payment receivable | $ 200 | ||||||||||
MainPointe (Nexafed) | |||||||||||
License Development and Commercialization Agreement [Line Items] | |||||||||||
Monthly license payment receivable | $ 2,500 | ||||||||||
Licensing Agreement, Royalty Percentage | 7.50% | ||||||||||
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. | ||||||||||
MainPointe (Nexafed) | UNITED KINGDOM | |||||||||||
License Development and Commercialization Agreement [Line Items] | |||||||||||
Monthly license payment receivable | $ 1,000 | ||||||||||
MainPointe (Nexafed) | JAPAN | |||||||||||
License Development and Commercialization Agreement [Line Items] | |||||||||||
Monthly license payment receivable | 500 | ||||||||||
MainPointe (Nexafed) | South Korea [Member] | |||||||||||
License Development and Commercialization Agreement [Line Items] | |||||||||||
Monthly license payment receivable | $ 250 | ||||||||||
Kempharm Agreement [Member] | |||||||||||
License Development and Commercialization Agreement [Line Items] | |||||||||||
Monthly license payment receivable | $ 3,500 | ||||||||||
Kempharm Agreement [Member] | Minimum | |||||||||||
License Development and Commercialization Agreement [Line Items] | |||||||||||
Additional Upfront Payment Receivable | $ 1,000 |
REVENUE FROM CONTRACTS WITH C_3
REVENUE FROM CONTRACTS WITH CUSTOMERS (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Royalty revenues | $ 14 | $ 172 | $ 81 | $ 285 |
Assertio (Oxaydo) | ||||
Royalty revenues | 11 | 171 | 72 | 269 |
MainPointe (Nexafed) | ||||
Royalty revenues | $ 3 | $ 1 | $ 9 | $ 16 |
REVENUE FROM CONTRACTS WITH C_4
REVENUE FROM CONTRACTS WITH CUSTOMERS - Additional Information (Details) - USD ($) $ in Thousands | Jun. 28, 2019 | Oct. 09, 2015 | Oct. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Apr. 30, 2020 | Jul. 31, 2021 | Dec. 31, 2019 |
Contract Balance And Performance Obligations description | The Company had no contract assets and contract liability balances under the license and collaboration agreements at either September 30, 2020 or 2019. | ||||||||||
Monthly license payment receivable | $ 5,000 | ||||||||||
Product sales return allowance liability | $ 0 | $ 223 | $ 0 | $ 223 | $ 0 | ||||||
Sales return allowance liability | 0 | $ 0 | 0 | $ 223 | |||||||
License fees received | $ 300 | $ 1,050 | $ 2,400 | $ 1,050 | |||||||
AD Pharma Agreement | Subsequent event | |||||||||||
Monthly license payment receivable | $ 200 | ||||||||||
Abuse Deterrent Pharma, LLC | |||||||||||
Monthly license payment receivable | $ 350 | ||||||||||
Abuse Deterrent Pharma, LLC | AD Pharma Agreement | |||||||||||
Monthly license payment receivable | $ 350 | $ 200 | |||||||||
Abuse Deterrent Pharma, LLC | AD Pharma Agreement | Subsequent event | |||||||||||
Monthly license payment receivable | $ 200 |
RESEARCH AND DEVELOPMENT (Detai
RESEARCH AND DEVELOPMENT (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2020USD ($) | |
AD Pharma Agreement | |
Financing Receivable, Impaired [Line Items] | |
Non-cancelable arrangements | $ 121 |
PROPERTY, PLANT AND EQUIPMENT_2
PROPERTY, PLANT AND EQUIPMENT (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Property, Plant and Equipment [Line Items] | ||
Total | $ 2,509 | $ 2,509 |
Less: accumulated depreciation | (2,011) | (1,969) |
Net property, plant and equipment | 498 | 540 |
Building and improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total | 1,273 | 1,273 |
Scientific equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total | 597 | 597 |
Computer hardware and software | ||
Property, Plant and Equipment [Line Items] | ||
Total | 106 | 106 |
Machinery and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total | 274 | 274 |
Land and improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total | 162 | 162 |
Other personal property | ||
Property, Plant and Equipment [Line Items] | ||
Total | 70 | 70 |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total | $ 27 | $ 27 |
PROPERTY, PLANT AND EQUIPMENT -
PROPERTY, PLANT AND EQUIPMENT - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
PROPERTY, PLANT AND EQUIPMENT | ||||
Depreciation | $ 13 | $ 17 | $ 42 | $ 51 |
ACCRUED EXPENSES (Details)
ACCRUED EXPENSES (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
ACCRUED EXPENSES | ||
Cost sharing expenses under license agreement | $ 428 | $ 363 |
Other fees and services | 1 | 15 |
Payroll, payroll taxes and benefits | 59 | 13 |
Professional services | 150 | 151 |
Financed insurance policies | 42 | |
Clinical, non-clinical and regulatory services | 23 | 20 |
Property taxes | 7 | 9 |
Franchise taxes | 11 | 14 |
Total | $ 721 | $ 585 |
DEBT - Interest Expense (Detail
DEBT - Interest Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
DEBT | ||||
Related party term loans | $ 113 | $ 111 | $ 338 | $ 279 |
Debt discount | 0 | 0 | 0 | 66 |
Financed insurance premiums | 0 | 0 | 0 | 3 |
Total interest expense | 113 | 111 | 338 | 348 |
Less: imputed interest income on related party loan | 0 | 0 | 0 | (13) |
Total interest expense, net | $ 113 | $ 111 | $ 338 | $ 335 |
DEBT - Additional Information (
DEBT - Additional Information (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | Jan. 02, 2020 | Jul. 02, 2019 | Jun. 28, 2019 | Jun. 27, 2019 | Oct. 05, 2018 | Jun. 28, 2018 | Sep. 30, 2020 | Sep. 30, 2019 | Jun. 27, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | Apr. 13, 2020 |
Debt Instrument [Line Items] | ||||||||||||||
Amount borrowed from related party | $ 725 | $ 0 | $ 1,650 | |||||||||||
Write-off of unamortized debt discount | 70 | |||||||||||||
Aggregate principal of promissory notes and accrued interest | $ 6,000 | 6,000 | ||||||||||||
Gain (Loss) on Extinguishment of Debt | 0 | $ 0 | 0 | $ (2,600) | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.01 | |||||||||||||
Related party loans made to Company | $ 5,000 | 5,000 | 5,000 | |||||||||||
Schutte | ||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||
Amount borrowed from related party | $ 650 | $ 4,350 | ||||||||||||
Spread on variable rate | 2.00% | |||||||||||||
Debt instrument principal amount | 5,000 | |||||||||||||
Unamortized debt discount balance | 126 | |||||||||||||
Proceeds from Issuance of Long-term Debt | 725 | $ 650 | 650 | |||||||||||
Accrued interest balance | $ 566 | $ 566 | $ 229 | 110 | ||||||||||
Benefit to interest income | $ 13 | |||||||||||||
Amount allocated to warrant | $ 1,145 | |||||||||||||
Write-off of unamortized debt discount | 73 | 73 | ||||||||||||
Aggregate principal of promissory notes and accrued interest | $ 6,000 | |||||||||||||
Debt instrument, interest rate, stated percentage | 7.50% | |||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.01 | |||||||||||||
Debt Conversion, Converted Instrument, Shares Issued | 37,500 | |||||||||||||
Debt Conversion, Converted Instrument, Warrants or Options Issued | 10,000 | |||||||||||||
Share Price | $ 0.16 | |||||||||||||
Debt Instrument, Increase, Accrued Interest | 275 | |||||||||||||
Schutte Note | ||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||
Debt instrument principal amount | $ 5,000 | $ 5,000 | ||||||||||||
Proceeds from Issuance of Long-term Debt | $ 725 | |||||||||||||
Amount allocated to warrant | 1,145 | |||||||||||||
Premium on convertible loan | 1,382 | |||||||||||||
Aggregate principal of promissory notes and accrued interest | $ 6,000 | $ 6,000 | ||||||||||||
Debt instrument, interest rate, stated percentage | 7.50% | |||||||||||||
Gain (Loss) on Extinguishment of Debt | $ (2,600) | |||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.01 | $ 0.01 | $ 0.01 | |||||||||||
Debt Conversion, Converted Instrument, Shares Issued | 37,500 | |||||||||||||
Debt Conversion, Converted Instrument, Warrants or Options Issued | 10,000 | 10,000 | ||||||||||||
Share Price | $ 0.16 | |||||||||||||
Oxford Loan Agreement | ||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||
Debt instrument principal amount | $ 172 | |||||||||||||
Debt instrument, interest rate, stated percentage | 10.16% | |||||||||||||
Oxford Loan Agreement | Schutte | ||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||
Amount borrowed from related party | $ 1,800 | |||||||||||||
Repayments of Debt | $ 1,500 | |||||||||||||
Oxford Loan Agreement | Schutte Note | Schutte | ||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||
Amount borrowed from related party | $ 4,350 | |||||||||||||
PPP Loan | ||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||
Debt instrument principal amount | $ 269 | |||||||||||||
Debt instrument, interest rate, stated percentage | 1.00% | |||||||||||||
Common stock purchase warrants | ||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||
Warrants to purchase common stock | 60 | 60 | ||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 2.52 | $ 2.52 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details) - USD ($) $ / shares in Units, $ in Thousands | Jun. 28, 2019 | Jun. 27, 2019 | Oct. 09, 2015 | Oct. 31, 2020 | Jul. 31, 2017 | Mar. 31, 2017 | Jun. 27, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Apr. 30, 2020 | Jul. 31, 2021 | Dec. 31, 2019 |
Related Party Transaction [Line Items] | ||||||||||||
Aggregate principal of promissory notes and accrued interest | $ 6,000 | |||||||||||
Number Of Common Stock Need To Hold To Designate As Director | 600,000 | |||||||||||
Proceeds from License Fees Received | $ 5,000 | |||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.01 | |||||||||||
Warrant to purchase shares of common stock | 10,000,000 | |||||||||||
Class Of Warrants Or Rights, Expiry Period | 5 years | |||||||||||
Royalty Receivable | 6 | $ 82 | ||||||||||
Subsequent event | AD Pharma Agreement | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Proceeds from License Fees Received | $ 200 | |||||||||||
MainPointe (Nexafed) | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Proceeds from License Fees Received | $ 2,500 | |||||||||||
Asset Transferred, License Agreement | $ 309 | |||||||||||
Licensing Agreement, Royalty Percentage | 7.50% | |||||||||||
MainPointe (Nexafed) | Royalty | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Royalty revenues | 9 | $ 16 | ||||||||||
Investor | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Warrant to purchase shares of common stock | 1,782,531 | |||||||||||
Investor | Private Placement | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Sale of Stock, Consideration Received on Transaction | $ 4,000 | |||||||||||
Sale of Stock, Number of Shares Issued in Transaction | 8,912,655 | |||||||||||
Sale of Stock, Price Per Share | $ 0.4488 | |||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.528 | |||||||||||
Sale Of Stock, Issue Price Description | 85% | |||||||||||
Warrants Not Settleable in Cash, Fair Value Disclosure | 495 | |||||||||||
Proceeds from Issuance of Warrants | $ 4,000 | |||||||||||
Warrant to purchase shares of common stock | 1,782,532 | |||||||||||
Schutte | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Aggregate principal of promissory notes and accrued interest | $ 6,000 | |||||||||||
Fixed interest rate | 7.50% | |||||||||||
Share Price | $ 0.16 | |||||||||||
Debt Conversion, Converted Instrument, Warrants or Options Issued | 10,000,000 | |||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.01 | |||||||||||
Debt Conversion, Converted Instrument, Shares Issued | 37,500,000 | |||||||||||
Proceeds from Issuance of Long-term Debt | $ 725 | $ 650 | $ 650 | |||||||||
Schutte | AD Pharma Agreement | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Aggregate principal of promissory notes and accrued interest | $ 6,000 | |||||||||||
Debt Conversion, Converted Instrument, Warrants or Options Issued | 10,000,000 | |||||||||||
Abuse Deterrent Pharma, LLC | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Proceeds from License Fees Received | $ 350 | |||||||||||
Abuse Deterrent Pharma, LLC | AD Pharma Agreement | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Proceeds from License Fees Received | $ 350 | $ 200 | ||||||||||
Abuse Deterrent Pharma, LLC | Subsequent event | AD Pharma Agreement | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Proceeds from License Fees Received | $ 200 | |||||||||||
Abuse Deterrent Pharma, LLC | MainPointe (Nexafed) | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Option product exercise price waived if the exercise of the option occured by five years | $ 500 | |||||||||||
Period to waive option product exercise price | 5 years |
COMMON STOCK PURCHASE WARRANT_2
COMMON STOCK PURCHASE WARRANTS - Warrant Activity (Details) - Common stock purchase warrants - $ / shares shares in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Number of Options | ||
Number of Options Outstanding, beginning | 11,842 | 1,842 |
Number of Options, Issued | 0 | 10,000 |
Number of Options, Exercised | 0 | 0 |
Number of Options, Expired | 0 | 0 |
Number of Options, Modification | 0 | 0 |
Number of Options Outstanding, ending | 11,842 | 11,842 |
Weighted Average Exercise Price | ||
Weighted Average Exercise Price, beginning | $ 0.10 | $ 0.59 |
Weighted Average Exercise Price, Issued | 0 | 0.01 |
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 | $ 0.10 | $ 0.10 |
COMMON STOCK PURCHASE WARRANT_3
COMMON STOCK PURCHASE WARRANTS - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | Jun. 28, 2018 | Jul. 31, 2017 | Sep. 30, 2020 | Jun. 28, 2019 | Dec. 31, 2013 |
Class of Warrant or Right [Line Items] | |||||
Warrant to purchase shares of common stock | 10,000,000 | ||||
Warrants expiration term | 5 years | ||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.01 | ||||
Secured Debt | $ 10,000 | ||||
Class Of Warrant Or Right Term | 5 years | ||||
Stock Issued During Period, Value, New Issues | $ 4,000 | ||||
Private Placement | |||||
Class of Warrant or Right [Line Items] | |||||
Stock Issued During Period, Value, New Issues | $ 495 | ||||
Investor | |||||
Class of Warrant or Right [Line Items] | |||||
Warrant to purchase shares of common stock | 1,782,531 | ||||
Investor | Private Placement | |||||
Class of Warrant or Right [Line Items] | |||||
Warrant to purchase shares of common stock | 1,782,532 | ||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.528 | ||||
Schutte | |||||
Class of Warrant or Right [Line Items] | |||||
Amount allocated to warrant | $ 1,145 | ||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.01 | ||||
Common stock purchase warrants | |||||
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 |
SHARE-BASED COMPENSATION EXPE_3
SHARE-BASED COMPENSATION EXPENSE - Non-Cash Share-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Total Stock Compensation | ||||
Allocated Share-based Compensation Expense | $ 9 | $ 48 | $ 42 | $ 116 |
Research and development costs | ||||
Total Stock Compensation | ||||
Allocated Share-based Compensation Expense | 0 | 5 | 0 | 17 |
Research and development costs | Stock options | ||||
Total Stock Compensation | ||||
Allocated Share-based Compensation Expense | 0 | 2 | 0 | 6 |
Research and development costs | Restricted stock units | ||||
Total Stock Compensation | ||||
Allocated Share-based Compensation Expense | 0 | 3 | 0 | 11 |
General and administrative costs | ||||
Total Stock Compensation | ||||
Allocated Share-based Compensation Expense | 9 | 43 | 42 | 99 |
General and administrative costs | Stock options | ||||
Total Stock Compensation | ||||
Allocated Share-based Compensation Expense | 0 | 3 | 0 | 10 |
General and administrative costs | Restricted stock units | ||||
Total Stock Compensation | ||||
Allocated Share-based Compensation Expense | $ 9 | $ 40 | $ 42 | $ 89 |
SHARE-BASED COMPENSATION EXPE_4
SHARE-BASED COMPENSATION EXPENSE - Stock Option plan activity (Details) - Stock Option Plan - $ / shares shares in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | |
Share based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of Options Outstanding, beginning | 1,356 | 1,560 | 1,560 |
Number of Options, Granted | 0 | 0 | |
Number of Options, Exercised | 0 | 0 | |
Number of Options, Forfeited | 0 | 0 | |
Number of Options, Expired | 12 | 182 | |
Number of Options Outstanding, ending | 1,344 | 1,378 | 1,356 |
Number of Options exercisable | 1,344 | 1,155 | |
Weighted Average Exercise Price, beginning | $ 4.45 | $ 7.38 | $ 7.38 |
Weighted Average Exercise Price, Granted | 0 | 0 | |
Weighted Average Exercise Price, Exercised | 0 | 0 | |
Weighted Average Exercise Price, Forfeited | 0 | 0 | |
Weighted Average Exercise Price, Expired | 27.35 | 30.83 | |
Weighted Average Exercise Price, ending | 4.24 | 4.44 | $ 4.45 |
Weighted Average Exercise Price, Options exercisable | $ 4.24 | $ 5.26 |
SHARE-BASED COMPENSATION EXPE_5
SHARE-BASED COMPENSATION EXPENSE - Summary of RSU Plan (Details) - shares shares in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Restricted Stock Units | ||
Share based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Outstanding, beginning | 1,017 | 951 |
Granted | 219 | 333 |
Distributed | (397) | (267) |
Vested | 0 | 0 |
Forfeited or expired | 0 | 0 |
Outstanding, ending | 839 | 1,017 |
Vested Restricted Stock Units (RSUs) | ||
Share based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Outstanding, beginning | 1,017 | 459 |
Granted | 0 | 0 |
Distributed | (397) | (267) |
Vested | 165 | 250 |
Forfeited or expired | 0 | 0 |
Outstanding, ending | 785 | 442 |
SHARE-BASED COMPENSATION EXPE_6
SHARE-BASED COMPENSATION EXPENSE- Additional Information (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Jan. 31, 2020 | Jan. 31, 2019 | Dec. 31, 2018 | Jan. 31, 2018 | Dec. 31, 2017 | May 31, 2014 | Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Nov. 30, 2017 |
Employee Benefit Plans Disclosure [Line Items] | ||||||||||||
Aggregate intrinsic value of the option awards vested | $ 22 | $ 22 | ||||||||||
Allocated Share-based Compensation Expense | 9 | $ 48 | 42 | $ 116 | ||||||||
Restricted stock units | Director | ||||||||||||
Employee Benefit Plans Disclosure [Line Items] | ||||||||||||
Deferred Compensation Arrangement with Individual, Recorded Liability | $ 29 | $ 16 | $ 16 | |||||||||
2017 Restricted Stock Unit Award Plan | ||||||||||||
Employee Benefit Plans Disclosure [Line Items] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 25.00% | 100.00% | 25.00% | 100.00% | ||||||||
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 by Share-based Payment Award, Number of Shares Authorized | 1,500,000 | |||||||||||
Share-Based Compensation Arrangement By Share-Based Payment Award, Equity Instruments Other Than Options, Grants In Period | 55,000 | 488,000 | 67,000 | 200,000 | ||||||||
2017 Restricted Stock Unit Award Plan | Employees | ||||||||||||
Employee Benefit Plans Disclosure [Line Items] | ||||||||||||
Share-Based Compensation Arrangement By Share-Based Payment Award, Equity Instruments Other Than Options, Grants In Period | 64,000 | |||||||||||
2017 Restricted Stock Unit Award Plan | Employees | Distributed And Settled In Common Stock | ||||||||||||
Employee Benefit Plans Disclosure [Line Items] | ||||||||||||
Share-Based Compensation Arrangement By Share-Based Payment Award, Equity Instruments Other Than Options, Grants In Period | 54,000 | |||||||||||
2017 Restricted Stock Unit Award Plan | Employees | Settlement For Purchase Price | ||||||||||||
Employee Benefit Plans Disclosure [Line Items] | ||||||||||||
Share-Based Compensation Arrangement By Share-Based Payment Award, Equity Instruments Other Than Options, Grants In Period | 10,000 | |||||||||||
2017 Restricted Stock Unit Award Plan | Four Non Employee Directors | ||||||||||||
Employee Benefit Plans Disclosure [Line Items] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 25.00% | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Description | stock, for up to 40% | |||||||||||
Share-Based Compensation Arrangement By Share-Based Payment Award, Equity Instruments Other Than Options, Grants In Period | 83,000 | |||||||||||
2014 Restricted Stock Unit Award Plan | ||||||||||||
Employee Benefit Plans Disclosure [Line Items] | ||||||||||||
Share-Based Compensation Arrangement By Share-Based Payment Award, Equity Instruments Other Than Options, Grants In Period | 400,000 | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Shares Purchased for Award | 0 | |||||||||||
Non-employee director | 2017 Restricted Stock Unit Award Plan | ||||||||||||
Employee Benefit Plans Disclosure [Line Items] | ||||||||||||
Share-Based Compensation Arrangement By Share-Based Payment Award, Equity Instruments Other Than Options, Grants In Period | 333,000 | |||||||||||
Non-employee director | 2017 Restricted Stock Unit Award Plan | Settled In Cash | ||||||||||||
Employee Benefit Plans Disclosure [Line Items] | ||||||||||||
Share-Based Compensation Arrangement By Share-Based Payment Award, Equity Instruments Other Than Options, Grants In Period | 33,000 | |||||||||||
Non-employee director | 2017 Restricted Stock Unit Award Plan | Distributed And Settled In Common Stock | ||||||||||||
Employee Benefit Plans Disclosure [Line Items] | ||||||||||||
Share-Based Compensation Arrangement By Share-Based Payment Award, Equity Instruments Other Than Options, Grants In Period | 296,000 | 267,000 | ||||||||||
Non-employee director | 2017 Restricted Stock Unit Award Plan | Settlement For Purchase Price | ||||||||||||
Employee Benefit Plans Disclosure [Line Items] | ||||||||||||
Share-Based Compensation Arrangement By Share-Based Payment Award, Equity Instruments Other Than Options, Grants In Period | 4,000 |
INCOME TAXES - Additional Infor
INCOME TAXES - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2017 | |
INCOME TAXES | |||||
Federal NOLs | $ 167,800 | $ 167,800 | $ 160,200 | ||
State income tax benefits | $ 1,000 | ||||
Operating Loss Carryforwards, Expiration Term | 20 years | ||||
Operating Loss Carry Forwards Expiration Year | 2037 | ||||
Tax Credit Carryforward, Amount | 150 | $ 150 | |||
Income Tax Expense (Benefit) | $ 0 | $ 0 | $ 0 | $ 0 |
NET EARNINGS (LOSS) PER SHARE_2
NET EARNINGS (LOSS) PER SHARE (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||
Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | |
Earnings (loss) per share - basic | |||||||||
Numerator: net income (loss) | $ (678) | $ 308 | $ (595) | $ 200 | $ (3,341) | $ (788) | $ (965) | $ (3,929) | $ (3,800) |
Common shares | 21,650 | 21,300 | 21,650 | 21,300 | |||||
RSUs - vested | 686 | 293 | 654 | 243 | |||||
RSUs | 686 | 293 | 654 | 243 | |||||
Stock options | 0 | 0 | 0 | 3,480 | |||||
Common stock purchase warrants | 10,000 | 10,000 | 10,000 | 3,480 | |||||
Basic weighted average shares outstanding | 32,336 | 31,593 | 32,304 | 25,023 | |||||
Earnings (loss) per share - basic | $ (0.02) | $ 0 | $ (0.03) | $ (0.16) | |||||
Earnings (loss) per share - diluted | |||||||||
Numerator: net income (loss) | $ (678) | $ 308 | $ (595) | $ 200 | $ (3,341) | $ (788) | $ (965) | $ (3,929) | $ (3,800) |
Denominator (weighted): | |||||||||
Diluted weighted average shares outstanding | 32,336 | 31,593 | 32,304 | 25,023 | |||||
Earnings (loss) per share - diluted | $ (0.02) | $ 0 | $ (0.03) | $ (0.16) | |||||
Common shares issuable: | |||||||||
Total excluded common shares | 40,807 | 41,262 | 40,807 | 41,262 | |||||
Restricted stock units | |||||||||
Common shares issuable: | |||||||||
Total excluded common shares | 121 | 542 | 121 | 542 | |||||
Stock options | |||||||||
Common shares issuable: | |||||||||
Total excluded common shares | 1,344 | 1,378 | 1,344 | 1,378 | |||||
Common stock purchase warrants | |||||||||
Common shares issuable: | |||||||||
Total excluded common shares | 1,842 | 1,842 | 1,842 | 1,842 | |||||
Convertible loan | |||||||||
Common shares issuable: | |||||||||
Total excluded common shares | 37,500 | 37,500 | 37,500 | 37,500 |
NET EARNINGS (LOSS) PER SHARE -
NET EARNINGS (LOSS) PER SHARE - Additional Information (Details) - $ / shares shares in Millions | Jun. 28, 2019 | Sep. 30, 2020 |
Antidilutive Securities Excluded from Computation of Earnings Per Share | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.01 | |
Schutte Note | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share | ||
Debt Conversion, Converted Instrument, Warrants or Options Issued | 10 | 10 |
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.01 | $ 0.01 |
SUBSEQUENT EVENT (Details)
SUBSEQUENT EVENT (Details) - USD ($) $ in Thousands | Jun. 28, 2019 | Oct. 09, 2015 | Oct. 31, 2020 | Apr. 30, 2020 | Jul. 31, 2021 |
SUBSEQUENT EVENT | |||||
Proceeds from License Fees Received | $ 5,000 | ||||
Abuse Deterrent Pharma, LLC | |||||
SUBSEQUENT EVENT | |||||
Proceeds from License Fees Received | $ 350 | ||||
AD Pharma Agreement | Abuse Deterrent Pharma, LLC | |||||
SUBSEQUENT EVENT | |||||
Proceeds from License Fees Received | $ 350 | $ 200 | |||
Subsequent event | AD Pharma Agreement | |||||
SUBSEQUENT EVENT | |||||
Proceeds from License Fees Received | $ 200 | ||||
Subsequent event | AD Pharma Agreement | Maximum | |||||
SUBSEQUENT EVENT | |||||
Proceeds from License Fees Received | $ 350 | ||||
Subsequent event | AD Pharma Agreement | Abuse Deterrent Pharma, LLC | |||||
SUBSEQUENT EVENT | |||||
Proceeds from License Fees Received | $ 200 |