Cover
Cover - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Mar. 01, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2020 | ||
Document Transition Report | false | ||
Entity File Number | 001-38193 | ||
Entity Registrant Name | OPIANT PHARMACEUTICALS, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 46-4744124 | ||
Entity Address, Address Line One | 233 Wilshire Blvd. | ||
Entity Address, Address Line Two | Suite 280 | ||
Entity Address, City or Town | Santa Monica | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 90401 | ||
City Area Code | 310 | ||
Local Phone Number | 598-5410 | ||
Title of 12(b) Security | Common Stock, par value $0.001 per share | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Trading Symbol | OPNT | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 38,450,688 | ||
Entity Common Stock, Shares Outstanding | 4,291,632 | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2020 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0001385508 | ||
Current Fiscal Year End Date | --12-31 | ||
ICFR Auditor Attestation Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets | ||
Cash and cash equivalents | $ 48,251,336 | $ 30,980,473 |
Accounts receivable | 8,910,975 | 7,218,367 |
Prepaid expenses and other current assets | 1,936,842 | 1,055,816 |
Total current assets | 59,099,153 | 39,254,656 |
Non-current assets | ||
Property and equipment, net | 171,190 | 243,039 |
Right of use assets - operating leases | 278,455 | 768,441 |
Patents and patent applications, net | 13,000 | 14,373 |
Other non-current assets | 1,051,234 | 0 |
Total assets | 60,613,032 | 40,280,509 |
Current liabilities | ||
Accounts payable and accrued liabilities | 2,966,479 | 1,316,773 |
Accrued salaries and wages | 908,516 | 1,237,661 |
Royalty payable | 1,908,072 | 1,620,182 |
Deferred revenue | 354,756 | 918,272 |
Operating leases - current | 282,421 | 516,931 |
Total current liabilities | 6,420,244 | 5,609,819 |
Long-term liabilities | ||
Operating leases - long term | 0 | 254,664 |
Convertible debt, net of unamortized discount | 18,700,546 | 0 |
Total liabilities | 25,120,790 | 5,864,483 |
Stockholders' equity | ||
Common stock; par value $0.001; 200,000,000 shares authorized; 4,186,438 and 3,845,361 shares issued and outstanding at December 31, 2020 and 2019, respectively. | 4,259 | 4,187 |
Additional paid-in capital | 100,203,979 | 97,239,455 |
Accumulated other comprehensive loss | (26,931) | 0 |
Accumulated deficit | (64,689,065) | (62,827,616) |
Total stockholders' equity | 35,492,242 | 34,416,026 |
Total liabilities and stockholders' equity | $ 60,613,032 | $ 40,280,509 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
Stockholders' equity | ||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 200,000,000 | 200,000,000 |
Common stock, shares issued (in shares) | 4,258,105 | 4,258,105 |
Common stock, shares outstanding (in shares) | 4,186,438 | 4,186,438 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Income (Loss) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Revenues | ||
Total Revenue | $ 29,625,181 | $ 40,519,800 |
Operating expenses | ||
General and administrative | 11,742,540 | 12,197,111 |
Research and development | 9,240,020 | 9,079,351 |
Sales and marketing | 4,686,932 | 611,571 |
Royalty expenses | 6,196,706 | 7,720,280 |
Total operating expenses | 31,866,198 | 29,608,313 |
Income (loss) from operations | (2,241,017) | 10,911,487 |
Other income (expense) | ||
Interest income, net | 93,877 | 437,653 |
Interest expense | (131,007) | 0 |
Gain on debt settlement | 0 | 16,503 |
Gain (loss) on foreign exchange | (8,981) | 50,172 |
Total other income (expense) | (46,111) | 504,328 |
Income (loss) before income taxes | (2,287,128) | 11,415,815 |
Income tax benefit | 425,679 | 177,235 |
Net income (loss) | (1,861,449) | 11,593,050 |
Other comprehensive income (loss) | ||
Foreign Currency Translation Adjustments | (26,931) | 0 |
Total comprehensive income (loss) | $ (1,888,380) | $ 11,593,050 |
Income (loss) per share of common stock: | ||
Basic (in dollars per share) | $ (0.44) | $ 2.88 |
Diluted (in dollars per share) | $ (0.44) | $ 2.17 |
Weighted average common stock outstanding | ||
Basic (in shares) | 4,249,832 | 4,018,464 |
Diluted (in shares) | 4,249,832 | 5,342,378 |
Royalty and licensing revenue | ||
Revenues | ||
Total Revenue | $ 27,401,919 | $ 37,592,401 |
Treatment investment revenue | ||
Revenues | ||
Total Revenue | 0 | 643,955 |
Grant and contract revenue | ||
Revenues | ||
Total Revenue | $ 2,223,262 | $ 2,283,444 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) | Total | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Beginning Balance (in shares) at Dec. 31, 2018 | 3,845,361 | ||||
Beginning Balance at Dec. 31, 2018 | $ 16,859,266 | $ 3,846 | $ 91,276,086 | $ (74,420,666) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of stock options (in shares) | 299,167 | 318,289 | |||
Exercise of stock options | $ 2,565,420 | $ 318 | 2,565,102 | ||
Exercise of warrants (in shares) | 11,000 | ||||
Exercise of warrants | $ 110,000 | $ 11 | 109,989 | ||
Stock issued for services (in shares) | 11,788 | 11,788 | |||
Stock issued for services | $ 160,906 | $ 12 | 160,894 | ||
Stock based compensation | 3,197,384 | 3,197,384 | |||
Offering fees | (70,000) | (70,000) | |||
Net income (loss) | 11,593,050 | 11,593,050 | |||
Ending Balance (in shares) at Dec. 31, 2019 | 4,186,438 | ||||
Ending Balance at Dec. 31, 2019 | 34,416,026 | $ 4,187 | 97,239,455 | (62,827,616) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of stock options (in shares) | 12,157 | ||||
Exercise of stock options | 90,000 | $ 12 | 89,988 | ||
Exercise of warrants (in shares) | 59,510 | ||||
Exercise of warrants | 595,100 | $ 60 | 595,040 | ||
Stock based compensation | 2,279,496 | 2,279,496 | |||
Foreign Currency Translation Adjustment | (26,931) | $ (26,931) | |||
Net income (loss) | (1,861,449) | (1,861,449) | |||
Ending Balance (in shares) at Dec. 31, 2020 | 4,258,105 | ||||
Ending Balance at Dec. 31, 2020 | $ 35,492,242 | $ 4,259 | $ 100,203,979 | $ (26,931) | $ (64,689,065) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Cash flows provided by (used in) operating activities | ||
Net income (loss) | $ (1,861,449) | $ 11,593,050 |
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: | ||
Depreciation and amortization | 123,680 | 60,809 |
Amortization of debt discount | 16,487 | 0 |
Operating leases amortization | 484,793 | 176,980 |
Stock based compensation expense | 2,279,496 | 3,197,384 |
(Gain) loss on settlement of debt | 0 | (16,503) |
Changes in assets and liabilities: | ||
Accounts receivable | (1,692,607) | (2,729,050) |
Prepaid expenses and other current assets | (1,918,109) | (788,194) |
Accounts payable and accrued liabilities | 1,636,326 | 361,223 |
License fees payable | 0 | (8,100,000) |
Accrued salaries and wages | (338,352) | 154,017 |
Decrease in operating lease liabilities | (483,412) | (173,826) |
Royalty payable | 287,890 | 621,877 |
Deferred revenue | (563,516) | (293,877) |
Net cash provided by (used in) operating activities | (2,028,773) | 4,063,890 |
Cash flows used in investing activities | ||
Purchase of property and equipment | (50,887) | (302,475) |
Net cash used in investing activities | (50,887) | (302,475) |
Cash flows provided by financing activities | ||
Proceeds from debt issuance | 20,000,000 | 0 |
Debt issuance costs | (1,315,941) | 0 |
Proceeds from exercise of options and warrants | 685,100 | 2,675,420 |
Payment of financing costs | 0 | (70,000) |
Proceeds from sale of common stock | 0 | 0 |
Net cash provided by financing activities | 19,369,159 | 2,605,420 |
Effect of foreign currency translation on cash | (18,636) | 0 |
Net increase in cash and cash equivalents | 17,270,863 | 6,366,835 |
Cash and cash equivalents, beginning of year | 30,980,473 | 24,613,638 |
Cash and cash equivalents, end of year | 48,251,336 | 30,980,473 |
Supplemental disclosure | ||
Taxes paid during the year | 39,000 | 800 |
Non-Cash Investing and Financing Transactions | ||
Cashless exercise of options | 2 | 19 |
Issuance of common stock as settlement of liability | 0 | 160,906 |
Right of use assets obtained in exchange for new lease obligations | $ 948,575 |
Organization and Basis of Prese
Organization and Basis of Presentation | 12 Months Ended |
Dec. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Basis of Presentation | Organization and Basis of Presentation Opiant Pharmaceuticals, Inc. (the “Company”), a Nevada corporation, is a specialty pharmaceutical company developing medicines for addictions and drug overdose. The Company was incorporated in the State of Nevada on June 21, 2005 as Madrona Ventures, Inc. and, on September 16, 2009, the Company changed its name to Lightlake Therapeutics Inc. On January 28, 2016, the Company again changed its name to Opiant Pharmaceuticals, Inc. The Company also has developed a treatment to reverse opioid overdoses, which is now known as NARCAN®. On October 2, 2017, the Company changed its state of incorporation from the State of Nevada to the State of Delaware pursuant to an Agreement and Plan of Merger, dated October 2, 2017, whereby the Company merged with and into its recently formed, wholly-owned Delaware subsidiary, Opiant Pharmaceuticals, Inc. |
Liquidity and Financial Conditi
Liquidity and Financial Condition | 12 Months Ended |
Dec. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Liquidity and Financial Condition | Liquidity and Financial Condition The Company had net loss of $1.9 million for the year ended December 31, 2020 and has an accumulated deficit of $64.7 million at 2020. The Company has $52.7 million of working capital at December 31, 2020. The Company has financed its operations from sale of Common Stock, and through non-equity cash investments by a number of investors, in exchange for an interest in any pre-tax profits received by the Company that was derived from the sale of the Opioid Overdose Reversal Treatment Product less any and all expenses incurred by and payments made by the Company in connection with the Opioid Overdose Reversal Treatment Product ("OORT"). During the year ended December 31, 2020, the Company received net cash proceeds of approximately $18.7 million from a debt offering, and $0.7 million from the exercise of stock options and warrants. During the year ended December 31, 2019, the Company received net cash proceeds of approximately $2.7 million from the exercise of stock options and warrants. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and the applicable rules and regulations of the Securities and Exchange Commission (“SEC”). Principles of Consolidation The consolidated financial statements have been prepared in accordance with GAAP and include the accounts for the Company and its wholly-owned subsidiary, Opiant Pharmaceuticals UK Limited. All inter-company transactions and balances have been eliminated in consolidation. Use of Estimates The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, and reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Cash and Cash Equivalents The Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. Cash and cash equivalents were $48.3 million, and $31.0 million at December 31, 2020 and December 31, 2019. The Company maintains cash balances at financial institutions insured up to $250,000 by the Federal Deposit Insurance Corporation ("FDIC") and as of December 31, 2020 maintains the majority of its cash balances in money market funds not insured by the FDIC. The Company also transfers certain daily available cash balances to an overnight account which earns interest and the amounts are not insured by the FDIC. Balances in the United Kingdom are insured up to £85,000 by the Financial Services Compensation Scheme (United Kingdom Equivalent). Although the Company’s cash balances exceeded these insured amounts, the Company has not experienced any losses on its cash and cash equivalents for the periods presented. Accounts Receivable The Company routinely assesses the recoverability of receivables to determine collectability by considering factors such as historical experience, credit quality, the age of the accounts receivable balances, and current economic conditions that may affect a customer's ability to pay. The Company determines its allowance for doubtful accounts by considering such factors as the length of time balances are past due, the Company’s previous loss history, the customer’s current ability to pay its obligations to the Company and the condition of the general economy and the industry as a whole. The Company has evaluated its accounts receivable history and determined that no allowance for doubtful accounts is required for the years ended December 31, 2020 and 2019. At December 31, 2020 and 2019 the Company's accounts receivable were primarily concentrated with one party, EBS. Long-Lived Assets The Company follows ASC 360, Property, Plant, and Equipment , for its fixed assets. Property and equipment is stated at cost less accumulated depreciation. Depreciation is computed by the straight-line method over estimated useful lives (3 to7 years). The Company capitalizes all asset purchases greater than $2,500 having a useful life greater than one year. The Company follows ASC 350, Intangibles – Goodwill and Other for its intellectual property asset. Intellectual property consists of patents which are stated at their fair value acquisition cost. Amortization is calculated by the straight-line method over their estimated useful lives (20 years). The Company recorded depreciation and amortization of $123,680 and $60,809 for the years ended December 31, 2020 and 2019, respectively. Long-lived assets such as property and equipment and identifiable intangibles are reviewed for impairment whenever facts and circumstances indicate that the carrying value may not be recoverable. When required, impairment losses on assets to be held and used are recognized based on the fair value of the asset. The fair value is determined based on estimates of future cash flows, market value of similar assets, if available, or independent appraisals, if required. If the carrying amount of the long-lived asset is not recoverable from its undiscounted cash flows, an impairment loss is recognized for the difference between the carrying amount and fair value of the asset. When fair values are not available, the Company estimates fair value using the expected future cash flows discounted at a rate commensurate with the risk associated with the recovery of the assets. The Company did not recognize any impairment losses for any years presented. Earnings (Loss) per Share The Company follows ASC 260, Earnings per Share . Basic earnings (loss) per share is computed by dividing the net income (loss) available to common stockholders by the weighted-average number of shares of Common Stock outstanding during the respective period presented in the Company’s accompanying consolidated financial statements. Fully diluted earnings (loss) per share is computed similar to basic income (loss) per share except that the denominator is increased to include the number of Common Stock equivalents (primarily outstanding options and warrants). Common Stock equivalents represent the dilutive effect of the assumed exercise of outstanding stock options and warrants, using the treasury stock method, at either the beginning of the respective period presented or the date of issuance, whichever is later, and only if the Common Stock equivalents are considered dilutive based upon the Company’s net income position at the calculation date. For the year ended December 31, 2020, Common Stock equivalents consisting of 3,077,260 stock options and 278,800 warrants were excluded from the calculation of diluted income (loss) per share as their effect would be anti-dilutive due to the Company's net loss. The following table illustrates the dilutive effect of the assumed exercise of the Company’s outstanding stock options and warrants, using the treasury stock method, for the year ended December 31, 2020 and 2019: Year Ended Year Ended Numerator: December 31, 2020 December 31, 2019 Net Income (loss) $ (1,861,449) $ 11,593,050 Denominator: Denominator for basic income (loss) per share - weighted average shares 4,249,832 4,018,464 Effect of dilutive securities: Stock options and warrants — 1,323,914 Denominator for diluted income (loss) per share 4,249,832 5,342,378 Income (loss) per share - Basic $ (0.44) $ 2.88 Income (loss) per share - Diluted $ (0.44) $ 2.17 Research and Development Costs The Company follows ASC 730, Research and Development , and expenses all research and development costs as incurred for which there is no alternative future use. These costs also include the expensing of employee compensation and employee stock based compensation Foreign Currency Translation The Company’s functional and reporting currency is the United States dollar. The functional currency of the Company's wholly-owned subsidiary, Opiant Pharmaceuticals UK Limited ("Opiant UK") is the British Pound, its local currency. Consequently, the assets and liabilities are translated at current rates of exchange at the balance sheet date. Income and expense items are translated at the average foreign currency exchange rates for the period. Adjustments resulting from the translation of the financial statements of Opiant UK, into U.S. dollars, the reporting currency, are excluded from the determination of net loss and are recorded in accumulated other comprehensive income or loss, a separate component of equity. Gains and losses arising on settlement of foreign currency denominated transactions or balances are included in the determination of income. Stock-Based Compensation ASC 718 Compensation – Stock Compensation prescribes accounting and reporting standards for all share-based payment transactions in which employee services are acquired. Transactions include incurring liabilities, or issuing or offering to issue shares, options, and other equity instruments such as employee stock ownership plans and stock appreciation rights. Share-based payments to employees, including grants of employee stock options, are recognized as compensation expense in the consolidated financial statements based on their fair values. That expense is recognized over the period during which an employee is required to provide services in exchange for the award, known as the requisite service period (usually the vesting period). In June 2018, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) No. 2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Non-employee Share-Based Payment Accounting, which aligns the accounting for share-based payment awards issued to non-employees with the guidance applicable to grants to employees. Under this new standard, equity-classified share-based payment awards issued to non-employees will be measured on the grant date, instead of the current requirement to remeasure the awards through the performance completion date. Further, compensation cost for awards with performance conditions will be recognized when it is probable the conditions will be achieved, rather than upon actual achievement of the conditions. The Company adopted this standard January 1, 2019. The adoption of this guidance did not have a material impact on the Company's consolidated financial statements. The Company had stock-based compensation of $2.3 million and $3.2 million for the years ended December 31, 2020 and 2019, respectively. Fair Value of Financial Instruments ASC 820 Fair Value Measurements and Disclosures defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy that distinguishes between (1) market participant assumptions developed based on market data obtained from independent sources (observable inputs) and (2) an entity’s own assumptions about market participant assumptions developed based on the best information available in the circumstances (unobservable inputs). The fair value hierarchy consists of three broad levels, which gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3). The three levels of the fair value hierarchy are described below: Level 1 - Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities. Level 2 - Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly, including quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar assets or liabilities in markets that are not active; inputs other than quoted prices that are observable for the asset or liability (e.g., interest rates); and inputs that are derived principally from or corroborated by observable market data by correlation or other means. Level 3 - Inputs that are both significant to the fair value measurement and unobservable. The carrying value of certain on-balance-sheet financial instruments approximated their fair values due to the short-term nature of these instruments. These financial instruments include cash and cash equivalents, accounts receivable, accounts payable, and long-term debt. The carrying value of long-term debt approximates fair value since the related rate of interest approximates current market rates. At December 31, 2020 and December 31, 2019, the Company did not have any financial assets or liabilities measured and recorded at fair value on the Company’s consolidated balance sheets on a recurring basis. Revenue Recognition The Company generates a large majority of revenue from the agreement with EBS. During the year ended December 31, 2020, the Company recognized 93% of revenue from its agreement with EBS. In May 2014, the FASB issued an accounting standard update ("ASU”), 2014-09, Revenue from Contracts with Customers (Topic 606). This ASU amends the existing accounting standards for revenue recognition and is based on the principle that revenue should be recognized to depict the transfer of goods or services to a customer at an amount that reflects the consideration a company expects to receive in exchange for those goods or services. On January 1, 2018, the Company adopted the new Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers using the modified retrospective method, and the Company determined the new guidance does not change the Company's policy of revenue recognition. The Company's primary source of revenue is through the recognition of royalty and milestone payments from EBS. Milestone revenue is recognized upon successful accomplishment of certain sales targets set forth in the EBS Agreement. Royalty revenue is determined based on the agreed upon royalty rate applied to NARCAN® sales reported by EBS. There are no performance obligations by the Company and the Company recognizes revenue according to the royalty report provided by EBS on a quarterly basis. In regards to treatment revenue, the Company received certain investments from investors in return for an interest in its existing treatments. Investors carry an option to exchange investment into shares of the Company. Revenue is deferred until such time that the option expires or milestones are achieved that eliminate the investor’s right to exercise the option. Once the option has expired, the Company determined its performance obligations under the agreement which typically is to perform R&D services related to treatments and recognizes revenue over a period of time which is usually the expected research and development period. The treatment revenue is disaggregated by program treatments. (See Note 8 to the Consolidated Financial Statements - Revenue). In June 2018, the FASB issued guidance clarifying the revenue recognition and measurement issues for grants, contracts, and similar arrangements, ASU Topic 958. Government grants and contracts are agreements that generally provide cost reimbursement for certain types of expenditures in return for research and development activities over a contractually defined period. The Company has evaluated its grant with National Institutes of Health (“NIH”) and the contract with Biomedical Advanced Research and Development Authority (“BARDA”) and determined they are non-exchange transactions and fall within the scope of ASU 958, and revenue should be recognized in accordance with Topic 958 guidance. Accordingly, the Company recognizes revenue from its grant and contract in the period during which the related costs are incurred, provided that the conditions under which the grants and contracts were provided have been met and only perfunctory performance obligations are outstanding. Licensing Agreement Pursuant to the Adapt Agreement, the Company provided a global license to develop and commercialize the Company’s intranasal naloxone opioid overdose reversal treatment, now known as NARCAN®. On December 15, 2014, the Company entered into a License Agreement (the "Adapt Agreement") with Adapt Pharma Operations Limited (“Adapt”), an Ireland based pharmaceutical company. Emergent BioSolutions, Inc acquired Adapt in October 2018 and Adapt became its wholly owned subsidiary (collectively with Adapt, “EBS”). Pursuant to the Adapt Agreement, we provided a global license to develop and commercialize our intranasal naloxone opioid overdose reversal treatment, now known as NARCAN®. In addition, on the SWK Closing Date, in connection with the SWK Purchase Agreement, as disclosed below, we entered into the EBS Amendment which amends the terms of the Adapt Agreement relating to the grant of a commercial sublicense outside of the United States and diligence efforts for commercialization of our Opioid Overdose Reversal Treatment Product. Under the terms of the EBS Amendment, EBS is required to use commercially reasonable efforts to commercialize the Opioid Overdose Reversal Treatment Product in the United States. In the event that EBS wishes to grant a commercial sublicense to a third party in the European Union or the United Kingdom, we have agreed to negotiate an additional amendment to the Adapt Agreement to include reduced financial terms with respect to the commercial sublicense. The Company also receives payments upon reaching various sales and regulatory milestones, as well as royalty payments for commercial sales of NARCAN® generated by EBS. During the years ended December 31, 2020 and 2019, the Company recognized royalty and milestone revenue of $27.4 million and $37.6 million, respectively. Interest in Treatments With respect to investments in interests in treatments, if an agreement provides an option that allows the investor in the treatment to convert an interest in a treatment into shares of Common Stock, then revenue is deferred until such time that the option expires or milestones are achieved that eliminate the investor’s right to exercise the option. Upon expiration of the exercise option, the deliverables of the arrangement are reviewed and evaluated under ASC 606. In the event the investor chooses to convert interests into shares of Common Stock, that transaction will be accounted for similar to a sale of shares of Common Stock for cash. Recently Issued Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board, or FASB, or other standard setting bodies and adopted by us as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s financial position or results of operations upon adoption. The Company has considered all other recently issued accounting pronouncements and does not believe the adoption of such pronouncements will have a material impact on its consolidated financial statements. Recently Issued Accounting Pronouncements Not Yet Adopted In August 2020, the FASB issued ASU No. 2020-06, "Accounting for Convertible Instruments and Contracts in an Entity's Own Equity." This new standard simplifies and adds disclosure requirements for the accounting and measurement of convertible instruments. It eliminates the treasury stock method for convertible instruments and requires application of the “if-converted” method for certain agreements. This standard is effective for the Company for fiscal years, and interim periods within those years, beginning January 1, 2022. Early adoption is permitted, but no earlier than fiscal years beginning January 1, |
Accounts Receivable
Accounts Receivable | 12 Months Ended |
Dec. 31, 2020 | |
Receivables [Abstract] | |
Accounts Receivable | Accounts Receivable As of December 31, 2020, the Company had accounts receivable of $8.3 million which relates to royalty revenue from sales of NARCAN®. At December 31, 2020 the Company's accounts receivable were from EBS and BARDA. |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 12 Months Ended |
Dec. 31, 2020 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Prepaid Expenses and Other Current Assets | Prepaid Expenses and Other Current Assets As of December 31, 2020, the Company had approximately $1.9 million recorded as prepaid expenses and other current assets. Of this amount approximately $0.9 million was for prepaid directors and officers insurance and the remaining $1.0 million was for other prepaid insurance, rent, software services, other general prepaid items, and other current assets. As of December 31, 2019, the Company had approximately $1.1 million recorded as prepaid expenses and other current assets. Of this amount approximately $0.7 million was for prepaid directors and officers insurance and the remaining $0.4 million was for other prepaid insurance, rent, software services, and other general prepaid items. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2020 | |
Leases [Abstract] | |
Leases | Leases On January 1, 2019, the Company adopted a new accounting standard, Topic 842, that amends the guidance for the accounting and reporting of leases. Leases with terms of 12 months or less are expensed on a straight-line basis over the term and are not recorded in the Company's Consolidated Balance Sheets. The Company entered into two operating leases during the year ended December 31, 2019 with terms greater than 12 months. In accordance with the guidance of Topic 842, the two leases which are classified as operating leases are included in the Company's Consolidated Balance Sheet as of December 31, 2020 and 2019. The Company's two operating leases do not include options to renew, do not contain residual value guarantees, do not have variable lease components, or impose significant restrictions or covenants. Right of use assets, "ROU assets", represent the right to use an underlying asset for the lease term, and lease liabilities represent the obligation to make lease payments over the respective lease term, with the ROU asset adjusted for deferred rent liability. Lease expense is recognized on a straight line basis over the lease term. As the implicit rate on the leases is not determinable, the Company used an estimated incremental borrowing rate of 9% as the discount rate to determine the present value of lease payments. The ROU assets and corresponding operating lease liability recognized at lease inception was $949 thousand. The weighted average discount rate used was 9% and the weighted average remaining lease term is 0.55 years at December 31, 2020. The following table summarizes information related to the Company's two operating leases and are included in the Company's Balance Sheet as of December 31, 2020. Balance Sheet descriptions Assets: (in thousands) Right of use assets - operating leases $ 278 Liabilities: Operating leases - current $ 282 Operating leases - long term — Total lease liabilities $ 282 The following table summarizes the components of operating lease cost for the year ended December 31, 2020. Lease costs (in thousands) Operating expenses - lease costs $ 574 As of December 31, 2020, future minimum operating leases payments related to the Company’s operating lease liabilities were as follows: (in thousands) 2021 290 Total lease payments 290 Less imputed interest (8) Present value of operating lease liabilities $ 282 |
Other Non-Current Assets
Other Non-Current Assets | 12 Months Ended |
Dec. 31, 2020 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Other Non-Current Assets | Prepaid Expenses and Other Current Assets As of December 31, 2020, the Company had approximately $1.9 million recorded as prepaid expenses and other current assets. Of this amount approximately $0.9 million was for prepaid directors and officers insurance and the remaining $1.0 million was for other prepaid insurance, rent, software services, other general prepaid items, and other current assets. As of December 31, 2019, the Company had approximately $1.1 million recorded as prepaid expenses and other current assets. Of this amount approximately $0.7 million was for prepaid directors and officers insurance and the remaining $0.4 million was for other prepaid insurance, rent, software services, and other general prepaid items. |
Revenue
Revenue | 12 Months Ended |
Dec. 31, 2019 | |
Revenue from Contract with Customer [Abstract] | |
Revenue | Revenue On September 19, 2018, the Company entered into a contract with BARDA, which is part of the U.S. Health and Human Services Office of the Assistant Secretary for Preparedness and Response, to accelerate the Company’s development of OPTN003, its lead product candidate. OPTN003, nasal nalmefene, is a potent, long-acting opioid antagonist currently in development for the treatment of opioid overdose. The contract will provide potential funding up to a maximum of approximately $4.6 million and cover activities related to a potential New Drug Application submission for OPTN003 with the Food and Drug Administration. On December 11, 2020, BARDA awarded an additional $3.5 million to advance the clinical development of OPNT003. The modification increases the total potential value of the contract to $8.1 million. BARDA has awarded approximately $6.5 million of the contract through December 20, 2021, with the balance expected to be funded, subject to satisfactory project progress, availability of funds and certain other conditions. During the year ended December 31, 2020, the Company recognized revenue of $0.7 million related to this contract. Deferred revenue On December 17, 2013, the Company entered into an agreement with an investor, Potomac, and subsequently received additional funding totaling $250 thousand for use by the Company for any purpose. In exchange for this funding, the Company agreed to provide the investor with a 0.5% interest in the Company’s BED treatment product (the “BED Treatment Product”) and pay the investor 0.5% of the BED Net Profit in perpetuity (the “2013 0.5% Investor Interest”). “BED Net Profit” is defined as the pre-tax profit generated from the BED Treatment Product after the deduction of all expenses incurred by and payments made by the Company in connection with the BED Treatment Product, including but not limited to an allocation of Company overhead. In the event that the BED Treatment Product was not approved by the FDA by December 17, 2016, the investor would have a 60-day option to exchange its entire 0.5% Investor Interest for 31,250 shares of Common Stock. On February 17, 2017, the investor’s option to receive the shares of Common Stock terminated by its terms, which resulted in the Company beginning to recognize revenue in relation to this agreement in February 2017. During June 2019 the Company determined it would not continue development efforts on the BED Treatment Product. During the years ended December 31, 2020 and 2019 the Company recognized approximately zero and $115.9 thousand, respectively of revenue relating to the agreement. On September 17, 2014, the Company entered into an agreement with an investor, Potomac, and subsequently received funding totaling $500 thousand for use by the Company for any purpose. In exchange for this funding, the Company agreed to provide the investor with a 1.0% interest in the Company’s BED Treatment Product and pay the investor 1.0% of the BED Net Profit generated from the BED Treatment Product in perpetuity (the “1.0% Investor Interest”). “BED Net Profit” is defined as the pre-tax profit generated from the BED Treatment Product after the deduction of all expenses incurred by and payments made by the Company in connection with the BED Treatment Product, including but not limited to an allocation of Company overhead. In the event that the BED Treatment Product was not approved by the FDA by September 17, 2017, the investor would have a 60-day option to exchange its entire 1.0% Investor Interest for 62,500 shares of Common Stock. On November 15, 2017, the investor’s option to receive the shares of Common Stock terminated by its terms, which resulted in the Company beginning to recognize revenue in relation to this agreement in November 2017. During June 2019 the Company determined it would not continue development efforts on the BED Treatment Product. During the years ended December 31, 2020 and 2019 the Company recognized approximately zero and $313.7 thousand, respectively of revenue relating to the agreement. On July 20, 2015, the Company entered into an agreement with an investor, Potomac, and subsequently received funding from an individual investor in the amount of $250 thousand for use by the Company for any purpose. In exchange for this funding, the Company agreed to provide the investor with a 0.5% interest in the BED Net Profit (the “2015 0.5% Investor Interest”) generated from the BED Treatment Product in perpetuity. The investor also has rights with respect to the 2015 0.5% Investor Interest if the BED Treatment Product is sold or the Company is sold. During June 2019 the Company determined it would not continue development efforts on the BED Treatment Product. During the years ended December 31, 2020 and 2019, the Company recognized revenue of approximately zero and $214.3 thousand, respectively related to this agreement. On April 17, 2018, the Company was awarded a grant of approximately $7.4 million from the National Institutes of Health’s National Institute on Drug Abuse, ("NIDA"). The grant provides the Company with additional resources for the ongoing development of OPNT003 (nasal nalmefene), a long-lasting opioid antagonist for the treatment of opioid overdose. The Company has been awarded approximately $5.6 million through the period ending March 31, 2021, with the remaining $1.8 million balance expected to be funded, subject to available funds and satisfactory progress on the development of OPNT003. Government grants are agreements that generally provide cost reimbursement for certain types of expenditures in return for research and development activities over a contractually defined period. The Company recognizes revenues from grants in the period during which the related costs were incurred, provided that the conditions under which the grants were provided had been met and only perfunctory obligations were outstanding. During the years ended December 31, 2020 and 2019, the Company received cash of $1.0 million and $2.4 million, respectively and recognized revenue of approximately $1.6 million and $2.0 million, respectively related to this grant. The following is a summary of the Company’s deferred revenue activity for the years ended December 31, 2020 and 2019: (in thousands) NIH Grant BED Total Balance as of December 31, 2018 $ 568 $ 644 $ 1,212 Cash Received from NIH 2,400 — 2,400 Recognized as revenue (2,050) (644) (2,694) Balance as of December 31, 2019 $ 918 $ — $ 918 Cash Received from NIH 1,000 — 1,000 Recognized as revenue (1,563) — (1,563) Balance as of December 31, 2020 $ 355 $ — $ 355 As of December 31, 2020, the Company had recorded approximately $0.4 million of its deferred revenue as a current liability because the Company expects to recognize that amount as revenue during the next 12 months. Current and long-term deferred revenue are detailed in the following table: Deferred Revenue (in thousands) NIH Grant BED Total Current portion $ 355 $ — $ 355 Long-term portion — — — Total $ 355 $ — $ 355 |
License Fee Payable
License Fee Payable | 12 Months Ended |
Dec. 31, 2020 | |
Payables and Accruals [Abstract] | |
License Fee Payable | License Fee PayableOn February 28, 2018, the Company was notified that EBS had entered into a license agreement with a Third Party (as defined in the Adapt Agreement) with regard to one or more patents pursuant to which EBS invoked its right under Section 5.5 of the Adapt Agreement to offset 50% of certain payments paid to such Third Party from the amounts payable by EBS to the Company under the Adapt Agreement and SWK under the SWK Purchase Agreement. On March 1, 2018, the Company received net milestone payments of $6.1 million, which was net of 50% of a license fee payment EBS made to the Third Party. EBS reduced such milestone payment by $6.25 million pursuant to Section 5.5 of the Adapt Agreement. The portion of the milestone payment that the Company would have otherwise received was reduced by $5.6 million. As provided in Amendment No. 2 to the Adapt Agreement, which the parties entered into on March 18, 2019, EBS has made and will in the future make payments to the Third Party Licensee and will be allowed to reduce the royalties and milestones that the Company would be due under the License Agreement by a maximum of $9.0 million in relation to such payments. Under the SWK Purchase Agreement, the Company retains 90% of the royalties payable under the Adapt Agreement, with SWK entitled to 10%. The maximum amount payable by the Company is therefore $8.1 million (90% of $9 million), of which the Company has recorded $5.4 million as a current liability and $2.7 million as a long-term liability at December 31, 2018. As provided in Amendment No. 2, EBS will be allowed to reduce the royalties and milestones that the Company would be due under the Adapt Agreement during the year ended December 31, 2019 by a maximum of $1.8 million each quarter. As provided in the Adapt Agreement, if Net NARCAN® Sales (as defined in the Adapt Agreement) exceed $200 million in any calendar year, the Company and SWK will be due a milestone of $15.0 million. Under Amendment No. 2, if this $15.0 million milestone becomes payable to the Company and SWK, EBS may deduct $2.7 million from the $13.5 million (90% of $15.0 million) milestone payable to the Company. |
Royalty Payable
Royalty Payable | 12 Months Ended |
Dec. 31, 2020 | |
Payables and Accruals [Abstract] | |
Royalty Payable | Royalty Payable The Company entered into various agreements and subsequently received funding from investors for use by the Company for the research and development its OORT Product. In exchange for this funding, the Company agreed to provide investors with interest in the OORT Net Profit generated from its OORT Product in perpetuity. The following table sets forth the royalty payable to certain investors as of December 31, 2020 and 2019: (in thousands) Net Profit % December 31, 2020 December 31, 2019 Potomac 10.2% $ 822 $ 698 LYL 5.0% 402 341 Welmers 1.5% 121 103 Foundation 6.0% 483 410 Pendergast 1.0% 80 68 Royalty payable 23.7% $ 1,908 $ 1,620 |
Long Term Debt
Long Term Debt | 12 Months Ended |
Dec. 31, 2020 | |
Debt Disclosure [Abstract] | |
Long Term Debt | Long Term Debt On December 10, 2020 (the “Closing Date”), the Company, entered into a Note Purchase and Security Agreement (the “Loan Agreement”) with a syndicate of Pontifax Medison Finance, and Kreos Capital VI (Expert Fund) LP, (collectively, the “Lender”). The Loan Agreement provides for term loans in an aggregate principal amount of up to $50.0 million in three tranches as follows: (a) on the Closing Date, a loan in the aggregate principal amount of $20.0 million, (b) upon the submission of a New Drug Application with the U.S. Food and Drug Administration, a loan in the aggregate principal amount of $10.0 million, and (c) upon FDA approval of an opioid overdose product, a loan in the aggregate principal amount of $20.0 million (each a “Loan, and collectively, the “Loans”). The outstanding principal of each term Loan bears an average interest rate of 8.75% per annum based on the date of issuance and a year consisting of 365 days. There is an interest-only period of 30 months, with interest on outstanding Loans payable on a quarterly basis based on the principal amount outstanding during the preceding quarter. After the interest-only period, principal of the outstanding Loans is payable in ten equal quarterly installments. All Loans have a maturity date of October 1, 2025. Each Lender may, at its option, elect to convert up to half of the then-outstanding Loans and all accrued and unpaid interest thereon into shares of Common Stock. The “Conversion Price” shall be $19.64 subject to certain customary adjustments as specified in the Loan Agreement. The Company’s obligations are secured by a security interest, senior to any current and future debts and to any security interest, in all of Company’s right, title, and interest in, to and under all of Company’s property and other assets, other than its NARCAN® Nasal Spray licensed intellectual property and other limited exceptions specified in the Loan Agreement. The Loan Agreement contains customary representations, warranties and covenants, including covenants by the Company limiting additional indebtedness, liens, including on intellectual property, guaranties, mergers and consolidations, substantial asset sales, investments and loans, certain corporate changes, transactions with affiliates and fundamental changes. The Loan Agreement provides for events of default customary for term loans of this type, including but not limited to non-payment, breaches or defaults in the performance of covenants, insolvency, bankruptcy and the occurrence of a material adverse effect on the Company. On December 10, 2020, The Company received the first tranche of $20 million. The Company recognized fees of approximately $1.3 million related to the debt offering which is amortized over the term of the debt. The Company amortized approximately $16 thousand of these fees to interest expense. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Commitments The Company has entered into various agreements related to its business activities. The following is a summary of the Company’s commitments: a. The Company entered into a consulting agreement with Torreya Partners LLP ("Torreya"), a financial advisory firm, under which Torreya agreed to provide certain financial advisory services. The Company is required to pay fees equivalent to 3.375% of all amounts received by the Company from net sales of NARCAN® into perpetuity. During the year ended December 31, 2020, the Company incurred approximately, $924,972 in aggregate fees related to Torreya. As of December 31, 2020, the Company has an accrued liability of $281,684 owed to Torreya. b. On November 19, 2015, the Company issued 14,327 shares of unregistered Common Stock upon the execution of a binding letter of intent to agree to negotiate and enter into an exclusive license agreement and collaboration agreement (“LOI”) with a pharmaceutical company with certain desirable proprietary information. The shares issued in this transaction were valued using the stock price at issuance date and amounted to approximately $120.3 thousand. Pursuant to the LOI, the Company is obligated to issue up to an additional 92,634 shares of unregistered Common Stock upon the occurrence of various milestones. As of September 30, 2019, the Company was required to issue an additional 11,788 shares of unregistered Common Stock pursuant to the LOI. The Company was obligated to issue these shares as a milestone payment when net NARCAN® Sales exceed $200.0 million, which occurred during the nine months ended September 30, 2019. The shares were issued December 9, 2019, and the Company recorded non-cash research and development expense of $177,409, and a $16,503 gain on settlement of liability recorded to other expense. c. On May 7, 2019, the Company entered into a Sub-Sublease with PERL Mortgage, Inc. to sublease office space located at 233 Wilshire Blvd., Suite 280, Santa Monica, CA 90401, and this is the Company's headquarters. The lease commenced on July 1, 2019 and expires August 31, 2021. Prior, the Company had a Sublease with Standish Management, LLC to sublease office space on a month-to-month basis, located at 201 Santa Monica Boulevard, Suite 500, Santa Monica, CA 90401, which was the Company's headquarters. The Company provided notice to terminate the lease with Standish Management, LLC effective July 31, 2019. On July 11, 2019, the Company entered into an Office Service Agreement with Regus to lease office space at One Kingdom Street, London, England, W2 6BD. The lease commenced on August 1, 2019 and ends May 31, 2021 with monthly rent of 20,000 GBP. Prior, the Company had an Office Service Agreement to lease office space at 83 Baker Street, London, England, W1U 6AG. Effective May 31, 2018 either party was able to terminate the Office Service Agreement by providing three months advance written notice of termination. The Company provided notice to terminate the lease effective July 31, 2019. During the years ended December 31, 2020 and 2019 Company incurred approximately $578 thousand and $523 thousand, respectively of rent expense. d. On June 22, 2017, the Company entered into a license agreement (the "License Agreement") and a related supply agreement (the “Supply Agreement”) with Aegis Therapeutics LLC ("Aegis") pursuant to which the Company was granted an exclusive license (the “License”) to Aegis’ proprietary chemically synthesizable delivery enhancement and stabilization agents, including, but not limited to, Aegis’ Intravail® absorption enhancement agents, ProTek® and HydroGel® (collectively, the “Technology”) to exploit (a) the Compounds (as such are defined in the License Agreement) and (b) a product containing a Compound and formulated using the Technology (“Aegis Product”), in each case of (a) and (b) for any and all purposes. The License Agreement restricts the Company's ability to manufacture any Aegis excipients included in the Technology (“Excipients”), except for certain instances of supply failure, supply shortage or termination of the Supply Agreement, and the Company shall obtain all supply of such Excipients from Aegis under the Supply Agreement. The License Agreement also restricts Aegis’s ability to compete with the Company worldwide with respect to the Exploitation (as defined in the License Agreement) of any therapeutic containing a Compound or derivative or active metabolite of a Compound without the Company's prior written consent. The effective date of the License Agreement and the Supply Agreement is January 1, 2017. As consideration for the grant of the License, the Company paid Aegis two immaterial upfront payments, of which the Company paid 50% by issuing Common Stock to Aegis, with the number of shares issued equal to 75% of the average closing price of the Common Stock over the 20 trading days preceding the date of payment. The License Agreement also provides for (A) additional developmental milestone payments for each Product containing a different Compound equal to up to an aggregate of $1.8 million, (B) additional commercialization milestone payments for each Aegis Product containing a different Compound equal to up to an aggregate of $5.0 million, and (C) single low digit royalties on the Annual Net Sales (as defined in the License Agreement) of all Aegis Products during the Royalty Term (as defined in the License Agreement) according to a tiered royalty rate based on Annual Net Sales of the Aegis Products by the Company, the Company's sublicensees and affiliates. The Company shall also pay to Aegis a sublicense fee based on a sublicense rate negotiated in good faith by the parties. The License Agreement contains customary representations and warranties, ownership, patent rights, confidentiality, indemnification and insurance provisions. The License Agreement shall expire upon the expiration of the Company's obligation to pay royalties under such License Agreement; provided, however, that the Company shall have the right to terminate the License granted on a product-by-product or country-by-country basis upon 30 days’ prior written notice to Aegis. Under the terms of the Supply Agreement, Aegis shall deliver to the Company any preclinical, clinical and commercial supply of the Excipients, which Aegis sources from various contract manufacturers. The Supply Agreement has a term of 20 years but shall terminate automatically in the event of expiration or termination of the License Agreement or at any time upon the written agreement of both parties. The Supply Agreement contains customary provisions relating to pricing for such materials, forecasts, delivery, inspection, indemnification, insurance and representations, warranties and covenants. The Supply Agreement includes technology transfer provisions for the transfer of all materials and know-how specific to the manufacturing of the Excipients that is necessary or useful for the Company to manufacture such Excipients. The Company does not have the right to manufacture such Excipients except in the event that Aegis is unable to supply and sell any portion of the material to the Company (subject to a 60-day cure period). Under the License Agreement, the Company will be required to pay Aegis $250,000 upon the successful filing of an NDA. For the years ended December 31, 2020 and 2019, the Company recorded $0 of expense associated with the License Agreement. e. On July 22, 2020, the Company entered into a Project Scope Agreement ("PSA") pursuant to a Master Services Agreement ("MSA") with Summit Biosciences, Inc. ("Summit"), to support the development and manufacture of a nasal spray device for opioid overdose, with the ability to expand to additional programs in the future. In accordance with the PSA, Summit will develop and produce certain pre-filled nasal spray products using a device previously evaluated as part of other FDA-approved nasal spray products. The Company will pay Summit estimated costs and fees up to approximately $7.2 million. The Company paid a deposit of approximately $1.1 million which is included in other non-current assets in the consolidated balance sheet at December 31, 2020. f. On October 26, 2020, the Company entered into a Master Services Agreement (“MSA”) with AptarGroup, Inc. (“Aptar”) to provide non-exclusive technology access and co-development services for the development and submission of an opioid antagonist for the treatment of opioid overdose using Aptar’s nasal Unidose device (the “UDS Device”). In addition to the cost of the UDS Devices, the Company expects to spend up to approximately $5.2 million over the course of the development program. Contingencies The Company may be subject to various legal proceedings and claims that arise in the ordinary course of business. The Company records a liability when it is probable that a loss has been incurred and the amount is reasonably estimable. There is significant judgment required in both the probability determination and as to whether an exposure can be reasonably estimated. If any legal matter, that may arise, were resolved against the Company in a reporting period for amounts in excess of management’s expectations, the Company’s would reflect any potential claim in the consolidated financial statements for that reporting period. The Company and EBS (collectively, “Plaintiffs”), filed complaints, in 2016 against Teva Pharmaceuticals Industries Ltd. (“Teva”) and in 2018 against Perrigo UK FINCO Limited Partnership (“Perrigo”), relating to Teva’s and Perrigo’s respective abbreviated new drug applications (each, an “ANDA”) seeking to market generic versions of NARCAN® (naloxone hydrochloride) Nasal Spray 4mg/spray. On February 12, 2020, Plaintiffs and Perrigo entered into a settlement agreement to resolve the ongoing litigation. Under the terms of the settlement, Perrigo has received a non-exclusive license under the Company's patents licensed to EBS to make, have made and market its generic naloxone hydrochloride nasal spray under its own ANDA. Perrigo’s license will be effective as of January 5, 2033 or earlier under certain circumstances including circumstances related to the outcome of the current litigation against Teva or litigation against future ANDA filers. The Perrigo settlement agreement is subject to review by the U.S. Department of Justice and the Federal Trade Commission, and entry of an order dismissing the litigation by the U.S. District Court for the District of New Jersey. Closing arguments in the Teva trial were held on February 26, 2020. On June 5, 2020, the District Court for the District of New Jersey entered a decision in the patent litigation regarding NARCAN® (naloxone HCl) Nasal Spray 4mg/spray product. The Court ruled in favor of Teva. Our commercial partner EBS, has appealed the decision to the Court of Appeals for the Federal Circuit. |
Stockholder's Equity
Stockholder's Equity | 12 Months Ended |
Dec. 31, 2020 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity | Stockholder's Equity Common Stock During the year ended December 31, 2020 Common Stock During the year ended December 31, 2020 the Company issued 71,667 shares of Common Stock as a result of employee stock option and warrant exercises, and received net cash proceeds of approximately $0.7 million. During the year ended December 31, 2019 During the year ended December 31, 2019 the Company issued 299,167 shares of Common Stock as a result of employee stock option exercises presented in the tables below, and received net cash proceeds of approximately $2.7 million. During the year ended December 31, 2019, the Company issued 19,122 shares of its Common Stock in relation to the cashless exercise of stock options that were granted outside of the Company's 2017 Long-Term Incentive Stock Plan (the "2017 Plan"). A total of 80,000 stock options were exercised with exercise prices between $10.00 and $15.00 per share. During the year ended December 31, 2019, the Company issued 11,000 shares of its Common Stock as a result of the exercise of stock purchase warrants with an exercise price of $10.00 per share for total proceeds of $110,000. During the year ended December 31, 2019 the Company issued 11,788 shares of its Common stock with an aggregate value of $160.9 thousand for services provided to the Company. Stock Options On September 8, 2017, the Company held its Annual Meeting of Stockholders (the “Annual Meeting”), at which time the 2017 Plan was approved by stockholder vote. The 2017 Plan allows the Company to grant both incentive stock options (“ISOs”) and non-qualified stock options (“NSOs”) to purchase a maximum of 400,000 shares of the Company's Common Stock. Under the terms of the 2017 Plan, ISOs may only be granted to Company employees and directors, while NSOs may be granted to employees, directors, advisors, and consultants. The Board has the authority to determine to whom options will be granted, the number of options, the term, and the exercise price. Options are to be granted at an exercise price not less than fair value for an ISO or an NSO. The vesting period is normally over a period of four years from the vesting date. The contractual term of an option is no longer than ten years. As of December 31, 2020, the Company had 161,342 shares available for future issuance under the 2017 Plan. Prior to adopting the 2017 Plan, the Company did not have a formal long-term incentive stock plan. Prior to the implementation of the 2017 Plan, the Company had discretion to provide designated employees of the Company and its affiliates, certain consultants, and advisors who perform services for the Company and its affiliates, and non-employee members of the Board and its affiliates with the opportunity to receive grants of non-qualified stock options (the "Pre-2017 Non-Qualified Stock Options"). All of the Pre-2017 Non-Qualified Stock Option Grants were intended to qualify as non-qualified stock options. There were no Pre-2017 Non-Qualified Stock Option Grants that were intended to qualify as incentive stock options. Stock option activity for the Pre-2017 Non-Qualified Stock Options for the years ended December 31, 2020 and 2019, is presented in the table below: Number of Weighted- Weighted- Aggregate Outstanding at December 31, 2018 2,885,500 $ 7.30 6.04 $ 20,633,100 Exercised (379,167) $ 9.03 Forfeited (5,833) $ 10.00 Outstanding at December 31, 2019 2,500,500 $ 7.03 5.05 $ 18,426,325 Exercised (20,000) $ 9.50 Forfeited (15,000) $ 10.00 Outstanding at December 31, 2020 2,465,500 $ 6.99 4.09 $ 2,773,190 Exercisable at December 31, 2020 2,430,502 $ 6.95 4.15 $ 2,773,190 During the years ended December 31, 2020 and 2019, the Company recognized approximately $1,235 and $152 thousand of non-cash expense related to vested Pre-2017 Non-Qualified Stock Options granted in prior periods. As of December 31, 2020, there is $0 of unrecognized compensation costs related to non-vested stock options. The 2017 Plan The assumptions used in the valuation of options granted under the 2017 Plan during the years ended December 31, 2020 and 2019 were as follows: Year Ended December 31, 2020 Year Ended December 31, 2019 Market value of stock on measurement date $8.79 to $13.60 $11.26 to $15.65 Risk-free interest rate 0.33% to 1.68% 1.67% to 2.57% Dividend yield — % — % Volatility factor 91% to 101% 104% to 139% Term (years) 5.5 to 6.25 5.5 to 6.25 Stock option activity for options granted under the 2017 Plan during the years ended December 31, 2020 and 2019 is presented in the table below: Number of Weighted- Weighted- Aggregate Outstanding at December 31, 2018 343,550 $ 28.97 8.95 $ 840 Granted 193,700 $ 13.82 Expired — Forfeited (45,300) $ 17.9 Outstanding at December 31, 2019 491,950 $ 24.08 8.43 $ 81,888 Granted 191,500 $ 12.12 Expired — Forfeited (71,690) $ 15.05 Balance at December 31, 2020 611,760 $ 21.39 7.85 $ — Exercisable at December 31, 2020 323,055 $ 26.01 7.25 $ — During the year ended December 31, 2020 and 2019, the Company recognized approximately $2.1 million and $3.0 million of non-cash expense related to vested options granted during these periods. As of December 31, 2020, there was approximately $1.3 million of unrecognized compensation costs related to non-vested stock options that were granted under the 2017 Plan. Restricted Stock Units Restricted stock activity during the year ended December 31, 2020 is presented in the following table. Number of Shares Grant Date Fair Value Per Share Restricted stock units outstanding December 31, 2019 27,000 $14.51 Restricted stock granted 49,600 $12.00 Restricted stock forfeited (27,000) $14.51 Restricted stock units outstanding December 31, 2020 49,600 $12.00 Twenty-five percent (25%) of the restricted stock units will vest on the one year anniversary of the vesting commencement date, and twenty-five percent (25%) will vest annually thereafter on the same day as the vesting commencement date. During the year ended December 31, 2020, the Company recognized approximately $0.2 million of non-cash expense related to restricted stock units. As of December 31, 2020, there was $0.3 million of total unrecognized compensation cost related to restricted stock units. Warrants Warrant activity for the years ended December 31, 2020 and 2019 is presented in the table below: Number of Weighted- Weighted- Aggregate Outstanding at December 31, 2018 353,610 $ 9.78 4.6 $ 1,651,165 Exercised (11,000) $ 10.00 Outstanding at December 31, 2019 342,610 $ 9.77 3.71 $ 1,585,084 Exercised (59,510) $ 10.00 Forfeited (4,300) $ 10.00 Outstanding at December 31, 2020 278,800 $ 9.72 3.51 $ 1,164 Exercisable at December 31, 2020 278,800 $ 9.72 3.51 $ 1,164 |
Potomac Amendment
Potomac Amendment | 12 Months Ended |
Dec. 31, 2020 | |
Investments, All Other Investments [Abstract] | |
Potomac Amendment | Potomac Amendment On April 12, 2017 (the “Potomac Effective Date”), the Company and Potomac Construction Limited (“Potomac”) entered into an amendment (the “Potomac Amendment”) to the following investment agreements with Potomac to provide for (in the case of Potomac Agreement No. 1 and Potomac Agreement No. 2 ), or modify (in the case of Potomac Agreement No. 3, Potomac Agreement No. 4 and Potomac Agreement No. 5 (each as defined below)), the Company’s right to buyback the Interest (as defined in each Potomac Amendment) in each Potomac Agreement (as defined below) from Potomac: (i) that certain Investment Agreement, dated as of April 16, 2013, as clarified by that certain letter agreement dated October 15, 2014 (“Potomac Agreement No. 1”); (ii) that certain Investment Agreement, dated as of May 30, 2013, as clarified by that certain letter agreement dated October 15, 2014 (“Potomac Agreement No. 2”); (iii) that certain Investment Agreement, dated as of September 9, 2014, as clarified by that certain letter agreement dated October 15, 2014 (“Potomac Agreement No. 3”); (iv) that certain Investment Agreement, dated as of October 31, 2014, as clarified by that certain letter agreement dated October 31, 2014 (“Potomac Agreement No. 4”); and (v) that certain Investment Agreement, dated as of December 8, 2015 (“Potomac Agreement No. 5”) ((i)–(v) collectively, the “Potomac Agreements” and, each, a “Potomac Agreement”). Under all of the Potomac Agreements listed above, any buyback rights provided in the Potomac Agreements or the Potomac Amendment have expired as of December 31, 2020. The Company granted Potomac the right to receive 2.5525% of the Net Profit (as defined in the Potomac Agreements) generated from OPNT003 (as defined in the Potomac Amendment). In the event that the Company is sold, Potomac will receive 2.5525% of the net proceeds of such sale, after the deduction of all expenses and costs related to such sale. Additionally, from the Potomac Effective Date until the four year anniversary of the Potomac Effective Date (the “Potomac OPNT003 Interest Buyback Expiration Date”), the Company may buyback all or any portion of the OPNT003 Interest (as defined in the Potomac Amendment) upon written notice to Potomac (the “Potomac OPNT003 Interest Buyback Notice), at the price of $382,875 per 2.5525% of OPNT003 Interest (the “Potomac OPNT003 Interest Buyback Amount”); provided, that in the event the Potomac OPNT003 Interest Buyback Notice is provided within 2.5 years of the Potomac Effective Date, the Company shall pay Potomac two times the Potomac OPNT003 Interest Buyback Amount within ten ten |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The Company recognizes deferred tax assets and liabilities using the asset and liability method. Deferred tax assets and liabilities are recorded based on the differences between the financial statement and tax bases of assets and liabilities and the tax rates in effect when these differences are expected to reverse. This method requires the reduction of deferred tax assets by a valuation allowance if, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. As of December 31, 2020, the Company’s deferred tax assets primarily relate to net operating loss (“NOL”) carryforwards that were derived from operating losses and stock based compensation from prior years. A full valuation allowance has been applied to the Company’s deferred tax assets. The valuation allowance will be reduced when and if the Company determines it is more likely than not that the related deferred income tax assets will be realized. At December 31, 2020, the Company had federal net operating loss carry forwards, which are available to offset future taxable income, of $7,740,730. The Company’s NOL carryforwards generated prior to January 1, 2018 of $2,504,711 can be carried forward to offset future taxable income for a period of 20 years for each tax year’s loss. These NOL carryforwards begin to expire in 2035. No provision was made for federal income taxes as the Company has NOLs. All of the Company's income tax years remained open for examination by taxing authorities. The provision for income taxes differs from the amounts which would be provided by applying the statutory federal income tax rate to the net loss before provision for income taxes for the following reasons: December 31, 2020 December 31, 2019 Net loss before taxes at statutory rate $ (352,562) $ 2,852,268 Permanent items 479,115 717,020 Temporary items 312,649 (2,169,777) Income tax expense at statutory rate 439,202 1,399,511 Valuation allowance (864,881) (1,576,746) Income tax benefit per books $ (425,679) $ (177,235) Net deferred tax assets consist of the following components as of: December 31, 2020 December 31, 2019 Net operating loss carryover at statutory rate $ 3,881,105 $ 3,960,658 Stock-based compensation expense 2,923,099 3,056,099 Fixed asset depreciation (38,863) (24,681) Intangibles amortization (1,081) (997) Other 307,044 103,604 Total $ 7,071,304 $ 7,094,683 Valuation allowance $ (7,071,304) $ (7,094,683) Net deferred tax asset $ — $ — The Company had no uncertain tax positions at December 31, 2020 and December 31, 2019. On December 22, 2017, H.R. 1, formally known as the Tax Cut and Jobs Act (the "Act") was enacted into law. The Act provides for significant tax law changes and modifications with varying effective dates. The major change that affects the Company is reducing the corporate income tax rate from 35% to 21%. In connection with the Company’s initial analysis of the impact of the Tax Act, no discrete net tax benefit or expense in the period ended December 31, 2017 is recorded. This is primarily due to the change in valuation allowance offsets a net benefit or expense for the corporate rate reduction. Open federal tax years are December 21, 2018 and December 31, 2019. Open state tax years are July 31, 2016 (California) December 31, 2017, December 31, 2018, and December 31, 2019. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events On January 4, 2021, the Company granted options to employees to purchase 15,300 shares of Common Stock at an exercise price of $11.60 per share, which represents the per share closing price of Common Stock on the dates of grant. These options were issued under the 2017 Plan and have a ten year term. The options vest as follows: 25% of the options vest starting March of 2021 through July of 2021 with 1/48th of the option shares vesting monthly thereafter. On January 26, 2021, the Company granted options to employees to purchase 114,310 shares of Common Stock at an exercise price of $12.15 per share, which represents the per share closing price of the Company’s Common Stock on the date of grant. These options were issued under the 2017 Plan and have a ten year term. The options vest as follows: 1/48th of the option vest every month on the anniversary of the grant date. On January 26, 2021, the Company also issued restricted common shares to certain employees for 61,043 shares of Common Stock. The price of the Common Stock on the date of issuance was $12.15 per share. The restricted stock options ("RSU") were issued under the 2017 Plan. Of the 61,043 RSU's issued, 47,250 vest 25% each year for the next four years on the anniversary of the grant date, and 13,793 of the RSU's vest 100% on the one year anniversary of the issue date. On February 10th and 11th, 2021, 20,000 options were exercised at a price of $6.00 per share. The Company received $120,000 of cash proceeds from the option exercises. On February 11th, 2021, 7,000 options were exercised at a price of $10.00 per share. The Company received $70,000 of cash proceeds from the option exercises. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Basis of Presentation | The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and the applicable rules and regulations of the Securities and Exchange Commission (“SEC”). |
Principles of Consolidation | The consolidated financial statements have been prepared in accordance with GAAP and include the accounts for the Company and its wholly-owned subsidiary, Opiant Pharmaceuticals UK Limited. All inter-company transactions and balances have been eliminated in consolidation. |
Use of Estimates | The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, and reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. |
Cash and Cash Equivalents | The Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. Cash and cash equivalents were $48.3 million, and $31.0 million at December 31, 2020 and December 31, 2019. The Company maintains cash balances at financial institutions insured up to $250,000 by the Federal Deposit Insurance Corporation ("FDIC") and as of December 31, 2020 maintains the majority of its cash balances in money market funds not insured by the FDIC. The Company also transfers certain daily available cash balances to an overnight account which earns interest and the amounts are not insured by the FDIC. Balances in the United Kingdom are insured up to £85,000 by the Financial Services Compensation Scheme (United Kingdom Equivalent). Although the Company’s cash balances exceeded these insured amounts, the Company has not experienced any losses on its cash and cash equivalents for the periods presented. |
Accounts Receivable | The Company routinely assesses the recoverability of receivables to determine collectability by considering factors such as historical experience, credit quality, the age of the accounts receivable balances, and current economic conditions that may affect a customer's ability to pay. The Company determines its allowance for doubtful accounts by considering such factors as the length of time balances are past due, the Company’s previous loss history, the customer’s current ability to pay its obligations to the Company and the condition of the general economy and the industry as a whole. |
Long-Lived Assets | The Company follows ASC 360, Property, Plant, and Equipment , for its fixed assets. Property and equipment is stated at cost less accumulated depreciation. Depreciation is computed by the straight-line method over estimated useful lives (3 to7 years). The Company capitalizes all asset purchases greater than $2,500 having a useful life greater than one year. The Company follows ASC 350, Intangibles – Goodwill and Other for its intellectual property asset. Intellectual property consists of patents which are stated at their fair value acquisition cost. Amortization is calculated by the straight-line method over their estimated useful lives (20 years). The Company recorded depreciation and amortization of $123,680 and $60,809 for the years ended December 31, 2020 and 2019, respectively. Long-lived assets such as property and equipment and identifiable intangibles are reviewed for impairment whenever facts and circumstances indicate that the carrying value may not be recoverable. When required, impairment losses on assets to be held and used are recognized based on the fair value of the asset. The fair value is determined based on estimates of future cash flows, market value of similar assets, if available, or independent appraisals, if required. If the carrying amount of the long-lived asset is not recoverable from its undiscounted cash flows, an impairment loss is recognized for the difference between the carrying amount and fair value of the asset. When fair values are not available, the Company estimates fair value using the expected future cash flows discounted at a rate commensurate with the risk associated with the recovery of the assets. The Company did not recognize any impairment losses for any years presented. |
Earnings (Loss) per Share | The Company follows ASC 260, Earnings per Share . Basic earnings (loss) per share is computed by dividing the net income (loss) available to common stockholders by the weighted-average number of shares of Common Stock outstanding during the respective period presented in the Company’s accompanying consolidated financial statements. Fully diluted earnings (loss) per share is computed similar to basic income (loss) per share except that the denominator is increased to include the number of Common Stock equivalents (primarily outstanding options and warrants). Common Stock equivalents represent the dilutive effect of the assumed exercise of outstanding stock options and warrants, using the treasury stock method, at either the beginning of the respective period presented or the date of issuance, whichever is later, and only if the Common Stock equivalents are considered dilutive based upon the Company’s net income position at the calculation date. |
Research and Development Costs | The Company follows ASC 730, Research and Development , and expenses all research and development costs as incurred for which there is no alternative future use. These costs also include the expensing of employee compensation and employee stock based compensation |
Foreign Currency Translation | The Company’s functional and reporting currency is the United States dollar. The functional currency of the Company's wholly-owned subsidiary, Opiant Pharmaceuticals UK Limited ("Opiant UK") is the British Pound, its local currency. Consequently, the assets and liabilities are translated at current rates of exchange at the balance sheet date. Income and expense items are translated at the average foreign currency exchange rates for the period. Adjustments resulting from the translation of the financial statements of Opiant UK, into U.S. dollars, the reporting currency, are excluded from the determination of net loss and are recorded in accumulated other comprehensive income or loss, a separate component of equity. Gains and losses arising on settlement of foreign currency denominated transactions or balances are included in the determination of income. |
Stock-Based Compensation | ASC 718 Compensation – Stock Compensation prescribes accounting and reporting standards for all share-based payment transactions in which employee services are acquired. Transactions include incurring liabilities, or issuing or offering to issue shares, options, and other equity instruments such as employee stock ownership plans and stock appreciation rights. Share-based payments to employees, including grants of employee stock options, are recognized as compensation expense in the consolidated financial statements based on their fair values. That expense is recognized over the period during which an employee is required to provide services in exchange for the award, known as the requisite service period (usually the vesting period). In June 2018, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) No. 2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Non-employee Share-Based Payment Accounting, which aligns the accounting for share-based payment awards issued to non-employees with the guidance applicable to grants to employees. Under this new standard, equity-classified share-based payment awards issued to non-employees will be measured on the grant date, instead of the current requirement to remeasure the awards through the performance completion date. Further, compensation cost for awards with performance conditions will be recognized when it is probable the conditions will be achieved, rather than upon actual achievement of the conditions. The Company adopted this standard January 1, 2019. The adoption of this guidance did not have a material impact on the Company's consolidated financial statements. |
Fair Value of Financial Instruments | ASC 820 Fair Value Measurements and Disclosures defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy that distinguishes between (1) market participant assumptions developed based on market data obtained from independent sources (observable inputs) and (2) an entity’s own assumptions about market participant assumptions developed based on the best information available in the circumstances (unobservable inputs). The fair value hierarchy consists of three broad levels, which gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3). The three levels of the fair value hierarchy are described below: Level 1 - Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities. Level 2 - Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly, including quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar assets or liabilities in markets that are not active; inputs other than quoted prices that are observable for the asset or liability (e.g., interest rates); and inputs that are derived principally from or corroborated by observable market data by correlation or other means. Level 3 - Inputs that are both significant to the fair value measurement and unobservable. The carrying value of certain on-balance-sheet financial instruments approximated their fair values due to the short-term nature of these instruments. These financial instruments include cash and cash equivalents, accounts receivable, accounts payable, and long-term debt. The carrying value of long-term debt approximates fair value since the related rate of interest approximates current market rates. |
Revenue Recognition | The Company generates a large majority of revenue from the agreement with EBS. During the year ended December 31, 2020, the Company recognized 93% of revenue from its agreement with EBS. In May 2014, the FASB issued an accounting standard update ("ASU”), 2014-09, Revenue from Contracts with Customers (Topic 606). This ASU amends the existing accounting standards for revenue recognition and is based on the principle that revenue should be recognized to depict the transfer of goods or services to a customer at an amount that reflects the consideration a company expects to receive in exchange for those goods or services. On January 1, 2018, the Company adopted the new Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers using the modified retrospective method, and the Company determined the new guidance does not change the Company's policy of revenue recognition. The Company's primary source of revenue is through the recognition of royalty and milestone payments from EBS. Milestone revenue is recognized upon successful accomplishment of certain sales targets set forth in the EBS Agreement. Royalty revenue is determined based on the agreed upon royalty rate applied to NARCAN® sales reported by EBS. There are no performance obligations by the Company and the Company recognizes revenue according to the royalty report provided by EBS on a quarterly basis. In regards to treatment revenue, the Company received certain investments from investors in return for an interest in its existing treatments. Investors carry an option to exchange investment into shares of the Company. Revenue is deferred until such time that the option expires or milestones are achieved that eliminate the investor’s right to exercise the option. Once the option has expired, the Company determined its performance obligations under the agreement which typically is to perform R&D services related to treatments and recognizes revenue over a period of time which is usually the expected research and development period. The treatment revenue is disaggregated by program treatments. (See Note 8 to the Consolidated Financial Statements - Revenue). In June 2018, the FASB issued guidance clarifying the revenue recognition and measurement issues for grants, contracts, and similar arrangements, ASU Topic 958. Government grants and contracts are agreements that generally provide cost reimbursement for certain types of expenditures in return for research and development activities over a contractually defined period. The Company has evaluated its grant with National Institutes of Health (“NIH”) and the contract with Biomedical Advanced Research and Development Authority (“BARDA”) and determined they are non-exchange transactions and fall within the scope of ASU 958, and revenue should be recognized in accordance with Topic 958 guidance. Accordingly, the Company recognizes revenue from its grant and contract in the period during which the related costs are incurred, provided that the conditions under which the grants and contracts were provided have been met and only perfunctory performance obligations are outstanding. Licensing Agreement Pursuant to the Adapt Agreement, the Company provided a global license to develop and commercialize the Company’s intranasal naloxone opioid overdose reversal treatment, now known as NARCAN®. On December 15, 2014, the Company entered into a License Agreement (the "Adapt Agreement") with Adapt Pharma Operations Limited (“Adapt”), an Ireland based pharmaceutical company. Emergent BioSolutions, Inc acquired Adapt in October 2018 and Adapt became its wholly owned subsidiary (collectively with Adapt, “EBS”). Pursuant to the Adapt Agreement, we provided a global license to develop and commercialize our intranasal naloxone opioid overdose reversal treatment, now known as NARCAN®. In addition, on the SWK Closing Date, in connection with the SWK Purchase Agreement, as disclosed below, we entered into the EBS Amendment which amends the terms of the Adapt Agreement relating to the grant of a commercial sublicense outside of the United States and diligence efforts for commercialization of our Opioid Overdose Reversal Treatment Product. Under the terms of the EBS Amendment, EBS is required to use commercially reasonable efforts to commercialize the Opioid Overdose Reversal Treatment Product in the United States. In the event that EBS wishes to grant a commercial sublicense to a third party in the European Union or the United Kingdom, we have agreed to negotiate an additional amendment to the Adapt Agreement to include reduced financial terms with respect to the commercial sublicense. The Company also receives payments upon reaching various sales and regulatory milestones, as well as royalty payments for commercial sales of NARCAN® generated by EBS. During the years ended December 31, 2020 and 2019, the Company recognized royalty and milestone revenue of $27.4 million and $37.6 million, respectively. Interest in Treatments With respect to investments in interests in treatments, if an agreement provides an option that allows the investor in the treatment to convert an interest in a treatment into shares of Common Stock, then revenue is deferred until such time that the option expires or milestones are achieved that eliminate the investor’s right to exercise the option. Upon expiration of the exercise option, the deliverables of the arrangement are reviewed and evaluated under ASC 606. In the event the investor chooses to convert interests into shares of Common Stock, that transaction will be accounted for similar to a sale of shares of Common Stock for cash. |
Recently Issued Accounting Pronouncements | From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board, or FASB, or other standard setting bodies and adopted by us as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s financial position or results of operations upon adoption. The Company has considered all other recently issued accounting pronouncements and does not believe the adoption of such pronouncements will have a material impact on its consolidated financial statements. Recently Issued Accounting Pronouncements Not Yet Adopted In August 2020, the FASB issued ASU No. 2020-06, "Accounting for Convertible Instruments and Contracts in an Entity's Own Equity." This new standard simplifies and adds disclosure requirements for the accounting and measurement of convertible instruments. It eliminates the treasury stock method for convertible instruments and requires application of the “if-converted” method for certain agreements. This standard is effective for the Company for fiscal years, and interim periods within those years, beginning January 1, 2022. Early adoption is permitted, but no earlier than fiscal years beginning January 1, |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Schedule of Earnings Per Share, Basic and Diluted | The following table illustrates the dilutive effect of the assumed exercise of the Company’s outstanding stock options and warrants, using the treasury stock method, for the year ended December 31, 2020 and 2019: Year Ended Year Ended Numerator: December 31, 2020 December 31, 2019 Net Income (loss) $ (1,861,449) $ 11,593,050 Denominator: Denominator for basic income (loss) per share - weighted average shares 4,249,832 4,018,464 Effect of dilutive securities: Stock options and warrants — 1,323,914 Denominator for diluted income (loss) per share 4,249,832 5,342,378 Income (loss) per share - Basic $ (0.44) $ 2.88 Income (loss) per share - Diluted $ (0.44) $ 2.17 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Leases [Abstract] | |
Summary of Operating Leases | The following table summarizes information related to the Company's two operating leases and are included in the Company's Balance Sheet as of December 31, 2020. Balance Sheet descriptions Assets: (in thousands) Right of use assets - operating leases $ 278 Liabilities: Operating leases - current $ 282 Operating leases - long term — Total lease liabilities $ 282 |
Summary of Components of Operating Lease Cost | The following table summarizes the components of operating lease cost for the year ended December 31, 2020. Lease costs (in thousands) Operating expenses - lease costs $ 574 |
Maturity of Operating Lease Liabilities | As of December 31, 2020, future minimum operating leases payments related to the Company’s operating lease liabilities were as follows: (in thousands) 2021 290 Total lease payments 290 Less imputed interest (8) Present value of operating lease liabilities $ 282 |
Revenue (Tables)
Revenue (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of Deferred Revenue | The following is a summary of the Company’s deferred revenue activity for the years ended December 31, 2020 and 2019: (in thousands) NIH Grant BED Total Balance as of December 31, 2018 $ 568 $ 644 $ 1,212 Cash Received from NIH 2,400 — 2,400 Recognized as revenue (2,050) (644) (2,694) Balance as of December 31, 2019 $ 918 $ — $ 918 Cash Received from NIH 1,000 — 1,000 Recognized as revenue (1,563) — (1,563) Balance as of December 31, 2020 $ 355 $ — $ 355 Deferred Revenue (in thousands) NIH Grant BED Total Current portion $ 355 $ — $ 355 Long-term portion — — — Total $ 355 $ — $ 355 |
Royalty Payable (Tables)
Royalty Payable (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Payables and Accruals [Abstract] | |
Schedule of Royalty Payable | The following table sets forth the royalty payable to certain investors as of December 31, 2020 and 2019: (in thousands) Net Profit % December 31, 2020 December 31, 2019 Potomac 10.2% $ 822 $ 698 LYL 5.0% 402 341 Welmers 1.5% 121 103 Foundation 6.0% 483 410 Pendergast 1.0% 80 68 Royalty payable 23.7% $ 1,908 $ 1,620 |
Stockholder's Equity (Tables)
Stockholder's Equity (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Stockholders' Equity Note [Abstract] | |
Schedule of Share-based Compensation, Stock Options, Activity | Stock option activity for the Pre-2017 Non-Qualified Stock Options for the years ended December 31, 2020 and 2019, is presented in the table below: Number of Weighted- Weighted- Aggregate Outstanding at December 31, 2018 2,885,500 $ 7.30 6.04 $ 20,633,100 Exercised (379,167) $ 9.03 Forfeited (5,833) $ 10.00 Outstanding at December 31, 2019 2,500,500 $ 7.03 5.05 $ 18,426,325 Exercised (20,000) $ 9.50 Forfeited (15,000) $ 10.00 Outstanding at December 31, 2020 2,465,500 $ 6.99 4.09 $ 2,773,190 Exercisable at December 31, 2020 2,430,502 $ 6.95 4.15 $ 2,773,190 Number of Weighted- Weighted- Aggregate Outstanding at December 31, 2018 343,550 $ 28.97 8.95 $ 840 Granted 193,700 $ 13.82 Expired — Forfeited (45,300) $ 17.9 Outstanding at December 31, 2019 491,950 $ 24.08 8.43 $ 81,888 Granted 191,500 $ 12.12 Expired — Forfeited (71,690) $ 15.05 Balance at December 31, 2020 611,760 $ 21.39 7.85 $ — Exercisable at December 31, 2020 323,055 $ 26.01 7.25 $ — |
Schedule of Assumptions Used in the Valuation | The assumptions used in the valuation of options granted under the 2017 Plan during the years ended December 31, 2020 and 2019 were as follows: Year Ended December 31, 2020 Year Ended December 31, 2019 Market value of stock on measurement date $8.79 to $13.60 $11.26 to $15.65 Risk-free interest rate 0.33% to 1.68% 1.67% to 2.57% Dividend yield — % — % Volatility factor 91% to 101% 104% to 139% Term (years) 5.5 to 6.25 5.5 to 6.25 |
Schedule of Nonvested Restricted Stock Units Activity | Restricted stock activity during the year ended December 31, 2020 is presented in the following table. Number of Shares Grant Date Fair Value Per Share Restricted stock units outstanding December 31, 2019 27,000 $14.51 Restricted stock granted 49,600 $12.00 Restricted stock forfeited (27,000) $14.51 Restricted stock units outstanding December 31, 2020 49,600 $12.00 |
Schedule of Share-based Compensation, Warrant Activity | Warrant activity for the years ended December 31, 2020 and 2019 is presented in the table below: Number of Weighted- Weighted- Aggregate Outstanding at December 31, 2018 353,610 $ 9.78 4.6 $ 1,651,165 Exercised (11,000) $ 10.00 Outstanding at December 31, 2019 342,610 $ 9.77 3.71 $ 1,585,084 Exercised (59,510) $ 10.00 Forfeited (4,300) $ 10.00 Outstanding at December 31, 2020 278,800 $ 9.72 3.51 $ 1,164 Exercisable at December 31, 2020 278,800 $ 9.72 3.51 $ 1,164 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Income Tax Expense (Benefit) | The provision for income taxes differs from the amounts which would be provided by applying the statutory federal income tax rate to the net loss before provision for income taxes for the following reasons: December 31, 2020 December 31, 2019 Net loss before taxes at statutory rate $ (352,562) $ 2,852,268 Permanent items 479,115 717,020 Temporary items 312,649 (2,169,777) Income tax expense at statutory rate 439,202 1,399,511 Valuation allowance (864,881) (1,576,746) Income tax benefit per books $ (425,679) $ (177,235) |
Schedule of Deferred Tax Assets and Liabilities | Net deferred tax assets consist of the following components as of: December 31, 2020 December 31, 2019 Net operating loss carryover at statutory rate $ 3,881,105 $ 3,960,658 Stock-based compensation expense 2,923,099 3,056,099 Fixed asset depreciation (38,863) (24,681) Intangibles amortization (1,081) (997) Other 307,044 103,604 Total $ 7,071,304 $ 7,094,683 Valuation allowance $ (7,071,304) $ (7,094,683) Net deferred tax asset $ — $ — |
Liquidity and Financial Condi_2
Liquidity and Financial Condition (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Net income (loss) | $ (1,861,449) | $ 11,593,050 |
Accumulated deficit | 64,689,065 | 62,827,616 |
Working capital | 52,700,000 | |
Proceeds from debt offering | 18,700,000 | |
Proceeds from exercise of options and warrants | $ 685,100 | $ 2,675,420 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Cash and Cash Equivalents (Details) | Dec. 31, 2020USD ($) | Dec. 31, 2020EUR (€) | Dec. 31, 2019USD ($) |
Cash and Cash Equivalents [Line Items] | |||
Cash and cash equivalents | $ 48,251,336 | $ 30,980,473 | |
Cash balances at financial institutions | $ 250,000 | ||
United Kingdom | |||
Cash and Cash Equivalents [Line Items] | |||
Cash balances at financial institutions | € | € 85,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Accounts Receivable (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Accounting Policies [Abstract] | ||
Allowance for doubtful accounts | $ 0 | $ 0 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Long-Lived Assets (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Property, Plant and Equipment [Line Items] | ||
Capitalized asset purchase price (greater than) | $ 2,500 | |
Finite-lived intangible asset, useful life | 20 years | |
Depreciation and amortization | $ 123,680 | $ 60,809 |
Impairment of long-lived assets | $ 0 | $ 0 |
Minimum | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, useful life | 3 years | |
Maximum | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, useful life | 7 years |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Schedule of Earnings (Loss) Per Share (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Basic: | ||
Net Income (loss) | $ (1,861,449) | $ 11,593,050 |
Denominator: | ||
Denominator for basic income (loss) per share - weighted average shares (in shares) | 4,249,832 | 4,018,464 |
Effect of dilutive securities | ||
Stock options and warrants (in shares) | 0 | 1,323,914 |
Denominator for diluted income (loss) per share (in shares) | 4,249,832 | 5,342,378 |
Income (loss) per share - Basic (in dollars per share) | $ (0.44) | $ 2.88 |
Income (loss) per share - Diluted (in dollars per share) | $ (0.44) | $ 2.17 |
Employee Stock Option | ||
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | ||
Anti-dilutive securities (in shares) | 3,077,260 | |
Warrant | ||
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | ||
Anti-dilutive securities (in shares) | 278,800 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Stock-Based Compensation (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Accounting Policies [Abstract] | ||
Share-based compensation | $ 2,279,496 | $ 3,197,384 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Fair Value of Financial Instruments (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial liabilities, fair value | $ 0 | $ 0 |
Summary of Significant Accou_10
Summary of Significant Accounting Policies - Revenue Recognition (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Disaggregation of Revenue [Line Items] | ||
Royalty and licensing revenue | $ 29,625,181 | $ 40,519,800 |
Revenue Benchmark | Adapt Agreement | ||
Disaggregation of Revenue [Line Items] | ||
Percent of revenue recognized | 93.00% | |
Royalty and licensing revenue | ||
Disaggregation of Revenue [Line Items] | ||
Royalty and licensing revenue | $ 27,401,919 | $ 37,592,401 |
Accounts Receivable (Details)
Accounts Receivable (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Accounts receivable | $ 8,910,975 | $ 7,218,367 |
Royalty Revenue from Sales of NARCAN | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Accounts receivable | $ 8,300,000 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Long-term Purchase Commitment [Line Items] | ||
Prepaid expenses and other current assets | $ 1,936,842 | $ 1,055,816 |
Prepaid expense | 1,000,000 | 400,000 |
Research and Development Arrangement | ||
Long-term Purchase Commitment [Line Items] | ||
Payments to acquire in-process research and development | $ 900,000 | $ 700,000 |
Leases - Narrative (Details)
Leases - Narrative (Details) | 12 Months Ended | ||
Dec. 31, 2020USD ($)lease | Dec. 31, 2019USD ($) | Jan. 01, 2019USD ($) | |
Leases [Abstract] | |||
Number operating leases | lease | 2 | ||
Estimated incremental borrowing rate | 9.00% | ||
Right of use assets - operating leases | $ 278,455 | $ 768,441 | $ 949,000 |
Present value of operating lease liabilities | $ 282,000 | $ 949,000 | |
Operating lease, weighted average discount rate, percent | 9.00% | ||
Operating lease, weighted average remaining lease term | 6 months 18 days |
Leases - Balance Sheet Descript
Leases - Balance Sheet Descriptions of Operating Leases (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 01, 2019 |
Assets: | |||
Right of use assets - operating leases | $ 278,455 | $ 768,441 | $ 949,000 |
Liabilities: | |||
Operating leases - current | 282,421 | 516,931 | |
Operating leases - long term | 0 | $ 254,664 | |
Total lease liabilities | $ 282,000 | $ 949,000 |
Leases - Components of Operatin
Leases - Components of Operating Lease Cost (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Leases [Abstract] | |
Operating expenses - lease costs | $ 574 |
Leases - Maturity of Operating
Leases - Maturity of Operating Lease Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Jan. 01, 2019 |
Leases [Abstract] | ||
2021 | $ 290 | |
Total lease payments | 290 | |
Less imputed interest | (8) | |
Present value of operating lease liabilities | $ 282 | $ 949 |
Other Non-Current Assets - Narr
Other Non-Current Assets - Narrative (Details) $ in Millions | Dec. 31, 2020USD ($) |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Other non-current assets | $ 1.1 |
Revenue - Narrative (Details)
Revenue - Narrative (Details) - USD ($) | Dec. 11, 2020 | Sep. 19, 2018 | Jul. 20, 2015 | Sep. 17, 2014 | Dec. 17, 2013 | Mar. 31, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Mar. 31, 2021 | Apr. 17, 2018 |
Disaggregation of Revenue [Line Items] | ||||||||||||
Proceeds from funding agreement | $ 250,000 | $ 500,000 | $ 250,000 | |||||||||
Interest in asset | 0.50% | 1.00% | 0.50% | |||||||||
Number of shares issuable term | 60 days | 60 days | ||||||||||
Number of shares issuable (in shares) | 62,500 | 31,250 | ||||||||||
Grants receivable | $ 7,400,000 | |||||||||||
Total Revenue | $ 29,625,181 | $ 40,519,800 | ||||||||||
Deferred revenue, period increase (decrease) | 1,000,000 | $ 2,400,000 | ||||||||||
Deferred revenue as a current liability | 354,756 | 918,272 | ||||||||||
Research and Development Arrangement December 17, 2013 | ||||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||||
Recognized as revenue | 0 | 115,900 | ||||||||||
Research and Development Arrangement September 17, 2014 | ||||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||||
Recognized as revenue | 0 | 313,700 | ||||||||||
Research and Development Arrangement July 20, 2015 | ||||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||||
Recognized as revenue | 0 | $ 214,300 | ||||||||||
Research And Development Arrangement September 19, 2018 | ||||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||||
Total Revenue | 700,000 | |||||||||||
Grant | ||||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||||
Total Revenue | 1,600,000 | $ 2,000,000 | ||||||||||
Grant | Scenario, Forecast | ||||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||||
Total Revenue | $ 1,800,000 | $ 5,600,000 | ||||||||||
Biomedical Advanced Research and Development Authority (BARDA) | ||||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||||
Proceeds from funding agreement | $ 3,500,000 | |||||||||||
Biomedical Advanced Research and Development Authority (BARDA) | Scenario, Forecast | ||||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||||
Proceeds from funding agreement | $ 6,500,000 | |||||||||||
Biomedical Advanced Research and Development Authority (BARDA) | Plan | ||||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||||
Proceeds from funding agreement | $ 4,600,000 | $ 8,100,000 |
Revenue - Summary of Deferred R
Revenue - Summary of Deferred Revenue Activity (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Movement in Deferred Revenue [Roll Forward] | ||
Balance at beginning of period | $ 918 | $ 1,212 |
Cash Received from NIH | 1,000 | 2,400 |
Recognized as revenue | (1,563) | (2,694) |
Balance at end of period | 355 | 918 |
NIH Grant | ||
Movement in Deferred Revenue [Roll Forward] | ||
Balance at beginning of period | 918 | 568 |
Cash Received from NIH | 1,000 | 2,400 |
Recognized as revenue | (1,563) | (2,050) |
Balance at end of period | 355 | 918 |
BED | ||
Movement in Deferred Revenue [Roll Forward] | ||
Balance at beginning of period | 0 | 644 |
Cash Received from NIH | 0 | 0 |
Recognized as revenue | 0 | (644) |
Balance at end of period | $ 0 | $ 0 |
Revenue - Summary Current vs. L
Revenue - Summary Current vs. Long Term Deferred Revenue (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Disaggregation of Revenue [Line Items] | |||
Current portion | $ 354,756 | $ 918,272 | |
Long-term portion | 0 | ||
Total | 355,000 | 918,000 | $ 1,212,000 |
NIH Grant | |||
Disaggregation of Revenue [Line Items] | |||
Current portion | 355,000 | ||
Long-term portion | 0 | ||
Total | 355,000 | 918,000 | 568,000 |
BED | |||
Disaggregation of Revenue [Line Items] | |||
Current portion | 0 | ||
Long-term portion | 0 | ||
Total | $ 0 | $ 0 | $ 644,000 |
License Fee Payable (Details)
License Fee Payable (Details) - USD ($) | Mar. 18, 2019 | Mar. 01, 2018 | Sep. 30, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Feb. 28, 2018 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Percent of counterparty payable offset by guarantor | 50.00% | ||||||
Proceeds from milestone payments | $ 6,100,000 | ||||||
License fee payment | 5,600,000 | ||||||
License fees payable | $ 8,100,000 | ||||||
License fees | $ 5,400,000 | ||||||
License fees | $ 18,700,546 | $ 0 | $ 2,700,000 | ||||
Net sales | $ 29,625,181 | 40,519,800 | |||||
License Agreement | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Percent of royalties payable under license agreement | 90.00% | ||||||
Adapt | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Reduction in Milestone Payment | $ 6,250,000 | ||||||
Adapt | SWK Purchase Agreement | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Milestone payment to be received if requirements are met | $ 2,700,000 | ||||||
Third Party Licensee | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Maximum reduction in quarterly royalty payable payments in next twelve months | $ 9,000,000 | ||||||
SWK Funding LLC | SWK Purchase Agreement | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Percent of royalties payable under license agreement | 10.00% | ||||||
EBS | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Maximum reduction in quarterly royalty payable payments in next twelve months | $ 1,800,000 | ||||||
Narcan | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
License fees | $ 8,100,000 | ||||||
Minimum sales requirement for milestone payment | 200,000,000 | ||||||
Milestone payment to be received if requirements are met | 15,000,000 | ||||||
Narcan | License Agreement | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Milestone payment to be received if requirements are met | $ 13,500,000 | ||||||
Narcan | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Net sales | $ 200,000,000 |
Royalty Payable (Details)
Royalty Payable (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Schedule of Royalties [Line Items] | ||
Net Profit % | 23.70% | |
Royalty payable | $ 1,908 | $ 1,620 |
Potomac | ||
Schedule of Royalties [Line Items] | ||
Net Profit % | 10.20% | |
Royalty payable | $ 822 | 698 |
LYL | ||
Schedule of Royalties [Line Items] | ||
Net Profit % | 5.00% | |
Royalty payable | $ 402 | 341 |
Welmers | ||
Schedule of Royalties [Line Items] | ||
Net Profit % | 1.50% | |
Royalty payable | $ 121 | 103 |
Foundation | ||
Schedule of Royalties [Line Items] | ||
Net Profit % | 6.00% | |
Royalty payable | $ 483 | 410 |
Pendergast | ||
Schedule of Royalties [Line Items] | ||
Net Profit % | 1.00% | |
Royalty payable | $ 80 | $ 68 |
Long Term Debt (Details)
Long Term Debt (Details) | Dec. 10, 2020USD ($)tranche$ / shares | Dec. 31, 2020$ / shares | Dec. 31, 2019$ / shares |
Line of Credit Facility [Line Items] | |||
Common stock, par value (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | |
Loan Agreement | |||
Line of Credit Facility [Line Items] | |||
Aggregate principal amount | $ 50,000,000 | ||
Number of tranche | tranche | 3 | ||
Average interest rate | 8.75% | ||
Interest on outstanding loans | 30 months | ||
Conversion price par value (in dollars per share) | $ / shares | $ 19.64 | ||
Debt fees | $ 1,300,000 | ||
Amortization of debt fees | 16,000 | ||
Loan Agreement | Tranche One | |||
Line of Credit Facility [Line Items] | |||
Aggregate principal amount | 20,000,000 | ||
Amount received the first tranche | 20,000,000 | ||
Loan Agreement | Tranche Two | |||
Line of Credit Facility [Line Items] | |||
Aggregate principal amount | 10,000,000 | ||
Loan Agreement | Tranche Three | |||
Line of Credit Facility [Line Items] | |||
Aggregate principal amount | $ 20,000,000 |
Commitments and Contingencies -
Commitments and Contingencies - 2014 Agreement (Details) - USD ($) | Sep. 30, 2019 | Dec. 31, 2020 |
Other Commitments [Line Items] | ||
Pay fees equivalent | 3.375% | |
Accrued liabilities | $ 281,684 | |
Stock issued during the period (in shares) | 11,788 | |
Torreya | ||
Other Commitments [Line Items] | ||
Advisory fees | $ 924,972 |
Commitments and Contingencies_2
Commitments and Contingencies - Binding LOI (Details) - USD ($) | Dec. 19, 2019 | Sep. 30, 2019 | Nov. 19, 2015 | Sep. 30, 2019 | Dec. 31, 2020 | Dec. 31, 2019 |
Other Commitments [Line Items] | ||||||
Stock issued during the period (in shares) | 11,788 | |||||
Non-cash research and development expense | $ 177,409 | $ 9,240,020 | $ 9,079,351 | |||
Gain on settlement of liability | $ 16,503 | |||||
Letter of Intent | ||||||
Other Commitments [Line Items] | ||||||
Stock issued during the period (in shares) | 14,327 | |||||
Stock issued during the period | $ 120,300 | |||||
Additional stock issued during the period, upon milestones (in shares) | 92,634 | |||||
Narcan | ||||||
Other Commitments [Line Items] | ||||||
Shares issued sales exceed amount | $ 200,000,000 |
Commitments and Contingencies_3
Commitments and Contingencies - Sublease Agreement (Details) £ in Thousands, $ in Thousands | Jul. 22, 2020USD ($) | Jul. 11, 2019GBP (£) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) |
Other Commitments [Line Items] | ||||
Rent expense | £ | £ 20 | |||
Standish Management, LLC | ||||
Other Commitments [Line Items] | ||||
Rent expense | $ 578 | $ 523 | ||
Summit BioScience, Inc. | ||||
Other Commitments [Line Items] | ||||
Agreement expense | $ 7,200 | |||
Deposit payment | $ 1,100 |
Commitments and Contingencies_4
Commitments and Contingencies - License Agreement (Details) £ in Thousands | Jul. 11, 2019GBP (£) | Jun. 22, 2017USD ($)trading_daypayment | Oct. 28, 2020USD ($) | Oct. 26, 2020USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) |
Other Commitments [Line Items] | ||||||
Rent expense | £ | £ 20 | |||||
License Agreement Cost | $ 250,000 | |||||
Development program cost | $ 5,200,000 | |||||
Severance costs | $ 1,200,000 | |||||
License Agreement | ||||||
Other Commitments [Line Items] | ||||||
Upfront payments | payment | 2 | |||||
Percent of upfront payments which may be paid by issuing common stock | 50.00% | |||||
Percent of average share price | 75.00% | |||||
Threshold trading days | trading_day | 20 | |||||
Rent expense | $ 0 | $ 0 | ||||
Maximum additional product milestone payments | $ 1,800,000 | |||||
Maximum additional commercialization milestone payments | $ 5,000,000 | |||||
Termination advance notice period | 30 days | |||||
Supply Agreement | ||||||
Other Commitments [Line Items] | ||||||
Other commitment, period | 20 years | |||||
Material cure period | 60 days |
Stockholder's Equity - Common S
Stockholder's Equity - Common Stock (Details) - USD ($) | Sep. 30, 2019 | Dec. 31, 2020 | Dec. 31, 2019 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock issued during the period (in shares) | 11,788 | ||
Proceeds from stock options exercised | $ 700,000 | ||
Exercise of stock options (in shares) | 299,167 | ||
Proceeds from exercise of options and warrants | $ 685,100 | $ 2,675,420 | |
Stock issued during period for services (in shares) | 11,788 | ||
Stock issued during period, value, issued for services | $ 160,906 | ||
Exercise Price Range, $10.00 to $15.00 | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock options exercisable (in shares) | 80,000 | ||
Exercise Price, $10.00 | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Proceeds from exercise of options and warrants | $ 110,000 | ||
Minimum | Exercise Price Range, $10.00 to $15.00 | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise price of options (in dollars per share) | $ 10 | ||
Maximum | Exercise Price Range, $10.00 to $15.00 | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise price of options (in dollars per share) | $ 15 | ||
Common Stock | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock issued during the period (in shares) | 71,667 | ||
Exercise of stock options (in shares) | 12,157 | 318,289 | |
Stock issued during period for services (in shares) | 11,788 | ||
Stock issued during period, value, issued for services | $ 12 | ||
Common Stock | Exercise Price Range, $10.00 to $15.00 | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock issued during the period (in shares) | 19,122 | ||
Common Stock | Exercise Price, $10.00 | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock issued during the period (in shares) | 11,000 | ||
Warrant | Exercise Price, $10.00 | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Price of warrant (in dollars per share) | $ 10 |
Stockholder's Equity - Stock Op
Stockholder's Equity - Stock Options (Details) - 2017 Plan - Employee Stock Option - shares | 12 Months Ended | |
Dec. 31, 2020 | Sep. 08, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Maximum shares authorized (in shares) | 400,000 | |
Award vesting period | 4 years | |
Expiration period | 10 years | |
Shares available for future issuance (in shares) | 161,342 |
Stockholder's Equity - Schedule
Stockholder's Equity - Schedule of Pre-2017 Non-Qualified Stock Options Outstanding (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Number of Shares | |||
Exercised (in shares) | (299,167) | ||
Pre-2017 Non-Qualified Stock Options | |||
Number of Shares | |||
Outstanding at beginning of period (in shares) | 2,500,500 | 2,885,500 | |
Exercised (in shares) | (20,000) | (379,167) | |
Forfeited (in shares) | (15,000) | (5,833) | |
Outstanding at end of period (in shares) | 2,465,500 | 2,500,500 | 2,885,500 |
Exercisable (in shares) | 2,430,502 | ||
Weighted- average Exercise Price | |||
Outstanding at beginning of period (in dollars per share) | $ 7.03 | $ 7.30 | |
Exercised (in dollars per share) | 9.50 | 9.03 | |
Forfeited (in dollars per share) | 10 | 10 | |
Outstanding at end of period (in dollars per share) | 6.99 | $ 7.03 | $ 7.30 |
Exercisable (in dollars per share) | $ 6.95 | ||
Weighted- average Remaining Contractual Term (years) | |||
Outstanding | 4 years 1 month 2 days | 5 years 18 days | 6 years 14 days |
Exercisable | 4 years 1 month 24 days | ||
Aggregate Intrinsic Value | |||
Outstanding | $ 2,773,190 | $ 18,426,325 | $ 20,633,100 |
Exercisable | $ 2,773,190 |
Stockholder's Equity - Schedu_2
Stockholder's Equity - Schedule of Pre-2017 Non-Qualified Stock Options Valuation Assumptions (Details) - 2017 Plan - Employee Stock Option - $ / shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Dividend yield | 0.00% | 0.00% |
Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Market value of stock on measurement date | $ 8.79 | $ 11.26 |
Risk-free interest rate | 0.33% | 1.67% |
Volatility factor | 91.00% | 104.00% |
Term (years) | 5 years 6 months | 5 years 6 months |
Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Market value of stock on measurement date | $ 13.60 | $ 15.65 |
Risk-free interest rate | 1.68% | 2.57% |
Volatility factor | 101.00% | 139.00% |
Term (years) | 6 years 3 months | 6 years 3 months |
Stockholder's Equity - Stock _2
Stockholder's Equity - Stock Options, Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based compensation expense | $ 200,000 | |
Stock based compensation expense | 2,279,496 | $ 3,197,384 |
2017 Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized compensation costs | 1,300,000 | |
Employee Stock Option | Pre-2017 Non-Qualified Stock Options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based compensation expense | 1,235,000 | |
Stock based compensation expense | 152,000 | |
Unrecognized compensation costs | 0 | |
Employee Stock Option | 2017 Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based compensation expense | $ 2,100,000 | $ 3,000,000 |
Stockholder's Equity - Schedu_3
Stockholder's Equity - Schedule of 2017 Plan Options Outstanding (Details) - 2017 Plan - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Number of Shares | |||
Outstanding at beginning of period (in shares) | 491,950 | 343,550 | |
Granted (in shares) | 191,500 | 193,700 | |
Expired (in shares) | 0 | 0 | |
Forfeited (in shares) | (71,690) | (45,300) | |
Outstanding at end of period (in shares) | 611,760 | 491,950 | 343,550 |
Exercisable (in shares) | 323,055 | ||
Weighted- average Exercise Price | |||
Outstanding at beginning of period (in dollars per share) | $ 24.08 | $ 28.97 | |
Granted (in dollars per share) | 12.12 | 13.82 | |
Forfeited (in dollars per share) | 15.05 | 17.9 | |
Outstanding at end of period (in dollars per share) | 21.39 | $ 24.08 | $ 28.97 |
Exercisable (in dollars per share) | $ 26.01 | ||
Weighted- average Remaining Contractual Term (years) | |||
Outstanding | 7 years 10 months 6 days | 8 years 5 months 4 days | 8 years 11 months 12 days |
Exercisable | 7 years 3 months | ||
Aggregate Intrinsic Value | |||
Outstanding | $ 0 | $ 81,888 | $ 840 |
Exercisable | $ 0 |
Stockholder's Equity - Schedu_4
Stockholder's Equity - Schedule of Restricted Stock Units Outstanding (Details) $ / shares in Units, $ in Millions | 12 Months Ended |
Dec. 31, 2020USD ($)$ / sharesshares | |
Number of Shares | |
Outstanding at beginning of period (in shares) | shares | 27,000,000 |
Granted (in shares) | shares | 49,600,000 |
Forfeited (in shares) | shares | (27,000,000) |
Outstanding at end of period (in shares) | shares | 49,600,000 |
Grant Date Fair Value Per Share | |
Outstanding at beginning of period (in dollars per share) | $ / shares | $ 14.51 |
Granted (in dollars per share) | $ / shares | 12 |
Forfeited (in dollars per share) | $ / shares | 14.51 |
Outstanding at end of period (in dollars per share) | $ / shares | $ 12 |
Share-based compensation expense | $ | $ 0.2 |
Compensation cost not yet recognized | $ | $ 0.3 |
Tranche One | |
Grant Date Fair Value Per Share | |
Vesting percentage | 25.00% |
Tranche Two | |
Grant Date Fair Value Per Share | |
Vesting percentage | 25.00% |
Stockholder's Equity - Schedu_5
Stockholder's Equity - Schedule of Warrants Outstanding (Details) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2018 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Number of Shares | ||||
Outstanding at beginning of period (in shares) | 27,000,000 | |||
Forfeited (in shares) | (27,000,000) | |||
Outstanding at end of period (in shares) | 49,600,000 | 27,000,000 | ||
Grant Date Fair Value Per Share | ||||
Outstanding at beginning of period (in dollars per share) | $ 14.51 | |||
Outstanding at end of period (in dollars per share) | 12 | $ 14.51 | ||
Forfeited (in dollars per share) | $ 14.51 | |||
Warrant | ||||
Number of Shares | ||||
Outstanding at beginning of period (in shares) | 342,610 | 353,610 | ||
Exercised (in share) | (59,510) | (11,000) | ||
Forfeited (in shares) | (4,300) | |||
Outstanding at end of period (in shares) | 278,800 | 342,610 | ||
Exercisable (in shares) | 278,800 | |||
Grant Date Fair Value Per Share | ||||
Outstanding at beginning of period (in dollars per share) | $ 9.77 | $ 9.78 | ||
Exercised (in dollars per share) | 10 | 10 | ||
Outstanding at end of period (in dollars per share) | 9.72 | $ 9.77 | ||
Forfeited (in dollars per share) | 10 | |||
Exercisable (in dollars per share) | $ 9.72 | |||
Weighted- average Remaining Contractual Term (years) | ||||
Outstanding | 4 years 7 months 6 days | 3 years 6 months 3 days | 3 years 8 months 15 days | |
Exercisable weighted average remaining contractual terms | 3 years 6 months 3 days | |||
Aggregate Intrinsic Value | ||||
Outstanding | $ 1,164 | $ 1,585,084 | $ 1,651,165 | |
Exercisable aggregate intrinsic value | $ 1,164 |
Potomac Amendment (Details)
Potomac Amendment (Details) - Potomac Amendment | Apr. 12, 2017USD ($) |
Investments, All Other Investments [Line Items] | |
Term of investment agreement | 4 years |
Price of right to buy back interest | $ 382,875 |
Percent of interest | 2.5525% |
Earliest period of notice | 2 years 6 months |
Payment ratio | 2 |
Period of payment after notice | 10 days |
Latest period of notice, payment ratio | 3.5 |
Counterparty right of net profit percentage | 2.5525% |
Counterparty right of net proceeds upon divestiture | 2.5525% |
Net profit determination, percent of actual amounts received | 2.5525% |
Minimum payment receivable | $ 765,500 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) | Dec. 22, 2017 | Dec. 31, 2020 | Dec. 31, 2017 |
Income Tax Examination [Line Items] | |||
Net operating loss carryforward | $ 7,740,730 | $ 2,504,711 | |
Maximum | |||
Income Tax Examination [Line Items] | |||
Corporate income tax rate | 35.00% | ||
Minimum | |||
Income Tax Examination [Line Items] | |||
Corporate income tax rate | 21.00% |
Income Taxes - Provision for In
Income Taxes - Provision for Income Taxes & Net Deferred Tax (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |||
Operating loss carryforwards | $ 7,740,730 | $ 2,504,711 | |
Income Tax Reconciliation | |||
Net loss before taxes at statutory rate | (352,562) | $ 2,852,268 | |
Permanent items | 479,115 | 717,020 | |
Temporary items | 312,649 | (2,169,777) | |
Income tax expense at statutory rate | 439,202 | 1,399,511 | |
Valuation allowance | (864,881) | (1,576,746) | |
Income tax benefit per books | (425,679) | (177,235) | |
Deferred Tax Assets Components | |||
Net operating loss carryover at statutory rate | 3,881,105 | 3,960,658 | |
Stock-based compensation expense | 2,923,099 | 3,056,099 | |
Fixed asset depreciation | (38,863) | (24,681) | |
Intangibles amortization | (1,081) | (997) | |
Other | 307,044 | 103,604 | |
Total | 7,071,304 | 7,094,683 | |
Valuation allowance | (7,071,304) | (7,094,683) | |
Net deferred tax asset | 0 | 0 | |
Unrecognized tax benefits | $ 0 | $ 0 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) | Feb. 11, 2021 | Feb. 11, 2021 | Jan. 26, 2021 | Jan. 04, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Feb. 10, 2021 |
Subsequent Event [Line Items] | |||||||
Vested (in shares) | 13,793 | ||||||
Exercise of stock options (in shares) | 299,167 | ||||||
Proceeds from stock options exercised | $ 700,000 | ||||||
Subsequent Event | |||||||
Subsequent Event [Line Items] | |||||||
Issuance price per share | $ 12.15 | ||||||
Issuance of restricted common shares | 61,043 | ||||||
Vested (in shares) | 47,250 | ||||||
Exercise of stock options (in shares) | 20,000 | 7,000 | |||||
Proceeds from stock options exercised | $ 120,000 | $ 70,000 | |||||
Market value of stock on measurement date (in dollars per share) | $ 10 | $ 10 | $ 6 | ||||
Tranche One | |||||||
Subsequent Event [Line Items] | |||||||
Vesting percentage | 25.00% | ||||||
Tranche Two | |||||||
Subsequent Event [Line Items] | |||||||
Vesting percentage | 25.00% | ||||||
Employee Stock Option | Subsequent Event | |||||||
Subsequent Event [Line Items] | |||||||
Options granted to employees (in shares) | 114,310 | 15,300 | |||||
Exercise price (in dollars per share) | $ 12.15 | $ 11.60 | |||||
Option term | 10 years | 10 years | |||||
Employee Stock Option | Tranche One | Subsequent Event | |||||||
Subsequent Event [Line Items] | |||||||
Vesting percentage | 25.00% | ||||||
Employee Stock Option | Tranche Two | Subsequent Event | |||||||
Subsequent Event [Line Items] | |||||||
Vesting percentage | 2.08% | ||||||
Restricted Stock | |||||||
Subsequent Event [Line Items] | |||||||
Vesting percentage | 100.00% | ||||||
Restricted Stock | Tranche One | Subsequent Event | |||||||
Subsequent Event [Line Items] | |||||||
Vesting percentage | 25.00% | ||||||
Restricted Stock | Tranche Two | Subsequent Event | |||||||
Subsequent Event [Line Items] | |||||||
Vesting percentage | 25.00% | ||||||
Restricted Stock | Tranche Three | Subsequent Event | |||||||
Subsequent Event [Line Items] | |||||||
Vesting percentage | 25.00% | ||||||
Restricted Stock | Tranche Four | Subsequent Event | |||||||
Subsequent Event [Line Items] | |||||||
Vesting percentage | 25.00% |