Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Jun. 30, 2018 | Aug. 03, 2018 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2018 | |
Document Fiscal Year Focus | 2,019 | |
Document Fiscal Period Focus | Q1 | |
Entity Registrant Name | ELITE PHARMACEUTICALS INC /NV/ | |
Entity Central Index Key | 1,053,369 | |
Current Fiscal Year End Date | --03-31 | |
Entity Filer Category | Accelerated Filer | |
Trading Symbol | ELTP | |
Entity Common Stock, Shares Outstanding | 810,126,509 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) | Jun. 30, 2018 | Mar. 31, 2018 |
Current assets: | ||
Cash | $ 5,644,053 | $ 7,179,237 |
Accounts receivable, net of allowance for doubtful accounts of $-0-, respectively | 1,061,979 | 675,879 |
Inventory | 4,140,190 | 4,898,001 |
Prepaid expenses and other current assets | 611,305 | 949,284 |
Total current assets | 11,457,527 | 13,702,401 |
Property and equipment, net of accumulated depreciation of $8,709,146 and $8,408,979, respectively | 8,872,099 | 8,993,708 |
Intangible assets, net of accumulated amortization of $-0-, respectively | 7,713,001 | 7,713,001 |
Other assets: | ||
Restricted cash - debt service for NJEDA bonds | 392,820 | 391,566 |
Security deposits | 59,805 | 81,932 |
Total other assets | 452,625 | 473,498 |
Total assets | 28,495,252 | 30,882,608 |
Current liabilities: | ||
Accounts payable | 1,065,435 | 1,658,137 |
Accrued expenses | 1,970,197 | 1,788,571 |
Deferred revenue, current portion | 1,013,333 | 1,013,333 |
Bonds payable, current portion, net of bond issuance costs | 75,822 | 75,822 |
Loans payable, current portion | 546,186 | 578,841 |
Total current liabilities | 4,670,973 | 5,114,704 |
Long-term liabilities: | ||
Deferred revenue, net of current portion | 998,890 | 1,252,223 |
Bonds payable, net of current portion and bond issuance costs | 1,511,678 | 1,508,134 |
Senior secured promissory note - related party | 1,200,000 | 1,200,000 |
Loans payable, net current portion | 664,718 | 623,020 |
Derivative financial instruments - warrants | 2,415,360 | 2,667,871 |
Other long-term liabilities | 41,145 | 41,144 |
Total long-term liabilities | 6,831,791 | 7,292,392 |
Total liabilities | 11,502,764 | 12,407,096 |
Mezzanine equity | ||
Series J convertible preferred stock; par value $0.01; 50 shares authorized, 24.0344 issued and outstanding as of June 30, 2018; 50 shares authorized, 24.0344 issued and outstanding as of March 31, 2018 | 13,903,960 | 13,903,960 |
Shareholders' equity: | ||
Common stock; par value $0.001; 995,000,000 shares authorized 804,650,058 shares issued and 804,550,058 outstanding as of June 30, 2018; 802,626,761 shares issued and 802,526,761 outstanding as of March 31, 2018 | 804,652 | 802,629 |
Additional paid-in capital | 146,805,221 | 146,602,502 |
Treasury stock; 100,000 shares as of June 30, 2018 and March 31, 2018; at cost | (306,841) | (306,841) |
Accumulated deficit | (144,214,504) | (142,526,738) |
Total shareholders' equity | 3,088,528 | 4,571,552 |
Total liabilities, mezzanine equity and shareholders' equity | $ 28,495,252 | $ 30,882,608 |
CONDENSED CONSOLIDATED BALANCE3
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) | Jun. 30, 2018 | Mar. 31, 2018 |
Allowance for Doubtful Accounts Receivable, Current | $ 0 | $ 0 |
Accumulated depreciation | 8,709,146 | 8,408,979 |
Accumulated amortization on intangible assets (in dollars) | $ 0 | $ 0 |
Temporary Equity, Par or Stated Value Per Share | $ 0.01 | $ 0.01 |
Temporary Equity, Shares Authorized | 50 | 50 |
Temporary Equity, Shares Issued | 24.0344 | 24.0344 |
Temporary Equity, Shares Outstanding | 24.0344 | 24.0344 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 995,000,000 | 995,000,000 |
Common stock, shares issued | 804,650,058 | 802,626,761 |
Common stock, shares outstanding | 804,550,058 | 802,526,761 |
Treasury stock, shares | 100,000 | 100,000 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 3 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2017 | |
Total revenue | $ 2,167,698 | $ 1,702,770 |
Cost of revenue | 1,576,399 | 1,015,060 |
Gross profit | 591,299 | 687,710 |
Operating expenses: | ||
Research and development | 1,326,628 | 1,965,883 |
General and administrative | 882,812 | 855,961 |
Non-cash compensation through issuance of stock options | 36,549 | 97,361 |
Depreciation and amortization | 203,704 | 6,776 |
Total operating expenses | 2,449,693 | 2,925,981 |
Loss from operations | (1,858,394) | (2,238,271) |
Other income (expense): | ||
Interest expense and amortization of debt issuance costs | (83,138) | (70,731) |
Change in fair value of derivative instruments | 252,511 | 139,260 |
Interest income | 1,255 | 3,982 |
Other income, net | 170,628 | 72,511 |
Loss from operations | (1,687,766) | (2,165,760) |
Income tax provision | 0 | 3,000 |
Net loss attributable to common shareholders | $ (1,687,766) | $ (2,168,760) |
Basic loss per share attributable to common shareholders | $ 0 | $ 0 |
Diluted loss per share attributable to common shareholders | $ 0 | $ 0 |
Basic weighted average Common Stock outstanding | 803,049,238 | 819,321,321 |
Diluted weighted average Common Stock outstanding | 803,049,238 | 819,321,321 |
Manufacturing fees [Member] | ||
Revenue from Contract with Customer, Including Assessed Tax | $ 1,541,858 | $ 1,010,896 |
Licensing fees [Member] | ||
Revenue from Contract with Customer, Including Assessed Tax | $ 625,840 | $ 691,874 |
CONSOLIDATED STATEMENTS OF SHAR
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY - 3 months ended Jun. 30, 2018 - USD ($) | Total | Common Stock [Member] | Additional Paid-In Capital [Member] | Treasury Stock [Member] | Accumulated Deficit [Member] |
Balane at Mar. 31, 2018 | $ 4,571,552 | $ 802,629 | $ 146,602,502 | $ (306,841) | $ (142,526,738) |
Balance (in shares) at Mar. 31, 2018 | 802,626,761 | 100,000 | |||
Net loss | (1,687,766) | $ 0 | 0 | $ 0 | (1,687,766) |
Common Stock sold pursuant to the Lincoln Park purchase agreement | 168,170 | $ 2,000 | 166,170 | 0 | 0 |
Common Stock sold pursuant to the Lincoln Park purchase agreement (in shares) | 2,000,000 | ||||
Common Stock issued as additional commitment shares pursuant to the LPC purchase agreement | 2,184 | $ 23 | 2,161 | 0 | 0 |
Common Stock issued as additional commitment shares pursuant to the LPC purchase agreement (in shares) | 23,297 | ||||
Costs associated with raising capital | (2,161) | $ 0 | (2,161) | 0 | 0 |
Non-cash compensation through the issuance of employee stock options | 36,549 | 0 | 36,549 | 0 | 0 |
Balance at Jun. 30, 2018 | $ 3,088,528 | $ 804,652 | $ 146,805,221 | $ (306,841) | $ (144,214,504) |
Balance (in shares) at Jun. 30, 2018 | 804,650,058 | 100,000 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 3 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2017 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (1,687,766) | $ (2,168,760) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 303,711 | 188,130 |
Change in fair value of derivative financial instruments – warrants | (252,511) | (139,260) |
Non-cash compensation accrued | 953,750 | 923,500 |
Non-cash compensation from the issuance of Common Stock and options | 36,549 | 97,361 |
Non-cash rent expense and lease accretion | 1,573 | 2,595 |
Change in operating assets and liabilities: | ||
Accounts receivable | (386,100) | 212,907 |
Inventory | 757,811 | 525,698 |
Prepaid expenses and other current assets | 181,547 | 205,106 |
Accounts payable, accrued expenses and other current liabilities | (1,364,826) | (685,002) |
Deferred revenue and customer deposits | (253,333) | (253,334) |
Net cash used in operating activities | (1,709,595) | (1,091,059) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of property and equipment | (178,558) | (275,344) |
Intellectual property costs | 0 | (60,483) |
Net cash used in investing activities | (178,558) | (335,827) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from the issuance of stock | 168,193 | 423,770 |
Proceeds from cash warrant and options exercises | 0 | 181,909 |
Other loan proceeds (payments), net | 186,030 | (160,528) |
Costs associated with raising capital | 0 | (39,741) |
Net cash provided by financing activities | 354,223 | 405,410 |
Net change in cash and restricted cash | (1,533,930) | (1,021,476) |
Cash and restricted cash, beginning of period | 7,570,803 | 10,983,774 |
Cash and restricted cash, end of period | 6,036,873 | 9,962,298 |
Supplemental disclosure of cash and non-cash transactions: | ||
Cash paid for interest | 24,044 | 19,688 |
Financing of equipment purchases and insurance renewal | 0 | 190,434 |
Issuance of Senior Secured Promissory Note pursuant ANDA asset acquisition | 0 | 1,200,000 |
Commitment shares issued to Lincoln Park Capital | 2,161 | 931,182 |
Retirement of Common Stock pursuant to the issuance of Series J convertible preferred shares | $ 0 | $ 20,378,631 |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended |
Jun. 30, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization, Consolidation and Presentation of Financial Statements Disclosure and Significant Accounting Policies [Text Block] | NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Overview Elite Pharmaceuticals, Inc. (the “Company” or “Elite”) was incorporated on October 1, 1997 under the laws of the State of Delaware, and its wholly-owned subsidiary Elite Laboratories, Inc. (“Elite Labs”) which was incorporated on August 23, 1990 under the laws of the State of Delaware. On January 5, 2012, Elite Pharmaceuticals was reincorporated under the laws of the State of Nevada. Elite Labs engages primarily in researching, developing and licensing proprietary orally administered, controlled-release drug delivery systems and products with abuse deterrent capabilities and the manufacture of generic, oral dose pharmaceuticals. The Company is equipped to manufacture controlled-release products on a contract basis for third parties and itself, if and when the products are approved. These products include drugs that cover therapeutic areas for pain, allergy, bariatric and infection. Research and development activities are done so with an objective of developing products that will secure marketing approvals from the United States Food and Drug Administration (“FDA”), and thereafter, commercially exploiting such products. Principles of Consolidation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) and in conformity with the instructions on Form 10-Q and Rule 8-03 of Regulation S-X and the related rules and regulations of the Securities and Exchange Commission (“SEC”). The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, Elite Laboratories, Inc. All significant intercompany accounts and transactions have been eliminated in consolidation. The unaudited condensed consolidated financial statements reflect all adjustments, consisting of normal recurring accruals, which are, in the opinion of management, necessary for a fair presentation of such statements. The results of operations for the three months ended June 30, 2018 are not necessarily indicative of the results that may be expected for the entire year. Going Concern In connection with the preparation of the financial statements as of and for the three months period ended June 30, 2018, the Company conducted an evaluation as to whether there were conditions and events, considered in the aggregate, which raised substantial doubt as to the entity’s ability to continue as a going concern within one year after the date of the issuance, or the date the financial statements were available for issuance, noting that there did not appear to be evidence of substantial doubt of the entity’s ability to continue as a going concern. Segment Information Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 280, Segment Reporting The Company has determined that its reportable segments are products whose marketing approvals were secured via an Abbreviated New Drug Applications (“ANDA”) and products whose marketing approvals were secured via a New Drug Application (“NDA”). ANDA products are referred to as generic pharmaceuticals and NDA products are referred to as branded pharmaceuticals. There are currently no intersegment revenues. Asset information by operating segment is not presented below since the chief operating decision maker does not review this information by segment. The reporting segments follow the same accounting policies used in the preparation of the Company’s condensed unaudited consolidated financial statements. Revenue Recognition The Company generates revenue from the development of pain management products, manufacturing of a line of generic pharmaceutical products with approved ANDA, commercialization of products either by license and the collection of royalties, or through the manufacture of formulations and the development of new products and the expansion of licensing agreements with other pharmaceutical companies, including co-development projects, joint ventures and other collaborations. The Company also generates revenue through its focus on the development of various types of drug products, including branded drug products which require NDAs. Under FASB Topic 606, Revenue from Contacts with Customers Nature of goods and services The following is a description of the Company’s goods and services from which the Company generates revenue, as well as the nature, timing of satisfaction of performance obligations, and significant payment terms for each, as applicable: a) Manufacturing Fees The Company is equipped to manufacture controlled-release products on a contract basis for third parties, if and when the products are approved. These products include products using controlled-release drug technology and products utilizing abuse deterrent technologies. The Company also develops and markets (either on its own or by license to other companies) generic and proprietary controlled-release and abuse deterrent pharmaceutical products. The Company recognizes revenue when the customer obtains control of the Company’s product based on the contractual shipping terms of the contract. Revenue on product are presented gross because the Company is primarily responsible for fulfilling the promise to provide the product, is responsible to ensure that the product is produced in accordance with the related supply agreement and bears risk of loss while the inventory is in-transit to the commercial partner. Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring products to a customer. b) License Fees The Company enters into licensing and development agreements, which may include multiple revenue generating activities, including milestones payments, licensing fees, product sales and services. The Company analyzes each element of its licensing and development agreements in accordance with ASC 606 to determine appropriate revenue recognition. The terms of the license agreement may include payment to the Company of licensing fees, non-refundable upfront license fees, milestone payments if specified objectives are achieved, and/or royalties on product sales. If the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. Contracts that contain multiple performance obligations require an allocation of the transaction price based on the estimated relative standalone selling prices of the promised products or services underlying each performance obligation. The Company determines standalone selling prices based on the price at which the performance obligation is sold separately. If the standalone selling price is not observable through past transactions, the Company estimates the standalone selling price taking into account available information such as market conditions and internally approved pricing guidelines related to the performance obligations. The Company recognizes revenue from non-refundable upfront payments at a point in time, typically upon fulfilling the delivery of the associated intellectual property to the customer. For those milestone payments which are contingent on the occurrence of particular future events (for example, payments due upon a product receiving FDA approval), the Company determined that these need to be considered for inclusion in the calculation of total consideration from the contract as a component of variable consideration using the most-likely amount method. As such, the Company assesses each milestone to determine the probability and substance behind achieving each milestone. Given the inherent uncertainty of the occurrence of future events, the Company will not recognize revenue from the milestone until there is not a high probability of a reversal of revenue, which typically occurs near or upon achievement of the event. Significant management judgment is required to determine the level of effort required under an arrangement and the period over which the Company expects to complete its performance obligations under the arrangement. If the Company cannot reasonably estimate when its performance obligations either are completed or become inconsequential, then revenue recognition is deferred until the Company can reasonably make such estimates. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method. When determining the transaction price of a contract, an adjustment is made if payment from a customer occurs either significantly before or significantly after performance, resulting in a significant financing component. Applying the practical expedient in paragraph 606-10-32-18, the Company does not assess whether a significant financing component exists if the period between when the Company performs its obligations under the contract and when the customer pays is one year or less. None of the Company’s contracts contained a significant financing component as of June 30, 2018. In accordance with ASC 606-10-55-65, royalties are recognized when the subsequent sale of the customer’s products occurs. Disaggregation of revenue In the following table, revenue is disaggregated by type of revenue generated by the Company and timing of revenue recognition. The table also includes a reconciliation of the disaggregated revenue with the reportable segments: For the Three Months Ended June 30, 2018 2017 NDA: Licensing fees $ 250,000 $ 250,000 Total NDA revenue 250,000 250,000 ANDA: Manufacturing fees $ 1,541,858 $ 1,010,896 Licensing fees 375,840 441,874 Total ANDA revenue 1,917,698 1,452,770 Total revenue $ 2,167,698 $ 1,702,770 Collaborative Arrangements Contracts are considered to be collaborative arrangements when they satisfy the following criteria defined in ASC 808, Collaborative Arrangements The parties to the contract must actively participate in the joint operating activity; and, The joint operating activity must expose the parties to the possibility of significant risk and rewards, based on whether or not the activity is successful. The Company entered into a sales and distribution licensing agreement with Epic Pharma LLC, dated June 4, 2015 (the “2015 Epic License Agreement”), which has been determined to satisfy the criteria for consideration as a collaborative agreement, and is accounted for accordingly, in accordance with GAAP. The Company entered into a Master Development and License Agreement with SunGen Pharma LLC dated August 24, 2016 (the “SunGen Agreement”), which has been determined to satisfy the criteria for consideration as a collaborative agreement, and is accounted for accordingly, in accordance with GAAP. Cash The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. Cash and cash equivalents consist of cash on deposit with banks and money market instruments. The Company places its cash and cash equivalents with high-quality, U.S. financial institutions and, to date has not experienced losses on any of its balances. Restricted Cash As of June 30, 2018, and March 31, 2018, the Company had $392,820 and $391,566, respectively, of restricted cash, related to debt service reserve in regard to the New Jersey Economic Development Authority (“NJEDA”) bonds (see Note 5). Accounts Receivable Accounts receivable are comprised of balances due from customers, net of estimated allowances for uncollectible accounts. In determining collectability, historical trends are evaluated, and specific customer issues are reviewed on a periodic basis to arrive at appropriate allowances. Inventory Inventory is recorded at the lower of cost or market on a first-in first-out basis. Long-Lived Assets The Company periodically evaluates the fair value of long-lived assets, which include property and equipment and intangibles, whenever events or changes in circumstances indicate that its carrying amounts may not be recoverable. Property and equipment are stated at cost. Depreciation is provided on the straight-line method based on the estimated useful lives of the respective assets which range from three to forty years. Major repairs or improvements are capitalized. Minor replacements and maintenance and repairs which do not improve or extend asset lives are expensed currently. Upon retirement or other disposition of assets, the cost and related accumulated depreciation are removed from the accounts and the resulting gain or loss, if any, is recognized in income. Intangible Assets The Company capitalizes certain costs to acquire intangible assets; if such assets are determined to have a finite useful life they are amortized on a straight-line basis over the estimated useful life. Costs to acquire indefinite lived intangible assets, such as costs related to ANDAs are capitalized accordingly. The Company tests its intangible assets for impairment at least annually (as of March 31st) and whenever events or circumstances change that indicate impairment may have occurred. A significant amount of judgment is involved in determining if an indicator of impairment has occurred. Such indicators may include, among others and without limitation: a significant decline in the Company’s expected future cash flows; a sustained, significant decline in the Company’s stock price and market capitalization; a significant adverse change in legal factors or in the business climate of the Company’s segments; unanticipated competition; and slower growth rates. As of June 30, 2018, the Company did not identify any indicators of impairment. Research and Development Research and development expenditures are charged to expense as incurred. Contingencies Occasionally, the Company may be involved in claims and legal proceedings arising from the ordinary course of its business. The Company records a provision for a liability when it believes that it is both probable that a liability has been incurred, and the amount can be reasonably estimated. If these estimates and assumptions change or prove to be incorrect, it could have a material impact on the Company’s condensed consolidated financial statements. Contingencies are inherently unpredictable, and the assessments of the value can involve a series of complex judgments about future events and can rely heavily on estimates and assumptions. Income Taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates in effect for the year in which those temporary differences are expected to be recovered or settled. Where applicable, the Company records a valuation allowance to reduce any deferred tax assets that it determines will not be realizable in the future. Warrants and Preferred Shares The accounting treatment of warrants and preferred share series issued is determined pursuant to the guidance provided by ASC 470, Debt Distinguishing Liabilities from Equity Derivatives and Hedging Stock-Based Compensation The Company accounts for stock-based compensation in accordance with ASC Topic 718, Compensation-Stock Compensation In accordance with the Company’s Director compensation policy and certain employment contracts, director’s fees and a portion of employee’s salaries are to be paid via the issuance of shares of the Company’s common stock, in lieu of cash, with the valuation of such share being calculated on a quarterly basis and equal to the average closing price of the Company’s common stock. Earnings (Loss) Per Share Applicable to Common Shareholders’ The Company follows ASC 260, Earnings Per Share The following is the computation of earnings (loss) per share applicable to common shareholders for the periods indicated: For the Three Months Ended June 30, 2018 2017 Numerator Net loss attributable to common shareholders – basic $ (1,687,766 ) $ (2,168,760 ) Effect of dilutive instrument on net loss – – Net loss attributable to common shareholders – diluted $ (1,687,766 ) $ (2,168,760 ) Denominator Weighted average shares of common stock outstanding – basic 803,049,238 819,321,321 Dilutive effect of stock options, warrants and convertible securities – – Weighted average shares of common stock outstanding – diluted 803,049,238 819,321,321 Net income (loss) per share Basic $ (0.00 ) $ (0.00 ) Diluted $ (0.00 ) $ (0.00 ) Fair Value of Financial Instruments ASC Topic 820, Fair Value Measurements and Disclosures ASC Topic 820 defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. ASC Topic 820 establishes a fair value hierarchy that distinguishes between (1) market participant assumptions developed based on market data obtained from independent sources (observable inputs) 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 under ASC Topic 820 are described as follows: Level 1 – Unadjusted quoted prices in active markets for identical assets or liabilities that are accessible at the measurement date. Level 2 – Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs include 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; and inputs that are derived principally from or corroborated by observable market data by correlation or other means. Level 3 – Inputs that are unobservable for the asset or liability. Measured on a Recurring Basis The following table presents information about our liabilities measured at fair value on a recurring basis as of June 30, 2018 and March 31, 2018, aggregated by the level in the fair value hierarchy within which those measurements fell: Amount at Fair Fair Value Measurement Using Value Level 1 Level 2 Level 3 June 30, 2018 Liabilities Derivative financial instruments - warrants $ 2,415,360 $ - $ - $ 2,415,360 March 31, 2018 Liabilities Derivative financial instruments - warrants $ 2,667,871 $ - $ - $ 2,667,871 See Note 11, for specific inputs used in determining fair value. The carrying amounts of the Company’s financial assets and liabilities, such as cash, accounts receivable, prepaid expenses and other current assets, accounts payable and accrued expenses, approximate their fair values because of the short maturity of these instruments. Non-Financial Assets that are Measured at Fair Value on a Non-Recurring Basis Non-financial assets such as intangible assets, and property and equipment are measured at fair value only when an impairment loss is recognized. The Company did not record an impairment charge related to these assets in the periods presented. Treasury Stock The Company records treasury stock at the cost to acquire it and includes treasury stock as a component of shareholders’ equity. Recently Adopted Accounting Pronouncements On April 1, 2018, the Company adopted ASC 606. In accordance with ASC 606, the Company has not changed any characteristics of its revenue recognition policy and has implemented the enhanced disclosure requirements necessary to apply the new standard. ASC 606 was applied using the modified retrospective method. There was no cumulative effect of the initial application to be recognized as an adjustment to opening retained earnings at April 1, 2018 as the adoption did not have an impact on the Company’s results of operations or financial condition. Accordingly, results for reporting periods beginning after April 1, 2018 are presented in accordance with ASC 606, while the comparative information has not been restated and reported under the accounting standards in effect for those periods. In November 2016, the FASB issued ASU No. 2016-18 , Restricted Cash (Topic 230): Statement of Cash Flows (“ASU No. 2016-18”). requires that a statement of cash flows explain the change during the period in the total of cash, cash equivalents and amounts generally described as restricted cash or restricted cash equivalents. Restricted cash and restricted cash equivalents will be included with cash and cash equivalents when reconciling the beginning of period and end of period balances on the statement of cash flows upon adoption of this standard. As a result of the adoption of the new guidance, the Company increased the beginning of year total amount shown on the condensed consolidated statement of cash flows by $391,566 and $389,081 for the three months ended June 30, 2018 and 2017, respectively. These amounts represent the balance of restricted cash included in the consolidated balance sheets as of March 31, 2018 and 2017, respectively. Restricted cash is related to debt service reserve in regard to the NJEDA bonds (see Note 5). As of April 1, 2018, the Company adopted ASU 2017-09, Compensation-Stock Compensation (Topic 718): Scope of Modification Accounting , which clarifies when to account for a change to the terms or conditions of a share-based payment award as a modification. The new standard does not change the accounting for modifications but clarifies that modification accounting guidance should only be applied if the fair value, vesting conditions, or classification of the award changes as a result of the change in terms or conditions. The adoption of this standard did not materially impact the Company’s stock-based compensation expense as no awards were modified during the three months ended June 30, 2018. In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows – Classification of Certain Cash Receipts and Cash Payments Recently Issued Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842), which is effective for public entities for annual reporting periods beginning after December 15, 2018. Under ASU 2016-02, lessees will be required to recognize the following for all leases (with the exception of short-term leases) at the commencement date: 1) a lease liability, which is a lessee’s obligation to make lease payments arising from a lease, measured on a discounted basis, and 2) a right-of-use asset, which is an asset that represents the lessee’s right to use, or control the use of, a specified asset for the lease term. The Company is currently evaluating the effects of ASU 2016-02 on its unaudited condensed financial statements. In June 2018, the FASB issued ASU 2018-07, “Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting” , which expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees and applies to all share-based payment transactions in which a grantor acquires goods or services to be used or consumed in a grantor’s own operations by issuing share-based payment awards. Topic 718 does not apply to share-based payments used to effectively provide (1) financing to the issuer or (2) awards granted in conjunction with selling goods or services to customers as part of a contract accounted for under Topic 606. This update is effective for public business entities for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. Early adoption is permitted, but no earlier than an entity’s adoption date of Topic 606. The Company is evaluating the effect that this update will have on its financial statements and related disclosures. Management has evaluated other recently issued accounting pronouncements and does not believe that any of these pronouncements will have a significant impact on our consolidated financial statements and related disclosures. |
INVENTORY
INVENTORY | 3 Months Ended |
Jun. 30, 2018 | |
Inventory Disclosure [Abstract] | |
Inventory Disclosure [Text Block] | NOTE 2. INVENTORY Inventory consisted of the following: June 30, 2018 March 31, 2018 Finished goods $ 10,016 $ 229,204 Work-in-progress 77,690 297,350 Raw materials 4,052,484 4,371,447 $ 4,140,190 $ 4,898,001 |
PROPERTY AND EQUIPMENT, NET
PROPERTY AND EQUIPMENT, NET | 3 Months Ended |
Jun. 30, 2018 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment Disclosure [Text Block] | NOTE 3. PROPERTY AND EQUIPMENT, NET Property and equipment consisted of the following: June 30, 2018 March 31, 2018 Land, building and improvements $ 5,260,523 $ 7,675,317 Laboratory, manufacturing and warehouse equipment 11,693,799 9,302,277 Office equipment and software 383,557 308,434 Furniture and fixtures 176,511 49,804 Transportation equipment 66,855 66,855 17,581,245 17,402,687 Less: Accumulated depreciation (8,709,146 ) (8,408,979 ) $ 8,872,099 $ 8,993,708 Depreciation expense was $300,167 and $184,586 for the three months ended June 30, 2018 and 2017, respectively. |
INTANGIBLE ASSETS
INTANGIBLE ASSETS | 3 Months Ended |
Jun. 30, 2018 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets Disclosure [Text Block] | NOTE 4. INTANGIBLE ASSETS The following table summarizes the Company’s intangible assets June 30, 2018 Estimated Gross Useful Carrying Accumulated Net Book Life Amount Additions Amortization Value Patent application costs * $ 465,684 $ - $ - $ 465,684 ANDA acquisition costs Indefinite 7,247,317 - - 7,247,317 $ 7,713,001 $ - $ - $ 7,713,001 March 31, 2018 Estimated Gross Useful Carrying Accumulated Net Book Life Amount Additions Amortization Value Patent application costs * $ 371,774 $ 93,910 $ - $ 465,684 ANDA acquisition costs Indefinite 6,047,317 1,200,000 - 7,247,317 $ 6,419,091 $ 1,293,910 $ - $ 7,713,001 Patent application costs were incurred in relation to the Company’s abuse deterrent opioid technology. Amortization of the patent costs will begin upon the issuance of marketing authorization by the FDA. Amortization will then be calculated on a straight-line basis through the expiry of the related patent(s). |
NJEDA BONDS
NJEDA BONDS | 3 Months Ended |
Jun. 30, 2018 | |
Debt Disclosure [Abstract] | |
Debt Disclosure [Text Block] | NOTE 5. NJEDA BONDS During August 2005, the Company refinanced a bond issue occurring in 1999 through the issuance of Series A and B Notes tax-exempt bonds (the “NJEDA Bonds” and/or “Bonds”). During July 2014, the Company retired all outstanding Series B Notes, at par, along with all accrued interest due and owed. In relation to the Series A Notes, the Company is required to maintain a debt service reserve. The debt serve reserve is classified as restricted cash on the accompanying unaudited condensed consolidated balance sheets. The NJEDA Bonds require the Company to make an annual principal payment on September 1 st st st The following tables summarize the Company’s bonds payable liability: June 30, 2018 March 31, 2018 Gross bonds payable NJEDA Bonds - Series A Notes $ 1,760,000 $ 1,760,000 Less: Current portion of bonds payable (prior to deduction of bond offering costs) (90,000 ) (90,000 ) Long-term portion of bonds payable (prior to deduction of bond offering costs) $ 1,670,000 $ 1,670,000 Bond offering costs $ - $ - Less: Accumulated amortization (181,952 ) (178,409 ) Bond offering costs, net $ (181,952 ) $ (178,409 ) Current portion of bonds payable - net of bond offering costs Current portions of bonds payable $ 90,000 $ 90,000 Less: Bonds offering costs to be amortized in the next 12 months (14,178 ) (14,178 ) Current portion of bonds payable, net of bond offering costs $ 75,822 $ 75,822 Long term portion of bonds payable - net of bond offering costs Long term portion of bonds payable $ 1,670,000 $ 1,670,000 Less: Bond offering costs to be amortized subsequent to the next 12 months (158,322 ) (161,866 ) Long term portion of bonds payable, net of bond offering costs $ 1,511,678 $ 1,508,134 Amortization expense was $3,544 for the three months ended June 30, 2018 and 2017. |
LOANS PAYABLE
LOANS PAYABLE | 3 Months Ended |
Jun. 30, 2018 | |
Debt Disclosure [Abstract] | |
Long-term Debt [Text Block] | NOTE 6. LOANS PAYABLE Loans payable consisted of the following: June 30, 2018 March 31, 2018 Equipment and insurance financing loans payable, between 3% and 13% interest and maturing between February 2019 and January 2023 $ 1,210,904 $ 1,201,861 Less: Current portion of loans payable (546,186 ) (578,841 ) Long-term portion of loans payable $ 664,718 $ 623,020 The interest expense associated with the loans payable was $24,043 and $21,759 for the three months ended June 30, 2018 and 2017, respectively. |
RELATED PARTY SECURED PROMISSOR
RELATED PARTY SECURED PROMISSORY NOTE WITH MIKAH PHARMA LLC | 3 Months Ended |
Jun. 30, 2018 | |
Mikah Pharma Lic [Member] | |
Related Party Transactions Disclosure [Text Block] | NOTE 7. RELATED PARTY SECURED PROMISSORY NOTE WITH MIKAH PHARMA LLC For consideration of the assets acquired on May 15, 2017, the Company issued a Secured Promissory Note (the “Note”) to Mikah for the principal sum of $1,200,000. The Note matures on December 31, 2020 in which the Company shall pay the outstanding principal balance of the Note. Interest shall be computed on the unpaid principal amount at the per annum rate of ten percent (10%); provided, upon the occurrence of an Event of Default as defined within the Note, the principal balance shall bear interest from the date of such occurrence until the date of actual payment at the per annum rate of fifteen percent (15%). All interest payable hereunder shall be computed on the basis of actual days elapsed and a year of 360 days. Installment payments of interest on the outstanding principal shall be paid as follows: quarterly commencing August 1, 2017 and on November 1, February 1, May 1 and August 1 of each year thereafter. All unpaid principal and accrued but unpaid interest shall be due and payable in full on the Maturity Date. The interest expense associated with the Note was $15,000 for the three months ended June 30, 2018 and 2017. |
DEFERRED REVENUE
DEFERRED REVENUE | 3 Months Ended |
Jun. 30, 2018 | |
Deferred Revenue Disclosure [Abstract] | |
Deferred Revenue Disclosure [Text Block] | NOTE 8. DEFERRED REVENUE Deferred revenues in the aggregate amount of $2,012,223 as of June 30, 2018, were comprised of a current component of $1,013,333 and a long-term component of $998,890. Deferred revenues in the aggregate amount of $2,265,556 as of March 31, 2018, were comprised of a current component of $1,013,333 and a long-term component of $1,252,223. These line items represent the unamortized amounts of a $200,000 advance payment received for a TAGI licensing agreement with a fifteen-year term beginning in September 2010 and ending in August 2025 and the $5,000,000 advance payment Epic Collaborative Agreement with a five-year term beginning in June 2015 and ending in May 2020. These advance payments were recorded as deferred revenue when received and are earned, on a straight-line basis over the life of the licenses. The current component is equal to the amount of revenue to be earned during the 12-month period immediately subsequent to the balance date and the long-term component is equal to the amount of revenue to be earned thereafter. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 3 Months Ended |
Jun. 30, 2018 | |
Loss Contingency [Abstract] | |
Contingencies Disclosure [Text Block] | NOTE 9. COMMITMENTS AND CONTINGENCIES Occasionally, the Company may be involved in claims and legal proceedings arising from the ordinary course of its business. The Company records a provision for a liability when it believes that is both probable that a liability has been incurred, and the amount can be reasonably estimated. If these estimates and assumptions change or prove to be incorrect, it could have a material impact on the Company’s condensed consolidated financial statements. Contingencies are inherently unpredictable, and the assessments of the value can involve a series of complex judgments about future events and can rely heavily on estimates and assumptions. Operating Leases – 135 Ludlow Ave. The Company entered into an operating lease for a portion of a one-story warehouse, located at 135 Ludlow Avenue, Northvale, New Jersey (the “135 Ludlow Ave. lease”). The 135 Ludlow Ave. lease is for approximately 15,000 square feet of floor space and began on July 1, 2010. During July 2014, the Company modified the 135 Ludlow Ave. lease in which the Company was permitted to occupy the entire 35,000 square feet of floor space in the building (“135 Ludlow Ave. modified lease”). The 135 Ludlow Ave. modified lease includes an initial term, which expired on December 31, 2016 with two tenant renewal options of five years each, at the sole discretion of the Company. On June 22, 2016, the Company exercised the first of these renewal options, with such option including a term that begins on January 1, 2017 and expires on December 31, 2021. The 135 Ludlow Ave. property required significant leasehold improvements and qualifications, as a prerequisite, for its intended future use. Manufacturing, packaging, warehousing and regulatory activities are currently conducted at this location. Additional renovations and construction to further expand the Company’s manufacturing resources are in progress. Rent expense is recorded on the straight-line basis. Rents paid in excess is recognized as deferred rent. Rent expense under the 135 Ludlow Ave. modified lease for the three-month ended June 30, 2018 and 2017 was $54,909. Rent expense is recorded in general and administrative expense in the unaudited condensed consolidated statements of operations. Deferred rent as of June 30, 2018 and March 31, 2018 was $10,804 and $9,702, respectively and recorded as a component of other long-term liabilities. The Company has an obligation for the restoration of its leased facility and the removal or dismantlement of certain property and equipment as a result of its business operation in accordance with ASC 410, Asset Retirement and Environmental Obligations – Asset Retirement Obligations |
MEZZANINE EQUITY
MEZZANINE EQUITY | 3 Months Ended |
Jun. 30, 2018 | |
Equity [Abstract] | |
Preferred Stock [Text Block] | NOTE 10. MEZZANINE EQUITY Series J convertible preferred stock On April 28, 2017, the Company created the Series J Convertible Preferred Stock (“Series J Preferred”) in conjunction with the Certificate of Designations (“Series J COD”). A total of 50 shares of Series J Preferred were authorized, 24.0344 shares are issued and outstanding, with a stated value of $1,000,000 per share and a par value of $0.01 as of June 30, 2018. The issued shares were pursuant to an Exchange Agreement with Nasrat Hakim, (“Hakim”) a related party and the Company’s President, CEO and Chairman of the Board of Directors Pursuant to the Exchange Agreement the Company exchanged 158,017,321 shares of Common Stock for 24.0344 shares of Series J Preferred and warrants to purchase 79,008,661 shares of common stock at $1.1521 per share. The aggregate stated value of the Series J Preferred issued was equal to the aggregate value of the shares of common stock exchanged, with such value of each share of Common Stock exchanged being equal to the closing price of the Common Stock on April 27, 2017. In connection with the Exchange Agreement, the Company also issued warrants to purchase 79,008,661 shares of common stock at $0.1521 per share, and such warrants are classified as liabilities on the accompanying unaudited condensed consolidated balance sheet as of June 30, 2018 (See Note 11). Each Series J Preferred is convertible at the option of the holder into shares of common stock, that is the earlier of (i) the date that shareholder approval is obtained, and the requisite corporate action has been effected regarding a Fundamental Transaction (as defined in the Series J COD); or (ii) not less than three years subsequent to the Original Issue Date (the date of the first issuance of any shares of the Series J Preferred Stock) (the “Conversion Date”). The number of common shares is calculated by dividing the Stated Value of such share of Series J Preferred by the Conversion Price. The conversion price for the Series J Preferred shall equal $0.1521, subject to adjustment as discussed below. Based on the current conversion price, the Series J Preferred is convertible into 158,017,321 shares of common stock. The conversion price is subject to the following adjustments: (i) stock dividends and splits, (ii) sale or grant of shares below the conversion price, (iii) pro rata distributions; or (iv) fundamental changes (merger, consolidation, or sale of all or substantially all assets). If upon any Conversion Date there is not a sufficient number of authorized shares of Common Stock (that are not issued, outstanding or reserved for issuance) available to effect the entire conversion of the then outstanding shares of Series J Preferred Stock and the then outstanding common stock purchase warrants issued in conjunction therewith (an “Authorized Share Deficiency”), such conversion shall not exceed the Issuable Maximum (as defined in the Series J COD); however, the Company shall use its best efforts to obtain shareholder approval within two (2) years of the date of first issuance of Series J Preferred Stock to permit the balance of the conversion. If shareholder approval is not obtained due to an insufficient number of shareholder votes for passage, the Company shall continue to solicit for shareholder approval annually thereafter. As of June 30, 2018, the Company does not have a sufficient number of unreserved authorized shares to effect the entire conversion, notwithstanding that the earliest possible Conversion Date is April 28, 2020. Solely during any period of time during which an Authorized Share Deficiency exists commencing on or after the fourth anniversary of the Original Issue Date (“Dividend Commencement Date” and collectively the “Dividend Entitlement Period”), holders of Series J Preferred shall be entitled to receive, and the Company shall pay, dividends at the rate per share (as a percentage of the Stated Value per share) of 20% per annum, payable quarterly, in arrears, on January 1, April 1, July 1 and October 1, in cash or duly authorized, validly issued, fully paid and non-assessable shares of Series J Preferred, or a combination thereof (the amount to be paid in shares of The form of dividend payments to each holder shall be made, at the option of the Holders, (i) in cash, to the extent that funds are legally available for the payment of dividends in cash, (ii) in shares of Series J Preferred Stock, or (iii) a combination thereof. The Series J Preferred shall rank senior to the common stock with respect to payment of dividends and pari passu to the common stock with respect to liquidation, dissolution or winding up of the Company. The holders of the Series J Preferred shall have voting rights on any matter presented to the shareholders of the Company for their action or consideration at any meeting of shareholders of the Company (or by written consent of shareholders in lieu of meeting). Each holder shall be entitled to cast the number of votes equal to the number of whole shares of common stock into which the shares of Series J Preferred held by the holder are convertible as of the record date for determining the shareholders entitled to vote on such matter regardless of whether an Authorized Share Deficiency Exists. The Company has determined that the Series J Preferred host instrument was more akin to equity than debt and that the above identified conversion feature, subject to adjustments, was clearly and closely related to the host instrument, and accordingly bifurcation and classification of the conversion feature as a derivative liability was not required. The Company has accounted for the Series J Preferred as contingently redeemable preferred stock for which redemption is not probable. Accordingly, the Series J Preferred is presented in mezzanine equity based on their initial measurement amount (fair value), as required by ASC 480-10-S99, Distinguishing Liabilities from Equity – SEC Materials The fair value of the Series J Preferred issued by the Company pursuant to the exchange agreement was calculated using a Monte Carlo Simulation of stock price and expected future behaviors related to shareholder approval provisions. The following are the key assumptions used in the Monte Carlo Simulation: April 28, 2017 Fair value of the Company's common stock $ 0.1521 Conversion price $ 0.1521 Number of Series J Preferred issued 24.0344 Fully diluted shares outstanding as of measurement date 923,392,780 Risk-free rate 2.30 % Volatility 90 % Shareholder approval threshold $ 0.1521 Probability of approval is ending stock price is greater than threshold - midpoint 82.50 % Probability of approval is ending stock price is less than threshold - midpoint 17.50 % Trials 200,000 Authorized, issued and outstanding shares, along with carrying value and change in value as of the periods presented are as follows: June 30, 2018 March 31, 2018 Shares authorized 50.000 50.000 Shares outstanding 24.0344 24.0344 Par value $ 0.01 $ 0.01 Stated value $ 1,000,000 $ 1,000,000 Conversion price $ 0.1521 $ 0.1521 Common Stock to be issued upon conversion 158,017,321 158,017,321 Carrying value of Series J convertible preferred stock $ 13,903,960 $ 13,903,960 |
DERIVATIVE FINANCIAL INSTRUMENT
DERIVATIVE FINANCIAL INSTRUMENTS - WARRANTS | 3 Months Ended |
Jun. 30, 2018 | |
Derivative Financial Instruments Warrants Disclosure [Abstract] | |
Derivative Financial Instruments Warrants [Text Block] | NOTE 11. DERIVATIVE FINANCIAL INSTRUMENTS – WARRANTS The Company evaluates and accounts for its freestanding instruments in accordance with ASC 815, Accounting for Derivative Instruments and Hedging Activities The Company issued warrants, with terms of five to seven years, to various corporations and individuals, in connection with the sale of securities, loan agreements and consulting agreements. A summary of warrant activity is as follows: June 30, 2018 March 31, 2018 Warrant Shares Weighted Average Exercise Price Warrant Shares Weighted Average Exercise Price Balance at beginning of period 79,008,661 $ 0.1521 9,379,219 $ 0.0625 Warrants granted pursuant to the issuance of Series J convertible preferred shares - - 79,008,661 $ 0.1521 Warrants exercised, forfeited and/or expired, net - - (9,379,219 ) $ 0.0625 Balance at end of period 79,008,661 $ 0.1521 79,008,661 $ 0.1521 On April 28, 2017, the Company entered into an exchange agreement (the “ Exchange Agreement Series J Preferred Securities The Series J Warrants are exercisable for a period of 10 years from the date of issuance, commencing on the earlier of (i) the date that Shareholder Approval is obtained, and the requisite corporate action has been effected; or (ii) April 28, 2020. The initial exercise price is $0.1521 per share and the Series J Warrants can be exercised for cash or on a cashless basis. The exercise price is subject to adjustment for any issuances or deemed issuances of common stock or common stock equivalents at an effective price below the then exercise price. Such exercise price adjustment feature prohibits the Company from being able to conclude the warrants are indexed to its own stock and thus such warrants are classified as liabilities and measured initially and subsequently at fair value. The Series J Warrants also provide for other standard adjustments upon the happening of certain customary events. The Series J Warrants are not exercisable during any period when an Authorized Share Deficiency exists and will expire on the expiry date, without regards to the existence of an Authorized Shares Deficiency (see Note 10). As of June 30, 2018, the Company does not have a sufficient number of unreserved authorized shares to effect the entire conversion of the Series J Preferred, therefore the Series J Warrants are not currently exercisable. The fair value of the warrants issued by the Company pursuant to the issuance of Series J convertible preferred shares (79,008,661 warrant shares) was calculated using a Monte Carlo Simulation because of the probability assumptions associated with the Shareholder Approval provisions. The following are the key assumptions used in the Monte Carlo Simulation: June 30, 2018 March 31, 2018 Fair value of the Company’s common stock $ 0.09 $ 0.10 Initial exercise price $ 0.1521 $ 0.1521 Number of common warrants 79,008,661 79,008,661 Fully diluted shares outstanding as of measurement date 803,638,620 791,516,930 Warrant term (in years) 8.83 9.08 Risk-free rate 2.83 % 2.72 % Volatility 90.00 % 90.00 % Shareholder approval threshold $ 0.1580 $ 0.1580 Probability of approval is ending stock price is greater than threshold - midpoint 82.50 % 82.50 % Probability of approval is ending stock price is greater than threshold - midpoint 17.50 % 17.50 % Trials 100,000 100,000 Fair value of derivative financial instruments - warrants $ 2,415,360 $ 2,667,871 The changes in warrants (Level 3 financial instruments) measured at fair value on a recurring basis for the three months ended June 30, 2018 were as follows: Balance as of March 31, 2018 $ 2,667,871 Change in fair value of derivative financial instruments - warrants (252,511 ) Balance as of June 30, 2018 $ 2,415,360 |
SHAREHOLDERS' EQUITY
SHAREHOLDERS' EQUITY | 3 Months Ended |
Jun. 30, 2018 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity Note Disclosure [Text Block] | NOTE 12. SHAREHOLDERS’ EQUITY Lincoln Park Capital – April 10, 2014 Purchase Agreement On April 10, 2014, the Company entered into a Purchase Agreement (the “2014 LPC Purchase Agreement”) and a Registration Rights Agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”). Pursuant to the terms of the 2014 LPC Purchase Agreement, Lincoln Park had agreed to purchase from the Company up to $40 million of common stock (subject to certain limitations) from time to time over a 36-month period. Upon execution of the 2014 LPC Purchase Agreement, the Company issued 1,928,641 shares of its common stock to Lincoln Park as consideration for its commitment to purchase additional shares of our common stock under that agreement and were obligated to issue up to an additional 1,928,641 commitment shares to Lincoln Park pro rata as up to $40 million of the Company’s common stock is purchased by Lincoln Park. The 2014 LPC Purchase Agreement expired on June 1, 2017. During the term of the 2014 LPC Purchase Agreement, the Company sold an aggregate of 110.6 million shares to Lincoln Park, for aggregate gross proceeds of approximately $27.0 million. In addition, the Company issued an aggregate of 3.2 million commitment shares. Lincoln Park Capital – May 1, 2017 Purchase Agreement On May 1, 2017, the Company entered into a purchase agreement (the “2017 LPC Purchase Agreement”), together with a registration rights agreement (the “2017 LPC Registration Rights Agreement”), with Lincoln Park. Under the terms and subject to the conditions of the 2017 LPC Purchase Agreement, the Company has the right to sell to and Lincoln Park is obligated to purchase up to $40 million in shares of common stock, subject to certain limitations, from time to time, over the 36-month period commencing on June 5, 2017. The Company may direct Lincoln Park, at its sole discretion and subject to certain conditions, to purchase up to 500,000 shares of common stock on any business day, provided that at least one business day has passed since the most recent purchase, increasing to up to 1,000,000 shares, depending upon the closing sale price of the common stock (such purchases, “Regular Purchases”). However, in no event shall a Regular Purchase be more than $1,000,000. The purchase price of shares of common stock related to the future funding will be based on the prevailing market prices of such shares at the time of sales. In addition, the Company may direct Lincoln Park to purchase additional amounts as accelerated purchases under certain circumstances. Sales of shares of common stock to Lincoln Park under the 2017 LPC Purchase Agreement are limited to no more than the number of shares that would result in the beneficial ownership by Lincoln Park and its affiliates, at any single point in time, of more than 4.99% of the then outstanding shares of common stock. In connection with the 2017 LPC Purchase Agreement, the Company issued to Lincoln Park 5,540,551 shares of common stock and are required to issue up to 5,540,551 additional shares of Common Stock pro rata as the Company requires Lincoln Park to purchase shares under the 2017 LPC Purchase Agreement over the term of the agreement. Lincoln Park has represented to the Company, among other things, that it is an “accredited investor” (as such term is defined in Rule 501(a) of Regulation D under the Securities Act of 1933, as amended (the “Securities Act”)). The Company sold the securities in reliance upon an exemption from registration contained in Section 4(a)(2) under the Securities Act. The securities sold may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. The 2017 LPC Purchase Agreement and the 2017 LPC Registration Rights Agreement contain customary representations, warranties, agreements and conditions to completing future sale transactions, indemnification rights and obligations of the parties. The Company has the right to terminate the 2017 LPC Purchase Agreement at any time, at no cost or penalty. Actual sales of shares of common stock to Lincoln Park under the 2017 LPC Purchase Agreement will depend on a variety of factors to be determined by us from time to time, including, among others, market conditions, the trading price of the Common Stock and determinations by us as to the appropriate sources of funding for us and our operations. There are no trading volume requirements or, other than the limitation on beneficial ownership discussed above, restrictions under the 2017 LPC Purchase Agreement. Lincoln Park has no right to require any sales by the Company but is obligated to make purchases from the Company as directed in accordance with the 2017 LPC Purchase Agreement. Lincoln Park has covenanted not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of our shares. The net proceeds received by us under the 2017 LPC Purchase Agreement will depend on the frequency and prices at which the Company sell shares of common stock to Lincoln Park. A registration statement on form S-3 was filed with the SEC on May 10, 2017 and was declared effective on June 5, 2017. The Company, from time to time and at the Company’s sole discretion but no more frequently than every other business day, could direct Lincoln Park to purchase (a “ Regular Purchase In addition to Regular Purchases, on any business day on which the Company has properly submitted a Regular Purchase notice and the closing sale price is not below $0.15, the Company may purchase (an “ Accelerated Purchase In the case of both Regular Purchases and Accelerated Purchases, the purchase price per share will be equitably adjusted for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction occurring during the business days used to compute the purchase price. Other than as set forth above, there are no trading volume requirements or restrictions under the Purchase Agreement, and the Company will control the timing and amount of any sales of the Company’s common stock to Lincoln Park. The Company’s sales of shares of common stock to Lincoln Park under the Purchase Agreement are limited to no more than the number of shares that would result in the beneficial ownership by Lincoln Park and its affiliates, at any single point in time, of more than 9.99% of the then outstanding shares of common stock. The Purchase Agreement and the Registration Rights Agreement contain customary representations, warranties, agreements, and conditions to completing future sale transactions, indemnification rights and obligations of the parties. The Company has the right to terminate the Purchase Agreement at any time, at no cost or penalty. Actual sales of shares of common stock to Lincoln Park under the Purchase Agreement will depend on a variety of factors to be determined by the Company from time to time, including, without limitation, market conditions, the trading price of the Common Stock and determinations by the Company as to appropriate sources of funding for the Company and its operations. There are no trading volume requirements or restrictions under the Purchase Agreement. Lincoln Park has no right to require any sales by the Company but is obligated to make purchases from the Company as it directs in accordance with the Purchase Agreement. Lincoln Park has covenanted not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of Company shares. The net proceeds under the Purchase Agreement to the Company will depend on the frequency and prices at which the Company sells shares of its stock to Lincoln Park. During the three months ended June 30, 2018, a total of 2,000,000 shares were sold to Lincoln Park pursuant to the 2017 LPC Agreement for net proceeds totaling $168,170. In addition, 23,297 shares were issued to Lincoln Park as additional commitment shares, pursuant to the 2017 LPC Agreement. |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 3 Months Ended |
Jun. 30, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Disclosure of Compensation Related Costs, Share-based Payments [Text Block] | NOTE 13. STOCK-BASED COMPENSATION Part of the compensation paid by the Company to its Directors and employees consists of the issuance of common stock or via the granting of options to purchase common stock. Stock-based Director Compensation The Company’s Director compensation policy was instituted in October 2009 and further revised in January 2016, includes provisions that a portion of director’s fees are to be paid via the issuance of shares of the Company’s common stock, in lieu of cash, with the valuation of such shares being calculated on quarterly basis and equal to the average closing price of the Company’s common stock. During the three months ended June 30, 2018, the Company did not issue any shares of common stock to its Directors in payment of director’s fees. During the three months ended June 30, 2018, the Company accrued director’s fees totaling $28,750, which will be paid via cash payments totaling $9,583 and the issuance of 206,538 shares of Common Stock. As of June 30, 2018, the Company owed its Directors a total of $17,083 in cash payments and 343,314 shares of Common Stock in payment of director fees totaling $51,250 due and owing. The Company anticipates that these shares of Common Stock will be issued prior to the end of the current fiscal year. Stock-based Employee/Consultant Compensation Employment contracts with the Company’s President and Chief Executive Officer, Chief Financial Officer and certain other employees and engagement contracts with certain consultants include provisions for a portion of each employee’s salaries or consultant’s fees to be paid via the issuance of shares of the Company’s Common Stock, in lieu of cash, with the valuation of such shares being calculated on a quarterly basis and equal to the average closing price of the Company’s Common Stock. During the three months ended June 30, 2018, the Company did not issue any shares pursuant to employment contracts with the Company’s President and Chief Executive Officer, Chief Financial Officer or certain other employees. During the three months ended June 30, 2018, the Company did not issue any shares pursuant to the engagement contracts with certain consultants. During the three months ended June 30, 2018, the Company accrued salaries totaling $201,250 owed to the Company’s President and Chief Executive Officer, Chief Financial Officer and certain other employees which will be paid via the issuance of 2,168,606 shares of Common Stock. As of June 30, 2018, the Company owed its President and Chief Executive Officer, Chief Financial Officer and certain other employees’ salaries totaling $902,500 which will be paid via the issuance of 8,038,031 shares of Common Stock. The Company anticipates that these shares of Common Stock will be issued prior to the end of the current fiscal year. During the three months ended June 30, 2018, the Company accrued consulting fees totaling $14,355 owed to certain consultants which will be paid via the issuance of 154,727 shares of Common Stock. As of June 30, 2018, the Company owed certain consultants fees of $54,135 which will be paid via the issuance of 270,052 shares of Common Stock. The Company anticipates that these shares of Common Stock will be issued prior to the end of the current fiscal year. Options Under its 2014 Stock Option Plan and prior options plans, the Company may grant stock options to officers, selected employees, as well as members of the Board of Directors and advisory board members. All options have generally been granted at a price equal to or greater than the fair market value of the Company’s Common Stock at the date of the grant. Generally, options are granted with a vesting period of up to three years and expire ten years from the date of grant. Weighted Weighted Average Shares Average Remaining Contractual Aggregate Intrinsic Underlying Options Exercise Price Term (in years) Value Outstanding at April 1, 2018 6,618,000 $ 0.16 6.1 $ 90,390 Granted - - - - Forfeited and expired (100,000 ) 0.21 - - Outstanding at June 30, 2018 6,518,000 $ 0.16 5.8 $ 60,000 Exercisable at June 30, 2018 5,635,000 $ 0.15 5.5 $ 60,000 The aggregate intrinsic value for outstanding options is calculated as the difference between the exercise price of the underlying awards and the quoted price of the Company common stock as of June 30, 2018 and March 31, 2018 of $0.09 and $0.10, respectively. The fair value of the options was calculated using the Black-Scholes model and the following assumptions: June 30, 2018 March 31, 2018 Volatility (based on the Company’s historical volatility) 121% - 123 % 121% - 123 % Exercise price $ 0.09 - 0.24 $ 0.09 - 0.24 Estimated term (in years) 10 10 Risk free interest rate (based on 1-year treasury rate) 2.2% - 2.8 % 2.2% - 2.4 % Forfeiture rate 4.7% - 20.1 % 0.0% - 20.1 % Fair value of options granted $ 85,377 $ 79,215 Non-cash compensation through issuance of stock options $ 36,549 $ 244,753 |
CONCENTRATIONS AND CREDIT RISK
CONCENTRATIONS AND CREDIT RISK | 3 Months Ended |
Jun. 30, 2018 | |
Risks and Uncertainties [Abstract] | |
Concentration Risk Disclosure [Text Block] | NOTE 14. CONCENTRATIONS AND CREDIT RISK Revenues Three customers accounted for substantially all the Company’s revenues for the three months ended June 30, 2018. These three customers accounted for approximately 56%, 21% and 9% of revenues each, respectively. Three customers accounted for substantially all the Company’s revenues for the three months ended June 30, 2017. These three customers accounted for approximately 59%, 29% and 11% of revenues each, respectively. Accounts Receivable Three customers accounted for substantially all the Company’s accounts receivable as of June 30, 2018. These three customers accounted for approximately 59%, 17% and 11% of accounts receivable each, respectively. Four customers accounted for substantially all the Company’s accounts receivable as of March 31, 2018. These four customers accounted for approximately 52%, 14%, 12%, and 11% of accounts receivable each, respectively. Purchasing Four suppliers accounted for more than 90% of the Company’s purchases of raw materials for the three months ended June 30, 2018. These four suppliers accounted for approximately 40%, 19%, 17% and 14% of purchases each, respectively. Four suppliers accounted for more than 75% of the Company’s purchases of raw materials for the three months ended June 30, 2017. These four suppliers accounted for approximately 41%, 12%, 12% and 12% of purchases each, respectively. |
SEGMENT RESULTS
SEGMENT RESULTS | 3 Months Ended |
Jun. 30, 2018 | |
Segment Reporting [Abstract] | |
Segment Reporting Disclosure [Text Block] | NOTE 15. SEGMENT RESULTS FASB ASC 280-10-50 requires use of the “management approach” model for segment reporting. The management approach is based on the way a company’s management organized segments within the company for making operating decisions and assessing performance. Reportable segments are based on products and services, geography, legal structure, management structure, or any other manner in which management disaggregates a company. The Company has determined that its reportable segments are Abbreviated New Drug Applications (“ANDA”) for generic products and New Drug Applications (“NDA”) for branded products. The Company identified its reporting segments based on the marketing authorization relating to each and the financial information used by its chief operating decision maker to make decisions regarding the allocation of resources to and the financial performance of the reporting segments. Asset information by operating segment is not presented below since the chief operating decision maker does not review this information by segment. The reporting segments follow the same accounting policies used in the preparation of the Company’s unaudited condensed consolidated financial statements. The table below reconciles the Company’s operating loss by segment to (loss) income from operations before provision for income taxes as reported in the Company’s unaudited condensed consolidated statements of operations. For the Three Months Ended June 30, 2018 2017 Operating loss by segment $ (373,283 ) $ (1,108,255 ) Corporate unallocated costs (1,022,359 ) (670,629 ) Interest income 1,255 3,982 Interest expense and amortization of debt issuance costs (83,138 ) (70,731 ) Depreciation and amortization expense (203,704 ) (6,776 ) Significant non-cash items (259,048 ) (452,611 ) Change in fair value of derivative instruments 252,511 139,260 Loss from operations $ (1,687,766 ) $ (2,165,760 ) |
COLLABORATIVE AGREEMENT WITH EP
COLLABORATIVE AGREEMENT WITH EPIC PHARMA LLC | 3 Months Ended |
Jun. 30, 2018 | |
Epic Pharma Llc [Member] | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Collaborative Arrangement Disclosure [Text Block] | NOTE 16. COLLABORATIVE AGREEMENT WITH EPIC PHARMA LLC On June 4, 2015, the Company entered into the 2015 Epic License Agreement, which provides for the exclusive right to market, sell and distribute, by Epic Pharma LLC (“Epic”) of SequestOx™, an abuse deterrent opioid which employs the Company’s proprietary pharmacological abuse-deterrent technology. Epic will be responsible for payment of product development and pharmacovigilance costs, sales, and marketing of SequestOx™, and Elite will be responsible for the manufacture of the product. Under the 2015 Epic License Agreement, Epic will pay Elite non-refundable payments totaling $15 million, with such amount representing the cost of an exclusive license to ELI-200, the cost of developing the product and certain filings and a royalty based on an amount equal to 50% of profits derived from net product sales as defined in the 2015 Epic License Agreement. The initial term of the exclusive right to product development sales and distribution is five years (“Epic Exclusivity Period”); the license is renewable upon mutual agreement at the end of the initial term. In June 2015, Elite received non-refundable payments totaling $5 million from Epic for the exclusive right to product development sales and distribution of SequestOx™ pursuant to the Epic Collaborative Agreement, under which it agreed to not permit marketing or selling of SequestOx™ within the United States of America to any other party. These nonrefundable payments represent consideration for certain exclusive rights to ELI-200 and will be recognized ratably over the Epic Exclusivity Period. In addition, in January 2016, a New Drug Application for SequestOx™ was filed, thereby earning the Company a non-refundable $2.5 million milestone, pursuant to the 2015 Epic License Agreement. Accordingly, the Company has recognized the $2.5 million milestone, which was paid by Epic and related to this deliverable as income during the year ended March 31, 2016. To date, the Company received payments totaling $7.5 million pursuant to the 2015 Epic License Agreement, with all amounts being non-refundable. An additional $7.5 million is due upon approval by the FDA of the NDA filed for SequestOx™, and license fees based on commercial sales of SequestOx™. Revenues relating to these additional amounts due under the 2015 Epic License Agreement will be recognized as the defined elements are completed and collectability is reasonably assured. Please note that on July 15, 2016, the FDA issued a Complete Response Letter, or CRL, regarding the NDA. The CRL stated that the review cycle for the SequestOx™ NDA is complete and the application is not ready for approval in its present form. Based on subsequent meetings and communications with the FDA, the Company believes that there is a clear path forward to address the issues cited in the CRL. The Company believes that the meeting minutes, received from the FDA on January 23, 2017, supported a plan to address the issues cited by the FDA in the CRL by modifying the SequestOx™ formulation. Such plan includes, without limitation, conducting bioequivalence and bioavailability fed and fasted studies, comparing the modified formulation to the original formulation. the Company modified the SequestOx™ formulation and, on January 30, 2018 reported positive topline results from a pilot study indicating the likelihood of achieving the required bioequivalence in a pivotal trial under fed conditions. The Company is reviewing these results with the FDA and discussing pharmacokinetic study requirements for a re-submission of the NDA. The 2015 Epic License Agreement expires on June 4, 2020, and Epic has previously advised the Company of their desire to extend this agreement. While discussions are ongoing, they are directly correlated to the regulatory status of SequestOx™. Furthermore, there can be no assurances that the parties will reach mutual agreement to extend the term of this agreement and no assurances that the terms and conditions of the agreement will be similar in all material aspects in the event that the agreement is extended by mutual consent of the parties. Non-receipt by the Company of the remaining $7.5 million milestone will have a material adverse effect on the Company’s financial condition. |
COLLABORATIVE AGREEMENT WITH SU
COLLABORATIVE AGREEMENT WITH SUNGEN PHARMA LLC | 3 Months Ended |
Jun. 30, 2018 | |
SunGen Pharma LLC [Member] | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Collaborative Arrangement Disclosure [Text Block] | NOTE 17. COLLABORATIVE AGREEMENT WITH SUNGEN PHARMA LLC On August 24, 2016, the Company entered into the SunGen Agreement. The SunGen Agreement, as amended, provides that Elite and SunGen Pharma LLC will engage in the research, development, sales, and marketing of eight generic pharmaceutical products. Two of the products are classified as CNS stimulants (the “CNS Products”), two of the products are classified as beta blockers (the “Beta Blocker Products”) and the remaining four products consist of antidepressants, antibiotics and antispasmodics. Under the terms of the SunGen Agreement, Elite and SunGen will share in the responsibilities and costs in the development of these products and will share substantially in the profits from sales of the Products. Upon approval, the know-how and intellectual property rights to the products will be owned jointly by Elite and SunGen. SunGen shall have the exclusive right to market and sell the Beta Blocker Products using SunGen’s label and Elite shall have the exclusive right to market and sell the CNS Products using Elite’s label. Elite will manufacture and package all four products on a cost-plus basis. On December 1, 2016 and July 24, 2017, Elite Labs and SunGen executed an amendment to the parties’ 2016 Development and License Agreement (the “ Amended Agreement Under the terms of the Amended Agreement, Elite and SunGen will share in the responsibilities and costs in the development of these products and will share substantially in the profits from sales of the products. Upon approval, the know-how and intellectual property rights to the products will be owned jointly by Elite and SunGen. Three products will be owned jointly by Elite and SunGen; three shall be owned by SunGen while Elite shall have the marketing rights once the products are approved by the FDA; and two shall be owned by Elite while SunGen shall have the marketing rights once the products are approved by the FDA. Elite will manufacture and package all eight products on a cost-plus basis. On February 8, 2018, the Company filed an ANDA with the FDA for a generic version of an immediate release central nervous system (“ CNS On May 24, 2018, the Company filed an ANDA with the FDA for a generic version of an extended release CNS stimulant. The ANDA represents the second filing for a product co-developed with SunGen under the SunGen Agreement. There can be no assurances that any of these products, including the two products for which ANDAs have already been filed, will receive marketing authorization and achieve commercialization within a reasonable time period, or at all. In addition, even if marketing authorization is received, there can be no assurances that there will be future revenues of profits, or that any such future revenues or profits would be in amounts that provide adequate return on the significant investments made to secure these marketing authorizations. |
RELATED PARTY TRANSACTION AGREE
RELATED PARTY TRANSACTION AGREEMENTS WITH EPIC PHARMA LLC | 3 Months Ended |
Jun. 30, 2018 | |
Epic Pharma Llc [Member] | |
Related Party Transactions Disclosure [Text Block] | NOTE 18. RELATED PARTY TRANSACTION AGREEMENTS WITH EPIC PHARMA LLC The Company has entered into two agreements with Epic which constitute agreements with a related party due to the management of Epic including a member on our Board of Directors at the time such agreements were executed. On June 4, 2015, the Company entered into the 2015 Epic License Agreement (please see Note 16 above). The 2015 Epic License Agreement includes milestone payments totaling $10 million upon the filing with and approval of an NDA with the FDA. The Company has determined these milestones to be substantive, with such assessment being made at the inception of the 2015 Epic License Agreement, and based on the following: The Company’s performance is required to achieve each milestone; and The milestones will relate to past performance, when achieved; and The milestones are reasonable relative to all of the deliverables and payment terms within the 2015 Epic License Agreement After marketing authorization is received from the FDA, Elite will receive a license fee which is based on profits achieved from the commercial sales of ELI-200. On January 14, 2016, the Company filed an NDA with the FDA for SequestOx™, thereby earning a $2.5 million milestone pursuant to the 2015 Epic License Agreement. The Company has received payment of this amount from Epic. An additional $7.5 million is due upon approval by the FDA of the NDA filed for SequestOx™. Please note that on July 15, 2016, the FDA issued a Complete Response Letter, or CRL, regarding the NDA. The CRL stated that the review cycle for the SequestOx™ NDA is complete and the application is not ready for approval in its present form. On December 21, 2016, the Company met with the FDA for an end-of-review meeting to discuss steps that it could take to obtain approval of SequestOx™. Based on this and the meeting minutes received from the FDA on January 23, 2017, the Company formulated a plan to address the issues cited by the FDA in the CRL, with such plan including, without limitation, modifying the SequestOx™ formulation, conducting bioequivalence and bioavailability fed and fasted studies, comparing the modified formulation to the original formulation. On July 7, 2017, the Company reported topline results from a pivotal bioequivalence fed study for SequestOx™. This study resulted in a mean Tmax of 4.6 hours, with a range of 0.5 hour to 12 hours. and a mean Tmax of the comparator, Roxicodone ® On October 2, 2013, Elite executed the Epic Pharma Manufacturing and License Agreement (the “Epic Generic Agreement”), which granted rights to Epic to manufacture twelve generic products whose ANDA’s are owned by Elite, and to market, in the United States and Puerto Rico, six of these products on an exclusive basis, and the remaining six products on a non-exclusive basis. These products will be manufactured at Epic, with Epic being responsible for the manufacturing site transfer supplements that are a prerequisite to each product being approved for commercial sale. In addition, Epic is responsible for all regulatory and pharmacovigilance matters, as well as all marketing and distribution activities. Elite has no further obligations or deliverables under the Epic Generic Agreement. Pursuant to the Epic Generic Agreement, Elite will receive $1.8 million, payable in increments that require the commercialization of all six exclusive products if the full amount is to be received, plus license fees equal to a percentage that is not less than 50% and not greater than 60% of profits achieved from commercial sales of the products, as defined in the Epic Generic Agreement. While Epic has launched four of the six exclusive products and Elite has collected $1.0 million of the $1.8 million total fee, collection of the remaining $800,000 is contingent upon Epic filing the required supplements with and receiving approval from the FDA for the remaining exclusive generic products. The Epic Generic Agreement expires on October 2, 2018. There can be no assurances of Epic filing these supplements or getting approval of any supplements filed. Accordingly, there can be no assurances of Elite receiving the remaining $800,000 due under the Epic Generic Agreement, or future license fees related thereto. Please also note that all commercialization, regulatory, manufacturing, marketing and distribution activities are being conducted solely by Epic, without Elite’s participation. Both the 2015 Epic License Agreement and the Epic Generic Agreement contain license fees that will be earned and payable to the Company, after the FDA has issued marketing authorization(s) for the related product(s). License fees are based on commercial sales of the products achieved by Epic and calculated as a percentage of net sales dollars realized from such commercial sales. Net sales dollars consist of gross invoiced sales less those costs and deductions directly attributable to each invoiced sale, including, without limitation, cost of goods sold, cash discounts, Medicaid rebates, state program rebates, price adjustments, returns, short date adjustments, charge backs, promotions, and marketing costs. The rate applied to the net sales dollars to determine license fees due to the Company is equal to an amount negotiated and agreed to by the parties to each agreement, with the following significant factors, inputs, assumptions, and methods, without limitation, being considered by either or both parties: Assessment of the opportunity for each product in the market, including consideration of the following, without limitation: market size, number of competitors, the current and estimated future regulatory, legislative, and social environment for abuse deterrent opioids and the other generic products to which the underlying contracts are relevant; Assessment of various avenues for monetizing SequestOx™ and the twelve ANDA’s owned by the Company, including the various combinations of sites of manufacture and marketing options; Elite’s resources and capabilities with regards to the concurrent development of abuse deterrent opioids and expansion of its generic business segment, including financial and operational resources required to achieve manufacturing site transfers for twelve approved ANDA’s; Capabilities of each party with regards to various factors, including, one or more of the following: manufacturing, marketing, regulatory and financial resources, distribution capabilities, ownership structure, personnel, assessments of operational efficiencies and entity stability, company culture and image; Stage of development of SequestOx™ and manufacturing site transfer and regulatory requirements relating to the commercialization of the generic products at the time of the discussions/negotiations, and an assessment of the risks, probability, and time frames for achieving marketing authorizations from the FDA for each product. Assessment of consideration offered; and Comparison of the above factors among the various entities with whom the Company was engaged in discussions relating to the commercialization of SequestOx™ and the manufacture/marketing of the twelve generics related to the Epic Generic Agreement. This transaction is not to be considered as an arms-length transaction. Please also note that, effective April 7, 2016, all Directors on the Company’s Board of Directors that were also owners/managers of Epic had resigned as Directors of the Company and all current members of the Company’s Board of Directors have no relationship to Epic. Accordingly, Epic no longer qualifies as a party that is related to the Company. |
MANUFACTURING, LICENSE AND DEVE
MANUFACTURING, LICENSE AND DEVELOPMENT AGREEMENTS | 3 Months Ended |
Jun. 30, 2018 | |
Related Party Transactions [Abstract] | |
Related Party Transaction, Manufacturing And License Agreement Disclosure [Text Block] | NOTE 19. MANUFACTURING, LICENSE AND DEVELOPMENT AGREEMENTS The Company has entered into the following active agreements: License agreement with Precision Dose, dated September 10, 2010 (the “Precision Dose License Agreement”) Master Development and License Agreement with SunGen Pharma LLC, dated August 24, 2016, as amended (the “SunGen Agreement”) and, Strategic Marketing Alliance with Glenmark Pharmaceuticals, Inc. USA dated May 29, 2018 (the “Glenmark Alliance”) The Precision Dose Agreement provides for the marketing and distribution, by Precision Dose and its wholly owned subsidiary, TAGI Pharma, of Phentermine 37.5mg tablets (launched in April 2011), Phentermine 15mg capsules (launched in April 2013), Phentermine 30mg capsules (launched in April 2013), Hydromorphone 8mg tablets (launched in March 2012), Naltrexone 50mg tablets (launched in September 2013) and certain additional products that require approval from the FDA which has not been received. Precision Dose will have the exclusive right to market these products in the United States and Puerto Rico and a non-exclusive right to market the products in Canada. Pursuant to the Precision Dose License Agreement, Elite received $200k at signing, and is receiving milestone payments and a license fee which is based on profits achieved from the commercial sale of the products included in the agreement. Revenue from the $200k payment made upon signing of the Precision Dose Agreement is being recognized over the life of the Precision Dose Agreement. The milestones, totaling $500k (with $405k already received), consist of amounts due upon the first shipment of each identified product, as follows: Phentermine 37.5mg tablets ($145k), Phentermine 15 & 30mg capsules ($45k), Hydromorphone 8mg ($125k), Naltrexone 50mg ($95k) and the balance of $95k due in relation to the first shipment of generic products which still require marketing authorizations from the FDA, and to which there can be no assurances of such marketing authorizations being granted and accordingly there can be no assurances that the Company will earn and receive these milestone amounts. These milestones have been determined to be substantive, with such determination being made by the Company after assessments based on the following: The Company’s performance is required to achieve each milestone; and The milestones will relate to past performance, when achieved; and The milestones are reasonable relative to all of the deliverables and payment terms within the Precision Dose License Agreement. The license fees provided for in the Precision Dose Agreement are calculated as a percentage of net sales dollars realized from commercial sales of the related products. Net sales dollars consist of gross invoiced sales less those costs and deductions directly attributable to each invoiced sale, including, without limitation, cost of goods sold, cash discounts, Medicaid rebates, state program rebates, price adjustments, returns, short date adjustments, charge backs, promotions, and marketing costs. The rate applied to the net sales dollars to determine license fees due to the Company is equal to an amount negotiated and agreed to by the parties to the Precision Dose License Agreement, with the following significant factors, inputs, assumptions, and methods, without limitation, being considered by either or both parties: Assessment of the opportunity for each generic product in the market, including consideration of the following, without limitation: market size, number of competitors, the current and estimated future regulatory, legislative, and social environment for each generic product, and the maturity of the market; Assessment of various avenues for monetizing the generic products, including the various combinations of sites of manufacture and marketing options; Capabilities of each party with regards to various factors, including, one or more of the following: manufacturing resources, marketing resources, financial resources, distribution capabilities, ownership structure, personnel, assessment of operational efficiencies and stability, company culture and image; Stage of development of each generic product, all of which did not have FDA approval at the time of the discussions/negotiations and an assessment of the risks, probability, and time frame for achieving marketing authorizations from the FDA for the products; Assessment of consideration offered by Precision and other entities with whom discussions were conducted; and Comparison of the above factors among the various entities with whom the Company was engaged in discussions relating to the commercialization of the generic products. The SunGen Agreement provides for the research, development, sales and marketing of eight generic pharmaceutical products. Two of the products are classified as CNS stimulants (the “CNS Products”), two of the products are classified as beta blockers and the remaining four products consist of antidepressants, antibiotics and antispasmodics. To date, the Company has filed ANDAs with the FDA for the two CNS Products identified in the SunGen Agreement. Under the terms of the SunGen Agreement, Elite and SunGen will share in the responsibilities and costs in the development of these products and will share substantially in the profits from sales. Upon approval, the know-how and intellectual property rights to the products will be owned jointly by Elite and SunGen. Three of the eight products will be jointly owned, three products will be owned by SunGen, with Elite having exclusive marketing rights and the remaining two products will be owned by Elite, with SunGen having exclusive marketing rights. Elite will manufacture and package all eight products on a cost-plus basis. The Glenmark Alliance, provides for the manufacture by Elite and marketing by Glenmark of identified generic products under license from Elite. In addition to the purchase prices for the products, Elite will receive license fees well in excess of 50% of gross profits. Gross profit is defined as net sales less the price paid to Elite for the products, distribution fees (less than 10%) and shipping costs. Glenmark will have semi-exclusive marketing rights to the ANDA approved generic product, phendimetrazine 35mg tablets, and exclusive marketing rights to generic Methadone HCl. Collectively, the brand products and their generic equivalents had total annual sales of approximately $33.6 million in 2017, according to Quintiles IMS Health data. The Agreement has an initial term of three years and automatically renews for one-year periods absent prior written notice of non-renewal. In addition to customary termination provisions, the Agreement permits Glenmark to terminate with regard to a product on at least three months’ prior written notice if it determines to stop marketing and selling such product, and it permits Elite to terminate with regard to a product if at any time after the first twelvemonths from the first commercial sale, the average license fee paid by Glenmark for such product is less than $100,000 for a six-month sales period. |
RELATED PARTY AGREEMENTS WITH M
RELATED PARTY AGREEMENTS WITH MIKAH PHARMA LLC | 3 Months Ended |
Jun. 30, 2018 | |
Mikah Pharma Llc [Member] | |
Related Party Transactions Disclosure [Text Block] | NOTE 20. RELATED PARTY AGREEMENTS WITH MIKAH PHARMA LLC Pursuant to an asset acquisition , On May 22, 2017, the Company executed an assignment agreement with Mikah, pursuant to which the Company acquired all rights, interests and obligations under a manufacturing and supply agreement with Epic Pharma LLC (“Epic”) originally entered into by Mikah on June 30, 2015 and relating to the manufacture and supply of Trimipramine (the “Manufacturing Agreement”). Mikah is owned by Nasrat Hakim, the CEO, President and Chairman of the Board of the Company. Under the Manufacturing Agreement, Epic will manufacture Trimipramine under license from the Company pursuant to the FDA approved and currently marketed ANDA that was acquired in conjunction with the Company’s entry into these agreements. Under the Distribution Agreement, the Company will supply Trimipramine on an exclusive basis to Dr. Reddy’s and Dr. Reddy’s will be responsible for all marketing and distribution of Trimipramine in the United States, its territories, possessions and commonwealth. The Trimipramine will be manufactured by Epic and transferred to Dr. Reddy’s at cost, without markup. Dr. Reddy’s will pay to the Company a share of the profits, calculated without any deduction for cost of sales and marketing, derived from the sale of Trimipramine. The Company’s share of these profits is in excess of 50%. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 3 Months Ended |
Jun. 30, 2018 | |
Subsequent Events [Abstract] | |
Subsequent Events [Text Block] | NOTE 21. SUBSEQUENT EVENTS The Company has evaluated subsequent events from the balance sheet date through August 3, 2018, the date the accompanying financial statements were issued. The following are material subsequent events. Common Stock issued and sold pursuant to the Lincoln Park Purchase Agreement Subsequent to June 30, 2018 and up to August 3, 2018 (the latest practicable date), a total of 4,970,349 shares of Common Stock were issued to Lincoln Park, with such shares consisting of 4,902,587 purchase shares and 67,762 additional commitment shares. Total proceeds from these transactions was $489,206. Approval of Oxycodone Hydrochloride and Acetaminophen, USP CII On July 2, 2018, the Company received approval by the U.S. Food and Drug Administration of the abbreviated new drug application (ANDA) filed for generic Percocet® (Oxycodone Hydrochloride and Acetaminophen, USP CII) 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg tablets. Approval of Methadone HCl 5mg and 10mg On August 3, 2018, the Company received approval of by the U.S. Food and Drug Administration of the ANDA filed for generic Methadone HCl 5mg and 10mg tablets. |
SUMMARY OF SIGNIFICANT ACCOUN28
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Jun. 30, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Accounting, Policy [Policy Text Block] | Overview Elite Pharmaceuticals, Inc. (the “Company” or “Elite”) was incorporated on October 1, 1997 under the laws of the State of Delaware, and its wholly-owned subsidiary Elite Laboratories, Inc. (“Elite Labs”) which was incorporated on August 23, 1990 under the laws of the State of Delaware. On January 5, 2012, Elite Pharmaceuticals was reincorporated under the laws of the State of Nevada. Elite Labs engages primarily in researching, developing and licensing proprietary orally administered, controlled-release drug delivery systems and products with abuse deterrent capabilities and the manufacture of generic, oral dose pharmaceuticals. The Company is equipped to manufacture controlled-release products on a contract basis for third parties and itself, if and when the products are approved. These products include drugs that cover therapeutic areas for pain, allergy, bariatric and infection. Research and development activities are done so with an objective of developing products that will secure marketing approvals from the United States Food and Drug Administration (“FDA”), and thereafter, commercially exploiting such products. |
Consolidation, Policy [Policy Text Block] | Principles of Consolidation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) and in conformity with the instructions on Form 10-Q and Rule 8-03 of Regulation S-X and the related rules and regulations of the Securities and Exchange Commission (“SEC”). The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, Elite Laboratories, Inc. All significant intercompany accounts and transactions have been eliminated in consolidation. The unaudited condensed consolidated financial statements reflect all adjustments, consisting of normal recurring accruals, which are, in the opinion of management, necessary for a fair presentation of such statements. The results of operations for the three months ended June 30, 2018 are not necessarily indicative of the results that may be expected for the entire year. |
Going Concern Policy [Policy Text Block] | Going Concern In connection with the preparation of the financial statements as of and for the three months period ended June 30, 2018, the Company conducted an evaluation as to whether there were conditions and events, considered in the aggregate, which raised substantial doubt as to the entity’s ability to continue as a going concern within one year after the date of the issuance, or the date the financial statements were available for issuance, noting that there did not appear to be evidence of substantial doubt of the entity’s ability to continue as a going concern. |
Segment Reporting, Policy [Policy Text Block] | Segment Information Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 280, Segment Reporting The Company has determined that its reportable segments are products whose marketing approvals were secured via an Abbreviated New Drug Applications (“ANDA”) and products whose marketing approvals were secured via a New Drug Application (“NDA”). ANDA products are referred to as generic pharmaceuticals and NDA products are referred to as branded pharmaceuticals. There are currently no intersegment revenues. Asset information by operating segment is not presented below since the chief operating decision maker does not review this information by segment. The reporting segments follow the same accounting policies used in the preparation of the Company’s condensed unaudited consolidated financial statements. |
Revenue Recognition, Policy [Policy Text Block] | Revenue Recognition The Company generates revenue from the development of pain management products, manufacturing of a line of generic pharmaceutical products with approved ANDA, commercialization of products either by license and the collection of royalties, or through the manufacture of formulations and the development of new products and the expansion of licensing agreements with other pharmaceutical companies, including co-development projects, joint ventures and other collaborations. The Company also generates revenue through its focus on the development of various types of drug products, including branded drug products which require NDAs. Under FASB Topic 606, Revenue from Contacts with Customers Nature of goods and services The following is a description of the Company’s goods and services from which the Company generates revenue, as well as the nature, timing of satisfaction of performance obligations, and significant payment terms for each, as applicable: a) Manufacturing Fees The Company is equipped to manufacture controlled-release products on a contract basis for third parties, if and when the products are approved. These products include products using controlled-release drug technology and products utilizing abuse deterrent technologies. The Company also develops and markets (either on its own or by license to other companies) generic and proprietary controlled-release and abuse deterrent pharmaceutical products. The Company recognizes revenue when the customer obtains control of the Company’s product based on the contractual shipping terms of the contract. Revenue on product are presented gross because the Company is primarily responsible for fulfilling the promise to provide the product, is responsible to ensure that the product is produced in accordance with the related supply agreement and bears risk of loss while the inventory is in-transit to the commercial partner. Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring products to a customer. b) License Fees The Company enters into licensing and development agreements, which may include multiple revenue generating activities, including milestones payments, licensing fees, product sales and services. The Company analyzes each element of its licensing and development agreements in accordance with ASC 606 to determine appropriate revenue recognition. The terms of the license agreement may include payment to the Company of licensing fees, non-refundable upfront license fees, milestone payments if specified objectives are achieved, and/or royalties on product sales. If the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. Contracts that contain multiple performance obligations require an allocation of the transaction price based on the estimated relative standalone selling prices of the promised products or services underlying each performance obligation. The Company determines standalone selling prices based on the price at which the performance obligation is sold separately. If the standalone selling price is not observable through past transactions, the Company estimates the standalone selling price taking into account available information such as market conditions and internally approved pricing guidelines related to the performance obligations. The Company recognizes revenue from non-refundable upfront payments at a point in time, typically upon fulfilling the delivery of the associated intellectual property to the customer. For those milestone payments which are contingent on the occurrence of particular future events (for example, payments due upon a product receiving FDA approval), the Company determined that these need to be considered for inclusion in the calculation of total consideration from the contract as a component of variable consideration using the most-likely amount method. As such, the Company assesses each milestone to determine the probability and substance behind achieving each milestone. Given the inherent uncertainty of the occurrence of future events, the Company will not recognize revenue from the milestone until there is not a high probability of a reversal of revenue, which typically occurs near or upon achievement of the event. Significant management judgment is required to determine the level of effort required under an arrangement and the period over which the Company expects to complete its performance obligations under the arrangement. If the Company cannot reasonably estimate when its performance obligations either are completed or become inconsequential, then revenue recognition is deferred until the Company can reasonably make such estimates. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method. When determining the transaction price of a contract, an adjustment is made if payment from a customer occurs either significantly before or significantly after performance, resulting in a significant financing component. Applying the practical expedient in paragraph 606-10-32-18, the Company does not assess whether a significant financing component exists if the period between when the Company performs its obligations under the contract and when the customer pays is one year or less. None of the Company’s contracts contained a significant financing component as of June 30, 2018. In accordance with ASC 606-10-55-65, royalties are recognized when the subsequent sale of the customer’s products occurs. Disaggregation of revenue In the following table, revenue is disaggregated by type of revenue generated by the Company and timing of revenue recognition. The table also includes a reconciliation of the disaggregated revenue with the reportable segments: For the Three Months Ended June 30, 2018 2017 NDA: Licensing fees $ 250,000 $ 250,000 Total NDA revenue 250,000 250,000 ANDA: Manufacturing fees $ 1,541,858 $ 1,010,896 Licensing fees 375,840 441,874 Total ANDA revenue 1,917,698 1,452,770 Total revenue $ 2,167,698 $ 1,702,770 |
Collaborative Arrangement, Accounting Policy [Policy Text Block] | Collaborative Arrangements Contracts are considered to be collaborative arrangements when they satisfy the following criteria defined in ASC 808, Collaborative Arrangements The parties to the contract must actively participate in the joint operating activity; and, The joint operating activity must expose the parties to the possibility of significant risk and rewards, based on whether or not the activity is successful. The Company entered into a sales and distribution licensing agreement with Epic Pharma LLC, dated June 4, 2015 (the “2015 Epic License Agreement”), which has been determined to satisfy the criteria for consideration as a collaborative agreement, and is accounted for accordingly, in accordance with GAAP. The Company entered into a Master Development and License Agreement with SunGen Pharma LLC dated August 24, 2016 (the “SunGen Agreement”), which has been determined to satisfy the criteria for consideration as a collaborative agreement, and is accounted for accordingly, in accordance with GAAP. |
Cash and Cash Equivalents, Unrestricted Cash and Cash Equivalents, Policy [Policy Text Block] | Cash The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. Cash and cash equivalents consist of cash on deposit with banks and money market instruments. The Company places its cash and cash equivalents with high-quality, U.S. financial institutions and, to date has not experienced losses on any of its balances. |
Cash and Cash Equivalents, Policy [Policy Text Block] | Restricted Cash As of June 30, 2018, and March 31, 2018, the Company had $392,820 and $391,566, respectively, of restricted cash, related to debt service reserve in regard to the New Jersey Economic Development Authority (“NJEDA”) bonds (see Note 5). |
Receivables, Policy [Policy Text Block] | Accounts Receivable Accounts receivable are comprised of balances due from customers, net of estimated allowances for uncollectible accounts. In determining collectability, historical trends are evaluated, and specific customer issues are reviewed on a periodic basis to arrive at appropriate allowances. |
Inventory, Policy [Policy Text Block] | Inventory Inventory is recorded at the lower of cost or market on a first-in first-out basis. |
Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block] | Long-Lived Assets The Company periodically evaluates the fair value of long-lived assets, which include property and equipment and intangibles, whenever events or changes in circumstances indicate that its carrying amounts may not be recoverable. Property and equipment are stated at cost. Depreciation is provided on the straight-line method based on the estimated useful lives of the respective assets which range from three to forty years. Major repairs or improvements are capitalized. Minor replacements and maintenance and repairs which do not improve or extend asset lives are expensed currently. Upon retirement or other disposition of assets, the cost and related accumulated depreciation are removed from the accounts and the resulting gain or loss, if any, is recognized in income. |
Intangible Assets, Finite-Lived, Policy [Policy Text Block] | Intangible Assets The Company capitalizes certain costs to acquire intangible assets; if such assets are determined to have a finite useful life they are amortized on a straight-line basis over the estimated useful life. Costs to acquire indefinite lived intangible assets, such as costs related to ANDAs are capitalized accordingly. The Company tests its intangible assets for impairment at least annually (as of March 31st) and whenever events or circumstances change that indicate impairment may have occurred. A significant amount of judgment is involved in determining if an indicator of impairment has occurred. Such indicators may include, among others and without limitation: a significant decline in the Company’s expected future cash flows; a sustained, significant decline in the Company’s stock price and market capitalization; a significant adverse change in legal factors or in the business climate of the Company’s segments; unanticipated competition; and slower growth rates. As of June 30, 2018, the Company did not identify any indicators of impairment. |
Research and Development Expense, Policy [Policy Text Block] | Research and Development Research and development expenditures are charged to expense as incurred. |
Commitments And Contingencies [Policy Text Block] | Contingencies Occasionally, the Company may be involved in claims and legal proceedings arising from the ordinary course of its business. The Company records a provision for a liability when it believes that it is both probable that a liability has been incurred, and the amount can be reasonably estimated. If these estimates and assumptions change or prove to be incorrect, it could have a material impact on the Company’s condensed consolidated financial statements. Contingencies are inherently unpredictable, and the assessments of the value can involve a series of complex judgments about future events and can rely heavily on estimates and assumptions. |
Income Tax, Policy [Policy Text Block] | Income Taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates in effect for the year in which those temporary differences are expected to be recovered or settled. Where applicable, the Company records a valuation allowance to reduce any deferred tax assets that it determines will not be realizable in the future. |
Warrants And Preferred Shares [Policy Text Block] | Warrants and Preferred Shares The accounting treatment of warrants and preferred share series issued is determined pursuant to the guidance provided by ASC 470, Debt Distinguishing Liabilities from Equity Derivatives and Hedging |
Share-based Compensation, Option and Incentive Plans Policy [Policy Text Block] | Stock-Based Compensation The Company accounts for stock-based compensation in accordance with ASC Topic 718, Compensation-Stock Compensation In accordance with the Company’s Director compensation policy and certain employment contracts, director’s fees and a portion of employee’s salaries are to be paid via the issuance of shares of the Company’s common stock, in lieu of cash, with the valuation of such share being calculated on a quarterly basis and equal to the average closing price of the Company’s common stock. |
Earnings Per Share, Policy [Policy Text Block] | Earnings (Loss) Per Share Applicable to Common Shareholders’ The Company follows ASC 260, Earnings Per Share The following is the computation of earnings (loss) per share applicable to common shareholders for the periods indicated: For the Three Months Ended June 30, 2018 2017 Numerator Net loss attributable to common shareholders – basic $ (1,687,766 ) $ (2,168,760 ) Effect of dilutive instrument on net loss – – Net loss attributable to common shareholders – diluted $ (1,687,766 ) $ (2,168,760 ) Denominator Weighted average shares of common stock outstanding – basic 803,049,238 819,321,321 Dilutive effect of stock options, warrants and convertible securities – – Weighted average shares of common stock outstanding – diluted 803,049,238 819,321,321 Net income (loss) per share Basic $ (0.00 ) $ (0.00 ) Diluted $ (0.00 ) $ (0.00 ) |
Fair Value of Financial Instruments, Policy [Policy Text Block] | Fair Value of Financial Instruments ASC Topic 820, Fair Value Measurements and Disclosures ASC Topic 820 defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. ASC Topic 820 establishes a fair value hierarchy that distinguishes between (1) market participant assumptions developed based on market data obtained from independent sources (observable inputs) 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 under ASC Topic 820 are described as follows: Level 1 – Unadjusted quoted prices in active markets for identical assets or liabilities that are accessible at the measurement date. Level 2 – Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs include 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; and inputs that are derived principally from or corroborated by observable market data by correlation or other means. Level 3 – Inputs that are unobservable for the asset or liability. Measured on a Recurring Basis The following table presents information about our liabilities measured at fair value on a recurring basis as of June 30, 2018 and March 31, 2018, aggregated by the level in the fair value hierarchy within which those measurements fell: Amount at Fair Fair Value Measurement Using Value Level 1 Level 2 Level 3 June 30, 2018 Liabilities Derivative financial instruments - warrants $ 2,415,360 $ - $ - $ 2,415,360 March 31, 2018 Liabilities Derivative financial instruments - warrants $ 2,667,871 $ - $ - $ 2,667,871 See Note 11, for specific inputs used in determining fair value. The carrying amounts of the Company’s financial assets and liabilities, such as cash, accounts receivable, prepaid expenses and other current assets, accounts payable and accrued expenses, approximate their fair values because of the short maturity of these instruments. Non-Financial Assets that are Measured at Fair Value on a Non-Recurring Basis Non-financial assets such as intangible assets, and property and equipment are measured at fair value only when an impairment loss is recognized. The Company did not record an impairment charge related to these assets in the periods presented. |
Treasury Stock Policy [Policy Text Block] | Treasury Stock The Company records treasury stock at the cost to acquire it and includes treasury stock as a component of shareholders’ equity. |
New Accounting Pronouncements, Policy [Policy Text Block] | Recently Adopted Accounting Pronouncements On April 1, 2018, the Company adopted ASC 606. In accordance with ASC 606, the Company has not changed any characteristics of its revenue recognition policy and has implemented the enhanced disclosure requirements necessary to apply the new standard. ASC 606 was applied using the modified retrospective method. There was no cumulative effect of the initial application to be recognized as an adjustment to opening retained earnings at April 1, 2018 as the adoption did not have an impact on the Company’s results of operations or financial condition. Accordingly, results for reporting periods beginning after April 1, 2018 are presented in accordance with ASC 606, while the comparative information has not been restated and reported under the accounting standards in effect for those periods. In November 2016, the FASB issued ASU No. 2016-18 , Restricted Cash (Topic 230): Statement of Cash Flows (“ASU No. 2016-18”). requires that a statement of cash flows explain the change during the period in the total of cash, cash equivalents and amounts generally described as restricted cash or restricted cash equivalents. Restricted cash and restricted cash equivalents will be included with cash and cash equivalents when reconciling the beginning of period and end of period balances on the statement of cash flows upon adoption of this standard. As a result of the adoption of the new guidance, the Company increased the beginning of year total amount shown on the condensed consolidated statement of cash flows by $391,566 and $389,081 for the three months ended June 30, 2018 and 2017, respectively. These amounts represent the balance of restricted cash included in the consolidated balance sheets as of March 31, 2018 and 2017, respectively. Restricted cash is related to debt service reserve in regard to the NJEDA bonds (see Note 5). As of April 1, 2018, the Company adopted ASU 2017-09, Compensation-Stock Compensation (Topic 718): Scope of Modification Accounting , which clarifies when to account for a change to the terms or conditions of a share-based payment award as a modification. The new standard does not change the accounting for modifications but clarifies that modification accounting guidance should only be applied if the fair value, vesting conditions, or classification of the award changes as a result of the change in terms or conditions. The adoption of this standard did not materially impact the Company’s stock-based compensation expense as no awards were modified during the three months ended June 30, 2018. In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows – Classification of Certain Cash Receipts and Cash Payments Recently Issued Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842), which is effective for public entities for annual reporting periods beginning after December 15, 2018. Under ASU 2016-02, lessees will be required to recognize the following for all leases (with the exception of short-term leases) at the commencement date: 1) a lease liability, which is a lessee’s obligation to make lease payments arising from a lease, measured on a discounted basis, and 2) a right-of-use asset, which is an asset that represents the lessee’s right to use, or control the use of, a specified asset for the lease term. The Company is currently evaluating the effects of ASU 2016-02 on its unaudited condensed financial statements. In June 2018, the FASB issued ASU 2018-07, “Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting” , which expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees and applies to all share-based payment transactions in which a grantor acquires goods or services to be used or consumed in a grantor’s own operations by issuing share-based payment awards. Topic 718 does not apply to share-based payments used to effectively provide (1) financing to the issuer or (2) awards granted in conjunction with selling goods or services to customers as part of a contract accounted for under Topic 606. This update is effective for public business entities for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. Early adoption is permitted, but no earlier than an entity’s adoption date of Topic 606. The Company is evaluating the effect that this update will have on its financial statements and related disclosures. Management has evaluated other recently issued accounting pronouncements and does not believe that any of these pronouncements will have a significant impact on our consolidated financial statements and related disclosures. |
SUMMARY OF SIGNIFICANT ACCOUN29
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 3 Months Ended |
Jun. 30, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Disaggregation of Revenue [Table Text Block] | In the following table, revenue is disaggregated by type of revenue generated by the Company and timing of revenue recognition. The table also includes a reconciliation of the disaggregated revenue with the reportable segments: For the Three Months Ended June 30, 2018 2017 NDA: Licensing fees $ 250,000 $ 250,000 Total NDA revenue 250,000 250,000 ANDA: Manufacturing fees $ 1,541,858 $ 1,010,896 Licensing fees 375,840 441,874 Total ANDA revenue 1,917,698 1,452,770 Total revenue $ 2,167,698 $ 1,702,770 |
Schedule of Earnings Per Share, Basic and Diluted [Table Text Block] | The following is the computation of earnings (loss) per share applicable to common shareholders for the periods indicated: For the Three Months Ended June 30, 2018 2017 Numerator Net loss attributable to common shareholders – basic $ (1,687,766 ) $ (2,168,760 ) Effect of dilutive instrument on net loss – – Net loss attributable to common shareholders – diluted $ (1,687,766 ) $ (2,168,760 ) Denominator Weighted average shares of common stock outstanding – basic 803,049,238 819,321,321 Dilutive effect of stock options, warrants and convertible securities – – Weighted average shares of common stock outstanding – diluted 803,049,238 819,321,321 Net income (loss) per share Basic $ (0.00 ) $ (0.00 ) Diluted $ (0.00 ) $ (0.00 ) |
Schedule of Derivative Liabilities at Fair Value [Table Text Block] | The following table presents information about our liabilities measured at fair value on a recurring basis as of June 30, 2018 and March 31, 2018, aggregated by the level in the fair value hierarchy within which those measurements fell: Amount at Fair Fair Value Measurement Using Value Level 1 Level 2 Level 3 June 30, 2018 Liabilities Derivative financial instruments - warrants $ 2,415,360 $ - $ - $ 2,415,360 March 31, 2018 Liabilities Derivative financial instruments - warrants $ 2,667,871 $ - $ - $ 2,667,871 |
INVENTORY (Tables)
INVENTORY (Tables) | 3 Months Ended |
Jun. 30, 2018 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory, Current [Table Text Block] | Inventory consisted of the following: June 30, 2018 March 31, 2018 Finished goods $ 10,016 $ 229,204 Work-in-progress 77,690 297,350 Raw materials 4,052,484 4,371,447 $ 4,140,190 $ 4,898,001 |
PROPERTY AND EQUIPMENT, NET (Ta
PROPERTY AND EQUIPMENT, NET (Tables) | 3 Months Ended |
Jun. 30, 2018 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment [Table Text Block] | Property and equipment consisted of the following: June 30, 2018 March 31, 2018 Land, building and improvements $ 5,260,523 $ 7,675,317 Laboratory, manufacturing and warehouse equipment 11,693,799 9,302,277 Office equipment and software 383,557 308,434 Furniture and fixtures 176,511 49,804 Transportation equipment 66,855 66,855 17,581,245 17,402,687 Less: Accumulated depreciation (8,709,146 ) (8,408,979 ) $ 8,872,099 $ 8,993,708 |
INTANGIBLE ASSETS (Tables)
INTANGIBLE ASSETS (Tables) | 3 Months Ended |
Jun. 30, 2018 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Intangible Assets and Goodwill [Table Text Block] | The following table summarizes the Company’s intangible assets June 30, 2018 Estimated Gross Useful Carrying Accumulated Net Book Life Amount Additions Amortization Value Patent application costs * $ 465,684 $ - $ - $ 465,684 ANDA acquisition costs Indefinite 7,247,317 - - 7,247,317 $ 7,713,001 $ - $ - $ 7,713,001 March 31, 2018 Estimated Gross Useful Carrying Accumulated Net Book Life Amount Additions Amortization Value Patent application costs * $ 371,774 $ 93,910 $ - $ 465,684 ANDA acquisition costs Indefinite 6,047,317 1,200,000 - 7,247,317 $ 6,419,091 $ 1,293,910 $ - $ 7,713,001 |
NJEDA BONDS (Tables)
NJEDA BONDS (Tables) | 3 Months Ended |
Jun. 30, 2018 | |
Debt Disclosure [Abstract] | |
Schedule of Securities Financing Transactions [Table Text Block] | The following tables summarize the Company’s bonds payable liability: June 30, 2018 March 31, 2018 Gross bonds payable NJEDA Bonds - Series A Notes $ 1,760,000 $ 1,760,000 Less: Current portion of bonds payable (prior to deduction of bond offering costs) (90,000 ) (90,000 ) Long-term portion of bonds payable (prior to deduction of bond offering costs) $ 1,670,000 $ 1,670,000 Bond offering costs $ - $ - Less: Accumulated amortization (181,952 ) (178,409 ) Bond offering costs, net $ (181,952 ) $ (178,409 ) Current portion of bonds payable - net of bond offering costs Current portions of bonds payable $ 90,000 $ 90,000 Less: Bonds offering costs to be amortized in the next 12 months (14,178 ) (14,178 ) Current portion of bonds payable, net of bond offering costs $ 75,822 $ 75,822 Long term portion of bonds payable - net of bond offering costs Long term portion of bonds payable $ 1,670,000 $ 1,670,000 Less: Bond offering costs to be amortized subsequent to the next 12 months (158,322 ) (161,866 ) Long term portion of bonds payable, net of bond offering costs $ 1,511,678 $ 1,508,134 |
LOANS PAYABLE (Tables)
LOANS PAYABLE (Tables) | 3 Months Ended |
Jun. 30, 2018 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt Instruments [Table Text Block] | Loans payable consisted of the following: June 30, 2018 March 31, 2018 Equipment and insurance financing loans payable, between 3% and 13% interest and maturing between February 2019 and January 2023 $ 1,210,904 $ 1,201,861 Less: Current portion of loans payable (546,186 ) (578,841 ) Long-term portion of loans payable $ 664,718 $ 623,020 |
MEZZANINE EQUITY (Tables)
MEZZANINE EQUITY (Tables) | 3 Months Ended |
Jun. 30, 2018 | |
Fair Value Measurement Inputs and Valuation Techniques [Table Text Block] | The fair value of the Series J Preferred issued by the Company pursuant to the exchange agreement was calculated using a Monte Carlo Simulation of stock price and expected future behaviors related to shareholder approval provisions. The following are the key assumptions used in the Monte Carlo Simulation: April 28, 2017 Fair value of the Company's common stock $ 0.1521 Conversion price $ 0.1521 Number of Series J Preferred issued 24.0344 Fully diluted shares outstanding as of measurement date 923,392,780 Risk-free rate 2.30 % Volatility 90 % Shareholder approval threshold $ 0.1521 Probability of approval is ending stock price is greater than threshold - midpoint 82.50 % Probability of approval is ending stock price is less than threshold - midpoint 17.50 % Trials 200,000 |
Series J Convertible preferred stock [Member] | |
Schedule of Preferred Stock Activity [Table Text Block] | Authorized, issued and outstanding shares, along with carrying value and change in value as of the periods presented are as follows: June 30, 2018 March 31, 2018 Shares authorized 50.000 50.000 Shares outstanding 24.0344 24.0344 Par value $ 0.01 $ 0.01 Stated value $ 1,000,000 $ 1,000,000 Conversion price $ 0.1521 $ 0.1521 Common Stock to be issued upon conversion 158,017,321 158,017,321 Carrying value of Series J convertible preferred stock $ 13,903,960 $ 13,903,960 |
DERIVATIVE FINANCIAL INSTRUME36
DERIVATIVE FINANCIAL INSTRUMENTS - WARRANTS (Tables) | 3 Months Ended |
Jun. 30, 2018 | |
Derivative Liabilities Warrants Disclosure [Abstract] | |
Schedule Of Warrants Activity [Table Text Block] | A summary of warrant activity is as follows: June 30, 2018 March 31, 2018 Warrant Shares Weighted Average Exercise Price Warrant Shares Weighted Average Exercise Price Balance at beginning of period 79,008,661 $ 0.1521 9,379,219 $ 0.0625 Warrants granted pursuant to the issuance of Series J convertible preferred shares - - 79,008,661 $ 0.1521 Warrants exercised, forfeited and/or expired, net - - (9,379,219 ) $ 0.0625 Balance at end of period 79,008,661 $ 0.1521 79,008,661 $ 0.1521 |
Fair Value, Assets and Liabilities Measured on Nonrecurring Basis, Valuation Techniques [Table Text Block] | The fair value of the warrants issued by the Company pursuant to the issuance of Series J convertible preferred shares (79,008,661 warrant shares) was calculated using a Monte Carlo Simulation because of the probability assumptions associated with the Shareholder Approval provisions. The following are the key assumptions used in the Monte Carlo Simulation: June 30, 2018 March 31, 2018 Fair value of the Company’s common stock $ 0.09 $ 0.10 Initial exercise price $ 0.1521 $ 0.1521 Number of common warrants 79,008,661 79,008,661 Fully diluted shares outstanding as of measurement date 803,638,620 791,516,930 Warrant term (in years) 8.83 9.08 Risk-free rate 2.83 % 2.72 % Volatility 90.00 % 90.00 % Shareholder approval threshold $ 0.1580 $ 0.1580 Probability of approval is ending stock price is greater than threshold - midpoint 82.50 % 82.50 % Probability of approval is ending stock price is greater than threshold - midpoint 17.50 % 17.50 % Trials 100,000 100,000 Fair value of derivative financial instruments - warrants $ 2,415,360 $ 2,667,871 |
Schedule Of Warrants Measurement With Unobservable Inputs Reconciliation Recurring Basis [Table Text Block] | The changes in warrants (Level 3 financial instruments) measured at fair value on a recurring basis for the three months ended June 30, 2018 were as follows: Balance as of March 31, 2018 $ 2,667,871 Change in fair value of derivative financial instruments - warrants (252,511 ) Balance as of June 30, 2018 $ 2,415,360 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 3 Months Ended |
Jun. 30, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Disclosure of Share-based Compensation Arrangements by Share-based Payment Award [Table Text Block] | Generally, options are granted with a vesting period of up to three years and expire ten years from the date of grant. Weighted Weighted Average Shares Average Remaining Contractual Aggregate Intrinsic Underlying Options Exercise Price Term (in years) Value Outstanding at April 1, 2018 6,618,000 $ 0.16 6.1 $ 90,390 Granted - - - - Forfeited and expired (100,000 ) 0.21 - - Outstanding at June 30, 2018 6,518,000 $ 0.16 5.8 $ 60,000 Exercisable at June 30, 2018 5,635,000 $ 0.15 5.5 $ 60,000 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | The fair value of the options was calculated using the Black-Scholes model and the following assumptions: June 30, 2018 March 31, 2018 Volatility (based on the Company’s historical volatility) 121% - 123 % 121% - 123 % Exercise price $ 0.09 - 0.24 $ 0.09 - 0.24 Estimated term (in years) 10 10 Risk free interest rate (based on 1-year treasury rate) 2.2% - 2.8 % 2.2% - 2.4 % Forfeiture rate 4.7% - 20.1 % 0.0% - 20.1 % Fair value of options granted $ 85,377 $ 79,215 Non-cash compensation through issuance of stock options $ 36,549 $ 244,753 |
SEGMENT RESULTS (Tables)
SEGMENT RESULTS (Tables) | 3 Months Ended |
Jun. 30, 2018 | |
Segment Reporting [Abstract] | |
Schedule of Segment Reporting Information, by Segment [Table Text Block] | The table below reconciles the Company’s operating loss by segment to (loss) income from operations before provision for income taxes as reported in the Company’s unaudited condensed consolidated statements of operations. For the Three Months Ended June 30, 2018 2017 Operating loss by segment $ (373,283 ) $ (1,108,255 ) Corporate unallocated costs (1,022,359 ) (670,629 ) Interest income 1,255 3,982 Interest expense and amortization of debt issuance costs (83,138 ) (70,731 ) Depreciation and amortization expense (203,704 ) (6,776 ) Significant non-cash items (259,048 ) (452,611 ) Change in fair value of derivative instruments 252,511 139,260 Loss from operations $ (1,687,766 ) $ (2,165,760 ) |
SUMMARY OF SIGNIFICANT ACCOUN39
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($) | 3 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2017 | |
Revenues | $ 2,167,698 | $ 1,702,770 |
New Drug Applications [Member] | ||
Revenue from Contract with Customer, Including Assessed Tax | 250,000 | 250,000 |
Abbreviated New Drug Applications [Member] | ||
Revenue from Contract with Customer, Including Assessed Tax | 1,917,698 | 1,452,770 |
License and Service [Member] | ||
Revenue from Contract with Customer, Including Assessed Tax | 625,840 | 691,874 |
License and Service [Member] | New Drug Applications [Member] | ||
Revenue from Contract with Customer, Including Assessed Tax | 250,000 | 250,000 |
License and Service [Member] | Abbreviated New Drug Applications [Member] | ||
Revenue from Contract with Customer, Including Assessed Tax | 375,840 | 441,874 |
Manufactured Product, Other [Member] | ||
Revenue from Contract with Customer, Including Assessed Tax | 1,541,858 | 1,010,896 |
Manufactured Product, Other [Member] | Abbreviated New Drug Applications [Member] | ||
Revenue from Contract with Customer, Including Assessed Tax | $ 1,541,858 | $ 1,010,896 |
SUMMARY OF SIGNIFICANT ACCOUN40
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 1) - USD ($) | 3 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2017 | |
Numerator | ||
Net loss attributable to common shareholders - basic | $ (1,687,766) | $ (2,168,760) |
Effect of dilutive instrument on net loss | 0 | 0 |
Net loss attributable to common shareholders - diluted | $ (1,687,766) | $ (2,168,760) |
Denominator | ||
Weighted average shares of common stock outstanding - basic (in shares) | 803,049,238 | 819,321,321 |
Dilutive effect of stock options, warrants and convertible securities (in shares) | 0 | 0 |
Weighted average shares of common stock outstanding - diluted (in shares) | 803,049,238 | 819,321,321 |
Net income (loss) per share | ||
Basic (in dollars per share) | $ 0 | $ 0 |
Diluted (in dollars per share) | $ 0 | $ 0 |
SUMMARY OF SIGNIFICANT ACCOUN41
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 2) - USD ($) | Jun. 30, 2018 | Mar. 31, 2018 |
Derivative financial instruments - warrants | $ 2,415,360 | $ 2,667,871 |
Fair Value, Inputs, Level 1 [Member] | ||
Derivative financial instruments - warrants | 0 | 0 |
Fair Value, Inputs, Level 2 [Member] | ||
Derivative financial instruments - warrants | 0 | 0 |
Fair Value, Inputs, Level 3 [Member] | ||
Derivative financial instruments - warrants | $ 2,415,360 | $ 2,667,871 |
SUMMARY OF SIGNIFICANT ACCOUN42
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Textual) - USD ($) | 3 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Mar. 31, 2018 | |
Restricted Cash and Cash Equivalents | $ 392,820 | $ 391,566 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 2,333,333 | ||
Accounting Standards Update 2016-18 [Member] | |||
Increase (Decrease) in Restricted Cash and Investments | $ 391,566 | $ 389,081 |
INVENTORY (Details)
INVENTORY (Details) - USD ($) | Jun. 30, 2018 | Mar. 31, 2018 |
Inventory [Line Items] | ||
Finished goods | $ 10,016 | $ 229,204 |
Work-in-progress | 77,690 | 297,350 |
Raw materials | 4,052,484 | 4,371,447 |
Inventory, Gross | $ 4,140,190 | $ 4,898,001 |
PROPERTY AND EQUIPMENT, NET (De
PROPERTY AND EQUIPMENT, NET (Details) - USD ($) | Jun. 30, 2018 | Mar. 31, 2018 |
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 17,581,245 | $ 17,402,687 |
Less: Accumulated depreciation | (8,709,146) | (8,408,979) |
Property and equipment, net | 8,872,099 | 8,993,708 |
Land, building and improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 5,260,523 | 7,675,317 |
Laboratory, manufacturing and warehouse equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 11,693,799 | 9,302,277 |
Office equipment and software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 383,557 | 308,434 |
Furniture and fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 176,511 | 49,804 |
Transportation equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 66,855 | $ 66,855 |
PROPERTY AND EQUIPMENT, NET (45
PROPERTY AND EQUIPMENT, NET (Details Textual) - USD ($) | 3 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2017 | |
Depreciation | $ 300,167 | $ 184,586 |
INTANGIBLE ASSETS (Details)
INTANGIBLE ASSETS (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |
Jun. 30, 2018 | Mar. 31, 2018 | ||
Finite-Lived Intangible Assets [Line Items] | |||
Estimated Useful Life | [1] | 0 years | 0 years |
Gross Carrying Amount | $ 7,713,001 | $ 6,419,091 | |
Additions | 0 | 1,293,910 | |
Accumulated Amortization | 0 | 0 | |
Net Book Value | 7,713,001 | 7,713,001 | |
Patent Application Cost [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Patent application costs, Gross Carrying Amount | 465,684 | 371,774 | |
Patent application costs, Additions | 0 | 93,910 | |
Accumulated Amortization | 0 | 0 | |
Net Book Value | 465,684 | 465,684 | |
ANDA Acquisition Cost [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Patent application costs, Gross Carrying Amount | 7,247,317 | 6,047,317 | |
Patent application costs, Additions | 0 | 1,200,000 | |
Accumulated Amortization | 0 | 0 | |
Net Book Value | $ 7,247,317 | $ 7,247,317 | |
[1] | Patent application costs were incurred in relation to the Company’s abuse deterrent opioid technology. Amortization of the patent costs will begin upon the issuance of marketing authorization by the FDA. Amortization will then be calculated on a straight-line basis through the expiry of the related patent(s). |
NJEDA BONDS (Details)
NJEDA BONDS (Details) - USD ($) | Jun. 30, 2018 | Mar. 31, 2018 |
Njeda Bonds [Line Items] | ||
Less: Current portion of bonds payable (prior to deduction of bond offering costs) | $ (75,822) | $ (75,822) |
Long-term portion of bonds payable (prior to deduction of bond offering costs) | 1,511,678 | 1,508,134 |
Bond offering costs | 0 | 0 |
Less: Accumulated amortization | (181,952) | (178,409) |
Bond offering costs, net | (181,952) | (178,409) |
Secured Debt, Current | 75,822 | 75,822 |
Njeda Bonds Series A Notes [Member] | ||
Njeda Bonds [Line Items] | ||
NJEDA Bonds - Series A Notes | 1,760,000 | 1,760,000 |
Less: Current portion of bonds payable (prior to deduction of bond offering costs) | (90,000) | (90,000) |
Long-term portion of bonds payable (prior to deduction of bond offering costs) | 1,670,000 | 1,670,000 |
Secured Debt, Current | 90,000 | 90,000 |
Njeda Bonds Current [Member] | ||
Njeda Bonds [Line Items] | ||
Less: Current portion of bonds payable (prior to deduction of bond offering costs) | (75,822) | (75,822) |
Long-term Debt, Gross | 90,000 | 90,000 |
Debt Instrument, Unamortized Discount | (14,178) | (14,178) |
Secured Debt, Current | 75,822 | 75,822 |
Njeda Bonds Non-Current [Member] | ||
Njeda Bonds [Line Items] | ||
Long-term portion of bonds payable (prior to deduction of bond offering costs) | 1,511,678 | 1,508,134 |
Long-term Debt, Gross | 1,670,000 | 1,670,000 |
Debt Instrument, Unamortized Discount | $ (158,322) | $ (161,866) |
NJEDA BONDS (Details Textual)
NJEDA BONDS (Details Textual) - USD ($) | 3 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2017 | |
Series A Note [Member] | ||
Debt Instrument, Interest Rate During Period | 6.50% | |
Njeda Bonds [Member] | ||
Amortization of Debt Issuance Costs | $ 3,544 | $ 3,544 |
LOANS PAYABLE (Details)
LOANS PAYABLE (Details) - USD ($) | Jun. 30, 2018 | Mar. 31, 2018 |
Debt Instrument [Line Items] | ||
Less: Current portion of loans payable | $ (546,186) | $ (578,841) |
Long-term portion of loans payable | 664,718 | 623,020 |
Secured Debt [Member] | ||
Debt Instrument [Line Items] | ||
Equipment and insurance financing loans payable, between 3% and 13% interest and maturing between February 2019 and January 2023 | 1,210,904 | 1,201,861 |
Less: Current portion of loans payable | (546,186) | (578,841) |
Long-term portion of loans payable | $ 664,718 | $ 623,020 |
LOANS PAYABLE (Details Textual)
LOANS PAYABLE (Details Textual) - USD ($) | 3 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2017 | |
Debt Instrument [Line Items] | ||
Interest Expense, Debt | $ 24,043 | $ 21,759 |
Maximum [Member] | ||
Debt Instrument [Line Items] | ||
Debt Instrument, Interest Rate, Stated Percentage | 13.00% | |
Minimum [Member] | ||
Debt Instrument [Line Items] | ||
Debt Instrument, Interest Rate, Stated Percentage | 3.00% |
RELATED PARTY SECURED PROMISS51
RELATED PARTY SECURED PROMISSORY NOTE WITH MIKAH PHARMA LLC (Details Textual) - USD ($) | May 15, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | Mar. 31, 2018 |
Interest Expense, Total | $ 83,138 | $ 70,731 | ||
Mikha Pharma LLC [Member] | ||||
Interest Payable | 135,000 | $ 105,000 | ||
Secured Promissory Note [Member] | ||||
Debt Instrument Default, Interest Rate Percentage | 15.00% | |||
Debt Instrument, Face Amount | $ 1,200,000 | |||
Debt Instrument, Maturity Date | Dec. 31, 2020 | |||
Debt Instrument, Interest Rate, Stated Percentage | 10.00% | |||
Interest Expense, Total | $ 15,000 | $ 15,000 |
DEFERRED REVENUE (Details Textu
DEFERRED REVENUE (Details Textual) - USD ($) | 3 Months Ended | |
Jun. 30, 2018 | Mar. 31, 2018 | |
Deferred Revenue Arrangement [Line Items] | ||
Deferred Revenue | $ 2,012,223 | $ 2,265,556 |
Deferred Revenue, Current | 1,013,333 | 1,013,333 |
Deferred Revenue, Noncurrent | $ 998,890 | $ 1,252,223 |
Licensing Agreements [Member] | ||
Deferred Revenue Arrangement [Line Items] | ||
Finite-Lived Intangible Assets, Amortization Method | straight-line basis | |
TAGI licensing agreement [Member] | ||
Deferred Revenue Arrangement [Line Items] | ||
Finite-Lived Intangible Assets, Amortization Method | fifteen-year | |
Advance Rent | $ 200,000 | |
Epic Collaborative Agreement [Member] | ||
Deferred Revenue Arrangement [Line Items] | ||
Finite-Lived Intangible Assets, Amortization Method | five-year | |
Advance Rent | $ 5,000,000 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details Textual) | 3 Months Ended | ||||
Jun. 30, 2018USD ($) | Jun. 30, 2017USD ($) | Mar. 31, 2018USD ($) | Jul. 31, 2014a | Jul. 01, 2010a | |
Other Noncurrent Liabilities [Member] | |||||
Operating Leases Rental Properties [Line Items] | |||||
Deferred Rent Credit | $ 10,804 | $ 9,702 | |||
Asset Retirement Obligation | 31,917 | $ 31,443 | |||
General and Administrative Expense [Member] | |||||
Operating Leases Rental Properties [Line Items] | |||||
Operating Leases, Rent Expense | $ 54,909 | $ 54,909 | |||
Property Subject to Operating Lease [Member] | Warehouse [Member] | |||||
Operating Leases Rental Properties [Line Items] | |||||
Area of Land | a | 15,000 | ||||
July 2014 Modification Agreement [Member] | Property Subject to Operating Lease [Member] | Warehouse [Member] | |||||
Operating Leases Rental Properties [Line Items] | |||||
Area of Land | a | 35,000 |
MEZZANINE EQUITY (Details)
MEZZANINE EQUITY (Details) | 1 Months Ended | ||
Apr. 28, 2017$ / sharesshares | Jun. 30, 2018$ / shares | Mar. 31, 2018$ / shares | |
Fair value of the Company's common stock | $ 0.1521 | $ 0.1521 | |
Conversion price | $ 0.1521 | $ 0.1521 | |
Trials | shares | 200,000 | ||
Series J Convertible preferred stock [Member] | |||
Fair value of the Company's common stock | $ 0.1521 | ||
Conversion price | $ 0.1521 | ||
Number of Series J Preferred issued | shares | 24.0344 | ||
Fully diluted shares outstanding as of measurement date | shares | 923,392,780 | ||
Warrants and Rights Outstanding, Measurement Input | 0.1521 | ||
Series J Convertible preferred stock [Member] | Measurement Input, Risk Free Interest Rate [Member] | |||
Fair Value Assumptions Percentage | 2.30% | ||
Series J Convertible preferred stock [Member] | Measurement Input, Price Volatility [Member] | |||
Fair Value Assumptions Percentage | 90.00% | ||
Series J Convertible preferred stock [Member] | Maximum [Member] | Measurement Input, Default Rate [Member] | |||
Fair Value Inputs Probability Percentage | 82.50% | ||
Series J Convertible preferred stock [Member] | Minimum [Member] | Measurement Input, Default Rate [Member] | |||
Fair Value Inputs Probability Percentage | 17.50% |
MEZZANINE EQUITY (Details 1)
MEZZANINE EQUITY (Details 1) - USD ($) | Jun. 30, 2018 | Mar. 31, 2018 |
Shares authorized | 50 | 50 |
Shares outstanding | 24.0344 | 24.0344 |
Par value | $ 0.01 | $ 0.01 |
Stated value | $ 1,000,000 | $ 1,000,000 |
Conversion price | $ 0.1521 | $ 0.1521 |
Common Shares To Be Issued Upon Conversion | 158,017,321 | 158,017,321 |
Series J Convertible preferred stock [Member] | ||
Carrying value of Series J convertible preferred stock | $ 13,903,960 | $ 13,903,960 |
MEZZANINE EQUITY (Details Textu
MEZZANINE EQUITY (Details Textual) - USD ($) | 1 Months Ended | 3 Months Ended | |
Apr. 28, 2017 | Jun. 30, 2018 | Mar. 31, 2018 | |
Fair value of the Company's common stock | $ 0.1521 | $ 0.1521 | |
Convertible Preferred Stock [Member] | |||
Fair value of the Company's common stock | $ 0.01 | ||
Conversion of Stock, Shares Converted | 50 | ||
Series J Convertible preferred stock [Member] | |||
Preferred Stock, Shares Issued | 24.0344 | ||
Fair value of the Company's common stock | $ 0.1521 | ||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 79,008,661 | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.1521 | ||
Preferred Stock, Dividend Rate, Percentage | 20.00% | ||
Equity, Fair Value Disclosure | $ 13,903,960 | ||
Preferred Stock, Par or Stated Value Per Share | $ 1,000,000 | ||
Series J Convertible preferred stock [Member] | Nasrat Hakim [Member] | |||
Conversion of Stock, Shares Converted | 158,017,321 | ||
Number of Series J Preferred issued | 24.0344 | ||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 79,008,661 | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 1.1521 |
DERIVATIVE FINANCIAL INSTRUME57
DERIVATIVE FINANCIAL INSTRUMENTS - WARRANTS (Details) - $ / shares | 3 Months Ended | 12 Months Ended |
Jun. 30, 2018 | Mar. 31, 2018 | |
Class of Warrant or Right [Line Items] | ||
Warrant Shares, Balance at beginning of period | 79,008,661 | 9,379,219 |
Warrants granted pursuant to the issuance of Series J convertible preferred shares | 0 | 79,008,661 |
Warrants exercised, forfeited and/or expired, net | 0 | (9,379,219) |
Warrant Shares, Balance at end of period | 79,008,661 | 79,008,661 |
Weighted Average Exercise Price, Balance at beginning of period | $ 0.1521 | $ 0.0625 |
Warrants granted pursuant to the issuance of Series J convertible preferred shares | 0 | 0.1521 |
Weighted Average Exercise Price, Warrants exercised, forfeited and/or expired, net | 0 | 0.0625 |
Weighted Average Exercise Price, Ending Balance | $ 0.1521 | $ 0.1521 |
DERIVATIVE FINANCIAL INSTRUME58
DERIVATIVE FINANCIAL INSTRUMENTS - WARRANTS (Details 1) | 3 Months Ended | 12 Months Ended |
Jun. 30, 2018USD ($)$ / sharesshares | Mar. 31, 2018USD ($)$ / sharesshares | |
Fair value of the Company's common stock | $ / shares | $ 0.1521 | $ 0.1521 |
Measurement Input, Expected Term [Member] | ||
Warrants and Rights Outstanding, Measurement Input | 8.83 | 9.08 |
Warrant [Member] | ||
Fair value of the Company's common stock | $ / shares | $ 0.09 | $ 0.10 |
Initial exercise price | $ / shares | $ 0.1521 | $ 0.1521 |
Number of common warrants | shares | 79,008,661 | 79,008,661 |
Fully diluted shares outstanding as of measurement date | shares | 803,638,620 | 791,516,930 |
Trials | shares | 100,000 | 100,000 |
Fair value of derivative financial instruments - warrants | $ | $ 2,415,360 | $ 2,667,871 |
Warrant [Member] | Measurement Input, Risk Free Interest Rate [Member] | ||
Fair Value Assumptions Percentage | 2.83% | 2.72% |
Warrant [Member] | Measurement Input, Price Volatility [Member] | ||
Fair Value Assumptions Percentage | 90.00% | 90.00% |
Warrant [Member] | Offered Quotes [Member] | ||
Warrants and Rights Outstanding, Measurement Input | 0.1580 | 0.1580 |
Warrant [Member] | Minimum [Member] | Measurement Input, Default Rate [Member] | ||
Fair Value Inputs Probability Percentage | 17.50% | 17.50% |
Warrant [Member] | Maximum [Member] | Measurement Input, Default Rate [Member] | ||
Fair Value Inputs Probability Percentage | 82.50% | 82.50% |
DERIVATIVE FINANCIAL INSTRUME59
DERIVATIVE FINANCIAL INSTRUMENTS - WARRANTS (Details 2) | 3 Months Ended |
Jun. 30, 2018USD ($) | |
Class of Warrant or Right [Line Items] | |
Balance as of March 31, 2018 | $ 2,667,871 |
Change in fair value of derivative financial instruments - warrants | (252,511) |
Balance as of June 30, 2018 | $ 2,415,360 |
DERIVATIVE FINANCIAL INSTRUME60
DERIVATIVE FINANCIAL INSTRUMENTS - WARRANTS (Details Textual) | 1 Months Ended |
Apr. 28, 2017USD ($)$ / sharesshares | |
Warrant Expiration Period | 10 years |
Chief Executive Officer [Member] | |
Conversion of Stock, Shares Issued | 23.0344 |
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 79,008,661 |
Conversion of Stock, Shares Converted | 158,017,321 |
Series J Convertible preferred stock [Member] | |
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 79,008,661 |
Warrants Not Settleable in Cash, Fair Value Disclosure | $ | $ 6,474,674 |
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 0.1521 |
SHAREHOLDERS' EQUITY (Details T
SHAREHOLDERS' EQUITY (Details Textual) - USD ($) | Jun. 05, 2017 | May 01, 2017 | Apr. 10, 2014 | Jun. 30, 2018 | Jun. 30, 2017 |
Class of Stock [Line Items] | |||||
Stock Issued During Period, Value, New Issues | $ 168,170 | ||||
Proceeds from Issuance of Common Stock | $ 168,193 | $ 423,770 | |||
Common Stock Traded Percent | 30.00% | ||||
Common Stock Weighted Average Price Percent | 97.00% | ||||
Lincoln Park [Member] | |||||
Class of Stock [Line Items] | |||||
Stock Issued During Period, Value, New Issues | $ 760,000 | ||||
Common Stock Shares Issued During Period | 40,000,000 | ||||
Proceeds from Issuance of Common Stock | $ 168,170 | ||||
Maximum [Member] | |||||
Class of Stock [Line Items] | |||||
Stock Issued During Period, Shares, New Issues | 800,000 | ||||
Share Price | $ 0.15 | ||||
Lincoln Park Capital Fund, LLC [Member] | |||||
Class of Stock [Line Items] | |||||
Common Stock Shares Issued During Period | 40,000,000 | 5,540,551 | 40,000,000 | 1,928,641 | |
Common Stock Additional Shares To Be Issued During Period | 1,928,641 | ||||
Proceeds from Issuance of Common Stock | $ 27,000,000 | ||||
Maximum Common Stock Shares Directed to Purchase | 500,000 | 500,000 | |||
Purchase of Common Stock Increasing Shares Per Purchase | 1,000,000 | ||||
Maximum Common Stock Value Directed to Purchase | $ 1,000,000 | ||||
Maximum Percentage to Purchase Common Stock Shares | 4.99% | 9.99% | |||
Stock Issued During Period, Shares, New Issues | 110,600,000 | ||||
Common Stock Additional Shares Issued | 5,540,551 | ||||
Stock Issued During Period, Shares, Issued for Capital Purchase Agreement | 3,200,000 | ||||
Common Stock Floor Price Per Share | $ 0.10 | ||||
Lincoln Park Capital Fund, LLC [Member] | Lincoln Park [Member] | |||||
Class of Stock [Line Items] | |||||
Common Stock Shares Issued During Period | 23,297 | ||||
Common Stock [Member] | |||||
Class of Stock [Line Items] | |||||
Stock Issued During Period, Value, New Issues | $ 2,000 | ||||
Stock Issued During Period, Shares, New Issues | 2,000,000 | ||||
Common Stock [Member] | Lincoln Park [Member] | |||||
Class of Stock [Line Items] | |||||
Stock Issued During Period, Shares, New Issues | 2,000,000 |
STOCK-BASED COMPENSATION (Detai
STOCK-BASED COMPENSATION (Details) - USD ($) | 3 Months Ended | 12 Months Ended |
Jun. 30, 2018 | Mar. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Options, Outstanding at April 1, 2018 | 6,618,000 | |
Options, Granted | 0 | |
Options, Forfeited and expired | (100,000) | |
Options, Outstanding at June 30, 2018 | 6,518,000 | 6,618,000 |
Options, Exercisable at June 30, 2018 | 5,635,000 | |
Weighted Average Exercise Price, Outstanding at April 1, 2018 | $ 0.16 | |
Weighted Average Exercise Price, Option Granted | 0 | |
Weighted Average Exercise Price, Option Forfeited and expired | 0.21 | |
Weighted Average Exercise Price, Outstanding at June 30, 2018 | 0.16 | $ 0.16 |
Weighted Average Exercise Price, Exercisable at June 30, 2018 | $ 0.15 | |
Weighted Average Remaining Contractual Term, Outstanding (in years) | 5 years 9 months 18 days | 6 years 1 month 6 days |
Weighted Average Remaining Contractual Term, Exercisable (in years) at June 30, 2018 | 5 years 6 months | |
Aggregate Intrinsic Value, Outstanding | $ 60,000 | $ 90,390 |
Aggregate Intrinsic Value, Exercisable at June 30, 2018 | $ 60,000 |
STOCK-BASED COMPENSATION (Det63
STOCK-BASED COMPENSATION (Details 1) - USD ($) | 3 Months Ended | 12 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2017 | Mar. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected volatility, Minimum | 121.00% | 121.00% | |
Expected volatility, Maximum | 123.00% | 123.00% | |
Expected term (in years) | 10 years | 10 years | |
Risk-free interest rate, Minimum | 2.20% | 2.20% | |
Risk-free interest rate, Maximum | 2.80% | 2.40% | |
Fair value of options granted | $ 85,377 | $ 79,215 | |
Non-cash compensation through issuance of stock options | $ 36,549 | $ 97,361 | $ 244,753 |
Minimum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise prices | $ 0.09 | $ 0.09 | |
Forfeiture rate | 4.70% | 0.00% | |
Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise prices | $ 0.24 | $ 0.24 | |
Forfeiture rate | 20.10% | 20.10% |
STOCK-BASED COMPENSATION (Det64
STOCK-BASED COMPENSATION (Details Textual) - USD ($) | 3 Months Ended | |
Jun. 30, 2018 | Mar. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Noninterest Expense Directors Fees | $ 902,500 | |
Stock Issued During Period Shares Payment Of Employee Salaries | 0 | |
Price Difference, Between Exercise Price And Quoted Price | $ 0.09 | $ 0.10 |
Stock Issued During Period, Shares, Issued for Services | 14,355 | |
Stock Issued During Period Value Payment Of Consultants Fees | $ 54,135 | |
Common Stock [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock Issued During Period, Shares, Issued for Services | 154,727 | |
Shares, Issued | 270,052 | |
Common Stock [Member] | Employee Stock Option [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock Issued During Period Shares Payment Of Employee Salaries | 8,038,031 | |
Director [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock Issued During Period Shares Payment Of Directors Fees | 206,538 | |
Shares For Payment Of Directors Fees Outstanding | 343,314 | |
Cash Made For Payment Of Director fees | $ 9,583 | |
Due to Officers or Stockholders | 17,083 | |
Director [Member] | Common Stock [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Noninterest Expense Directors Fees | $ 51,250 | |
Stock Issued During Period Shares Payment Of Employee Salaries | 2,168,606 | |
Stock Issued During Period Value Payment Of Directors Fees | $ 28,750 | |
Management [Member] | Common Stock [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock Issued During Period Shares Payment Of Employee Salaries | 201,250 |
CONCENTRATIONS AND CREDIT RISK
CONCENTRATIONS AND CREDIT RISK (Details Textual) | 3 Months Ended | 12 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2017 | Mar. 31, 2018 | |
Sales Revenue, Net [Member] | Customer Four [Member] | |||
Concentration Risk [Line Items] | |||
Concentration Risk, Percentage | 9.00% | 11.00% | |
Sales Revenue, Net [Member] | Customer One [Member] | |||
Concentration Risk [Line Items] | |||
Concentration Risk, Percentage | 56.00% | 59.00% | |
Sales Revenue, Net [Member] | Customer Two [Member] | |||
Concentration Risk [Line Items] | |||
Concentration Risk, Percentage | 21.00% | 29.00% | |
Accounts Receivable [Member] | Customer Three [Member] | |||
Concentration Risk [Line Items] | |||
Concentration Risk, Percentage | 11.00% | 12.00% | |
Accounts Receivable [Member] | Customer Four [Member] | |||
Concentration Risk [Line Items] | |||
Concentration Risk, Percentage | 11.00% | ||
Accounts Receivable [Member] | Customer One [Member] | |||
Concentration Risk [Line Items] | |||
Concentration Risk, Percentage | 59.00% | 52.00% | |
Accounts Receivable [Member] | Customer Two [Member] | |||
Concentration Risk [Line Items] | |||
Concentration Risk, Percentage | 17.00% | 14.00% | |
Cost of Goods, Total [Member] | Customer Concentration Risk [Member] | |||
Concentration Risk [Line Items] | |||
Concentration Risk, Percentage | 90.00% | 75.00% | |
Cost of Goods, Total [Member] | Supplier One [Member] | |||
Concentration Risk [Line Items] | |||
Concentration Risk, Percentage | 40.00% | 41.00% | |
Cost of Goods, Total [Member] | Supplier Three [Member] | |||
Concentration Risk [Line Items] | |||
Concentration Risk, Percentage | 17.00% | 12.00% | |
Cost of Goods, Total [Member] | Supplier Two [Member] | |||
Concentration Risk [Line Items] | |||
Concentration Risk, Percentage | 19.00% | 12.00% | |
Cost of Goods, Total [Member] | Supplier Four [Member] | |||
Concentration Risk [Line Items] | |||
Concentration Risk, Percentage | 14.00% | 12.00% |
SEGMENT RESULTS (Details)
SEGMENT RESULTS (Details) - USD ($) | 3 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2017 | |
Operating loss by segment | $ (1,858,394) | $ (2,238,271) |
Interest income | 1,255 | 3,982 |
Depreciation and amortization expense | (203,704) | (6,776) |
Income (loss) from operations | (1,687,766) | (2,165,760) |
Business Segment [Member] | ||
Operating loss by segment | (373,283) | (1,108,255) |
Corporate unallocated costs | (1,022,359) | (670,629) |
Interest income | 1,255 | 3,982 |
Interest expense and amortization of debt issuance costs | (83,138) | (70,731) |
Depreciation and amortization expense | (203,704) | (6,776) |
Significant non-cash items | (259,048) | (452,611) |
Change in fair value of derivative instruments | 252,511 | 139,260 |
Income (loss) from operations | $ (1,687,766) | $ (2,165,760) |
COLLABORATIVE AGREEMENT WITH 67
COLLABORATIVE AGREEMENT WITH EPIC PHARMA LLC (Details Textual) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | ||
Jan. 31, 2016 | Jun. 30, 2015 | Jun. 30, 2018 | Jan. 14, 2016 | |
Epic Collaborative Agreement [Member] | ||||
Revenue Recognition, Milestone Method [Line Items] | ||||
Revenue Recognition, Milestone Method, Description | On June 4, 2015, the Company entered into the 2015 Epic License Agreement, which provides for the exclusive right to market, sell and distribute, by Epic Pharma LLC (“Epic”) of SequestOx™, an abuse deterrent opioid which employs the Company’s proprietary pharmacological abuse-deterrent technology. Epic will be responsible for payment of product development and pharmacovigilance costs, sales, and marketing of SequestOx™, and Elite will be responsible for the manufacture of the product. Under the 2015 Epic License Agreement, Epic will pay Elite non-refundable payments totaling $15 million, with such amount representing the cost of an exclusive license to ELI-200, the cost of developing the product and certain filings and a royalty based on an amount equal to 50% of profits derived from net product sales as defined in the 2015 Epic License Agreement. The initial term of the exclusive right to product development sales and distribution is five years (“Epic Exclusivity Period”); the license is renewable upon mutual agreement at the end of the initial term. | |||
Proceeds from Divestiture of Interest in Consolidated Subsidiaries | $ 5 | |||
Non Refundable Milestone Payments | $ 15 | |||
Epic License Agreement [Member] | ||||
Revenue Recognition, Milestone Method [Line Items] | ||||
Proceeds from License Fees Received | $ 7.5 | |||
Deferred Revenue, Additions | $ 2.5 | |||
Epic Pharma Llc [Member] | ||||
Revenue Recognition, Milestone Method [Line Items] | ||||
To Be Receive Future License Fees | $ 7.5 | $ 7.5 |
RELATED PARTY TRANSACTION AGR68
RELATED PARTY TRANSACTION AGREEMENTS WITH EPIC PHARMA LLC (Details Textual) $ in Thousands | 3 Months Ended |
Jun. 30, 2018USD ($) | |
Epic Pharma Llc [Member] | |
Milestone Payments | $ 2,500 |
To Be Receive Future License Fees | 7,500 |
Due to Related Parties | 1,800 |
Related Party Transaction, Amounts of Transaction | 1,000 |
Epic Generic Agreement [Member] | |
Related Party Transaction, Amounts of Transaction | 800,000 |
Epic [Member] | |
Milestone Payments | $ 10,000 |
MANUFACTURING, LICENSE AND DE69
MANUFACTURING, LICENSE AND DEVELOPMENT AGREEMENTS (Details Textual) - USD ($) | 3 Months Ended | 12 Months Ended |
Jun. 30, 2018 | Mar. 31, 2017 | |
Revenue Recognition, Milestone Method, Milestone | The milestones, totaling $500k (with $405k already received), consist of amounts due upon the first shipment of each identified product, as follows: Phentermine 37.5mg tablets ($145k), Phentermine 15 & 30mg capsules ($45k), Hydromorphone 8mg ($125k), Naltrexone 50mg ($95k) and the balance of $95k due in relation to the first shipment of generic products which still require marketing authorizations from the FDA, and to which there can be no assurances of such marketing authorizations being granted and accordingly there can be no assurances that the Company will earn and receive these milestone amounts. | |
License and Maintenance [Member] | ||
Revenue from Contract with Customer, Including Assessed Tax | $ 200,000 | |
Health Care [Member] | ||
Revenue from Contract with Customer, Including Assessed Tax | $ 33.6 |
SUBSEQUENT EVENTS (Details Text
SUBSEQUENT EVENTS (Details Textual) - USD ($) | 1 Months Ended | 3 Months Ended | |
Aug. 03, 2018 | Jun. 30, 2018 | Jun. 30, 2017 | |
Subsequent Event [Line Items] | |||
Proceeds from Issuance of Common Stock | $ 168,193 | $ 423,770 | |
Lincoln Park Capital Fund, LLC [Member] | |||
Subsequent Event [Line Items] | |||
Proceeds from Issuance of Common Stock | $ 27,000,000 | ||
Stock Issued During Period, Shares, New Issues | 110,600,000 | ||
Stock Issued During Period, Shares, Issued for Capital Purchase Agreement | 3,200,000 | ||
Subsequent Event [Member] | Lpc Purchase Agreement [Member] | |||
Subsequent Event [Line Items] | |||
Proceeds from Issuance of Common Stock | $ 489,206 | ||
Stock Issued During Period, Shares, Additional Commitment Issues | 67,762 | ||
Stock Issued During Period, Shares, Issued for Capital Purchase Agreement | 4,902,587 | ||
Subsequent Event [Member] | Lincoln Park Capital Fund, LLC [Member] | |||
Subsequent Event [Line Items] | |||
Stock Issued During Period, Shares, New Issues | 4,970,349 |