Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Sep. 30, 2020 | Nov. 10, 2020 | |
Document Information Line Items | ||
Entity Registrant Name | ELITE PHARMACEUTICALS INC /NV/ | |
Document Type | 10-Q | |
Current Fiscal Year End Date | --03-31 | |
Entity Common Stock, Shares Outstanding | 1,009,176,752 | |
Amendment Flag | false | |
Entity Central Index Key | 0001053369 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Document Period End Date | Sep. 30, 2020 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q2 | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity File Number | 001-15697 | |
Entity Incorporation, State or Country Code | NV | |
Entity Interactive Data Current | Yes |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Sep. 30, 2020 | Mar. 31, 2020 |
Current assets: | ||
Cash | $ 4,365,667 | $ 1,131,728 |
Accounts receivable, net of allowance for doubtful accounts of $-0-, respectively | 4,075,972 | 4,106,846 |
Inventory | 4,462,563 | 4,142,472 |
Prepaid expenses and other current assets | 370,889 | 870,233 |
Total current assets | 13,275,091 | 10,251,279 |
Property and equipment, net of accumulated depreciation of $11,546,074 and $10,957,334, respectively | 6,892,376 | 7,227,648 |
Intangible assets, net of accumulated depreciation of $-0-, respectively | 6,634,035 | 6,634,035 |
Operating lease - right-of-use asset | 263,455 | 363,282 |
Other assets: | ||
Restricted cash - debt service for NJEDA bonds | 404,994 | 404,802 |
Security deposits | 135,967 | 75,534 |
Total other assets | 540,961 | 480,336 |
Total assets | 27,605,918 | 24,956,580 |
Current liabilities: | ||
Accounts payable | 589,428 | 1,577,860 |
Accrued expenses | 4,508,935 | 4,821,132 |
Deferred revenue, current portion | 13,333 | 180,000 |
Bonds payable, current portion, net of bond issuance costs | 95,822 | 90,822 |
Loans payable, current portion | 386,511 | 561,550 |
Lease obligation - operating lease | 216,774 | 208,184 |
Senior secured promissory note - related party, current portion | 1,200,000 | 1,200,000 |
Total current liabilities | 7,010,803 | 8,639,548 |
Long-term liabilities: | ||
Deferred revenue, net of current portion | 55,558 | 58,891 |
Bonds payable, net of current portion and bond issuance costs | 1,233,580 | 1,336,489 |
Loans payable, net of current portion | 1,558,170 | 463,902 |
Lease obligation - operating lease, net of current portion | 56,538 | 167,109 |
Derivative financial instruments - warrants | 3,037,902 | 3,599,378 |
Other long-term liabilities | 36,519 | 35,442 |
Total long-term liabilities | 5,978,267 | 5,661,211 |
Total liabilities | 12,989,070 | 14,300,759 |
Shareholders’ equity: | ||
Series J convertible preferred stock; par value of $0.01; 50 shares authorized; 0 issued and outstanding as of September 30, 2020 and 24.0344 issued and outstanding as of March 31, 2020 | 13,903,960 | |
Common Stock; par value $0.001; 1,445,000,000 shares authorized; 1,009,276,752 shares issued and 1,009,176,752 outstanding as of September 30, 2020; 840,504,367 shares issued and 840,404,367 shares outstanding as of March 31, 2020 | 1,009,279 | 840,507 |
Additional paid-in capital | 164,401,909 | 150,264,605 |
Treasury stock; 100,000 shares as of September 30, 2020 and March 31, 2020; at cost | (306,841) | (306,841) |
Accumulated deficit | (150,487,499) | (154,046,410) |
Total shareholders’ equity | 14,616,848 | 10,655,821 |
Total liabilities and shareholders’ equity | $ 27,605,918 | $ 24,956,580 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parentheticals) - USD ($) | Sep. 30, 2020 | Mar. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Allowance for doubtful accounts receivable, current (in Dollars) | $ 0 | $ 0 |
Accumulated depreciation (in Dollars) | 11,546,074 | 10,957,334 |
Accumulated amortization on intangible assets (in Dollars) | $ 0 | $ 0 |
Preferred stock, par value (in Dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 50 | 50 |
Preferred stock, shares issued | 0 | 24.0344 |
Preferred stock, shares outstanding | 0 | 24.0344 |
Common stock, par value (in Dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 1,445,000,000 | 1,445,000,000 |
Common stock, shares issued | 1,009,276,752 | 840,504,367 |
Common stock, shares outstanding | 1,009,176,752 | 840,404,367 |
Treasury stock, shares | 100,000 | 100,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Revenue: | ||||
Manufacturing fees | $ 6,172,724 | $ 4,169,346 | $ 12,809,963 | $ 7,096,704 |
Licensing fees | 1,227,168 | 465,641 | 2,128,673 | 897,523 |
Total revenue | 7,399,892 | 4,634,987 | 14,938,636 | 7,994,227 |
Cost of revenue | 3,778,496 | 3,306,256 | 8,340,846 | 5,366,542 |
Gross profit | 3,621,396 | 1,328,731 | 6,597,790 | 2,627,685 |
Operating expenses: | ||||
Research and development | 1,147,739 | 637,489 | 2,091,618 | 2,045,525 |
General and administrative | 796,966 | 798,572 | 1,665,743 | 1,480,048 |
Non-cash compensation through issuance of stock options | 2,089 | 15,522 | 7,610 | 41,716 |
Depreciation and amortization | 334,345 | 331,680 | 661,962 | 662,633 |
Total operating expenses | 2,281,139 | 1,783,263 | 4,426,933 | 4,229,922 |
Income (loss) from operations | 1,340,257 | (454,532) | 2,170,857 | (1,602,237) |
Other income (expense): | ||||
Interest expense and amortization of debt issuance costs | (79,753) | (91,465) | (159,184) | (189,135) |
Gain on sale of fixed assets | 3,400 | 41,490 | ||
Change in fair value of derivative instruments | 1,220,069 | (1,053,031) | 561,476 | 469,000 |
Interest income | 89 | 5,287 | 365 | 8,333 |
Other income (expense), net | 1,143,805 | (1,139,209) | 444,147 | 288,198 |
Income (loss) from operations before income taxes | 2,484,062 | (1,593,741) | 2,615,004 | (1,314,039) |
Income tax expense | (2,500) | (2,000) | (2,500) | (2,000) |
Net benefit from the sale of state net operating loss credits | 946,407 | |||
Net income (loss) | $ 2,481,562 | $ (1,595,741) | $ 3,558,911 | $ (1,316,039) |
Basic net income (loss) (in Dollars per share) | $ 0 | $ 0 | $ 0 | $ 0 |
Diluted net income (loss) (in Dollars per share) | $ 0 | $ 0 | $ 0 | $ 0 |
Basic weighted average Common Stock outstanding (in Shares) | 913,544,660 | 829,394,203 | 877,180,630 | 828,466,951 |
Diluted weighted average Common Stock outstanding (in Shares) | 913,576,523 | 829,394,203 | 877,212,493 | 828,466,951 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements Of Shareholders’ Equity (Unaudited) - USD ($) | Series J Preferred Stock | Common Stock | Additional Paid-In Capital | Treasury Stock | Accumulated Deficit | Total |
Balance at at Mar. 31, 2019 | $ 824,949 | $ 148,780,087 | $ (306,841) | $ (151,806,059) | $ (2,507,864) | |
Balance at (in Shares) at Mar. 31, 2019 | 824,946,559 | 100,000 | ||||
Net income/loss | 279,702 | 279,702 | ||||
Common Stock sold pursuant to the 2020 Lincoln Park purchase agreement | $ 4,000 | 336,300 | 340,300 | |||
Common Stock sold pursuant to the 2020 Lincoln Park purchase agreement (in Shares) | 4,000,000 | |||||
Common Stock issued as additional commitment shares pursuant to the 2020 Lincoln Park purchase agreement | $ 47 | 4,153 | 4,200 | |||
Common Stock issued as additional commitment shares pursuant to the 2020 Lincoln Park purchase agreement (in Shares) | 47,136 | |||||
Costs associated with raising capital | (4,200) | (4,200) | ||||
Non-cash compensation through the issuance of employee stock options | 26,194 | 26,194 | ||||
Balance at at Jun. 30, 2019 | $ 828,996 | 149,142,534 | $ (306,841) | (151,526,357) | (1,861,668) | |
Balance at (in Shares) at Jun. 30, 2019 | 828,993,695 | 100,000 | ||||
Net income/loss | (1,595,741) | (1,595,741) | ||||
Common Stock sold pursuant to the 2020 Lincoln Park purchase agreement | $ 3,895 | 379,692 | 383,587 | |||
Common Stock sold pursuant to the 2020 Lincoln Park purchase agreement (in Shares) | 3,895,233 | |||||
Common Stock issued as additional commitment shares pursuant to the 2020 Lincoln Park purchase agreement | $ 53 | 5,915 | 5,968 | |||
Common Stock issued as additional commitment shares pursuant to the 2020 Lincoln Park purchase agreement (in Shares) | 53,132 | |||||
Costs associated with raising capital | (5,968) | (5,968) | ||||
Non-cash compensation through the issuance of employee stock options | 15,522 | 15,522 | ||||
Balance at at Sep. 30, 2019 | $ 832,944 | 149,537,695 | $ (306,841) | (153,122,098) | (3,058,300) | |
Balance at (in Shares) at Sep. 30, 2019 | 832,942,060 | 100,000 | ||||
Balance at at Mar. 31, 2020 | $ 13,903,960 | $ 840,507 | 150,264,605 | $ (306,841) | (154,046,410) | 10,655,821 |
Balance at (in Shares) at Mar. 31, 2020 | 24 | 840,504,367 | 100,000 | |||
Net income/loss | 1,077,349 | 1,077,349 | ||||
Non-cash compensation through the issuance of employee stock options | 5,521 | 5,521 | ||||
Shares issued in payment of salaries | $ 574 | 49,426 | 50,000 | |||
Shares issued in payment of salaries (in Shares) | 574,597 | |||||
Balance at at Jun. 30, 2020 | $ 13,903,960 | $ 841,081 | 150,319,552 | $ (306,841) | (152,969,061) | 11,788,691 |
Balance at (in Shares) at Jun. 30, 2020 | 24 | 841,078,964 | 100,000 | |||
Balance at at Mar. 31, 2020 | $ 13,903,960 | $ 840,507 | 150,264,605 | $ (306,841) | (154,046,410) | 10,655,821 |
Balance at (in Shares) at Mar. 31, 2020 | 24 | 840,504,367 | 100,000 | |||
Balance at at Sep. 30, 2020 | $ 1,009,279 | 164,401,909 | $ (306,841) | (150,487,499) | 14,616,848 | |
Balance at (in Shares) at Sep. 30, 2020 | 1,009,276,752 | 100,000 | ||||
Balance at at Jun. 30, 2020 | $ 13,903,960 | $ 841,081 | 150,319,552 | $ (306,841) | (152,969,061) | 11,788,691 |
Balance at (in Shares) at Jun. 30, 2020 | 24 | 841,078,964 | 100,000 | |||
Net income/loss | 2,481,562 | 2,481,562 | ||||
Conversion of Preferred Stock to Common Stock | $ (13,903,960) | $ 158,017 | 13,745,943 | |||
Conversion of Preferred Stock to Common Stock (in Shares) | (24) | 158,017,321 | ||||
Initial commitment shares issued pursuant to the 2020 Lincoln Park purchase agreement | $ 5,976 | 463,129 | 469,105 | |||
Initial commitment shares issued pursuant to the 2020 Lincoln Park purchase agreement (in Shares) | 5,975,857 | |||||
Common Stock sold pursuant to the 2020 Lincoln Park purchase agreement | $ 641 | 41,582 | 42,223 | |||
Common Stock sold pursuant to the 2020 Lincoln Park purchase agreement (in Shares) | 640,543 | |||||
Common Stock issued as additional commitment shares pursuant to the 2020 Lincoln Park purchase agreement | $ 10 | 722 | 732 | |||
Common Stock issued as additional commitment shares pursuant to the 2020 Lincoln Park purchase agreement (in Shares) | 10,094 | |||||
Costs associated with raising capital | (469,837) | (469,837) | ||||
Non-cash compensation through the issuance of employee stock options | 2,089 | 2,089 | ||||
Shares issued in payment of Director fees | $ 1,551 | 133,449 | 135,000 | |||
Shares issued in payment of Director fees (in Shares) | 1,550,343 | |||||
Shares issued in payment of salaries | $ 71 | 6,179 | 6,250 | |||
Shares issued in payment of salaries (in Shares) | 71,739 | |||||
Shares issued in payment of consulting expenses | $ 1,932 | 159,101 | 161,033 | |||
Shares issued in payment of consulting expenses (in Shares) | 1,931,891 | |||||
Balance at at Sep. 30, 2020 | $ 1,009,279 | $ 164,401,909 | $ (306,841) | $ (150,487,499) | $ 14,616,848 | |
Balance at (in Shares) at Sep. 30, 2020 | 1,009,276,752 | 100,000 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 6 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net income (loss) | $ 3,558,911 | $ (1,316,039) |
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating | ||
Depreciation and amortization | 661,961 | 662,637 |
Amortization of operating leases - right-of-use assets | 99,827 | (93,974) |
Gain on the disposal of property and equipment | (41,490) | |
Change in fair value of derivative financial instruments - warrants | (561,476) | (469,000) |
Non-cash compensation accrued | 460,490 | 492,755 |
Non-cash compensation through the issuance of employee stock options | 7,610 | 41,716 |
Non-cash rent expense and lease accretion | 1,077 | 1,036 |
Change in operating assets and liabilities: | ||
Accounts receivable | 30,874 | (708,250) |
Inventory | (320,091) | 783,501 |
Prepaid expenses and other current assets | 488,912 | 637,485 |
Accounts payable, accrued expenses and other current liabilities | (1,408,835) | 199,714 |
Deferred revenue and customer deposits | (170,000) | (601,036) |
Lease obligations - operating leases | (99,828) | 93,930 |
Net cash provided by (used in) operating activities | 2,707,942 | (275,525) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of property and equipment | (94,848) | (3,148) |
Proceeds from disposal of property and equipment | 54,675 | |
Net cash used in investing activities | (40,173) | (3,148) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from the issuance of Common Stock | 42,223 | 723,887 |
Other loan proceeds | 1,013,480 | |
Payment of bond principal | (105,000) | (95,000) |
Other loan payments | (384,341) | (368,121) |
Net cash provided by financing activities | 566,362 | 260,766 |
Net change in cash and restricted cash | 3,234,131 | (17,907) |
Cash and restricted cash, beginning of period | 1,536,530 | 2,675,768 |
Cash and restricted cash, end of period | 4,770,661 | 2,657,861 |
Supplemental disclosure of cash and non-cash transactions: | ||
Cash paid for interest | 160,266 | 129,649 |
Financing of equipment purchases and insurance renewal | 237,936 | 54,462 |
Stock issued in payment of Directors fees, salaries and consulting expenses | 352,283 | |
Commitment shares issued to Lincoln Park Capital | 469,837 | $ 10,168 |
Conversion of preferred stock to Common Stock | $ 13,903,960 |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Sep. 30, 2020 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 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”) 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, licensing and 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 allergy, bariatric, attention deficit and infection. Research and development activities are performed 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”). 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 items, which are, in the opinion of management, necessary for a fair presentation of such statements. The results of operations for the three and six months ended September 30, 2020 are not necessarily indicative of the results that may be expected for the entire year. Segment Information Financial Accounting Standards Board (“FASB”) Accounting Standards Codification 280 (“ASC 280”), Segment Reporting The Company’s chief operating decision maker is the Chief Executive Officer, who reviews the financial performance and the results of operations of the segments prepared in accordance with GAAP when making decisions about allocating resources and assessing performance of the Company. 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. Please see Note 15 for further details. Revenue Recognition The Company generates revenue primarily from manufacturing and licensing fees. Manufacturing fees include the development of pain management products, manufacturing of a line of generic pharmaceutical products with approved ANDA, through the manufacture of formulations and the development of new products. Licensing fees include the commercialization of products either by license and the collection of royalties, or the expansion of licensing agreements with other pharmaceutical companies, including co-development projects, joint ventures and other collaborations. Under ASC 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. The Company also develops and markets (either on its own or by license to other companies) generic and proprietary controlled-release 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. 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 recognize revenue from the milestone when 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 ASC 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 September 30, 2020. In accordance with ASC 606-10-55-65, royalties are recognized when the subsequent sale of the customer’s products occurs. The Company entered into a sales and distribution licensing agreement with Epic Pharma LLC, (“Epic”) 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. The 2015 Epic License Agreement expired on June 4, 2020 without renewal. 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. On April 3, 2020, Elite and SunGen mutually agreed to discontinue any further joint product development activities. Disaggregation of revenue In the following table, revenue is disaggregated by type of revenue generated by the Company. The table also includes a reconciliation of the disaggregated revenue with the reportable segments: For the Three Months Ended For the Six Months Ended 2020 2019 2020 2019 NDA: Licensing fees $ — $ 250,000 $ 166,167 $ 500,000 Total NDA revenue — 250,000 166,167 500,000 ANDA: Manufacturing fees $ 6,172,724 $ 4,169,346 $ 12,809,963 $ 7,096,704 Licensing fees 1,227,168 215,641 1,962,506 397,523 Total ANDA revenue 7,399,892 4,384,987 14,772,469 7,494,227 Total revenue $ 7,399,892 $ 4,634,987 $ 14,938,636 $ 7,994,227 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 September 30, 2020, and March 31, 2020, the Company had $404,994 and $404,802, of restricted cash, respectively, 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 specific identification by lot number 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 September 30, 2020, the Company did not identify any indicators of impairment. Please also see Note 4 for further details on intangible assets. 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. The Company recognizes the benefit of an uncertain tax position that it has taken or expects to take on income tax returns it files if such tax position is more likely than not to be sustained on examination by the taxing authorities, based on the technical merits of the position. These tax benefits are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate resolution. The Company operates in multiple tax jurisdictions within the United States of America. The Company remains subject to examination in all tax jurisdiction until the applicable statutes of limitation expire. As of September 30, 2020, a summary of the tax years that remain subject to examination in our major tax jurisdictions are: United States – Federal, 2016 and forward, and State, 2012 and forward. The Company did not record unrecognized tax positions for the three and six months ended September 30, 2020 and 2019. 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 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 (“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 Attributable 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 For the Six Months Ended 2020 2019 2020 2019 Numerator Net income (loss) - basic $ 2,481,562 $ (1,595,741 ) $ 3,558,911 $ (1,316,039 ) Effect of dilutive instrument on net income (1,220,069 ) — (561,476 ) — Net income (loss) - diluted $ 1,261,493 $ (1,595,741 ) $ 2,997,435 $ (1,316,039 ) Denominator Weighted average shares of Common Stock outstanding - basic 913,544,660 829,394,203 877,180,630 828,466,951 Dilutive effect of stock options and convertible securities 31,863 — 31,863 — Weighted average shares of Common Stock outstanding - diluted 913,576,523 829,394,203 877,212,493 828,466,951 Net income (loss) per share Basic $ 0.00 $ (0.00 ) $ 0.00 $ (0.00 ) Diluted $ 0.00 $ (0.00 ) $ 0.00 $ (0.00 ) Fair Value of Financial Instruments ASC 820, Fair Value Measurements and Disclosures ASC 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 820 establishes a fair value hierarchy that distinguishes between (1) market participant assumptions developed based on market data obtained from independent sources (observable inputs) and (2) an entity’s own assumptions about market participant assumptions developed based on the best information available in the circumstances (unobservable inputs). The fair value hierarchy consists of three broad levels, which gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3). The three levels of the fair value hierarchy under ASC 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, aggregated by the level in the fair value hierarchy within which those measurements fell: Amount at Fair Value Measurement Using September 30, 2020 Fair Value Level 1 Level 2 Level 3 Liabilities Derivative financial instruments - warrants $ 3,037,902 $ — $ — $ 3,037,902 March 31, 2020 Liabilities Derivative financial instruments - warrants $ 3,599,378 $ — $ — $ 3,599,378 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. Based upon current borrowing rates with similar maturities the carrying value of long-term debt approximates fair value. 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 In November 2018, the FASB issued Accounting Standards Update (“ASU”) 2018-18, Collaborative Arrangements (ASC 808), Clarifying the Interaction between ASC 808 and ASC 606 Recently Issued Accounting Pronouncements In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments 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 | 6 Months Ended |
Sep. 30, 2020 | |
Inventory Disclosure [Abstract] | |
INVENTORY | NOTE 2. INVENTORY Inventory consisted of the following: September 30, March 31, Finished goods $ 51,642 $ 138,981 Work-in-progress 796,697 677,824 Raw materials 3,614,224 3,325,667 4,462,563 4,142,472 Less: Inventory reserve — — $ 4,462,563 $ 4,142,472 |
Property and Equipment, Net
Property and Equipment, Net | 6 Months Ended |
Sep. 30, 2020 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT, NET | NOTE 3. PROPERTY AND EQUIPMENT, NET Property and equipment consisted of the following: September 30, March 31, Land, building and improvements $ 5,273,023 $ 5,260,524 Laboratory, manufacturing, warehouse and transportation equipment 12,408,722 12,167,754 Office equipment and software 373,601 373,601 Furniture and fixtures 383,103 383,103 18,438,449 18,184,982 Less: Accumulated depreciation (11,546,073 ) (10,957,334 ) $ 6,892,376 $ 7,227,648 Depreciation expense was $255,118 and $328,140 for the three months ended, and $654,871 and $655,548 for the six months ended September 30, 2020 and 2019, respectively. |
Intangible Assets
Intangible Assets | 6 Months Ended |
Sep. 30, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
INTANGIBLE ASSETS | NOTE 4. INTANGIBLE ASSETS The following table summarizes the Company’s intangible assets: September 30, 2020 Estimated Useful Life Gross Carrying Amount Additions Reductions Accumulated Amortization Net Book Value Patent application costs * $ 465,684 $ — $ — $ — $ 465,684 ANDA acquisition costs Indefinite 6,168,351 — — — 6,168,351 $ 6,634,035 $ — $ — $ — $ 6,634,035 March 31, 2020 Estimated Useful Life Gross Carrying Amount Additions Reductions Accumulated Amortization Net Book Value Patent application costs * $ 465,684 $ — $ — $ — $ 465,684 ANDA acquisition costs Indefinite 6,168,351 — — — 6,168,351 $ 6,634,035 $ — $ — $ — $ 6,634,035 * 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 | 6 Months Ended |
Sep. 30, 2020 | |
Debt Disclosure [Abstract] | |
NJEDA BONDS | 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 service 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 1st based on the amount specified in the loan documents and semi-annual interest payments on March 1st and September 1st, equal to interest due on the outstanding principal. The annual interest rate on the Series A Note is 6.5%. The NJEDA Bonds are collateralized by a first lien on the Company’s facility and equipment acquired with the proceeds of the original and refinanced bonds. The following tables summarize the Company’s bonds payable liability: September 30, March 31, Gross bonds payable NJEDA Bonds - Series A Notes $ 1,470,001 $ 1,575,000 Less: Current portion of bonds payable (prior to deduction of bond offering costs) (110,000 ) (105,000 ) Long-term portion of bonds payable (prior to deduction of bond offering costs) $ 1,360,001 $ 1,470,000 Bond offering costs $ 354,454 $ 354,454 Less: Accumulated amortization (213,855 ) (206,765 ) Bond offering costs, net $ 140,599 $ 147,689 Current portion of bonds payable - net of bond offering costs Current portions of bonds payable $ 110,000 $ 105,000 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 $ 95,822 $ 90,822 Long term portion of bonds payable - net of bond offering costs Long term portion of bonds payable 1,360,000 $ 1,470,000 Less: Bond offering costs to be amortized subsequent to the next 12 months (126,420 ) (133,511 ) Long term portion of bonds payable, net of bond offering costs $ 1,233,580 $ 1,336,489 Amortization expense was $3,545 and $3,540 for the three months ended, and $7,090 and $7,085 for the six months ended September 30, 2020 and 2019, respectively. |
Loans Payable
Loans Payable | 6 Months Ended |
Sep. 30, 2020 | |
Debt Disclosure [Abstract] | |
LOANS PAYABLE | NOTE 6. LOANS PAYABLE Loans payable consisted of the following: September 30, March 31, Equipment and insurance financing loans payable, between 3.5% and 12.73% interest and maturing between October 2020 and December 2023 $ 931,201 $ 1,025,452 Loan received pursuant to the Payroll Protection Program Term Note 1,013,480 — Less: Current portion of loans payable (386,511 ) (561,550 ) Long-term portion of loans payable $ 1,558,170 $ 463,902 The interest expense associated with the loans payable was $20,760 and $20,792 for the three months ended, and $38,640 and $44,879 for the six months ended September 30, 2020 and 2019, respectively. 2020 Paycheck Protection Program Term Note In April 2020, the Company entered into a Paycheck Protection Program Term Note (the “PPP Note”) with TD Bank, NA in the amount of $1,013,480. The PPP Note was issued to the Company pursuant to the Coronavirus, Aid, Relief, and Economic Security Act’s (the “CARES Act”) (P.L. 116-136) Paycheck Protection Program (the “Program”). Under the Program, all or a portion of the PPP Note may be forgiven in accordance with the Program requirements. The PPP Note carries a maturity date of April 2022, at a 1% interest rate. No payments are required for six months from the date of issuance. The amount of the forgiveness shall be calculated (and may be reduced) in accordance with the requirements of the Program, including the provisions of the CARES Act. No more than 25% of the amount forgiven can be attributable to non-payroll costs, as defined in the Program. |
Related Party Secured Promissor
Related Party Secured Promissory Note with Mikah Pharma, LLC | 6 Months Ended |
Sep. 30, 2020 | |
Epic Pharma Llc [Member] | |
Related Party Secured Promissory Note with Mikah Pharma, LLC [Line Items] | |
RELATED PARTY SECURED PROMISSORY NOTE WITH MIKAH PHARMA, LLC | 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 Pharma, LLC (“Mikah”) for the principal sum of $1,200,000. Mikah was founded in 2009 by Nasrat Hakim (“Hakim”), a related party and the Company’s President, Chief Executive Officer and Chairman of the Board. The Note matures on December 31, 2020 at which time 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. No principal or interest payments have been made on the Note since its issuance. 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 $30,000 for the three months ended and $60,000 for the six months ended September 30, 2020 and 2019, respectively. Accrued interest due and owing on this note was $405,000 and $345,000 as of September 30, 2020 and March 31, 2020, respectively. |
Deferred Revenue
Deferred Revenue | 6 Months Ended |
Sep. 30, 2020 | |
Deferred Revenues Disclosure [Abstract] | |
DEFERRED REVENUE | NOTE 8. DEFERRED REVENUE Deferred revenues in the aggregate amount of $68,891 as of September 30, 2020, were comprised of a current component of $13,333 and a long-term component of $55,558. Deferred revenues in the aggregate amount of $238,891 as of March 31, 2020, were comprised of a current component of $180,000 and a long-term component of $58,891. These line items represent the unamortized amounts of a $200,000 advance payment received for a TAGI Pharma (“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 | 6 Months Ended |
Sep. 30, 2020 | |
Loss Contingency [Abstract] | |
COMMITMENTS AND CONTINGENCIES | 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. The Company assesses whether an arrangement is a lease or contains a lease at inception. For arrangements considered leases or that contain a lease that is accounted for separately, the Company determines the classification and initial measurement of the right-of-use asset and lease liability at the lease commencement date, which is the date that the underlying asset becomes available for use. The Company has elected to account for non-lease components associated with our leases and lease components as a single lease component. The Company recognizes a right-of-use asset, which represents the Company’s right to use the underlying asset for the lease term, and a lease liability, which represents the present value of the Company’s obligation to make payments arising over the lease term. The present value of the lease payments is calculated using either the implicit interest rate in the lease or an incremental borrowing rate. Lease assets and liabilities are classified as follows on the condensed consolidated balance sheet: Lease Classification As of Assets Operating Operating lease – right-of-use asset $ 263,455 Total leased assets $ 263,455 Liabilities Current Operating Lease obligation – operating lease $ 216,774 Long-term Operating Lease obligation – operating lease, net of current portion 56,538 Total lease liabilities $ 273,312 Rent expense is recorded on the straight-line basis. Rent expense under the 135 Ludlow Ave. modified lease for the three months ended September 30, 2020 and 2019 was $55,986 and $54,888, respectively, and $111,972 and $109,776 for the six months ended September 30, 2020 and 2019, respectively. Rent expense is recorded in general and administrative expense in the unaudited condensed consolidated statements of operations. The table below show the future minimum rental payments, exclusive of taxes, insurance and other costs, under the 135 Ludlow Ave. modified lease: Years ending March 31, Amount 2021 $ 113,091 2022 171,315 Total future minimum lease payments 284,406 Less: interest (11,094 ) Present value of lease payments $ 273,312 The weighted-average remaining lease term and the weighted-average discount rate of our lease was as follows: Lease Term and Discount Rate September 30, Remaining lease term (years) Operating leases 1.3 Discount rate Operating leases 6 % 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 |
Preferred Stock
Preferred Stock | 6 Months Ended |
Sep. 30, 2020 | |
Equity Abstract | |
PREFERRED STOCK | NOTE 10. PREFERRED STOCK 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, zero shares are issued and outstanding, with a stated value of $1,000,000 per share and a par value of $0.01 as of September 30, 2020. On April 27, 2017, a total of 24.0344 shares of Series J Preferred were issued pursuant to an exchange agreement (the “Exchange Agreement”) with Hakim, a related party and the Company’s President, Chief Executive Officer and Chairman of the Board of Directors. The Exchange Agreement provided for Hakim to exchange 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 $0.1521 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 September 30, 2020 (See Note 11). An amendment to the Company’s Articles of Incorporation to increase the number of shares of Common Stock the Company is authorized to issue from 995,000,000 shares to 1,445,000,000 shares was approved at the Company’s Annual Meeting of Shareholders held on December 4, 2019. Prior to the approval of the increase in the number of authorized shares, there were insufficient authorized shares if the Series J Preferred Stock were converted. As a result, the shares were classified in mezzanine equity. After the approval of the increase in the number of authorized shares, there are now sufficient authorized shares in the event of a full conversion of Series J Preferred Stock. With the approval of the increase in the number of authorized shares, there is no longer the presumption that a cash settlement will be required. Therefore, the Series J Preferred was reclassified from mezzanine equity to permanent equity at its carrying amount of $13,903,960 on the consolidated balance sheet as of March 31, 2020. On June 23, 2020, the Company held a Special Meeting of Shareholders, with such including a proposal for shareholders to again vote on the above referenced amendment to the Company’s Articles of Incorporation. This proposal was also passed by shareholder vote. On August 24, 2020, Hakim converted the 24.0344 shares of Series J Preferred into 158,017,321 shares of Common Stock at a conversion price of $0.1521 per share. |
Derivative Financial Instrument
Derivative Financial Instruments - Warrants | 6 Months Ended |
Sep. 30, 2020 | |
Derivative Financial Instruments Warrants [Abstract] | |
DERIVATIVE FINANCIAL INSTRUMENTS – WARRANTS | 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 a term of ten years, to affiliates in connection with an exchange agreement dated April 28, 2017, as further described in this note below. A summary of warrant activity is as follows: September 30, March 31, Warrant Shares Weighted Average Exercise Price Warrant Shares Weighted Average Exercise Price Balance at beginning of period 79,008,661 $ 0.1521 79,008,661 $ 0.1521 Warrants granted pursuant to the issuance of Series J convertible preferred shares — — $ — Warrants exercised, forfeited and/or expired, net — — $ — 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 with Hakim, the Chairman of the Board, President, and Chief Executive Officer of the Company, pursuant to which the Company issued to Hakim 24.0344 shares of its Series J Preferred and warrants to purchase an aggregate of 79,008,661 shares of its Common Stock (the “Series J Warrants” and, along with the Series J Preferred issued to Hakim, the “Securities”) in exchange for 158,017,321 shares of Common Stock owned by Hakim. The fair value of the Series J Warrants was determined to be $6,474,674 upon issuance at April 28, 2017. The Series J Warrants are exercisable for a period of 10 years from the date of issuance, commencing 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 fair value of the Series J Warrants was calculated using a Black-Scholes model instead of a Monte Carlo Simulation because the probability with the shareholder approval provisions was no longer a factor. The following assumptions were used in the Black-Scholes model to calculate the fair value of the Series J Warrants: September 30, March 31, Fair value of the Company’s Common Stock $ 0.0680 $ 0.0720 Volatility 79.77 % 83.81 % Initial exercise price $ 0.1521 $ 0.1521 Warrant term (in years) 6.6 7.1 Risk free rate 0.47 % 0.55 % The changes in warrants (Level 3 financial instruments) measured at fair value on a recurring basis for the six months ended September 30, 2020 were as follows: Balance at March 31, 2020 $ 3,599,378 Change in fair value of derivative financial instruments - warrants (561,476 ) Balance at September 30, 2020 $ 3,037,902 |
Shareholders' Equity
Shareholders' Equity | 6 Months Ended |
Sep. 30, 2020 | |
Stockholders' Equity Note [Abstract] | |
SHAREHOLDERS’ EQUITY | NOTE 12. SHAREHOLDERS’ EQUITY 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 had the right to sell to and Lincoln Park was 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 that commenced on June 5, 2017. The 2017 LPC Agreement expired on July 1, 2020. During the six months ended September 30, 2020, there were no shares sold to Lincoln Park pursuant to the 2017 LPC Agreement. In addition, there were no shares issued to Lincoln Park as additional commitment shares, pursuant to the 2017 LPC Agreement. During the six months ended September 30, 2019, a total of 7,895,233 shares were sold to Lincoln Park pursuant to the 2017 LPC Agreement for net proceeds totaling $723,887. In addition, 100,268 shares were issued to Lincoln Park as additional commitment shares, pursuant to the 2017 LPC Agreement. Lincoln Park Capital Transaction - July 8, 2020 Purchase Agreement On July 8, 2020, the Company entered into a purchase agreement (the “2020 LPC Purchase Agreement”), and a registration rights agreement (the “2020 LPC Registration Rights Agreement”), with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which Lincoln Park has committed to purchase up to $25.0 million of the Company’s Common Stock, $0.001 par value per share, from time to time over the term of the 2020 LPC Purchase Agreement, at the Company’s direction. During the six months ended September 30, 2020 the Company issued an aggregate of 5,975,857 shares of Common Stock in the amount of $469,105 to Lincoln Park as initial commitment shares. The Company sold 640,543 shares of its Common Stock pursuant to the 2020 LPC Purchase Agreement during the six months ended September 30, 2020 for net proceeds totaling $42,223. In addition, 10,094 shares were issued to Lincoln Park as additional commitment shares, pursuant to the 2020 LPC Agreement. The Company did not issue any shares of its Common Stock pursuant to the 2020 LPC Purchase Agreement during the six months ended September 30, 2019. In addition, there were no shares issued to Lincoln Park as additional commitment shares, pursuant to the 2020 LPC Agreement. |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Sep. 30, 2020 | |
Share-based Payment Arrangement [Abstract] | |
STOCK-BASED COMPENSATION | 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, 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 six months ended September 30, 2020, the Company issued 1,550,343 shares of Common Stock to its Directors in payment of director’s fees totaling an aggregate of $135,000 and with such aggregate director’s fees being earned and accrued over the twenty-seven month period beginning on January 1, 2018 and ending on March 31, 2020. In addition, the Company made cash payments totaling an aggregate of $67,500 in payment of director’s fees earned over the same twenty-seven month period. During the six months ended September 30, 2020, the Company accrued director’s fees totaling $45,000, which will be paid via cash payments totaling $15,000 and the issuance of 391,574 shares of Common Stock. As of September 30, 2020, the Company owed its Directors a total of $15,000 in cash payments and 391,574 shares of Common Stock in payment of director fees totaling $45,000 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 six months ended September 30, 2020, the Company issued 646,336 shares of Common Stock in payment of salaries totaling $56,250 pursuant to the employment contract of the Company’s Executive Vice President of Operations and with such salaries being earned and accrued over the thirty month period beginning on January 1, 2018 and ending on June 30, 2020. During the six months ended September 30, 2020, the Company accrued salaries totaling $396,250 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 5,182,380 shares of Common Stock. As of September 30, 2020, the Company owed its President and Chief Executive Officer, Chief Financial Officer and certain other employees’ salaries totaling $2,657,500 which will be paid via the issuance of 29,442,712 shares of Common Stock. During the six months ended September 30, 2020, the Company issued 1,931,891 shares of Common Stock in payment of consulting fees totaling $161,033, pursuant to engagement contracts with a certain consultant, and with such consulting expenses being earned and accrued over the twenty seven month period beginning on January 1, 2018 and ending March 31, 2020. 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. A summary of the activity of Company’s 2014 Stock Option Plan for the six months ended September 30, 2020 is as follows: Shares Weighted Weighted Average Aggregate Intrinsic Outstanding at April 1, 2020 5,375,000 $ 0.14 4.1 $ 6,000 Forfeited and expired (60,000 ) Outstanding at September 30, 2020 5,315,000 $ 0.14 3.8 $ 6,000 Exercisable at September 30, 2020 5,220,001 $ 0.14 3.8 $ 6,000 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’s Common Stock as of September 30, 2020 and March 31, 2020 of $0.06 and $0.07, respectively. |
Concentrations and Credit Risk
Concentrations and Credit Risk | 6 Months Ended |
Sep. 30, 2020 | |
Risks and Uncertainties [Abstract] | |
CONCENTRATIONS AND CREDIT RISK | NOTE 14. CONCENTRATIONS AND CREDIT RISK Revenues Two customers accounted for approximately 93% of the Company’s revenues for the six months ended September 30, 2020. These two customers accounted for approximately 78% and 15% of revenues each, respectively. The same two customers accounted for 83% and 11% of revenues each, respectively, for the three months ended September 30, 2020. Three customers accounted for approximately 87% of the Company’s revenues for the six months ended September 30, 2019. These three customers accounted for approximately 44%, 30%, and 13% of revenues each, respectively. The same three customers accounted for approximately 55%, 23% and 11% of revenues each for three months ended September 30, 2019. Accounts Receivable Two customers accounted for approximately 95% of the Company’s accounts receivable as of September 30, 2020. These two customers accounted for approximately 84% and 11% of accounts receivable each, respectively. Four customers accounted for substantially all the Company’s accounts receivable as of March 31, 2020. These four customers accounted for approximately 73%, 13%, 8%, and 5% of accounts receivable each, respectively. Purchasing Four suppliers accounted for more than 83% of the Company’s purchases of raw materials for the six months ended September 30, 2020. These four suppliers accounted for approximately 63%, 11%, 5% and 4% of purchases each, respectively. Seven suppliers accounted for more than 85% of the Company’s purchases of raw materials for the six months ended September 30, 2019. Included in these seven suppliers were three suppliers accounting for approximately 35%, 18%, and 15% of purchases each, respectively. |
Segment Results
Segment Results | 6 Months Ended |
Sep. 30, 2020 | |
Segment Reporting [Abstract] | |
SEGMENT RESULTS | 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 ANDAs for generic products and NDAs 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 following represents selected information for the Company’s reportable segments: For the Three Months Ended For the Six Months Ended 2020 2019 2020 2019 Operating Income by Segment ANDA $ 2,180,670 $ 759,049 $ 4,050,161 $ 106,654 NDA — 64,041 153,784 271,745 $ 2,180,670 $ 823,090 $ 4,203,945 $ 378,399 The table below reconciles the Company’s operating income by segment to income (loss) from operations before provision for income taxes as reported in the Company’s unaudited condensed consolidated statements of operations. For the Three Months Ended For the Six Months Ended 2020 2019 2020 2019 Operating income by segment $ 2,180,670 $ 823,090 $ 4,203,945 $ 378,399 Corporate unallocated costs (276,504 ) (793,672 ) (861,536 ) (1,000,789 ) Interest income 89 5,287 365 8,333 Interest expense and amortization of debt issuance costs (79,753 ) (91,464 ) (159,184 ) (189,134 ) Depreciation and amortization expense (334,345 ) (331,680 ) (661,962 ) (662,633 ) Significant non-cash items (226,164 ) (154,271 ) (468,100 ) (319,215 ) Change in fair value of derivative instruments 1,220,069 (1,053,031 ) 561,476 469,000 Income (loss) from operations $ 2,484,062 $ (1,595,741 ) $ 2,615,004 $ (1,316,039 ) |
Related Party Agreements with M
Related Party Agreements with Mikah Pharama, LLC | 6 Months Ended |
Sep. 30, 2020 | |
Mikah Pharma LLC [Member] | |
Related Party Agreements with Mikah Pharama, LLC [Line Items] | |
RELATED PARTY AGREEMENTS WITH MIKAH PHARMA, LLC | NOTE 16. RELATED PARTY AGREEMENTS WITH MIKAH PHARMA, LLC On December 3, 2018, the Company executed a development agreement with Mikah pursuant to which Mikah and the Company will collaborate to develop and commercialize generic products including formulation development, analytical method development, bioequivalence studies and manufacture of development batches of generic products. As of the date of this report, the Company has incurred costs which are $229,451 in excess of advanced payments received to date from Mikah. This balance due from Mikah is included in the financial statement line of prepaid expenses and other current assets on the accompanying consolidated balance sheet. |
Income Taxes
Income Taxes | 6 Months Ended |
Sep. 30, 2020 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | NOTE 17. INCOME TAXES Sale of New Jersey Net Operating Loss In April 2020, Elite Laboratories Inc., a wholly owned subsidiary of Elite Pharmaceuticals Inc., received final approval from the New Jersey Economic Development Authority for the sale of net tax benefits of $607,635 relating to New Jersey net operating losses and net tax benefits of $338,772, relating to R&D tax credits. The Company sold the net tax benefits approved for sale for total proceeds of $946,407. |
Covid-19 Update
Covid-19 Update | 6 Months Ended |
Sep. 30, 2020 | |
Covid Update [Abstract] | |
COVID-19 UPDATE | NOTE 18. COVID-19 UPDATE In December 2019, the Novel Corona Virus, COVID-19 was reported to have emerged in Wuhan, China. In March 2020, the World Health Organization (“WHO”) declared the COVID-19 outbreak a global pandemic. Governments at the national, state and local level in the United States, and globally, have implemented aggressive actions to reduce the spread of the virus, with such actions including, without limitation, lockdown and shelter in place orders, limitations on non-essential gatherings of people, suspension of all non-essential travel, and ordering certain businesses and governmental agencies to cease non-essential operations at physical locations. The Company’s business is deemed essential and it has continued to operate in all aspects of its pharmaceutical manufacturing, distribution, product development, regulatory compliance and other activities. The Company’s management has developed and implemented a range of measures to address the risks, uncertainties, and operational challenges associated with operating in a COVID-19 environment. The Company is closely monitoring the rapidly evolving and changing situation and are implementing plans intended to limit the impact of COVID-19 on our business so that the Company can continue to manufacture those medicines used by end user patients. Actions the Company has taken to date are, without limitation, further described below. Workforce The Company has taken and will continue to take, proactive measures to provide for the well-being of its workforce while continuing to safely produce pharmaceutical products. The Company has implemented alternative working practices, which include, without limitation, modified schedules, shift rotation and work at home abilities for appropriate employees to best ensure adequate social distancing. In addition, the Company increased its already thorough cleaning protocols throughout its facilities and has prohibited visits from non-essential visitors. Certain of these measures have resulted in increased costs. Manufacturing and Supply Chain During the three and six months ended September 30, 2020, and as of the date of this Quarterly Report on Form 10-Q, the Company has not experienced material, detrimental issues related to COVID-19 in its manufacturing, supply chain, quality assurance and regulatory compliance activities, and has been able to operate without interruption. The Company has taken, and plans to continue to take, commercially practical measures to keep its facilities open. Company supply chains remain intact and operational, and the Company is in regular communications with its suppliers and third-party partners. A prolonging of the current situation relating to COVID-19 may result in an increased risk of interruption in the Company supply chain in the future, with no assurances given as the materiality of such future interruption on the Company’s business, financial condition, results of operations and cash flows. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Sep. 30, 2020 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 19. SUBSEQUENT EVENTS The Company has evaluated subsequent events from the condensed consolidated balance sheet date through November 16, 2020 and determined that there were no material subsequent events. |
Accounting Policies, by Policy
Accounting Policies, by Policy (Policies) | 6 Months Ended |
Sep. 30, 2020 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | 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”). 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 items, which are, in the opinion of management, necessary for a fair presentation of such statements. The results of operations for the three and six months ended September 30, 2020 are not necessarily indicative of the results that may be expected for the entire year. |
Segment Information | Segment Information Financial Accounting Standards Board (“FASB”) Accounting Standards Codification 280 (“ASC 280”), Segment Reporting The Company’s chief operating decision maker is the Chief Executive Officer, who reviews the financial performance and the results of operations of the segments prepared in accordance with GAAP when making decisions about allocating resources and assessing performance of the Company. 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. Please see Note 15 for further details. |
Revenue Recognition | Revenue Recognition The Company generates revenue primarily from manufacturing and licensing fees. Manufacturing fees include the development of pain management products, manufacturing of a line of generic pharmaceutical products with approved ANDA, through the manufacture of formulations and the development of new products. Licensing fees include the commercialization of products either by license and the collection of royalties, or the expansion of licensing agreements with other pharmaceutical companies, including co-development projects, joint ventures and other collaborations. Under ASC 606, Revenue from Contacts with Customers |
Nature of goods and services | 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. The Company also develops and markets (either on its own or by license to other companies) generic and proprietary controlled-release 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. 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 recognize revenue from the milestone when 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 ASC 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 September 30, 2020. In accordance with ASC 606-10-55-65, royalties are recognized when the subsequent sale of the customer’s products occurs. The Company entered into a sales and distribution licensing agreement with Epic Pharma LLC, (“Epic”) 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. The 2015 Epic License Agreement expired on June 4, 2020 without renewal. 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. On April 3, 2020, Elite and SunGen mutually agreed to discontinue any further joint product development activities. |
Disaggregation of revenue | Disaggregation of revenue In the following table, revenue is disaggregated by type of revenue generated by the Company. The table also includes a reconciliation of the disaggregated revenue with the reportable segments: For the Three Months Ended For the Six Months Ended 2020 2019 2020 2019 NDA: Licensing fees $ — $ 250,000 $ 166,167 $ 500,000 Total NDA revenue — 250,000 166,167 500,000 ANDA: Manufacturing fees $ 6,172,724 $ 4,169,346 $ 12,809,963 $ 7,096,704 Licensing fees 1,227,168 215,641 1,962,506 397,523 Total ANDA revenue 7,399,892 4,384,987 14,772,469 7,494,227 Total revenue $ 7,399,892 $ 4,634,987 $ 14,938,636 $ 7,994,227 |
Cash | 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 | Restricted Cash As of September 30, 2020, and March 31, 2020, the Company had $404,994 and $404,802, of restricted cash, respectively, related to debt service reserve in regard to the New Jersey Economic Development Authority (“NJEDA”) bonds (see Note 5). |
Accounts Receivable | 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 Inventory is recorded at the lower of cost or market on specific identification by lot number basis. |
Long-Lived Assets | 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 | 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 September 30, 2020, the Company did not identify any indicators of impairment. Please also see Note 4 for further details on intangible assets. |
Research and Development | Research and Development Research and development expenditures are charged to expense as incurred. |
Contingencies | 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 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. The Company recognizes the benefit of an uncertain tax position that it has taken or expects to take on income tax returns it files if such tax position is more likely than not to be sustained on examination by the taxing authorities, based on the technical merits of the position. These tax benefits are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate resolution. The Company operates in multiple tax jurisdictions within the United States of America. The Company remains subject to examination in all tax jurisdiction until the applicable statutes of limitation expire. As of September 30, 2020, a summary of the tax years that remain subject to examination in our major tax jurisdictions are: United States – Federal, 2016 and forward, and State, 2012 and forward. The Company did not record unrecognized tax positions for the three and six months ended September 30, 2020 and 2019. |
Warrants and Preferred Shares | 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 | Stock-Based Compensation The Company accounts for stock-based compensation in accordance with ASC 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 (“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 Attributable to Common Shareholders’ | Earnings (Loss) Per Share Attributable 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 For the Six Months Ended 2020 2019 2020 2019 Numerator Net income (loss) - basic $ 2,481,562 $ (1,595,741 ) $ 3,558,911 $ (1,316,039 ) Effect of dilutive instrument on net income (1,220,069 ) — (561,476 ) — Net income (loss) - diluted $ 1,261,493 $ (1,595,741 ) $ 2,997,435 $ (1,316,039 ) Denominator Weighted average shares of Common Stock outstanding - basic 913,544,660 829,394,203 877,180,630 828,466,951 Dilutive effect of stock options and convertible securities 31,863 — 31,863 — Weighted average shares of Common Stock outstanding - diluted 913,576,523 829,394,203 877,212,493 828,466,951 Net income (loss) per share Basic $ 0.00 $ (0.00 ) $ 0.00 $ (0.00 ) Diluted $ 0.00 $ (0.00 ) $ 0.00 $ (0.00 ) |
Fair Value of Financial Instruments | Fair Value of Financial Instruments ASC 820, Fair Value Measurements and Disclosures ASC 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 820 establishes a fair value hierarchy that distinguishes between (1) market participant assumptions developed based on market data obtained from independent sources (observable inputs) and (2) an entity’s own assumptions about market participant assumptions developed based on the best information available in the circumstances (unobservable inputs). The fair value hierarchy consists of three broad levels, which gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3). The three levels of the fair value hierarchy under ASC 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, aggregated by the level in the fair value hierarchy within which those measurements fell: Amount at Fair Value Measurement Using September 30, 2020 Fair Value Level 1 Level 2 Level 3 Liabilities Derivative financial instruments - warrants $ 3,037,902 $ — $ — $ 3,037,902 March 31, 2020 Liabilities Derivative financial instruments - warrants $ 3,599,378 $ — $ — $ 3,599,378 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. Based upon current borrowing rates with similar maturities the carrying value of long-term debt approximates fair value. 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 | 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 | Recently Adopted Accounting Pronouncements In November 2018, the FASB issued Accounting Standards Update (“ASU”) 2018-18, Collaborative Arrangements (ASC 808), Clarifying the Interaction between ASC 808 and ASC 606 |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments 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 Accoun_2
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Sep. 30, 2020 | |
Accounting Policies [Abstract] | |
Schedule of disaggregation of revenue | For the Three Months Ended For the Six Months Ended 2020 2019 2020 2019 NDA: Licensing fees $ — $ 250,000 $ 166,167 $ 500,000 Total NDA revenue — 250,000 166,167 500,000 ANDA: Manufacturing fees $ 6,172,724 $ 4,169,346 $ 12,809,963 $ 7,096,704 Licensing fees 1,227,168 215,641 1,962,506 397,523 Total ANDA revenue 7,399,892 4,384,987 14,772,469 7,494,227 Total revenue $ 7,399,892 $ 4,634,987 $ 14,938,636 $ 7,994,227 |
Schedule of earnings (loss) per share applicable to common shareholders | For the Three Months Ended For the Six Months Ended 2020 2019 2020 2019 Numerator Net income (loss) - basic $ 2,481,562 $ (1,595,741 ) $ 3,558,911 $ (1,316,039 ) Effect of dilutive instrument on net income (1,220,069 ) — (561,476 ) — Net income (loss) - diluted $ 1,261,493 $ (1,595,741 ) $ 2,997,435 $ (1,316,039 ) Denominator Weighted average shares of Common Stock outstanding - basic 913,544,660 829,394,203 877,180,630 828,466,951 Dilutive effect of stock options and convertible securities 31,863 — 31,863 — Weighted average shares of Common Stock outstanding - diluted 913,576,523 829,394,203 877,212,493 828,466,951 Net income (loss) per share Basic $ 0.00 $ (0.00 ) $ 0.00 $ (0.00 ) Diluted $ 0.00 $ (0.00 ) $ 0.00 $ (0.00 ) |
Schedule of liabilities measured at fair value on a recurring basis | Amount at Fair Value Measurement Using September 30, 2020 Fair Value Level 1 Level 2 Level 3 Liabilities Derivative financial instruments - warrants $ 3,037,902 $ — $ — $ 3,037,902 March 31, 2020 Liabilities Derivative financial instruments - warrants $ 3,599,378 $ — $ — $ 3,599,378 |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Sep. 30, 2020 | |
Inventory Disclosure [Abstract] | |
Schedule of inventory | September 30, March 31, Finished goods $ 51,642 $ 138,981 Work-in-progress 796,697 677,824 Raw materials 3,614,224 3,325,667 4,462,563 4,142,472 Less: Inventory reserve — — $ 4,462,563 $ 4,142,472 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 6 Months Ended |
Sep. 30, 2020 | |
Property, Plant and Equipment [Abstract] | |
Schedule of property and equipment | September 30, March 31, Land, building and improvements $ 5,273,023 $ 5,260,524 Laboratory, manufacturing, warehouse and transportation equipment 12,408,722 12,167,754 Office equipment and software 373,601 373,601 Furniture and fixtures 383,103 383,103 18,438,449 18,184,982 Less: Accumulated depreciation (11,546,073 ) (10,957,334 ) $ 6,892,376 $ 7,227,648 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 6 Months Ended |
Sep. 30, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of intangible assets | September 30, 2020 Estimated Useful Life Gross Carrying Amount Additions Reductions Accumulated Amortization Net Book Value Patent application costs * $ 465,684 $ — $ — $ — $ 465,684 ANDA acquisition costs Indefinite 6,168,351 — — — 6,168,351 $ 6,634,035 $ — $ — $ — $ 6,634,035 March 31, 2020 Estimated Useful Life Gross Carrying Amount Additions Reductions Accumulated Amortization Net Book Value Patent application costs * $ 465,684 $ — $ — $ — $ 465,684 ANDA acquisition costs Indefinite 6,168,351 — — — 6,168,351 $ 6,634,035 $ — $ — $ — $ 6,634,035 * 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 (Tables)
NJEDA Bonds (Tables) | 6 Months Ended |
Sep. 30, 2020 | |
Debt Disclosure [Abstract] | |
Schedule of bonds payable liability | September 30, March 31, Gross bonds payable NJEDA Bonds - Series A Notes $ 1,470,001 $ 1,575,000 Less: Current portion of bonds payable (prior to deduction of bond offering costs) (110,000 ) (105,000 ) Long-term portion of bonds payable (prior to deduction of bond offering costs) $ 1,360,001 $ 1,470,000 Bond offering costs $ 354,454 $ 354,454 Less: Accumulated amortization (213,855 ) (206,765 ) Bond offering costs, net $ 140,599 $ 147,689 Current portion of bonds payable - net of bond offering costs Current portions of bonds payable $ 110,000 $ 105,000 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 $ 95,822 $ 90,822 Long term portion of bonds payable - net of bond offering costs Long term portion of bonds payable 1,360,000 $ 1,470,000 Less: Bond offering costs to be amortized subsequent to the next 12 months (126,420 ) (133,511 ) Long term portion of bonds payable, net of bond offering costs $ 1,233,580 $ 1,336,489 |
Loans Payable (Tables)
Loans Payable (Tables) | 6 Months Ended |
Sep. 30, 2020 | |
Debt Disclosure [Abstract] | |
Schedule of loans payable | September 30, March 31, Equipment and insurance financing loans payable, between 3.5% and 12.73% interest and maturing between October 2020 and December 2023 $ 931,201 $ 1,025,452 Loan received pursuant to the Payroll Protection Program Term Note 1,013,480 — Less: Current portion of loans payable (386,511 ) (561,550 ) Long-term portion of loans payable $ 1,558,170 $ 463,902 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Sep. 30, 2020 | |
Loss Contingency [Abstract] | |
Schedule of lease assets and liabilities | Lease Classification As of Assets Operating Operating lease – right-of-use asset $ 263,455 Total leased assets $ 263,455 Liabilities Current Operating Lease obligation – operating lease $ 216,774 Long-term Operating Lease obligation – operating lease, net of current portion 56,538 Total lease liabilities $ 273,312 |
Schedule of the future minimum rental payments | Years ending March 31, Amount 2021 $ 113,091 2022 171,315 Total future minimum lease payments 284,406 Less: interest (11,094 ) Present value of lease payments $ 273,312 |
Schedule of weighted-average remaining lease term and the weighted-average discount rate | Lease Term and Discount Rate September 30, Remaining lease term (years) Operating leases 1.3 Discount rate Operating leases 6 % |
Derivative Financial Instrume_2
Derivative Financial Instruments - Warrants (Tables) | 6 Months Ended |
Sep. 30, 2020 | |
Derivative Financial Instruments Warrants [Abstract] | |
Schedule of warrant activity | September 30, March 31, Warrant Shares Weighted Average Exercise Price Warrant Shares Weighted Average Exercise Price Balance at beginning of period 79,008,661 $ 0.1521 79,008,661 $ 0.1521 Warrants granted pursuant to the issuance of Series J convertible preferred shares — — $ — Warrants exercised, forfeited and/or expired, net — — $ — Balance at end of period 79,008,661 $ 0.1521 79,008,661 $ 0.1521 |
Schedule of the fair value of the warrants issued | September 30, March 31, Fair value of the Company’s Common Stock $ 0.0680 $ 0.0720 Volatility 79.77 % 83.81 % Initial exercise price $ 0.1521 $ 0.1521 Warrant term (in years) 6.6 7.1 Risk free rate 0.47 % 0.55 % |
Schedule of changes in warrants measured at fair value on a recurring basis | Balance at March 31, 2020 $ 3,599,378 Change in fair value of derivative financial instruments - warrants (561,476 ) Balance at September 30, 2020 $ 3,037,902 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Sep. 30, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of stock option plan | Shares Weighted Weighted Average Aggregate Intrinsic Outstanding at April 1, 2020 5,375,000 $ 0.14 4.1 $ 6,000 Forfeited and expired (60,000 ) Outstanding at September 30, 2020 5,315,000 $ 0.14 3.8 $ 6,000 Exercisable at September 30, 2020 5,220,001 $ 0.14 3.8 $ 6,000 |
Segment Results (Tables)
Segment Results (Tables) | 6 Months Ended |
Sep. 30, 2020 | |
Segment Reporting [Abstract] | |
Schedule of selected information for reportable segments | For the Three Months Ended For the Six Months Ended 2020 2019 2020 2019 Operating Income by Segment ANDA $ 2,180,670 $ 759,049 $ 4,050,161 $ 106,654 NDA — 64,041 153,784 271,745 $ 2,180,670 $ 823,090 $ 4,203,945 $ 378,399 |
Schedule of operating loss by segment to (loss) income from operations | For the Three Months Ended For the Six Months Ended 2020 2019 2020 2019 Operating income by segment $ 2,180,670 $ 823,090 $ 4,203,945 $ 378,399 Corporate unallocated costs (276,504 ) (793,672 ) (861,536 ) (1,000,789 ) Interest income 89 5,287 365 8,333 Interest expense and amortization of debt issuance costs (79,753 ) (91,464 ) (159,184 ) (189,134 ) Depreciation and amortization expense (334,345 ) (331,680 ) (661,962 ) (662,633 ) Significant non-cash items (226,164 ) (154,271 ) (468,100 ) (319,215 ) Change in fair value of derivative instruments 1,220,069 (1,053,031 ) 561,476 469,000 Income (loss) from operations $ 2,484,062 $ (1,595,741 ) $ 2,615,004 $ (1,316,039 ) |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) - USD ($) | 6 Months Ended | |
Sep. 30, 2020 | Mar. 31, 2020 | |
Accounting Policies [Abstract] | ||
Restricted cash | $ 404,994 | $ 404,802 |
Description of tax benefits | The Company recognizes the benefit of an uncertain tax position that it has taken or expects to take on income tax returns it files if such tax position is more likely than not to be sustained on examination by the taxing authorities, based on the technical merits of the position. These tax benefits are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate resolution. |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) - Schedule of disaggregation of revenue - USD ($) | 3 Months Ended | 6 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Licensing fees [Member] | NDA [Member] | ||||
NDA: | ||||
Total revenue | $ 250,000 | $ 166,167 | $ 500,000 | |
Licensing fees [Member] | ANDA [Member] | ||||
NDA: | ||||
Total revenue | 1,227,168 | 215,641 | 1,962,506 | 397,523 |
Manufacturing fees [Member] | ANDA [Member] | ||||
NDA: | ||||
Total revenue | $ 6,172,724 | $ 4,169,346 | $ 12,809,963 | $ 7,096,704 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies (Details) - Schedule of earnings (loss) per share applicable to common shareholders - USD ($) | 3 Months Ended | 6 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Numerator | ||||
Net income (loss) - basic | $ 2,481,562 | $ (1,595,741) | $ 3,558,911 | $ (1,316,039) |
Effect of dilutive instrument on net income | (1,220,069) | (561,476) | ||
Net income (loss) - diluted | $ 1,261,493 | $ (1,595,741) | $ 2,997,435 | $ (1,316,039) |
Denominator | ||||
Weighted average shares of Common Stock outstanding - basic | 913,544,660 | 829,394,203 | 877,180,630 | 828,466,951 |
Dilutive effect of stock options and convertible securities | 31,863 | 31,863 | ||
Weighted average shares of Common Stock outstanding - diluted | 913,576,523 | 829,394,203 | 877,212,493 | 828,466,951 |
Basic | $ 0 | $ 0 | $ 0 | $ 0 |
Diluted | $ 0 | $ 0 | $ 0 | $ 0 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies (Details) - Schedule of liabilities measured at fair value on a recurring basis - USD ($) | Sep. 30, 2020 | Mar. 31, 2020 |
Liabilities | ||
Derivative financial instruments - warrants | $ 3,037,902 | $ 3,599,378 |
Level 1 [Member] | ||
Liabilities | ||
Derivative financial instruments - warrants | ||
Level 2 [Member] | ||
Liabilities | ||
Derivative financial instruments - warrants | ||
Level 3 [Member] | ||
Liabilities | ||
Derivative financial instruments - warrants | $ 3,037,902 |
Inventory (Details) - Schedule
Inventory (Details) - Schedule of inventory - USD ($) | Sep. 30, 2020 | Mar. 31, 2020 |
Schedule of inventory [Abstract] | ||
Finished goods | $ 51,642 | $ 138,981 |
Work-in-progress | 796,697 | 677,824 |
Raw materials | 3,614,224 | 3,325,667 |
Inventory, gross | 4,462,563 | 4,142,472 |
Less: Inventory reserve | ||
Inventory, net | $ 4,462,563 | $ 4,142,472 |
Property and Equipment, Net (De
Property and Equipment, Net (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Property, Plant and Equipment [Abstract] | ||||
Depreciation expense | $ 255,118 | $ 328,140 | $ 654,871 | $ 655,548 |
Property and Equipment, Net (_2
Property and Equipment, Net (Details) - Schedule of property and equipment - USD ($) | Sep. 30, 2020 | Mar. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 18,438,449 | $ 18,184,982 |
Less: Accumulated depreciation | (11,546,074) | (10,957,334) |
Property and equipment, net | 6,892,376 | 7,227,648 |
Land, building and improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 5,273,023 | 5,260,524 |
Laboratory, manufacturing, warehouse and transportation equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 12,408,722 | 12,167,754 |
Office equipment and software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 373,601 | 373,601 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 383,103 | $ 383,103 |
Intangible Assets (Details) - S
Intangible Assets (Details) - Schedule of intangible assets - USD ($) | 6 Months Ended | 12 Months Ended | |
Sep. 30, 2020 | Mar. 31, 2020 | ||
Finite-Lived Intangible Assets [Line Items] | |||
Gross Carrying Amount | $ 6,634,035 | ||
Additions | |||
Reductions | |||
Accumulated Amortization | 0 | 0 | |
Net Book Value | $ 6,634,035 | 6,634,035 | |
Patent application costs [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Estimated Useful Life | [1] | ||
Gross Carrying Amount | $ 465,684 | ||
Additions | |||
Reductions | |||
Accumulated Amortization | |||
Net Book Value | 465,684 | ||
ANDA acquisition costs [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Estimated Useful Life | Indefinite | ||
Gross Carrying Amount | $ 6,168,351 | ||
Additions | |||
Reductions | |||
Accumulated Amortization | |||
Net Book Value | $ 6,168,351 | ||
[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 ($) | 3 Months Ended | 6 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Senior Notes [Member] | ||||
NJEDA Bonds (Details) [Line Items] | ||||
Annual interest rate | 6.50% | |||
Njeda Bonds [Member] | ||||
NJEDA Bonds (Details) [Line Items] | ||||
Amortization expense | $ 3,545 | $ 3,540 | $ 7,090 | $ 7,085 |
NJEDA Bonds (Details) - Schedul
NJEDA Bonds (Details) - Schedule of bonds payable liability - USD ($) | Sep. 30, 2020 | Mar. 31, 2020 |
Njeda Bonds Series A Notes [Member] | ||
Gross bonds payable | ||
NJEDA Bonds - Series A Notes | $ 1,470,001 | $ 1,575,000 |
Less: Current portion of bonds payable (prior to deduction of bond offering costs) | (110,000) | (105,000) |
Long-term portion of bonds payable (prior to deduction of bond offering costs) | 1,360,001 | 1,470,000 |
Bond offering costs | 354,454 | 354,454 |
Less: Accumulated amortization | (213,855) | (206,765) |
Bond offering costs, net | 140,599 | 147,689 |
Njeda Bonds Current [Member] | ||
Current portion of bonds payable - net of bond offering costs | ||
Current portions of bonds payable | 110,000 | 105,000 |
Less: Bonds offering costs to be amortized in the next 12 months | (14,178) | (14,178) |
Long term portion of bonds payable, net of bond offering costs | 95,822 | 90,822 |
Njeda Bonds Non-Current [Member] | ||
Current portion of bonds payable - net of bond offering costs | ||
Current portions of bonds payable | 1,360,000 | 1,470,000 |
Less: Bonds offering costs to be amortized in the next 12 months | (126,420) | (133,511) |
Long term portion of bonds payable, net of bond offering costs | $ 1,233,580 | $ 1,336,489 |
Loans Payable (Details)
Loans Payable (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Apr. 30, 2020 | Mar. 31, 2020 | |
Debt Disclosure [Abstract] | ||||||
Interest expense | $ 20,760 | $ 20,792 | $ 38,640 | $ 44,879 | ||
Note amount | $ 931,201 | $ 931,201 | $ 1,013,480 | $ 1,025,452 | ||
Interest rate | 25.00% | 25.00% | 1.00% |
Loans Payable (Details) - Sched
Loans Payable (Details) - Schedule of loans payable - USD ($) | Sep. 30, 2020 | Apr. 30, 2020 | Mar. 31, 2020 |
Schedule of loans payable [Abstract] | |||
Equipment and insurance financing loans payable, between 3.5% and 12.73% interest and maturing between October 2020 and December 2023 | $ 931,201 | $ 1,013,480 | $ 1,025,452 |
Loan received pursuant to the Payroll Protection Program Term Note | 1,013,480 | ||
Less: Current portion of loans payable | (386,511) | (561,550) | |
Long-term portion of loans payable | $ 1,558,170 | $ 463,902 |
Related Party Secured Promiss_2
Related Party Secured Promissory Note with Mikah Pharma, LLC (Details) - Secured Promissory Note [Member] - USD ($) | May 15, 2017 | Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Mar. 31, 2020 |
Related Party Secured Promissory Note with Mikah Pharma, LLC (Details) [Line Items] | ||||||
Principal amount | $ 1,200,000 | |||||
Maturity date | Dec. 31, 2020 | |||||
Interest rate | 10.00% | 15.00% | ||||
Interest expense, total | $ 30,000 | $ 30,000 | $ 60,000 | $ 60,000 | ||
Accrued interest | $ 405,000 | $ 405,000 | $ 345,000 |
Deferred Revenue (Details)
Deferred Revenue (Details) - USD ($) | 6 Months Ended | |
Sep. 30, 2020 | Mar. 31, 2020 | |
Deferred Revenue (Details) [Line Items] | ||
Deferred revenues | $ 68,891 | $ 238,891 |
Deferred revenues current component | 13,333 | 180,000 |
Deferred revenues long-term component | $ 55,558 | $ 58,891 |
Deferred revenues term, description | fifteen-year term beginning in September 2010 and ending in August 2025 | |
TAGI licensing agreement [Member] | ||
Deferred Revenue (Details) [Line Items] | ||
Advance payment of deferred revenue | $ 200,000 | |
Epic Collaborative Agreement [Member] | ||
Deferred Revenue (Details) [Line Items] | ||
Advance payment of deferred revenue | $ 5,000,000 | |
Deferred revenues term, description | five-year term beginning in June 2015 and ending in May 2020. |
Commitments and Contingencies_2
Commitments and Contingencies (Details) | 3 Months Ended | 6 Months Ended | |||||
Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Jul. 02, 2020m² | Mar. 31, 2020USD ($) | Jul. 31, 2014m² | |
Commitments and Contingencies (Details) [Line Items] | |||||||
Operating lease, terms | 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. | ||||||
General and Administrative Expense [Member] | |||||||
Commitments and Contingencies (Details) [Line Items] | |||||||
Rent expense | $ | $ 55,986 | $ 54,888 | $ 111,972 | $ 109,776 | |||
Warehouse [Member] | Property Subject to Operating Lease [Member] | |||||||
Commitments and Contingencies (Details) [Line Items] | |||||||
Building floor space (in Square Meters) | m² | 15,000 | ||||||
July 2014 Modification Agreement [Member] | Warehouse [Member] | Property Subject to Operating Lease [Member] | |||||||
Commitments and Contingencies (Details) [Line Items] | |||||||
Building floor space (in Square Meters) | m² | 35,000 | ||||||
Other Noncurrent Liabilities [Member] | |||||||
Commitments and Contingencies (Details) [Line Items] | |||||||
Other long-term liabilities | $ | $ 36,518 | $ 36,518 | $ 35,442 |
Commitments and Contingencies_3
Commitments and Contingencies (Details) - Schedule of lease assets and liabilities - USD ($) | Sep. 30, 2020 | Mar. 31, 2020 |
Schedule of lease assets and liabilities [Abstract] | ||
Operating lease – right-of-use asset | $ 263,455 | $ 363,282 |
Total leased assets | 263,455 | |
Current | ||
Lease obligation - operating lease | 216,774 | 208,184 |
Long-term | ||
Lease obligation - operating lease, net of current portion | 56,538 | $ 167,109 |
Total lease liabilities | $ 273,312 |
Commitments and Contingencies_4
Commitments and Contingencies (Details) - Schedule of the future minimum rental payments | Sep. 30, 2020USD ($) |
Schedule of the future minimum rental payments [Abstract] | |
2021 | $ 113,091 |
2022 | 171,315 |
Total future minimum lease payments | 284,406 |
Less: interest | (11,094) |
Present value of lease payments | $ 273,312 |
Commitments and Contingencies_5
Commitments and Contingencies (Details) - Schedule of weighted-average remaining lease term and the weighted-average discount rate | Sep. 30, 2020 |
Schedule of weighted-average remaining lease term and the weighted-average discount rate [Abstract] | |
Remaining lease term (years) Operating leases | 1 year 109 days |
Discount rate Operating leases | 6.00% |
Preferred Stock (Details)
Preferred Stock (Details) - USD ($) | Sep. 30, 2020 | Apr. 24, 2020 | Mar. 31, 2020 | Dec. 04, 2019 | Apr. 27, 2017 |
Preferred Stock (Details) [Line Items] | |||||
Preferred stock shares issued | 50 | 50 | 24.0344 | ||
Preferred stock shares outstanding | 0 | 24.0344 | |||
(in Dollars per share) | $ 0.1521 | $ 0.1521 | |||
Warrant to purchase (in Dollars per share) | $ 79,008,661 | ||||
Increased number of common stock shares authorized | 1,445,000,000 | 1,445,000,000 | |||
Carrying value of Series J convertible preferred stock (in Dollars) | $ 13,903,960 | $ 13,903,960 | |||
Minimum [Member] | |||||
Preferred Stock (Details) [Line Items] | |||||
Increased number of common stock shares authorized | 995,000,000 | ||||
Maximum [Member] | |||||
Preferred Stock (Details) [Line Items] | |||||
Increased number of common stock shares authorized | 1,445,000,000 | ||||
Series J Convertible preferred stock [Member] | |||||
Preferred Stock (Details) [Line Items] | |||||
Preferred stock share authorized | 50 | ||||
Preferred stock shares issued | 0 | ||||
Preferred stock shares outstanding | 0 | ||||
Convertible preferred stock stated value (in Dollars) | $ 1,000,000 | ||||
Convertible preferred stock par value per share (in Dollars per share) | $ 0.01 | ||||
Series J Convertible preferred stock [Member] | Nasrat Hakim [Member] | |||||
Preferred Stock (Details) [Line Items] | |||||
Preferred stock shares issued | 24.0344 | 24.0344 | |||
Shares of common stock | 158,017,321 | 158,017,321 | |||
Warrants to purchase | 79,008,661 | ||||
Warrant to purchase (in Dollars per share) | $ 0.1521 |
Derivative Financial Instrume_3
Derivative Financial Instruments - Warrants (Details) - USD ($) | 1 Months Ended | 6 Months Ended |
Apr. 28, 2017 | Sep. 30, 2020 | |
Derivative Financial Instruments - Warrants (Details) [Line Items] | ||
Date of issuance | Apr. 28, 2020 | |
Warrant expiration period | 10 years | |
Initial exercise price (in Dollars per share) | $ 79,008,661 | |
Series J Convertible preferred stock [Member] | Chief Executive Officer [Member] | ||
Derivative Financial Instruments - Warrants (Details) [Line Items] | ||
Conversion of stock, shares issued | 24.0344 | |
Series J Convertible preferred stock [Member] | Nasrat Hakim [Member] | ||
Derivative Financial Instruments - Warrants (Details) [Line Items] | ||
Conversion of stock, shares issued | 158,017,321 | |
Warrant to purchase shares | 79,008,661 | |
Fair value of the warrants (in Dollars) | $ 6,474,674 | |
Series J Warrant [Member] | ||
Derivative Financial Instruments - Warrants (Details) [Line Items] | ||
Initial exercise price (in Dollars per share) | $ 0.1521 |
Derivative Financial Instrume_4
Derivative Financial Instruments - Warrants (Details) - Schedule of warrant activity - $ / shares | 6 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Mar. 31, 2020 | |
Schedule of warrant activity [Abstract] | ||
Warrant Shares, Balance at beginning of period | 79,008,661 | 79,008,661 |
Weighted Average Exercise Price, Balance at beginning of period (in Dollars per share) | $ 0.1521 | $ 0.1521 |
Warrant Shares, Warrants granted pursuant to the issuance of Series J convertible preferred shares | ||
Weighted Average Exercise Price, Warrants granted pursuant to the issuance of Series J convertible preferred shares (in Dollars per share) | ||
Warrant Shares, Warrants exercised, forfeited and/or expired, net | ||
Weighted Average Exercise Price, Warrants exercised, forfeited and/or expired, net (in Dollars per share) | ||
Warrant Shares, Balance at end of period | 79,008,661 | 79,008,661 |
Weighted Average Exercise Price, Balance at end of period (in Dollars per share) | $ 0.1521 | $ 0.1521 |
Derivative Financial Instrume_5
Derivative Financial Instruments - Warrants (Details) - Schedule of the fair value of the warrants issued - $ / shares | 6 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Mar. 31, 2020 | |
Schedule of the fair value of the warrants issued [Abstract] | ||
Fair value of the Company’s Common Stock | $ 0.0680 | $ 0.0720 |
Volatility | 79.77% | 83.81% |
Initial exercise price | $ 0.1521 | $ 0.1521 |
Warrant term (in years) | 6 years 219 days | 7 years 36 days |
Risk free rate | 0.47% | 0.55% |
Derivative Financial Instrume_6
Derivative Financial Instruments - Warrants (Details) - Schedule of changes in warrants measured at fair value on a recurring basis - Level 3 [Member] - Warrant [Member] | 6 Months Ended |
Sep. 30, 2020USD ($) | |
Derivative Financial Instruments - Warrants (Details) - Schedule of changes in warrants measured at fair value on a recurring basis [Line Items] | |
Balance at March 31, 2020 | $ 3,599,378 |
Change in fair value of derivative financial instruments - warrants | (561,476) |
Balance at September 30, 2020 | $ 3,037,902 |
Shareholders' Equity (Details)
Shareholders' Equity (Details) - USD ($) | Jul. 08, 2020 | Jun. 05, 2017 | Sep. 30, 2020 | Sep. 30, 2019 | Mar. 31, 2020 |
Shareholders' Equity (Details) [Line Items] | |||||
Purchase shares of common stock amount | $ 40,000,000 | ||||
Common stock, par value per share | $ 0.001 | $ 0.001 | |||
Proceeds from issuance stock | $ 42,223 | $ 723,887 | |||
2020 LPC Purchase Agreement [Member] | |||||
Shareholders' Equity (Details) [Line Items] | |||||
Common stock additional shares issued | 10,094 | ||||
Shares, issued | 640,543 | ||||
Proceeds from issuance stock | $ 42,223 | ||||
Lincoln Park [Member] | |||||
Shareholders' Equity (Details) [Line Items] | |||||
Purchase of common stock, Shares | 7,895,233 | ||||
Purchase of common stock, amount | $ 25,000,000 | $ 723,887 | |||
Common stock additional shares issued | 100,268 | ||||
Common stock, par value per share | $ 0.001 | ||||
Shares, issued | 5,975,857 | ||||
Common stock amount | $ 469,105 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2020 | Mar. 31, 2020 | |
Stock-Based Compensation (Details) [Line Items] | |||
Issuance of shares of common stock (in Shares) | 391,574 | ||
Shares issued in payment of director fees | $ 135,000 | ||
Cash payment made to director fees | $ 15,000 | ||
Payment of employee salaries (in Shares) | 29,442,712 | ||
Price difference between exercise price and quoted price (in Dollars per share) | $ 0.06 | $ 0.06 | $ 0.07 |
Employee Stock [Member] | |||
Stock-Based Compensation (Details) [Line Items] | |||
Payment of employee salaries (in Shares) | 646,336 | ||
Payment of salaries | $ 56,250 | ||
Common Stock [Member] | |||
Stock-Based Compensation (Details) [Line Items] | |||
Issuance of shares of common stock (in Shares) | 1,931,891 | ||
Shares issued in payment of director fees | $ 1,551 | ||
Shares issued in payment of consulting fees | $ 161,033 | ||
Director [Member] | |||
Stock-Based Compensation (Details) [Line Items] | |||
Cash payment made to director fees | $ 67,500 | ||
Director [Member] | Common Stock [Member] | |||
Stock-Based Compensation (Details) [Line Items] | |||
Issuance of shares of common stock (in Shares) | 1,550,343 | ||
Shares issued in payment of director fees | $ 135,000 | ||
Accrued directors fees | 45,000 | ||
Due to officers or stockholders | $ 15,000 | $ 15,000 | |
Shares for payment of directors fees outstanding (in Shares) | 391,574 | 391,574 | |
Noninterest expense directors fees | $ 45,000 | ||
Chief Executive Officer [Member] | Common Stock [Member] | |||
Stock-Based Compensation (Details) [Line Items] | |||
Payment of employee salaries (in Shares) | 396,250 | ||
Management [Member] | Common Stock [Member] | |||
Stock-Based Compensation (Details) [Line Items] | |||
Noninterest expense directors fees | $ 2,657,500 | ||
Payment of employee salaries (in Shares) | 5,182,380 |
Stock-Based Compensation (Det_2
Stock-Based Compensation (Details) - Schedule of stock option plan | 6 Months Ended |
Sep. 30, 2020USD ($)$ / sharesshares | |
Schedule of stock option plan [Abstract] | |
Shares Underlying Options, Outstanding at Beginning | 5,375,000 |
Weighted Average Exercise Price, Outstanding at Beginning (in Dollars per share) | $ / shares | $ 0.14 |
Weighted Average Remaining Contractual Term (in years), Outstanding at Beginning | 4 years 36 days |
Aggregate Intrinsic Value, Outstanding at Beginning (in Dollars) | $ | $ 6,000 |
Shares Underlying Options, Forfeited and expired | (60,000) |
Shares Underlying Options, Outstanding at Ending | 5,315,000 |
Weighted Average Exercise Price, Outstanding at Ending (in Dollars per share) | $ / shares | $ 0.14 |
Weighted Average Remaining Contractual Term (in years), Outstanding at Ending | 3 years 292 days |
Aggregate Intrinsic Value, Outstanding at Ending (in Dollars) | $ | $ 6,000 |
Shares Underlying Options, Exercisable | 5,220,001 |
Weighted Average Exercise Price, Exercisable (in Dollars per share) | $ / shares | $ 0.14 |
Weighted Average Remaining Contractual Term (in years), Exercisable | 3 years 292 days |
Aggregate Intrinsic Value, Exercisable (in Dollars) | $ | $ 6,000 |
Concentrations and Credit Risk
Concentrations and Credit Risk (Details) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Mar. 31, 2020 | |
Revenues [Member] | |||||
Concentrations and Credit Risk (Details) [Line Items] | |||||
Concentration risk, percentage | 93.00% | 87.00% | |||
Accounts Receivable [Member] | |||||
Concentrations and Credit Risk (Details) [Line Items] | |||||
Concentration risk, percentage | 95.00% | ||||
Supplier One [Member] | |||||
Concentrations and Credit Risk (Details) [Line Items] | |||||
Concentration risk, percentage | 85.00% | ||||
Customer One [Member] | Revenues [Member] | |||||
Concentrations and Credit Risk (Details) [Line Items] | |||||
Concentration risk, percentage | 83.00% | 55.00% | 78.00% | 44.00% | 73.00% |
Customer One [Member] | Accounts Receivable [Member] | |||||
Concentrations and Credit Risk (Details) [Line Items] | |||||
Concentration risk, percentage | 84.00% | ||||
Customer Two [Member] | Revenues [Member] | |||||
Concentrations and Credit Risk (Details) [Line Items] | |||||
Concentration risk, percentage | 11.00% | 23.00% | 30.00% | ||
Customer Two [Member] | Accounts Receivable [Member] | |||||
Concentrations and Credit Risk (Details) [Line Items] | |||||
Concentration risk, percentage | 11.00% | 13.00% | |||
Customer Three [Member] | Revenues [Member] | |||||
Concentrations and Credit Risk (Details) [Line Items] | |||||
Concentration risk, percentage | 11.00% | 13.00% | |||
Customer Three [Member] | Accounts Receivable [Member] | |||||
Concentrations and Credit Risk (Details) [Line Items] | |||||
Concentration risk, percentage | 8.00% | ||||
Customer Four [Member] | Accounts Receivable [Member] | |||||
Concentrations and Credit Risk (Details) [Line Items] | |||||
Concentration risk, percentage | 5.00% | ||||
Revenues [Member] | Customer Two [Member] | |||||
Concentrations and Credit Risk (Details) [Line Items] | |||||
Concentration risk, percentage | 15.00% | ||||
Supplier One [Member] | |||||
Concentrations and Credit Risk (Details) [Line Items] | |||||
Concentration risk, percentage | 83.00% | ||||
Supplier One [Member] | Purchases [Member] | |||||
Concentrations and Credit Risk (Details) [Line Items] | |||||
Concentration risk, percentage | 63.00% | 35.00% | |||
Supplier Two [Member] | Purchases [Member] | |||||
Concentrations and Credit Risk (Details) [Line Items] | |||||
Concentration risk, percentage | 11.00% | 18.00% | |||
Supplier Three [Member] | Purchases [Member] | |||||
Concentrations and Credit Risk (Details) [Line Items] | |||||
Concentration risk, percentage | 5.00% | 15.00% | |||
Supplier Four [Member] | Purchases [Member] | |||||
Concentrations and Credit Risk (Details) [Line Items] | |||||
Concentration risk, percentage | 4.00% |
Segment Results (Details) - Sch
Segment Results (Details) - Schedule of selected information for reportable segments - USD ($) | 3 Months Ended | 6 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Operating Income by Segment | ||||
Operating Income (Loss) by Segment | $ 1,340,257 | $ (454,532) | $ 2,170,857 | $ (1,602,237) |
ANDA [Member] | ||||
Operating Income by Segment | ||||
Operating Income (Loss) by Segment | 2,180,670 | 759,049 | 4,050,161 | 106,654 |
NDA [Member] | ||||
Operating Income by Segment | ||||
Operating Income (Loss) by Segment | $ 64,041 | $ 153,784 | $ 271,745 |
Segment Results (Details) - S_2
Segment Results (Details) - Schedule of operating loss by segment to (loss) income from operations - Business Segment [Member] - USD ($) | 3 Months Ended | 6 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Segment Reporting Information [Line Items] | ||||
Operating income by segment | $ 2,180,670 | $ 823,090 | $ 4,203,945 | $ 378,399 |
Corporate unallocated costs | (276,504) | (793,672) | (861,536) | (1,000,789) |
Interest income | 89 | 5,287 | 365 | 8,333 |
Interest expense and amortization of debt issuance costs | (79,753) | (91,464) | (159,184) | (189,134) |
Depreciation and amortization expense | (334,345) | (331,680) | (661,962) | (662,633) |
Significant non-cash items | (226,164) | (154,271) | (468,100) | (319,215) |
Change in fair value of derivative instruments | 1,220,069 | (1,053,031) | 561,476 | 469,000 |
Income (loss) from operations | $ 2,484,062 | $ (1,595,741) | $ 2,615,004 | $ (1,316,039) |
Related Party Agreements with_2
Related Party Agreements with Mikah Pharama, LLC (Details) | Dec. 03, 2018USD ($) |
Mikah [Member] | |
Related Party Agreements with Mikah Pharama, LLC (Details) [Line Items] | |
Advance payment for purchase received | $ 229,451 |
Income Taxes (Details)
Income Taxes (Details) | 1 Months Ended |
Apr. 30, 2020USD ($) | |
Income Tax Disclosure [Abstract] | |
Sale of net tax benefits | $ 607,635 |
Operating losses net tax | 338,772 |
Total proceeds | $ 946,407 |