Cover
Cover - shares | 9 Months Ended | |
Dec. 31, 2023 | Feb. 14, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Dec. 31, 2023 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2024 | |
Current Fiscal Year End Date | --03-31 | |
Entity File Number | 001-15697 | |
Entity Registrant Name | ELITE PHARMACEUTICALS, INC. | |
Entity Central Index Key | 0001053369 | |
Entity Tax Identification Number | 22-3542636 | |
Entity Incorporation, State or Country Code | NV | |
Entity Address, Address Line One | 165 LUDLOW AVENUE | |
Entity Address, City or Town | NORTHVALE | |
Entity Address, State or Province | NJ | |
Entity Address, Postal Zip Code | 07647 | |
City Area Code | (201) | |
Local Phone Number | 750-2646 | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Trading Symbol | ELTP | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 1,017,781,199 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) | Dec. 31, 2023 | Mar. 31, 2023 |
Current assets: | ||
Cash | $ 5,816,211 | $ 7,832,247 |
Accounts receivable, net of allowance for expected credit losses of $194,600 and $0 as of December 31, 2023 and March 31, 2023, respectively | 16,009,614 | 3,094,549 |
Inventory | 14,325,041 | 9,550,716 |
Prepaid expenses and other current assets | 1,005,636 | 1,032,785 |
Total current assets | 37,156,502 | 21,510,297 |
Property and equipment, net of accumulated depreciation of $15,578,471 and $14,586,335 respectively | 10,095,029 | 10,426,158 |
Intangible assets, net of accumulated amortization of $-0- | 6,341,228 | 6,341,228 |
Finance lease - right-of-use asset | 408,428 | |
Operating lease - right-of-use asset | 26,231 | 13,062 |
Deferred income tax asset | 20,233,603 | 2,171,821 |
Other assets: | ||
Restricted cash - debt service for NJEDA bonds | 427,999 | 412,434 |
Security deposits | 7,259 | 21,018 |
Total other assets | 435,258 | 433,452 |
Total assets | 74,696,279 | 40,896,018 |
Current liabilities: | ||
Accounts payable | 2,890,717 | 2,446,810 |
Accrued expenses | 11,884,645 | 5,047,726 |
Deferred revenue, current portion | 13,333 | 13,333 |
Bonds payable, current portion, net of bond issuance costs | 115,822 | 110,822 |
Loans payable, current portion | 190,607 | 200,032 |
Related party loans payable (Note 7) | 4,000,000 | |
Lease obligation - finance lease, current portion | 37,444 | |
Lease obligation - operating lease, current portion | 26,231 | 14,914 |
Total current liabilities | 19,158,799 | 7,833,637 |
Long-term liabilities: | ||
Deferred revenue, net of current portion | 8,889 | 18,890 |
Bonds payable, net of current portion and bond issuance costs | 909,654 | 1,029,018 |
Loans payable, net of current portion and loan costs | 2,407,077 | 2,532,502 |
Lease obligation - finance lease, net of current portion | 200,939 | |
Derivative financial instruments - warrants | 5,597,200 | 521,711 |
Total long-term liabilities | 9,123,759 | 4,102,121 |
Total liabilities | 28,282,558 | 11,935,758 |
Shareholders’ equity: | ||
Common Stock; par value $0.001; 1,445,000,000 shares authorized; 1,017,881,199 and 1,014,015,081 shares issued as of December 31, 2023 and March 31, 2023, respectively; 1,017,781,199 and 1,013,915,081 shares outstanding as of December 31, 2023 and March 31, 2023, respectively | 1,017,885 | 1,014,019 |
Additional paid-in capital | 165,417,811 | 164,750,980 |
Treasury stock; 100,000 shares as of December 31, 2023 and March 31, 2023, respectively, at cost | (306,841) | (306,841) |
Accumulated deficit | (119,715,134) | (136,497,898) |
Total shareholders’ equity | 46,413,721 | 28,960,260 |
Total liabilities and shareholders’ equity | $ 74,696,279 | $ 40,896,018 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - USD ($) | Dec. 31, 2023 | Mar. 31, 2023 |
Statement of Financial Position [Abstract] | ||
Allowance for doubtful accounts receivable, current | $ 194,600 | $ 0 |
Accumulated depreciation | 15,578,471 | 14,586,335 |
Intangible assets accumulated amortization | $ 0 | $ 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 1,445,000,000 | 1,445,000,000 |
Common stock, shares issued | 1,017,881,199 | 1,014,015,081 |
Common stock, shares outstanding | 1,017,781,199 | 1,013,915,081 |
Treasury stock, shares | 100,000 | 100,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Revenue: | ||||
Manufacturing fees | $ 14,791,110 | $ 7,798,159 | $ 36,208,217 | $ 21,312,663 |
Licensing fees | 747,690 | 1,451,907 | 2,467,844 | 4,200,888 |
Total revenue | 15,538,800 | 9,250,066 | 38,676,061 | 25,513,551 |
Cost of manufacturing | 8,497,727 | 4,330,841 | 20,437,354 | 12,360,935 |
Gross profit | 7,041,073 | 4,919,225 | 18,238,707 | 13,152,616 |
Operating expenses: | ||||
Research and development | 1,403,790 | 1,443,361 | 5,165,684 | 3,775,107 |
General and administrative | 1,711,275 | 1,186,049 | 4,906,187 | 4,356,752 |
Non-cash compensation through issuance of stock options | 49,815 | 13,030 | 107,592 | 24,325 |
Depreciation and amortization | 343,537 | 317,685 | 999,059 | 933,531 |
Total operating expenses | 3,508,417 | 2,960,125 | 11,178,522 | 9,089,715 |
Income from operations | 3,532,656 | 1,959,100 | 7,060,185 | 4,062,901 |
Other income (expense): | ||||
Change in fair value of derivative financial instruments - warrants | (2,417,772) | 372,894 | (5,075,489) | 561,070 |
Change in fair value of stock-based liabilities | (2,854,556) | (4,921,376) | ||
Interest expense and amortization of debt issuance costs | (121,628) | (322,681) | (371,478) | (782,221) |
Gain from settlement agreements | 1,761,792 | 1,761,792 | ||
Gain on sale of ANDA | 1,000,000 | 1,000,000 | ||
Interest income | 5,249 | 15 | 16,085 | 187 |
Other (expense) income, net | (3,626,915) | 1,050,228 | (8,590,466) | 779,036 |
(Loss) income before income taxes | (94,259) | 3,009,328 | (1,530,281) | 4,841,937 |
Income tax benefit (expense) | 800,613 | (39,250) | 18,313,045 | (50,837) |
Net income attributable to common shareholders | $ 706,354 | $ 2,970,078 | $ 16,782,764 | $ 4,791,100 |
Basic net income per share attributable to common shareholders | $ 0 | $ 0 | $ 0.02 | $ 0 |
Diluted net income per share attributable to common shareholders | $ 0 | $ 0 | $ 0.02 | $ 0.01 |
Basic weighted average Common Stock outstanding | 1,014,768,071 | 1,013,915,081 | 1,014,265,162 | 1,012,480,115 |
Diluted weighted average Common Stock outstanding | 1,024,448,445 | 1,013,915,081 | 1,019,511,813 | 1,012,480,115 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Shareholders' Equity (Unaudited) - USD ($) | Preferred Stock [Member] Series J Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Treasury Stock, Common [Member] | Retained Earnings [Member] | Total |
Balance at Mar. 31, 2022 | $ 1,011,385 | $ 164,577,227 | $ (306,841) | $ (140,059,744) | $ 25,222,027 | |
Balance, shares at Mar. 31, 2022 | 1,011,381,988 | 100,000 | ||||
Net income (Loss) | 305,883 | 305,883 | ||||
Non-cash compensation through the issuance of employee stock options | 5,322 | 5,322 | ||||
Balance at Jun. 30, 2022 | $ 1,011,385 | 164,582,549 | $ (306,841) | (139,753,861) | 25,533,232 | |
Balance, shares at Jun. 30, 2022 | 1,011,381,988 | 100,000 | ||||
Balance at Mar. 31, 2022 | $ 1,011,385 | 164,577,227 | $ (306,841) | (140,059,744) | 25,222,027 | |
Balance, shares at Mar. 31, 2022 | 1,011,381,988 | 100,000 | ||||
Net income (Loss) | 4,791,100 | |||||
Balance at Dec. 31, 2022 | $ 1,014,019 | 164,735,980 | $ (306,841) | (135,268,644) | 30,174,514 | |
Balance, shares at Dec. 31, 2022 | 1,014,015,081 | 100,000 | ||||
Balance at Jun. 30, 2022 | $ 1,011,385 | 164,582,549 | $ (306,841) | (139,753,861) | 25,533,232 | |
Balance, shares at Jun. 30, 2022 | 1,011,381,988 | 100,000 | ||||
Net income (Loss) | 1,515,139 | 1,515,139 | ||||
Non-cash compensation through the issuance of employee stock options | 5,974 | 5,974 | ||||
Shares issued in payment of director salaries | $ 1,379 | 58,621 | 60,000 | |||
Shares issued in payment of director salaries, shares | 1,378,608 | |||||
Shares issued in payment of consultant fees | $ 1,255 | 75,807 | 77,062 | |||
Shares issued in payment of consultants, shares | 1,254,485 | |||||
Balance at Sep. 30, 2022 | $ 1,014,019 | 164,722,951 | $ (306,841) | (138,238,722) | 27,191,407 | |
Balance, shares at Sep. 30, 2022 | 1,014,015,081 | 100,000 | ||||
Net income (Loss) | 2,970,078 | 2,970,078 | ||||
Non-cash compensation through the issuance of employee stock options | 13,029 | 13,029 | ||||
Balance at Dec. 31, 2022 | $ 1,014,019 | 164,735,980 | $ (306,841) | (135,268,644) | 30,174,514 | |
Balance, shares at Dec. 31, 2022 | 1,014,015,081 | 100,000 | ||||
Balance at Mar. 31, 2023 | $ 1,014,019 | 164,750,980 | $ (306,841) | (136,497,898) | 28,960,260 | |
Balance, shares at Mar. 31, 2023 | 1,014,015,081 | 100,000 | ||||
Net income (Loss) | 1,141,809 | 1,141,809 | ||||
Non-cash compensation through the issuance of employee stock options | 15,000 | 15,000 | ||||
Balance at Jun. 30, 2023 | $ 1,014,019 | 164,765,980 | $ (306,841) | (135,356,089) | 30,117,069 | |
Balance, shares at Jun. 30, 2023 | 1,014,015,081 | 100,000 | ||||
Balance at Mar. 31, 2023 | $ 1,014,019 | 164,750,980 | $ (306,841) | (136,497,898) | 28,960,260 | |
Balance, shares at Mar. 31, 2023 | 1,014,015,081 | 100,000 | ||||
Net income (Loss) | 16,782,764 | |||||
Balance at Dec. 31, 2023 | $ 1,017,885 | 165,417,811 | $ (306,841) | (119,715,134) | 46,413,721 | |
Balance, shares at Dec. 31, 2023 | 1,017,881,199 | 100,000 | ||||
Balance at Jun. 30, 2023 | $ 1,014,019 | 164,765,980 | $ (306,841) | (135,356,089) | 30,117,069 | |
Balance, shares at Jun. 30, 2023 | 1,014,015,081 | 100,000 | ||||
Net income (Loss) | 14,934,601 | 14,934,601 | ||||
Non-cash compensation through the issuance of employee stock options | 42,777 | 42,777 | ||||
Balance at Sep. 30, 2023 | $ 1,014,019 | 164,808,757 | $ (306,841) | (120,421,488) | 45,094,447 | |
Balance, shares at Sep. 30, 2023 | 1,014,015,081 | 100,000 | ||||
Net income (Loss) | 706,354 | 706,354 | ||||
Non-cash compensation through the issuance of employee stock options | 49,815 | 49,815 | ||||
Shares issued in payment of director salaries | $ 1,643 | 250,224 | 251,867 | |||
Shares issued in payment of director salaries, shares | 1,642,971 | |||||
Shares issued in payment of consultant fees | $ 2,223 | 309,015 | 311,238 | |||
Shares issued in payment of consultants, shares | 2,223,147 | |||||
Balance at Dec. 31, 2023 | $ 1,017,885 | $ 165,417,811 | $ (306,841) | $ (119,715,134) | $ 46,413,721 | |
Balance, shares at Dec. 31, 2023 | 1,017,881,199 | 100,000 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net income | $ 16,782,764 | $ 4,791,100 |
Adjustments to reconcile net income to net cash (used in) provided by operating activities: | ||
Depreciation and amortization | 992,136 | 933,531 |
Bad debt expense | 194,600 | |
Amortization of operating leases - right-of-use assets | 18,153 | 61,621 |
Non-cash compensation accrued | 563,105 | 430,778 |
Change in fair value of derivative financial instruments - warrants | 5,075,489 | (561,070) |
Change in fair value of stock-based liabilities | 4,921,376 | |
Gain on settlement of Common Stock to consultant | (1,761,792) | |
Non-cash compensation through the issuance of employee stock options | 107,592 | 24,325 |
Non-cash rent expense and lease accretion | 602 | |
Deferred revenue | (10,001) | (10,003) |
Change in operating assets and liabilities: | ||
Accounts receivable | (13,109,665) | (2,487,930) |
Inventory | (4,774,325) | (1,860,688) |
Prepaid expenses and other current assets | 40,908 | (581,113) |
Deferred income tax asset | (18,061,782) | |
Accounts payable, accrued expenses and other current liabilities | 3,702,825 | (309,950) |
Interest expense of finance lease liability | (2,915) | |
Lease obligations - operating leases | (20,005) | (61,182) |
Net cash (used in) provided by operating activities | (5,341,537) | 370,021 |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of property and equipment | (406,007) | (5,200,407) |
Net cash used in investing activities | (406,007) | (5,200,407) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Payment of bond principal | (125,000) | (115,000) |
Proceeds from related party loans payable | 4,000,000 | |
Proceeds from loans payable | 14,550,001 | |
Amortization of finance leases - right-of-use assets | 6,923 | |
Loan payments | (134,850) | (230,770) |
Net cash provided by financing activities | 3,747,073 | 14,204,231 |
Net change in cash and restricted cash | (2,000,471) | 9,373,845 |
Cash and restricted cash, beginning of period | 8,244,681 | 8,940,396 |
Cash and restricted cash, end of period | 6,244,210 | 18,314,241 |
Supplemental disclosure of cash and non-cash transactions: | ||
Cash paid for interest | 119,412 | 782,221 |
Cash paid for income taxes | 292,000 | 127,522 |
Stock issued in satisfaction of accrued directors salaries and consultant fees | 563,105 | 137,067 |
Recognition of right of use asset and lease liabilities entered into | 272,620 | |
Reconciliation of cash and restricted cash | ||
Cash | 5,816,211 | 17,909,077 |
Restricted cash - debt service for NJEDA bonds | 427,999 | 405,164 |
Total cash and restricted cash shown in statement of cash flows | $ 6,244,210 | $ 18,314,241 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) | 3 Months Ended | 9 Months Ended | ||||||
Dec. 31, 2023 | Sep. 30, 2023 | Jun. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Jun. 30, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Pay vs Performance Disclosure [Table] | ||||||||
Net Income (Loss) Attributable to Parent | $ 706,354 | $ 14,934,601 | $ 1,141,809 | $ 2,970,078 | $ 1,515,139 | $ 305,883 | $ 16,782,764 | $ 4,791,100 |
Insider Trading Arrangements
Insider Trading Arrangements | 9 Months Ended |
Dec. 31, 2023 | |
Insider Trading Arrangements [Line Items] | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Dec. 31, 2023 | |
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, manufacturing, and sales 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 product candidates 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 product candidates that will secure marketing approvals from the United States Food and Drug Administration (“FDA”), and thereafter, commercially exploiting such products. Basis of Presentation The accompanying unaudited condensed consolidated financial statements of the Company are presented in conformity with accounting principles generally accepted in the United States of America (“GAAP”) and pursuant to the rules and regulations of the SEC. The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, Elite Labs. All significant intercompany accounts and transactions have been eliminated in consolidation. Certain information or footnote disclosures normally included in condensed financial statements prepared in accordance with GAAP have been condensed or omitted, pursuant to the rules and regulations of the SEC for interim financial reporting. Accordingly, they do not include all the information and footnotes necessary for a comprehensive presentation of financial position, results of operations, or cash flows. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments, consisting of a normal recurring nature, which are necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the Company’s Form 10-K as filed with the SEC on June 29, 2023. The interim results for the nine months ended December 31, 2023 are not necessarily indicative of the results to be expected for the fiscal year ending March 31, 2024 or for any future periods. 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 Application (“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. ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) Revenue Recognition The Company generates revenue from manufacturing and licensing fees and sales of generic pharmaceuticals bearing the Elite label to pharmaceutical distributors for pharmacies and institutions. 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. Revenues earned from the sale of Elite label products are recorded at their net realizable value which consists of gross amounts invoiced reduced by contractual reductions, including, without limitation, chargebacks, discounts and program rebates, as applicable. 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, at which time the performance obligation is deemed to be completed. 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. ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) 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 December 31, 2023. In accordance with ASC 606-10-55-65, royalties are recognized when the subsequent sale of the customer’s products occurs. c) Sale of product under the Elite label The Company began direct sales of products under the Company’s own label on April 1, 2023. License agreements will remain in place for select products. With this transition, however, a large portion of the manufacturing and license fees now reported will be replaced with revenues from sales of Elite labeled pharmaceutical products to distributors for pharmacies and institutions. The Company recognizes revenue when the customer obtains control of the Company’s product based on the contractual shipping terms, at which time the performance obligation is deemed to be completed. The Company is primarily responsible for fulfilling the promise to deliver the product and bears risk of loss while the inventory is in-transit to the purchaser. Revenue is measured as the amount of consideration earned from the sale of Elite labeled pharmaceutical products are recorded at their net realizable value which consists of gross amounts invoiced reduced by contractual reductions, including, without limitation, chargebacks, discounts and program rebates, as applicable. Disaggregation of revenue In the following table, revenue is disaggregated by type of revenue generated by the Company. The Company recognizes revenue at a point in time for all performance obligations. The table also includes a reconciliation of the disaggregated revenue with the reportable segments: SCHEDULE OF DISAGGREGATION OF REVENUE For the Three Months Ended December 31, For the Nine Months Ended December 31, 2023 2022 2023 2022 NDA: Manufacturing fees $ - $ - $ - $ - Licensing fees $ — $ — $ — $ — Total NDA revenue — — — — ANDA: Manufacturing fees $ 14,791,110 $ 7,798,159 $ 36,208,217 $ 21,312,663 Licensing fees 747,690 1,451,907 2,467,844 4,200,888 Total ANDA revenue 15,538,800 9,250,066 38,676,061 25,513,551 Total revenue $ 15,538,800 $ 9,250,066 $ 38,676,061 $ 25,513,551 Selected information on reportable segments and reconciliation of operating income by segment to income from operations before income taxes are disclosed within Note 15. ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) Cash Cash consists of cash on deposit with banks and money market instruments. The Company places its cash with high-quality, U.S. financial institutions and, to date has not experienced losses on any of its balances. Restricted Cash As of December 31, 2023, and March 31, 2023, the Company had $ 427,999 412,434 Accounts Receivable and Allowance for Expected Credit Losses Accounts receivable are comprised of balances due from customers, net of estimated allowances for expected credit losses, and other contractual deductions, including, without limitation, chargebacks, discounts and program rebates. In determining collectability, historical trends are evaluated, and specific customer issues are reviewed on a periodic basis to arrive at appropriate allowances. The allowance for expected credit losses is based on the probability of future collection under the current expected credited loss (“CECL”) impairment model under Accounting Standards Update (“ASU”) 2016-13, Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses on Financial Assets, which was adopted by the Company on April 1, 2023, as discussed below within Recently Adopted Accounting Pronouncements. Under the CECL impairment model, the Company determines its allowance by applying a loss-rate method based on an aging schedule using the Company’s historical loss rate. The Company also considers reasonable and supportable current information in determining its estimated loss rates, such as external forecasts, macroeconomic trends or other factors including customers’ credit risk and historical loss experience. The adequacy of the allowance is evaluated on a regular basis. Account balances are written off after all means of collection are exhausted and the balance is deemed uncollectible. Subsequent recoveries are credited to the allowance. Changes in the allowance are recorded as adjustments to credit losses in the period incurred. Prior to April 1, 2023, trade receivables were presented net of allowance for expected credit losses based on the credit risk of specific clients, past collection history, and management’s evaluation of other risks. Expected credit losses stemming from unbilled receivables expected to be billed between March 31, 2024 and March 31, 2028 include additional risk premiums estimated based on factors such as projected inflation, projected decreases in GDP, and projected unemployment. Inventory Inventory is recorded at the lower of cost or net realizable value 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. ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) During the year ended March 31, 2023, the Company determined indicators of impairment occurred and recorded impairment expense of $ 292,807 no The following table summarizes the Company’s intangible assets as of and for the periods ended December 31, 2023 and March 31, 2023: SCHEDULE OF INTANGIBLE ASSETS December 31, 2023 Estimated Useful Life Gross Carrying Amount Impairment losses Accumulated Amortization Net Book Value Patent application costs * $ 289,039 $ — $ — $ 289,039 ANDA acquisition costs Indefinite 6,052,189 — — 6,052,189 $ 6,341,228 $ — $ — $ 6,341,228 March 31, 2023 Estimated Useful Life Gross Carrying Amount Impairment losses Accumulated Amortization Net Book Value Patent application costs * $ 465,684 $ (176,645 ) $ — $ 289,039 ANDA acquisition costs Indefinite 6,168,351 (116,162 ) — 6,052,189 $ 6,634,035 $ (292,807 ) $ — $ 6,341,228 Research and Development Research and development expenditures are charged to expenses 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. On August 17, 2023, Elite filed a paragraph IV certification with its ANDA to generic Oxycontin and after Elite got acceptance of the ANDA by the FDA on September 19, 2023, Elite sent the patentee and NDA holder a Notice Letter as required under the Hatch-Waxman Act. On November 14, 2023, a patent infringement suit was filed in the District Court of New Jersey by Purdue Pharma. Elite obtained agreement with Purdue to stay the litigation for six months. Elite’s launch of a generic Oxycontin will depend on the approval by the FDA and the outcome of various litigations involving Purdue or the expiry of the patents listed on the Orange Book. As of December 31, 2023, the results of such proceedings cannot be predicted with certainty, but the Company does not anticipate that the final outcome, if any, arising out of any such matters will have a material adverse effect on its business, financial condition or results of operations. 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 December 31, 2023, a summary of the tax years that remain subject to examination in our major tax jurisdictions are: United States – Federal, 2016 and forward. The Company did not record unrecognized tax positions for the nine months ended December 31, 2023. 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 ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) 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. The Company records earned but unissued stock-based compensation in accrued expenses. Sale of ANDA During the quarter ended December 31, 2022, the Company entered into an agreement with Pyros Pharmaceuticals, Inc. (“Pyros”) pursuant to which the Company sold to Pyros its rights in and to the Company’s approved abbreviated new drug applications (ANDAs) for its generic Sabril drug (the “Sabril Product”). The Company sold its rights to Pyros for $ 1,000,000 In conjunction with the sale of its Sabril Product to Pyros, the Company executed a Manufacturing and Supply Agreement (the “Pyros Agreement”) with Pyros. Under the terms of the Pyros Agreement, the Company will receive an agreed-upon price per drug for the manufacturing and packaging of Sabril over a term of three years. Revenue per the Pyros Agreement will be recognized as control of the manufactured and supplied drugs is transferred to Pyros (at the time of delivery). Earnings Per Share Attributable to Common Shareholders’ The Company follows ASC 260, Earnings Per Share As the average market price of Common Stock for the three and nine months ended December 31, 2023 and 2022 did not exceed the exercise price of th he potential dilutio into 79,008,661 ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) The following is the computation of earnings per share applicable to common shareholders for the periods indicated: SCHEDULE OF EARNINGS (LOSS) PER SHARE APPLICABLE TO COMMON SHAREHOLDERS For the Three Months Ended December 31, For the Nine Months Ended December 31, 2023 2022 2023 2022 Numerator Net income - basic $ 706,354 $ 2,970,078 $ 16,782,764 $ 4,791,100 Effect of dilutive instrument on net income — 372,894 — 561,070 Net income - diluted $ 706,354 $ 3,342,972 $ 16,782,764 $ 5,352,170 Denominator Weighted average shares of Common Stock outstanding - basic 1,014,768,071 1,013,915,081 1,014,265,162 1,012,480,115 Dilutive effect of stock options and convertible securities 9,680,374 — 5,246,651 — Weighted average shares of Common Stock outstanding - diluted 1,024,448,445 1,013,915,081 1,019,511,813 1,012,480,115 Net income per share Basic $ 0.00 $ 0.00 $ 0.02 $ 0.00 Diluted $ 0.00 $ 0.00 $ 0.02 $ 0.01 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. ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) 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: SCHEDULE OF LIABILITIES MEASURED AT FAIR VALUE ON A RECURRING BASIS Fair Value Measurement Amount at Fair Value Level 1 Level 2 Level 3 Balance as of April 1, 2023 $ 521,711 $ — $ — $ 521,711 Change in fair value of derivative financial instruments - warrants 5,075,489 — — 5,075,489 Balance as of December 31, 2023 $ 5,597,200 $ — $ — $ 5,597,200 Fair Value Measurement Amount at Fair Value Level 1 Level 2 Level 3 Balance as of April 1, 2022 $ 936,837 $ — $ — $ 936,837 Change in fair value of derivative financial instruments - warrants (561,070 ) — — (561,070 ) Balance as of December 31, 2022 $ 375,767 $ — $ — $ 375,767 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. Financial Instruments — Credit Losses (ASU 2016-13) In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (“CECL”). The amendments in this update introduce a new accounting model to measure credit losses for financial assets measured at amortized cost. The FASB has also issued additional ASUs to clarify the scope and provide additional guidance for ASU 2016-13. Credit losses for financial assets measured at amortized cost should be determined based on the total current expected credit losses over the life of the financial asset or group of financial assets. In effect, the financial asset or group of financial assets should be presented at the net amount expected to be collected. Credit losses will no longer be recorded under the current incurred loss model for financial assets measured at amortized cost. The amendments also modify the accounting for available-for-sale debt securities whereby credit losses will be recorded through an allowance for credit losses rather than a write-down to the security’s cost basis, which allows for reversals of credit losses when estimated credit losses decline. Credit losses for available-for-sale debt securities should be measured in a manner similar to current GAAP. The amendments were effective on April 1, 2023 for the Company, and must be applied using a modified retrospective approach with a cumulative-effect adjustment through retained earnings as of the beginning of the fiscal year upon adoption as required. While the standard modifies the measurement of the allowance for credit losses, it does not alter the credit risk of our trade or unbilled receivables. The impact of applying the CECL methodology upon adoption effective on April 1, 2023 was immaterial to the Company’s consolidated financial statements. The Company’s quantitative allowance for credit loss estimates under CECL was determined using the loss rate method, which is impacted by certain forecasted economic factors. In addition to the Company’s quantitative allowance for credit losses, the Company also incorporates qualitative adjustments that may relate to unique risks, changes in current economic conditions that may not be reflected in quantitatively derived results, or other relevant factors to further inform the Company’s estimate of the allowance for credit losses. ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) Additionally, due to the expansion of the time horizon over which the Company is required to estimate future credit losses, the Company may experience increased volatility in its future provisions for credit losses. Factors that could contribute to such volatility include, but are not limited to, changes in the composition and credit quality of customer base, economic conditions and forecasts, the allowance for credit loss models that are used, the data that is included in the models, the associated qualitative allowance framework, and the Company’s estimation techniques. The Company has had no recordable write offs for bad debts or uncollectible invoiced amounts during the for the nine months ended December 31, 2023 or the prior twelve months ended March 31, 2023. In applying the CECL methodology, the Company recorded an estimated allowance of $ 194,600 Treasury Stock The Company records treasury stock at the cost to acquire it and includes treasury stock as a component of shareholders’ equity. Recently Issued Accounting Pronouncements Management has evaluated 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 | 9 Months Ended |
Dec. 31, 2023 | |
Inventory Disclosure [Abstract] | |
INVENTORY | NOTE 2. INVENTORY Inventory consisted of the following: SCHEDULE OF INVENTORY December 31, 2023 March 31, 2023 Finished goods $ 5,544,848 $ 2,352,330 Work-in-progress 1,247,307 1,791,311 Raw materials 7,532,886 5,407,075 Inventory $ 14,325,041 $ 9,550,716 |
PROPERTY AND EQUIPMENT, NET
PROPERTY AND EQUIPMENT, NET | 9 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT, NET | NOTE 3. PROPERTY AND EQUIPMENT, NET Property and equipment consisted of the following: SCHEDULE OF PROPERTY AND EQUIPMENT December 31, 2023 March 31, 2023 Land, building and improvements $ 10,269,297 $ 10,768,181 Laboratory, manufacturing, warehouse and transportation equipment 14,518,570 13,364,512 Office equipment and software 373,601 395,563 Furniture and fixtures 512,032 484,237 Property and equipment, gross 25,673,500 25,012,493 Less: Accumulated depreciation (15,578,471 ) (14,586,335 ) Property and equipment, net $ 10,095,029 $ 10,426,158 Depreciation expense was $ 336,614 314,610 992,136 923,365 ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) |
ACCRUED EXPENSES
ACCRUED EXPENSES | 9 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
ACCRUED EXPENSES | NOTE 4. ACCRUED EXPENSES As of December 31, 2023 and March 31, 2023, the Company’s accrued expenses consisted of the following: SUMMARY OF ACCRUED EXPENSES December 31, 2023 March 31, 2023 Salaries and fees payable in Common Stock inclusive of the change in fair value of Common stock underlying such liabilities $ 6,934,812 $ 4,125,000 Income tax — 414,989 Co-development profit split 3,389,949 — Consultant contract fees 10,000 193,333 Audit fees 125,000 125,000 Director dues 22,500 70,000 Legal and professional expense 75,000 — Employee bonuses 712,384 — Other accrued expenses 615,000 119,404 Total accrued expenses $ 11,884,645 $ 5,047,726 |
NJEDA BONDS
NJEDA BONDS | 9 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
NJEDA BONDS | NOTE 5. NJEDA BONDS 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 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 following tables summarize the Company’s bonds payable liability: SCHEDULE OF BONDS PAYABLE LIABILITY December 31, 2023 March 31, 2023 Gross bonds payable NJEDA Bonds - Series A Notes $ 1,120,000 $ 1,245,000 Less: Current portion of bonds payable (prior to deduction of bond offering costs) (130,000 ) (125,000 ) Long-term portion of bonds payable (prior to deduction of bond offering costs) $ 990,000 $ 1,120,000 Bond offering costs $ 354,454 $ 354,454 Less: Accumulated amortization (259,930 ) (249,294 ) Bond offering costs, net $ 94,524 $ 105,160 Current portion of bonds payable - net of bond offering costs Current portions of bonds payable $ 130,000 $ 125,000 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 $ 115,822 $ 110,822 Long term portion of bonds payable - net of bond offering costs Long term portion of bonds payable $ 990,000 $ 1,120,000 Less: Bond offering costs to be amortized subsequent to the next 12 months (80,346 ) (90,982 ) Long term portion of bonds payable, net of bond offering costs $ 909,654 $ 1,029,018 Amortization expense was $ 3,540 3,544 10,636 10,629 24,267 6,744 18,200 20,231 57,985 63,808 ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) Maturities of bonds for the next five years, exclusive of the nine months ended December 31, 2023 are as follows: SCHEDULE OF MATURITIES OF BONDS Years ending March 31, Amount 2024 $ — 2025 130,000 2026 140,000 2027 150,000 2028 160,000 Thereafter 540,000 Total $ 1,120,000 |
LOANS PAYABLE
LOANS PAYABLE | 9 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
LOANS PAYABLE | NOTE 6. LOANS PAYABLE On April 2, 2022, the Company and Elite Labs entered into a Loan and Security Agreement (the “EWB Loan Agreement”) with East West Bank (“EWB”). Pursuant to the EWB Loan Agreement, the Company and Elite Labs received one term loan for a principal amount of $ 12,000,000 2,000,000 9.73 1.73 five years May 1, 2027 8.87 0.87 May 1, 2027 40,120 The EWB Loans are secured by a security interest in the personal property of the Company and Elite Labs. The EWB Loan Agreement contains customary representations, warranties and covenants. These covenants include, but are not limited to, maintaining maximum leverage ratios of 3.50 to 1.00, minimum liquidity of $5,000,000, minimum cash of $1,000,000, a fixed charge coverage ratio of 1.25 to 1.00 and restrictions on mergers or sales of assets and debt borrowings In place of the EWB Term Loan, the Company has entered into a collateralized promissory note with individual lenders with rates comparable to the EWB Term Loan but with less restrictive covenants (a “Promissory Note”). As of June 2, 2023, a Promissory Note was placed with Nasrat Hakim, CEO and Chairman of the Board of Directors, for $ 3,000,000 9 10 Loans payable consisted of the following: SCHEDULE OF LOANS PAYABLE December 31, 2023 March 31, 2023 Mortgage loan payable 4.75 $ 2,438,958 $ 2,472,923 Equipment and insurance financing loans payable, between 7.10 12.02 158,726 259,611 Less: Current portion of loans payable (190,607 ) (200,032 ) Long-term portion of loans payable $ 2,407,077 $ 2,532,502 The interest expense associated with the loans payable was $ 30,384 317,844 101,478 579,109 ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) Loan principal payments for the next five years are as follows: SCHEDULE OF LOAN PRINCIPAL PAYMENTS Future principal balances Years ending March 31, Amount 2024 (excluding the nine months ended December 31, 2023) $ 44,535 2025 186,657 2026 120,748 2027 92,773 2028 94,433 2029 and thereafter 2,058,538 Total remaining principal balance $ 2,597,684 |
RELATED PARTY LOANS
RELATED PARTY LOANS | 9 Months Ended |
Dec. 31, 2023 | |
Related Party Transactions [Abstract] | |
RELATED PARTY LOANS | NOTE 7. RELATED PARTY LOANS The Company has entered into a collateralized promissory note with individual lenders with rates comparable to the EWB Term Loan but with fewer covenants (the “Hakim Promissory Note”). These covenants include filing timely tax returns and financial statements, and an agreement not to sell, lease, or transfer a substantial portion of the Company’s assets during the term of the Hakim Promissory Note. On June 2, 2023, the Company entered into a Promissory Note with Nasrat Hakim, CEO and Chairman of the Board of Directors, pursuant to which the Company borrowed funds in the aggregate principal amount of $ 3,000,000 9 10 67,500 202,500 On July 1, 2022, the EWB provided a mortgage loan (“EWB Mortgage Loan”) in the amount of $ 2.55 10 bears interest at a rate of 4.75% fixed for 5 years then adjustable at the Wall Street Journal Prime Rate (“WSJP”) plus 0.5% with floor rate of 4.5% 13,251 The EWB Mortgage Loan contains customary representations, warranties and covenants. These covenants include maintaining a minimum debt coverage ratio of 1.50 to 1.00 tested annually and a minimum trailing 12-month debt coverage ratio of 1.50 to 1.00. As of the date of this filing, the Company was in compliance with each financial covenant On June 30, 2023, the Company entered into a collateralized promissory note with Davis Caskey (the “Caskey Promissory Note”). The Caskey Promissory Note has a principal balance of $ 1,000,000 9 10 22,500 67,500 |
DEFERRED REVENUE
DEFERRED REVENUE | 9 Months Ended |
Dec. 31, 2023 | |
Revenue from Contract with Customer [Abstract] | |
DEFERRED REVENUE | NOTE 8. DEFERRED REVENUE Deferred revenues in the aggregate amount of $ 22,222 13,333 8,889 32,223 13,333 18,890 200,000 September 2010 August 2025 ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 9 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [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 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. On August 17, 2023, Elite filed a paragraph IV certification with its ANDA to generic Oxycontin and after Elite got acceptance of the ANDA by the FDA on September 19, 2023, Elite sent the patentee and NDA holder a Notice Letter as required under the Hatch-Waxman Act. On November 14, 2023, a patent infringement suit was filed in the District Court of New Jersey by Purdue Pharma. Elite obtained agreement with Purdue to stay the litigation for six months. Elite’s launch of a generic Oxycontin will depend on the approval by the FDA and the outcome of various litigations involving Purdue or the expiry of the patents listed on the Orange Book. As of December 31, 2023, the results of such proceedings cannot be predicted with certainty, but the Company does not anticipate that the final outcome, if any, arising out of any such matters will have a material adverse effect on its business, financial condition or results of operations. Operating Leases The Company entered into an operating lease for a portion of a one-story warehouse, located at 135 Ludlow Avenue, Northvale, New Jersey (the “Ludlow Ave. lease”) which began in 2010. On June 30, 2021, the Company exercised a renewal option, with such option including a term that begins on January 1, 2022 and expires on December 31, 2026. The Ludlow Ave. lease was terminated on July 1, 2022, when the Company purchased the underlying property. In October 2020, the Company entered into an operating lease for office space in Pompano Beach, Florida (the “Pompano Office Lease”). The Pompano Office Lease is for approximately 1,275 The Pompano Office Lease had a term of three years, ending on October 31, 2023. The Pompano Office Lease was extended for one additional year to October 31, 2024. 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 its 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. Finance Leases In November 2023, the Company entered into an finance lease for equipment (the “Waters Equipment Lease”). The Waters Equipment Lease is related to lab equipment with an acquisition cost of $ 499,775 The Waters equipment lease has a term of five years, ending on November 29, 2028. 1 A lease is classified as a finance lease if any of the following criteria are met: (i) ownership of the underlying asset transfers to the Company by the end of the lease term; (ii) the lease contains an option to purchase the underlying asset that the Company is reasonably expected to exercise; (iii) the lease term is for a major part of the remaining economic life of the underlying asset; (iv) the present value of the sum of lease payments and any residual value guaranteed by the Company equals or exceeds substantially all of the fair value of the underlying asset; or (v) the underlying asset is of a specialized nature that it is expected to have no alternative use to the lessor at the end of the lease term. ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) Lease assets and liabilities are classified as follows on the condensed consolidated balance sheet: SCHEDULE OF LEASE ASSETS AND LIABILITIES Lease Classification December 31, 2023 Assets Finance Finance lease – right-of-use asset $ 408,428 Operating Operating lease – right-of-use asset 26,231 Total leased assets $ 434,659 Liabilities Current Finance Lease obligation – finance lease $ 37,444 Operating Lease obligation – operating lease 26,231 Long-term Finance Lease obligation – finance lease, net of current portion 200,939 Operating Lease obligation – operating lease, net of current portion — Total lease liabilities $ 264,614 Rent expense is recorded on the straight-line basis. Rent expense under the 135 Ludlow Ave. modified lease was $ 0 0 58,248 7,565 6,456 20,603 19,116 The table below shows the future minimum rental payments, exclusive of taxes, insurance and other costs, under the Pompano Office Lease and Waters Equipment Lease: SCHEDULE OF FUTURE MINIMUM RENTAL PAYMENTS Years ending March 31, Operating Lease Amount Financing Lease Amount Total 2024 (excluding the nine months ended December 31, 2023) $ 8,087 $ 16,286 $ 24,373 2025 18,870 65,145 84,015 2026 — 65,145 65,145 2027 — 65,145 65,145 2028 — 65,145 65,145 Thereafter — 43,429 43,429 Less: interest (727 ) (81,911 ) (82,638 ) Present value of lease payments $ 26,230 $ 238,384 $ 264,614 The weighted-average remaining lease term and the weighted-average discount rate of our leases were as follows: SCHEDULE OF WEIGHTED -AVERAGE REMAINING TERM AND THE WEIGHTED-AVERAGE DISCOUNT RATE Lease Term and Discount Rate December 31, 2023 Remaining lease term (years) Operating leases 0.8 Finance leases 4.9 Discount rate Operating leases 6.0 % Finance leases 12.5 % ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) |
PREFERRED STOCK
PREFERRED STOCK | 9 Months Ended |
Dec. 31, 2023 | |
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. A total of 50 zero 1,000,000 0.01 |
DERIVATIVE FINANCIAL INSTRUMENT
DERIVATIVE FINANCIAL INSTRUMENTS – WARRANTS | 9 Months Ended |
Dec. 31, 2023 | |
Derivative Instruments and Hedging Activities Disclosure [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. The Company has 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 79,008,661 158,017,321 6,474,674 The Series J Warrants are exercisable for a period of 10 0.1521 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. 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. The following assumptions were used in the Black-Scholes model to calculate the fair value of the Series J Warrants: SCHEDULE OF FAIR VALUE OF WARRANTS ISSUED December 31, 2023 March 31, 2023 Fair value of the Company’s Common Stock $ 0.1393 $ 0.0290 Volatility 73.50 % 74.37 % Initial exercise price $ 0.1521 $ 0.1521 Warrant term (in years) 3.3 4.1 Risk free rate 4.01 % 3.55 % The changes in warrants (Level 3 financial instruments) measured at fair value on a recurring basis for the nine months ended December 31, 2023 were as follows: SCHEDULE OF CHANGES IN WARRANTS MEASURED AT FAIR VALUE ON A RECURRING BASIS Balance at March 31, 2023 $ 521,711 Change in fair value of derivative financial instruments - warrants 5,075,489 Balance at December 31, 2023 $ 5,597,200 ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) |
SHAREHOLDERS_ EQUITY
SHAREHOLDERS’ EQUITY | 9 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
SHAREHOLDERS’ EQUITY | NOTE 12. SHAREHOLDERS’ EQUITY 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, with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which Lincoln Park has committed to purchase up to $ 25.0 0.001 The Company did not issue any shares of its Common Stock pursuant to the 2020 LPC Purchase Agreement during the three and nine months ended December 31, 2023 and 2022. In addition, there were no shares issued to Lincoln Park as additional commitment shares, pursuant to the 2020 LPC Purchase Agreement. The 2020 LPC Purchase Agreement expired on August 1, 2023. Summary of Common Stock Activity On November 22, 2023, the Company issued 1,642,971 shares of Common Stock in payment of director fees to be paid via the issuance of common stock, with such shares having an aggregate value on the date of original accrual of $ 60,000 0.1533 per share. The aggregate value of the shares on the date of their issuance was $ 251,867 . On December 29, 2023, the Company issued 2,223,147 shares of Common Stock in payment of consultant fees to be paid via the issuance of common stock, with such shares having an aggregate value on the date of original accrual of $ 153,333 which were owed for periods prior to the current fiscal year and accrued as of the date of share issuance. The price of the Company’s Common Stock on December 29, 2023, was $ 0.14 per share. The aggregate value of the shares on the date of their issuance was $ 311,238 . As of December 31, 2023, there were 1,017,881,199 1,017,781,199 |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 9 Months Ended |
Dec. 31, 2023 | |
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 nine months ended December 31, 2023, the Company accrued director’s fees totaling $ 22,500 22,500 SCHEDULE OF STOCK BASED COMPENSATION Balance of common stock owed at April 1, 2023 $ 60,000 Awarded shares — Change in fair value of stock-based liabilities 191,867 Issuance of common stock on November 22, 2023 (251,867 ) Balance of common stock owed at December 31, 2023 $ — Stock-based Employee/Consultant Compensation Employment contracts with the Company’s President and Chief Executive 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. SCHEDULE OF STOCK BASED COMPENSATION Balance of common stock owed at April 1, 2023 $ 4,278,333 Awarded shares — Change in fair value of stock-based liabilities 4,729,509 Common stock issued (311,238 ) Settlement of non-cash liability (1,761,792 ) Balance of common stock owed at December 31, 2023 $ 6,934,812 During the nine months ended December 31, 2023, the Company accrued no 6,934,812 ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) On November 6, 2023, the Company entered into a Settlement Agreement with a former executive who was terminated on February 7, 2022. The employment agreement with the former executive included annual compensation of $ 250,000 to be paid via the issuance of shares of Common Stock. At the date of the former executive’s termination an aggregate of 14,892,580 shares of Common Stock (the “Deferred Shares”) were due to the former executive, with such number of shares representing an aggregate of $ 1,000,000 250,000 Deferred Shares. The Company is released of any obligation to issue the Deferred Shares and further acknowledges that no Deferred Shares will be issued to or received by the former employee. The price of the Company’s Common Stock on November 6, 2023 was $ 0.1183 1,761,792 On December 29, 2023, the Company issued 2,223,147 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. The fair value of option awards is estimated on the date of grant using the Black-Scholes option-pricing model. The exercise price of each award is generally not less than the per share fair value in effect as of that award date. The determination of fair value using the Black-Scholes model is affected by the Company’s share fair value as well as assumptions regarding a number of complex and subjective variables, including expected price volatility, risk-free interest rate and projected employee share option exercise behaviors. The Company estimates its expected volatility by using a combination of historical share price volatilities of similar companies within our industry. The expected term of the Company’s stock options for employees has been determined utilizing the “simplified” method for awards, since the Company does not have sufficient exercise history to estimate term of its historical option awards. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve. Expected dividend yield is zero based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future. The grant date fair value of option awards is determined using the Black Scholes option-pricing model. The following assumptions were used for the nine months ended December 31, 2023 and year ended March 31, 2023: SCHEDULE OF GRANT DATE FAIR VALUE OF OPTION AWARDS December 31, 2023 March 31, 2023 Term (in years) 10 10 Exercise Price $ 0.08 0.09 $ 0.03 0.04 Dividend Yield — — Expected Volatility 80 81 % 79 80 % Risk Free Rate 4.27 4.69 % 2.99 4.01 % A summary of the activity of Company’s 2014 Stock Option Plan for the nine months ended December 31, 2023 is as follows: SCHEDULE OF STOCK OPTION PLAN Shares Weighted Weighted Average Remaining Contractual Aggregate Underlying Options Average Exercise Price Term (in years) Intrinsic Value Outstanding at March 31, 2023 15,370,000 $ 0.07 7.4 $ — Granted 4,100,000 $ 0.09 10.0 $ — Expired and Forfeited (3,840,000 ) $ 0.07 1.8 $ — Outstanding at December 31, 2023 15,630,000 $ 0.05 9.0 $ 1,429,822 Exercisable at December 31, 2023 343,334 $ 0.19 4.6 $ 6,850 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 December 31, 2023 of $ 0.14 450,470 in unrecognized stock based compensation expense that will be recognized over a weighted average 2.37 year period. On September 5, 2023, options were granted to the Chief Financial Officer pursuant to the 2014 Plan to purchase an aggregate of 3,000,000 0.0898 The options granted will vest one third for each of the next three years upon the anniversary date of the grant and have a ten-year expiration date. ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) On September 19, 2023, options were granted to one employee pursuant to the 2014 Plan to purchase an aggregate of 1,000,000 0.0819 The options granted will vest one third for each of the next three years upon the anniversary date of the grant and have a ten-year expiration date. On October 2, 2023, options were granted to one employee pursuant to the 2014 Plan to purchase an aggregate of 100,000 0.0938 The options granted will vest one third for each of the next three years upon the anniversary date of the grant and have a ten-year expiration date. The weighted-average grant-date fair value of stock options granted during the nine months ended December 31, 2023 under the 2014 Plan was $ 0.0754 |
CONCENTRATIONS AND CREDIT RISK
CONCENTRATIONS AND CREDIT RISK | 9 Months Ended |
Dec. 31, 2023 | |
Risks and Uncertainties [Abstract] | |
CONCENTRATIONS AND CREDIT RISK | NOTE 14. CONCENTRATIONS AND CREDIT RISK Revenues Two customers accounted for approximately 57 30 27 Two customers accounted for approximately 96 85 11 Accounts Receivable Two customers accounted for approximately 77 45 32 One customer accounted for approximately 89 Purchasing Two suppliers accounted for approximately 43 30 13 One supplier accounted for approximately 62 |
SEGMENT RESULTS
SEGMENT RESULTS | 9 Months Ended |
Dec. 31, 2023 | |
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. ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) The following represents selected information for the Company’s reportable segments: SCHEDULE OF SELECTED INFORMATION FOR REPORTABLE SEGMENTS 2023 2022 2023 2022 For the Three Months Ended December 31, For the Nine Months Ended December 31, 2023 2022 2023 2022 Operating Income by Segment ANDA $ 5,637,283 $ 3,828,493 $ 13,073,023 $ 7,947,118 Operating income by Segment $ 5,637,283 $ 3,828,493 $ 13,073,023 $ 7,947,118 The Company notes that there was no The table below reconciles the Company’s operating income by segment to income before income taxes as reported in the Company’s unaudited condensed consolidated statements of operations: SCHEDULE OF OPERATING INCOME BY SEGMENT TO INCOME FROM OPERATIONS 2023 2022 2023 2022 For the Three Months Ended December 31, For the Nine Months Ended December 31, 2023 2022 2023 2022 Operating income by segment $ 5,637,283 $ 3,828,493 $ 13,073,023 $ 7,947,118 Corporate unallocated costs (1,711,275 ) (378,867 ) (4,906,187 ) (1,465,792 ) Interest income 5,249 15 16,085 187 Interest expense and amortization of debt issuance costs (121,628 ) (322,681 ) (371,478 ) (782,221 ) Depreciation and amortization expense (343,537 ) (317,685 ) (999,059 ) (933,531 ) Significant non-cash items 1,711,977 (172,841 ) 1,654,200 (484,894 ) Change in fair value of derivative instruments (2,417,772 ) 372,894 (5,075,489 ) 561,070 Change in fair value of stock-based liabilities (2,854,556 ) — (4,921,376 ) — Income(Loss) before income taxes $ (94,259 ) $ 3,009,328 $ (1,530,281 ) $ 4,841,937 |
RELATED PARTY AGREEMENTS
RELATED PARTY AGREEMENTS | 9 Months Ended |
Dec. 31, 2023 | |
Related Party Agreements | |
RELATED PARTY AGREEMENTS | NOTE 16. RELATED PARTY AGREEMENTS Mikah Pharma, LLC Agreements In May 2020, Praxgen (formerly known as SunGen Pharma LLC), pursuant to an asset purchase agreement, assigned its rights and obligations under the Praxgen Agreement for Amphetamine IR and Amphetamine ER to Mikah Pharma LLC (“Mikah”). The ANDAs for Amphetamine IR and Amphetamine ER are now registered under Elite’s name. Mikah will now be Elite’s partner with respect to Amphetamine IR and ER and will assume all the rights and obligations for these products from Praxgen. Mikah was founded in 2009 by Nasrat Hakim, a related party and the Company’s President, Chief Executive Officer and Chairman of the Board. In June 2021, the Company entered into a development and license agreement with Mikah, pursuant to which Mikah will engage in the research, development, sales and licensing of generic pharmaceutical products. In addition, Mikah will collaborate to develop and commercialize generic products including formulation development, analytical method development, manufacturing, sales and marketing of generic products. Initially two generic products were identified for the parties to develop. As of December 31, 2023, the Company owes an aggregate of $ 3,389,949 to Mikah in accordance with the agreements, with such amount being recorded as an accrued expense on the unaudited condensed consolidated balance sheets. Consultants Agreements Employment contracts with certain consultants include provisions for a portion of the 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. On December 29, 2023, the Company issued 2,223,147 shares of Common Stock in satisfaction of accrued consultant fees owed to one consultant. ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) |
INCOME TAXES
INCOME TAXES | 9 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | NOTE 17. INCOME TAXES The Company’s income tax benefit was $ 18.3 0.05 The Company’s income tax benefit was $ 0.8 0.04 During the nine months ended December 31, 2023, the Company recorded a discrete tax benefit of $ 18.1 million related to the Company’s release of the valuation allowance against deferred tax assets related to U.S. federal net operating losses carryforwards and research and development tax credits, which are expected to be realized based on demonstrated current profitability and its expectations of forecasted income. 21 |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 9 Months Ended |
Dec. 31, 2023 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 18. SUBSEQUENT EVENTS The Company has evaluated subsequent events from the balance sheet date through February 14, 2024, and note the following subsequent events: 140 Ludlow Office Lease The Company entered into a five-year office lease agreement for a portion of a one-story warehouse, located at 140 Ludlow Avenue, Northvale, New Jersey (the 140 Ludlow Ave. lease”) which began on January 22, 2024 and ends on December 31, 2028. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements of the Company are presented in conformity with accounting principles generally accepted in the United States of America (“GAAP”) and pursuant to the rules and regulations of the SEC. The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, Elite Labs. All significant intercompany accounts and transactions have been eliminated in consolidation. Certain information or footnote disclosures normally included in condensed financial statements prepared in accordance with GAAP have been condensed or omitted, pursuant to the rules and regulations of the SEC for interim financial reporting. Accordingly, they do not include all the information and footnotes necessary for a comprehensive presentation of financial position, results of operations, or cash flows. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments, consisting of a normal recurring nature, which are necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the Company’s Form 10-K as filed with the SEC on June 29, 2023. The interim results for the nine months ended December 31, 2023 are not necessarily indicative of the results to be expected for the fiscal year ending March 31, 2024 or for any future periods. |
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 Application (“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. ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) |
Revenue Recognition | Revenue Recognition The Company generates revenue from manufacturing and licensing fees and sales of generic pharmaceuticals bearing the Elite label to pharmaceutical distributors for pharmacies and institutions. 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. Revenues earned from the sale of Elite label products are recorded at their net realizable value which consists of gross amounts invoiced reduced by contractual reductions, including, without limitation, chargebacks, discounts and program rebates, as applicable. 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, at which time the performance obligation is deemed to be completed. 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. ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) 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 December 31, 2023. In accordance with ASC 606-10-55-65, royalties are recognized when the subsequent sale of the customer’s products occurs. c) Sale of product under the Elite label The Company began direct sales of products under the Company’s own label on April 1, 2023. License agreements will remain in place for select products. With this transition, however, a large portion of the manufacturing and license fees now reported will be replaced with revenues from sales of Elite labeled pharmaceutical products to distributors for pharmacies and institutions. The Company recognizes revenue when the customer obtains control of the Company’s product based on the contractual shipping terms, at which time the performance obligation is deemed to be completed. The Company is primarily responsible for fulfilling the promise to deliver the product and bears risk of loss while the inventory is in-transit to the purchaser. Revenue is measured as the amount of consideration earned from the sale of Elite labeled pharmaceutical products are recorded at their net realizable value which consists of gross amounts invoiced reduced by contractual reductions, including, without limitation, chargebacks, discounts and program rebates, as applicable. |
Disaggregation of revenue | Disaggregation of revenue In the following table, revenue is disaggregated by type of revenue generated by the Company. The Company recognizes revenue at a point in time for all performance obligations. The table also includes a reconciliation of the disaggregated revenue with the reportable segments: SCHEDULE OF DISAGGREGATION OF REVENUE For the Three Months Ended December 31, For the Nine Months Ended December 31, 2023 2022 2023 2022 NDA: Manufacturing fees $ - $ - $ - $ - Licensing fees $ — $ — $ — $ — Total NDA revenue — — — — ANDA: Manufacturing fees $ 14,791,110 $ 7,798,159 $ 36,208,217 $ 21,312,663 Licensing fees 747,690 1,451,907 2,467,844 4,200,888 Total ANDA revenue 15,538,800 9,250,066 38,676,061 25,513,551 Total revenue $ 15,538,800 $ 9,250,066 $ 38,676,061 $ 25,513,551 Selected information on reportable segments and reconciliation of operating income by segment to income from operations before income taxes are disclosed within Note 15. ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) |
Cash | Cash Cash consists of cash on deposit with banks and money market instruments. The Company places its cash 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 December 31, 2023, and March 31, 2023, the Company had $ 427,999 412,434 |
Accounts Receivable and Allowance for Expected Credit Losses | Accounts Receivable and Allowance for Expected Credit Losses Accounts receivable are comprised of balances due from customers, net of estimated allowances for expected credit losses, and other contractual deductions, including, without limitation, chargebacks, discounts and program rebates. In determining collectability, historical trends are evaluated, and specific customer issues are reviewed on a periodic basis to arrive at appropriate allowances. The allowance for expected credit losses is based on the probability of future collection under the current expected credited loss (“CECL”) impairment model under Accounting Standards Update (“ASU”) 2016-13, Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses on Financial Assets, which was adopted by the Company on April 1, 2023, as discussed below within Recently Adopted Accounting Pronouncements. Under the CECL impairment model, the Company determines its allowance by applying a loss-rate method based on an aging schedule using the Company’s historical loss rate. The Company also considers reasonable and supportable current information in determining its estimated loss rates, such as external forecasts, macroeconomic trends or other factors including customers’ credit risk and historical loss experience. The adequacy of the allowance is evaluated on a regular basis. Account balances are written off after all means of collection are exhausted and the balance is deemed uncollectible. Subsequent recoveries are credited to the allowance. Changes in the allowance are recorded as adjustments to credit losses in the period incurred. Prior to April 1, 2023, trade receivables were presented net of allowance for expected credit losses based on the credit risk of specific clients, past collection history, and management’s evaluation of other risks. Expected credit losses stemming from unbilled receivables expected to be billed between March 31, 2024 and March 31, 2028 include additional risk premiums estimated based on factors such as projected inflation, projected decreases in GDP, and projected unemployment. |
Inventory | Inventory Inventory is recorded at the lower of cost or net realizable value 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. ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) During the year ended March 31, 2023, the Company determined indicators of impairment occurred and recorded impairment expense of $ 292,807 no The following table summarizes the Company’s intangible assets as of and for the periods ended December 31, 2023 and March 31, 2023: SCHEDULE OF INTANGIBLE ASSETS December 31, 2023 Estimated Useful Life Gross Carrying Amount Impairment losses Accumulated Amortization Net Book Value Patent application costs * $ 289,039 $ — $ — $ 289,039 ANDA acquisition costs Indefinite 6,052,189 — — 6,052,189 $ 6,341,228 $ — $ — $ 6,341,228 March 31, 2023 Estimated Useful Life Gross Carrying Amount Impairment losses Accumulated Amortization Net Book Value Patent application costs * $ 465,684 $ (176,645 ) $ — $ 289,039 ANDA acquisition costs Indefinite 6,168,351 (116,162 ) — 6,052,189 $ 6,634,035 $ (292,807 ) $ — $ 6,341,228 |
Research and Development | Research and Development Research and development expenditures are charged to expenses 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. On August 17, 2023, Elite filed a paragraph IV certification with its ANDA to generic Oxycontin and after Elite got acceptance of the ANDA by the FDA on September 19, 2023, Elite sent the patentee and NDA holder a Notice Letter as required under the Hatch-Waxman Act. On November 14, 2023, a patent infringement suit was filed in the District Court of New Jersey by Purdue Pharma. Elite obtained agreement with Purdue to stay the litigation for six months. Elite’s launch of a generic Oxycontin will depend on the approval by the FDA and the outcome of various litigations involving Purdue or the expiry of the patents listed on the Orange Book. As of December 31, 2023, the results of such proceedings cannot be predicted with certainty, but the Company does not anticipate that the final outcome, if any, arising out of any such matters will have a material adverse effect on its business, financial condition or results of operations. |
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 December 31, 2023, a summary of the tax years that remain subject to examination in our major tax jurisdictions are: United States – Federal, 2016 and forward. The Company did not record unrecognized tax positions for the nine months ended December 31, 2023. |
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 ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) |
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. The Company records earned but unissued stock-based compensation in accrued expenses. |
Sale of ANDA | Sale of ANDA During the quarter ended December 31, 2022, the Company entered into an agreement with Pyros Pharmaceuticals, Inc. (“Pyros”) pursuant to which the Company sold to Pyros its rights in and to the Company’s approved abbreviated new drug applications (ANDAs) for its generic Sabril drug (the “Sabril Product”). The Company sold its rights to Pyros for $ 1,000,000 In conjunction with the sale of its Sabril Product to Pyros, the Company executed a Manufacturing and Supply Agreement (the “Pyros Agreement”) with Pyros. Under the terms of the Pyros Agreement, the Company will receive an agreed-upon price per drug for the manufacturing and packaging of Sabril over a term of three years. Revenue per the Pyros Agreement will be recognized as control of the manufactured and supplied drugs is transferred to Pyros (at the time of delivery). |
Earnings Per Share Attributable to Common Shareholders’ | Earnings Per Share Attributable to Common Shareholders’ The Company follows ASC 260, Earnings Per Share As the average market price of Common Stock for the three and nine months ended December 31, 2023 and 2022 did not exceed the exercise price of th he potential dilutio into 79,008,661 ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) The following is the computation of earnings per share applicable to common shareholders for the periods indicated: SCHEDULE OF EARNINGS (LOSS) PER SHARE APPLICABLE TO COMMON SHAREHOLDERS For the Three Months Ended December 31, For the Nine Months Ended December 31, 2023 2022 2023 2022 Numerator Net income - basic $ 706,354 $ 2,970,078 $ 16,782,764 $ 4,791,100 Effect of dilutive instrument on net income — 372,894 — 561,070 Net income - diluted $ 706,354 $ 3,342,972 $ 16,782,764 $ 5,352,170 Denominator Weighted average shares of Common Stock outstanding - basic 1,014,768,071 1,013,915,081 1,014,265,162 1,012,480,115 Dilutive effect of stock options and convertible securities 9,680,374 — 5,246,651 — Weighted average shares of Common Stock outstanding - diluted 1,024,448,445 1,013,915,081 1,019,511,813 1,012,480,115 Net income per share Basic $ 0.00 $ 0.00 $ 0.02 $ 0.00 Diluted $ 0.00 $ 0.00 $ 0.02 $ 0.01 |
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. ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) 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: SCHEDULE OF LIABILITIES MEASURED AT FAIR VALUE ON A RECURRING BASIS Fair Value Measurement Amount at Fair Value Level 1 Level 2 Level 3 Balance as of April 1, 2023 $ 521,711 $ — $ — $ 521,711 Change in fair value of derivative financial instruments - warrants 5,075,489 — — 5,075,489 Balance as of December 31, 2023 $ 5,597,200 $ — $ — $ 5,597,200 Fair Value Measurement Amount at Fair Value Level 1 Level 2 Level 3 Balance as of April 1, 2022 $ 936,837 $ — $ — $ 936,837 Change in fair value of derivative financial instruments - warrants (561,070 ) — — (561,070 ) Balance as of December 31, 2022 $ 375,767 $ — $ — $ 375,767 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. |
Financial Instruments — Credit Losses (ASU 2016-13) | Financial Instruments — Credit Losses (ASU 2016-13) In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (“CECL”). The amendments in this update introduce a new accounting model to measure credit losses for financial assets measured at amortized cost. The FASB has also issued additional ASUs to clarify the scope and provide additional guidance for ASU 2016-13. Credit losses for financial assets measured at amortized cost should be determined based on the total current expected credit losses over the life of the financial asset or group of financial assets. In effect, the financial asset or group of financial assets should be presented at the net amount expected to be collected. Credit losses will no longer be recorded under the current incurred loss model for financial assets measured at amortized cost. The amendments also modify the accounting for available-for-sale debt securities whereby credit losses will be recorded through an allowance for credit losses rather than a write-down to the security’s cost basis, which allows for reversals of credit losses when estimated credit losses decline. Credit losses for available-for-sale debt securities should be measured in a manner similar to current GAAP. The amendments were effective on April 1, 2023 for the Company, and must be applied using a modified retrospective approach with a cumulative-effect adjustment through retained earnings as of the beginning of the fiscal year upon adoption as required. While the standard modifies the measurement of the allowance for credit losses, it does not alter the credit risk of our trade or unbilled receivables. The impact of applying the CECL methodology upon adoption effective on April 1, 2023 was immaterial to the Company’s consolidated financial statements. The Company’s quantitative allowance for credit loss estimates under CECL was determined using the loss rate method, which is impacted by certain forecasted economic factors. In addition to the Company’s quantitative allowance for credit losses, the Company also incorporates qualitative adjustments that may relate to unique risks, changes in current economic conditions that may not be reflected in quantitatively derived results, or other relevant factors to further inform the Company’s estimate of the allowance for credit losses. ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) Additionally, due to the expansion of the time horizon over which the Company is required to estimate future credit losses, the Company may experience increased volatility in its future provisions for credit losses. Factors that could contribute to such volatility include, but are not limited to, changes in the composition and credit quality of customer base, economic conditions and forecasts, the allowance for credit loss models that are used, the data that is included in the models, the associated qualitative allowance framework, and the Company’s estimation techniques. The Company has had no recordable write offs for bad debts or uncollectible invoiced amounts during the for the nine months ended December 31, 2023 or the prior twelve months ended March 31, 2023. In applying the CECL methodology, the Company recorded an estimated allowance of $ 194,600 |
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 Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements Management has evaluated 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_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 9 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
SCHEDULE OF DISAGGREGATION OF REVENUE | In the following table, revenue is disaggregated by type of revenue generated by the Company. The Company recognizes revenue at a point in time for all performance obligations. The table also includes a reconciliation of the disaggregated revenue with the reportable segments: SCHEDULE OF DISAGGREGATION OF REVENUE For the Three Months Ended December 31, For the Nine Months Ended December 31, 2023 2022 2023 2022 NDA: Manufacturing fees $ - $ - $ - $ - Licensing fees $ — $ — $ — $ — Total NDA revenue — — — — ANDA: Manufacturing fees $ 14,791,110 $ 7,798,159 $ 36,208,217 $ 21,312,663 Licensing fees 747,690 1,451,907 2,467,844 4,200,888 Total ANDA revenue 15,538,800 9,250,066 38,676,061 25,513,551 Total revenue $ 15,538,800 $ 9,250,066 $ 38,676,061 $ 25,513,551 |
SCHEDULE OF INTANGIBLE ASSETS | The following table summarizes the Company’s intangible assets as of and for the periods ended December 31, 2023 and March 31, 2023: SCHEDULE OF INTANGIBLE ASSETS December 31, 2023 Estimated Useful Life Gross Carrying Amount Impairment losses Accumulated Amortization Net Book Value Patent application costs * $ 289,039 $ — $ — $ 289,039 ANDA acquisition costs Indefinite 6,052,189 — — 6,052,189 $ 6,341,228 $ — $ — $ 6,341,228 March 31, 2023 Estimated Useful Life Gross Carrying Amount Impairment losses Accumulated Amortization Net Book Value Patent application costs * $ 465,684 $ (176,645 ) $ — $ 289,039 ANDA acquisition costs Indefinite 6,168,351 (116,162 ) — 6,052,189 $ 6,634,035 $ (292,807 ) $ — $ 6,341,228 |
SCHEDULE OF EARNINGS (LOSS) PER SHARE APPLICABLE TO COMMON SHAREHOLDERS | The following is the computation of earnings per share applicable to common shareholders for the periods indicated: SCHEDULE OF EARNINGS (LOSS) PER SHARE APPLICABLE TO COMMON SHAREHOLDERS For the Three Months Ended December 31, For the Nine Months Ended December 31, 2023 2022 2023 2022 Numerator Net income - basic $ 706,354 $ 2,970,078 $ 16,782,764 $ 4,791,100 Effect of dilutive instrument on net income — 372,894 — 561,070 Net income - diluted $ 706,354 $ 3,342,972 $ 16,782,764 $ 5,352,170 Denominator Weighted average shares of Common Stock outstanding - basic 1,014,768,071 1,013,915,081 1,014,265,162 1,012,480,115 Dilutive effect of stock options and convertible securities 9,680,374 — 5,246,651 — Weighted average shares of Common Stock outstanding - diluted 1,024,448,445 1,013,915,081 1,019,511,813 1,012,480,115 Net income per share Basic $ 0.00 $ 0.00 $ 0.02 $ 0.00 Diluted $ 0.00 $ 0.00 $ 0.02 $ 0.01 |
SCHEDULE OF LIABILITIES MEASURED AT FAIR VALUE 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: SCHEDULE OF LIABILITIES MEASURED AT FAIR VALUE ON A RECURRING BASIS Fair Value Measurement Amount at Fair Value Level 1 Level 2 Level 3 Balance as of April 1, 2023 $ 521,711 $ — $ — $ 521,711 Change in fair value of derivative financial instruments - warrants 5,075,489 — — 5,075,489 Balance as of December 31, 2023 $ 5,597,200 $ — $ — $ 5,597,200 Fair Value Measurement Amount at Fair Value Level 1 Level 2 Level 3 Balance as of April 1, 2022 $ 936,837 $ — $ — $ 936,837 Change in fair value of derivative financial instruments - warrants (561,070 ) — — (561,070 ) Balance as of December 31, 2022 $ 375,767 $ — $ — $ 375,767 |
INVENTORY (Tables)
INVENTORY (Tables) | 9 Months Ended |
Dec. 31, 2023 | |
Inventory Disclosure [Abstract] | |
SCHEDULE OF INVENTORY | Inventory consisted of the following: SCHEDULE OF INVENTORY December 31, 2023 March 31, 2023 Finished goods $ 5,544,848 $ 2,352,330 Work-in-progress 1,247,307 1,791,311 Raw materials 7,532,886 5,407,075 Inventory $ 14,325,041 $ 9,550,716 |
PROPERTY AND EQUIPMENT, NET (Ta
PROPERTY AND EQUIPMENT, NET (Tables) | 9 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
SCHEDULE OF PROPERTY AND EQUIPMENT | Property and equipment consisted of the following: SCHEDULE OF PROPERTY AND EQUIPMENT December 31, 2023 March 31, 2023 Land, building and improvements $ 10,269,297 $ 10,768,181 Laboratory, manufacturing, warehouse and transportation equipment 14,518,570 13,364,512 Office equipment and software 373,601 395,563 Furniture and fixtures 512,032 484,237 Property and equipment, gross 25,673,500 25,012,493 Less: Accumulated depreciation (15,578,471 ) (14,586,335 ) Property and equipment, net $ 10,095,029 $ 10,426,158 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 9 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
SUMMARY OF ACCRUED EXPENSES | As of December 31, 2023 and March 31, 2023, the Company’s accrued expenses consisted of the following: SUMMARY OF ACCRUED EXPENSES December 31, 2023 March 31, 2023 Salaries and fees payable in Common Stock inclusive of the change in fair value of Common stock underlying such liabilities $ 6,934,812 $ 4,125,000 Income tax — 414,989 Co-development profit split 3,389,949 — Consultant contract fees 10,000 193,333 Audit fees 125,000 125,000 Director dues 22,500 70,000 Legal and professional expense 75,000 — Employee bonuses 712,384 — Other accrued expenses 615,000 119,404 Total accrued expenses $ 11,884,645 $ 5,047,726 |
NJEDA BONDS (Tables)
NJEDA BONDS (Tables) | 9 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
SCHEDULE OF BONDS PAYABLE LIABILITY | The following tables summarize the Company’s bonds payable liability: SCHEDULE OF BONDS PAYABLE LIABILITY December 31, 2023 March 31, 2023 Gross bonds payable NJEDA Bonds - Series A Notes $ 1,120,000 $ 1,245,000 Less: Current portion of bonds payable (prior to deduction of bond offering costs) (130,000 ) (125,000 ) Long-term portion of bonds payable (prior to deduction of bond offering costs) $ 990,000 $ 1,120,000 Bond offering costs $ 354,454 $ 354,454 Less: Accumulated amortization (259,930 ) (249,294 ) Bond offering costs, net $ 94,524 $ 105,160 Current portion of bonds payable - net of bond offering costs Current portions of bonds payable $ 130,000 $ 125,000 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 $ 115,822 $ 110,822 Long term portion of bonds payable - net of bond offering costs Long term portion of bonds payable $ 990,000 $ 1,120,000 Less: Bond offering costs to be amortized subsequent to the next 12 months (80,346 ) (90,982 ) Long term portion of bonds payable, net of bond offering costs $ 909,654 $ 1,029,018 |
SCHEDULE OF MATURITIES OF BONDS | Maturities of bonds for the next five years, exclusive of the nine months ended December 31, 2023 are as follows: SCHEDULE OF MATURITIES OF BONDS Years ending March 31, Amount 2024 $ — 2025 130,000 2026 140,000 2027 150,000 2028 160,000 Thereafter 540,000 Total $ 1,120,000 |
LOANS PAYABLE (Tables)
LOANS PAYABLE (Tables) | 9 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
SCHEDULE OF LOANS PAYABLE | Loans payable consisted of the following: SCHEDULE OF LOANS PAYABLE December 31, 2023 March 31, 2023 Mortgage loan payable 4.75 $ 2,438,958 $ 2,472,923 Equipment and insurance financing loans payable, between 7.10 12.02 158,726 259,611 Less: Current portion of loans payable (190,607 ) (200,032 ) Long-term portion of loans payable $ 2,407,077 $ 2,532,502 |
SCHEDULE OF LOAN PRINCIPAL PAYMENTS | Loan principal payments for the next five years are as follows: SCHEDULE OF LOAN PRINCIPAL PAYMENTS Future principal balances Years ending March 31, Amount 2024 (excluding the nine months ended December 31, 2023) $ 44,535 2025 186,657 2026 120,748 2027 92,773 2028 94,433 2029 and thereafter 2,058,538 Total remaining principal balance $ 2,597,684 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 9 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
SCHEDULE OF LEASE ASSETS AND LIABILITIES | Lease assets and liabilities are classified as follows on the condensed consolidated balance sheet: SCHEDULE OF LEASE ASSETS AND LIABILITIES Lease Classification December 31, 2023 Assets Finance Finance lease – right-of-use asset $ 408,428 Operating Operating lease – right-of-use asset 26,231 Total leased assets $ 434,659 Liabilities Current Finance Lease obligation – finance lease $ 37,444 Operating Lease obligation – operating lease 26,231 Long-term Finance Lease obligation – finance lease, net of current portion 200,939 Operating Lease obligation – operating lease, net of current portion — Total lease liabilities $ 264,614 |
SCHEDULE OF FUTURE MINIMUM RENTAL PAYMENTS | The table below shows the future minimum rental payments, exclusive of taxes, insurance and other costs, under the Pompano Office Lease and Waters Equipment Lease: SCHEDULE OF FUTURE MINIMUM RENTAL PAYMENTS Years ending March 31, Operating Lease Amount Financing Lease Amount Total 2024 (excluding the nine months ended December 31, 2023) $ 8,087 $ 16,286 $ 24,373 2025 18,870 65,145 84,015 2026 — 65,145 65,145 2027 — 65,145 65,145 2028 — 65,145 65,145 Thereafter — 43,429 43,429 Less: interest (727 ) (81,911 ) (82,638 ) Present value of lease payments $ 26,230 $ 238,384 $ 264,614 |
SCHEDULE OF WEIGHTED -AVERAGE REMAINING TERM AND THE WEIGHTED-AVERAGE DISCOUNT RATE | The weighted-average remaining lease term and the weighted-average discount rate of our leases were as follows: SCHEDULE OF WEIGHTED -AVERAGE REMAINING TERM AND THE WEIGHTED-AVERAGE DISCOUNT RATE Lease Term and Discount Rate December 31, 2023 Remaining lease term (years) Operating leases 0.8 Finance leases 4.9 Discount rate Operating leases 6.0 % Finance leases 12.5 % |
DERIVATIVE FINANCIAL INSTRUME_2
DERIVATIVE FINANCIAL INSTRUMENTS – WARRANTS (Tables) | 9 Months Ended |
Dec. 31, 2023 | |
Reclassification Adjustment out of Accumulated Other Comprehensive Income on Derivatives [Line Items] | |
SCHEDULE OF CHANGES IN WARRANTS MEASURED AT FAIR VALUE ON A RECURRING BASIS | The changes in warrants (Level 3 financial instruments) measured at fair value on a recurring basis for the nine months ended December 31, 2023 were as follows: SCHEDULE OF CHANGES IN WARRANTS MEASURED AT FAIR VALUE ON A RECURRING BASIS Balance at March 31, 2023 $ 521,711 Change in fair value of derivative financial instruments - warrants 5,075,489 Balance at December 31, 2023 $ 5,597,200 |
Warrant [Member] | |
Reclassification Adjustment out of Accumulated Other Comprehensive Income on Derivatives [Line Items] | |
SCHEDULE OF FAIR VALUE OF WARRANTS ISSUED | SCHEDULE OF FAIR VALUE OF WARRANTS ISSUED December 31, 2023 March 31, 2023 Fair value of the Company’s Common Stock $ 0.1393 $ 0.0290 Volatility 73.50 % 74.37 % Initial exercise price $ 0.1521 $ 0.1521 Warrant term (in years) 3.3 4.1 Risk free rate 4.01 % 3.55 % |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 9 Months Ended |
Dec. 31, 2023 | |
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items] | |
SCHEDULE OF STOCK BASED COMPENSATION | SCHEDULE OF STOCK BASED COMPENSATION Balance of common stock owed at April 1, 2023 $ 4,278,333 Awarded shares — Change in fair value of stock-based liabilities 4,729,509 Common stock issued (311,238 ) Settlement of non-cash liability (1,761,792 ) Balance of common stock owed at December 31, 2023 $ 6,934,812 |
SCHEDULE OF GRANT DATE FAIR VALUE OF OPTION AWARDS | The grant date fair value of option awards is determined using the Black Scholes option-pricing model. The following assumptions were used for the nine months ended December 31, 2023 and year ended March 31, 2023: SCHEDULE OF GRANT DATE FAIR VALUE OF OPTION AWARDS December 31, 2023 March 31, 2023 Term (in years) 10 10 Exercise Price $ 0.08 0.09 $ 0.03 0.04 Dividend Yield — — Expected Volatility 80 81 % 79 80 % Risk Free Rate 4.27 4.69 % 2.99 4.01 % |
SCHEDULE OF STOCK OPTION PLAN | A summary of the activity of Company’s 2014 Stock Option Plan for the nine months ended December 31, 2023 is as follows: SCHEDULE OF STOCK OPTION PLAN Shares Weighted Weighted Average Remaining Contractual Aggregate Underlying Options Average Exercise Price Term (in years) Intrinsic Value Outstanding at March 31, 2023 15,370,000 $ 0.07 7.4 $ — Granted 4,100,000 $ 0.09 10.0 $ — Expired and Forfeited (3,840,000 ) $ 0.07 1.8 $ — Outstanding at December 31, 2023 15,630,000 $ 0.05 9.0 $ 1,429,822 Exercisable at December 31, 2023 343,334 $ 0.19 4.6 $ 6,850 |
Director [Member] | |
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items] | |
SCHEDULE OF STOCK BASED COMPENSATION | SCHEDULE OF STOCK BASED COMPENSATION Balance of common stock owed at April 1, 2023 $ 60,000 Awarded shares — Change in fair value of stock-based liabilities 191,867 Issuance of common stock on November 22, 2023 (251,867 ) Balance of common stock owed at December 31, 2023 $ — |
SEGMENT RESULTS (Tables)
SEGMENT RESULTS (Tables) | 9 Months Ended |
Dec. 31, 2023 | |
Segment Reporting [Abstract] | |
SCHEDULE OF SELECTED INFORMATION FOR REPORTABLE SEGMENTS | The following represents selected information for the Company’s reportable segments: SCHEDULE OF SELECTED INFORMATION FOR REPORTABLE SEGMENTS 2023 2022 2023 2022 For the Three Months Ended December 31, For the Nine Months Ended December 31, 2023 2022 2023 2022 Operating Income by Segment ANDA $ 5,637,283 $ 3,828,493 $ 13,073,023 $ 7,947,118 Operating income by Segment $ 5,637,283 $ 3,828,493 $ 13,073,023 $ 7,947,118 |
SCHEDULE OF OPERATING INCOME BY SEGMENT TO INCOME FROM OPERATIONS | The table below reconciles the Company’s operating income by segment to income before income taxes as reported in the Company’s unaudited condensed consolidated statements of operations: SCHEDULE OF OPERATING INCOME BY SEGMENT TO INCOME FROM OPERATIONS 2023 2022 2023 2022 For the Three Months Ended December 31, For the Nine Months Ended December 31, 2023 2022 2023 2022 Operating income by segment $ 5,637,283 $ 3,828,493 $ 13,073,023 $ 7,947,118 Corporate unallocated costs (1,711,275 ) (378,867 ) (4,906,187 ) (1,465,792 ) Interest income 5,249 15 16,085 187 Interest expense and amortization of debt issuance costs (121,628 ) (322,681 ) (371,478 ) (782,221 ) Depreciation and amortization expense (343,537 ) (317,685 ) (999,059 ) (933,531 ) Significant non-cash items 1,711,977 (172,841 ) 1,654,200 (484,894 ) Change in fair value of derivative instruments (2,417,772 ) 372,894 (5,075,489 ) 561,070 Change in fair value of stock-based liabilities (2,854,556 ) — (4,921,376 ) — Income(Loss) before income taxes $ (94,259 ) $ 3,009,328 $ (1,530,281 ) $ 4,841,937 |
SCHEDULE OF DISAGGREGATION OF R
SCHEDULE OF DISAGGREGATION OF REVENUE (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Product Information [Line Items] | ||||
Total revenue | $ 15,538,800 | $ 9,250,066 | $ 38,676,061 | $ 25,513,551 |
New Drug Applications [Member] | ||||
Product Information [Line Items] | ||||
Total revenue | ||||
New Drug Applications [Member] | Manufacturing [Member] | ||||
Product Information [Line Items] | ||||
Total revenue | ||||
New Drug Applications [Member] | Licensing [Member] | ||||
Product Information [Line Items] | ||||
Total revenue | ||||
Abbreviated New Drug Applications [Member] | ||||
Product Information [Line Items] | ||||
Total revenue | 15,538,800 | 9,250,066 | 38,676,061 | 25,513,551 |
Abbreviated New Drug Applications [Member] | Manufacturing [Member] | ||||
Product Information [Line Items] | ||||
Total revenue | 14,791,110 | 7,798,159 | 36,208,217 | 21,312,663 |
Abbreviated New Drug Applications [Member] | Licensing [Member] | ||||
Product Information [Line Items] | ||||
Total revenue | $ 747,690 | $ 1,451,907 | $ 2,467,844 | $ 4,200,888 |
SCHEDULE OF INTANGIBLE ASSETS (
SCHEDULE OF INTANGIBLE ASSETS (Details) - USD ($) | 9 Months Ended | 12 Months Ended |
Dec. 31, 2023 | Mar. 31, 2023 | |
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | $ 6,341,228 | $ 6,634,035 |
Reductions | 0 | 292,807 |
Accumulated Amortization | 0 | 0 |
Net Book Value | 6,341,228 | 6,341,228 |
Reductions | 0 | (292,807) |
Patent Application Costs [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | 289,039 | 465,684 |
Reductions | 0 | 176,645 |
Accumulated Amortization | ||
Net Book Value | 289,039 | 289,039 |
Reductions | 0 | (176,645) |
ANDA Acquisition Costs [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | 6,052,189 | 6,168,351 |
Reductions | 0 | 116,162 |
Accumulated Amortization | ||
Net Book Value | $ 6,052,189 | $ 6,052,189 |
Estimated Useful Life | Indefinite | Indefinite |
Reductions | $ 0 | $ (116,162) |
SCHEDULE OF EARNINGS (LOSS) PER
SCHEDULE OF EARNINGS (LOSS) PER SHARE APPLICABLE TO COMMON SHAREHOLDERS (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Accounting Policies [Abstract] | ||||
Net income - basic | $ 706,354 | $ 2,970,078 | $ 16,782,764 | $ 4,791,100 |
Effect of dilutive instrument on net income | 372,894 | 561,070 | ||
Net income - diluted | $ 706,354 | $ 3,342,972 | $ 16,782,764 | $ 5,352,170 |
Weighted average shares of Common Stock outstanding - basic | 1,014,768,071 | 1,013,915,081 | 1,014,265,162 | 1,012,480,115 |
Dilutive effect of stock options and convertible securities | $ 9,680,374 | $ 5,246,651 | ||
Weighted average shares of Common Stock outstanding - diluted | 1,024,448,445 | 1,013,915,081 | 1,019,511,813 | 1,012,480,115 |
Basic | $ 0 | $ 0 | $ 0.02 | $ 0 |
Diluted | $ 0 | $ 0 | $ 0.02 | $ 0.01 |
SCHEDULE OF LIABILITIES MEASURE
SCHEDULE OF LIABILITIES MEASURED AT FAIR VALUE ON A RECURRING BASIS (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Platform Operator, Crypto-Asset [Line Items] | ||||
Derivative liabilities, beginning balance | $ 521,711 | $ 936,837 | ||
Change in fair value of derivative instruments | $ 2,417,772 | $ (372,894) | 5,075,489 | (561,070) |
Derivative liabilities, ending balance | 5,597,200 | 375,767 | 5,597,200 | 375,767 |
Fair Value, Inputs, Level 1 [Member] | ||||
Platform Operator, Crypto-Asset [Line Items] | ||||
Derivative liabilities, beginning balance | ||||
Change in fair value of derivative instruments | ||||
Derivative liabilities, ending balance | ||||
Fair Value, Inputs, Level 2 [Member] | ||||
Platform Operator, Crypto-Asset [Line Items] | ||||
Derivative liabilities, beginning balance | ||||
Change in fair value of derivative instruments | ||||
Derivative liabilities, ending balance | ||||
Fair Value, Inputs, Level 3 [Member] | ||||
Platform Operator, Crypto-Asset [Line Items] | ||||
Derivative liabilities, beginning balance | 521,711 | 936,837 | ||
Change in fair value of derivative instruments | 5,075,489 | (561,070) | ||
Derivative liabilities, ending balance | $ 5,597,200 | $ 375,767 | $ 5,597,200 | $ 375,767 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | Mar. 31, 2023 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||
Restricted cash | $ 427,999 | $ 427,999 | $ 412,434 | ||
Impairment expense | $ 0 | 292,807 | |||
Description of tax benefits | These tax benefits are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate resolution | ||||
Gain loss on disposition of assets | $ 1,000,000 | $ 1,000,000 | 1,000,000 | ||
Estimated allowance | $ 194,600 | $ 194,600 | $ 0 | ||
Common Stock [Member] | |||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||
Conversion of warrants into stock | 79,008,661 | 79,008,661 | 79,008,661 | 79,008,661 |
SCHEDULE OF INVENTORY (Details)
SCHEDULE OF INVENTORY (Details) - USD ($) | Dec. 31, 2023 | Mar. 31, 2023 |
Inventory Disclosure [Abstract] | ||
Finished goods | $ 5,544,848 | $ 2,352,330 |
Work-in-progress | 1,247,307 | 1,791,311 |
Raw materials | 7,532,886 | 5,407,075 |
Inventory | $ 14,325,041 | $ 9,550,716 |
SCHEDULE OF PROPERTY AND EQUIPM
SCHEDULE OF PROPERTY AND EQUIPMENT (Details) - USD ($) | Dec. 31, 2023 | Mar. 31, 2023 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 25,673,500 | $ 25,012,493 |
Less: Accumulated depreciation | (15,578,471) | (14,586,335) |
Property and equipment, net | 10,095,029 | 10,426,158 |
Land, Buildings and Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 10,269,297 | 10,768,181 |
Laboratory Manufacturing Warehouse and Transportation Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 14,518,570 | 13,364,512 |
Office Equipment and Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 373,601 | 395,563 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 512,032 | $ 484,237 |
PROPERTY AND EQUIPMENT, NET (De
PROPERTY AND EQUIPMENT, NET (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | ||||
Depreciation expense | $ 336,614 | $ 314,610 | $ 992,136 | $ 923,365 |
SUMMARY OF ACCRUED EXPENSES (De
SUMMARY OF ACCRUED EXPENSES (Details) - USD ($) | Dec. 31, 2023 | Mar. 31, 2023 |
Payables and Accruals [Abstract] | ||
Salaries and fees payable in Common Stock inclusive of the change in fair value of Common stock underlying such liabilities | $ 6,934,812 | $ 4,125,000 |
Income tax | 414,989 | |
Co-development profit split | 3,389,949 | |
Consultant contract fees | 10,000 | 193,333 |
Audit fees | 125,000 | 125,000 |
Director dues | 22,500 | 70,000 |
Legal and professional expense | 75,000 | |
Employee bonuses | 712,384 | |
Other accrued expenses | 615,000 | 119,404 |
Total accrued expenses | $ 11,884,645 | $ 5,047,726 |
SCHEDULE OF BONDS PAYABLE LIABI
SCHEDULE OF BONDS PAYABLE LIABILITY (Details) - USD ($) | Dec. 31, 2023 | Mar. 31, 2023 |
Njeda Bonds Series A Notes [Member] | ||
Debt Instrument [Line Items] | ||
NJEDA Bonds - Series A Notes | $ 1,120,000 | $ 1,245,000 |
Less: Current portion of bonds payable (prior to deduction of bond offering costs) | (130,000) | (125,000) |
Long term portion of bonds payable | 990,000 | 1,120,000 |
Bond offering costs | 354,454 | 354,454 |
Less: Accumulated amortization | (259,930) | (249,294) |
Bond offering costs, net | 94,524 | 105,160 |
Current portions of bonds payable | 130,000 | 125,000 |
Njeda Bonds Current [Member] | ||
Debt Instrument [Line Items] | ||
Less: Current portion of bonds payable (prior to deduction of bond offering costs) | (130,000) | (125,000) |
Current portions of bonds payable | 130,000 | 125,000 |
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 | 115,822 | 110,822 |
Njeda Bonds Noncurrent [Member] | ||
Debt Instrument [Line Items] | ||
Long term portion of bonds payable | 990,000 | 1,120,000 |
Less: Bond offering costs to be amortized subsequent to the next 12 months | (80,346) | (90,982) |
Long term portion of bonds payable, net of bond offering costs | $ 909,654 | $ 1,029,018 |
SCHEDULE OF MATURITIES OF BONDS
SCHEDULE OF MATURITIES OF BONDS (Details) - NJEDA Bonds [Member] | Dec. 31, 2023 USD ($) |
Debt Instrument [Line Items] | |
2024 | |
2025 | 130,000 |
2026 | 140,000 |
2027 | 150,000 |
2028 | 160,000 |
Thereafter | 540,000 |
Total | $ 1,120,000 |
NJEDA BONDS (Details Narrative)
NJEDA BONDS (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | Mar. 31, 2023 | |
Debt Instrument [Line Items] | |||||
Interest expense | $ 121,628 | $ 322,681 | $ 371,478 | $ 782,221 | |
Njeda Bonds Series A Notes [Member] | |||||
Debt Instrument [Line Items] | |||||
Annual interest rate | 6.50% | ||||
NJEDA Bonds [Member] | |||||
Debt Instrument [Line Items] | |||||
Amortization expense | 3,540 | 3,544 | $ 10,636 | 10,629 | |
Interest payable | 24,267 | 24,267 | $ 6,744 | ||
Interest expense | $ 18,200 | $ 20,231 | $ 57,985 | $ 63,808 |
SCHEDULE OF LOANS PAYABLE (Deta
SCHEDULE OF LOANS PAYABLE (Details) - USD ($) | Dec. 31, 2023 | Mar. 31, 2023 |
Defined Benefit Plan Disclosure [Line Items] | ||
Less: Current portion of loans payable | $ (190,607) | $ (200,032) |
Long-term portion of loans payable | 2,407,077 | 2,532,502 |
Nonrelated Party [Member] | ||
Defined Benefit Plan Disclosure [Line Items] | ||
Mortgage loan payable 4.75% interest and maturing June 2032 | 2,438,958 | 2,472,923 |
Equipment and insurance financing loans payable, between 7.10% and 12.02% interest and maturing between January 2024 and October 2025 | 158,726 | 259,611 |
Less: Current portion of loans payable | (190,607) | (200,032) |
Long-term portion of loans payable | $ 2,407,077 | $ 2,532,502 |
SCHEDULE OF LOANS PAYABLE (De_2
SCHEDULE OF LOANS PAYABLE (Details) (Parenthetical) | Dec. 31, 2023 | Mar. 31, 2023 |
Mortgage Loan [Member] | ||
Debt Instrument [Line Items] | ||
Debt interest rate | 4.75% | 4.75% |
Equipment and Insurance Financing Loan [Member] | Minimum [Member] | ||
Debt Instrument [Line Items] | ||
Debt interest rate | 7.10% | 7.10% |
Equipment and Insurance Financing Loan [Member] | Maximum [Member] | ||
Debt Instrument [Line Items] | ||
Debt interest rate | 12.02% | 12.02% |
SCHEDULE OF LOAN PRINCIPAL PAYM
SCHEDULE OF LOAN PRINCIPAL PAYMENTS (Details) - Loans Payable [Member] | Dec. 31, 2023 USD ($) |
Debt Instrument [Line Items] | |
2024 (excluding the nine months ended December 31, 2023) | $ 44,535 |
2025 | 186,657 |
2026 | 120,748 |
2027 | 92,773 |
2028 | 94,433 |
2029 and thereafter | 2,058,538 |
Total | $ 2,597,684 |
LOANS PAYABLE (Details Narrativ
LOANS PAYABLE (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | ||||||
Jul. 02, 2022 | Apr. 02, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | Jun. 02, 2023 | Mar. 31, 2023 | |
Line of Credit Facility [Line Items] | ||||||||
Interest expense loans payable | $ 30,384 | $ 317,844 | $ 101,478 | $ 579,109 | ||||
Promissory Note [Member] | Board of Directors [Member] | ||||||||
Line of Credit Facility [Line Items] | ||||||||
Debt instrument, interest rate, stated percentage | 9% | |||||||
Note payable | $ 3,000,000 | |||||||
Debt instrument, interest rate, effective percentage | 10% | |||||||
Loan and Security Agreement [Member] | ||||||||
Line of Credit Facility [Line Items] | ||||||||
Principal amount | $ 12,000,000 | |||||||
Debt instrument, interest rate, stated percentage | 9.73% | |||||||
Debt term | 5 years | |||||||
Debt maturity date | May 01, 2027 | |||||||
Debt issuance cost | $ 40,120 | |||||||
Debt instrument, description | The EWB Mortgage Loan contains customary representations, warranties and covenants. These covenants include maintaining a minimum debt coverage ratio of 1.50 to 1.00 tested annually and a minimum trailing 12-month debt coverage ratio of 1.50 to 1.00. As of the date of this filing, the Company was in compliance with each financial covenant | The EWB Loans are secured by a security interest in the personal property of the Company and Elite Labs. The EWB Loan Agreement contains customary representations, warranties and covenants. These covenants include, but are not limited to, maintaining maximum leverage ratios of 3.50 to 1.00, minimum liquidity of $5,000,000, minimum cash of $1,000,000, a fixed charge coverage ratio of 1.25 to 1.00 and restrictions on mergers or sales of assets and debt borrowings | ||||||
Loan and Security Agreement [Member] | Prime Rate [Member] | ||||||||
Line of Credit Facility [Line Items] | ||||||||
Debt instrument, interest rate, stated percentage | 1.73% | |||||||
Loan and Security Agreement [Member] | Revolving Credit Facility [Member] | ||||||||
Line of Credit Facility [Line Items] | ||||||||
Line of credit maximum borrowing capacity | $ 2,000,000 | |||||||
Line of credit, interest rate | 8.87% | |||||||
Line of credit, maturity date | May 01, 2027 | |||||||
Loan and Security Agreement [Member] | Revolving Credit Facility [Member] | Prime Rate [Member] | ||||||||
Line of Credit Facility [Line Items] | ||||||||
Line of credit, interest rate | 0.87% |
RELATED PARTY LOANS (Details Na
RELATED PARTY LOANS (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | |||||
Jul. 02, 2022 | Apr. 02, 2022 | Dec. 31, 2023 | Dec. 31, 2023 | Jun. 30, 2023 | Jun. 02, 2023 | Mar. 31, 2023 | |
EWB Mortgage Loan [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Debt issuance cost | $ 13,251 | $ 13,251 | |||||
Loan and Security Agreement [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Debt term | 5 years | ||||||
Debt issuance cost | $ 40,120 | ||||||
Debt instrument, description | The EWB Mortgage Loan contains customary representations, warranties and covenants. These covenants include maintaining a minimum debt coverage ratio of 1.50 to 1.00 tested annually and a minimum trailing 12-month debt coverage ratio of 1.50 to 1.00. As of the date of this filing, the Company was in compliance with each financial covenant | The EWB Loans are secured by a security interest in the personal property of the Company and Elite Labs. The EWB Loan Agreement contains customary representations, warranties and covenants. These covenants include, but are not limited to, maintaining maximum leverage ratios of 3.50 to 1.00, minimum liquidity of $5,000,000, minimum cash of $1,000,000, a fixed charge coverage ratio of 1.25 to 1.00 and restrictions on mergers or sales of assets and debt borrowings | |||||
East West Bank (EWB) [Member] | Mortgages [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Proceeds from issuance of debt | $ 2,550,000 | ||||||
Debt term | 10 years | ||||||
Interest rate, description | bears interest at a rate of 4.75% fixed for 5 years then adjustable at the Wall Street Journal Prime Rate (“WSJP”) plus 0.5% with floor rate of 4.5% | ||||||
Nasrat Hakim CEO and Chairman [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Promissory Note | $ 3,000,000 | ||||||
Nasrat Hakim CEO and Chairman [Member] | First Year [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Promissory note, interest rate | 9% | 9% | |||||
Nasrat Hakim CEO and Chairman [Member] | Second Year [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Promissory note, interest rate | 10% | 10% | |||||
Hakim Promissory Note [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Interest expense | 675 | $ 2,025 | |||||
Davis Caskey [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Promissory Note | $ 1,000,000 | ||||||
Caskey Promissory Note [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Interest expense | $ 225 | $ 675 |
DEFERRED REVENUE (Details Narra
DEFERRED REVENUE (Details Narrative) - USD ($) | 9 Months Ended | |
Dec. 31, 2023 | Mar. 31, 2023 | |
Deferred revenues | $ 22,222 | $ 32,223 |
Deferred revenues current | 13,333 | 13,333 |
Deferred revenues non current | 8,889 | $ 18,890 |
TAGI Pharma [Member] | ||
Debt Instrument, Unamortized Premium | $ 200,000 | |
Maturity start date | September 2010 | |
Maturity End date | August 2025 |
SCHEDULE OF LEASE ASSETS AND LI
SCHEDULE OF LEASE ASSETS AND LIABILITIES (Details) - USD ($) | Dec. 31, 2023 | Mar. 31, 2023 |
Commitments and Contingencies Disclosure [Abstract] | ||
Finance lease- right-of-use asset | $ 408,428 | |
Operating lease- right-of-use asset | 26,231 | 13,062 |
Total leased assets | 434,659 | |
Lease obligation- finance lease | 37,444 | |
Lease obligation- operating lease | 26,231 | 14,914 |
Lease obligation-finance lease, net of current portion | 200,939 | |
Lease obligation-operating lease, net of current portion | ||
Total lease liabilities | $ 264,614 |
SCHEDULE OF FUTURE MINIMUM RENT
SCHEDULE OF FUTURE MINIMUM RENTAL PAYMENTS (Details) | Dec. 31, 2023 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
Operating Lease Amount 2024 | $ 8,087 |
Financing Lease Amount 2024 | 16,286 |
Total Lease Amount 2024 | 24,373 |
Operating Lease Amount 2025 | 18,870 |
Financing Lease Amount 2025 | 65,145 |
Total Lease Amount 2025 | 84,015 |
Operating Lease Amount 2026 | |
Financing Lease Amount 2026 | 65,145 |
Total Lease Amount 2026 | 65,145 |
Operating Lease Amount 2027 | |
Financing Lease Amount 2027 | 65,145 |
Total Lease Amount 2027 | 65,145 |
Operating Lease Amount 2028 | |
Financing Lease Amount 2028 | 65,145 |
Total Lease Amount 2028 | 65,145 |
Operating Lease Amount Thereafter | |
Financing Lease Amount Thereafter | 43,429 |
Total Lease Amount Thereafter | 43,429 |
Operating Lease Amount Less: interest | (727) |
Financing Lease Amount Less: interest | (81,911) |
Total Lease Amount Less: interest | (82,638) |
Operating Lease Amount Present value of lease payments | 26,230 |
Financing Lease Amount Present value of lease payments | 238,384 |
Total Lease Amount Present value of lease payments | $ 264,614 |
SCHEDULE OF WEIGHTED -AVERAGE R
SCHEDULE OF WEIGHTED -AVERAGE REMAINING TERM AND THE WEIGHTED-AVERAGE DISCOUNT RATE (Details) | Dec. 31, 2023 |
Commitments and Contingencies Disclosure [Abstract] | |
Remaining lease term (years) Operating leases | 9 months 18 days |
Remaining lease term (years) Finance leases | 4 years 10 months 24 days |
Discount rate Operating leases | 6% |
Discount rate Finance leases | 12.50% |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES (Details Narrative) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
Nov. 30, 2023 USD ($) | Oct. 31, 2020 ft² | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Dec. 01, 2023 USD ($) | |
SEC Schedule, 12-28, Real Estate Companies, Investment in Real Estate and Accumulated Depreciation [Line Items] | |||||||
Description of lessee's finance lease | (i) ownership of the underlying asset transfers to the Company by the end of the lease term; (ii) the lease contains an option to purchase the underlying asset that the Company is reasonably expected to exercise; (iii) the lease term is for a major part of the remaining economic life of the underlying asset; (iv) the present value of the sum of lease payments and any residual value guaranteed by the Company equals or exceeds substantially all of the fair value of the underlying asset; or (v) the underlying asset is of a specialized nature that it is expected to have no alternative use to the lessor at the end of the lease term. | ||||||
Rent expense | $ 0 | $ 0 | $ 0 | $ 58,248 | |||
Water Equipment Lease [Member] | |||||||
SEC Schedule, 12-28, Real Estate Companies, Investment in Real Estate and Accumulated Depreciation [Line Items] | |||||||
Finance lease acquisition cost | $ 499,775 | ||||||
Finance lease, terms | The Waters equipment lease has a term of five years, ending on November 29, 2028. | ||||||
Finance lease purchase of asset | $ 1 | ||||||
Pompano Office Lease [Member] | |||||||
SEC Schedule, 12-28, Real Estate Companies, Investment in Real Estate and Accumulated Depreciation [Line Items] | |||||||
Rent expense | $ 7,565 | $ 6,456 | $ 20,603 | $ 19,116 | |||
Pompano Office Lease [Member] | Property Subject to Operating Lease [Member] | |||||||
SEC Schedule, 12-28, Real Estate Companies, Investment in Real Estate and Accumulated Depreciation [Line Items] | |||||||
Area of land | ft² | 1,275 | ||||||
Operating lease, terms | The Pompano Office Lease had a term of three years, ending on October 31, 2023. The Pompano Office Lease was extended for one additional year to October 31, 2024. |
PREFERRED STOCK (Details Narrat
PREFERRED STOCK (Details Narrative) - Series J Convertible Preferred Stock [Member] | Apr. 28, 2017 USD ($) $ / shares shares |
Class of Stock [Line Items] | |
Preferred stock share authorized | 50 |
Preferred stock, shares issued | 0 |
Preferred stock, shares outstanding | 0 |
Convertible preferred stock stated value | $ | $ 1,000,000 |
Convertible preferred stock par value per share | $ / shares | $ 0.01 |
SCHEDULE OF FAIR VALUE OF WARRA
SCHEDULE OF FAIR VALUE OF WARRANTS ISSUED (Details) | Dec. 31, 2023 | Mar. 31, 2023 |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant term (in years) | 3 years 3 months 18 days | 4 years 1 month 6 days |
Measurement Input, Share Price [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants and rights outstanding, measurement input | 0.1393 | 0.0290 |
Measurement Input, Price Volatility [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants and rights outstanding, measurement input | 73.50 | 74.37 |
Measurement Input, Exercise Price [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants and rights outstanding, measurement input | 0.1521 | 0.1521 |
Measurement Input, Risk Free Interest Rate [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants and rights outstanding, measurement input | 4.01 | 3.55 |
SCHEDULE OF CHANGES IN WARRANTS
SCHEDULE OF CHANGES IN WARRANTS MEASURED AT FAIR VALUE ON A RECURRING BASIS (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Platform Operator, Crypto-Asset [Line Items] | ||||
Change in fair value of derivative financial instruments - warrants | $ (2,417,772) | $ 372,894 | $ (5,075,489) | $ 561,070 |
Fair Value, Inputs, Level 3 [Member] | ||||
Platform Operator, Crypto-Asset [Line Items] | ||||
Change in fair value of derivative financial instruments - warrants | (5,075,489) | $ 561,070 | ||
Fair Value, Inputs, Level 3 [Member] | Warrant [Member] | ||||
Platform Operator, Crypto-Asset [Line Items] | ||||
Beginning balance | 521,711 | |||
Change in fair value of derivative financial instruments - warrants | 5,075,489 | |||
Ending balance | $ 5,597,200 | $ 5,597,200 |
DERIVATIVE FINANCIAL INSTRUME_3
DERIVATIVE FINANCIAL INSTRUMENTS – WARRANTS (Details Narrative) - USD ($) | Apr. 28, 2017 | Dec. 31, 2023 | Mar. 31, 2023 |
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items] | |||
Exercise price | $ 0.1521 | $ 0.1521 | |
Series J Warrants [Member] | |||
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items] | |||
Exercise price | $ 0.1521 | ||
Warrant expiration period | 10 years | ||
Nasrat Hakim [Member] | Series J Warrants [Member] | |||
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items] | |||
Fair value of the warrants | $ 6,474,674 | ||
Nasrat Hakim [Member] | Series J Convertible Preferred Stock [Member] | |||
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items] | |||
Warrant shares | 79,008,661 | 79,008,661 | |
Warrant to purchase shares | 79,008,661 | ||
Conversion of stock, shares issued | 158,017,321 | ||
Chief Executive Officer [Member] | Series J Convertible Preferred Stock [Member] | |||
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items] | |||
Shares issued | 24.0344 |
SHAREHOLDERS_ EQUITY (Details N
SHAREHOLDERS’ EQUITY (Details Narrative) - USD ($) | Dec. 29, 2023 | Nov. 22, 2023 | Jul. 08, 2020 | Dec. 31, 2023 | Mar. 31, 2023 |
Restructuring Cost and Reserve [Line Items] | |||||
Common stock, par value per share | $ 0.001 | $ 0.001 | |||
Common Stock in payment of director salaries | 1,642,971 | ||||
Accrual amount | $ 153,333 | $ 60,000 | |||
Share Price | $ 0.14 | $ 0.1533 | |||
[custom:CommonStockValueIssuedInPaymentOfDirectorsSalaries] | $ 251,867 | ||||
[custom:CommonStockIssuedInPaymentOfConsultingFees] | 2,223,147 | ||||
[custom:CommonStockValueIssuedInPaymentOfConsultingFees] | $ 311,238 | ||||
Common stock, shares issued | 1,017,881,199 | 1,014,015,081 | |||
Common stock, shares outstanding | 1,017,781,199 | 1,013,915,081 | |||
Lincoln Park [Member] | |||||
Restructuring Cost and Reserve [Line Items] | |||||
Purchase of common stock, amount | $ 25,000,000 | ||||
Common stock, par value per share | $ 0.001 |
SCHEDULE OF STOCK BASED COMPENS
SCHEDULE OF STOCK BASED COMPENSATION (Details) | 9 Months Ended |
Dec. 31, 2023 USD ($) | |
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items] | |
Beginning balance | $ 4,278,333 |
Awarded shares | |
Change in fair value of stock-based liabilities | 4,729,509 |
Common stock issued | (311,238) |
Settlement of non-cash liability | (1,761,792) |
Ending balance | 6,934,812 |
Director [Member] | |
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items] | |
Balance | 60,000 |
Awarded shares | |
Change in fair value of non-cash liabilities | 191,867 |
Issuance of common stock | (251,867) |
Balance |
SCHEDULE OF GRANT DATE FAIR VAL
SCHEDULE OF GRANT DATE FAIR VALUE OF OPTION AWARDS (Details) - $ / shares | 9 Months Ended | 12 Months Ended |
Dec. 31, 2023 | Mar. 31, 2023 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Term (in years) | 10 years | 10 years |
Dividend Yield | ||
Expected Volatility Minimum | 80% | 79% |
Expected Volatility Maximum | 81% | 80% |
Risk Free Rate Minimum | 4.27% | 2.99% |
Risk Free Rate Maximum | 4.69% | 4.01% |
Minimum [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Exercise Price | $ 0.08 | $ 0.03 |
Maximum [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Exercise Price | $ 0.09 | $ 0.04 |
SCHEDULE OF STOCK OPTION PLAN (
SCHEDULE OF STOCK OPTION PLAN (Details) - USD ($) | 9 Months Ended | 12 Months Ended |
Dec. 31, 2023 | Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | ||
Shares Underlying Options, Outstanding, Beginning Balance | 15,370,000 | |
Weighted Average Exercise Price, Outstanding, Beginning Balance | $ 0.07 | |
Weighted Average Remaining Contractual Term (in years), Outstanding | 9 years | 7 years 4 months 24 days |
Aggregate Intrinsic Value, Outstanding, Beginning Balance | ||
Shares Underlying Options, Granted | 4,100,000 | |
Weighted Average Exercise Price, Granted | $ 0.09 | |
Weighted Average Remaining Contractual Term (in years), Granted | 10 years | |
Shares Underlying Options, Expired, and Forfeited | (3,840,000) | |
Weighted Average Exercise Price, Expired and Forfeited | $ 0.07 | |
Weighted Average Remaining Contractual Term (in years), Expired and Forfeited | 1 year 9 months 18 days | |
Shares Underlying Options, Outstanding, Ending Balance | 15,630,000 | 15,370,000 |
Weighted Average Exercise Price, Outstanding, Ending Balance | $ 0.05 | $ 0.07 |
Aggregate Intrinsic Value, Outstanding, Ending Balance | $ 1,429,822 | |
Shares Underlying Options, Exercisable | 343,334 | |
Weighted Average Exercise Price, Exercisable | $ 0.19 | |
Weighted Average Remaining Contractual Term (in years), Exercisable | 4 years 7 months 6 days | |
Aggregate Intrinsic Value, Outstanding, Exerciseable | $ 6,850 |
STOCK-BASED COMPENSATION (Detai
STOCK-BASED COMPENSATION (Details Narrative) - USD ($) | 9 Months Ended | ||||||
Dec. 29, 2023 | Nov. 06, 2023 | Oct. 02, 2023 | Sep. 19, 2023 | Sep. 05, 2023 | Dec. 31, 2023 | Nov. 22, 2023 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||
Share price | $ 0.14 | $ 0.1533 | |||||
Common Stock in payment of consultant fees | 2,223,147 | ||||||
Price difference between exercise price and quoted price | $ 0.14 | ||||||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount | $ 450,470 | ||||||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition | 2 years 4 months 13 days | ||||||
Shares underlying options, granted | 4,100,000 | ||||||
Weighted average exercise price, granted | $ 0.09 | ||||||
2014 Plan [Member] | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||
Weighted average exercise price, granted | $ 0.0754 | ||||||
Settlement Agreement [Member] | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||
Employee Benefits and Share-Based Compensation | $ 250,000 | ||||||
Deferred Compensation Arrangement with Individual, Shares Issued | 14,892,580 | ||||||
Compensation earned | $ 1,000,000 | ||||||
Share price | $ 0.1183 | ||||||
Aggregate value of number of shares issued | $ 1,761,792 | ||||||
Director [Member] | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||
Accrued director fees | $ 22,500 | ||||||
Cash payments | 22,500 | ||||||
President and Chief Executive Officer and Other Employees [Member] | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||
Accrued salaries | 0 | ||||||
Share based compensation | $ 6,934,812 | ||||||
Chief Financial Officer [Member] | 2014 Plan [Member] | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||
Shares underlying options, granted | 3,000,000 | ||||||
Weighted average exercise price, granted | $ 0.0898 | ||||||
Vesting description | The options granted will vest one third for each of the next three years upon the anniversary date of the grant and have a ten-year expiration date. | ||||||
One Employee [Member] | 2019 Plan [Member] | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||
Shares underlying options, granted | 100,000 | 1,000,000 | |||||
Weighted average exercise price, granted | $ 0.0938 | $ 0.0819 | |||||
Vesting description | The options granted will vest one third for each of the next three years upon the anniversary date of the grant and have a ten-year expiration date. | The options granted will vest one third for each of the next three years upon the anniversary date of the grant and have a ten-year expiration date. |
CONCENTRATIONS AND CREDIT RISK
CONCENTRATIONS AND CREDIT RISK (Details Narrative) | 9 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Customers [Member] | Revenue Benchmark [Member] | Customer Concentration Risk [Member] | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 57% | 96% |
Customers [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 77% | 89% |
Customer One [Member] | Revenue Benchmark [Member] | Customer Concentration Risk [Member] | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 30% | 85% |
Customer One [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 45% | |
Customer Two [Member] | Revenue Benchmark [Member] | Customer Concentration Risk [Member] | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 27% | 11% |
Customer Two [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 32% | |
Suppliers [Member] | Purchases [Member] | Supplier Concentration Risk [Member] | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 43% | 62% |
Supplier One [Member] | Purchases [Member] | Supplier Concentration Risk [Member] | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 30% | |
Supplier Two [Member] | Purchases [Member] | Supplier Concentration Risk [Member] | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 13% |
SCHEDULE OF SELECTED INFORMATIO
SCHEDULE OF SELECTED INFORMATION FOR REPORTABLE SEGMENTS (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Segment Reporting Information [Line Items] | ||||
Operating income by Segment | $ 3,532,656 | $ 1,959,100 | $ 7,060,185 | $ 4,062,901 |
Abbreviated New Drug Applications [Member] | ||||
Segment Reporting Information [Line Items] | ||||
Operating income by Segment | 5,637,283 | 3,828,493 | 13,073,023 | 7,947,118 |
Business Segment [Member] | ||||
Segment Reporting Information [Line Items] | ||||
Operating income by Segment | $ 5,637,283 | $ 3,828,493 | $ 13,073,023 | $ 7,947,118 |
SCHEDULE OF OPERATING INCOME BY
SCHEDULE OF OPERATING INCOME BY SEGMENT TO INCOME FROM OPERATIONS (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Segment Reporting Information [Line Items] | ||||
Operating income by segment | $ 3,532,656 | $ 1,959,100 | $ 7,060,185 | $ 4,062,901 |
Interest income | 5,249 | 15 | 16,085 | 187 |
Depreciation and amortization expense | (343,537) | (317,685) | (999,059) | (933,531) |
(Loss) income before income taxes | (94,259) | 3,009,328 | (1,530,281) | 4,841,937 |
Operating Segments [Member] | ||||
Segment Reporting Information [Line Items] | ||||
Operating income by segment | 5,637,283 | 3,828,493 | 13,073,023 | 7,947,118 |
Corporate unallocated costs | (1,711,275) | (378,867) | (4,906,187) | (1,465,792) |
Interest income | 5,249 | 15 | 16,085 | 187 |
Interest expense and amortization of debt issuance costs | (121,628) | (322,681) | (371,478) | (782,221) |
Depreciation and amortization expense | (343,537) | (317,685) | (999,059) | (933,531) |
Significant non-cash items | 1,711,977 | (172,841) | 1,654,200 | (484,894) |
Change in fair value of derivative instruments | (2,417,772) | 372,894 | (5,075,489) | 561,070 |
Change in fair value of stock-based liabilities | (2,854,556) | (4,921,376) | ||
(Loss) income before income taxes | $ (94,259) | $ 3,009,328 | $ (1,530,281) | $ 4,841,937 |
SEGMENT RESULTS (Details Narrat
SEGMENT RESULTS (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Segment Reporting Information [Line Items] | ||||
NDA | $ 3,532,656 | $ 1,959,100 | $ 7,060,185 | $ 4,062,901 |
New Drug Applications [Member] | ||||
Segment Reporting Information [Line Items] | ||||
NDA | $ 0 | $ 0 | $ 0 | $ 0 |
RELATED PARTY AGREEMENTS (Detai
RELATED PARTY AGREEMENTS (Details Narrative) - USD ($) | 9 Months Ended | |
Dec. 29, 2023 | Dec. 31, 2023 | |
Defined Benefit Plan Disclosure [Line Items] | ||
[custom:CommonStockIssuedInPaymentOfConsultingFees] | 2,223,147 | |
Mikah Pharma LLC [Member] | ||
Defined Benefit Plan Disclosure [Line Items] | ||
Related Party Transaction, Amounts of Transaction | $ 3,389,949 |
INCOME TAXES (Details Narrative
INCOME TAXES (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||||
Income tax benefit | $ 800,613 | $ (39,250) | $ 18,313,045 | $ (50,837) |
Income tax expense | $ (800,613) | $ 39,250 | (18,313,045) | $ 50,837 |
[custom:DiscreteTaxBenefit] | $ 18,100,000 | |||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21% |