Date: 8/14/2025
Form: 10-Q - Quarterly Report
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR
THE QUARTERLY PERIOD ENDED
OR
| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO |
Commission
File Number
(Exact name of Registrant as specified in its Charter)
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s
telephone number, including area code:
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) |
Name of each exchange on which registered | ||
| OTCQB |
Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. X NO ☐
Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files). X NO ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of "large accelerated filer,” "accelerated filer,” "smaller reporting company,” and "emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer | ☐ | Accelerated filer | ☐ |
| X | Smaller reporting company | ||
| Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES ☐ NO
The number of shares outstanding of each of the registrant’s classes of common stock, as of August 14, 2025:
Common Stock - shares
Table of Contents
| i |
PART I - FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
| June 30, 2025 | March 31, 2025 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash | $ | $ | ||||||
| Accounts receivable, net
of allowance for expected credit losses of approximately $ | ||||||||
| Inventory | ||||||||
| Prepaid expenses and other current assets | ||||||||
| Total current assets | ||||||||
| Property and equipment,
net of accumulated depreciation of $ | ||||||||
| Intangible assets | ||||||||
| Finance lease - right-of-use asset | ||||||||
| Operating lease - right-of-use asset | ||||||||
| Deferred income tax asset | ||||||||
| Other assets: | ||||||||
| Restricted cash - debt service for NJEDA bonds | ||||||||
| Security deposits | ||||||||
| Total other assets | ||||||||
| Total assets | $ | $ | ||||||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued expenses | ||||||||
| Deferred revenue | ||||||||
| Bonds payable, current portion, net of bond issuance costs | ||||||||
| Loans payable, current portion | ||||||||
| Related party loans payable (Note 8) | ||||||||
| Lease obligation - finance lease, current portion | ||||||||
| Lease obligation - operating lease, current portion | ||||||||
| Total current liabilities | ||||||||
| Long-term liabilities: | ||||||||
| Bonds payable, net of current portion and bond issuance costs | ||||||||
| Loans payable, net of current portion and loan costs | ||||||||
| Lease obligation - finance lease, net of current portion | ||||||||
| Lease obligation - operating lease, net of current portion | ||||||||
| Derivative financial instruments - warrants | ||||||||
| Total long-term liabilities | ||||||||
| Total liabilities | ||||||||
| Commitments and Contingencies (Note 9) | ||||||||
| Shareholders’ equity: | ||||||||
| Common Stock; par value $; shares authorized; and shares issued as of June 30, 2025 and March 31, 2025, respectively; and shares outstanding as of June 30, 2025 and March 31, 2025, respectively | ||||||||
| Additional paid-in capital | ||||||||
| Treasury stock; shares as of both June 30, 2025 and March 31, 2025, at cost | ( | ) | ( | ) | ||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total shareholders’ equity | ||||||||
| Total liabilities and shareholders’ equity | $ | $ | ||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
| F-1 |
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
| For the Three Months Ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| Revenue: | ||||||||
| Manufacturing fees | $ | $ | ||||||
| Licensing fees | ||||||||
| Total revenue | ||||||||
| Cost of manufacturing | ||||||||
| Gross profit | ||||||||
| Operating expenses: | ||||||||
| Research and development | ||||||||
| General and administrative | ||||||||
| Non-cash compensation through issuance of stock options | ||||||||
| Depreciation and amortization | ||||||||
| Total operating expenses | ||||||||
| Income from operations | ||||||||
| Other (expense) income: | ||||||||
| Change in fair value of derivative financial instruments - warrants | ( | ) | ( | ) | ||||
| Interest expense and amortization of debt issuance costs | ( | ) | ( | ) | ||||
| Interest income | ||||||||
| Other income | ||||||||
| Other expense, net | ( | ) | ( | ) | ||||
| (Loss) income before income taxes | ( | ) | ||||||
| Income tax expense | ( | ) | ( | ) | ||||
| Net (loss) income | $ | ( | ) | $ | ||||
| Basic net (loss) income per share attributable to common shareholders | $ | ( | ) | $ | ||||
| Diluted net (loss) income per share attributable to common shareholders | $ | ( | ) | $ | ||||
| Basic weighted average common stock outstanding | ||||||||
| Diluted weighted average common stock outstanding | ||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
| F-2 |
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY
(UNAUDITED)
| Series J Preferred Stock | Common Stock | Additional Paid-In | Treasury Stock | Accumulated | Total Shareholders’ | |||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Capital | Shares | Amount | Deficit | Equity | ||||||||||||||||||||||||||||
| Balance as of March 31, 2025 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||||||||||||
| Net loss | — | — | — | ( | ) | ( | ) | |||||||||||||||||||||||||||||
| Non-cash compensation through the issuance of employee stock options | — | — | — | |||||||||||||||||||||||||||||||||
| Balance at June 30, 2025 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||||||||||||
| Series J Preferred Stock | Common Stock | Additional Paid-In | Treasury Stock | Accumulated | Total Shareholders’ | |||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Capital | Shares | Amount | Deficit | Equity | ||||||||||||||||||||||||||||
| Balance as of March 31, 2024 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||||||||||||
| Net income | — | — | — | |||||||||||||||||||||||||||||||||
| Non-cash compensation through the issuance of employee stock options | — | — | — | |||||||||||||||||||||||||||||||||
| Balance at June 30, 2024 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||||||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
| F-3 |
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
| For the Three Months Ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net (loss) income | $ | ( | ) | $ | ||||
| Adjustments to reconcile net (loss) income to net cash provided by operating activities: | ||||||||
| Depreciation and amortization | ||||||||
| Provision for losses on accounts receivable | ||||||||
| Amortization of operating leases - right-of-use assets | ||||||||
| Amortization of finance leases - right-of-use assets | ||||||||
| Amortization of debt discount - bonds offering costs | ||||||||
| Loss on asset disposal | ||||||||
| Change in fair value of derivative financial instruments - warrants | ||||||||
| Deferred tax expense | ||||||||
| Non-cash compensation through the issuance of employee stock options | ||||||||
| Change in operating assets and liabilities: | ||||||||
| Accounts receivable | ( | ) | ( | ) | ||||
| Inventory | ( | ) | ( | ) | ||||
| Prepaid expenses and other current assets | ||||||||
| Accounts payable | ( | ) | ||||||
| Accrued expenses | ||||||||
| Deferred revenue | ( | ) | ( | ) | ||||
| Lease obligations - operating leases | ( | ) | ( | ) | ||||
| Net cash provided by operating activities | ||||||||
| CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
| Purchase of property and equipment | ( | ) | ( | ) | ||||
| Purchase of intangible assets | ( | ) | ||||||
| Proceeds from disposition of property and equipment | ||||||||
| Net cash used in investing activities | ( | ) | ( | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Payments of related party loans payable | ( | ) | ||||||
| Payments on principal on finance lease obligations | ( | ) | ( | ) | ||||
| Loan payments | ( | ) | ( | ) | ||||
| Net cash used in financing activities | ( | ) | ( | ) | ||||
| Net change in cash and restricted cash | ||||||||
| Cash and restricted cash, beginning of period | ||||||||
| Cash and restricted cash, end of period | $ | $ | ||||||
| Supplemental disclosure of cash and non-cash transactions: | ||||||||
| Cash paid for interest | $ | $ | ||||||
| Finance directors and officers insurance premium | $ | $ | ||||||
| Reconciliation of cash and restricted cash | ||||||||
| Cash | $ | $ | ||||||
| Restricted cash - debt service for NJEDA bonds | ||||||||
| Total cash and restricted cash shown in statement of cash flows | $ | $ | ||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
| F-4 |
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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 30, 2025. The interim results for the three months ended June 30, 2025 are not necessarily indicative of the results to be expected for the fiscal year ending March 31, 2026 or for any future periods.
The Company’s significant accounting policies and recent accounting standards are summarized in Note 1 of the Company’s consolidated financial statements for the year ended March 31, 2025. There were no significant changes to these accounting policies during the three months ended June 30, 2025.
Use of Estimates
The preparation of the unaudited condensed consolidated financial statements in conformity with GAAP requires management to make certain estimates and assumptions. These estimates and assumptions affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements, as well as reported amounts of revenues and expenses during the reporting period. Such management estimates and assumptions include, but are not limited to, chargeback liabilities related to revenue recognition, standalone selling price for each distinct performance obligation included in customer contracts with multiple performance obligations, warrant derivative liability, valuation of intangible assets, the useful life of property and equipment and identifiable intangible assets, stock-based compensation expense and income taxes. The Company continually evaluates its estimates, which are based on information that is currently available to the Company and on various other assumptions that it believes to be reasonable under the circumstances. Actual results could differ from those estimates.
Segment Information
Financial Accounting Standards Board ("FASB”) Accounting Standards Codification 280 ("ASC 280”), Segment Reporting, establishes standards for reporting information about operating segments. Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated regularly by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance.
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.
| F-5 |
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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. 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. The Company paused further development of NDAs and has not engaged in business activities. Accordingly, during the three months ended June 30, 2025 and 2024, the Company has only engaged in business activities in a single operating segment.
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 unaudited condensed consolidated financial statements. Please see Note 14 for further details.
Revenue Recognition
The Company generates revenue from manufacturing and licensing fees and direct sales 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. 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 ("ASC 606”), the Company recognizes revenue when the customer obtains control of promised goods or services, in an amount that reflects the consideration which is expected to be received in exchange for those goods or services. The Company recognizes revenues following the five-step model prescribed under ASC 606: (i) identify contract(s) with a customer; (ii) identify the performance obligation(s) in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligation(s) in the contract; and (v) recognize revenues when (or as) the Company satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Sales, value add, and other taxes collected on behalf of third parties are excluded from revenue.
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 manufacturing fees related to revenue generated from wholesale customers and from direct sale customers. Wholesalers represent customers that purchase the Company’s products and sell them to end customers such as hospitals, group purchasing organizations, institutions, and pharmacies. Direct sales customers purchase products directly from the Company.
The Company provides for chargebacks to wholesalers for sales to various end-customers to include, but not limited to, hospitals, group purchasing organizations, and pharmacies. Chargebacks represent the difference between the price the wholesaler pays and the price that the end-customer pays for a product. The Company’s estimate for chargebacks is developed based upon management’s assumption of anticipated claims as well as historical information. Chargebacks represent variable consideration within the Company’s contracts and therefore as such, revenue recognized is limited to the amount for which a significant reversal of revenue related to this variable consideration is not probable.
| F-6 |
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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 fulfilling the promise to deliver the product and bears risk of loss while the inventory is in-transit to the purchaser or commercial partner. Revenue is measured as the amount of consideration the Company expects to receive from the sale of its products, including Elite-labeled pharmaceutical products, and is recorded at net realizable value which consists of gross amounts invoiced reduced by contractual reductions, including, without limitation, chargebacks, discounts and program rebates, as applicable.
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.
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 June 30, 2025.
In accordance with ASC 606-10-55-65, royalties are recognized when the subsequent sale of the customer’s products occurs.
| F-7 |
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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. During the three months ended June 30, 2025 and 2024, the Company had paused further development of NDAs and has not engaged in business activities in that segment. Accordingly, during the three months ended June 30, 2025 and 2024, the Company has only engaged in business activities in a single operating segment. The table also includes a reconciliation of the disaggregated revenue with the reportable segments:
| For the Three Months Ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| ANDA: | ||||||||
| Manufacturing fees | $ | $ | ||||||
| Licensing fees | ||||||||
| Total ANDA revenue | $ | $ | ||||||
Selected information on reportable segments and reconciliation of operating income by segment to income from operations before income taxes are disclosed within Note 14.
Restricted Cash
As
of June 30, 2025, and March 31, 2025, the Company had $
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.
Due to temporary differences in the timing of recognition of items included in income for accounting and tax purposes, deferred tax assets or liabilities are recorded to reflect the impact arising from these differences on future tax payments. 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.
The Company operates in multiple tax jurisdictions within the United States. The Company remains subject to examination in all tax jurisdiction until the applicable statutes of limitation expire. As of June 30, 2025, a summary of the tax years that remain subject to examination in our major tax jurisdictions are: United States – Federal, 2021 and forward. The Company did not record unrecognized tax positions for the three months ended June 30, 2025.
The Company follows ASC 260, Earnings Per Share, which requires presentation of basic and diluted (loss) earnings per share ("EPS”) on the face of the income statement for all entities with complex capital structures and requires a reconciliation of the numerator and denominator of the basic EPS computation to the numerator and denominator of the diluted EPS computation. In the accompanying financial statements, basic (loss) income per share is computed by dividing net (loss) income by the weighted average number of shares of Common Stock outstanding during the period.
As the Company was in a net loss position for the three months ended June 30, 2025, the potential dilution from the warrants converting into shares of Common Stock and the stock options converting into of Common Stock for these periods have been excluded from the number of shares used in calculating diluted net (loss) income per share as their inclusion would have been antidilutive.
As the average market price of Common Stock for the three months ended June 30, 2024 did not exceed the exercise price of the warrants, the potential dilution from the warrants converting into shares of Common Stock for all periods have been excluded from the number of shares used in calculating diluted net income per share as their inclusion would have been antidilutive.
| F-8 |
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
| For the Three Months Ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| Numerator | ||||||||
| Net (loss) income - basic | $ | ( | ) | $ | ||||
| Effect of dilutive instrument on net income | ||||||||
| Net (loss) income - diluted | $ | ( | ) | $ | ||||
| Denominator | ||||||||
| Weighted average shares of Common Stock outstanding - basic | ||||||||
| Dilutive effect of stock options | ||||||||
| Weighted average shares of Common Stock outstanding - diluted | ||||||||
| Net (loss) income per share | ||||||||
| Basic | $ | ( | ) | $ | ||||
| Diluted | $ | ( | ) | $ | ||||
Recently Issued Accounting Pronouncements
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to income tax disclosures, which enhances the disclosure requirements for the income tax rate reconciliation, domestic and foreign income taxes paid, requiring disclosure of disaggregated income taxes paid by jurisdiction, unrecognized tax benefits, and modifies other income tax-related disclosures. The amendments are effective for the Company’s Annual Report on Form 10-K for the fiscal year ended March 31, 2026. The Company is currently evaluating the impact of adopting this guidance on its disclosures.
In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. In January 2025, the FASB issued ASU No. 2025-01, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40), Clarifying the Effective Date. ASU 2024-03 requires public companies to disclose, in interim and reporting periods, additional information about certain expenses in the financial statements. ASU 2024-03, as clarified by ASU 2025-01, is effective for public entities for annual periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted and is effective on either a prospective basis or retrospective basis. The Company is currently evaluating the impact that the updated standard will have on the Company’s disclosures within the unaudited condensed consolidated financial statements.
In May 2025, the FASB issued ASU 2025-04, Compensation-Stock Compensation (Topic 718) and Revenue from Contracts with Customers (Topic 606): Clarifications to Share-Based Consideration Payable to a Customer to reduce diversity in practice and improve the decision usefulness and operability of the guidance for share-based consideration payable to a customer in conjunction with selling goods or services. The ASU is effective for fiscal years beginning after December 15, 2026 with updates to be applied on a retrospective or modified retrospective basis. Early adoption is permitted. The Company is evaluating the impact that this standard will have on the Company’s unaudited condensed consolidated financial statements.
Management has evaluated recently issued accounting pronouncements outside of those mentioned above and does not believe that any of these pronouncements will have a significant impact on the Company’s unaudited condensed consolidated financial statements and related disclosures.
| F-9 |
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
NOTE 2. INVENTORY
Inventory consisted of the following:
| June 30, 2025 | March 31, 2025 | |||||||
| Finished goods | $ | $ | ||||||
| Work-in-progress | ||||||||
| Raw materials | ||||||||
| Inventory | $ | $ | ||||||
NOTE 3. PROPERTY AND EQUIPMENT, NET
Property and equipment consisted of the following:
| June 30, 2025 | March 31, 2025 | |||||||
| Land, building and improvements | $ | $ | ||||||
| Laboratory, manufacturing, warehouse and transportation equipment | ||||||||
| Office equipment and software | ||||||||
| Furniture and fixtures | ||||||||
| Property and equipment, gross | ||||||||
| Less: Accumulated depreciation | ( | ) | ( | ) | ||||
| Property and equipment, net | $ | $ | ||||||
Depreciation
and amortization expense was $
NOTE 4. INTANGIBLE ASSETS
The following table summarizes the Company’s intangible assets as of and for the periods ended June 30, 2025 and March 31, 2025:
| June 30, 2025 | ||||||||||||||||||||||
| Estimated Useful Life | Gross Carrying Amount | Additions | Impairment losses | Accumulated Amortization | Net Book Value | |||||||||||||||||
| Patent application costs | * | $ | $ | $ | $ | $ | ||||||||||||||||
| ANDA acquisition costs | ||||||||||||||||||||||
| $ | $ | $ | $ | $ | ||||||||||||||||||
| March 31, 2025 | ||||||||||||||||||||||
| Estimated Useful Life | Gross Carrying Amount | Additions | Impairment losses | Accumulated Amortization | Net Book Value | |||||||||||||||||
| Patent application costs | * | $ | $ | $ | $ | $ | ||||||||||||||||
| ANDA acquisition costs | ( | ) | ||||||||||||||||||||
| $ | $ | $ | ( | ) | $ | $ | ||||||||||||||||
On
June 17, 2024, the Company and Nostrum Laboratories Inc. ("Nostrum”) entered into an Asset Purchase Agreement (the "Asset
Purchase Agreement”), pursuant to which Nostrum was obligated to (i) sell to the Company all of its rights in and to the approved
abbreviated new drug applications (ANDAs) for generic Norco® (Hydrocodone Bitartrate and Acetaminophen tablets, USP CII), generic
Percocet® (Oxycodone Hydrochloride and Acetaminophen, USP CII), and generic Dolophine® (Methadone Hydrochloride tablets), each
a "Product”, and (ii) grant to the Company a royalty-free, non-exclusive perpetual license to use the manufacturing technology,
proprietary information, processes, techniques, protocols, methods, know-how, and improvements necessary or used to manufacture each
Product in accordance with the applicable ANDA, in exchange for $
| F-10 |
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The
Company tests its intangible assets for impairment at least annually (as of March 31st) and whenever events or circumstances indicate
that impairment may have occurred. Indicators of impairment may include, among others: a significant decline in expected future cash
flows; a sustained, significant decline in stock price and market capitalization; a significant adverse change in legal factors or business
climate; unanticipated competition; and slower growth rates.
* Patent application costs were incurred in relation to the Company’s abuse deterrent opioid technology. Amortization of the patent costs will begin upon the issuance of marketing authorization by the FDA. Amortization will then be calculated on a straight-line basis through the expiry of the related patent(s).
NOTE 5. ACCRUED EXPENSES
As of June 30, 2025 and March 31, 2025, the Company’s accrued expenses consisted of the following:
| June 30, 2025 | March 31, 2025 | |||||||
| Co-development profit split | $ | $ | ||||||
| Income tax | ||||||||
| Employee bonuses | ||||||||
| Other accrued expenses | ||||||||
| Legal and professional expense | ||||||||
| Salaries and fees payable | ||||||||
| Audit fees | ||||||||
| Director dues | ||||||||
| Accrued interest - related parties | ||||||||
| Total accrued expenses | $ | $ | ||||||
NOTE 6. NJEDA BONDS
During
August 2005, the Company refinanced a prior 1999 bond issue occurring in 1999 through the issuance of Series A and B Notes new
tax-exempt bonds (the "NJEDA Bonds” and/or "Bonds”). The refinancing involved borrowing $
In
relation to the Series A Notes, the Company is required to maintain a debt service reserve fund. The debt service reserve is classified
as restricted cash on the accompanying unaudited condensed consolidated balance sheets. The NJEDA Bonds require the Company to make
an annual principal payment on September 1st based on the amount specified in the loan documents and semi-annual interest payments
on March 1st and September 1st, equal to interest due on the outstanding principal. The annual interest rate on the Series A Note is
| F-11 |
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The following tables summarize the NJEDA Bonds’ payable liability:
| June 30, 2025 | March 31, 2025 | |||||||
| Gross bonds payable | ||||||||
| NJEDA Bonds - Series A Notes | $ | $ | ||||||
| Less: Current portion of bonds payable (prior to deduction of bond offering costs) | ( | ) | ( | ) | ||||
| Long-term portion of bonds payable (prior to deduction of bond offering costs) | $ | $ | ||||||
| Bond offering costs | $ | $ | ||||||
| Less: Accumulated amortization | ( | ) | ( | ) | ||||
| Bond offering costs, net | $ | $ | ||||||
| Current portion of bonds payable - net of bond offering costs | ||||||||
| Current portions of bonds payable | $ | $ | ||||||
| Less: Bonds offering costs to be amortized in the next 12 months | ( | ) | ( | ) | ||||
| Current portion of bonds payable, net of bond offering costs | $ | $ | ||||||
| Long term portion of bonds payable - net of bond offering costs | ||||||||
| Long term portion of bonds payable | $ | $ | ||||||
| Less: Bond offering costs to be amortized subsequent to the next 12 months | ( | ) | ( | ) | ||||
| Long term portion of bonds payable, net of bond offering costs | $ | $ | ||||||
Amortization
expense was $
Maturities of bonds for the next five years and thereafter are as follows:
| Years ending March 31, | Amount | |||
| Remainder of 2026 | $ | |||
| 2027 | ||||
| 2028 | ||||
| 2029 | ||||
| 2030 | ||||
| Thereafter | ||||
| $ | ||||
NOTE 7. LOANS PAYABLE
Loans payable consisted of the following:
| June 30, 2025 | March 31, 2025 | |||||||
| Mortgage loan payable | $ | $ | ||||||
| Equipment and insurance financing loans payable,
between | ||||||||
| Less: Current portion of loans payable | ( | ) | ( | ) | ||||
| Long-term portion of loans payable | $ | $ | ||||||
The
interest expense associated with the loans payable was $
| F-12 |
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Loan principal payments for the next five years and thereafter are as follows:
Future principal balances
| Years ending March 31, | Amount | |||
| Remainder of 2026 | $ | |||
| 2027 | ||||
| 2028 | ||||
| 2029 | ||||
| 2030 | ||||
| Thereafter | ||||
| Total remaining principal balance | $ | |||
NOTE 8. RELATED PARTY LOANS
The
Company has entered into a collateralized promissory note with individual lenders with rates comparable to the mortgage loan, dated July
1, 2022, provided by East West Bank to the Company but with fewer covenants. 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, President, Chief Executive Officer
and Chairman of the Board of Directors of the Company (the "Board”), pursuant to which the Company borrowed funds in the
aggregate principal amount of $3,000,000
(the "Hakim Promissory Note”). The Hakim
Promissory Note had an interest rate of
On
June 30, 2023, the Company entered into a collateralized promissory note with Davis Caskey (the "Caskey Promissory Note”).
The Caskey Promissory Note had a principal balance of $
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 unaudited 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 has obtained several agreements with Purdue to stay the litigation, with the latest being a stipulation and order submitted on March 19, 2025 lifting the existing stipulated stay. An amended complaint was filed by Purdue on April 18, 2025. Elite’s launch of a generic Oxycontin will depend on the approval by the FDA and the outcome of various litigation involving Purdue or the expiry of the patents listed on the Orange Book. As of June 30, 2025, the results of such proceedings cannot be predicted with certainty and are neither probable nor estimable.
| F-13 |
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Operating Leases
The
Company entered into an operating lease for office space in North Bay Village, Pompano FL (the "NBV Pompano Office Lease”).
The Company took occupancy on October 1, 2024. The NBV Pompano Office Lease has a term of
The
Company entered into a lease agreement for a portion of a one-story warehouse, located at 144 Ludlow Avenue, Northvale, New Jersey (the
"144 Ludlow Ave. lease”). The lease agreement began on January 22, 2024, and has a term of
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. Operating leases are included in operating lease right-of-use assets and lease liabilities in the condensed consolidated balance sheets. Lease expense for operating expense payment is recognized on a straight-line basis over the lease term.
Finance Leases
In
November 2023, the Company entered into a finance lease for equipment (the "Waters Equipment Lease”). The Waters Equipment
Lease is related to lab equipment with an acquisition cost of $
In
February 2024, the Company entered into a finance lease for warehouse equipment (the "Warehouse Equipment Lease”). The Warehouse
Equipment Lease is related to warehouse equipment with an acquisition cost of $
In
February 2024, the Company entered into a finance lease for equipment (the "February 2024 Equipment Lease”). The February
2024 Equipment Lease is related to manufacturing equipment with an acquisition cost of $
In
March 2024, the Company entered into three separate finance leases for manufacturing assets (the "March 2024 Equipment Leases”).
The March 2024 Equipment Leases are related to manufacturing equipment and vault installed at the Company’s facility located at
144 Ludlow Avenue, Northvale NJ with an aggregate acquisition cost of $
In
July 2024, the Company entered into two separate finance leases for manufacturing assets (the "July 2024 Equipment Leases”).
The July 2024 Equipment Leases are related warehouse and laboratory equipment with an aggregate acquisition cost of $
A
lease is classified as a finance lease if any of the following criteria are met:
| F-14 |
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Rent expense is recorded on the straight-line basis and in cost of manufacturing in the unaudited condensed consolidated statements of operations. Rent expense is as follows:
| For the Three Months Ended June 30, | ||||||||
| Lease | 2025 | 2024 | ||||||
| Ludlow-144 | $ | $ | ||||||
| Pompano-2311 | ||||||||
| NBV-610 | ||||||||
The table below shows the future minimum rental payments, exclusive of taxes, insurance and other costs:
| Years ending March 31, | Operating Lease Amount | Financing Lease Amount | Total | |||||||||
| Remainder of 2026 | $ | $ | $ | |||||||||
| 2027 | ||||||||||||
| 2028 | ||||||||||||
| 2029 | ||||||||||||
| 2030 | ||||||||||||
| Less: interest | ( | ) | ( | ) | ( | ) | ||||||
| Present value of lease payments | $ | $ | $ | |||||||||
The weighted-average remaining lease term and the weighted-average discount rate of the Company’s leases were as follows:
| For the Three Months Ended June 30, | ||||||||
| Lease Term and Discount Rate | 2025 | 2024 | ||||||
| Remaining lease term (years) | ||||||||
| Operating leases | ||||||||
| Finance leases | ||||||||
| Discount rate | ||||||||
| Operating leases | % | % | ||||||
| Finance leases | % | % | ||||||
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 shares of Series J Preferred were authorized, shares are issued and outstanding, with
a stated value of $
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
| F-15 |
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The
Company has
On
April 28, 2017, the Company entered into an Exchange Agreement with Nasrat Hakim, the Chairman of the Board, President, and Chief
Executive Officer of the Company, pursuant to which the Company issued to Nasrat Hakim
shares of its Series J Preferred and warrants to purchase an aggregate of
The
Series J Warrants are exercisable for a period of
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:
| June 30, 2025 | March 31, 2025 | |||||||
| Fair value of the Company’s Common Stock | $ | $ | ||||||
| Volatility | % | % | ||||||
| Initial exercise price | $ | $ | ||||||
| Warrant term (in years) | ||||||||
| Risk free rate | % | % | ||||||
The changes in warrants (Level 3 financial instruments) measured at fair value on a recurring basis were as follows:
| Balance at March 31, 2024 | $ | |||
| Change in fair value of derivative financial instruments - warrants | ||||
| Balance at March 31, 2025 | $ | |||
| Change in fair value of derivative financial instruments - warrants | ||||
| Balance at June 30, 2025 | $ |
Measured on a Recurring Basis
The following table presents information about the Company’s liabilities measured at fair value on a recurring basis, aggregated by the level in the fair value hierarchy within which those measurements fell:
| Amount at Fair | Fair Value Measurement | |||||||||||||||
| Value | Level 1 | Level 2 | Level 3 | |||||||||||||
| Balance as of March 31, 2025 | $ | $ | $ | $ | ||||||||||||
| Change in fair value of derivative financial instruments - warrants | ||||||||||||||||
| Balance as of June 30, 2025 | $ | $ | $ | $ | ||||||||||||
| F-16 |
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
| Amount at Fair | Fair Value Measurement | |||||||||||||||
| Value | Level 1 | Level 2 | Level 3 | |||||||||||||
| Balance as of March 31, 2024 | $ | $ | $ | $ | ||||||||||||
| Change in fair value of derivative financial instruments - warrants | ||||||||||||||||
| Balance as of June 30, 2024 | $ | $ | $ | $ | ||||||||||||
Part of the compensation paid by the Company to employees consists of the granting of options to purchase Common Stock.
Options
Under
its 2014 Equity Incentive Plan and 2024 Equity Incentive Plan, the Company did grant and may grant stock options to officers,
selected employees, as well as members of the Board and advisory board members. On July 1, 2024 the Company restated the 2014 Equity
Incentive Plan to increase the shares reserved under the option plan by
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 the Company’s 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.
| Shares
Underlying Options | Weighted
Average Exercise Price | Weighted
Average Remaining Contractual Term (in years) | Aggregate
Intrinsic Value | |||||||||||||
| Outstanding at March 31, 2025 | $ | $ | ||||||||||||||
| Granted | $ | — | $ | — | ||||||||||||
| Exercised | $ | — | $ | — | ||||||||||||
| Expired and Forfeited | $ | — | $ | — | ||||||||||||
| Outstanding at June 30, 2025 | $ | $ | ||||||||||||||
| Exercisable at June 30, 2025 | $ | $ | ||||||||||||||
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 June 30, 2025 of $
| F-17 |
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
NOTE 13. CONCENTRATIONS AND CREDIT RISK
Revenues
Three
customers accounted for approximately
Two
customers accounted for approximately
Accounts Receivable
Three
customers accounted for approximately
Two
customers accounted for approximately
Purchasing
Three
suppliers accounted for approximately
Two
suppliers accounted for approximately
NOTE 14. 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.
Consolidated loss from operations, which is reported in the accompanying unaudited condensed consolidated statements of operations, is the measure of segment profit or loss that is regularly reviewed by the Chief Operating Decision Maker ("CODM”). Our CODM is our President and Chief Executive Officer. This enables the CODM to assess the overall level of available resources and determine how best to deploy these resources across research and development projects in line with the long-term company-wide strategic goals. The reporting segments follow the same accounting policies used in the preparation of the Company’s unaudited condensed consolidated financial statements.
The following represents selected information for the Company’s reportable segments:
| For the Three Months Ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| Operating Income by Segment | ||||||||
| ANDA | $ | $ | ||||||
| Operating income by Segment | $ | $ | ||||||
The
Company notes that there was
| F-18 |
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The table below reconciles the Company’s operating income by segment to (loss) income before income taxes as reported in the Company’s unaudited condensed consolidated statements of operations:
| For the Three Months Ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| Operating income by segment | $ | $ | ||||||
| Corporate unallocated costs | ( | ) | ( | ) | ||||
| Interest income | ||||||||
| Interest expense and amortization of debt issuance costs | ( | ) | ( | ) | ||||
| Depreciation and amortization expense | ( | ) | ( | ) | ||||
| Significant non-cash items | ( | ) | ( | ) | ||||
| Change in fair value of derivative instruments | ( | ) | ( | ) | ||||
| Other income | ||||||||
| (Loss) income before income taxes | $ | ( | ) | $ | ||||
NOTE 15. 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 Amphetamine ER and assumed 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 engages 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 June 30, 2025, the Company owes an aggregate of $
NOTE 16. INCOME TAXES
The
determination of income tax expense in the accompanying unaudited condensed consolidated statements of income is based on the effective
tax rate for the year, adjusted for the impact of any discrete items which are accounted for in the period in which they occur. The Company’s
income tax expense was $
NOTE 17. SUBSEQUENT EVENTS
On July 3, 2025, Douglas Plassche exercised stock options for shares of Common Stock of the Company at an exercise price of $ per share.
On July 4, 2025, tax legislation known as the One Big Beautiful Bill Act (the "OBBBA”) was enacted in the United States. The Company is currently evaluating the impact of U.S. tax law changes introduced by the OBBBA on our consolidated financial statements.
| F-19 |
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion of our financial condition and results of operations for the three months ended June 30, 2025 and 2024 should be read in conjunction with our unaudited condensed consolidated financial statements and the notes to those statements that are included elsewhere in this report. Our discussion includes forward-looking statements based upon current expectations that involve risks and uncertainties, such as our plans, objectives, expectations and intentions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of a number of factors, including those set forth under Item 1A. Risk Factors appearing in our Annual Report on Form 10-K for the year ended March 31, 2025. We use words such as "anticipate,” "estimate,” "plan,” "project,” "continuing,” "ongoing,” "expect,” "believe,” "intend,” "may,” "will,” "should,” "could,” and similar expressions to identify forward-looking statements.
Unless expressly indicated or the context requires otherwise, the terms "Elite”, the "Company”, "we”, "us”, and "our” refer to Elite Pharmaceuticals, Inc. and subsidiary.
Background
Elite Pharmaceuticals, Inc., a Nevada corporation (the "Company”, "Elite”, "Elite Pharmaceuticals”, the "registrant”, "we”, "us” or "our”) 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.
We are a specialty pharmaceutical company principally engaged in the development and manufacture of oral, controlled-release products, and the manufacture of generic pharmaceuticals. Our strategy includes developing generic versions of controlled-release drug products with high barriers to entry.
We occupy manufacturing, warehouse, laboratory and office space at 135, 144 and 165 Ludlow Avenue in Northvale, NJ (the "Northvale Facility”). The Northvale Facility operates under Current Good Manufacturing Practice ("cGMP”) and is a United States Drug Enforcement Agency ("DEA”) registered facility for research, development, and manufacturing. We are also party to an operating lease for office space at Pompano Beach, Florida (the "Pompano Office Lease”).
Strategy
We focus our efforts on the following areas: (i) manufacturing of a line of generic pharmaceutical products with approved Abbreviated New Drug Applications ("ANDAs”); (ii) development of additional generic pharmaceutical products; (iii) development of the other product candidates in our pipeline including products co-developed with partners; (iv) commercial exploitation of our products either by sales under our own label, license and the collection of royalties, or through the manufacture of our formulations; and (v) development of new products for sale under our own label, and the expansion of our licensing agreements with other pharmaceutical companies, including co-development projects, joint ventures and other collaborations.
We continue to evaluate opportunities for the development of various types of drug products, including branded drug products which require New Drug Applications ("NDAs”) under Section 505(b)(1) or 505(b)(2) of the Drug Price Competition and Patent Term Restoration Act of 1984 (the "Drug Price Competition Act”) as well as generic drug products which require ANDAs.
We believe that our business strategy enables us to reduce its risk by having a diverse product portfolio.
Recent Developments
On April 30, 2025 the Company announced the commercial launch of its generic version of Percocet® (Oxycodone hydrochloride and acetaminophen tablets, "Oxy APAP”). Oxy APAP is indicated for the relief of moderate to moderately severe pain.
On June 16, 2025, the Company reported positive results from a pivotal bioequivalence study for an undisclosed anticoagulant generic drug problem. IQVIA, a legal global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry, reported branded product sales of Percocet® for the twelve months ending April 2025 of $27 billion. There is no generic product on the market, and the brand has an unexpired patent listed in the Orange Book. Commercialization of a generic product depends on successful filing, United States Food and Drug Administration ("FDA”) approval, and addressing the unexpired patent. The studies conducted were open-label, randomized, balanced, single oral dose, two-treatment, two-period, two-sequence, crossover bioequivalence studies in normal, healthy, adult, human subjects under fasting conditions. The results indicated that the generic product is bioequivalent to the branded product. The Company is compiling the data for this product to file an ANDA with the FDA.
| 1 |
Commercial Products
We own, license, contract manufacture or have contractual rights to receive royalties from the following products currently approved for commercial sale:
| Product | Branded Product Equivalent | Therapeutic Category | Launch Date | |||
| Phentermine HCl 37.5mg tablets ("Phentermine 37.5mg”) | Adipex-P® | Bariatric | April 2011 | |||
| Phendimetrazine Tartrate 35mg tablets ("Phendimetrazine 35mg”) | Bontril® | Bariatric | November 2012 | |||
| Phentermine HCl 15mg and 30mg capsules ("Phentermine 15mg” and "Phentermine 30mg”) | Adipex-P® | Bariatric | April 2013 | |||
| Naltrexone HCl 50mg tablets ("Naltrexone 50mg”) | Revia® | Pain | September 2013 | |||
| Isradipine 2.5mg and 5mg capsules ("Isradipine 2.5mg” and "Isradipine 5mg”) | N/A | Cardiovascular | January 2015 | |||
| Trimipramine Maleate Immediate Release 25mg, 50mg and 100mg capsules ("Trimipramine 25mg”, "Trimipramine 50mg”, "Trimipramine 100mg”) | Surmontil® | Antidepressant | May 2017 | |||
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Immediate Release 5mg, 7.5mg, 10mg, 12.5mg, 15mg, 20mg and 30mg tablets ("Amphetamine IR 5mg”, "Amphetamine IR 7.5mg”, "Amphetamine IR 10mg”, "Amphetamine IR 12.5mg”, "Amphetamine IR 15mg”, "Amphetamine IR 20mg” and "Amphetamine IR 30mg”) | Adderall® | Central Nervous System ("CNS”) Stimulant | April 2019 | |||
| Dantrolene Sodium Capsules 25mg, 50mg and 100mg ("Dantrolene 25mg”, "Dantrolene 50mg”, "Dantrolene 100mg”) | Dantrium® | Muscle Relaxant | June 2019 | |||
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended Release 5mg, 10mg, 15mg, 20mg, 25mg, and 30mg capsules ("Amphetamine ER 5mg”, "Amphetamine ER 10mg”, "Amphetamine ER 15mg”, "Amphetamine ER 20mg”, "Amphetamine ER 25mg”, and "Amphetamine ER 30mg”) | Adderall XR® | Central Nervous System ("CNS”) Stimulant | March 2020 | |||
| Loxapine Succinate 5mg, 10mg, 25mg and 50gm capsules ("Loxapine 5mg”, "Loxapine 10mg”, "Loxapine 25mg”, and Loxapine 50mg”) | Loxapine® | Antipsychotic | May 2021 | |||
| Methotrexate Sodium 2.5mg tablets ("Methotrexate 2.5mg”) | Otrexup PF® | Antimetabolite | August 2024 | |||
| Acetaminophen and Codeine Phosphate 300mg/15mg, 300mg/30mg, 300mg/60mg tablets ("APAP Codeine 300mg/15mg”, "APAP Codeine 300mg/30mg”, and "APAP Codeine 300mg/60mg”) | Tylenol® with Codeine | Pain | October 2024 | |||
| Acetaminophen and Hydrocodone Bitartrate 325mg/2.5mg, 325mg/5mg, 325mg/7.5mg and 325mg/10mg tablets ("APAP Hydrocodone 325mg/2.5mg”, "APAP Hydrocodone 325mg/5mg”, APAP Hydrocodone 325mg/7.5mg and APAP Hydrocodone 325mg/10mg”) | Norco® | Pain | December 2024 | |||
| Lisdexamfetamine Dimesylate 10mg, 20mg, 30mg, 40mg, 50mg, 60mg and 70mg capsules ("Lisdex 10mg”, "Lisdex 20mg”, "Lisdex 30mg”, "Lisdex 40mg”, "Lisdex 50mg”, "Lisdex 60mg” and "Lisdex 70mg”) | Vyvanse® | ADHD | December 2024 | |||
| Oxycodone Hydrochloride and Acetaminophen 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets ("Oxy APAP 5/325”, "Oxy APAP 7.5/325” and "Oxy APAP 10/325”) | Percocet® | Pain | April 2025 |
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Products Under FDA Review
SequestOx™ - Immediate Release Oxycodone with sequestered Naltrexone
SequestOx™ is our abuse-deterrent candidate for the management of moderate to severe pain where the use of an opioid analgesic is appropriate. SequestOx™ is an immediate-release Oxycodone Hydrochloride containing sequestered Naltrexone which incorporates 5mg, 10mg, 15mg, 20mg and 30mg doses of oxycodone into capsules.
In January 2016, the Company submitted a 505(b)(2) NDA for SequestOx™, after receiving a waiver of the $2.3 million filing fee from the FDA. In March 2016, the Company received notification of the FDA’s acceptance of this filing and that such filing has been granted priority review by the FDA with a target action under the Prescription Drug User Fee Act ("PDUFA”) of July 14, 2016.
On July 15, 2016, the FDA issued a Complete Response Letter, ("CRL”), regarding the NDA. The CRL stated that the review cycle for the SequestOx™ NDA was complete and the application is not ready for approval in its present form.
On July 7, 2017, the Company reported topline results from a pivotal bioequivalence fed study for SequestOx™. The mean Tmax (the amount of time that a drug is present at the maximum concentration in serum) of SequestOx™ was 4.6 hr. with a range of 0.5 hr. to 12 hr. and the mean Tmax of the comparator, Roxicodone®, was 3.4 hr. with a range of 0.5 hr. to 12 hr. A key objective for the study was to determine if the reformulated SequestOx™ had a similar Tmax to the comparator when taken with a high fat meal. Based on these results, the Company paused clinical trials for this formulation of SequestOx™. On January 30, 2018, the Company reported positive topline results from a pilot study conducted for a modified SequestOx™ wherein, based on the results of this pilot study, the modified SequestOx™ formulation is expected to achieve bioequivalence with a Tmax range equivalent to the reference product when conducted in a pivotal trial under fed conditions. The Company has provided the pilot data to the FDA, requesting clarification as to the requirements for resubmission of the NDA. The FDA has provided guidance for repeated bio-equivalence studies in order to bridge the new formulation to the original SequestOx™ studies. Due to the prohibitive cost of such repeated bio-equivalence studies and the uncertain commercial viability given the regulatory and competitive landscape, the Company has paused development of this product candidate.
There can be no assurances of the Company conducting future clinical trials, or if such trials are conducted, there can be no assurances of the success of any future clinical trials, or if such trials are successful, there can be no assurances that an intended future resubmission of the NDA product filing, if made, will be accepted by or receive marketing approval from the FDA. In addition, even if marketing authorization is received, there can be no assurances that there will be future revenues or profits, or that any such future revenues or profits would be in amounts that provide adequate return on the significant investments made to secure this marketing authorization.
Generic Products Filed
Currently the Company has filed the following ANDA’s which have been accepted for review by the FDA:
● Generic dopamine agonist accepted for review in December 2022
● Generic opiate analgesic for pain management accepted for review in September 2023
Approved Products Not Yet Commercialized
Doxycycline Hyclate Tablets
The Company received approval in April 2022 from the FDA of an ANDA for a generic version of an antibiotic product, Doxycycline Hyclate Tablets. The product is jointly owned by Elite and Praxgen Pharmaceuticals LLC, formerly SunGen Pharma LLC, ("Praxgen”).
Methadone Hydrochloride Tablets
Pursuant to the Nostrum Asset Purchase Agreement, dated June 17, 2024, by and between the Company and Nostrum Laboratories Inc., pursuant to which the Company acquired all rights in and to the approved ANDA for Methadone Hyrochloride Tablets and a royalty-free, non-exclusive perpetual license to use the manufacturing technology, proprietary information, processes, techniques, protocols, methods, know-how and improvements necessary or used to manufacture this product.
There can be no assurances in relation to any of the above approved products not yet commercialized, that there will be future revenues of profits, or that any such future revenues or profits would be in amounts that provide adequate return on the significant investments made to secure these marketing authorizations.
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Discontinued and Transferred Products
As part of standard operating practices, the Company, from time to time, as relevant, conducts evaluations of all ANDAs owned, consisting, without limitation, of ANDAs acquired or approved prior to the quarter ended June 30, 2025 and ANDAs acquired or approved during the quarter ended June 30, 2025. Such evaluations include, without limitation, costs and benefits analyses relating to each ANDA owned, with such costs including those fees required under the FDA’s Generic Drug User Fee Amendment which is significantly influenced by the number of ANDAs owned, and other costs and benefits taking into consideration various specific market factors for each ANDA. Those ANDAs with a cost/benefit profile not consistent with management criteria for continuation are identified for disposition and effort is made to determine the optimal course of action to achieve disposition of the ANDA.
Critical Accounting Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with United States generally accepted accounting principles ("GAAP”). The preparation of our consolidated financial statements and related disclosures requires us to make estimates, assumptions and judgments that affect the reported amount of assets, liabilities, costs and expenses and related disclosures. Our critical accounting estimates are those estimates that involve a significant level of uncertainty at the time the estimate was made, and changes in them have had or are reasonably likely to have a material effect on our financial condition or results of operations. Accordingly, actual results could differ materially from our estimates. The following discussion addresses our most critical accounting estimates, which are those that are both important to the portrayal of our financial condition and results of operations and that require significant judgment or use of complex estimates.
Revenue Recognition - Manufacturing Fees
The Company’s revenues are offset by variable consideration, which may include, without limitation, chargebacks, distribution fees, rebates, group purchasing organization fees, prompt payment cash discounts, consideration payable to the customer, billbacks, Medicaid and other government pricing programs, price protection and shelf stock adjustments, sales returns and profit shares. The Company’s estimates for variable consideration are adjusted as required at each reporting period for specific known developments that may result in a change in the amount of total consideration it expects to receive as well as updating estimate assumptions to reflect current and/or historical trends.
Like most competitors in this market, our marketing partners also give credits for chargebacks to wholesalers that have contracts with our marketing partners, prospectively, for their sales to hospitals, group purchasing organizations, pharmacies, or other customers. We do the same in the case of prospective direct sales made by us. A chargeback is the difference between the price the wholesaler pays and the price that the wholesaler’s end-customer pays for a product. Although, our marketing partners establish, and prospectively we would also establish reserves based on prior experience and best estimates of the impact that these policies may have in subsequent periods, we cannot ensure that such reserves established are adequate or that actual product returns, rebates, allowances, and chargebacks will not exceed estimates. Differences between established reserves and actual amounts of such credits and charges, could result in a material adverse effect on our business, financial condition, results of operations, cash flow and stock price.
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.
Results of Operations:
The following set forth our results of operations for the periods presented. The period-to-period comparison of financial results is not necessarily indicative of future results.
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Three months ended June 30, 2025 compared to the three months ended June 30, 2024
Revenue, Cost of manufacturing and Gross profit:
For the Three Months Ended June 30, | Change | |||||||||||||||
| 2025 | 2024 | Dollars | Percentage | |||||||||||||
| Manufacturing fees | $ | 39,777,763 | $ | 18,443,918 | $ | 21,333,845 | 116 | % | ||||||||
| Licensing fees | 433,334 | 359,145 | 74,189 | 21 | % | |||||||||||
| Total revenue | 40,211,097 | 18,803,063 | 21,408,034 | 114 | % | |||||||||||
| Cost of manufacturing | 12,985,127 | 10,328,285 | 2,656,842 | 26 | % | |||||||||||
| Gross profit | $ | 27,225,970 | $ | 8,474,778 | $ | 18,751,192 | 221 | % | ||||||||
| Gross profit - percentage | 68 | % | 45 | % | ||||||||||||
Total revenues for the three months ended June 30, 2025 increased by $21.4 million or 114%, to $40.2 million, as compared to $18.8 million, for the corresponding period of the prior year.
Manufacturing fees revenue increased by $21.3 million, or 116%, primarily due to the Elite label products achieving greater sales fifteen months after their launch, as compared to the comparable period of the prior year which was the period in which the Elite label was initially launched combined with the fact that the three months ended June 30, 2025 included sales from new products, including, without limitation the Lisdexamfetamine products, which were commercially launched subsequent to the comparable period of the prior year.
Licensing fees revenue increased by $0.1 million, or 21%. This increase is primarily due to higher profit achieved by the Company’s third-party license during the three months ended June 30, 2025, as compared to the comparable period of the prior year. Please note that the Company is transitioning away from licensing products to third parties and focusing on marketing of the Elite label, which does not result in license fee revenue.
Cost of manufacturing consists of manufacturing and assembly costs. Our cost of manufacturing increased by $2.7 million or 26%, to $13.0 million as compared to $10.3 million for the comparable period of the prior fiscal year. This increase was primarily due to an increased volume of products sold during the three months ended June 30, 2025, as compared to the comparable period of the prior year, as noted above.
Our gross profit margin was 68% during the three months ended June 30, 2025 as compared to 45% for the corresponding period in the prior year. The increase is primarily due to sales achieved during the three months ended June 30, 2025 being comprised of a greater proportion of higher margin products, combined with a greater proportion of direct sales (as opposed to indirect sales), as compared to the product mix of sales achieved during the comparable period of the prior year.
Operating expenses:
For the Three Months Ended June 30, | Change | |||||||||||||||
| 2025 | 2024 | Dollars | Percentage | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 1,674,964 | $ | 2,163,527 | $ | (488,563 | ) | (23 | )% | |||||||
| General and administrative | 3,404,084 | 1,969,154 | 1,434,930 | 73 | % | |||||||||||
| Non-cash compensation | 52,329 | 52,329 | — | — | % | |||||||||||
| Depreciation and amortization | 394,886 | 425,712 | (30,826 | ) | (7 | )% | ||||||||||
| Total operating expenses | $ | 5,526,263 | $ | 4,610,722 | $ | 915,541 | 20 | % | ||||||||
Operating expenses for the three months ended June 30, 2025 increased by $0.9 million, or 20%, to $5.5 million as compared to $4.6 million for the corresponding period in the prior year, largely due to an increase in general and administrative expenses of $1.4 million, offset by a decrease in research and development of $0.5 million.
Research and development costs during the three months ended June 30, 2025 were $1.7 million, a decrease of $0.5 million, or 23%, from approximately $2.2 million for the prior year. The decrease was a result of the number, timing and nature of product development activities during the three months ended June 30, 2025 as compared to the comparable period in the prior fiscal year, with the three months ended June 30, 2024 requiring increased product development resources related to the product approvals achieved in subsequent periods.
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General and administrative expenses for the three months ended June 30, 2025 were $3.4 million as compared to $2.0 million for the comparable period in the prior year, an increase of $1.4 million or approximately 73%, largely due to an increased human resource headcount, regulatory compliance and consulting costs as compared to the corresponding period in the prior year.
Non-cash compensation expense for the three months ended June 30, 2025 and 2024 was less than $0.1 million.
Depreciation and amortization expenses from the three months ended June 30, 2025 were $0.4 million flat to the comparable period in the prior fiscal year.
As a result of the foregoing, our income from operations during the three months ended June 30, 2025 was $21.7 million, compared to income from operations of $3.9 million for the comparable period in the prior fiscal year.
Other (expense) income:
For the Three Months Ended June 30, | Change | |||||||||||||||
| 2025 | 2024 | Dollars | Percentage | |||||||||||||
| Other (expense) income: | ||||||||||||||||
| Change in fair value of derivative financial instruments - warrants | $ | (22,109,537 | ) | $ | (2,782,913 | ) | $ | (19,326,624 | ) | 694 | % | |||||
| Interest expense and amortization of debt issuance costs | (158,926 | ) | (250,781 | ) | 91,855 | (37 | )% | |||||||||
| Interest income | 4,542 | 5,390 | (848 | ) | (16 | )% | ||||||||||
| Other income | — | 12,000 | (12,000 | ) | (100 | )% | ||||||||||
| Other expense, net | $ | (22,263,921 | ) | $ | (3,016,304 | ) | $ | (19,247,617 | ) | 638 | % | |||||
Other expense, net for the three months ended June 30, 2025 was $22.3 million, an increase of $19.2 million as compared to the corresponding period in the prior year. The increase was primarily due to a net increase of $19.3 million relating to the change in fair value of warrant derivative instruments, offset by a $0.1 million relating decrease in interest expense and amortization of debt issuance costs. The change in the fair value of derivative instruments and stock-based liabilities is determined in large part by the change in the closing price of the Company’s Common Stock as of the end of the period, as compared to the closing price at the beginning of the period, with a strong inverse relationship between changes in the closing price of the Company’s Common Stock and amounts recorded as other expenses on the statement of operations. The decrease in interest expense is primarily due to reduced principal amounts outstanding during the three months ended June 30, 2025 as compared to the comparable period of the prior year.
As a result of the foregoing, our net loss before income taxes for the three months ended June 30, 2025 was $0.6 million, compared to net income before income taxes of $0.8 million for the comparable period in the prior year.
Income Taxes:
The Company recorded tax expense of approximately (943.0)% and 27.4% of income before income tax expense, for each of the three-month period ended June 30, 2025 and 2024, respectively. Our effective tax rate is subject to volatility as changes in the fair value adjustments in our derivative liabilities significantly impact pre-tax earnings. These valuation shifts have a disproportionate impact on pre-tax income, thereby amplifying the effective tax rate for the current period. The fair value adjustment of derivatives decreased the effective tax rate by 967.69% for the three-month period ended June 30, 2025.
Liquidity and Capital Resources
Capital Resources
| June 30, 2025 | March 31, 2025 | Change | ||||||||||
| Current assets | $ | 77,861,100 | $ | 57,739,147 | $ | 20,121,953 | ||||||
| Current liabilities | $ | 10,762,657 | $ | 11,840,435 | $ | (1,077,778 | ) | |||||
| Working capital | $ | 67,098,443 | $ | 45,898,712 | $ | 21,199,730 | ||||||
Our working capital (total current assets less total current liabilities) increased by $21.2 million from $45.9 million as of March 31, 2025 to $67.1 million as of June 30, 2025, with such increase being primarily related to the increase in finished goods inventory and accounts receivable, associated with increased customer orders during the three months ended June 30, 2025 and an increase in cash balances, paired with a decrease in total current liabilities over the same period.
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Summary of Cash Flows:
| For the Three Months Ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| Net cash provided by operating activities | $ | 14,775,842 | $ | 3,144,463 | ||||
| Net cash used in investing activities | $ | (218,204 | ) | $ | (1,663,277 | ) | ||
| Net cash used in financing activities | $ | (4,130,684 | ) | $ | (174,906 | ) | ||
Net cash provided by operating activities for the three months ended June 30, 2025 was $14.8 million, which included, without limitation, net loss of $5.9 million, increased by the change in fair value of derivative financial instruments - warrants of $22.1 million, deferred tax expenses of $4.9 million, and reduced by the change in operating assets and liabilities totaling $7.1 million. Net cash provided by operating activities during comparable period in the prior fiscal year included, without limitation, net income of $0.6 million increased by depreciation and other non-cash expenses totaling $3.5 million and reduced by the change in operating activities and liabilities totaling $0.9 million.
Net cash used in investing activities for the three months ended June 30, 2025 was comprised of purchases of property and equipment of approximately $0.2 million. Net cash used in investing activities during the prior fiscal year was comprised of purchases of property and equipment of approximately $0.8 million and purchase of intangible assets of $0.9 million.
Net cash used in financing activities was $4.1 million for the three months ended June 30, 2025 was mainly comprised of payments of loan principal on related party loans totaling $4.0 million. Net cash used in financing activities of $0.2 million for the prior fiscal year was for payments of loan principal and finance lease obligations totaling $0.2 million.
East West Bank
On July 1, 2022, East West Bank ("EWB”) provided a mortgage loan ("EWB Mortgage Loan”) in the amount of $2.55 million for the purchase of the property at 135-137 Ludlow Avenue, which was formerly a lease held by the Company. The EWB Mortgage Loan matures in ten years and bears interest at a fixed rate of 4.75% fixed for the first five years then adjustable at WSJP plus 0.5% with floor rate of 4.5%. The total transaction costs associated with the EWB Mortgage Loan incurred as of June 30, 2025, were $13,251, which are being amortized on a monthly basis over ten years, beginning in July 2022. 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 June 30, 2025, and through the date of filing of this Quarterly Report on Form 10-Q, the Company was not aware of the existence of any violations of financial covenants included in the EWB Mortgage Loan.
NJEDA Bonds
On August 31, 2005, the Company successfully completed a refinancing of a prior 1999 bond issue (the "1999 Bonds”) through the issuance of new tax-exempt bonds (the "NJEDA Bonds”). The refinancing involved borrowing $4,155,000, evidenced by a 6.5% Series A Note in the principal amount of $3,660,000 maturing on September 1, 2030 and a 9% Series B Note in the principal amount of $495,000 maturing on September 1, 2012. The net proceeds, after payment of issuance costs, were used (i) to redeem the outstanding tax-exempt 1999 Bonds originally issued by the New Jersey Economic Development Authority on September 2, 1999, (ii) to refinance other equipment financing and (iii) for the purchase of certain equipment to be used in the manufacture of pharmaceutical products. As of March 31, 2016, all of the proceeds were utilized by the Company for such stated purposes.
The NJEDA Bonds are collateralized by a first lien on the Company’s facility and equipment acquired with the proceeds of the 1999 Bonds and NJEDA Bonds. The related Indenture requires the maintenance of a debt service reserve fund of $366,000 in relation to the Series A Notes.
Bond issue costs of $354,454 were paid from the proceeds of the NJEDA Bonds and are being amortized over the life of the NJEDA bonds. Amortization of bond issuance costs amounted to $3,545 for the three months ended June 30, 2025.
The NJEDA Bonds require the Company to make an annual principal payment on September 1st of varying amounts as specified in the loan documents and semi-annual interest payments on March 1st and September 1st, equal to interest due on the outstanding principal at the applicable rate for the semi-annual period just ended.
In addition, the Company had previously received Notices of Default from the Trustee of the NJEDA Bonds as a result of the utilization of the debt service reserve fund being used to pay interest payments as well as the Company’s failure to make scheduled principal payments. All monetary defaults were cured during Fiscal Year 2015 and the Company is current on all NJEDA Bond interest and principal payments.
As of the date of filing of this Quarterly Report on Form 10-Q, there are no interest or principal amounts in arrears. The Series B Notes were retired, at par in July 2014.
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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
As a smaller reporting company, we are not required to provide the information required by this Item.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
The term "disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended (the "Exchange Act”), refers to controls and procedures that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the Securities Exchange Commission’s (the "SEC”) rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. As required by Rules 13a-15(b) and 15d-15(b) of the Exchange Act, our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures based on the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission on Internal Control ("COSO”), as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on that evaluation, our Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures were not effective as of June 30, 2025 to ensure that information required to be disclosed by the Company in reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms and such information is accumulated and communicated to management as appropriate to allow timely decisions regarding required disclosures.
A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. As of June 30, 2025, we identified the following control deficiencies that we believe constituted individually, and in the aggregate, material weaknesses in the design and operation components of our internal controls within the COSO framework:
● We were unable to formalize and implement revised controls, policies and procedure documentation to evidence a system of internal controls, including testing of such revised controls, that was consistent with available personnel and resources;
● We failed to maintain effective control activities over our control environment, risk assessment, information technology and monitoring components and;
● We had insufficient segregation of duties, oversight of work performed and lack of compensating controls in our finance and accounting functions due to limited personnel and resources.
Management’s Report on Internal Control Over Financial Reporting
Internal control over financial reporting refers to the process designed by, or under the supervision of, our Chief Executive Officer and Chief Financial Officer, and effected by our Board, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles, and includes those policies and procedures that: (i) pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of our assets; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on the financial statements.
Internal control over financial reporting may not prevent or detect all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are achieved. Further, the design of a control system must be balanced against resource constraints, and therefore the benefits of controls must be considered relative to their costs. Given the inherent limitations in all systems of controls, no evaluation of controls can provide absolute assurance all control issues and instances of fraud, if any, within a company have been detected. These inherent limitations include the realities that judgments in decision making can be faulty and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the controls. The design of any system of controls is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions or the degree of compliance with policies or procedures may deteriorate. Accordingly, given the inherent limitations in a system of internal control, financial statement misstatements due to error or fraud may occur and may not be detected. Our disclosure controls and procedures are designed to provide reasonable, not absolute, assurance of achieving their objectives. We conduct periodic evaluations of our systems of controls to enhance, where necessary, our control policies and procedures.
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Management is responsible for establishing and maintaining adequate internal control over our financial reporting, as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting. Management has used the framework set forth in the report entitled "Internal Control—Integrated Framework (2013)” published by the Committee of Sponsoring Organizations of the Treadway Commission to evaluate the effectiveness of our internal control over financial reporting. Based on its evaluation, utilizing those criteria, management has determined that, as of June 30, 2025, because of the material weaknesses described below, our internal control over financial reporting was not effective.
A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. As of June 30, 2025, we identified the following control deficiencies that we believe constituted individually, and in the aggregate, material weaknesses in the design and operation components of our internal controls within the COSO framework:
The deficiencies in our internal controls over financial reporting and disclosure controls and procedures are described above and our efforts to remediate these deficiencies are described below. Please also see "Risk Factors” in Item 1A-Risk of our Annual Report on Form 10-K for the period ended March 31, 2025.
Changes in Internal Controls Over Financial Reporting
During the quarter ended June 30, 2025, as a result of reviews and assessments of internal controls over financial reporting conducted by the Company’s Chief Financial Officer, the Company identified material weaknesses in internal controls over financial reporting as further detailed above and began remediation efforts which are detailed below, with such activities expected to result in further changes in internal control over financial reporting as necessary to remediate the identified material weaknesses.
Remediation efforts to address material weaknesses in internal controls over financial reporting
We intend to revise the existing control environment documentation, designing and implementing controls, policies and procedure documentation that is consistent with our current personnel, resources and capabilities, with significant focus on controls relating to financial oversight, management, analysis and reporting of operations emanating from the Company’s manufacturing, marketing and distribution of its Elite Label product line. Please note that these material weaknesses cannot be considered remediated until the applicable remedial controls operate for a sufficient period of time, allowing management, through testing, to reach a conclusion on such controls design and operational effectiveness.
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Part II - OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
Pending Litigation
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. The parties submitted several stipulations and proposed orders for staying the case until March 19, 2025 where the parties submitted a stipulation and order lifting the existing stipulated stay. On April 18, 2025 Purdue filed an amended complaint. On June 17, Elite filed a Motion to Dismiss Purdue’s First Amended Complaint and on July 3, 2025 Purdue filed a Second Amended Complaint. Elite filed a Motion to Dismiss Purdue’s Second Amended Complaint on August 7, 2025.
Elite’s launch of a generic Oxycontin will depend on approval by the FDA and the outcome of various litigation involving Purdue or the expiry of the patents listed on the Orange Book.
In the ordinary course of business, we may be subject to litigation from time to time. There is no current, pending or, to our knowledge, threatened litigation or administrative action to which we are a party or of which our property is the subject (including litigation or actions involving our officers, directors, affiliates, or other key personnel, or holders of record or beneficially of more than 5% of any class of our voting securities, or any associate of any such party) which in our opinion has, or is expected to have, a material adverse effect upon our business, prospects financial condition or operations. A significant increase in the number of claims or an increase in amounts owing under successful claims could materially adversely affect our business, financial condition, results of operations and cash flows.
ITEM 1A. RISK FACTORS
There have been no material changes in the risk factors described in our Annual Report on Form 10-K for the fiscal year ended March 31, 2025.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5. OTHER INFORMATION
During
the fiscal quarter ended June 30, 2025, none of the Company’s directors or officers (as defined in Rule 16a-1(f) of the Securities
Exchange Act of 1934, as amended)
ITEM 6. EXHIBITS
| Exhibit No. | Description | |
| 31.1 | Certification of Chief Executive Officer pursuant to Exchange Act Rule 13a-14(a) and Rule 15d-14(a)* | |
| 31.2 | Certification of Chief Financial Officer pursuant to Exchange Act Rule 13a-14(a) and Rule 15d-14(a)* | |
| 32.1 | Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002** | |
| 32.2 | Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002** | |
| 101.INS* | XBRL Instance Document | |
| 101.SCH* | XBRL Taxonomy Schema Document | |
| 101.CAL* | XBRL Taxonomy Extension Calculation Linkbase Document | |
| 101.DEF* | XBRL Taxonomy Extension Definition Linkbase Document | |
| 101.LAB* | XBRL Taxonomy Extension Label Linkbase Document | |
| 101.PRE* | XBRL Taxonomy Extension Presentation Linkbase Document | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
* Filed herewith.
** Furnished herewith.
| 10 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| ELITE PHARMACEUTICALS, INC. | ||
| August 14, 2025 | By: | /s/ Nasrat Hakim |
| Nasrat Hakim | ||
| Chief Executive Officer, President and Chairman of the Board of Directors | ||
| (Principal Executive Officer) | ||
| August 14, 2025 | By: | /s/ Carter Ward |
Carter Ward | ||
| Chief Financial Officer | ||
| (Principal Accounting Officer and Principal Financial Officer) | ||
| 11 |
Exhibit 31.1
CERTIFICATION BY PRINCIPAL EXECUTIVE OFFICER
I, Nasrat Hakim, certify that:
| 1. | I have reviewed this Quarterly Report on Form 10-Q for the quarter ended June 30, 2025 of Elite Pharmaceuticals, Inc. (the “Registrant”) | |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; | |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; | |
| 4. | The Registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have: |
| a. | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | |
| b. | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; | |
| c. | Evaluated the effectiveness of the Registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | |
| d. | Disclosed in this report any change in the Registrant’s internal control over financial reporting that occurred during the Registrant’s most recent fiscal quarter (the Registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Registrant’s internal control over financial reporting and |
| 5. | The Registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant’s auditors and the audit committee of the Registrant’s board of directors (or persons performing the equivalent functions): |
| a. | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant’s ability to record, process, summarize and report financial information; and | |
| b. | Any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant’s internal control over financial reporting. |
| Date: August 14, 2025 | /s/ Nasrat Hakim |
Nasrat Hakim | |
| Chief Executive Officer |
Exhibit 31.2
CERTIFICATION BY PRINCIPAL FINANCIAL OFFICER
I, Carter Ward, certify that:
| 1. | I have reviewed this Quarterly Report on Form 10-Q for the quarter ended June 30, 2025 of Elite Pharmaceuticals, Inc. (the “Registrant”) |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. | The Registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have: |
| a. | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| b. | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
| c. | Evaluated the effectiveness of the Registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| d. | Disclosed in this report any change in the Registrant’s internal control over financial reporting that occurred during the Registrant’s most recent fiscal quarter (the Registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Registrant’s internal control over financial reporting and |
| 5. | The Registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant’s auditors and the audit committee of the Registrant’s board of directors (or persons performing the equivalent functions): |
| a. | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant’s ability to record, process, summarize and report financial information; and |
| b. | Any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant’s internal control over financial reporting. |
| Date: August 14, 2025 | By: | /s/ Carter Ward |
Carter Ward | ||
| Chief Financial Officer | ||
| (Principal Accounting Officer and Principal Financial Officer) |
Exhibit 32.1
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of Elite Pharmaceuticals, Inc. (the “Registrant”) on Form 10-Q for the quarter ended June 30, 2025 filed with the Securities and Exchange Commission (the “Report”), I, Nasrat Hakim, Chief Executive Officer of the Registrant, certify, pursuant to 18 U.S. C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
Information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Registrant.
| Date: August 14, 2025 | /s/ Nasrat Hakim |
Nasrat Hakim | |
| Chief Executive Officer |
This certification has been furnished solely pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
A signed original of this written statement required by Section 906 has been provided to Elite Pharmaceuticals, Inc. and will be retained by Elite Pharmaceuticals Inc. and furnished to the Securities and Exchange Commission or its staff upon request.
Exhibit 32.2
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of Elite Pharmaceuticals, Inc. (the “Registrant”) on Form 10-Q for the quarter ended June 30, 2025 filed with the Securities and Exchange Commission (the “Report”), I, Carter Ward, Chief Financial Officer of the Registrant, certify, pursuant to 18 U.S. C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
Information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Registrant.
| Date: August 14, 2025 | By: | /s/ Carter Ward |
Carter Ward | ||
| Chief Financial Officer | ||
| (Principal Accounting Officer and Principal Financial Officer) |
This certification has been furnished solely pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
A signed original of this written statement required by Section 906 has been provided to Elite Pharmaceuticals, Inc. and will be retained by Elite Pharmaceuticals Inc. and furnished to the Securities and Exchange Commission or its staff upon request.