Item 1. Financial Statements
ITEM
1. FINANCIAL STATEMENTS
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
CONDENSED
CONSOLIDATED BALANCE SHEETS
June
30, 2025
March
31, 2025
(Unaudited)
ASSETS
Current assets:
Cash
$ 21,737,797
$ 11,315,385
Accounts receivable, net
of allowance for expected credit losses of approximately $ 598,958 and $ 387,533 respectively
36,218,671
29,207,028
Inventory
19,356,728
16,240,376
Prepaid
expenses and other current assets
547,904
976,358
Total current assets
77,861,100
57,739,147
Property and equipment,
net of accumulated depreciation of $ 17,304,113 and $ 17,028,700 respectively
10,270,036
10,327,245
Intangible assets
5,637,802
5,637,802
Finance lease - right-of-use
asset
1,652,021
1,771,494
Operating lease - right-of-use
asset
1,886,899
2,000,284
Deferred income tax asset
13,481,213
18,365,748
Other assets:
Restricted cash - debt
service for NJEDA bonds
458,318
453,776
Security
deposits
91,981
91,981
Total
other assets
550,299
545,757
Total
assets
$ 111,339,370
$ 96,387,477
LIABILITIES AND SHAREHOLDERS’
EQUITY
Current liabilities:
Accounts payable
$ 5,088,869
$ 2,957,584
Accrued expenses
4,581,743
3,795,227
Deferred revenue
2,222
5,556
Bonds payable, current
portion, net of bond issuance costs
125,822
125,822
Loans payable, current
portion
104,799
120,744
Related party loans payable
(Note 8)
—
4,000,000
Lease obligation - finance
lease, current portion
371,443
363,112
Lease
obligation - operating lease, current portion
487,759
472,390
Total current liabilities
10,762,657
11,840,435
Long-term liabilities:
Bonds payable, net of current
portion and bond issuance costs
790,926
787,381
Loans payable, net of current
portion and loan costs
2,223,181
2,245,743
Lease obligation - finance
lease, net of current portion
1,147,113
1,247,621
Lease obligation - operating
lease, net of current portion
1,424,120
1,552,075
Derivative
financial instruments - warrants
47,308,730
25,199,193
Total
long-term liabilities
52,894,070
31,032,013
Total
liabilities
63,656,727
42,872,448
Commitments and Contingencies
(Note 9)
-
-
Shareholders’ equity:
Common Stock; par value $ 0.001 ; 1,445,000,000 shares authorized; 1,068,463,108
and 1,068,463,108 shares issued as of June 30, 2025 and March 31, 2025, respectively; 1,068,363,108 and 1,068,363,108 shares outstanding
as of June 30, 2025 and March 31, 2025, respectively
1,068,467
1,068,467
Additional paid-in capital
173,509,658
173,457,329
Treasury stock; 100,000 shares as of both
June 30, 2025 and March 31, 2025, at cost
( 306,841 )
( 306,841 )
Accumulated deficit
( 126,588,641 )
( 120,703,926 )
Total
shareholders’ equity
47,682,643
53,515,029
Total
liabilities and shareholders’ equity
$ 111,339,370
$ 96,387,477
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)
2025
2024
For
the Three Months Ended June 30,
2025
2024
Revenue:
Manufacturing
fees
$ 39,777,763
$ 18,443,918
Licensing
fees
433,334
359,145
Total revenue
40,211,097
18,803,063
Cost of manufacturing
12,985,127
10,328,285
Gross profit
27,225,970
8,474,778
Operating expenses:
Research and development
1,674,964
2,163,527
General and administrative
3,404,084
1,969,154
Non-cash compensation through
issuance of stock options
52,329
52,329
Depreciation
and amortization
394,886
425,712
Total operating expenses
5,526,263
4,610,722
Income from operations
21,699,707
3,864,056
Other (expense) income:
Change in fair value of
derivative financial instruments - warrants
( 22,109,537 )
( 2,782,913 )
Interest expense and amortization
of debt issuance costs
( 158,926 )
( 250,781 )
Interest income
4,542
5,390
Other
income
—
12,000
Other expense, net
( 22,263,921 )
( 3,016,304 )
(Loss) income before income taxes
( 564,214 )
847,752
Income tax expense
( 5,320,501 )
( 231,979 )
Net (loss) income
$ ( 5,884,715 )
$ 615,773
Basic net (loss) income per share attributable
to common shareholders
$ ( 0.01 )
$ 0.00
Diluted net (loss) income per share attributable
to common shareholders
$ ( 0.01 )
$ 0.00
Basic weighted average common stock outstanding
1,068,363,108
1,068,273,108
Diluted weighted average common stock outstanding
1,068,363,108
1,076,250,204
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
—
$ —
1,068,463,108
$ 1,068,467
$ 173,457,329
100,000
$ ( 306,841 )
$ ( 120,703,926 )
$ 53,515,029
Net loss
—
—
—
—
—
—
—
( 5,884,715 )
( 5,884,715 )
Non-cash compensation through the issuance
of employee stock options
—
—
—
—
52,329
—
—
—
52,329
Balance at June 30,
2025
—
$ —
1,068,463,108
$ 1,068,467
$ 173,509,658
100,000
$ ( 306,841 )
$ ( 126,588,641 )
$ 47,682,643
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
—
$ —
1,068,373,108
$ 1,068,377
$ 173,210,549
100,000
$ ( 306,841 )
$ ( 116,389,267 )
$ 57,582,818
Balance
—
$ —
1,068,373,108
$ 1,068,377
$ 173,210,549
100,000
$ ( 306,841 )
$ ( 116,389,267 )
$ 57,582,818
Net income
—
—
—
—
—
—
—
615,773
615,773
Net income (loss)
—
—
—
—
—
—
—
615,773
615,773
Non-cash compensation through the issuance
of employee stock options
—
—
—
—
52,329
—
—
—
52,329
Balance at June 30,
2024
—
$ —
1,068,373,108
$ 1,068,377
$ 173,262,878
100,000
$ ( 306,841 )
$ ( 115,773,494 )
$ 58,250,920
Balance
—
$ —
1,068,373,108
$ 1,068,377
$ 173,262,878
100,000
$ ( 306,841 )
$ ( 115,773,494 )
$ 58,250,920
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)
2025
2024
For
the Three Months Ended June 30,
2025
2024
CASH FLOWS FROM OPERATING
ACTIVITIES:
Net (loss) income
$ ( 5,884,715 )
$ 615,773
Adjustments to reconcile net (loss) income
to net cash provided by operating activities:
Depreciation and amortization
275,413
322,103
Provision for losses on
accounts receivable
211,425
9,810
Amortization of operating
leases - right-of-use assets
113,385
133,029
Amortization of finance
leases - right-of-use assets
119,473
103,609
Amortization of debt discount
- bonds offering costs
3,545
3,544
Loss on asset disposal
—
45,599
Change in fair value of
derivative financial instruments - warrants
22,109,537
2,782,913
Deferred tax expense
4,884,535
18,209
Non-cash compensation through
the issuance of employee stock options
52,329
52,329
Change in operating assets
and liabilities:
Accounts receivable
( 7,223,068 )
( 1,042,910 )
Inventory
( 3,116,352 )
( 900,854 )
Prepaid expenses and other
current assets
428,454
286,950
Accounts payable
2,131,285
( 107,274 )
Accrued expenses
786,516
926,348
Deferred revenue
( 3,334 )
( 3,334 )
Lease
obligations - operating leases
( 112,586 )
( 101,381 )
Net
cash provided by operating activities
14,775,842
3,144,463
CASH FLOWS FROM INVESTING
ACTIVITIES:
Purchase of property and
equipment
( 218,204 )
( 778,527 )
Purchase of intangible
assets
—
( 900,000 )
Proceeds
from disposition of property and equipment
—
15,250
Net
cash used in investing activities
( 218,204 )
( 1,663,277 )
CASH FLOWS FROM FINANCING
ACTIVITIES:
Payments of related party
loans payable
( 4,000,000 )
—
Payments on principal on
finance lease obligations
( 92,177 )
( 71,329 )
Loan
payments
( 38,507 )
( 103,577 )
Net
cash used in financing activities
( 4,130,684 )
( 174,906 )
Net change in cash and restricted cash
10,426,954
1,306,280
Cash and restricted cash, beginning of period
11,769,161
7,539,094
Cash and restricted
cash, end of period
$ 22,196,115
$ 8,845,374
Supplemental disclosure of cash and non-cash
transactions:
Cash paid for interest
$ 158,926
$ 222,970
Finance directors and officers
insurance premium
$ —
$ 198,457
Reconciliation of cash and
restricted cash
Cash
$ 21,737,797
$ 8,407,152
Restricted
cash - debt service for NJEDA bonds
458,318
438,222
Total
cash and restricted cash shown in statement of cash flows
$ 22,196,115
$ 8,845,374
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:
SCHEDULE OF DISAGGREGATION OF REVENUE
2025
2024
For
the Three Months Ended June 30,
2025
2024
ANDA:
Manufacturing fees
$ 39,777,763
$ 18,443,918
Licensing fees
433,334
359,145
Total ANDA revenue
$ 40,211,097
$ 18,803,063
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 $ 458,318 and $ 453,776 , of restricted cash, respectively, related to debt service
reserve in regard to the New Jersey Economic Development Authority (“NJEDA”) bonds (see Note 6).
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.
These tax benefits are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate resolution.
The
Company operates in multiple tax jurisdictions within the United States. 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.
(Loss)
Earnings Per Share Attributable to Common Shareholders’
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 79,008,661 shares of Common Stock and the stock options converting into 15,640,000 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 79,008,661 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)
The
following is the computation of earnings per share applicable to common shareholders for the periods indicated:
SCHEDULE
OF EARNINGS PER SHARE APPLICABLE TO COMMON SHAREHOLDERS
2025
2024
For
the Three Months Ended June 30,
2025
2024
Numerator
Net (loss) income - basic
$ ( 5,884,715 )
$ 615,773
Effect
of dilutive instrument on net income
—
—
Net (loss) income -
diluted
$ ( 5,884,715 )
$ 615,773
Denominator
Weighted average shares of Common Stock outstanding - basic
1,068,363,108
1,068,273,108
Dilutive effect of stock
options
—
7,977,096
Weighted average shares of Common Stock
outstanding - diluted
1,068,363,108
1,076,250,204
Net (loss) income per share
Basic
$ ( 0.01 )
$ 0.00
Diluted
$ ( 0.01 )
$ 0.00
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:
SCHEDULE OF INVENTORY
June
30, 2025
March
31, 2025
Finished goods
$ 5,889,729
$ 4,816,458
Work-in-progress
1,997,785
1,422,005
Raw materials
11,469,214
10,001,913
Inventory
$ 19,356,728
$ 16,240,376
NOTE
3. PROPERTY AND EQUIPMENT, NET
Property
and equipment consisted of the following:
SCHEDULE OF PROPERTY AND EQUIPMENT
June
30, 2025
March
31, 2025
Land, building and improvements
$ 11,649,918
$ 11,649,918
Laboratory, manufacturing, warehouse and transportation
equipment
14,994,212
14,776,008
Office equipment and software
373,601
373,601
Furniture and fixtures
556,418
556,418
Property and equipment, gross
27,574,149
27,355,945
Less: Accumulated depreciation
( 17,304,113 )
( 17,028,700 )
Property and equipment,
net
$ 10,270,036
$ 10,327,245
Depreciation
and amortization expense was $ 275,413 and $ 322,103 for the three months ended June 30, 2025 and 2024, respectively.
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:
SCHEDULE OF INTANGIBLE ASSETS
June
30, 2025
Estimated
Useful Life
Gross
Carrying Amount
Additions
Impairment
losses
Accumulated
Amortization
Net
Book Value
Patent application costs
- *
$ 289,039
$ —
$ —
$ —
$ 289,039
ANDA acquisition costs
Indefinite
5,348,763
—
—
—
5,348,763
$ 5,637,802
$ —
$ —
$ —
$ 5,637,802
March
31, 2025
Estimated
Useful Life
Gross
Carrying Amount
Additions
Impairment
losses
Accumulated
Amortization
Net
Book Value
Patent application costs
- *
$ 289,039
$ —
$ —
$ —
$ 289,039
ANDA acquisition costs
Indefinite
6,052,189
900,000
( 1,603,426 )
—
5,348,763
$ 6,341,228
$ 900,000
$ ( 1,603,426 )
$ —
$ 5,637,802
* 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).
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 $ 900,000 in cash (the “Transaction”). The Asset Purchase
Agreement includes customary representations and warranties and various customary covenants. The closing of the Transaction occurred
on June 21, 2024.
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. No such impairment was recorded during the three months ended June 30, 2025
and the three months ended June 30, 2024.
*
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:
SCHEDULE OF ACCRUED EXPENSES
June
30, 2025
March
31, 2025
Co-development profit split
$ 1,864,456
$ 2,617,210
Income tax
753,406
340,614
Employee bonuses
554,502
121,885
Other accrued expenses
336,450
290,363
Legal and professional expense
610,000
55,000
Salaries and fees payable
167,179
172,655
Audit fees
248,250
75,000
Director dues
22,500
22,500
Accrued interest - related
parties
25,000
100,000
Total accrued expenses
$ 4,581,743
$ 3,795,227
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 $ 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 . During July 2014, the Company retired all the outstanding Series B
Notes, at par, along with all accrued interest due and owed.
In
relation to the Series A Notes, the Company is required to maintain a debt service reserve 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 6.5 %.
The NJEDA Bonds are collateralized by a first lien on the Company’s facility and equipment acquired with the proceeds of the
original and refinanced bonds. The bonds mature on September 1, 2030.
F- 11
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The
following tables summarize the NJEDA Bonds’ payable liability:
SCHEDULE OF BONDS PAYABLE LIABILITY
June
30, 2025
March
31, 2025
Gross bonds payable
NJEDA Bonds
- Series A Notes
$ 990,000
$ 990,000
Less:
Current portion of bonds payable (prior to deduction of bond offering costs)
( 140,000 )
( 140,000 )
Long-term
portion of bonds payable (prior to deduction of bond offering costs)
$ 850,000
$ 850,000
Bond offering costs
$ 354,454
$ 354,454
Less:
Accumulated amortization
( 281,202 )
( 277,657 )
Bond
offering costs, net
$ 73,252
$ 76,797
Current portion
of bonds payable - net of bond offering costs
Current portions of bonds
payable
$ 140,000
$ 140,000
Less:
Bonds offering costs to be amortized in the next 12 months
( 14,178 )
( 14,178 )
Current
portion of bonds payable, net of bond offering costs
$ 125,822
$ 125,822
Long term portion
of bonds payable - net of bond offering costs
Long term portion of bonds
payable
$ 850,000
$ 850,000
Less:
Bond offering costs to be amortized subsequent to the next 12 months
( 59,074 )
( 62,619 )
Long
term portion of bonds payable, net of bond offering costs
$ 790,926
$ 787,381
Amortization
expense was $ 3,545 and $ 3,544 for the three months ended June 30, 2025 and 2024, respectively. Interest payable was $ 21,450 and $ 5,363
as of June 30, 2025 and March 31, 2025, respectively. Interest expense was $ 16,087 and $ 18,200 for the three months ended June 30, 2025
and 2024, respectively.
Maturities
of bonds for the next five years and thereafter are as follows:
SCHEDULE OF MATURITIES OF BONDS
Years
ending March 31,
Amount
Remainder of 2026
$ 140,000
2027
150,000
2028
160,000
2029
170,000
2030
180,000
Thereafter
190,000
Total
$ 990,000
NOTE
7. LOANS PAYABLE
Loans
payable consisted of the following:
SCHEDULE OF LOANS PAYABLE
June
30, 2025
March
31, 2025
Mortgage loan payable 4.75 % interest
and maturing June 2032
$ 2,312,679
$ 2,334,163
Equipment and insurance financing loans payable,
between 5.99 % and 12.02 % interest and maturing between July 2024 and October 2025
15,301
32,324
Less: Current portion
of loans payable
( 104,799 )
( 120,744 )
Long-term portion of
loans payable
$ 2,223,181
$ 2,245,743
The
interest expense associated with the loans payable was $ 28,797 and $ 34,883 for the three months ended June 30, 2025 and 2024, respectively.
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:
SCHEDULE OF LOAN PRINCIPAL PAYMENTS
Future
principal balances
Years
ending March 31,
Amount
Remainder of 2026
$ 82,238
2027
92,772
2028
94,433
2029
98,447
2030
103,817
Thereafter
1,856,273
Total remaining principal
balance
$ 2,327,980
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 9 %
for the first year and 10 %
for an optional second year and the proceeds were used for working capital and other business purposes. The original maturity date of
the Hakim Promissory Note was June 2, 2024, with an optional second year extension. The second year extension was exercised pursuant
to the terms of the Hakim Promissory Note. For the three months ended June 30, 2025 and 2024, interest expense on the Hakim Promissory
Note totaled $ 50,000
and $ 67,500 ,
respectively, recorded on the unaudited condensed consolidated statements of operations in interest expense and amortization of debt
issuance costs. On June 2, 2025, the Hakim Promissory Note was paid in full and no balance was outstanding as of this date.
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 $ 1,000,000 and an interest rate of 9 % for the first year and 10 % for an optional
second year. The Caskey Promissory Note was subject to the same covenants as are contained in the Hakim Promissory Note. The proceeds
will be used for working capital and other business purposes. The original maturity date of the Caskey Promissory Note was June 30, 2024,
with an optional second year extension. The second year extension was exercised pursuant to the terms of the Caskey Promissory Note.
For the three months ended June 30, 2025 and 2024, interest expense on the Caskey Promissory Note totaled $ 25,000 and $ 22,500 , respectively,
recorded on the unaudited condensed consolidated statements of operations in interest expense and amortization of debt issuance costs.
On June 26, 2025, the Caskey Promissory Note was paid in full and no balance was outstanding as of this date.
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 three years , ending on September 30, 2027 .
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 five years . The 144 Ludlow Ave.
lease will expire on December 31, 2028 .
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 $ 499,775 , with the Company taking ownership of the asset on December 1,
2023. The Waters equipment lease has a term of five years , ending on November 29, 2028 . The Company also has the option to purchase the
asset at the end of the lease term for the amount of $ 1 , which is probable to be exercised.
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 $ 37,500 , with the Company taking ownership of the asset
during February 2024. The Warehouse Equipment Lease has a term of two years , ending in February 2026 . The Company also has the option
to purchase the asset at the end of the lease term for the amount of $ 1 , which is probable to be exercised.
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 $ 455,000 , with the Company taking ownership of
the asset during February 2024. The February 2024 Equipment Lease has a term of five years , ending in February 2029 . The Company will
retain ownership of the equipment at lease termination .
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 $ 1,100,000 . Each of the separate leases included in the March 2024
Equipment Leases have a term of five years , ending in March 2029 . The Company will retain ownership of all related assets at lease termination .
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 $ 153,745 . Each of
the separate leases included in the July 2024 Equipment Lease have a term of five years , ending in July 2029 . The Company will retain
ownership of all related assets at lease terminations .
A
lease is classified as a finance lease if any of the following criteria are met: (i) ownership of the underlying asset transfers to the
Company by the end of the lease term; (ii) the lease contains an option to purchase the underlying asset that the Company is reasonably
expected to exercise; (iii) the lease term is for a major part of the remaining economic life of the underlying asset; (iv) the present
value of the sum of lease payments and any residual value guaranteed by the Company equals or exceeds substantially all of the fair value
of the underlying asset; or (v) the underlying asset is of a specialized nature that it is expected to have no alternative use to the
lessor at the end of the lease term. A lease that does not meet any of the criteria to be classified as a finance lease is classified
as an operating lease. As the Company expects to exercise the option to purchase the asset at the end of the lease term, the Waters equipment
lease was determined to be a finance lease. The finance lease is included on the unaudited condensed consolidated balance sheets as Finance
lease - right-of-use asset and Lease obligation - finance lease. The finance lease costs are split between Depreciation and amortization
expense related to the asset and Interest expense and amortization of debt issuance costs on the lease liability, using the effective
rate charged by the lessor. The Company has elected to account for lease and non-lease components separately.
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:
SCHEDULE OF RENT EXPENSE STRAIGHT-LINE BASIS
For
the Three Months Ended June 30,
Lease
2025
2024
Ludlow-144
$ 154,777
$ 151,515
Pompano-2311
—
8,087
NBV-610
7,303
—
Rent expense
7,303
—
The
table below shows the future minimum rental payments, exclusive of taxes, insurance and other costs:
SCHEDULE OF FUTURE MINIMUM RENTAL PAYMENTS
Years
ending March 31,
Operating
Lease Amount
Financing
Lease Amount
Total
Remainder of 2026
$ 491,012
$ 387,506
$ 878,518
2027
667,307
484,151
1,151,458
2028
666,207
479,337
1,145,544
2029
440,159
438,045
878,204
2030
—
13,740
13,740
Less: interest
( 352,806 )
( 284,224 )
( 637,030 )
Present value of lease
payments
$ 1,911,879
$ 1,518,555
$ 3,430,435
The
weighted-average remaining lease term and the weighted-average discount rate of the Company’s leases were as follows:
SCHEDULE OF WEIGHTED -AVERAGE REMAINING TERM AND THE WEIGHTED-AVERAGE DISCOUNT RATE
For
the Three Months Ended June 30,
Lease Term
and Discount Rate
2025
2024
Remaining lease term (years)
Operating leases
3.4
4.4
Finance leases
3.6
4.6
Discount rate
Operating leases
10.0 %
10.0 %
Finance leases
9.5 %
9.5 %
NOTE
10. PREFERRED STOCK
Series
J convertible preferred stock
On
April 28, 2017, the Company created the Series J Convertible Preferred Stock (“Series J Preferred”) in conjunction with the
Certificate of Designations. A total of 50 shares of Series J Preferred were authorized, zero shares are issued and outstanding, with
a stated value of $ 1,000,000 per share and a par value of $ 0.01 .
NOTE
11. DERIVATIVE FINANCIAL INSTRUMENTS – WARRANTS
The
Company evaluates and accounts for its freestanding instruments in accordance with ASC 815, Accounting for Derivative Instruments
and Hedging Activities .
The
Company issued warrants, with a term of ten years , to affiliates in connection with an exchange agreement dated April 28, 2017, as further
described in this note below.
F- 15
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The
Company has 79,008,661 total warrants to purchase shares of Common Stock outstanding with a weighted average exercise price of $ 0.1521
as of June 30, 2025 and March 31, 2025.
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 24.0344
shares of its Series J Preferred and warrants to purchase an aggregate of 79,008,661
shares of its Common Stock (the “Series J Warrants” and, along with the Series J Preferred issued to Nasrat Hakim, the
“Securities”) in exchange for 158,017,321
shares of Common Stock owned by Nasrat Hakim. The fair value of the Series J Warrants was determined to be $ 6,474,674
upon issuance at April 28, 2017.
The
Series J Warrants are exercisable for a period of 10 years from the date of issuance, commencing April 28, 2020. The initial exercise
price is $ 0.1521 per share and the Series J Warrants can be exercised for cash or on a cashless basis, including a provision within that
provides the holder a choice of net cash settlement or settlement in shares upon a cashless exercise. The net cash settlement amount
is the cash value obtained by subtracting the then exercise price from the closing price of the Company’s Common Stock (provided
such closing price is higher than the exercise price) and multiplying the difference by the number of shares exercised. As this event
is at the holder’s option, it is considered outside of the Company’s control. As a result of the net cash settlement at the
option of the holder, such warrants are classified as liabilities and measured initially and subsequently at fair value.
The
exercise price is subject to adjustment for any issuances or deemed issuances of Common Stock or Common Stock equivalents at an effective
price below the then exercise price. The Series J Warrants also provide for other standard adjustments upon the happening of certain
customary events.
The
fair value of the Series J Warrants was calculated using a Black-Scholes model. The following assumptions were used in the Black-Scholes
model to calculate the fair value of the Series J Warrants:
SCHEDULE OF FAIR VALUE OF WARRANTS ISSUED
June
30, 2025
March
31, 2025
Fair value of the Company’s
Common Stock
$ 0.7320
$ 0.4350
Volatility
80.00 %
82.80 %
Initial exercise price
$ 0.1521
$ 0.1521
Warrant term (in years)
1.8
2.1
Risk free rate
3.72 %
3.89 %
The
changes in warrants (Level 3 financial instruments) measured at fair value on a recurring basis were as follows:
SCHEDULE OF CHANGES IN WARRANTS MEASURED AT FAIR VALUE ON A RECURRING BASIS
Balance at March 31, 2024
$ 6,298,008
Change in fair value of
derivative financial instruments - warrants
18,901,185
Balance at March 31, 2025
$ 25,199,193
Change in fair value of
derivative financial instruments - warrants
22,109,537
Balance at June 30, 2025
$ 47,308,730
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:
SCHEDULE
OF LIABILITIES MEASURED AT FAIR VALUE ON A RECURRING BASIS
Amount at Fair
Fair
Value Measurement
Value
Level
1
Level
2
Level
3
Balance as of March 31, 2025
$ 25,199,193
$ —
$ —
$ 25,199,193
Change
in fair value of derivative financial instruments - warrants
22,109,537
—
—
22,109,537
Balance as of June
30, 2025
$ 47,308,730
$ —
$ —
$ 47,308,730
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
$ 6,298,008
$ —
$ —
$ 6,298,008
Change
in fair value of derivative financial instruments - warrants
2,782,913
—
—
2,782,913
Balance as of June
30, 2024
$ 9,080,921
$ —
$ —
$ 9,080,921
NOTE
12. STOCK-BASED COMPENSATION
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 12,730,000 shares .
Under the 2024 Equity Incentive Plan, 80,000,000
options are available for grant. All options have generally been granted at a price equal to or greater than the fair market value
of the Company’s Common Stock at the date of the grant. Generally, options are granted with a vesting period of up to three
years and expire ten years from the date of grant.
The
fair value of option awards is estimated on the date of grant using the Black-Scholes option-pricing model. The exercise price of each
award is generally not less than the per share fair value in effect as of that award date. The determination of fair value using the
Black-Scholes model is affected by the Company’s share fair value as well as assumptions regarding a number of complex and subjective
variables, including expected price volatility, risk-free interest rate and projected employee share option exercise behaviors. The Company
estimates its expected volatility by using a combination of historical share price volatilities of similar companies within 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.
A
summary of the activity of Company’s 2024 Equity Incentive plan and prior equity incentive plan for the three months ended June
30, 2025:
SCHEDULE OF STOCK OPTION PLAN
Shares
Underlying
Options
Weighted
Average
Exercise Price
Weighted
Average
Remaining Contractual
Term (in years)
Aggregate
Intrinsic
Value
Outstanding at March 31, 2025
15,640,000
$ 0.05
7.8
$ 6,000,552
Granted
—
$ —
—
$ —
Exercised
—
$ —
—
$ —
Expired and Forfeited
—
$ —
—
$ —
Outstanding at June 30, 2025
15,640,000
$ 0.05
7.6
$ 10,645,632
Exercisable at June 30, 2025
9,066,668
$ 0.05
7.4
$ 6,220,922
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 $ 0.73 for those awards with strike prices lower than
the quoted price of the Company’s Common Stock as of June 30, 2025. As of June 30, 2025, there was $ 175,837 in unrecognized stock
based compensation expense that will be recognized over a weighted average 1.06 year period.
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 76 % of the Company’s revenues for the three months ended June 30, 2025. These three customers
accounted for approximately 51 %, 15 %, and 10 % of revenues, respectively.
Two
customers accounted for approximately 68 % of the Company’s revenues for the three months ended June 30, 2024. These two customers
accounted for approximately 44 % and 24 % of revenue, respectively.
Accounts
Receivable
Three
customers accounted for approximately 77 %
of the Company’s accounts receivable as of June 30, 2025. These three customers accounted for approximately 54 %, 12 %,
and 11 %
of the accounts receivable, respectively.
Two
customers accounted for approximately 74 %
of the Company’s accounts receivable as of June 30, 2024. These two customers accounted for approximately 50 %
and 24 %
of the accounts receivable, respectively.
Purchasing
Three
suppliers accounted for approximately 75 % of the Company’s purchases of raw materials for the three months ended June 30, 2025.
These three suppliers accounted for approximately 31 %, 25 %, and 19 % of purchasing, respectively.
Two
suppliers accounted for approximately 61 % of the Company’s purchases of raw materials for the three months ended June 30, 2024.
These two suppliers accounted for approximately 39 % and 22 % of purchasing, respectively.
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:
SCHEDULE OF SELECTED INFORMATION FOR REPORTABLE SEGMENTS
2025
2024
For
the Three Months Ended June 30,
2025
2024
Operating
Income by Segment
ANDA
$ 25,551,006
$ 6,311,251
Operating income by
Segment
$ 25,551,006
$ 6,311,251
The
Company notes that there was no revenue related to the NDA segment for the three months ended June 30, 2025 and 2024.
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:
SCHEDULE OF OPERATING INCOME BY SEGMENT TO INCOME FROM OPERATIONS
2025
2024
For
the Three Months Ended June 30,
2025
2024
Operating income by segment
$ 25,551,006
$ 6,311,251
Corporate unallocated costs
( 3,404,084 )
( 1,969,154 )
Interest income
4,542
5,390
Interest expense and amortization
of debt issuance costs
( 158,926 )
( 250,781 )
Depreciation and amortization
expense
( 394,886 )
( 425,712 )
Significant non-cash items
( 52,329 )
( 52,329 )
Change in fair value of
derivative instruments
( 22,109,537 )
( 2,782,913 )
Other
income
—
12,000
(Loss) income before
income taxes
$ ( 564,214 )
$ 847,752
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 $ 1,864,456 to Mikah in accordance with the agreements, with such amount being recorded
as an accrued expense on the unaudited condensed consolidated balance sheets.
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 $ 5,320,501
and $ 231,979
for the three months ended June 30, 2025 and 2024, respectively.
The Company recorded tax expense of approximately ( 943.0 )%
and 27.4 %
of income before income tax expense, for the three month period ended June 30, 2025 and 2024, respectively. The increase of the effective
tax rate for the current period as compared to the prior period is primarily due to the nondeductible fair market value change in the
Company’s warrant derivative liabilities.
NOTE
17. SUBSEQUENT EVENTS
On
July 3, 2025, Douglas Plassche exercised stock options for 2,500,000 shares of Common Stock of the Company at an exercise price of $ 0.03
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
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.