Item 1. Financial Statements
ITEM
1. FINANCIAL STATEMENTS
September 30, 2025
March 31, 2025
(Unaudited)
ASSETS
Current assets:
Cash
$ 26,617,346
$ 11,315,385
Accounts receivable, net of allowance for expected credit losses of $ 1,240,555 and $ 387,533 respectively
40,871,924
29,207,028
Inventory
18,164,934
16,240,376
Prepaid expenses and other current assets
139,494
976,358
Total current assets
85,793,698
57,739,147
Property and equipment, net of accumulated depreciation of $ 17,579,504 and $ 17,028,700 respectively
10,097,979
10,327,245
Intangible assets
5,637,802
5,637,802
Finance lease - right-of-use asset, net of accumulated depreciation of $ 740,487 and $ 501,541 respectively
1,532,547
1,771,494
Operating lease - right-of-use asset
1,770,693
2,000,284
Deferred income tax asset
11,804,166
18,365,748
Other assets:
Restricted cash - debt service for NJEDA bonds
463,240
453,776
Security deposits
147,686
91,981
Total other assets
610,926
545,757
Total assets
$ 117,247,811
$ 96,387,477
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$ 3,424,625
$ 2,957,584
Accrued expenses
6,152,304
3,795,227
Deferred revenue
—
5,556
Bonds payable, current portion, net of bond issuance costs
135,822
125,822
Loans payable, current portion
95,529
120,744
Related party loans payable
—
4,000,000
Lease obligation - finance lease, current portion
361,723
363,112
Lease obligation - operating lease, current portion
503,513
472,390
Total current liabilities
10,673,516
11,840,435
Long-term liabilities:
Bonds payable, net of current portion and bond issuance costs
644,470
787,381
Loans payable, net of current portion and loan costs
2,200,343
2,245,743
Lease obligation - finance lease, net of current portion
1,062,473
1,247,621
Lease obligation - operating lease, net of current portion
1,292,960
1,552,075
Derivative financial instruments - warrants
39,789,081
25,199,193
Total long-term liabilities
44,989,327
31,032,013
Total liabilities
55,662,843
42,872,448
Commitments and Contingencies (Note 9)
-
Shareholders’ equity:
Common Stock; par value $ 0.001 ; 1,445,000,000 shares authorized; 1,073,463,108 and 1,068,463,108 shares issued as of September 30, 2025 and March 31, 2025, respectively; 1,073,363,108 and 1,068,363,108 shares outstanding as of September 30, 2025 and March 31, 2025, respectively
1,073,467
1,068,467
Additional paid-in capital
173,704,576
173,457,329
Treasury stock; 100,000 shares as of both September 30, 2025 and March 31, 2025, at cost
( 306,841 )
( 306,841 )
Accumulated deficit
( 112,886,234 )
( 120,703,926 )
Total shareholders’ equity
61,584,968
53,515,029
Total liabilities and shareholders’ equity
$ 117,247,811
$ 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
2025
2024
For the Three Months Ended
September 30,
For the Six Months Ended
September 30,
2025
2024
2025
2024
Revenue:
Manufacturing fees
$ 36,196,254
$ 18,225,190
$ 75,974,017
$ 36,669,108
Licensing fees
125,450
655,155
558,784
1,014,300
Total revenue
36,321,704
18,880,345
76,532,801
37,683,408
Cost of manufacturing
22,248,671
10,682,917
35,233,798
21,011,202
Gross profit
14,073,033
8,197,428
41,299,003
16,672,206
Operating expenses:
Research and development
1,385,306
1,966,094
3,060,270
4,129,621
General and administrative
4,029,199
2,273,744
7,433,283
4,242,898
Non-cash compensation through issuance of stock options
49,918
52,329
102,247
104,658
Depreciation and amortization
394,864
420,318
789,750
846,030
Total operating expenses
5,859,287
4,712,485
11,385,550
9,323,207
Income from operations
8,213,746
3,484,943
29,913,453
7,348,999
Other income (expense):
Change in fair value of derivative financial instruments - warrants
7,519,649
( 12,754,735 )
( 14,589,888 )
( 15,537,648 )
Interest expense and amortization of debt issuance costs
( 82,470 )
( 255,136 )
( 241,396 )
( 505,917 )
Interest income
4,922
5,902
9,464
11,292
Other income
34,500
—
34,500
12,000
Other income (expense), net
7,476,601
( 13,003,969 )
( 14,787,320 )
( 16,020,273 )
Income (loss) before income taxes
15,690,347
( 9,519,026 )
15,126,133
( 8,671,274 )
Income tax expense
( 1,987,940 )
( 1,517,203 )
( 7,308,441 )
( 1,749,182 )
Net income (loss) attributable to common shareholders
$ 13,702,407
$ ( 11,036,229 )
$ 7,817,692
$ ( 10,420,456 )
Basic net income (loss) per share attributable to common shareholders
$ 0.01
$ ( 0.01 )
$ 0.01
$ ( 0.01 )
Diluted net income (loss) per share attributable to common shareholders
$ 0.01
$ ( 0.01 )
$ 0.01
$ ( 0.01 )
Basic weighted average Common Stock outstanding
1,071,897,174
1,068,273,108
1,070,180,140
1,068,273,108
Diluted weighted average Common Stock outstanding
1,141,536,381
1,068,273,108
1,081,817,730
1,068,273,108
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)
Shares
Amount
Shares
Amount
Capital
Shares
Amount
Deficit
Equity
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
Shares issued pursuant to exercise of employee stock options
—
—
5,000,000
5,000
145,000
—
—
—
150,000
Net income
—
—
—
—
—
—
—
13,702,407
13,702,407
Non-cash compensation through the issuance of employee stock options
—
—
—
—
49,918
—
—
—
49,918
Balance at September 30, 2025
—
$ —
1,073,463,108
$ 1,073,467
$ 173,704,576
100,000
$ ( 306,841 )
$ ( 112,886,234 )
$ 61,584,968
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 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, 2024
—
$ —
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
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
Net loss
—
—
—
—
—
—
—
( 11,036,229 )
( 11,036,229 )
Net income (loss)
—
—
—
—
—
—
—
( 11,036,229 )
( 11,036,229 )
Non-cash compensation through the issuance of employee stock options
—
—
—
—
52,329
—
—
—
52,329
Balance at September 30, 2024
—
$ —
1,068,373,108
$ 1,068,377
$ 173,315,207
100,000
$ ( 306,841 )
$ ( 126,809,723 )
$ 47,267,020
Balance
—
$ —
1,068,373,108
$ 1,068,377
$ 173,315,207
100,000
$ ( 306,841 )
$ ( 126,809,723 )
$ 47,267,020
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
F- 4
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
2025
2024
For the Six Months Ended
September 30,
2025
2024
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income (loss)
$ 7,817,692
$ ( 10,420,456 )
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
Depreciation and amortization
550,804
622,947
Provision for losses on accounts receivable
750,075
24,584
Amortization of operating leases - right-of-use assets
229,592
266,177
Amortization of finance leases - right-of-use assets
238,946
223,088
Amortization of debt discount - bonds offering costs
7,089
7,089
Loss on asset disposal
—
121,481
Change in fair value of derivative financial instruments - warrants
14,589,888
15,537,648
Deferred tax expense
6,561,582
1,317,391
Non-cash compensation through the issuance of employee stock options
102,247
104,658
Change in operating assets and liabilities:
Accounts receivable
( 12,414,971 )
( 2,014,838 )
Inventory
( 1,924,558 )
( 1,234,481 )
Prepaid expenses and other current assets
836,864
587,233
Security deposits
( 55,705 )
—
Accounts payable
467,041
( 731,026 )
Accrued expenses
2,357,077
401,717
Deferred revenue
( 5,556 )
( 6,667 )
Lease obligations - operating leases
( 227,992 )
( 205,238 )
Net cash provided by operating activities
19,880,115
4,601,307
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment
( 321,538 )
( 870,972 )
Purchase of intangible assets
—
( 900,000 )
Proceeds from disposition of property and equipment
—
125,250
Net cash used in investing activities
( 321,538 )
( 1,645,722 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Payment of bond principal
( 140,000 )
( 130,000 )
Payments of related party loans payable
( 4,000,000 )
—
Payments on principal on finance lease obligations
( 186,537 )
( 158,179 )
Proceeds from exercise of stock options
150,000
—
Loan payments
( 70,615 )
( 207,413 )
Net cash used in financing activities
( 4,247,152 )
( 495,592 )
Net change in cash and restricted cash
15,311,425
2,459,993
Cash and restricted cash, beginning of period
11,769,161
7,539,094
Cash and restricted cash, end of period
$ 27,080,586
$ 9,999,087
Supplemental disclosure of cash and non-cash transactions:
Cash paid for interest
$ 128,920
$ 367,135
Cash paid for income taxes
$ 796,101
$ 496,262
Finance directors and officers insurance premium
$ —
$ 198,457
Recognition of finance lease right of use asset and lease liabilities entered into
$ —
$ 153,870
Reconciliation of cash and restricted cash
Cash
$ 26,617,346
$ 9,554,963
Restricted cash - debt service for NJEDA bonds
463,240
444,124
Total cash and restricted cash shown in statement of cash flows
$ 27,080,586
$ 9,999,087
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
F- 5
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, infection, and Parkinson’s disease. 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 six months ended September 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 six
months ended September 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.
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 and six months ended September
30, 2025 and 2024, the Company has only engaged in business activities in a single operating segment.
F- 6
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
There
are currently no intersegment revenues. Asset information by operating segment is not presented below since the chief operating decision
maker does not review this information by segment. The reporting segments follow the same accounting policies used in the preparation
of the Company’s condensed 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.
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 ensuring that the product is produced in accordance with the related supply agreement,
and fulfilling the promise to deliver the product and bearing the 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.
F- 7
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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 September 30, 2025.
In
accordance with ASC 606-10-55-65, royalties are recognized when the subsequent sale of the customer’s products occurs.
Disaggregation
of revenue
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 six months ended September 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 six months ended September 30, 2025 and 2024, the Company has only engaged in business
activities in a single operating segment.
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 September 30, 2025, and March 31, 2025, the Company had $ 463,240 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.
F- 8
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The
Company recognizes the benefit of an uncertain tax position that it has taken or expects to take on income tax returns it files if such
tax position is more likely than not to be sustained on examination by the taxing authorities, based on the technical merits of the position.
These tax benefits are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate resolution .
The
Company operates in multiple tax jurisdictions within the United States of America. The Company remains subject to examination in all
tax jurisdiction until the applicable statutes of limitation expire. As of September 30, 2025, a summary of the tax years that remain
subject to examination in our major tax jurisdictions is: United States – Federal, 2021 and forward. The Company did not record
unrecognized tax positions for the six months ended September 30, 2025.
Earnings
(Loss) Per Share Attributable to Common Shareholders’
The
Company follows ASC 260, Earnings Per Share , which requires presentation of basic and diluted income (loss) 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 income (loss) per share is computed by dividing net income (loss) by
the weighted average number of shares of Common Stock outstanding during the period. The computation of diluted net income (loss)
per share includes the assumed exercise of options and warrants if the effect is dilutive. The assumed exercise of the Series J
Warrants was dilutive for the three months ended September 30, 2025, and is therefore included in the diluted EPS calculation for
that period. However, for the six months ended September 30, 2025, the assumed exercise of the Series J Warrants would have an
antidilutive effect and is therefore excluded from the diluted EPS calculation.
As
the Company was in a net loss position for the three and six months ended September 30, 2024, the potential dilution from the Series
J Warrants converting into 79,008,661 shares of Common Stock and the stock options converting into 10,640,000 shares of Common Stock
for these periods have been excluded from the number of shares used in calculating diluted net income (loss) per share as their inclusion
would have been antidilutive. The assumed exercise of the Series J Warrants would have an antidilutive effect for the three and six months
ended September 30, 2024.
The
following is the computation of net income (loss) per share applicable to common shareholders for the periods indicated:
SCHEDULE
OF EARNINGS PER SHARE APPLICABLE TO COMMON SHAREHOLDERS
2025
2024
2025
2024
For the Three Months Ended
September 30,
For the Six Months Ended
September 30,
2025
2024
2025
2024
Numerator
Net income (loss) - basic
$ 13,702,407
$ ( 11,036,229 )
$ 7,817,692
$ ( 10,420,456 )
Effect of dilutive instrument on net income
( 7,519,649 )
—
—
—
Net income (loss) - diluted
$ 6,182,758
$ ( 11,036,229 )
$ 7,817,692
$ ( 10,420,456 )
Denominator
Weighted average shares of Common Stock outstanding - basic
1,071,897,174
1,068,273,108
1,070,180,140
1,068,273,108
Dilutive effect of stock options and convertible securities
69,639,207
—
11,637,590
—
Weighted average shares of Common Stock outstanding - diluted
1,141,536,381
1,068,273,108
1,081,817,730
1,068,273,108
Net income (loss) per share
Basic
$ 0.01
$ ( 0.01 )
$ 0.01
$ ( 0.01 )
Diluted
$ 0.01
$ ( 0.01 )
$ 0.01
$ ( 0.01 )
F- 9
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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”). 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.
In
July 2025, the FASB issued ASU 2025-05, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses for Accounts
Receivable and Contract Assets . The ASU introduces a practical expedient and an accounting policy election to simplify the estimation
of expected credit losses for current accounts receivable and current contract assets arising from transactions accounted for under ASC
606. The practical expedient allows entities to assume that conditions at the balance sheet date remain unchanged for the asset’s
remaining life when preparing forecasts as part of estimating expected credit losses. The ASU is effective for fiscal years beginning
after December 15, 2025, and is to be adopted on a prospective basis. Early adoption is permitted. The Company is currently evaluating
the impact of this standard on its 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.
NOTE
2. INVENTORY
Inventory
consisted of the following:
SCHEDULE OF INVENTORY
September 30, 2025
March 31, 2025
Finished goods
$ 5,342,146
$ 4,816,458
Work-in-progress
2,262,444
1,422,005
Raw materials
10,560,344
10,001,913
Inventory
$ 18,164,934
$ 16,240,376
NOTE
3. PROPERTY AND EQUIPMENT, NET
Property
and equipment consisted of the following:
SCHEDULE OF PROPERTY AND EQUIPMENT
September 30, 2025
March 31, 2025
Land, building and improvements
$ 11,649,918
$ 11,649,918
Laboratory, manufacturing, warehouse and transportation equipment
15,097,546
14,776,008
Office equipment and software
373,601
373,601
Furniture and fixtures
556,418
556,418
Property and equipment, gross
27,677,483
27,355,945
Less: Accumulated depreciation
( 17,579,504 )
( 17,028,700 )
Property and equipment, net
$ 10,097,979
$ 10,327,245
Depreciation
expense was $ 275,391 and $ 227,356 for the three months ended September 30, 2025 and 2024, respectively, and $ 550,804 and $ 622,947 for
the six months ended September 30, 2025 and 2024, respectively.
F- 10
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
NOTE
4. INTANGIBLE ASSETS
The
following table summarizes the Company’s intangible assets as of and for the periods ended September 30, 2025 and March 31, 2025:
SCHEDULE OF INTANGIBLE ASSETS
September 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
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.
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 six months ended September 30,
2025 or the six months ended September 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).
F- 11
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
NOTE
5. ACCRUED EXPENSES
As
of September 30, 2025 and March 31, 2025, the Company’s accrued expenses consisted of the following:
SCHEDULE OF ACCRUED EXPENSES
September
30, 2025
March
31, 2025
Co-development
profit split
$ 4,263,410
$ 2,617,210
Employee bonuses
498,837
121,885
Income tax
268,311
340,614
Legal and professional expense
279,013
55,000
Audit fees
250,000
75,000
Director dues
22,500
22,500
Salaries and fees payable
180,628
172,655
Other accrued expenses
389,605
290,363
Accrued
interest - related parties
—
100,000
Total
accrued expenses
$ 6,152,304
$ 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”). 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.
The
following tables summarize the Company’s bonds payable liability:
SCHEDULE OF BONDS PAYABLE LIABILITY
September
30, 2025
March
31, 2025
Gross
bonds payable
NJEDA
Bonds - Series A Notes
$ 850,000
$ 990,000
Less:
Current portion of bonds payable (prior to deduction of bond offering costs)
( 150,000 )
( 140,000 )
Long-term
portion of bonds payable (prior to deduction of bond offering costs)
$ 700,000
$ 850,000
Bond offering
costs
$ 354,454
$ 354,454
Less:
Accumulated amortization
( 284,746 )
( 277,657 )
Bond
offering costs, net
$ 69,708
$ 76,797
Current
portion of bonds payable - net of bond offering costs
Current
portions of bonds payable
$ 150,000
$ 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
$ 135,822
$ 125,822
Long
term portion of bonds payable - net of bond offering costs
Long term
portion of bonds payable
$ 700,000
$ 850,000
Less:
Bond offering costs to be amortized subsequent to the next 12 months
( 55,530 )
( 62,619 )
Long
term portion of bonds payable, net of bond offering costs
$ 644,470
$ 787,381
F- 12
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Amortization
expense was $ 3,545 and $ 3,545 for the three months ended September 30, 2025 and 2024, respectively, and $ 7,089 and $ 7,089 for the six
months ended September 30, 2025 and 2024, respectively. Interest payable was $ 4,604 and $ 5,363 as of September 30, 2025 and March 31,
2025, respectively. Interest expense was $ 15,329 and $ 18,200 for the three months ended September 30, 2025 and 2024, respectively, and
$ 31,417 and $ 39,785 for the six months ended September 30, 2025 and 2024, respectively.
Maturities
of bonds for the next five years are as follows:
SCHEDULE OF MATURITIES OF BONDS
Years
ending March 31,
Amount
Remainder of 2026
$ —
2027
150,000
2028
160,000
2029
170,000
2030
180,000
Thereafter
190,000
Total
$ 850,000
NOTE
7. LOANS PAYABLE
Loans
payable consisted of the following:
SCHEDULE OF LOANS PAYABLE
September
30, 2025
March
31, 2025
Mortgage loan
payable 4.75 % interest and maturing June 2032
$ 2,290,931
$ 2,334,163
Equipment and insurance financing
loans payable, between 5.99 % and 12.02 % interest and maturing between July 2024 and October 2025
4,941
32,324
Less:
Current portion of loans payable
( 95,529 )
( 120,744 )
Long-term
portion of loans payable
$ 2,200,343
$ 2,245,743
The
interest expense associated with the loans payable was $ 28,237 and $ 33,135 for the three months ended September 30, 2025 and 2024, respectively,
and $ 57,034 and $ 68,017 for the six months ended September 30, 2025 and 2024, respectively.
F- 13
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Loan
principal payments for the next five years are as follows:
SCHEDULE OF LOAN PRINCIPAL PAYMENTS
Future
principal balances
Years
ending March 31,
Amount
Remainder of 2026
$ 50,130
2027
92,772
2028
94,433
2029
98,447
2030
103,817
Thereafter
1,856,273
Total
remaining principal balance
$ 2,295,872
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 September 30, 2025 and 2024, interest expense
on the Hakim Promissory Note totaled $ 0 and $ 75,000 , respectively. For the six months ended September 30, 2025 and 2024, interest expense
on the Hakim Promissory Note totaled $ 50,000 and $ 142,500 , 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 September 30, 2025 and 2024, interest expense on the Caskey Promissory Note totaled $ 0 and $ 25,000 , respectively.
For the six months ended September 30, 2025 and 2024, interest expense on the Caskey Promissory Note totaled $ 25,000 and $ 47,500 , 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 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. On June 17, 2025 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. On September 2, 2025 Purdue filed an Opposition to Defendants’ Motion to Dismiss Plantiffs’
Second Amended Complaint and Cross-Motion to Extend the 30-Month Stay. On September 29, 2025 Elite filed a Reply memorandum in Support
of their Motion to Dismiss and in Opposition to Plantiffs’ Cross Motion to Extend the 30-Month Stay.
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 September
30, 2025, the results of such proceedings cannot be predicted with certainty and are neither probable nor estimable.
F- 14
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 $ 1.1 million. 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 to 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 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 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- 15
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
Lease
2025
2024
2025
2024
For
the Three Months Ended
September
30,
For
the Six Months Ended
September
30,
Lease
2025
2024
2025
2024
Ludlow-144
158,317
151,515
316,634
303,030
Pompano-2311
—
8,087
—
16,175
NBV-610
4,562
—
9,125
—
Rent expense
4,562
—
9,125
—
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
$ 328,934
$ 257,773
$ 586,707
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
( 306,134 )
( 248,850 )
( 554,984 )
Present
value of lease payments
$ 1,796,473
$ 1,424,196
$ 3,220,669
The
weighted-average remaining lease term and the weighted-average discount rate of our leases were as follows:
SCHEDULE OF WEIGHTED -AVERAGE REMAINING TERM AND THE WEIGHTED-AVERAGE DISCOUNT RATE
For
the Six Months Ended
September
30,
Lease
Term and Discount Rate
2025
2024
Remaining lease term (years)
Operating
leases
3.1
4.2
Finance
leases
3.4
4.3
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.
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 September 30, 2025 and March 31, 2025.
F- 16
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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 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
September
30, 2025
March
31, 2025
Fair value of
the Company’s Common Stock
$ 0.6401
$ 0.4350
Volatility
77.30 %
82.80 %
Initial exercise price
$ 0.1521
$ 0.1521
Warrant term (in years)
1.6
2.1
Risk free rate
3.60 %
3.89 %
The
changes in warrants (Level 3 financial instruments) measured at fair value on a recurring basis were as follows for the periods ended
September 30, 2025 and 2024:
SCHEDULE OF CHANGES IN WARRANTS MEASURED AT FAIR VALUE ON A RECURRING BASIS
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
Change
in fair value of derivative financial instruments - warrants
( 7,519,649 )
Balance at September
30, 2025
$ 39,789,081
Balance at March 31, 2024
$ 6,298,008
Change
in fair value of derivative financial instruments - warrants
2,782,913
Balance at June 30, 2024
9,080,921
Change
in fair value of derivative financial instruments - warrants
12,754,735
Balance at September
30, 2024
$ 21,835,656
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
Value Measurement
Fair
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
14,589,888
—
—
14,589,888
Balance
as of September 30, 2025
$ 39,789,081
$ —
$ —
$ 39,789,081
Amount at
Fair
Value Measurement
Fair
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
15,537,648
—
—
15,537,648
Balance
as of September 30, 2024
$ 21,835,656
$ —
$ —
$ 21,835,656
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.
F- 17
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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 plans for the six months ended September
30, 2025 is as follows:
SCHEDULE OF STOCK OPTION PLAN
Weighted
Weighted
Average
Aggregate
Shares
Average
Remaining
Contractual
Intrinsic
Underlying
Options
Exercise
Price
Term
(in years)
Value
Outstanding
at March 31, 2025
15,640,000
$ 0.05
7.8
$ 6,000,552
Granted
—
—
—
$ —
Exercised
( 5,000,000 )
0.03
—
$ —
Expired
and Forfeited
—
—
—
$ —
Outstanding at September
30, 2025
10,640,000
$ 0.06
7.3
$ 6,157,816
Exercisable at September
30, 2025
6,400,001
$ 0.07
7.2
$ 3,678,662
The
aggregate intrinsic value for outstanding options is calculated as the difference between the exercise price of the underlying awards
and the quoted price of the Company’s Common Stock as of September 30, 2025 of $ 0.64 for those awards with strike prices lower
than the quoted price of the Company’s Common Stock as of September 30, 2025. As of September 30, 2025, there was $ 125,919 in unrecognized
stock-based compensation expense that will be recognized over a weighted average 0.88 year period.
NOTE
13. CONCENTRATIONS AND CREDIT RISK
Revenues
Three
customers accounted for approximately 81 % of the Company’s revenues for the six months ended September 30, 2025. These three customers
accounted for approximately 64 %, 9 %, and 8 % of revenues, respectively.
Three
customers accounted for approximately 72 % of the Company’s revenues for the six months ended September 30, 2024. These three customers
accounted for approximately 42 %, 22 %, and 8 % of revenues, respectively.
Accounts
Receivable
Three
customers accounted for approximately 88 % of the Company’s accounts receivable as of September 30, 2025. These three customers
accounted for approximately 76 %, 8 %, and 4 % of accounts receivable, respectively.
Two
customers accounted for approximately 70 % of the Company’s accounts receivable as of September 30, 2024. These two customers accounted
for approximately 46 % and 24 % of accounts receivable, respectively.
Purchasing
Three
suppliers accounted for approximately 73 % of the Company’s purchases of raw materials for the six months ended September 30, 2025.
These three suppliers accounted for approximately 38 %, 21 %, and 14 % of purchasing, respectively.
Two
suppliers accounted for approximately 60 % of the Company’s purchases of raw materials for the six months ended September 30, 2024.
These two suppliers accounted for approximately 43 %, and 17 %, 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.
F- 18
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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”). The Company’s
CODM is the 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
2025
2024
For
the Three Months Ended
September
30,
For
the Six Months Ended
September
30,
2025
2024
2025
2024
Operating
Income by Segment
ANDA
$ 12,687,727
$ 6,231,334
$ 38,238,733
$ 12,542,585
Operating
income by Segment
$ 12,687,727
$ 6,231,334
$ 38,238,733
$ 12,542,585
The
Company notes that there was no revenue related to the NDA segment for the three and six months ended September 30, 2025 and 2024.
The
table below reconciles the Company’s operating income by segment to income before income taxes as reported in the Company’s
condensed consolidated statements of operations:
SCHEDULE OF OPERATING INCOME BY SEGMENT TO INCOME FROM OPERATIONS
2025
2024
2025
2024
For
the Three Months Ended
September
30,
For
the Six Months Ended
September
30,
2025
2024
2025
2024
Operating income
by segment
$ 12,687,727
$ 6,231,334
$ 38,238,733
$ 12,542,585
Corporate
unallocated costs
( 4,029,199 )
( 2,273,744 )
( 7,433,283 )
( 4,242,898 )
Interest
income
4,922
5,902
9,464
11,292
Interest
expense and amortization of debt issuance costs
( 82,470 )
( 255,136 )
( 241,396 )
( 505,917 )
Depreciation
and amortization expense
( 394,864 )
( 420,318 )
( 789,750 )
( 846,030 )
Non-cash
compensation through issuance of stock options
( 49,918 )
( 52,329 )
( 102,247 )
( 104,658 )
Change
in fair value of derivative instruments
7,519,649
( 12,754,735 )
( 14,589,888 )
( 15,537,648 )
Other
income
34,500
—
34,500
12,000
Income
(loss) before income taxes
$ 15,690,347
$ ( 9,519,026 )
$ 15,126,133
$ ( 8,671,274 )
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 has agreed to be Elite’s partner with respect to Amphetamine
IR and ER and has agreed to assume all the rights and obligations for these products from Praxgen. Mikah was founded in 2009 by Nasrat Hakim,
a related party and the Company’s President, Chief Executive Officer and Chairman of the Board.
In
June 2021, the Company entered into a development and license agreement with Mikah, pursuant to which Mikah will engage in the research,
development, sales and licensing of generic pharmaceutical products. In addition, Mikah will collaborate to develop and commercialize
generic products including formulation development, analytical method development, manufacturing, sales and marketing of generic products.
Initially two generic products were identified for the parties to develop.
As
of September 30, 2025, the Company owes an aggregate of $ 4,263,410 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 $ 1,987,940
and $ 1,517,203
for the three months ended September 30, 2025 and 2024, respectively. The Company’s income tax expense was $ 7,308,441 and $ 1,749,182 for the six months ended September 30, 2025 and 2024
The
Company recorded tax expense of approximately 12.7 %
and ( 15.9 ) % of
income before income tax expense, for the three months ended September 30, 2025 and 2024, respectively. The Company recorded tax
expense of approximately 48.3 %
and ( 20.2 ) %
of income before income tax expense, for the six months ended September 30, 2025 and 2024, respectively. The Company’s
effective tax rate is subject to volatility as changes in the fair value adjustments in the Company’s derivative
liabilities significantly impact pre-tax earnings.
On
July 4, 2025, tax legislation known as the One Big Beautiful Bill Act (“OBBBA”) was enacted in the United States. The Company
has evaluated the impact of U.S. tax law changes introduced by OBBBA on its consolidated financial statements and the impact to the current
year’s financial statements is not material.
NOTE
17. SUBSEQUENT EVENTS
FDA approval for generic
Requip XL ®
On November 12, 2025,
the Company announced that it received approval from the FDA for an ANDA for a generic version of Requip XL® (Ropinirole Extended-Release
Tablets USP), with strengths of 2mg, 4mg, 6mg, 8mg and 12mg tablets. Ropinirole belongs to a class of drugs known as non-ergoline dopamine
agonist used to treat symptoms of Parkinson’s disease. This product will be marketed and sold under the Elite Laboratories, Inc.
label.
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.