UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
FOR
THE QUARTERLY PERIOD ENDED June 30, 2026
OR
☐
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO
Commission
File Number 001-15697
Elite
Pharmaceuticals, Inc.
(Exact
name of Registrant as specified in its Charter)
Nevada
22-3542636
(State or other jurisdiction of
incorporation or organization)
(I.R.S. Employer
Identification No.)
165
Ludlow Avenue
Northvale ,
New Jersey
07647
(Address
of principal executive offices)
(Zip
Code)
Registrant’s
telephone number, including area code: (201) 750-2646
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
Trading
Symbol(s)
Name
of each exchange on which registered
Common
Stock, par value $0.001 per share
ELTP
OTCQB
Indicate
by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. YES ☒ NO ☐
Indicate
by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant
was required to submit such files). YES ☒ NO ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company,
or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller
reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer
☐
Accelerated
filer
☐
Non-accelerated
filer
☒
Smaller
reporting company
☒
Emerging
growth company
☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES ☐ NO ☒
The
number of shares outstanding of each of the registrant’s classes of common stock, as of August 13, 2026:
Common
Stock - 1,077,136,442 shares
PAGE
PART
I
FINANCIAL INFORMATION
F-1
ITEM
1.
Financial Statements
F-1
Condensed
Consolidated Balance Sheets as of June 30, 2026 (Unaudited) and March 31, 2026
F-1
Condensed Consolidated Statements of Operations for the three months ended June 30, 2026 and 2025 (Unaudited)
F-2
Condensed Consolidated Statements of Changes in Shareholders’ Equity for the three months ended June 30, 2026 and 2025 (Unaudited)
F-3
Condensed Consolidated Statements of Cash Flows for the three months ended June 30, 2026 and 2025 (Unaudited)
F-4
Notes to the Unaudited Condensed Consolidated Financial Statements
F-5
ITEM
2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
1
ITEM
3.
Quantitative and Qualitative Disclosure About Market Risk
9
ITEM
4.
Controls and Procedures
9
PART
II
OTHER INFORMATION
11
ITEM
1.
Legal Proceedings
11
ITEM
1A.
Risk Factors
11
ITEM
2.
Unregistered Sales of Equity Securities and Use of Proceeds
11
ITEM
3.
Defaults Upon Senior Securities
11
ITEM
4.
Mine Safety Disclosures
11
ITEM
5.
Other Information
11
ITEM
6.
Exhibits
12
SIGNATURES
13
i
PART
I - FINANCIAL INFORMATION
ITEM
1. FINANCIAL STATEMENTS
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
CONDENSED
CONSOLIDATED BALANCE SHEETS
June 30, 2026
March 31, 2026
(Unaudited)
ASSETS
Current assets:
Cash
$ 38,940,138
$ 29,797,800
Accounts receivable, net of allowance for expected credit losses of $ 1,280,030 and $ 1,441,523 respectively
50,441,624
59,715,676
Inventory
24,200,388
21,259,898
Prepaid expenses and other current assets
905,552
1,333,177
Total current assets
114,487,702
112,106,551
Property and equipment, net of accumulated depreciation of $ 18,353,218 and $ 18,100,243 respectively
10,737,317
10,181,328
Intangible assets
4,790,790
4,790,790
Finance lease - right-of-use asset, net of accumulated amortization of $ 1,099,587 and $ 984,801 respectively
1,180,377
1,295,163
Operating lease - right-of-use asset
1,404,216
1,529,468
Deferred income tax asset
6,501,308
7,823,039
Other assets:
Restricted cash - debt service for NJEDA bonds
475,441
471,520
Security deposits
91,981
91,981
Total other assets
567,422
563,501
Total assets
$ 139,669,132
$ 138,289,840
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$ 5,591,368
$ 6,053,444
Accrued expenses
6,429,800
10,194,222
Bonds payable, current portion, net of bond issuance costs
135,822
135,822
Loans payable, current portion
93,904
92,774
Lease obligation - finance lease, current portion
387,847
378,775
Lease obligation - operating lease, current portion
553,534
536,427
Derivative financial instruments - warrants
17,249,339
—
Total current liabilities
30,441,614
17,391,464
Long-term liabilities:
Bonds payable, net of current portion and bond issuance costs
655,103
651,559
Loans payable, net of current portion and loan costs
2,129,277
2,152,969
Lease obligation - finance lease, net of current portion
746,496
851,640
Lease obligation - operating lease, net of current portion
870,586
1,015,647
Derivative financial instruments - warrants
—
17,343,586
Total long-term liabilities
4,401,462
22,015,401
Total liabilities
34,843,076
39,406,865
Commitments and Contingencies (Note 9)
-
-
Shareholders’ equity:
Common Stock; par value $ 0.001 ; 1,445,000,000 shares authorized; 1,077,236,442 and 1,077,196,442 shares issued as of June 30, 2026 and March 31, 2026, respectively; 1,077,136,442 and 1,077,096,442 shares outstanding as of June 30, 2026 and March 31, 2026 respectively
1,077,240
1,077,200
Additional paid-in capital
173,976,332
173,943,856
Treasury stock; 100,000 shares as of both June 30, 2026 and March 31, 2026 at cost
( 306,841 )
( 306,841 )
Accumulated deficit
( 69,920,675 )
( 75,831,240 )
Total shareholders’ equity
104,826,056
98,882,975
Total liabilities and shareholders’ equity
$ 139,669,132
$ 138,289,840
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)
2026
2025
For the Three Months Ended June 30,
2026
2025
Revenue
$ 32,355,283
$ 40,211,097
Cost of manufacturing
18,847,738
12,985,127
Gross profit
13,507,545
27,225,970
Operating expenses:
Research and development
2,032,471
1,674,964
General and administrative
3,549,556
3,404,084
Non-cash compensation through issuance of stock options
28,476
52,329
Depreciation and amortization
367,761
394,886
Total operating expenses
5,978,264
5,526,263
Income from operations
7,529,281
21,699,707
Other income (expense):
Change in fair value of derivative financial instruments - warrants
94,247
( 22,109,537 )
Interest expense and amortization of debt issuance costs
( 73,103 )
( 158,926 )
Interest income
166,117
4,542
Other income (expense), net
187,261
( 22,263,921 )
Income (loss) before income taxes
7,716,542
( 564,214 )
Income tax expense
( 1,805,977 )
( 5,320,501 )
Net income (loss)
$ 5,910,565
$ ( 5,884,715 )
Basic net income (loss) per share
$ 0.01
$ ( 0.01 )
Diluted net income (loss) per share
$ 0.01
$ ( 0.01 )
Basic weighted average common stock outstanding
1,077,236,002
1,068,363,108
Diluted weighted average common stock outstanding
1,128,661,497
1,068,363,108
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, 2026
—
$ —
1,077,196,442
$ 1,077,200
$ 173,943,856
100,000
$ ( 306,841 )
$ ( 75,831,240 )
$ 98,882,975
Net income
—
—
—
—
—
—
—
5,910,565
5,910,565
Non-cash compensation through the issuance of employee stock options
—
—
—
—
28,476
—
—
—
28,476
Shares issued pursuant to exercise of employee stock options
—
—
40,000
40
4,000
—
—
—
4,040
Balance at June 30, 2026
—
$ —
1,077,236,442
$ 1,077,240
$ 173,976,332
100,000
$ ( 306,841 )
$ ( 69,920,675 )
$ 104,826,056
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
Balance
—
$ —
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 )
Net income (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
Balance
—
$ —
1,068,463,108
$ 1,068,467
$ 173,509,658
100,000
$ ( 306,841 )
$ ( 126,588,641 )
$ 47,682,643
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)
2026
2025
For
the Three Months Ended June 30
2026
2025
CASH
FLOWS FROM OPERATING ACTIVITIES:
Net
income (loss)
$ 5,910,565
$ ( 5,884,715 )
Adjustments
to reconcile net income (loss) to net cash provided by operating activities:
Depreciation
and amortization
252,975
275,413
(Recovery)
provision for losses on accounts receivable
( 161,493 )
211,425
Amortization
of operating leases - right-of-use assets
125,252
113,385
Amortization
of finance leases - right-of-use assets
114,786
119,473
Amortization
of debt discount - bonds offering costs
3,544
3,545
Change
in fair value of derivative financial instruments - warrants
( 94,247 )
22,109,537
Deferred
tax expense
1,321,731
4,884,535
Non-cash
compensation through the issuance of employee stock options
28,476
52,329
Change
in operating assets and liabilities:
Accounts
receivable
9,435,545
( 7,223,068 )
Inventory
( 2,940,490 )
( 3,116,352 )
Prepaid
expenses and other current assets
427,625
428,454
Accounts
payable
( 462,076 )
2,131,285
Accrued
expenses
( 3,764,422 )
786,516
Deferred
revenue
—
( 3,334 )
Lease
obligations - operating leases
( 127,954 )
( 112,586 )
Net
cash provided by operating activities
10,069,817
14,775,842
CASH
FLOWS FROM INVESTING ACTIVITIES:
Purchase
of property and equipment
( 808,964 )
( 218,204 )
Net
cash used in investing activities
( 808,964 )
( 218,204 )
CASH
FLOWS FROM FINANCING ACTIVITIES:
Payments
of related party loans payable
—
( 4,000,000 )
Payments
on principal on finance lease obligations
( 96,072 )
( 92,177 )
Proceeds
from exercise of stock options
4,040
—
Loan
payments
( 22,562 )
( 38,507 )
Net
cash used in financing activities
( 114,594 )
( 4,130,684 )
Net
change in cash and restricted cash
9,146,259
10,426,954
Cash
and restricted cash, beginning of period
30,269,320
11,769,161
Cash
and restricted cash, end of period
$ 39,415,579
$ 22,196,115
Supplemental
disclosure of cash and non-cash transactions:
Cash
paid for interest
$ 27,170
$ 158,926
Cash
paid for income taxes
$ 19,547
$ —
Reconciliation
of cash and restricted cash
Cash
$ 38,940,138
$ 21,737,797
Restricted
cash - debt service for NJEDA bonds
475,441
458,318
Total
cash and restricted cash shown in statement of cash flows
$ 39,415,579
$ 22,196,115
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, 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 29, 2026. The interim
results for the three months ended June 30, 2026 are not necessarily indicative of the results to be expected for the fiscal year ending
March 31, 2027 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, 2026. There were no significant changes to these accounting policies during the three
months ended June 30, 2026.
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, valuation of intangible assets, the useful life of property and equipment and identifiable intangible
assets, stock-based compensation expense and income taxes. The Company continuously evaluates its estimates, which are based on the 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 (“CODM”),
or decision-making group, in deciding how to allocate resources and in assessing performance.
F- 5
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The
Company’s CODM 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 identifies its operating and reportable segments based on the financial information regularly reviewed by its CODM for purposes of assessing operating performance, allocating resources, and making strategic decisions.
The Company’s operations consist of its generic pharmaceuticals product portfolio whose marketing approvals were secured via an
Abbreviated New Drug Application (“ANDA”). The CODM evaluates the business, manages resources, and reviews financial results
of the Company on a consolidated basis. Additionally, the Company’s ANDA products share similar economic characteristics, operating
processes, and regulatory environments, and are managed as a single business unit. Accordingly, as of June 30, 2026, the Company has
determined that it operates in a 1 single operating and reportable segment.
Asset
information by operating segment is not presented below since the chief operating decision maker does not review this information by
segment. The ANDA segment follows the same accounting policies used in the preparation of the Company’s consolidated financial
statements. Please see Note 14 for further details.
Revenue
Recognition
The
Company primarily generates revenue from manufacturing 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. The Company
also generates revenue from licensing fees from 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 Contracts 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
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 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.
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.
Selected
information on the Company’s reportable segment and the reconciliation of operating income by segment to income from operations
and to income (loss) before income taxes are disclosed within Note 14.
The
Company disaggregates manufacturing fees revenue by sales channel, consisting of revenues from direct and indirect wholesalers, which
have different cash flows and contract economics as margins generated differ between direct and indirect revenues. Additionally, although
the underlying arrangements are substantially similar, pricing to direct wholesalers yields higher margins than pricing to indirect wholesalers,
while the timing and uncertainty of cash flows do not differ materially.
Additionally,
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
following table summarizes manufacturing fees by sales channel and revenues from licensing fees for the three months ended June 30, 2026
and 2025:
SCHEDULE OF DISAGGREGATION OF REVENUE
2026
2025
For the Three Months Ended June 30,
2026
2025
Direct sales to Wholesalers
$ 16,403,265
$ 19,032,232
Indirect sales to Wholesalers
15,731,055
20,745,531
Total ANDA revenue
32,134,320
39,777,763
Licensing Fees
220,963
433,334
Total revenue
$ 32,355,283
$ 40,211,097
The
Company’s revenue-generating products consist of two categories: (i) products containing an active ingredient listed by the United
States Drug Enforcement Agency as a scheduled substance under the Controlled Substances Act of 1970 (“Scheduled Products”)
and (ii) products not containing such a scheduled active ingredient (“Unscheduled Products”). The following table summarizes
the breakdown of revenues by product category for the three months ended June 30, 2026 and 2025:
2026
2025
For the Three Months Ended June 30,
2026
2025
Scheduled Products - Manufacturing Fees
$ 27,809,738
$ 38,913,885
Scheduled Products - Licensing Fees
220,963
-
Unscheduled Products - Manufacturing Fees
4,324,582
863,878
Unscheduled Products - Licensing Fees
-
433,334
Total Revenue
$ 32,355,283
$ 40,211,097
F- 7
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Restricted
Cash
As
of June 30, 2026 and March 31, 2026, the Company had $ 475,441 and $ 471,520 , 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 of America. The Company remains subject to examination in all
tax jurisdiction until the applicable statutes of limitation expire. As of June 30, 2026, a summary of the tax years that remain subject
to examination in the Company’s major tax jurisdictions are: United States – Federal, 2022 and forward, and State, 2022 and
forward. The Company did not have any unrecognized tax positions for the three months ended June 30, 2026 and 2025.
Earnings
(Loss) Per Share
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 and stock options were dilutive for the three months
ended June 30, 2026, and are therefore included in the diluted EPS calculation for that period. For the three months ended June 30, 2026,
there were no potentially diluted shares excluded from the calculation of diluted EPS.
As
the Company was in a net loss position for the three months ended June 30, 2025, the potential dilution from the Series J Warrants converting
into 79,008,661 shares of Common Stock and the stock options converting into 15,640,000 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.
F- 8
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The
following is the computation of net income (loss) per share applicable to common shareholders for the periods indicated:
SCHEDULE OF EARNINGS (LOSS) PER SHARE APPLICABLE TO COMMON SHAREHOLDERS
2026
2025
For the Three Months Ended June 30,
2026
2025
Numerator
Net income (loss) - basic
$ 5,910,565
$ ( 5,884,715 )
Effect of dilutive instrument on net income
( 94,247 )
—
Net income (loss) - diluted
$ 5,816,318
$ ( 5,884,715 )
Denominator
Weighted average shares of Common Stock outstanding - basic
1,077,236,002
1,068,363,108
Dilutive effect of stock options and convertible securities
51,425,495
—
Weighted average shares of Common Stock outstanding - diluted
1,128,661,497
1,068,363,108
Net income (loss) per share
Basic
$ 0.01
$ ( 0.01 )
Diluted
$ 0.01
$ ( 0.01 )
Recently
Issued Accounting Pronouncements - Adopted
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. The Company adopted the ASU during the three months ending June
30, 2026 and the adoption did not have a material impact on the unaudited condensed consolidated financial statements.
Recently
Issued Accounting Pronouncements - Not Yet Adopted
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.
F- 9
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
In
December 2025, the FASB issued ASU 2025-11, Interim Reporting (Topic 270)—Narrow-Scope Improvements . The ASU clarifies the
scope of interim reporting guidance, reorganizes disclosure requirements for ease of navigation, and introduces a principle requiring
disclosure of material events occurring after the last annual reporting period but before interim financial statements are issued. The
ASU is effective for interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The Company
is currently evaluating the impact 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.
NOTE
2. INVENTORY
Inventory
consisted of the following:
SCHEDULE OF INVENTORY
June 30, 2026
March 31, 2026
Finished goods
$ 7,956,873
$ 5,389,291
Work-in-progress
2,133,372
3,267,705
Raw materials
14,110,143
12,602,902
Inventory
$ 24,200,388
$ 21,259,898
NOTE
3. PROPERTY AND EQUIPMENT, NET
Property
and equipment consisted of the following:
SCHEDULE OF PROPERTY AND EQUIPMENT
June 30, 2026
March 31, 2026
Land, building and improvements
$ 11,907,253
$ 11,649,918
Laboratory, manufacturing, warehouse and transportation equipment
16,253,263
15,701,634
Office equipment and software
373,601
373,601
Furniture and fixtures
556,418
556,418
Property and equipment, gross
29,090,535
28,281,571
Less: Accumulated depreciation
( 18,353,218 )
( 18,100,243 )
Property and equipment, net
$ 10,737,317
$ 10,181,328
Depreciation
expense was $ 252,975 and $ 275,413 for the three months ended June 30, 2026 and 2025, respectively.
NOTE
4. INTANGIBLE ASSETS
The
following table summarizes the Company’s intangible assets as of and for the periods ended June 30, 2026 and March 31, 2026:
SCHEDULE OF INTANGIBLE ASSETS
June 30, 2026
Estimated Useful Life
Gross Carrying Amount
Additions
Impairment losses
Accumulated Amortization
Net Book Value
ANDA acquisition costs
Indefinite
$ 4,790,790
$ —
$ —
$ —
$ 4,790,790
$ 4,790,790
$ —
$ —
$ —
$ 4,790,790
F- 10
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
March 31, 2026
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
—
( 557,973 )
—
4,790,790
$ 5,637,802
$ —
$ ( 847,012 )
$ —
$ 4,790,790
* Patent application
costs were incurred in relation to the Company’s abuse deterrent opioid technology. Amortization of the patent costs would have
begun upon the issuance of marketing authorization by the FDA. During the year ended March 31, 2026, these costs were impaired in full.
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, 2026
and 2025.
* Patent application costs were incurred in relation to the Company’s abuse deterrent opioid technology. Amortization of the patent costs would have begun upon the issuance of marketing authorization by the FDA. During the year ended March 31, 2026, these costs were impaired in full.
NOTE
5. ACCRUED EXPENSES
As
of June 30, 2026 and March 31, 2026, the Company’s accrued expenses consisted of the following:
SCHEDULE OF ACCRUED EXPENSES
June 30, 2026
March 31, 2026
Co-development profit split
$ 2,776,060
$ 2,616,950
Employee bonuses
1,580,813
5,285,256
Income tax
1,058,880
594,181
Legal and professional expense
174,224
282,672
Audit fees
250,000
500,000
Director dues
22,500
22,500
Salaries and fees payable
73,907
273,059
Other accrued expenses
493,416
619,604
Total accrued expenses
$ 6,429,800
$ 10,194,222
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.
F- 11
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The
following tables summarize the Company’s bonds payable liability:
SCHEDULE OF BONDS PAYABLE LIABILITY
June 30, 2026
March 31, 2026
Gross bonds payable
NJEDA Bonds - Series A Notes
$ 850,000
$ 850,000
Less: Current portion of bonds payable (prior to deduction of bond offering costs)
( 150,000 )
( 150,000 )
Long-term portion of bonds payable (prior to deduction of bond offering costs)
$ 700,000
$ 700,000
Bond offering costs
$ 354,454
$ 354,454
Less: Accumulated amortization
( 295,379 )
( 291,835 )
Bond offering costs, net
$ 59,075
$ 62,619
Current portion of bonds payable - net of bond offering costs
Current portions of bonds payable
$ 150,000
$ 150,000
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
$ 135,822
Long term portion of bonds payable - net of bond offering costs
Long term portion of bonds payable
$ 700,000
$ 700,000
Less: Bond offering costs to be amortized subsequent to the next 12 months
( 44,897 )
( 48,441 )
Long term portion of bonds payable, net of bond offering costs
$ 655,103
$ 651,559
Amortization
expense was $ 3,544 and $ 3,545 for the three months ended June 30, 2026 and 2025, respectively. Interest payable was $ 18,417 and $ 4,604
as of June 30, 2026 and March 31, 2026, respectively. Interest expense was $ 13,813 and $ 16,087 for the three months ended June 30, 2026
and 2025, respectively.
Maturities
of bonds for the next five years are as follows:
SCHEDULE OF MATURITIES OF BONDS
Years ending March 31,
Amount
Remainder of 2027
$ 150,000
2028
160,000
2029
170,000
2030
180,000
2031
190,000
Total
$ 850,000
NOTE
7. LOANS PAYABLE
Loans
payable consisted of the following:
SCHEDULE OF LOANS PAYABLE
June 30, 2026
March 31, 2026
Mortgage loan payable 4.75 % interest and maturing June 2032
$ 2,223,181
$ 2,245,743
Less: Current portion of loans payable
( 93,904 )
( 92,774 )
Long-term portion of loans payable
$ 2,129,277
$ 2,152,969
The
interest expense associated with the loans payable was $ 27,170 and $ 28,797 for the three months ended June 30, 2026 and 2025, respectively.
F- 12
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 2027
$ 70,212
2028
94,433
2029
98,447
2030
103,817
2031
109,482
Thereafter
1,746,790
Total remaining principal balance
$ 2,223,181
NOTE
8. RELATED PARTY LOANS
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. For the three months ended
June 30, 2026 there was no interest expense on the Hakim Promissory Note. For the three months ended June 30, 2025, interest
expense on the Hakim Promissory Note totaled $ 50,000
and was 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 June 2,
2025.
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. For the three months ended June 30, 2026 there was no interest expense on the Caskey Promissory
Note. For the three months ended June 30, 2025, interest on the Caskey Promissory Note totaled $25,000 and was 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 June 26, 2025.
F- 13
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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 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. The Parties agreed
to a stipulated dismissal of the case and the judge signed the order dismissing the case on June 12, 2026.
Elite’s
launch of a generic OxyContin ® will depend on the approval by the FDA.
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 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 had a term of two years , which ended in February 2026 . The Company had the option
to purchase the asset at the end of the lease term for the amount of $ 1 , which the Company 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.
F- 14
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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 $ 1,085,177 . Each of the separate leases included in the March 2024
Equipment Leases has 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 . One
of the July 2024 Equipment Leases has a term of five years , ending in July 2029 , and the other lease has a term of two years, ending
in July 2026 . 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 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.
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
2026
2025
For the Three Months Ended June 30,
Lease
2026
2025
Ludlow-144
$ 158,317
$ 154,777
NBV-610
4,563
7,303
Rent expense
4,563
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 2027
$ 501,723
$ 359,494
$ 861,217
2028
666,207
479,337
1,145,544
2029
440,159
438,045
878,204
2030
—
13,740
13,740
Total future minimum lease payments
1,608,089
1,290,616
2,898,705
Less: interest
( 183,969 )
( 156,273 )
( 340,242 )
Present value of lease payments
$ 1,424,120
$ 1,134,343
$ 2,558,463
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 Three Months Ended June 30,
Lease Term and Discount Rate
2026
2025
Remaining lease term (years)
Operating leases
2.4
3.4
Finance leases
2.7
3.6
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 .
F- 15
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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 warrants
are exercisable from the date of issuance, commencing April 28, 2020.
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, 2026 and March 31, 2026.
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
June 30, 2026
March 31, 2026
Fair value of the Company’s Common Stock
$ 0.3651
$ 0.3601
Volatility
50.90 %
63.96 %
Initial exercise price
$ 0.1521
$ 0.1521
Warrant term (in years)
0.8
1.1
Risk free rate
3.47 %
3.47 %
The
changes in warrants (Level 3 financial instruments) measured at fair value on a recurring basis were as follows for the periods ended
three months ended June 30, 2026 and 2025:
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
Balance at March 31, 2026
$
17,343,586
Change
in fair value of derivative financial instruments - warrants
( 94,247
)
Balance
at June 30, 2026
17,249,339
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
Fair Value Measurement
Amount
at Fair Value
Level 1
Level 2
Level 3
Balance as of March 31, 2026
$ 17,343,586
$ —
$ —
$ 17,343,586
Change in fair value of derivative financial instruments - warrants
( 94,247 )
—
—
( 94,247 )
Balance as of June 30, 2026
$ 17,249,339
$ —
$ —
$ 17,249,339
Fair Value Measurement
Amount
at 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
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)
NOTE
12. STOCK-BASED COMPENSATION
Under
its 2014 Equity Incentive Plan and its 2024 Equity Incentive Plan, the Company did grant and may grant stock options to officers, selected
employees, as well as members of the Board of Directors 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 . 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 plans for the three months ended June
30, 2026 is as follows:
SCHEDULE OF STOCK OPTION PLAN
Shares
Weighted
Average
Weighted
Average
Remaining
Contractual
Aggregate
Underlying
Exercise
Term
Intrinsic
Options
Price
(in years)
Value
Outstanding at March 31, 2026
6,906,666
$ 0.07
6.8
$ 2,002,996
Granted
—
$ —
—
$ —
Exercised
( 40,000 )
$ 0.10
—
$ —
Expired and Forfeited
—
$ —
—
$ —
Outstanding at June 30, 2026
6,866,666
$ 0.07
6.6
$ 2,026,965
Exercisable at June 30, 2026
5,400,000
$ 0.06
6.4
$ 1,627,492
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, 2026 of $ 0.37 for those awards with strike prices lower than
the quoted price of the Company’s Common Stock as of June 30, 2026. As of June 30, 2026, there was $ 23,183 in unrecognized stock-based
compensation expense that will be recognized over a weighted average 0.27 year period.
NOTE
13. CONCENTRATIONS AND CREDIT RISK
Revenues
Two
customers accounted for approximately 73 % of the Company’s revenues for the three months ended June 30, 2026. These customers
accounted for approximately 60 % and 13 % of revenues, respectively.
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.
F- 17
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Accounts
Receivable
Two
customers accounted for approximately 76 % of the Company’s accounts receivable as of June 30, 2026. These two customers accounted
for approximately 66 % and 10 % of receivables, respectively.
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 accounts receivable, respectively.
Purchasing
Three
suppliers accounted for approximately 78 % of the Company’s purchases of raw materials for the three months ended June 30, 2026.
These three suppliers accounted for approximately 32 %, 31 %, and 14 % of purchasing, respectively.
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.
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
income from operations, which is reported in the accompanying consolidated statements of operations, is the measure of segment profit
or loss that is regularly reviewed by the CODM. 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.
There are no significant segment expenses or other segment items that are separately provided to the CODM beyond research and development
and general and administrative expenses. The CODM does not receive segment level information related to depreciation, amortization, capital
expenditures, or other non-cash items, and therefore such items are excluded. The ANDA segment follows the same accounting policies used
in the preparation of the Company’s consolidated financial statements.
The
following represents selected information for the Company’s reportable segment:
SCHEDULE OF SELECTED INFORMATION FOR REPORTABLE SEGMENTS
2026
2025
For
the Three Months Ended June 30,
2026
2025
Operating Income by Segment
ANDA
$ 11,475,074
$ 25,551,006
Operating income by Segment
$ 11,475,074
$ 25,551,006
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 income (loss) before income taxes as reported in the Company’s
condensed consolidated statements of operations:
SCHEDULE OF OPERATING INCOME BY SEGMENT TO INCOME FROM OPERATIONS
2026
2025
For
the Three Months Ended June 30,
2026
2025
Operating income by segment
$ 11,475,074
$ 25,551,006
Corporate unallocated costs
( 3,549,556 )
( 3,404,084 )
Depreciation and amortization expense
( 367,761 )
( 394,886 )
Non-cash compensation through issuance of stock options
( 28,476 )
( 52,329 )
Income from operations
7,529,281
21,699,707
Interest income
166,117
4,542
Interest expense and amortization of debt issuance costs
( 73,103 )
( 158,926 )
Change in fair value of derivative instruments
94,247
( 22,109,537 )
Income (loss) before income taxes
$ 7,716,542
$ ( 564,214 )
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 ER and will assume all the rights and obligations for these products from Praxgen. Mikah was founded in 2009 by Nasrat Hakim,
a related party and the Company’s President, Chief Executive Officer and Chairman of the Board.
In
June 2021, the Company entered into a development and license agreement with Mikah, pursuant to which Mikah will engage in the research,
development, sales and licensing of generic pharmaceutical products. In addition, Mikah will collaborate to develop and commercialize
generic products including formulation development, analytical method development, manufacturing, sales and marketing of generic products.
Initially two generic products were identified for the parties to develop.
As
of June 30, 2026 and March 31, 2026, the Company owed an aggregate of $ 2,776,060 and $ 2,616,950 , respectively, 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 $ 1,805,977 and $ 5,320,501 for the three months ended June 30, 2026 and 2025, respectively.
The
Company recorded tax expense of approximately 23.4 % and ( 943.0 )% of income before income tax expense, for the three months ended June
30, 2026 and 2025, 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.
NOTE
17. SUBSEQUENT EVENTS
On
August 4, 2026, the Company issued a press release to announce the launch of Elite’s generic version of Requip XL® (Ropinirole
Extended-Release Tablets USP), with strengths of 2 mg, 4 mg, 6 mg, 8 mg, and 12 mg tablets. Ropinirole belongs to a class of drugs known
as a non-ergoline dopamine agonist used to treat Parkinson’s disease. This product is marketed and sold under the Elite Laboratories,
Inc. label.
F- 19
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The
following discussion of our financial condition and results of operations for the three months ended June 30, 2026 and 2025 should be
read in conjunction with our unaudited condensed consolidated financial statements and the notes to those statements that are included
elsewhere in this report. Our discussion includes forward-looking statements based upon current expectations that involve risks and uncertainties,
such as our plans, objectives, expectations and intentions. Actual results and the timing of events could differ materially from those
anticipated in these forward-looking statements as a result of a number of factors, including those set forth under Item 1A. Risk Factors
appearing in our Annual Report on Form 10-K for the year ended March 31, 2026. We use words such as “anticipate,” “estimate,”
“plan,” “project,” “continuing,” “ongoing,” “expect,” “believe,”
“intend,” “may,” “will,” “should,” “could,” and similar expressions to identify
forward-looking statements.
Unless
expressly indicated or the context requires otherwise, the terms “Elite”, the “Company”, “we”, “us”,
and “our” refer to Elite Pharmaceuticals, Inc. and subsidiary.
Background
Elite
Pharmaceuticals, Inc., a Nevada corporation (the “Company”, “Elite”, “Elite Pharmaceuticals”, the
“registrant”, “we”, “us” or “our”) was incorporated on October 1, 1997 under the laws
of the State of Delaware, and its wholly-owned subsidiary, Elite Laboratories, Inc. (“Elite Labs”), was incorporated on August
23, 1990 under the laws of the State of Delaware. On January 5, 2012, Elite Pharmaceuticals was reincorporated under the laws of the
State of Nevada.
We
are a specialty pharmaceutical company principally engaged in the development and manufacture of oral, controlled-release products, and
the manufacture of generic pharmaceuticals. Our strategy includes developing generic versions of controlled-release drug products with
high barriers to entry.
We
occupy manufacturing, warehouse, laboratory and office space at 135, 144 and 165 Ludlow Avenue in Northvale, NJ (the “Northvale
Facility”). The Northvale Facility operates under Current Good Manufacturing Practice and is a United States Drug Enforcement Agency
registered facility for research, development, and manufacturing. We are also party to an operating lease for office space at Pompano
Beach, Florida.
Strategy
We
focus our efforts on the following areas: (i) manufacturing of a line of generic pharmaceutical products with approved Abbreviated New
Drug Applications (“ANDAs”); (ii) development of additional generic pharmaceutical products; (iii) development of the other
product candidates in our pipeline including products co-developed with partners; (iv) commercial exploitation of our products either
by sales under our own label, license and the collection of royalties, or through the manufacture of our formulations; and (v) development
of new products for sale under our own label, and the expansion of our licensing agreements with other pharmaceutical companies, including
co-development projects, joint ventures and other collaborations.
We
continue to evaluate opportunities for the development of various types of drug products, including branded drug products which require
New Drug Applications (“NDAs”) under Section 505(b)(1) or 505(b)(2) of the Drug Price Competition and Patent Term Restoration
Act of 1984 as well as generic drug products which require ANDAs.
We
believe that our business strategy enables us to reduce our risk by having a diverse product portfolio.
Recent
Developments
On
April 2, 2026, we announced the commercial launch of our generic methadone hydrochloride 5 mg and 10 mg tablets. The product is marketed
and sold under the Elite Labs label and represents an expansion of the Company’s generic product portfolio.
On
June 1, 2026, we filed an Abbreviated New Drug Application with the US Food and Drug Administration for a generic version of an undisclosed
drug product in the class of medications called anticoagulants.
On
June 12, 2026, pursuant to a stipulated dismissal agreed to by both parties, the District Court of New Jersey signed an order dismissing
the patent infringement suit filed by Purdue Pharma against the Company in November 2023.
On
June 15, 2026, we reported positive results from a pivotal bioequivalence study for an undisclosed anticonvulsant generic drug product.
On
August 4, 2026, the Company issued a press release to announce the launch of Elite’s generic version of Requip XL® (Ropinirole
Extended-Release Tablets USP), with strengths of 2 mg, 4 mg, 6 mg, 8 mg, and 12 mg tablets. Ropinirole belongs to a class of drugs known
as a non-ergoline dopamine agonist used to treat Parkinson’s disease. This product is marketed and sold under the Elite Laboratories,
Inc. label.
1
Commercial
Products
We
own, license, contract manufacture or have contractual rights to receive royalties from the following products currently approved for
commercial sale:
Product
Branded
Product
Equivalent
Therapeutic
Category
Launch
Date
Phentermine HCl 37.5mg tablets (“Phentermine
37.5mg”)
Adipex-P®
Bariatric
April 2011
Phendimetrazine Tartrate 35mg tablets (“Phendimetrazine
35mg”)
Bontril®
Bariatric
November 2012
Phentermine HCl 15mg and 30mg capsules (“Phentermine
15mg” and “Phentermine 30mg”)
Adipex-P®
Bariatric
April 2013
Naltrexone HCl 50mg tablets (“Naltrexone 50mg”)
Revia®
Pain
September 2013
Isradipine 2.5mg and 5mg capsules (“Isradipine
2.5mg” and “Isradipine 5mg”)
N/A
Cardiovascular
January 2015
Trimipramine Maleate Immediate Release 25mg, 50mg and
100mg capsules (“Trimipramine 25mg”, “Trimipramine 50mg”, “Trimipramine 100mg”)
Surmontil®
Antidepressant
May 2017
Dextroamphetamine Saccharate, Amphetamine Aspartate,
Dextroamphetamine Sulfate, Amphetamine Sulfate Immediate Release 5mg, 7.5mg, 10mg, 12.5mg, 15mg, 20mg and 30mg tablets (“Amphetamine
IR 5mg”, “Amphetamine IR 7.5mg”, “Amphetamine IR 10mg”, “Amphetamine IR 12.5mg”, “Amphetamine
IR 15mg”, “Amphetamine IR 20mg” and “Amphetamine IR 30mg”)
Adderall®
Central Nervous System (“CNS”)
Stimulant
April 2019
Dantrolene Sodium Capsules 25mg, 50mg and 100mg (“Dantrolene
25mg”, “Dantrolene 50mg”, “Dantrolene 100mg”)
Dantrium®
Muscle Relaxant
June 2019
Dextroamphetamine Saccharate, Amphetamine Aspartate,
Dextroamphetamine Sulfate, Amphetamine Sulfate Extended Release 5mg, 10mg, 15mg, 20mg, 25mg, and 30mg capsules (“Amphetamine
ER 5mg”, “Amphetamine ER 10mg”, “Amphetamine ER 15mg”, “Amphetamine ER 20mg”, “Amphetamine
ER 25mg”, and “Amphetamine ER 30mg”)
Adderall XR®
Central Nervous System (“CNS”)
Stimulant
March 2020
Loxapine Succinate 5mg, 10mg, 25mg and 50gm capsules
(“Loxapine 5mg”, “Loxapine 10mg”, “Loxapine 25mg”, and Loxapine 50mg”)
Loxapine®
Antipsychotic
May 2021
Methotrexate Sodium 2.5mg tablets (“Methotrexate
2.5mg”)
Otrexup PF®
Antimetabolite
August 2024
Acetaminophen and Codeine Phosphate 300mg/15mg, 300mg/30mg,
300mg/60mg tablets (“APAP Codeine 300mg/15mg”, “APAP Codeine 300mg/30mg”, and “APAP Codeine 300mg/60mg”)
Tylenol® with Codeine
Pain
October 2024
Acetaminophen and Hydrocodone Bitartrate 325mg/2.5mg,
325mg/5mg, 325mg/7.5mg and 325mg/10mg tablets (“APAP Hydrocodone 325mg/2.5mg”, “APAP Hydrocodone 325mg/5mg”,
APAP Hydrocodone 325mg/7.5mg and APAP Hydrocodone 325mg/10mg”)
Norco®
Pain
December 2024
Lisdexamfetamine Dimesylate 10mg, 20mg, 30mg, 40mg,
50mg, 60mg and 70mg capsules (“Lisdex 10mg”, “Lisdex 20mg”, “Lisdex 30mg”, “Lisdex 40mg”,
“Lisdex 50mg”, “Lisdex 60mg” and “Lisdex 70mg”)
Vyvanse®
ADHD
December 2024
Oxycodone Hydrochloride and Acetaminophen 5mg/325mg,
7.5mg/325mg and 10mg/325mg tablets (“Oxy APAP 5/325”, “Oxy APAP 7.5/325” and “Oxy APAP 10/325”)
Percocet®
Pain
April 2025
Methadone Hydrochloride 5mg and 10mg tablets (“Methadone
5mg” and “Methadone 10mg”)
Dolophine®
Pain
April 2026
Ropinirole Extended Release 2mg, 4mg, 6mg and 12mg
tablets (“Ropinirole 2mg”, “Ropinirole 4mg”, “Ropinirole 6mg” and “Ropinirole 12mg”)
Requip XL®
Non-Ergoline Dopamine Agonist
July 2026
2
Products
Under FDA Review
SequestOx™
- Immediate Release Oxycodone with sequestered Naltrexone
SequestOx™
is our abuse-deterrent candidate for the management of moderate to severe pain where the use of an opioid analgesic is appropriate. SequestOx™
is an immediate-release Oxycodone Hydrochloride containing sequestered Naltrexone which incorporates 5mg, 10mg, 15mg, 20mg and 30mg doses
of oxycodone into capsules.
In
January 2016, the Company submitted a 505(b)(2) NDA for SequestOx™, after receiving a waiver of the $2.3 million filing fee from
the FDA. In March 2016, the Company received notification of the FDA’s acceptance of this filing and that such filing has been
granted priority review by the FDA with a target action under the Prescription Drug User Fee Act (“PDUFA”) of July 14, 2016.
On
July 15, 2016, the FDA issued a Complete Response Letter, (“CRL”), regarding the NDA. The CRL stated that the review cycle
for the SequestOx™ NDA was complete and the application is not ready for approval in its present form.
On
July 7, 2017, the Company reported topline results from a pivotal bioequivalence fed study for SequestOx™. The mean Tmax (the amount
of time that a drug is present at the maximum concentration in serum) of SequestOx™ was 4.6 hr. with a range of 0.5 hr. to 12 hr.
and the mean Tmax of the comparator, Roxicodone®, was 3.4 hr. with a range of 0.5 hr. to 12 hr. A key objective for the study was
to determine if the reformulated SequestOx™ had a similar Tmax to the comparator when taken with a high fat meal. Based on these
results, the Company paused clinical trials for this formulation of SequestOx™. On January 30, 2018, the Company reported positive
topline results from a pilot study conducted for a modified SequestOx™ wherein, based on the results of this pilot study, the modified
SequestOx™ formulation is expected to achieve bioequivalence with a Tmax range equivalent to the reference product when conducted
in a pivotal trial under fed conditions. The Company has provided the pilot data to the FDA, requesting clarification as to the requirements
for resubmission of the NDA. The FDA has provided guidance for repeated bio-equivalence studies in order to bridge the new formulation
to the original SequestOx™ studies. Due to the prohibitive cost of such repeated bio-equivalence studies and the uncertain commercial
viability given the regulatory and competitive landscape, the Company has paused development of this product candidate.
There
can be no assurances of the Company conducting future clinical trials, or if such trials are conducted, there can be no assurances of
the success of any future clinical trials, or if such trials are successful, there can be no assurances that an intended future resubmission
of the NDA product filing, if made, will be accepted by or receive marketing approval from the FDA. In addition, even if marketing authorization
is received, there can be no assurances that there will be future revenues or profits, or that any such future revenues or profits would
be in amounts that provide adequate return on the significant investments made to secure this marketing authorization.
Generic
Products Filed
Currently
the Company has filed the following ANDA’s which have been accepted for review by the FDA:
● Generic
dopamine agonist accepted for review in December 2022
● Generic
opiate analgesic for pain management accepted for review in September 2023
Approved
Product Not Yet Commercialized
Doxycycline
Hyclate Tablets
The
Company received approval in April 2022 from the FDA of an ANDA for a generic version of an antibiotic product, Doxycycline Hyclate Tablets.
The product is jointly owned by Elite and Praxgen Pharmaceuticals LLC, formerly SunGen Pharma LLC, (“Praxgen”).
There
can be no assurances in relation to the above approved products not yet commercialized, that there will be future revenues or
profits, or that any such future revenues or profits would be in amounts that provide adequate return on the significant investment
made to secure the marketing authorizations.
3
Discontinued
and Transferred Products
As
part of standard operating practices, the Company, from time to time, as relevant, conducts evaluations of all ANDAs owned, consisting,
without limitation, of ANDAs acquired or approved prior to the quarter ended June 30, 2026 and ANDAs acquired or approved during the
quarter ended June 30, 2026. Such evaluations include, without limitation, costs and benefits analyses relating to each ANDA owned, with
such costs including those fees required under the FDA’s Generic Drug User Fee Amendment which is significantly influenced by the
number of ANDAs owned, and other costs and benefits taking into consideration various specific market factors for each ANDA. Those ANDAs
with a cost/benefit profile not consistent with management criteria for continuation are identified for disposition and effort is made
to determine the optimal course of action to achieve disposition of the ANDA. The Company did not discontinue or transfer any ANDA during
the quarter ended June 30, 2026.
Critical
Accounting Estimates
Our
management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial
statements, which have been prepared in accordance with United States generally accepted accounting principles (“GAAP”).
The preparation of our condensed consolidated financial statements and related disclosures requires us to make estimates, assumptions
and judgments that affect the reported amount of assets, liabilities, costs and expenses and related disclosures. Our critical accounting
estimates are those estimates that involve a significant level of uncertainty at the time the estimate was made, and changes in them
have had or are reasonably likely to have a material effect on our financial condition or results of operations. Accordingly, actual
results could differ materially from our estimates. The following discussion addresses our most critical accounting estimates, which
are those that are both important to the portrayal of our financial condition and results of operations and that require significant
judgment or use of complex estimates.
Revenue
Recognition - Manufacturing Fees
The
Company’s revenues are offset by variable consideration, which may include, without limitation, chargebacks, distribution fees,
rebates, group purchasing organization fees, prompt payment cash discounts, consideration payable to the customer, billbacks, Medicaid
and other government pricing programs, price protection and shelf stock adjustments, sales returns and profit shares. The Company’s
estimates for variable consideration are adjusted as required at each reporting period for specific known developments that may result
in a change in the amount of total consideration it expects to receive as well as updating estimate assumptions to reflect current and/or
historical trends.
Like
most competitors in this market, our marketing partners also give credits for chargebacks to wholesalers that have contracts with our
marketing partners, prospectively, for their sales to hospitals, group purchasing organizations, pharmacies, or other customers. We do
the same in the case of prospective direct sales made by us. A chargeback is the difference between the price the wholesaler pays and
the price that the wholesaler’s end-customer pays for a product. Although, our marketing partners establish, and prospectively
we would also establish reserves based on prior experience and best estimates of the impact that these policies may have in subsequent
periods, we cannot ensure that such reserves established are adequate or that actual product returns, rebates, allowances, and chargebacks
will not exceed estimates. Differences between established reserves and actual amounts of such credits and charges, could result in a
material adverse effect on our business, financial condition, results of operations, cash flow and stock price.
4
Income
Taxes
Income
taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the estimated future
tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and
their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates in effect for the year in which
those temporary differences are expected to be recovered or settled. Where applicable, the Company records a valuation allowance to reduce
any deferred tax assets that it determines will not be realizable in the future.
Results
of Operations
The
following set forth our results of operations for the periods presented. The period-to-period comparison of financial results is not
necessarily indicative of future results.
t hree
months ended June 30, 2026 compared to the three months ended June 30, 2025
Revenue,
Cost of manufacturing and Gross profit:
For
the Three Months Ended June 30,
Change
2026
2025
Dollars
Percentage
Revenue
$ 32,355,283
$ 40,211,097
$ (7,855,814 )
(20 )%
Cost of manufacturing
18,847,738
12,985,127
5,862,611
45 %
Gross profit
$ 13,507,545
$ 27,225,970
$ (13,718,425 )
(50 )%
Gross profit - percentage
42 %
68 %
Total
revenues for the three months ended June 30, 2026 decreased by $7.9 million or 20%, to $32.4 million, as compared to $40.2 million, for
the corresponding period of the prior year. This decrease is primarily due to a decrease in manufacturing fees revenue of $7.6 million,
primarily due to increased market competition, as compared to the comparable period of the prior year, resulting in decreased average
net prices being achieved from the sales of Elite label products, including, without limitation lower net sales prices of the Lisdexamfetamine
product line. Additionally, licensing fees revenue decreased by $0.2 million, primarily due to the comparable period of the prior year
including licensing fee revenues from the Precision Dose License agreement which expired in September 2025 and accordingly had no material
effect on license fees revenues during the three months ended June 30, 2026.
Cost
of manufacturing consists of manufacturing and assembly costs. Our cost of manufacturing increased by $5.9 million or 45%, to $18.8 million
as compared to $13.0 million for the corresponding period in the prior fiscal year. These costs have a strong positive correlation with
manufacturing operations and the increase was due to an increased volume of products sold during the three months ended June 30, 2026,
as compared to the comparable period of the prior fiscal year, especially and without limitation in sales volumes generated by Elite’s
Lisdexamfetamine, Amphetamine IR and Amphetamine ER product lines.
Our
gross profit margin was 42% during the three months ended June 30, 2026 as compared to 68% during the comparable period of the prior
fiscal year. The decrease is primarily due to the decrease in average net prices resulting from increased market competition during the
three months ended June 30, 2026, as compared to the comparable period of the prior year.
Operating
expenses:
For
the Three Months Ended June 30,
Change
2026
2025
Dollars
Percentage
Operating expenses:
Research and development
$ 2,032,471
$ 1,674,964
$ 357,507
21 %
General and administrative
3,549,556
3,404,084
145,472
4 %
Non-cash compensation
28,476
52,329
(23,853 )
(46 )%
Depreciation and amortization
367,761
394,886
(27,125 )
(7 )%
Total operating expenses
$ 5,978,264
$ 5,526,263
$ 452,001
8 %
5
Operating
expenses for the three months ended June 30, 2026 increased by $0.5 million, or 8%, to $6.0 million as compared to $5.5 million for the
corresponding period in the prior fiscal year, largely due to increases in research and development expenses of $0.4 million and general
and administrative expenses of $0.1 million.
Research
and development costs during the three months ended June 30, 2026 were $2.0 million, an increase of $0.4 million, or 21 %, from approximately
$1.7 million of such costs for the comparable period of the prior year. The increase was the result of costs incurred in relation to
the successful pivotal bio equivalence study and ANDA filed during the three months ended June 30, 2026. In addition, the number, timing
and nature of product development activities always has a significant effect on research and development expenses incurred during any
period.
General
and administrative expenses for the three months ended June 30, 2026 were $3.5 million as compared to $3.4 million for the corresponding
period in the prior fiscal year, an increase of $0.1 million or approximately 4 %. This increase is due primarily to general increases
in costs of human resources, legal, consulting, regulatory, other professional services and overhead operating costs as compared to the
comparable period of the prior year.
As
a result of the foregoing, our income from operations during the three months ended June 30, 2026 was $7.5 million, compared to income
from operations of $21.7 million for the comparable period of the prior fiscal year.
Other
income (expense):
For
the Three Months Ended June 30,
Change
2026
2025
Dollars
Percentage
Other income (expense):
Change in fair value of derivative financial instruments - warrants
$ 94,247
$ (22,109,537 )
$ 22,203,784
(100 )%
Interest expense and amortization of debt issuance costs
(73,103 )
(158,926 )
85,823
(54 )%
Interest income
166,117
4,542
161,575
3557 %
Other income (expense), net
$ 187,261
$ (22,263,921 )
$ 22,451,182
(101 )%
Net
other income (expenses) for the three months ended June 30, 2026 was a net other income of $0.2 million, an increase in other income
of $22.5 million from a net other expense of $22.3 million for the comparable period of the prior fiscal year. The increase in other
income was primarily due to increases in other income relating to the change in fair value of derivative financial instruments of $22.3
million and interest income of $0.2 million, and decreases in interest expense of $0.1 million, as compared to the comparable period
of the prior year.
The
change in the fair value of derivative instruments is determined in large part by the change in the closing price of the Company’s
Common Stock as of the end of the period, as compared to the closing price at the beginning of the period. There is a strong correlation
between changes in the closing price of the Company’s Common Stock and other income (expense) recorded, with increases in the closing
price resulting in other expenses and decreases in closing price resulting in other income. The closing price of the Company’s
common stock as of June 30, 2026 was essentially unchanged from the closing price at the beginning of the three months ended June 30,
2026, therefore, reflecting the impact of other factors, resulted in a small other income being recorded, while the closing price as
of June 30, 2025 was $0.30 higher than the closing price at the beginning of the three month period ended June 30, 2025, resulting in
a large other expense being recorded.
The
decrease in interest expense is primarily related to the Company servicing a lesser principal amount of loans payable during the three
months ended June 30, 2026 as compared to the comparable period of the prior year.
As
a result of the foregoing, our net income before income taxes for the three months ended June 30, 2026 was $7.7 million, compared to
net loss before income taxes of $0.6 million for the comparable period of the prior fiscal year.
6
Liquidity
and Capital Resources
Capital
Resources
June 30, 2026
March 31, 2026
Change
Current assets
$ 114,487,702
$ 112,106,551
$ 2,381,151
Current liabilities
$ 30,441,614
$ 17,391,464
$ 13,050,150
Working capital
$ 84,046,088
$ 94,715,087
$ (10,668,999 )
Our
working capital (total current assets less total current liabilities) decreased by $10.7 million from $94.7 million as of March 31, 2026
to $84.0 million as of June 30, 2026, with such decrease being due to the reclassification of derivative financial instruments - warrants,
valued at $17.3 million, from non-current liabilities as of March 31, 2026 to current liabilities as of June 30, 2026.
Summary
of Cash Flows:
For
the Three Months Ended June 30,
2026
2025
Net cash provided by operating activities
$ 10,069,817
$ 14,775,842
Net cash used in investing activities
$ (808,964 )
$ (218,204 )
Net cash used in financing activities
$ (114,594 )
$ (4,130,684 )
Net
cash provided by operating activities for the three months ended June 30, 2026 was $10.1 million, which included, without limitation,
net income of $5.9 million, decreased by the change in fair value of derivative financial instruments-warrants of $0.1 million, recovery
for losses on accounts receivable of $0.2 million, decrease in deferred tax of $1.3 million, increased by other non-cash expenses totaling
$0.3 million and increased by changes in operating assets and liabilities totaling $2.6 million. Net cash provided by operating activities
during the comparable period in the prior fiscal year was $14.8 million, which included, without limitation, net loss of $5.9 million,
increased by the change in fair value of derivative financial instruments - warrants of $22.1 million, deferred tax expenses of $4.9
million, and reduced by the change in operating assets and liabilities totaling $7.1 million.
Net
cash used in investing activities for the three months ended June 30, 2026 was comprised of purchases of property and equipment of approximately
$0.8 million. Net cash used in investing activities during the comparable period in the prior fiscal year was comprised of purchases
of property and equipment of approximately $0.2 million.
Net
cash used in financing activities was $0.1 million for the three months ended June 30, 2026, primarily related to payments on finance
lease obligations, compared to net cash used in financing activities of $4.1 million for the corresponding period of the prior year.
Net cash used in financing activities of $4.1 million during the prior fiscal year was due to payments of loan principal totaling $4.0
million and payments on principal on finance lease obligations of $0.1 million.
East
West Bank
On
July 1, 2022, East West Bank (“EWB”) provided a mortgage loan (“EWB Mortgage Loan”) in the amount of $2.55 million
for the purchase of the property at 135-137 Ludlow Avenue, which was formerly a lease held by the Company. The EWB Mortgage Loan matures
in ten years and bears interest at a fixed rate of 4.75% fixed for the first five years then adjustable at WSJP plus 0.5% with floor
rate of 4.5%. The total transaction costs associated with the EWB Mortgage Loan incurred as of June 30, 2026, were $13,251, which are
being amortized on a monthly basis over ten years, beginning in July 2022. The EWB Mortgage Loan contains customary representations,
warranties and covenants. These covenants include maintaining a minimum debt coverage ratio of 1.50 to 1.00 tested annually and a minimum
trailing 12-month debt coverage ratio of 1.50 to 1.00. As of June 30, 2026, and through the date of filing of this Quarterly Report on
Form 10-Q, the Company was not aware of the existence of any violations of financial covenants included in the EWB Mortgage Loan.
7
NJEDA
Bonds
On
August 31, 2005, the Company successfully completed a refinancing of a prior 1999 bond issue (the “1999 Bonds”) through
the issuance of new tax-exempt bonds (the “NJEDA Bonds”). The refinancing involved borrowing $4,155,000, evidenced by a
6.5% Series A Note in the principal amount of $3,660,000 maturing on September 1, 2030. The net proceeds, after payment of issuance
costs, were used (i) to redeem the outstanding tax-exempt 1999 Bonds originally issued by the New Jersey Economic Development
Authority on September 2, 1999, (ii) to refinance other equipment financing and (iii) for the purchase of certain equipment to be
used in the manufacture of pharmaceutical products. As of June 30, 2026, all of the proceeds were utilized by the Company for such
stated purposes.
Interest
is payable semi-annually on March 1 and September 1. The NJEDA Bonds are collateralized by a first lien on the Company’s
facility and equipment acquired with the proceeds of the 1999 Bonds and NJEDA Bonds. The related Indenture requires the maintenance
of a debt service reserve fund of $366,000 in relation to the Series A Notes.
Bond
issue costs of $354,454 were paid from the proceeds of the NJEDA Bonds and are being amortized over the life of the NJEDA bonds. Amortization
of bond issuance costs amounted to $3,544 for the three months ended June 30, 2026.
The
NJEDA Bonds require the Company to make an annual principal payment on September 1st of varying amounts as specified in the loan documents
and semi-annual interest payments on March 1st and September 1st, equal to interest due on the outstanding principal at the applicable
rate for the semi-annual period just ended.
In
addition, the Company had previously received Notices of Default from the Trustee of the NJEDA Bonds as a result of the utilization of
the debt service reserve fund being used to pay interest payments as well as the Company’s failure to make scheduled principal
payments. All monetary defaults were cured during Fiscal Year 2015 and the Company is current on all NJEDA Bond interest and principal
payments.
As
of the date of filing of this Quarterly Report on Form 10-Q, there are no interest or principal amounts in arrears.
8
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
As
a smaller reporting company, we are not required to provide the information required by this Item.
ITEM
4. CONTROLS AND PROCEDURES
Evaluation
of Disclosure Controls and Procedures
The
term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of
1934, as amended (the “Exchange Act”), refers to controls and procedures that are designed to ensure that information required
to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported
within the time periods specified in the Securities Exchange Commission’s (the “SEC”) rules and forms. Disclosure controls
and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a
company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management,
including its principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required
disclosure. As required by Rules 13a-15(b) and 15d-15(b) of the Exchange Act, our management, with the participation of our Chief Executive
Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures based on the criteria set
forth by the Committee of Sponsoring Organizations of the Treadway Commission on Internal Control (“COSO”), as of the end
of the period covered by this Quarterly Report on Form 10-Q. Based on that evaluation, our Chief Executive Officer and our Chief Financial
Officer concluded that our disclosure controls and procedures were not effective as of June 30, 2026 to ensure that information required
to be disclosed by the Company in reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported
within the time periods specified in SEC rules and forms and such information is accumulated and communicated to management as appropriate
to allow timely decisions regarding required disclosures.
A
material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a
reasonable possibility that a misstatement of our annual or interim financial statements will not be prevented or detected on a timely
basis. As of June 30, 2026, we identified the following control deficiencies that we believe constituted individually, and in the aggregate,
material weaknesses in the design and operation components of our internal controls within the COSO framework:
● We
were unable to formalize and implement revised controls, policies and procedure documentation
to evidence a system of internal controls, including testing of such revised controls, that
was consistent with available personnel and resources;
● We
failed to maintain effective control activities over our control environment, risk assessment,
information technology and monitoring components and;
● We
had insufficient segregation of duties, oversight of work performed and lack of compensating
controls in our finance and accounting functions due to limited personnel and resources.
Management’s
Report on Internal Control Over Financial Reporting
Internal
control over financial reporting refers to the process designed by, or under the supervision of, our Chief Executive Officer and Chief
Financial Officer, and effected by our Board, management and other personnel, to provide reasonable assurance regarding the reliability
of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting
principles, and includes those policies and procedures that: (i) pertain to the maintenance of records that in reasonable detail accurately
and fairly reflect the transactions and dispositions of our assets; (ii) provide reasonable assurance that transactions are recorded
as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our
receipts and expenditures are being made only in accordance with authorizations of our management and directors; and (iii) provide reasonable
assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that
could have a material effect on the financial statements.
9
Internal
control over financial reporting may not prevent or detect all errors and all fraud. A control system, no matter how well conceived and
operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are achieved. Further, the design
of a control system must be balanced against resource constraints, and therefore the benefits of controls must be considered relative
to their costs. Given the inherent limitations in all systems of controls, no evaluation of controls can provide absolute assurance all
control issues and instances of fraud, if any, within a company have been detected. These inherent limitations include the realities
that judgments in decision making can be faulty and that breakdowns can occur because of a simple error or mistake. Additionally, controls
can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the controls.
The design of any system of controls is also based in part upon certain assumptions about the likelihood of future events, and there
can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls
may become inadequate because of changes in conditions or the degree of compliance with policies or procedures may deteriorate. Accordingly,
given the inherent limitations in a system of internal control, financial statement misstatements due to error or fraud may occur and
may not be detected. Our disclosure controls and procedures are designed to provide reasonable, not absolute, assurance of achieving
their objectives. We conduct periodic evaluations of our systems of controls to enhance, where necessary, our control policies and procedures.
Management
is responsible for establishing and maintaining adequate internal control over our financial reporting, as such term is defined in Rules
13a-15(f) and 15d-15(f) under the Exchange Act. Under the supervision and with the participation of our management, including our Chief
Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness of our internal control over financial
reporting. Management has used the framework set forth in the report entitled “Internal Control—Integrated Framework (2013)”
published by the Committee of Sponsoring Organizations of the Treadway Commission to evaluate the effectiveness of our internal control
over financial reporting. Based on its evaluation, utilizing those criteria, management has determined that, as of June 30, 2026, because
of the material weaknesses described below, our internal control over financial reporting was not effective.
A
material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a
reasonable possibility that a misstatement of our annual or interim financial statements will not be prevented or detected on a timely
basis. As of June 30, 2026, we identified the following control deficiencies that we believe constituted individually, and in the aggregate,
material weaknesses in the design and operation components of our internal controls within the COSO framework:
The
deficiencies in our internal controls over financial reporting and disclosure controls and procedures are described above and our efforts
to remediate these deficiencies are described below. Please also see “Risk Factors” in Item 1A of our Annual Report on Form
10-K for the period ended March 31, 2026.
Changes
in Internal Controls Over Financial Reporting
During
the three months ended June 30, 2026, as a result of reviews and assessments of internal controls over financial reporting conducted
by the Company’s Chief Financial Officer, the Company identified material weaknesses in internal controls over financial reporting
as further detailed above and began remediation efforts which are detailed below, with such activities expected to result in further
changes in internal control over financial reporting as necessary to remediate the identified material weaknesses.
Remediation
efforts to address material weaknesses in internal controls over financial reporting
We
intend to revise the existing control environment documentation, designing and implementing controls, policies and procedure documentation
that is consistent with our current personnel, resources and capabilities, with significant focus on controls relating to financial oversight,
management, analysis and reporting of operations emanating from the Company’s manufacturing, marketing and distribution of its
Elite Label product line. Please note that these material weaknesses cannot be considered remediated until the applicable remedial controls
operate for a sufficient period of time, allowing management, through testing, to reach a conclusion on such controls design and operational
effectiveness.
10
PART
II - OTHER INFORMATION
ITEM
1. LEGAL PROCEEDINGS
Pending
Litigation
On
August 17, 2023, the Company filed a Paragraph IV certification with its ANDA to generic OxyContin® and after the Company received
acceptance of the ANDA by the FDA on September 19, 2023, Elite sent the patentee and NDA holder a Notice Letter as required under the
Hatch-Waxman Act. On November 14, 2023, a patent infringement suit was filed in the District Court of New Jersey by Purdue Pharma. The
parties agreed to a stipulated dismissal of the case and the judge signed the order dismissing the case on June 12, 2026.
Elite’s
launch of a generic OxyContin® will depend on approval by the FDA and the outcome of various litigation involving Purdue or the expiry
of the patents listed on the Orange Book.
In
the ordinary course of business, we may be subject to litigation from time to time. There is no current, pending or, to our knowledge,
threatened litigation or administrative action to which we are a party or of which our property is the subject (including litigation
or actions involving our officers, directors, affiliates, or other key personnel, or holders of record or beneficially of more than 5%
of any class of our voting securities, or any associate of any such party) which in our opinion has, or is expected to have, a material
adverse effect upon our business, prospects financial condition or operations. A significant increase in the number of claims or an increase
in amounts owing under successful claims could materially adversely affect our business, financial condition, results of operations and
cash flows.
ITEM
1A. RISK FACTORS
There
have been no material changes in the risk factors described in our Annual Report on Form 10-K for the fiscal year ended March 31, 2026.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM
4. MINE SAFETY DISCLOSURES
Not
applicable.
ITEM
5. OTHER INFORMATION
During
the fiscal quarter ended June 30, 2026, none of the Company’s directors or officers (as defined in Rule 16a-1(f) of the Securities
Exchange Act of 1934, as amended) adopted or terminated a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement (as
such terms are defined in Item 408 of Regulation S-K of the Securities Act of 1933, as amended).
11
ITEM
6. EXHIBITS
Exhibit
No.
Description
31.1
Certification of Chief Executive Officer pursuant to Exchange Act Rule 13a-14(a) and Rule 15d-14(a)*
31.2
Certification of Chief Financial Officer pursuant to Exchange Act Rule 13a-14(a) and Rule 15d-14(a)*
32.1
Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002**
32.2
Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002**
101.INS
Inline XBRL Instance Document
101.SCH
Inline XBRL Taxonomy Schema
Document
101.CAL
Inline XBRL Taxonomy Extension
Calculation Linkbase Document
101.DEF
Inline XBRL Taxonomy Extension
Definition Linkbase Document
101.LAB
Inline XBRL Taxonomy Extension
Label Linkbase Document
101.PRE
Inline XBRL Taxonomy Extension
Presentation Linkbase Document
104
Cover Page Interactive
Data File (embedded within the Inline XBRL document)
*
Filed herewith.
**
Furnished herewith.
12
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.
ELITE PHARMACEUTICALS, INC.
August 13, 2026
By:
/s/
Nasrat Hakim
Nasrat
Hakim
Chief
Executive Officer, President and Chairman of the Board of Directors
(Principal
Executive Officer)
August 13, 2026
By:
/s/
Carter Ward
Carter
Ward
Chief
Financial Officer
(Principal
Accounting Officer and Principal Financial Officer)
13
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.