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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, 2024
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
12, 2024:
Common
Stock - 1,068,273,108 shares
Table
of Contents
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
CONDENSED
CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
PART
I - FINANCIAL INFORMATION
ITEM
1. FINANCIAL STATEMENTS
| |
June 30, 2024 | | |
March 31, 2024 | |
ASSETS | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash | |
$ | 8,407,152 | | |
$ | 7,106,262 | |
Accounts receivable, net of allowance for expected credit losses of approximately $233,000 and $236,000 respectively | |
| 20,486,401 | | |
| 19,453,301 | |
Inventory | |
| 13,831,318 | | |
| 12,930,464 | |
Prepaid expenses and other current assets | |
| 435,669 | | |
| 524,162 | |
Total current assets | |
| 43,160,540 | | |
| 40,014,189 | |
| |
| | | |
| | |
Property and equipment, net of accumulated depreciation of $16,197,891 and $15,906,853 respectively | |
| 10,570,868 | | |
| 10,175,293 | |
Intangible assets | |
| 7,241,228 | | |
| 6,341,228 | |
Finance lease - right-of-use asset | |
| 1,976,049 | | |
| 2,079,658 | |
Operating lease - right-of-use asset | |
| 2,222,172 | | |
| 2,355,201 | |
Deferred income tax asset | |
| 22,142,686 | | |
| 22,160,895 | |
Other assets: | |
| | | |
| | |
Restricted cash - debt service for NJEDA bonds | |
| 438,222 | | |
| 432,832 | |
Security deposits | |
| 94,240 | | |
| 94,240 | |
Total other assets | |
| 532,462 | | |
| 527,072 | |
Total assets | |
$ | 87,846,005 | | |
$ | 83,653,536 | |
| |
| | | |
| | |
LIABILITIES AND SHAREHOLDERS’ EQUITY | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 2,607,032 | | |
$ | 2,714,306 | |
Accrued expenses | |
| 6,228,095 | | |
| 5,301,747 | |
Deferred revenue, current portion | |
| 13,333 | | |
| 13,333 | |
Bonds payable, current portion, net of bond issuance costs | |
| 115,822 | | |
| 115,822 | |
Loans payable, current portion | |
| 313,786 | | |
| 180,399 | |
Related party loans payable (Note 7) | |
| 4,000,000 | | |
| 4,000,000 | |
Lease obligation - finance lease, current portion | |
| 319,803 | | |
| 312,739 | |
Lease obligation - operating lease, current portion | |
| 416,764 | | |
| 411,418 | |
Total current liabilities | |
| 14,014,635 | | |
| 13,049,764 | |
| |
| | | |
| | |
Long-term liabilities: | |
| | | |
| | |
Deferred revenue, net of current portion | |
| 2,222 | | |
| 5,556 | |
Bonds payable, net of current portion and bond issuance costs | |
| 916,747 | | |
| 913,203 | |
Loans payable, net of current portion and loan costs | |
| 2,327,980 | | |
| 2,366,487 | |
Lease obligation - finance lease, net of current portion | |
| 1,401,924 | | |
| 1,480,317 | |
Lease obligation - operating lease, net of current portion | |
| 1,850,656 | | |
| 1,957,383 | |
Derivative financial instruments - warrants | |
| 9,080,921 | | |
| 6,298,008 | |
Total long-term liabilities | |
| 15,580,450 | | |
| 13,020,954 | |
Total liabilities | |
| 29,595,085 | | |
| 26,070,718 | |
| |
| | | |
| | |
Shareholders’ equity: | |
| | | |
| | |
Common Stock; par value $0.001; 1,445,000,000 shares authorized; 1,068,373,108 and 1,068,373,108 shares issued as of June 30, 2024 and March 31, 2024, respectively; 1,068,273,108 and 1,068,273,108 shares outstanding as of June 30, 2024 and March 31, 2024, respectively | |
| 1,068,377 | | |
| 1,068,377 | |
Additional paid-in capital | |
| 173,262,878 | | |
| 173,210,549 | |
Treasury stock; 100,000 shares as of June 30, 2024 and March 31, 2024, respectively, at cost | |
| (306,841 | ) | |
| (306,841 | ) |
Accumulated deficit | |
| (115,773,494 | ) | |
| (116,389,267 | ) |
Total shareholders’ equity | |
| 58,250,920 | | |
| 57,582,818 | |
Total liabilities and shareholders’ equity | |
$ | 87,846,005 | | |
$ | 83,653,536 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
| |
2024 | | |
2023 | |
| |
For the Three Months Ended June 30, | |
| |
2024 | | |
2023 | |
Revenue: | |
| | | |
| | |
Manufacturing fees | |
$ | 18,443,918 | | |
$ | 7,909,237 | |
Licensing fees | |
| 359,145 | | |
| 1,070,839 | |
Total revenue | |
| 18,803,063 | | |
| 8,980,076 | |
Cost of manufacturing | |
| 10,328,285 | | |
| 4,229,521 | |
Gross profit | |
| 8,474,778 | | |
| 4,750,555 | |
| |
| | | |
| | |
Operating expenses: | |
| | | |
| | |
Research and development | |
| 2,163,527 | | |
| 1,143,545 | |
General and administrative | |
| 1,969,154 | | |
| 1,661,704 | |
Non-cash compensation through issuance of stock options | |
| 52,329 | | |
| 15,000 | |
Depreciation and amortization | |
| 425,712 | | |
| 328,282 | |
Total operating expenses | |
| 4,610,722 | | |
| 3,148,531 | |
| |
| | | |
| | |
Income from operations | |
| 3,864,056 | | |
| 1,602,024 | |
| |
| | | |
| | |
Other (expense) income: | |
| | | |
| | |
Change in fair value of derivative financial instruments - warrants | |
| (2,782,913 | ) | |
| (189,367 | ) |
Interest expense and amortization of debt issuance costs | |
| (250,781 | ) | |
| (119,412 | ) |
Interest income | |
| 5,390 | | |
| 3,516 | |
Other income | |
| 12,000 | | |
| — | |
Other expense, net | |
| (3,016,304 | ) | |
| (305,263 | ) |
| |
| | | |
| | |
| |
| | | |
| | |
Income tax expense | |
| (231,979 | ) | |
| (154,952 | ) |
| |
| | | |
| | |
Net income | |
$ | 615,773 | | |
$ | 1,141,809 | |
| |
| | | |
| | |
Basic net income per share attributable to common shareholders
| |
$ | 0.00 | | |
$ | 0.00 | |
Diluted net income per share attributable to common shareholders | |
$ | 0.00 | | |
$ | 0.00 | |
| |
| | | |
| | |
Basic weighted average Common Stock outstanding | |
| 1,068,273,108 | | |
| 1,013,915,081 | |
Diluted weighted average Common Stock outstanding | |
| 1,076,250,204 | | |
| 1,014,572,821 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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, 2024 | |
| — | | |
$ | — | | |
| 1,068,373,108 | | |
$ | 1,068,377 | | |
$ | 173,210,549 | | |
| 100,000 | | |
$ | (306,841 | ) | |
$ | (116,389,267 | ) | |
$ | 57,582,818 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net income | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 615,773 | | |
| 615,773 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Non-cash compensation through the issuance of employee stock options | |
| — | | |
| — | | |
| — | | |
| — | | |
| 52,329 | | |
| — | | |
| — | | |
| — | | |
| 52,329 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance at June 30, 2024 | |
| — | | |
$ | — | | |
| 1,068,373,108 | | |
$ | 1,068,377 | | |
$ | 173,262,878 | | |
| 100,000 | | |
$ | (306,841 | ) | |
$ | (115,773,494 | ) | |
$ | 58,250,920 | |
| |
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, 2023 | |
| — | | |
| — | | |
| 1,014,015,081 | | |
$ | 1,014,019 | | |
$ | 164,750,980 | | |
| 100,000 | | |
$ | (306,841 | ) | |
$ | (136,497,898 | ) | |
$ | 28,960,260 | |
Balance | |
| — | | |
| — | | |
| 1,014,015,081 | | |
$ | 1,014,019 | | |
$ | 164,750,980 | | |
| 100,000 | | |
$ | (306,841 | ) | |
$ | (136,497,898 | ) | |
$ | 28,960,260 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net income | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 1,141,809 | | |
| 1,141,809 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Non-cash compensation through the issuance of employee stock options | |
| — | | |
| — | | |
| — | | |
| — | | |
| 15,000 | | |
| — | | |
| — | | |
| — | | |
| 15,000 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance at June 30, 2023 | |
| — | | |
$ | — | | |
| 1,014,015,081 | | |
$ | 1,014,019 | | |
$ | 164,765,980 | | |
| 100,000 | | |
$ | (306,841 | ) | |
$ | (135,356,089 | ) | |
$ | 30,117,069 | |
Balance | |
| — | | |
$ | — | | |
| 1,014,015,081 | | |
$ | 1,014,019 | | |
$ | 164,765,980 | | |
| 100,000 | | |
$ | (306,841 | ) | |
$ | (135,356,089 | ) | |
$ | 30,117,069 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
| |
2024 | | |
2023 | |
| |
For the Three Months Ended June 30, | |
| |
2024 | | |
2023 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |
| | | |
| | |
Net income | |
$ | 615,773 | | |
$ | 1,141,809 | |
Adjustments to reconcile net income to net cash provided by (used in) operating activities: | |
| | | |
| | |
Depreciation and amortization | |
| 322,103 | | |
| 328,282 | |
Provision for losses on accounts receivable | |
| 9,810 | | |
| 100,000 | |
Amortization of operating leases - right-of-use assets | |
| 133,029 | | |
| 5,534 | |
Amortization of finance leases - right-of-use assets | |
| 103,609 | | |
| — | |
Amortization of debt discount - bonds offering costs | |
| 3,544 | | |
| — | |
Change in fair value of derivative financial instruments - warrants | |
| 2,782,913 | | |
| 189,367 | |
Deferred tax expense | |
| 18,209 | | |
| — | |
Non-cash compensation through the issuance of employee stock options | |
| 52,329 | | |
| 15,000 | |
Non-cash rent expense and lease accretion | |
| — | | |
| 192 | |
Non-cash loss on asset disposal | |
| 45,599 | | |
| — | |
Change in operating assets and liabilities: | |
| | | |
| | |
Accounts receivable | |
| (1,042,910 | ) | |
| (3,206,899 | ) |
Inventory | |
| (900,854 | ) | |
| (1,617,715 | ) |
Prepaid expenses and other current assets | |
| 286,950 | | |
| 34,727 | |
Accounts payable | |
| (107,274 | ) | |
| (571,885 | ) |
Accrued expenses | |
| 926,348 | | |
| 881,435 | |
Deferred revenue | |
| (3,334 | ) | |
| (3,334 | ) |
Lease obligations - operating leases | |
| (101,381 | ) | |
| (6,328 | ) |
Net cash provided by (used in) operating activities | |
| 3,144,463 | | |
| (2,709,815 | ) |
| |
| | | |
| | |
CASH FLOWS FROM INVESTING ACTIVITIES: | |
| | | |
| | |
Purchase of property and equipment | |
| (778,527 | ) | |
| — | |
Purchase of intangible assets | |
| (900,000 | ) | |
| — | |
Proceeds from disposition of property and equipment | |
| 15,250 | | |
| — | |
Net cash used in investing activities | |
| (1,663,277 | ) | |
| — | |
| |
| | | |
| | |
CASH FLOWS FROM FINANCING ACTIVITIES: | |
| | | |
| | |
Proceeds from related party loans payable | |
| — | | |
| 4,000,000 | |
Payments on principal on finance lease obligations | |
| (71,329 | ) | |
| — | |
Loan payments | |
| (103,577 | ) | |
| (42,777 | ) |
Net cash (used in) provided by financing activities | |
| (174,906 | ) | |
| 3,957,223 | |
| |
| | | |
| | |
Net change in cash and restricted cash | |
| 1,306,280 | | |
| 1,247,408 | |
Cash and restricted cash, beginning of period | |
| 7,539,094 | | |
| 8,244,681 | |
Cash and restricted cash, end of period | |
$ | 8,845,374 | | |
$ | 9,492,089 | |
| |
| | | |
| | |
Supplemental disclosure of cash and non-cash transactions: | |
| | | |
| | |
Cash paid for interest | |
$ | 222,970 | | |
$ | 119,412 | |
Cash paid for income taxes | |
$ | — | | |
$ | 127,522 | |
Finance directors and officers insurance premium | |
$ | 198,457 | | |
$ | — | |
| |
| | | |
| | |
Reconciliation of cash and restricted cash | |
| | | |
| | |
Cash | |
$ | 8,407,152 | | |
$ | 9,076,659 | |
Restricted cash - debt service for NJEDA bonds | |
| 438,222 | | |
| 415,430 | |
Total cash and restricted cash shown in statement of cash flows | |
$ | 8,845,374 | | |
$ | 9,492,089 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
NOTE
1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Overview
Elite
Pharmaceuticals, Inc. (the “Company” or “Elite”) was incorporated on October 1, 1997 under the laws of the State
of Delaware, and its wholly-owned subsidiary Elite Laboratories, Inc. (“Elite Labs”) was incorporated on August 23, 1990
under the laws of the State of Delaware. On January 5, 2012, Elite Pharmaceuticals was reincorporated under the laws of the State of
Nevada. Elite Labs engages primarily in researching, developing, licensing, manufacturing, and sales of generic, oral dose pharmaceuticals.
The Company is equipped to manufacture controlled-release products on a contract basis for third parties and itself, if and when the
product candidates are approved. These products include drugs that cover therapeutic areas for allergy, bariatric, attention deficit
and infection. Research and development activities are performed with an objective of developing product candidates that will secure
marketing approvals from the United States Food and Drug Administration (“FDA”), and thereafter, commercially exploiting
such products.
Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements of the Company are presented in conformity with accounting principles
generally accepted in the United States of America (“GAAP”) and pursuant to the rules and regulations of the SEC. The unaudited
condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, Elite Labs. All significant
intercompany accounts and transactions have been eliminated in consolidation. Certain information or footnote disclosures normally included
in condensed financial statements prepared in accordance with GAAP have been condensed or omitted, pursuant to the rules and regulations
of the SEC for interim financial reporting. Accordingly, they do not include all the information and footnotes necessary for a comprehensive
presentation of financial position, results of operations, or cash flows. In the opinion of management, the accompanying unaudited condensed
consolidated financial statements include all adjustments, consisting of a normal recurring nature, which are necessary for a fair presentation
of the financial position, operating results and cash flows for the periods presented. The accompanying unaudited condensed consolidated
financial statements should be read in conjunction with the Company’s Form 10-K as filed with the SEC on July 1, 2024. The interim
results for the three months ended June 30, 2024 are not necessarily indicative of the results to be expected for the fiscal year ending
March 31, 2025 or for any future periods.
Use
of Estimates
The
preparation of 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 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, standalone selling price for
each distinct performance obligation included in customer contracts with multiple performance obligations, the period of benefit for
deferred commissions, valuation of intangible assets, the useful life of property and equipment and identifiable intangible assets, stock-based
compensation expense and income taxes. Actual results could differ from those estimates.
Segment
Information
Financial
Accounting Standards Board (“FASB”) Accounting Standards Codification 280 (“ASC 280”), Segment Reporting, establishes
standards for reporting information about operating segments. Operating segments are defined as components of an enterprise about which
separate financial information is available that is evaluated regularly by the chief operating decision maker, or decision-making group,
in deciding how to allocate resources and in assessing performance.
The
Company’s chief operating decision maker is the Chief Executive Officer, who reviews the financial performance and the results
of operations of the segments prepared in accordance with GAAP when making decisions about allocating resources and assessing performance
of the Company.
The
Company has determined that its reportable segments are products whose marketing approvals were secured via an Abbreviated New Drug Application
(“ANDA”) and products whose marketing approvals were secured via a New Drug Application (“NDA”). ANDA products
are referred to as generic pharmaceuticals and NDA products are referred to as branded pharmaceuticals. The Company paused further development
of NDAs and has not engaged in business activities. Accordingly, during the three months ended June 30, 2024 and 2023, the Company has
only engaged in business activities in a single operating segment.
There
are currently no intersegment revenues. Asset information by operating segment is not presented below since the chief operating decision
maker does not review this information by segment. The reporting segments follow the same accounting policies used in the preparation
of the Company’s condensed consolidated financial statements. Please see Note 13 for further details.
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Revenue
Recognition
The
Company generates revenue from manufacturing and licensing fees and direct sales to pharmaceutical distributors for pharmacies and institutions.
Manufacturing fees include the development of pain management products, manufacturing of a line of generic pharmaceutical products with
approved ANDA, through the manufacture of formulations and the development of new products. Licensing fees include the commercialization
of products either by license and the collection of royalties, or the expansion of licensing agreements with other pharmaceutical companies,
including co-development projects, joint ventures and other collaborations.
Under
ASC 606, Revenue from Contacts with Customers (“ASC 606”), the Company recognizes revenue when the customer obtains
control of promised goods or services, in an amount that reflects the consideration which is expected to be received in exchange for
those goods or services. The Company recognizes revenues following the five-step model prescribed under ASC 606: (i) identify contract(s)
with a customer; (ii) identify the performance obligation(s) in the contract; (iii) determine the transaction price; (iv) allocate the
transaction price to the performance obligation(s) in the contract; and (v) recognize revenues when (or as) the Company satisfies a performance
obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration
it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined
to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that
are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the
amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is
satisfied. Sales, value add, and other taxes collected on behalf of third parties are excluded from revenue.
Nature
of goods and services
The
following is a description of the Company’s goods and services from which the Company generates revenue, as well as the nature,
timing of satisfaction of performance obligations, and significant payment terms for each, as applicable:
a)
Manufacturing Fees
The
Company is equipped to manufacture controlled-release products on a contract basis for third parties, if, and when, the products are
approved. These products include products using controlled-release drug technology. The Company also develops and markets (either on
its own or by license to other companies) generic and proprietary controlled-release pharmaceutical products.
The
Company recognizes revenue when the customer obtains control of the Company’s product based on the contractual shipping terms of
the contract, at which time the performance obligation is deemed to be completed. The Company is primarily responsible for fulfilling
the promise to provide the product, is responsible to ensure that the product is produced in accordance with the related supply agreement
and bears risk of loss while the inventory is in-transit to the commercial partner. Revenue is measured as the amount of consideration
the Company expects to receive in exchange for transferring products to a customer.
b)
License Fees
The
Company enters into licensing and development agreements, which may include multiple revenue generating activities, including milestones
payments, licensing fees, product sales and services. The Company analyzes each element of its licensing and development agreements in
accordance with ASC 606 to determine appropriate revenue recognition. The terms of the license agreement may include payment to the Company
of licensing fees, non-refundable upfront license fees, milestone payments if specified objectives are achieved, and/or royalties on
product sales.
If
the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation.
Contracts that contain multiple performance obligations require an allocation of the transaction price based on the estimated relative
standalone selling prices of the promised products or services underlying each performance obligation. The Company determines standalone
selling prices based on the price at which the performance obligation is sold separately. If the standalone selling price is not observable
through past transactions, the Company estimates the standalone selling price taking into account available information such as market
conditions and internally approved pricing guidelines related to the performance obligations.
The
Company recognizes revenue from non-refundable upfront payments at a point in time, typically upon fulfilling the delivery of the associated
intellectual property to the customer. For those milestone payments which are contingent on the occurrence of particular future events
(for example, payments due upon a product receiving FDA approval), the Company determined that these need to be considered for inclusion
in the calculation of total consideration from the contract as a component of variable consideration using the most-likely amount method.
As such, the Company assesses each milestone to determine the probability and substance behind achieving each milestone. Given the inherent
uncertainty of the occurrence of future events, the Company will recognize revenue from the milestone when there is not a high probability
of a reversal of revenue, which typically occurs near or upon achievement of the event.
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Significant
management judgment is required to determine the level of effort required under an arrangement and the period over which the Company
expects to complete its performance obligations under the arrangement. If the Company cannot reasonably estimate when its performance
obligations either are completed or become inconsequential, then revenue recognition is deferred until the Company can reasonably make
such estimates. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method.
When
determining the transaction price of a contract, an adjustment is made if payment from a customer occurs either significantly before
or significantly after performance, resulting in a significant financing component. Applying the practical expedient in ASC 606-10-32-18,
the Company does not assess whether a significant financing component exists if the period between when the Company performs its obligations
under the contract and when the customer pays is one year or less. None of the Company’s contracts contained a significant financing
component as of June 30, 2024.
In
accordance with ASC 606-10-55-65, royalties are recognized when the subsequent sale of the customer’s products occurs.
c)
Sale of product under the Elite label
The
Company began direct sales of products under the Company’s own label on April 1, 2023. License agreements will remain in place
for select products. With this transition, however, a large portion of the manufacturing and license fees now reported will be replaced
with revenues from sales of Elite labeled pharmaceutical products to distributors for pharmacies and institutions.
The
Company recognizes revenue when the customer obtains control of the Company’s product based on the contractual shipping terms,
at which time the performance obligation is deemed to be completed. The Company is primarily responsible for fulfilling the promise to
deliver the product and bears risk of loss while the inventory is in-transit to the purchaser. Revenue is measured as the amount of consideration
earned from the sale of Elite labeled pharmaceutical products are recorded at their net realizable value which consists of gross amounts
invoiced reduced by contractual reductions, including, without limitation, chargebacks, discounts and program rebates, as applicable.
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
product returns, other rebates, as well as historical information.
Disaggregation
of revenue
In
the following table, revenue is disaggregated by type of revenue generated by the Company. The Company recognizes revenue at a point
in time for all performance obligations. During the three months ended June 30, 2024 and 2023, the Company had paused further
development of NDAs and has not engaged in business activities in that segment. Accordingly, during the three months ended June 30,
2024 and 2023, the Company has only engaged in business activities in a single operating segment. The table also includes a
reconciliation of the disaggregated revenue with the reportable segments:
SCHEDULE
OF DISAGGREGATION OF REVENUE
| |
For the Three Months Ended June 30, | |
| |
2024 | | |
2023 | |
ANDA: | |
| | | |
| | |
Manufacturing fees | |
$ | 18,443,918 | | |
$ | 7,909,237 | |
Licensing fees | |
| 359,145 | | |
| 1,070,839 | |
Total ANDA revenue | |
$ | 18,803,063 | | |
$ | 8,980,076 | |
Selected
information on reportable segments and reconciliation of operating income by segment to income from operations before income taxes are
disclosed within Note 13.
Restricted
Cash
As
of June 30, 2024, and March 31, 2024, the Company had $438,222 and $432,832, of restricted cash, respectively, related to debt service
reserve in regard to the New Jersey Economic Development Authority (“NJEDA”) bonds (see Note 5).
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Long-Lived
Assets
The
Company periodically evaluates the fair value of long-lived assets, which include property and equipment and intangibles, whenever events
or changes in circumstances indicate that its carrying amounts may not be recoverable.
Property
and equipment are stated at cost. Depreciation is provided on the straight-line method based on the estimated useful lives of the respective
assets which range from three to forty years. Major repairs or improvements are capitalized. Minor replacements and maintenance and repairs
which do not improve or extend asset lives are expensed currently.
Upon
retirement or other disposition of assets, the cost and related accumulated depreciation are removed from the accounts and the resulting
gain or loss, if any, is recognized in income.
Intangible
Assets
The
Company capitalizes certain costs to acquire intangible assets; if such assets are determined to have a finite useful life they are amortized
on a straight-line basis over the estimated useful life. Costs to acquire indefinite lived intangible assets, such as costs related to
ANDAs are capitalized accordingly.
The
Company tests its intangible assets for impairment at least annually (as of March 31st) and whenever events or circumstances change that
indicate impairment may have occurred. A significant amount of judgment is involved in determining if an indicator of impairment has
occurred. Such indicators may include, among others and without limitation: a significant decline in the Company’s expected future
cash flows; a sustained, significant decline in the Company’s stock price and market capitalization; a significant adverse change
in legal factors or in the business climate of the Company’s segments; unanticipated competition; and slower growth rates.
There
were no such impairments recorded during the three months ended June 30, 2024 and three months ended June 30, 2023. The Company notes
that none of its patents relate to any of the Company’s revenue producing activities.
On
June 17, 2024, the Company and Nostrum Laboratories Inc. (“Nostrum”) entered into an Asset Purchase Agreement (the “Asset
Purchase Agreement”), pursuant to which Nostrum was obligated to (i) sell to the Company all of its rights in and to the approved
abbreviated new drug applications (ANDAs) for generic Norco® (Hydrocodone Bitartrate and Acetaminophen tablets, USP CII), generic
Percocet® (Oxycodone Hydrochloride and Acetaminophen, USP CII), and generic Dolophine® (Methadone Hydrochloride tablets), each
a “Product”, and (ii) grant to the Company a royalty-free, non-exclusive perpetual license to use the manufacturing technology,
proprietary information, processes, techniques, protocols, methods, know-how, and improvements necessary or used to manufacture each
Product in accordance with the applicable ANDA, in exchange for $900,000 in cash (the “Transaction”). The Asset Purchase
Agreement includes customary representations and warranties and various customary covenants. The closing of the Transaction occurred
on June 21, 2024.
The
following table summarizes the Company’s intangible assets as of and for the periods ended June 30, 2024 and March 31, 2024:
SCHEDULE
OF INTANGIBLE ASSETS
| |
June 30, 2024 |
| |
Estimated Useful Life | |
Gross Carrying Amount | | |
Additions | | |
Impairment losses | | |
Accumulated Amortization | | |
Net Book Value | |
Patent application costs | |
-* | |
$ | 289,039 | | |
$ | — | | |
$ | — | | |
$ | — | | |
$ | 289,039 | |
ANDA acquisition costs | |
Indefinite | |
| 6,052,189 | | |
| 900,000 | | |
| — | | |
| — | | |
| 6,952,189 | |
| |
| |
$ | 6,341,228 | | |
$ | 900,000 | | |
$ | — | | |
$ | — | | |
$ | 7,241,228 | |
| |
March 31, 2024 |
| |
Estimated Useful Life | |
Gross Carrying Amount | | |
Additions | | |
Impairment losses | | |
Accumulated Amortization | | |
Net Book Value | |
Patent application costs | |
-* | |
$ | 289,039 | | |
$ | — | | |
$ | — | | |
$ | — | | |
$ | 289,039 | |
ANDA acquisition costs | |
Indefinite | |
| 6,052,189 | | |
| — | | |
| — | | |
| — | | |
| 6,052,189 | |
| |
| |
$ | 6,341,228 | | |
$ | — | | |
$ | — | | |
$ | — | | |
$ | 6,341,228 | |
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Income
Taxes
Income
taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the estimated future
tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and
their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates in effect for the year in which
those temporary differences are expected to be recovered or settled. Where applicable, the Company records a valuation allowance to reduce
any deferred tax assets that it determines will not be realizable in the future.
The
Company recognizes the benefit of an uncertain tax position that it has taken or expects to take on income tax returns it files if such
tax position is more likely than not to be sustained on examination by the taxing authorities, based on the technical merits of the position.
These tax benefits are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate resolution.
The
Company operates in multiple tax jurisdictions within the United States of America. The Company remains subject to examination in all
tax jurisdiction until the applicable statutes of limitation expire. As of June 30, 2024, a summary of the tax years that remain subject
to examination in our major tax jurisdictions are: United States – Federal, 2020 and forward, and State, 2019 and forward. The
Company’s policy for recording interest and penalties associated with unrecognized tax benefits is to record such interest and
penalties as a component of income tax expense. The Company did not have any unrecognized tax positions as of June 30, 2024 and March
31, 2024.
Earnings
Per Share Attributable to Common Shareholders’
The
Company follows ASC 260, Earnings Per Share, which requires presentation of basic and diluted earnings per share (“EPS”)
on the face of the income statement for all entities with complex capital structures and requires a reconciliation of the numerator and
denominator of the basic EPS computation to the numerator and denominator of the diluted EPS computation. In the accompanying financial
statements, basic earnings per share is computed by dividing net income by the weighted average number of shares of Common Stock outstanding
during the period. The computation of diluted net income per share does not include the change in fair value of derivative instruments
or the conversion of securities that would have an antidilutive effect.
As
the average market price of Common Stock for the three months ended June 30, 2024 and 2023 did not exceed the exercise price of the warrants,
the potential dilution from the warrants converting into 79,008,661 shares of Common Stock for all periods have been excluded from the
number of shares used in calculating diluted net income per share as their inclusion would have been antidilutive.
The
following is the computation of earnings per share applicable to common shareholders for the periods indicated:
SCHEDULE
OF EARNINGS (LOSS) PER SHARE APPLICABLE TO COMMON SHAREHOLDERS
| |
2024 | | |
2023 | |
| |
For the Three Months Ended June 30, | |
| |
2024 | | |
2023 | |
Numerator | |
| | | |
| | |
Net income - basic | |
$ | 615,773 | | |
$ | 1,141,809 | |
Effect of dilutive instrument on net income | |
| — | | |
| — | |
Net income - diluted | |
$ | 615,773 | | |
$ | 1,141,809 | |
| |
| | | |
| | |
Denominator | |
| | | |
| | |
Weighted average shares of Common Stock outstanding - basic | |
| 1,068,273,108 | | |
| 1,013,915,081 | |
Dilutive effect of stock options | |
| 7,977,096 | | |
| 657,740 | |
Weighted average shares of Common Stock outstanding - diluted | |
| 1,076,250,204 | | |
| 1,014,572,821 | |
| |
| | | |
| | |
Net income per share | |
| | | |
| | |
Basic | |
$ | 0.00 | | |
$ | 0.00 | |
Diluted | |
$ | 0.00 | | |
$ | 0.00 | |
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Fair
Value of Financial Instruments
ASC
820, Fair Value Measurements and Disclosures (“ASC 820”) provides a framework for measuring fair value in accordance
with generally accepted accounting principles.
ASC
820 defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction
between market participants at the measurement date. ASC 820 establishes a fair value hierarchy that distinguishes between (1) market
participant assumptions developed based on market data obtained from independent sources (observable inputs) and (2) an entity’s
own assumptions about market participant assumptions developed based on the best information available in the circumstances (unobservable
inputs).
The
fair value hierarchy consists of three broad levels, which gives the highest priority to unadjusted quoted prices in active markets for
identical assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3). The three levels of the fair value
hierarchy under ASC 820 are described as follows:
|
● |
Level
1 – Unadjusted quoted prices in active markets for identical assets or liabilities that are accessible at the measurement date. |
|
|
|
|
● |
Level
2 – Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly
or indirectly. Level 2 inputs include quoted prices for similar assets or liabilities in active markets; quoted prices for identical
or similar assets or liabilities in markets that are not active; inputs other than quoted prices that are observable for the asset
or liability; and inputs that are derived principally from or corroborated by observable market data by correlation or other means. |
|
|
|
|
● |
Level
3 – Inputs that are unobservable for the asset or liability. |
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, 2024 | |
$ | 6,298,008 | | |
$ | — | | |
$ | — | | |
$ | 6,298,008 | |
Change in fair value of derivative financial instruments - warrants | |
| 2,782,913 | | |
| — | | |
| — | | |
| 2,782,913 | |
Balance as of June 30, 2024 | |
$ | 9,080,921 | | |
$ | — | | |
$ | — | | |
$ | 9,080,921 | |
| |
| | |
Fair Value Measurement | |
| |
Amount at Fair Value | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Balance as of March 31, 2023 | |
$ | 521,711 | | |
$ | — | | |
$ | — | | |
$ | 521,711 | |
Change in fair value of derivative financial instruments - warrants | |
| 189,367 | | |
| — | | |
| — | | |
| 189,367 | |
Balance as of June 30, 2023 | |
$ | 711,078 | | |
$ | — | | |
$ | — | | |
$ | 711,078 | |
See
Note 10 for specific inputs used in determining fair value.
The
carrying amounts of the Company’s financial assets and liabilities, such as cash, accounts receivable, prepaid expenses and other
current assets, accounts payable and accrued expenses, approximate their fair values because of the short maturity of these instruments.
Based upon current borrowing rates with similar maturities the carrying value of long-term debt, and related party loans payable approximates
fair value.
Non-Financial
Assets that are Measured at Fair Value on a Non-Recurring Basis
Non-financial
assets such as intangible assets, and property and equipment are measured at fair value only when an impairment loss is recognized. The
Company did not record an impairment charge related to these assets in the periods presented.
Recently
Issued Accounting Pronouncements
In
December 2023, the FASB issued ASU 2023-09 (Topic 740), Improvements to income tax disclosures, which enhances the disclosure requirements
for the income tax rate reconciliation, domestic and foreign income taxes paid, requiring disclosure of disaggregated income taxes paid
by jurisdiction, unrecognized tax benefits, and modifies other income tax-related disclosures. The amendments are effective for annual
periods beginning after December 15, 2024. Early adoption is permitted and should be applied prospectively. The Company is currently
evaluating the effect of adopting this guidance on its condensed consolidated financial statements.
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
In
November 2023, the FASB issued ASU 2023-07, “Segment Reporting (Topic 280): Improvements to Reportable Segments,” which aims
to improve financial reporting by requiring disclosure of incremental segment information on an annual and interim basis for all public
entities to enable investors to develop more decision-useful financial analyses. Currently, Topic 280 requires that a public entity disclose
certain information about its reportable segments. Topic 280 also requires other specified segment items and amounts to be disclosed
under certain circumstances. The amendments in this ASU do not change or remove those disclosure requirements and do not change how a
public entity identifies its operating segments, aggregates those operating segments, or applies the quantitative thresholds to determine
its reportable segments. This ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal
years beginning after December 15, 2024. Early adoption is permitted. The Company does not expect that the requirements of ASU 2023 – 07 will
have a material impact on its condensed consolidated financial statements.
Management
has evaluated recently issued accounting pronouncements and does not believe that any of these pronouncements will have a significant
impact on the Company’s condensed consolidated financial statements and related disclosures.
NOTE
2. INVENTORY
Inventory
consisted of the following:
SCHEDULE
OF INVENTORY
| |
June 30, 2024 | | |
March 31, 2024 | |
Finished goods | |
$ | 4,264,775 | | |
$ | 4,465,970 | |
Work-in-progress | |
| 2,260,532 | | |
| 1,804,426 | |
Raw materials | |
| 7,306,011 | | |
| 6,660,068 | |
Inventory | |
$ | 13,831,318 | | |
$ | 12,930,464 | |
NOTE
3. PROPERTY AND EQUIPMENT, NET
Property
and equipment consisted of the following:
SCHEDULE
OF PROPERTY AND EQUIPMENT
| |
June 30, 2024 | | |
March 31, 2024 | |
Land, building and improvements | |
$ | 11,612,950 | | |
$ | 11,061,149 | |
Laboratory, manufacturing, warehouse and transportation equipment | |
| 14,225,790 | | |
| 14,090,978 | |
Office equipment and software | |
| 373,601 | | |
| 373,601 | |
Furniture and fixtures | |
| 556,418 | | |
| 556,418 | |
Property and equipment, gross | |
| 26,768,759 | | |
| 26,082,146 | |
Less: Accumulated depreciation | |
| (16,197,891 | ) | |
| (15,906,853 | ) |
Property and equipment, net | |
$ | 10,570,868 | | |
$ | 10,175,293 | |
Depreciation
and amortization expense was $322,103 and $328,282 for the three months ended June 30, 2024 and 2023, respectively.
NOTE
4. ACCRUED EXPENSES
As
of June 30, 2024 and March 31, 2024, the Company’s accrued expenses consisted of the following:
SCHEDULE
OF ACCRUED EXPENSES
| |
June 30, 2024 | | |
March 31, 2024 | |
Co-development profit split | |
$ | 4,435,536 | | |
$ | 3,684,587 | |
Income tax | |
| 699,097 | | |
| 485,327 | |
Employee bonuses | |
| 370,869 | | |
| 206,225 | |
Other accrued expenses | |
| 324,265 | | |
| 668,108 | |
Legal and professional expense | |
| 165,000 | | |
| 90,000 | |
Salaries and fees payable | |
| 160,828 | | |
| — | |
Audit fees | |
| 50,000 | | |
| 125,000 | |
Director dues | |
| 22,500 | | |
| 22,500 | |
Consultant contract fees | |
| — | | |
| 20,000 | |
Total accrued expenses | |
$ | 6,228,095 | | |
$ | 5,301,747 | |
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
NOTE
5. NJEDA BONDS
During
August 2005, the Company refinanced a bond issue occurring in 1999 through the issuance of Series A and B Notes tax-exempt bonds (the
“NJEDA Bonds” and/or “Bonds”). During July 2014, the Company retired all 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. The debt service reserve is classified as
restricted cash on the accompanying 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
following tables summarize the Company’s bonds payable liability:
SCHEDULE OF BONDS PAYABLE LIABILITY
| |
June 30, 2024 | | |
March 31, 2024 | |
Gross bonds payable | |
| | | |
| | |
NJEDA Bonds - Series A Notes | |
$ | 1,120,000 | | |
$ | 1,120,000 | |
Less: Current portion of bonds payable (prior to deduction of bond offering costs) | |
| (130,000 | ) | |
| (130,000 | ) |
Long-term portion of bonds payable (prior to deduction of bond offering costs) | |
$ | 990,000 | | |
$ | 990,000 | |
| |
| | | |
| | |
Bond offering costs | |
$ | 354,454 | | |
$ | 354,454 | |
Less: Accumulated amortization | |
| (267,023 | ) | |
| (263,479 | ) |
Bond offering costs, net | |
$ | 87,431 | | |
$ | 90,975 | |
| |
| | | |
| | |
Current portion of bonds payable - net of bond offering costs | |
| | | |
| | |
Current portions of bonds payable | |
$ | 130,000 | | |
$ | 130,000 | |
Less: Bonds offering costs to be amortized in the next 12 months | |
| (14,178 | ) | |
| (14,178 | ) |
Current portion of bonds payable, net of bond offering costs | |
$ | 115,822 | | |
$ | 115,822 | |
| |
| | | |
| | |
Long term portion of bonds payable - net of bond offering costs | |
| | | |
| | |
Long term portion of bonds payable | |
$ | 990,000 | | |
$ | 990,000 | |
Less: Bond offering costs to be amortized subsequent to the next 12 months | |
| (73,253 | ) | |
| (76,797 | ) |
Long term portion of bonds payable, net of bond offering costs | |
$ | 916,747 | | |
$ | 913,203 | |
Amortization
expense was $3,544 and $3,548 for the three months ended June 30, 2024 and 2023, respectively. Interest payable was $24,267 and $6,067
as of June 30, 2024 and March 31, 2024, respectively. Interest expense was $18,200 and $20,232 for the three months ended June 30, 2024
and 2023, respectively.
Maturities
of bonds for the next five years and thereafter are as follows:
SCHEDULE OF MATURITIES OF BONDS
Years ending March 31, | |
Amount | |
Remainder of 2025 | |
$ | 130,000 | |
2026 | |
| 140,000 | |
2027 | |
| 150,000 | |
2028 | |
| 160,000 | |
2029 | |
| 170,000 | |
Thereafter | |
| 370,000 | |
Total | |
$ | 1,120,000 | |
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
NOTE
6. LOANS PAYABLE
Loans
payable consisted of the following:
SCHEDULE OF LOANS PAYABLE
| |
June 30, 2024 | | |
March 31, 2024 | |
Mortgage loan payable 4.75% interest and maturing June 2032 | |
$ | 2,397,969 | | |
$ | 2,418,426 | |
Equipment and insurance financing loans payable, between 5.99% and 12.02% interest and maturing between July 2024 and October 2025 | |
| 243,797 | | |
| 128,460 | |
Less: Current portion of loans payable | |
| (313,786 | ) | |
| (180,399 | ) |
Long-term portion of loans payable | |
$ | 2,327,980 | | |
$ | 2,366,487 | |
The
interest expense associated with the loans payable was $34,883 and $77,238 for the three months ended June 30, 2024 and 2023, respectively.
Loan
principal payments for the next five years and thereafter are as follows:
SCHEDULE OF LOAN PRINCIPAL PAYMENTS
Future principal balances | |
| |
Years ending March 31, | |
Amount | |
Remainder of 2025 | |
$ | 275,282 | |
2026 | |
| 120,749 | |
2027 | |
| 92,773 | |
2028 | |
| 94,433 | |
2029 | |
| 98,447 | |
Thereafter | |
| 1,960,082 | |
Total remaining principal balance | |
$ | 2,641,766 | |
NOTE
7. RELATED PARTY LOANS
The
Company has entered into a collateralized promissory note with individual lenders with rates comparable to the EWB Term Loan but with
fewer covenants (the “Hakim Promissory Note”). These covenants include filing timely tax returns and financial statements,
and an agreement not to sell, lease, or transfer a substantial portion of the Company’s assets during the term of the Hakim Promissory
Note. On June 2, 2023, the Company entered into a Promissory Note with Nasrat Hakim, CEO and Chairman of the Board of Directors, pursuant
to which the Company borrowed funds in the aggregate principal amount of $3,000,000. The Hakim Promissory Note has an interest rate of
9% for the first year and 10% for an optional second year and the proceeds were used for working capital and other business purposes.
The original maturity date of the Hakim Promissory Note was June 2, 2024, with an optional second year extension. The second year extension
was exercised pursuant to the terms of the Hakim Promissory Note. For the three months ended June 30, 2024, interest expense on the Hakim
Promissory Note totaled $67,500, recorded on the Condensed Consolidated Balance Sheets in accrued expenses and on the Condensed Consolidated
Statements of Operations in interest expense and amortization of debt issuance costs.
On
June 30, 2023, the Company entered into a collateralized promissory note with Davis Caskey (the “Caskey Promissory Note”).
The Caskey Promissory Note has a principal balance of $1,000,000 and an interest rate of 9% for the first year and 10% for an optional
second year. The Caskey Promissory Note is subject to the same covenants as are contained in the Hakim Promissory Note. The proceeds
will be used for working capital and other business purposes. The original maturity date of the Caskey Promissory Note was June 30, 2024,
with an optional second year extension. The second year extension was exercised pursuant to the terms of the Caskey Promissory Note.
For the three months ended June 30, 2024, interest expense on the Caskey Promissory Note totaled $22,500, recorded on the Condensed Consolidated
Balance Sheets in accrued expenses and on the Condensed Consolidated Statements of Operations in interest expense and amortization of
debt issuance costs.
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
NOTE
8. COMMITMENTS AND CONTINGENCIES
Occasionally,
the Company may be involved in claims and legal proceedings arising from the ordinary course of its business. The Company records a provision
for a liability when it believes that it is both probable that a liability has been incurred, and the amount can be reasonably estimated.
If these estimates and assumptions change or prove to be incorrect, it could have a material impact on the Company’s condensed
consolidated financial statements. Contingencies are inherently unpredictable, and the assessments of the value can involve a series
of complex judgments about future events and can rely heavily on estimates and assumptions.
On
August 17, 2023, Elite filed a paragraph IV certification with its ANDA to generic Oxycontin and after Elite got acceptance of the ANDA
by the FDA on September 19, 2023, Elite sent the patentee and NDA holder a Notice Letter as required under the Hatch-Waxman Act. On November
14, 2023, a patent infringement suit was filed in the District Court of New Jersey by Purdue Pharma. Elite obtained agreement with Purdue
to stay the litigation for six months. Elite’s launch of a generic Oxycontin will depend on the approval by the FDA and the outcome
of various litigations involving Purdue or the expiry of the patents listed on the Orange Book. As of June 30, 2024, the results of such
proceedings cannot be predicted with certainty and are neither probable nor estimable.
Operating
Leases
In
October 2020, the Company entered into an operating lease for office space in Pompano Beach, Florida (the “Pompano Office Lease”).
The Pompano Office Lease is for approximately 1,275 square feet of office space, with the Company taking occupancy on November 1, 2020.
The Pompano Office Lease had a term of three years, ending on October 31, 2023. The Pompano Office Lease was extended for one additional
year to October 31, 2024.
The
Company 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.
Finance
Leases
In
November 2023, the Company entered into a finance lease for equipment (the “Waters Equipment Lease”). The Waters Equipment
Lease is related to lab equipment with an acquisition cost of $499,775, with the Company taking ownership of the asset on December 1,
2023. The Waters equipment lease has a term of five years, ending on November 29, 2028. The Company also has the option to purchase the
asset at the end of the lease term for the amount of $1, which is probable to be exercised.
In
February 2024, the Company entered into a finance lease for warehouse equipment (the “Warehouse Equipment Lease”). The Warehouse
Equipment Lease is related to warehouse equipment with an acquisition cost of $37,500, with the Company taking ownership of the asset
during February 2024. The Warehouse Equipment Lease has a term of two years, ending in February 2026. The Company also has the option
to purchase the asset at the end of the lease term for the amount of $1, which is probable to be exercised.
In
February 2024, the Company entered into a finance lease for equipment ( the “February 2024 Equipment Lease”). The February
2024 Equipment Lease is related to manufacturing equipment with an acquisition cost of $455,000, with the Company taking ownership of
the asset during February 2024. The February 2024 Equipment Lease has a term of five years, ending in February 2029. The Company will retain
ownership of the equipment at lease termination.
In
March 2024, the Company entered into three separate finance leases for manufacturing assets (the “March 2024 Equipment Leases”).
The March 2024 Equipment Leases are related to manufacturing equipment and vault installed at the Company’s facility located at
144 Ludlow Avenue, Northvale NJ with an aggregate acquisition cost of $1.1 million. Each of the separate leases included in the March
2024 Equipment Leases have a term of five years, ending in March 2029. The Company will retain ownership of all related assets at lease termination.
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
A
lease is classified as a finance lease if any of the following criteria are met: (i) ownership of the underlying asset transfers to the
Company by the end of the lease term; (ii) the lease contains an option to purchase the underlying asset that the Company is reasonably
expected to exercise; (iii) the lease term is for a major part of the remaining economic life of the underlying asset; (iv) the present
value of the sum of lease payments and any residual value guaranteed by the Company equals or exceeds substantially all of the fair value
of the underlying asset; or (v) the underlying asset is of a specialized nature that it is expected to have no alternative use to the
lessor at the end of the lease term. A lease that does not meet any of the criteria to be classified as a finance lease is classified
as an operating lease. As the Company expects to exercise the option to purchase the asset at the end of the lease term, the Waters equipment
lease was determined to be a finance lease. The finance lease is included on the condensed consolidated balance sheets as Finance lease
- right-of-use asset and Lease obligation - finance lease. The finance lease costs are split between Depreciation and amortization expense
related to the asset and Interest expense and amortization of debt issuance costs on the lease liability, using the effective rate charged
by the lessor. The Company has elected to account for lease and non-lease components separately.
Lease
assets and liabilities are classified as follows on the condensed consolidated balance sheet:
SCHEDULE OF LEASE ASSETS AND LIABILITIES
Lease | |
Classification | |
June 30, 2024 | | |
March 31, 2024 | |
Assets | |
| |
| | | |
| | |
Finance | |
Finance lease – right-of-use asset | |
$ | 1,976,049 | | |
$ | 2,079,658 | |
Operating | |
Operating lease – right-of-use asset | |
| 2,222,172 | | |
| 2,355,201 | |
Total leased assets | |
| |
$ | 4,198,221 | | |
$ | 4,434,859 | |
| |
| |
| | | |
| | |
Liabilities | |
| |
| | | |
| | |
Current | |
| |
| | | |
| | |
Finance | |
Lease obligation – finance lease | |
$ | 319,803 | | |
$ | 312,739 | |
Operating | |
Lease obligation – operating lease | |
| 416,764 | | |
| 411,418 | |
| |
| |
| | | |
| | |
Long-term | |
| |
| | | |
| | |
Finance | |
Lease obligation – finance lease, net of current portion | |
| 1,401,924 | | |
| 1,480,317 | |
Operating | |
Lease obligation – operating lease, net of current portion | |
| 1,850,656 | | |
| 1,957,383 | |
Total lease liabilities | |
| |
$ | 3,989,147 | | |
$ | 4,161,857 | |
Rent
expense is recorded on the straight-line basis. Rent expense under the Pompano Office Lease was $8,087 and $6,519 for the three months
ended June 30, 2024 and 2023, respectively. Rent expense under the 144 Ludlow lease was $151,515 and $0 for the three months ended June
30, 2024 and 2023, respectively. Rent expense is recorded in general and administrative expense in the condensed consolidated statements of operations.
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The
table below shows the future minimum rental payments, exclusive of taxes, insurance and other costs, under the Pompano Office Lease and
Waters Equipment Lease:
SCHEDULE OF FUTURE MINIMUM RENTAL PAYMENTS
Years ending March 31, | |
Operating Lease Amount | | |
Financing Lease Amount | | |
Total | |
Remainder of 2025 | |
$ | 469,677 | | |
$ | 352,565 | | |
$ | 822,242 | |
2026 | |
| 623,565 | | |
| 468,391 | | |
| 1,091,956 | |
2027 | |
| 637,050 | | |
| 449,745 | | |
| 1,086,795 | |
2028 | |
| 650,871 | | |
| 449,745 | | |
| 1,100,616 | |
2029 | |
| 440,159 | | |
| 408,453 | | |
| 848,612 | |
Thereafter | |
| — | | |
| 6,340 | | |
| 6,340 | |
Less: interest | |
| (553,899 | ) | |
| (413,515 | ) | |
| (967,414 | ) |
Present value of lease payments | |
$ | 2,267,423 | | |
$ | 1,721,724 | | |
$ | 3,989,147 | |
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 | |
2024 | | |
2023 | |
Remaining lease term (years) | |
| | | |
| | |
Operating leases | |
| 4.4 | | |
| 0.3 | |
Finance leases | |
| 4.6 | | |
| — | |
Discount rate | |
| | | |
| | |
Operating leases | |
| 10.0 | % | |
| 6.0 | % |
Finance leases | |
| 9.5 | % | |
| — | |
NOTE
9. PREFERRED STOCK
Series
J convertible preferred stock
On
April 28, 2017, the Company created the Series J Convertible Preferred Stock (“Series J Preferred”) in conjunction with the
Certificate of Designations. A total of 50 shares of Series J Preferred were authorized, zero shares are issued and outstanding, with
a stated value of $1,000,000 per share and a par value of $0.01.
NOTE
10. DERIVATIVE FINANCIAL INSTRUMENTS – WARRANTS
The
Company evaluates and accounts for its freestanding instruments in accordance with ASC 815, Accounting for Derivative Instruments
and Hedging Activities.
The
Company issued warrants, with a term of ten years, to affiliates in connection with an exchange agreement dated April 28, 2017, as further
described in this note below.
The
Company has 79,008,661 total warrants to purchase shares of Common Stock outstanding with a weighted average exercise price of $0.1521
as of June 30, 2024 and March 31, 2024.
On
April 28, 2017, the Company entered into an Exchange Agreement with Hakim, the Chairman of the Board, President, and Chief Executive
Officer of the Company, pursuant to which the Company issued to Hakim 24.0344 shares of its Series J Preferred and warrants to purchase
an aggregate of 79,008,661 shares of its Common Stock (the “Series J Warrants” and, along with the Series J Preferred issued
to Hakim, the “Securities”) in exchange for 158,017,321 shares of Common Stock owned by Hakim. The fair value of the Series
J Warrants was determined to be $6,474,674 upon issuance at April 28, 2017.
The
Series J Warrants are exercisable for a period of 10 years from the date of issuance, commencing April 28, 2020. The initial exercise
price is $0.1521 per share and the Series J Warrants can be exercised for cash or on a cashless basis, including a provision within that
provides the holder a choice of net cash settlement or settlement in shares upon a cashless exercise. The net cash settlement amount
is the cash value obtained by subtracting the then exercise price from the closing price of the Company’s Common Stock (provided
such closing price is higher than the exercise price) and multiplying the difference by the number of shares exercised. As this event
is at the holder’s option, it is considered outside of the Company’s control. As a result of the net cash settlement at the
option of the holder, such warrants are classified as liabilities and measured initially and subsequently at fair value.
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The
exercise price is subject to adjustment for any issuances or deemed issuances of Common Stock or Common Stock equivalents at an effective
price below the then exercise price. The Series J Warrants also provide for other standard adjustments upon the happening of certain
customary events.
The
fair value of the Series J Warrants was calculated using a Black-Scholes model. The following assumptions were used in the Black-Scholes
model to calculate the fair value of the Series J Warrants:
SCHEDULE OF FAIR VALUE OF WARRANTS ISSUED
| |
June 30, 2024 | | |
March 31, 2024 | |
Fair value of the Company’s Common Stock | |
$ | 0.1990 | | |
$ | 0.1543 | |
Volatility | |
| 75.70 | % | |
| 72.90 | % |
Initial exercise price | |
$ | 0.1521 | | |
$ | 0.1521 | |
Warrant term (in years) | |
| 2.8 | | |
| 3.1 | |
Risk free rate | |
| 4.52 | % | |
| 4.40 | % |
The
changes in warrants (Level 3 financial instruments) measured at fair value on a recurring basis were as follows:
SCHEDULE OF CHANGES IN WARRANTS MEASURED AT FAIR VALUE ON A RECURRING BASIS
Balance at March 31, 2023 | |
$ | 521,711 | |
Change in fair value of derivative financial instruments - warrants | |
| 5,776,297 | |
Balance at March 31, 2024 | |
$ | 6,298,008 | |
Change in fair value of derivative financial instruments - warrants | |
| 2,782,913 | |
Balance at June 30, 2024 | |
$ | 9,080,921 | |
NOTE
11. STOCK-BASED COMPENSATION
Part
of the compensation paid by the Company to employees consists of the granting of
options to purchase Common Stock.
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Options
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. All options have generally been granted at a price
equal to or greater than the fair market value of the Company’s Common Stock at the date of the grant. Generally, options are granted
with a vesting period of up to three years and expire ten years from the date of grant.
The
fair value of option awards is estimated on the date of grant using the Black-Scholes option-pricing model. The exercise price of each
award is generally not less than the per share fair value in effect as of that award date. The determination of fair value using the
Black-Scholes model is affected by the Company’s share fair value as well as assumptions regarding a number of complex and subjective
variables, including expected price volatility, risk-free interest rate and projected employee share option exercise behaviors. The Company
estimates its expected volatility by using a combination of historical share price volatilities of similar companies within our industry.
The expected term of the Company’s stock options for employees has been determined utilizing the “simplified” method
for awards, since the Company does not have sufficient exercise history to estimate term of its historical option awards. The risk-free
interest rate is determined by reference to the U.S. Treasury yield curve. Expected dividend yield is zero based on the fact that the
Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future.
The
grant date fair value of option awards is determined using the Black Scholes option-pricing model. No options were issued for the three
months ended June 30, 2024 and 2023.
A
summary of the activity of Company’s 2024 Equity Incentive plan and prior equity incentive plans for the three months ended June
30, 2024 is as follows:
SCHEDULE OF STOCK OPTION PLAN
| |
| | |
| | |
Weighted | | |
| |
| |
Shares | | |
Weighted | | |
Average
Remaining | | |
Aggregate | |
| |
Underlying
Options | | |
Average
Exercise Price | | |
Contractual
Term (in years) | | |
Intrinsic
Value | |
Outstanding at March 31, 2024 | |
| 15,730,000 | | |
$ | 0.05 | | |
| 8.8 | | |
$ | 1,626,748 | |
Granted | |
| — | | |
$ | — | | |
| — | | |
$ | — | |
Expired and Forfeited | |
| — | | |
$ | — | | |
| — | | |
$ | — | |
Outstanding at June 30, 2024 | |
| 15,730,000 | | |
$ | 0.05 | | |
| 8.5 | | |
$ | 2,319,442 | |
Exercisable at June 30, 2024 | |
| 4,050,000 | | |
$ | 0.04 | | |
| 7.9 | | |
$ | 633,054 | |
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, 2024 of $0.20 for those awards with strike prices lower than
the quoted price of the Company’s Common Stock as of June 30, 2024. As of June 30, 2024, there was $385,592 in unrecognized stock
based compensation expense that will be recognized over a weighted average 1.94 year period.
NOTE
12. CONCENTRATIONS AND CREDIT RISK
Revenues
Two
customers accounted for approximately 68% of the Company’s revenues for the three months ended June 30, 2024. These two customers
accounted for approximately 44% and 24% of revenues each, respectively.
Five
customers accounted for approximately 76% of the Company’s revenues for the three months ended June 30, 2023. These five customers
accounted for approximately 21%, 16%, 15%, 14%, and 10% of revenue each, respectively.
Accounts
Receivable
Two
customers accounted for approximately 74% of the Company’s accounts receivable as of June 30, 2024. These two customers accounted
for approximately 50% and 24%of accounts receivable each, respectively.
Three
customers accounted for approximately 56% of the Company’s accounts receivable as of June 30, 2023. These three customers accounted
for approximately 22%, 21%, and 13% of accounts receivable each, respectively.
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Purchasing
Two
suppliers accounted for approximately 61% of the Company’s purchases of raw materials for the three months ended June 30, 2024.
These two customers accounted for approximately 39% and 22% of purchasing each, respectively.
One
supplier accounted for approximately 39% of the Company’s purchases of raw materials for the three months ended June 30, 2023.
NOTE
13. SEGMENT RESULTS
FASB
ASC 280-10-50 requires use of the “management approach” model for segment reporting. The management approach is based on
the way a company’s management organized segments within the company for making operating decisions and assessing performance.
Reportable segments are based on products and services, geography, legal structure, management structure, or any other manner in which
management disaggregates a company.
The
Company has historically determined that its reportable segments are ANDAs for generic products and NDAs for branded products. The
Company identified its reporting segments based on the marketing authorization relating to each and the financial information used
by its chief operating decision maker to make decisions regarding the allocation of resources to and the financial performance of
the reporting segments. During fiscal years ended March 31, 2024 and 2023, the Company had paused further development of NDAs and
has not engaged in business activities in that segment. Accordingly, during the three months ended June 30, 2024 and 2023, the Company has only engaged in business activities in a single operating segment.
Asset
information by operating segment is not presented below since the chief operating decision maker does not review this information by
segment. The reporting segments follow the same accounting policies used in the preparation of the Company’s condensed consolidated
financial statements.
The
following represents selected information for the Company’s reportable segments:
SCHEDULE OF SELECTED INFORMATION FOR REPORTABLE SEGMENTS
| |
| | |
| |
| |
For the Three Months Ended June 30, | |
| |
2024 | | |
2023 | |
Operating Income by Segment | |
| | | |
| | |
ANDA | |
$ | 6,311,251 | | |
$ | 3,607,010 | |
Operating income by Segment | |
$ | 6,311,251 | | |
$ | 3,607,010 | |
The
Company notes that there was no revenue related to the NDA segment for the three months ended June 30, 2024 and 2023.
The
table below reconciles the Company’s operating income by segment to income before income taxes as reported in the Company’s
condensed consolidated statements of operations:
SCHEDULE OF OPERATING INCOME BY SEGMENT TO INCOME FROM OPERATIONS
| |
| | |
| |
| |
For the Three Months Ended June 30, | |
| |
2024 | | |
2023 | |
Operating income by segment | |
$ | 6,311,251 | | |
$ | 3,607,010 | |
Corporate unallocated costs | |
| (1,969,154 | ) | |
| (1,519,736 | ) |
Interest income | |
| 5,390 | | |
| 3,516 | |
Interest expense and amortization of debt issuance costs | |
| (250,781 | ) | |
| (119,412 | ) |
Depreciation and amortization expense | |
| (425,712 | ) | |
| (328,282 | ) |
Significant non-cash items | |
| (52,329 | ) | |
| (156,968 | ) |
Change in fair value of derivative instruments | |
| (2,782,913 | ) | |
| (189,367 | ) |
Other income | |
| 12,000 | | |
| — | |
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
NOTE
14. 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, 2024, the Company owes an aggregate of $4,435,536 to Mikah in accordance with the agreements, with such amount being recorded
as an accrued expense on the condensed consolidated balance sheets.
NOTE
15. 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 $231,979 and
$154,975 for the three months ended June 30, 2024 and June 30, 2023, respectively. The Company recorded tax expense of approximately
27.4% and 11.9% of income before income tax expense, for each of the three-month period ended June 30, 2024 and 2023, respectively. The
increase of the effective tax rate for the current period as compared to the prior period is primarily due to the release of the valuation
allowance on the Company’s deferred tax assets as of March 31, 2024.
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, 2024 and 2023 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, 2024. We use words such as “anticipate,” “estimate,”
“plan,” “project,” “continuing,” “ongoing,” “expect,” “believe,”
“intend,” “may,” “will,” “should,” “could,” and similar expressions to identify
forward-looking statements.
Unless
expressly indicated or the context requires otherwise, the terms “Elite”, the “Company”, “we”, “us”,
and “our” refer to Elite Pharmaceuticals, Inc. and subsidiary.
Background
Elite
Pharmaceuticals, Inc., a Nevada corporation (the “Company”, “Elite”, “Elite Pharmaceuticals”, the
“registrant”, “we”, “us” or “our”) was incorporated on October 1, 1997 under the laws
of the State of Delaware, and its wholly-owned subsidiary, Elite Laboratories, Inc. (“Elite Labs”), was incorporated on August
23, 1990 under the laws of the State of Delaware. On January 5, 2012, Elite Pharmaceuticals was reincorporated under the laws of the
State of Nevada.
We
are a specialty pharmaceutical company principally engaged in the development and manufacture of oral, controlled-release products, and
the manufacture of generic pharmaceuticals. Our strategy includes developing generic versions of controlled-release drug products with
high barriers to entry.
We
occupy manufacturing, warehouse, laboratory and office space at 135, 144 and 165 Ludlow Avenue in Northvale, NJ (the “Northvale
Facility”). The Northvale Facility operates under Current Good Manufacturing Practice (“cGMP”) and is a United States
Drug Enforcement Agency (“DEA”) registered facility for research, development, and manufacturing. We are also party to an
operating lease for office space at Pompano Beach, Florida (the “Pompano Office Lease”).
Strategy
We
focus our efforts on the following areas: (i) manufacturing of a line of generic pharmaceutical products with approved Abbreviated New
Drug Applications (“ANDAs”); (ii) development of additional generic pharmaceutical products; (iii) development of the other
product candidates in our pipeline including products co-developed with partners; (iv) commercial exploitation of our product candidates
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.
Our
focus is on the development of various types of drug products, including generic drug products which require ANDAs as well as 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.
We
believe that our business strategy enables us to reduce its risk by having a diverse product portfolio that includes generic products
in various therapeutic categories and to build collaborations and establish licensing agreements with companies with greater resources
thereby allowing us to share costs of development and improve cash-flow.
Recent
Developments
On
May 20, 2024, the Company reported that it received approval from the FDA for a generic version of Methotrexate Sodium 2.5mg tablets.
Methotrexate Sodium belongs to a class of drugs known as antimetabolites and will be sold under the Elite Laboratories Inc. label. As
of the date of filing of this Quarterly Report on Form 10-Q, this product had not yet been commercially launched.
On
June 17, 2024, the Company entered into an asset purchase agreement with Nostrum Laboratories Inc. (the “Nostrum Asset Purchase
Agreement”), pursuant to which the Company acquired all rights in and to the approved ANDAs as well as royalty free, non-exclusive
perpetual licenses to use the manufacturing technology, proprietary information, processes, techniques, protocols, methods, know-how
and improvements necessary to manufacture the following products:
|
● |
Hydrocodone
Bitartrate and Acetaminophen tablets |
|
● |
Oxycodone
Hydrochloride and Acetaminophen tablets |
|
● |
Methodone
Hydrochloride tablets |
As of the date of filing of this Quarterly report on Form 10-Q, these products have not yet been commercially launched.
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 |
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) New Drug Application 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 of July 14, 2016.
On
July 15, 2016, the FDA issued a Complete Response Letter, or CRL, regarding the NDA. The CRL stated that the review cycle for the SequestOx™
NDA is 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 or 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 and also extended our filing fee waiver until July 2023. 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
antimetabolite accepted for review in April 2023 |
|
|
|
|
● |
Generic
opiate analgesic for pain management accepted for review in September 2023 |
|
|
|
|
● |
Generic
central nervous system stimulant accepted for review in December 2023 |
Approved
Products Not Yet Commercialized
Acetaminophen
and Codeine Phosphate
The
Company received approval on September 10, 2019 from the FDA of an ANDA for a generic version of Tylenol® with Codeine (acetaminophen
and codeine phosphate) 300mg/7.5mg, 300mg/15mg, 300mg/30mg and 300mg/60mg tablets. Acetaminophen with codeine is a combination medication
indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments
are inadequate. The Company is currently assessing commercialization options for this product.
Doxycycline
Hyclate Tablets
The
Company received approval in April 2022 from the FDA of an ANDA for a generic version of an antibiotic product. The product is jointly
owned by Elite and Praxgen Pharmaceuticals LLC, formerly SunGen Pharma LLC, (“Praxgen”).
Methotrexate
Sodium Tablets
On
May 10, 2024, the Company received approval from the FDA for an ANDA for generic Methotrexate Sodium 2.5 mg tablets. Methotrexate belongs
to a class of drugs known as antimetabolites and will be sold under the Elite Laboratories, Inc. label.
Hydrocodone
Bitartrate and Acetaminophen Tablets
On
June 17, 2024, the Company entered into an asset purchase agreement with Nostrum Laboratories Inc. (the “Nostrum Asset Purchase
Agreement”), pursuant to which the Company acquired all rights in and to the approved ANDA to this product and a royalty-free,
non-exclusive perpetual license to use the manufacturing technology, proprietary information, processes, techniques, protocols, methods,
know-how and improvements necessary or used to manufacture this product.
Oxycodone
Hydrochloride and Acetaminophen Tablets
Pursuant to the Nostrum Asset Purchase
Agreement, the Company acquired all rights in and to the approved ANDA to this product and a royalty-free,
non-exclusive perpetual license to use the manufacturing technology, proprietary information, processes, techniques, protocols, methods,
know-how and improvements necessary or used to manufacture this product.
Methadone
Hydrochloride Tablets
Pursuant to the Nostrum Asset Purchase
Agreement, the Company acquired all rights in and to the approved ANDA to this product and a royalty-free,
non-exclusive perpetual license to use the manufacturing technology, proprietary information, processes, techniques, protocols, methods,
know-how and improvements necessary or used to manufacture this product.
There
can be no assurances in relation to any of the above approved products not yet commercialized, that there will be future revenues of
profits, or that any such future revenues or profits would be in amounts that provide adequate return on the significant investments
made to secure these marketing authorizations.
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 fiscal year ended March 31, 2024 (“Fiscal 2024”) and ANDAs
acquired or approved during the quarterly period ending June 30, 2024. Such evaluations include, without limitation, costs and benefits 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 transfer or discontinue any ANDAs during the quarterly period ending June 30, 2024 or Fiscal 2024.
Critical
Accounting Policies and Estimates
The
preparation of the unaudited condensed consolidated financial statements and related disclosures in conformity with GAAP, and our discussion
and analysis of the Company’s financial condition and operating results require our management to make judgments, assumptions and
estimates that affect the amounts reported in the Company’s unaudited condensed consolidated financial statements and accompanying
notes. Management bases its estimates on historical experience and on various other assumptions it believes to be reasonable under the
circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results
may differ from these estimates and such differences may be material. We have identified below the critical accounting policies, which
are assumptions made by management about matters that are highly uncertain and that are of critical importance in the presentation of
our financial position, results of operations and cash flows. Due to the need to make estimates about the effect of matters that are
inherently uncertain, materially different amounts could be reported under different conditions or using different assumptions. On a
regular basis, we review our critical accounting policies and how they are applied in the preparation our financial statements.
Use
of estimates - The preparation of financial statements in conformity with accounting principles generally accepted in the United
States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses
during the reporting period. Actual results could differ from those estimates.
Revenue
Recognition - The Company generates revenue from manufacturing and licensing fees and sales of generic pharmaceuticals bearing the
Elite label to pharmaceutical distributors for pharmacies and institutions. Manufacturing fees include the development of pain management
products, manufacturing of a line of generic pharmaceutical products with approved ANDA, through the manufacture of formulations and
the development of new products. Revenues earned from the sale of Elite label products are recorded at their net realizable value which
consists of gross amounts invoiced reduced by contractual reductions, including, without limitation, chargebacks, discounts and program
rebates, as applicable. Licensing fees include the commercialization of products either by license and the collection of royalties, or
the expansion of licensing agreements with other pharmaceutical companies, including co-development projects, joint ventures and other
collaborations.
Under
ASC 606, Revenue from Contacts with Customers (“ASC 606”), the Company recognizes revenue when the customer obtains control
of promised goods or services, in an amount that reflects the consideration which is expected to be received in exchange for those goods
or services. The Company recognizes revenues following the five-step model prescribed under ASC 606: (i) identify contract(s) with a
customer; (ii) identify the performance obligation(s) in the contract; (iii) determine the transaction price; (iv) allocate the transaction
price to the performance obligation(s) in the contract; and (v) recognize revenues when (or as) the Company satisfies a performance obligation.
The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled
to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within
the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance
obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the
transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Sales,
value add, and other taxes collected on behalf of third parties are excluded from revenue.
Nature
of goods and services
The
following is a description of the Company’s goods and services from which the Company generates revenue, as well as the nature,
timing of satisfaction of performance obligations, and significant payment terms for each, as applicable:
a)
Manufacturing Fees
The
Company is equipped to manufacture controlled-release products on a contract basis for third parties, if, and when, the products are
approved. These products include products using controlled-release drug technology. The Company also develops and markets (either on
its own or by license to other companies) generic and proprietary controlled-release pharmaceutical products.
The
Company recognizes revenue when the customer obtains control of the Company’s product based on the contractual shipping terms of
the contract, at which time the performance obligation is deemed to be completed. The Company is primarily responsible for fulfilling
the promise to provide the product, is responsible to ensure that the product is produced in accordance with the related supply agreement
and bears risk of loss while the inventory is in-transit to the commercial partner. Revenue is measured as the amount of consideration
the Company expects to receive in exchange for transferring products to a customer.
b)
License Fees
The
Company enters into licensing and development agreements, which may include multiple revenue generating activities, including milestones
payments, licensing fees, product sales and services. The Company analyzes each element of its licensing and development agreements in
accordance with ASC 606 to determine appropriate revenue recognition. The terms of the license agreement may include payment to the Company
of licensing fees, non-refundable upfront license fees, milestone payments if specified objectives are achieved, and/or royalties on
product sales.
If
the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation.
Contracts that contain multiple performance obligations require an allocation of the transaction price based on the estimated relative
standalone selling prices of the promised products or services underlying each performance obligation. The Company determines standalone
selling prices based on the price at which the performance obligation is sold separately. If the standalone selling price is not observable
through past transactions, the Company estimates the standalone selling price taking into account available information such as market
conditions and internally approved pricing guidelines related to the performance obligations.
The
Company recognizes revenue from non-refundable upfront payments at a point in time, typically upon fulfilling the delivery of the associated
intellectual property to the customer. For those milestone payments which are contingent on the occurrence of particular future events
(for example, payments due upon a product receiving FDA approval), the Company determined that these need to be considered for inclusion
in the calculation of total consideration from the contract as a component of variable consideration using the most-likely amount method.
As such, the Company assesses each milestone to determine the probability and substance behind achieving each milestone. Given the inherent
uncertainty of the occurrence of future events, the Company will recognize revenue from the milestone when there is not a high probability
of a reversal of revenue, which typically occurs near or upon achievement of the event.
Significant
management judgment is required to determine the level of effort required under an arrangement and the period over which the Company
expects to complete its performance obligations under the arrangement. If the Company cannot reasonably estimate when its performance
obligations either are completed or become inconsequential, then revenue recognition is deferred until the Company can reasonably make
such estimates. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method.
When
determining the transaction price of a contract, an adjustment is made if payment from a customer occurs either significantly before
or significantly after performance, resulting in a significant financing component. Applying the practical expedient in ASC 606-10-32-18,
the Company does not assess whether a significant financing component exists if the period between when the Company performs its obligations
under the contract and when the customer pays is one year or less. None of the Company’s contracts contained a significant financing
component as of December 31, 2023.
In
accordance with ASC 606-10-55-65, royalties are recognized when the subsequent sale of the customer’s products occurs.
c)
Sale of product under the Elite label
The
Company began direct sales of products under the Company’s own label on April 1, 2023. License agreements will remain in place
for select products. With this transition, however, a large portion of the manufacturing and license fees now reported will be replaced
with revenues from sales of Elite labeled pharmaceutical products to distributors for pharmacies and institutions.
The
Company recognizes revenue when the customer obtains control of the Company’s product based on the contractual shipping terms,
at which time the performance obligation is deemed to be completed. The Company is primarily responsible for fulfilling the promise to
deliver the product and bears risk of loss while the inventory is in-transit to the purchaser. Revenue is measured as the amount of consideration
earned from the sale of Elite labeled pharmaceutical products are recorded at their net realizable value which consists of gross amounts
invoiced reduced by contractual reductions, including, without limitation, chargebacks, discounts and program rebates, as applicable.
Accounts
Receivable and Allowance for Expected Credit Losses - Accounts receivable are comprised of balances due from customers, net of estimated
allowances for expected credit losses, and other contractual deductions, including, without limitation, chargebacks, discounts and program
rebates. In determining collectability, historical trends are evaluated, and specific customer issues are reviewed on a periodic basis
to arrive at appropriate allowances.
The
allowance for expected credit losses is based on the probability of future collection under the current expected credited loss (“CECL”)
impairment model under Accounting Standards Update (“ASU”) 2016-13, Financial Instruments - Credit Losses (Topic 326), Measurement
of Credit Losses on Financial Assets, which was adopted by the Company on April 1, 2023, as discussed below within Recently Adopted Accounting
Pronouncements. Under the CECL impairment model, the Company determines its allowance by applying a loss-rate method based on an aging
schedule using the Company’s historical loss rate. The Company also considers reasonable and supportable current information in
determining its estimated loss rates, such as external forecasts, macroeconomic trends or other factors including customers’ credit
risk and historical loss experience. The adequacy of the allowance is evaluated on a regular basis. Account balances are written off
after all means of collection are exhausted and the balance is deemed uncollectible. Subsequent recoveries are credited to the allowance.
Changes in the allowance are recorded as adjustments to credit losses in the period incurred.
Expected
credit losses stemming from unbilled receivables expected to be billed between June 30, 2024 and June 30, 2028 include additional risk
premiums estimated based on factors such as projected inflation, projected decreases in GDP, and projected unemployment.
Income
Taxes - Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for
the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets
and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates in effect for
the year in which those temporary differences are expected to be recovered or settled. Where applicable, the Company records a valuation
allowance to reduce any deferred tax assets that it determines will not be realizable in the future.
The
Company recognizes the benefit of an uncertain tax position that it has taken or expects to take on income tax returns it files if such
tax position is more likely than not to be sustained on examination by the taxing authorities, based on the technical merits of the position.
These tax benefits are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate resolution.
The
Company operates in multiple tax jurisdictions within the United States of America. The Company remains subject to examination in all
tax jurisdiction until the applicable statutes of limitation expire. As of December 31, 2023, a summary of the tax years that remain
subject to examination in our major tax jurisdictions are: United States – Federal, 2020 and forward, and State, 2019 and forward.
The Company did not record unrecognized tax positions for the three months ended June 30, 2024.
New
Accounting Pronouncements
For
a description of recent accounting standards, including the expected dates of adoption and estimated effects, if any, on our financial
statements, see “Note 1. Summary of Significant Accounting Polices: Recently Issued Accounting Pronouncements” in Part II,
Item 1 of this Form 10-Q.
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.
Three
months ended June 30, 2024 compared to the three months ended June 30, 2023
Revenue,
Cost of revenue and Gross profit:
| |
For the Three Months Ended
June 30, | | |
Change | |
| |
2024 | | |
2023 | | |
Dollars | | |
Percentage | |
Manufacturing fees | |
$ | 18,443,918 | | |
$ | 7,909,237 | | |
$ | 10,534,681 | | |
| 133 | % |
Licensing fees | |
| 359,145 | | |
| 1,070,839 | | |
| (711,694 | ) | |
| (66 | )% |
Total revenue | |
| 18,803,063 | | |
| 8,980,076 | | |
| 9,822,987 | | |
| 109 | % |
Cost of manufacturing | |
| 10,328,285 | | |
| 4,229,521 | | |
| 6,098,764 | | |
| 144 | % |
Gross profit | |
$ | 8,474,778 | | |
$ | 4,750,555 | | |
$ | 3,724,223 | | |
| 78 | % |
| |
| | | |
| | | |
| | | |
| | |
Gross profit - percentage | |
| 45 | % | |
| 53 | % | |
| | | |
| | |
Total
revenues for the three months ended June 30, 2024 increased by $9.8 million or 109%, to $18.8 million, as compared to $9.0 million, for
the corresponding period of the prior year, primarily due to the Elite label products achieving greater sales fifteen months
after their launch, as compared to the comparable period of the prior year being the period in which the Elite label was initially launched.
Manufacturing
fees revenue increased by $10.5 million, or 133%, primarily due to the Elite label products achieving greater sales fifteen months
after their launch, as compared to the comparable period of the prior year being the period in which the Elite label was initially launched.
Licensing
fees revenue decreased by $0.7 million, or 66%. This decrease is primarily due to the Company’s transitioning away from licensing
products to third parties to marketing of the Elite label, which does not result in license fee revenues.
Cost
of revenue consists of manufacturing and assembly costs. Our cost of revenue increased by $6.1 million or 144%, to $10.3 million as
compared to $4.2 million for the comparable period of the prior fiscal year. This increase was due to an increased volume of
products sold during the three months ended June 30, 2024, as compared to the comparable period of the prior fiscal year, as noted
above.
Our
gross profit margin was 45% during the three months ended June 30, 2024 as compared to 53% for the corresponding period in the prior
fiscal year. The decrease is due to a combination of increased overheads resulting from facility expansion necessary to support volumes
in excess of current levels and lower product margins required to increase and maintain the level of sales.
Operating
expenses:
| |
For the Three Months Ended
June 30, | | |
Change | |
| |
2024 | | |
2023 | | |
Dollars | | |
Percentage | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
$ | 2,163,527 | | |
$ | 1,143,545 | | |
$ | 1,019,982 | | |
| 89 | % |
General and administrative | |
| 1,969,154 | | |
| 1,661,704 | | |
| 307,450 | | |
| 19 | % |
Non-cash compensation | |
| 52,329 | | |
| 15,000 | | |
| 37,329 | | |
| 249 | % |
Depreciation and amortization | |
| 425,712 | | |
| 328,282 | | |
| 97,430 | | |
| 30 | % |
Total operating expenses | |
$ | 4,610,722 | | |
$ | 3,148,531 | | |
$ | 1,462,191 | | |
| 46 | % |
Operating
expenses consist of research and development costs, general and administrative costs, non-cash compensation and depreciation and amortization
expenses. Operating expenses for the three months ended June 30, 2024 increased by $1.5 million, or 46%, to $4.6 million as compared
to $3.1 million for the corresponding period in the prior fiscal year, largely due to an increase in research and development of $1.0
million and general and administrative expenses of $0.3 million.
Research
and development costs during the three months ended June 30, 2024 were $2.2 million, an increase of $1.0 million, or 89%, from
approximately $1.1 million of such costs for the prior year. The increase was a result of the number, timing and nature of product
development activities during the three months ended June 30, 2024 as compared to the comparable period in the prior fiscal
year.
General
and administrative expenses for the three months ended June 30, 2024 were $2.0 million as compared to $1.7 million for the comparable
period in the prior fiscal year, an increase of $0.3 million or approximately 19%, largely due to an increased human resource headcount
and costs as compared to the corresponding period in the prior fiscal year as well as infrastructure costs related to Elite label commercial
activities resulting from the commercial launch of the Elite label product line during the three months ended June 30, 2024.
Depreciation
and amortization expenses from the three months ended June 30, 2024 were $0.4 million as compared to $0.3 million for the comparable
period in the prior fiscal year, an increase of $0.1 million or approximately 30%. This increase is due to depreciation expense being
recorded on an increased fixed asset base which resulted from additional investments in capital manufacturing facilities.
As
a result of the foregoing, our income from operations during the three months ended June 30, 2024 was $3.9 million, compared to income
from operations of $1.6 million for the comparable period in the prior fiscal year.
Other
income (expense):
Other expense | |
For the Three Months Ended
June 30, | | |
Change | |
| |
2024 | | |
2023 | | |
Dollars | | |
Percentage | |
Other expense: | |
| | | |
| | | |
| | | |
| | |
Change in fair value of derivative financial instruments - warrants | |
$ | (2,782,913 | ) | |
$ | (189,367 | ) | |
$ | (2,593,546 | ) | |
| 1370 | % |
Interest expense and amortization of debt issuance costs | |
| (250,781 | ) | |
| (119,412 | ) | |
| (131,369 | ) | |
| 110 | % |
Interest income | |
| 5,390 | | |
| 3,516 | | |
| 1,874 | | |
| 53 | % |
Other income | |
| 12,000 | | |
| — | | |
| 12,000 | | |
| — | % |
Other expense, net | |
$ | (3,016,304 | ) | |
$ | (305,263 | ) | |
$ | (2,711,041 | ) | |
| 888 | % |
Other
expense, net for the three months ended June 30, 2024 was $3.0 million, an increase of $2.7 million for the corresponding
period in the prior fiscal year. The increase was primarily due to a net increases in other expenses of $2.6 million relating to the
change in fair value of warrant derivative instruments, $0.1 million relating to increased interest expense and amortization of debt
issuance costs, less than $0.1 million relating to the loss on asset disposal, and less than $0.1 million relating to the increase in
interest income, offset by increases in other income totaling less than $0.1 million. The change in the fair value of derivative instruments
and stock-based liabilities is determined in large part by the change in the closing price of the Company’s Common Stock as of
the end of the period, as compared to the closing price at the beginning of the period, with a strong inverse relationship between the
fair value of the Company’s derivative instruments and stock-based liabilities and decreases in the closing price of the Company’s
Common Stock. The increase in interest expense associated with the loans payable is due in large part to increased right of use financing
agreements related to ongoing facility expansion.
As
a result of the foregoing, our net income before income taxes for the three months ended June 30, 2024 was $0.8 million, compared to
net income before income taxes of $1.3 million for the comparable period in the prior fiscal year.
Liquidity
and Capital Resources
Capital
Resources
| |
June 30, 2024 | | |
March 31, 2024 | | |
Change | |
Current assets | |
$ | 43,160,540 | | |
$ | 40,014,189 | | |
$ | 3,146,351 | |
Current liabilities | |
$ | 14,014,635 | | |
$ | 13,049,764 | | |
$ | 964,871 | |
Working capital | |
$ | 29,145,905 | | |
$ | 26,964,425 | | |
$ | 2,181,480 | |
Our
working capital (total current assets less total current liabilities) increased by $2.2 million from $27.0 million as of March 31, 2024
to $29.1 million as of June 30, 2024, with such increase being primarily related to the increase in finished goods inventory and accounts
receivable, associated with increased customer orders during the three months ended June 30, 2024 exceeding the increase in total current
liabilities over the same period.
Summary
of Cash Flows:
| |
For the Three Months Ended June 30, | |
| |
2024 | | |
2023 | |
Net cash provided by (used in) operating activities | |
$ | 3,144,463 | | |
$ | (2,709,815 | ) |
Net cash used in investing activities | |
$ | (1,663,277 | ) | |
$ | — | |
Net cash (used in) provided by financing activities | |
$ | (174,906 | ) | |
$ | 3,957,223 | |
Net
cash provided by operating activities for the three months ended June 30, 2024 was $3.1 million, which included net income of $0.6 million,
increased by depreciation and other non-cash expenses totaling $3.5 million and reduced by the change in operating assets and liabilities
totaling $0.9 million.
Net
cash used in investing activities for the three months ended June 30, 2024 was comprised of purchases of property and equipment of approximately
$0.8 million and purchase of intangible assets of $0.9 million.
Net
cash used in financing activities was $0.2 million for the three months ended June 30, 2024 payments of loan principal totaling
$0.2 million.
Hakim
Promissory Note
The
Company has entered into a collateralized promissory note with individual lenders with rates comparable to the EWB Term Loan but with
fewer restrictive covenants. These covenants include filing timely tax returns and financial statements, and an agreement not to sell,
lease, or transfer a substantial portion of the Company’s assets during the term of the note. On June 2, 2023, the Company entered
into a Promissory Note with Nasrat Hakim, CEO and Chairman of the Board of Directors, pursuant to which the Company borrowed funds in
the aggregate principal amount of $3,000,000 (the “Hakim Promissory Note”). The Hakim Promissory Note has an interest rate
of 9% for the first year and 10% for an optional second year and the proceeds were used for working capital and other business purposes.
The original maturity date of the Hakim Promissory Note was June 2, 2024, with an optional second year extension. The second year extension
of the Hakim Promissory Note was agreed to by both parties, with the maturity date being extended to June 2, 2025.
Caskey
Promissory Note
On
June 30, 2023, the Company entered into a collateralized promissory note with Davis Caskey (the “Caskey Promissory Note”).
The Caskey Promissory Note has a principal balance of $1,000,000 and an interest rate of 9% for the first year and 10% for an optional
second year. The Caskey Promissory Note is subject to the same covenants as are contained in the Hakim Promissory Note. The proceeds
were used for working capital and other business purposes. The original maturity date of the Caskey Promissory Note was June 30, 2024,
with both parties agreeing to the optional second year extension, as provided in the Caskey Promissory Note. The Caskey Promissory Note
has a current maturity date of June 30, 2025.
East
West Bank
On
April 2, 2022, the Company and Elite Labs entered into a Loan and Security Agreement (the “EWB Loan Agreement”) with East
West Bank (“EWB”). Pursuant to the EWB Loan Agreement, the Company and Elite Labs received one term loan for a principal
amount of $12,000,000 (the “EWB Term Loan”) and a revolving line of credit up to $2,000,000 (the “EWB Revolver,”
together with the “EWB Term Loan,” the EWB Loans”), each of which shall be used for working capital. As of March 31,
2023, the principal and interest on the EWB Term Loan has been paid in full by the Company and the EWB Loan Agreement is terminated.
On
July 1, 2022, 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 10 years and bears interest
at a rate of 4.75% fixed for 5 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, 2024, 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, 2024, and through the date of filing of this quarterly report on Form 10-Q, the Company is not aware of the existence of
any violations of financial covenants included in the EWB Mortgage Loan.
Lincoln
Park Capital – July 8, 2020 Purchase Agreement
On
July 8, 2020, the Company entered into a purchase agreement (the “2020 LPC Purchase Agreement”), and a registration rights
agreement, with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which Lincoln Park has committed to purchase
up to $25.0 million of the Company’s Common Stock, $0.001 par value per share, from time to time over the term of the 2020 LPC
Purchase Agreement, at the Company’s direction. The 2020 LPC Purchase Agreement expired on August 1, 2023.
During
the three months ended June 30, 2024 and 2023, the Company did not issue any shares of Common Stock to Lincoln Park.
NJEDA
Bonds
On
August 31, 2005, the Company successfully completed a refinancing of a prior 1999 bond issue through the issuance of new tax-exempt bonds
(the “Bonds”). The refinancing involved borrowing $4,155,000, evidenced by a 6.5% Series A Note in the principal amount of
$3,660,000 maturing on September 1, 2030 and a 9% Series B Note in the principal amount of $495,000 maturing on September 1, 2012. The
net proceeds, after payment of issuance costs, were used (i) to redeem the outstanding tax-exempt Bonds originally issued by the Authority
on September 2, 1999, (ii) refinance other equipment financing and (iii) for the purchase of certain equipment to be used in the manufacture
of pharmaceutical products. As of March 31, 2016, all of the proceeds were utilized by the Company for such stated purposes.
Interest
is payable semi-annually on March 1 and September 1 of each year. The 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 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 bond proceeds and are being amortized over the life of the bonds. Amortization of bond issuance
costs amounted to $3,544 for the three months ended June 30, 2024.
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 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 2015 and the Company is current on all NJEDA Bond interest and principal payments.
As
of the date of filing of this Quarterly Report on Form 10-Q, there are no interest or principal amounts in arrears. The Series B Notes
were retired, at par in July 2014.
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 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 SEC’s 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 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, 2024 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 Securities and Exchange Commission rules and forms and such information is accumulated
and communicated to management as appropriate to allow timely decisions regarding required disclosures.
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 of directors, 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:(1) pertain to the maintenance of records that in reasonable
detail accurately and fairly reflect the transactions and dispositions of our assets; (2) 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 (3)
provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the company’s
assets that could have a material effect on the financial statements.
Internal
control over financial reporting may not prevent or detect all errors and all fraud. A control system, no matter how well conceived and
operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are achieved. Further, the design
of a control system must be balanced against resource constraints, and therefore the benefits of controls must be considered relative
to their costs. Given the inherent limitations in all systems of controls, no evaluation of controls can provide absolute assurance all
control issues and instances of fraud, if any, within a company have been detected. These inherent limitations include the realities
that judgments in decision making can be faulty and that breakdowns can occur because of a simple error or mistake. Additionally, controls
can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the controls.
The design of any system of controls is also based in part upon certain assumptions about the likelihood of future events, and there
can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls
may become inadequate because of changes in conditions or the degree of compliance with policies or procedures may deteriorate. Accordingly,
given the inherent limitations in a cost-effective 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, the Company has concluded that due to the material weaknesses in our internal control
over financial reporting noted below, our disclosure controls and procedures were not effective as of June 30, 2024 at the reasonable assurance level.
●
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.
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 Laboratory 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
Changes
in Internal Controls Over Financial Reporting
There
have been no changes in our internal controls over financial reporting during the three months ended June 30, 2024 that have materially
affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Part
II - OTHER INFORMATION
ITEM
1. LEGAL PROCEEDINGS
Pending
Litigation
On
August 17, 2023, Elite filed a paragraph IV certification with its ANDA to generic Oxycontin and after Elite got acceptance of the ANDA
by the FDA on September 19, 2023, Elite sent the patentee and NDA holder a Notice Letter as required under the Hatch-Waxman Act. On November
14, 2023, a patent infringement suit was filed in the District Court of New Jersey by Purdue Pharma. Elite obtained agreement with Purdue
to stay the litigation for six months. 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.
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, 2024.
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, 2024, 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).
ITEM
6. EXHIBITS
* |
Filed
herewith. |
** |
Furnished
herewith. |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
|
ELITE
PHARMACEUTICALS, INC. |
|
|
|
August
14, 2024 |
By: |
/s/
Nasrat Hakim |
|
|
Nasrat
Hakim
Chief
Executive Officer, President and Chairman of the Board of Directors
(Principal
Executive Officer) |
|
|
|
August
14, 2024 |
By: |
/s/
Carter Ward |
|
|
Carter
Ward
Chief
Financial Officer
(Principal
Accounting and Financial Officer) |
Exhibit
31.1
CERTIFICATION
BY PRINCIPAL EXECUTIVE OFFICER, PRINCIPAL FINANCIAL OFFICER AND PRINCIPAL ACCOUNTING OFFICER
I,
Nasrat Hakim, certify that:
|
1. |
I
have reviewed this Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 of Elite Pharmaceuticals, Inc. (the “Registrant”) |
|
|
|
|
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
|
|
|
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in
this report; |
|
|
|
|
4. |
The
Registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have: |
|
a. |
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
b. |
Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
c. |
Evaluated
the effectiveness of the Registrant’s disclosure controls and procedures and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
|
|
|
d. |
Disclosed
in this report any change in the Registrant’s internal control over financial reporting that occurred during the Registrant’s
most recent fiscal quarter (the Registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the Registrant’s internal control over financial reporting. |
|
5. |
The
Registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the Registrant’s auditors and the audit committee of the Registrant’s board of directors (or persons performing
the equivalent functions): |
|
a. |
All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the Registrant’s ability to record, process, summarize and report financial information;
and |
|
|
|
|
b. |
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant’s
internal control over financial reporting. |
Date:
August 14, 2024 |
/s/
Nasrat Hakim |
|
Nasrat
Hakim |
|
Chief
Executive Officer, President and |
|
Chairman
of the Board of Directors |
|
(Principal
Executive Officer, Principal Financial Officer, and Principal Accounting Officer) |
Exhibit
31.2
CERTIFICATION
BY PRINCIPAL FINANCIAL OFFICER
I,
Carter Ward, certify that:
|
1. |
I
have reviewed this Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 of Elite Pharmaceuticals, Inc. (the “Registrant”) |
|
|
|
|
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
|
|
|
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in
this report; |
|
|
|
|
4. |
The
Registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have: |
|
a. |
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
b. |
Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
c. |
Evaluated
the effectiveness of the Registrant’s disclosure controls and procedures and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
|
|
|
d. |
Disclosed
in this report any change in the Registrant’s internal control over financial reporting that occurred during the Registrant’s
most recent fiscal quarter (the Registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the Registrant’s internal control over financial reporting. |
|
5. |
The
Registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the Registrant’s auditors and the audit committee of the Registrant’s board of directors (or persons performing
the equivalent functions): |
|
a. |
All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the Registrant’s ability to record, process, summarize and report financial information;
and |
|
|
|
|
b. |
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant’s
internal control over financial reporting. |
Date:
August 14, 2024 |
By: |
/s/
Carter Ward |
|
|
Carter
Ward
Chief
Financial Officer
(Principal
Accounting and Financial Officer) |
Exhibit
32.1
CERTIFICATION
PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the Quarterly Report of Elite Pharmaceuticals, Inc. (the “Registrant”) on Form 10-Q for the quarter ended
June 30, 2024 filed with the Securities and Exchange Commission (the “Report”), I, Nasrat Hakim, Chief Executive Officer
of the Registrant, certify, pursuant to 18 U.S. C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002,
that:
The
Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
Information
contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Registrant.
Date:
August 14, 2024 |
/s/
Nasrat Hakim |
|
Nasrat
Hakim |
|
Chief
Executive Officer, President and |
|
Chairman
of the Board of Directors |
|
(Principal
Executive Officer, Principal Financial Officer, and Principal Accounting Officer) |
This
certification has been furnished solely pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
A
signed original of this written statement required by Section 906 has been provided to Elite Pharmaceuticals, Inc. and will be retained
by Elite Pharmaceuticals Inc. and furnished to the Securities and Exchange Commission or its staff upon request.
Exhibit
32.2