Item 1. Financial Statements
ITEM
1. FINANCIAL STATEMENTS
December 31, 2023
March 31, 2023
ASSETS
Current assets:
Cash
$ 5,816,211
$ 7,832,247
Accounts receivable, net of allowance for expected credit losses of $ 194,600 and $ 0 as of December 31, 2023 and March 31, 2023, respectively
16,009,614
3,094,549
Inventory
14,325,041
9,550,716
Prepaid expenses and other current assets
1,005,636
1,032,785
Total current assets
37,156,502
21,510,297
Property and equipment, net of accumulated depreciation of $ 15,578,471 and $ 14,586,335 respectively
10,095,029
10,426,158
Intangible assets, net of accumulated amortization of $- 0 -
6,341,228
6,341,228
Finance lease - right-of-use asset
408,428
—
Operating lease - right-of-use asset
26,231
13,062
Deferred income tax asset
20,233,603
2,171,821
Other assets:
Restricted cash - debt service for NJEDA bonds
427,999
412,434
Security deposits
7,259
21,018
Total other assets
435,258
433,452
Total assets
$ 74,696,279
$ 40,896,018
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$ 2,890,717
$ 2,446,810
Accrued expenses
11,884,645
5,047,726
Deferred revenue, current portion
13,333
13,333
Bonds payable, current portion, net of bond issuance costs
115,822
110,822
Loans payable, current portion
190,607
200,032
Related party loans payable (Note 7)
4,000,000
—
Lease obligation - finance lease, current portion
37,444
—
Lease obligation - operating lease, current portion
26,231
14,914
Total current liabilities
19,158,799
7,833,637
Long-term liabilities:
Deferred revenue, net of current portion
8,889
18,890
Bonds payable, net of current portion and bond issuance costs
909,654
1,029,018
Loans payable, net of current portion and loan costs
2,407,077
2,532,502
Lease obligation - finance lease, net of current portion
200,939
—
Derivative financial instruments - warrants
5,597,200
521,711
Total long-term liabilities
9,123,759
4,102,121
Total liabilities
28,282,558
11,935,758
Shareholders’ equity:
Common Stock; par value $ 0.001 ; 1,445,000,000 shares authorized; 1,017,881,199 and 1,014,015,081 shares issued as of December 31, 2023 and March 31, 2023, respectively; 1,017,781,199 and 1,013,915,081 shares outstanding as of December 31, 2023 and March 31, 2023, respectively
1,017,885
1,014,019
Additional paid-in capital
165,417,811
164,750,980
Treasury stock; 100,000 shares as of December 31, 2023 and March 31, 2023, respectively, at cost
( 306,841 )
( 306,841 )
Accumulated deficit
( 119,715,134 )
( 136,497,898 )
Total shareholders’ equity
46,413,721
28,960,260
Total liabilities and shareholders’ equity
$ 74,696,279
$ 40,896,018
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
F- 1
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
For the Three Months Ended December 31,
For the Nine Months Ended December 31,
2023
2022
2023
2022
Revenue:
Manufacturing fees
$ 14,791,110
$ 7,798,159
$ 36,208,217
$ 21,312,663
Licensing fees
747,690
1,451,907
2,467,844
4,200,888
Total revenue
15,538,800
9,250,066
38,676,061
25,513,551
Cost of manufacturing
8,497,727
4,330,841
20,437,354
12,360,935
Gross profit
7,041,073
4,919,225
18,238,707
13,152,616
Operating expenses:
Research and development
1,403,790
1,443,361
5,165,684
3,775,107
General and administrative
1,711,275
1,186,049
4,906,187
4,356,752
Non-cash compensation through issuance of stock options
49,815
13,030
107,592
24,325
Depreciation and amortization
343,537
317,685
999,059
933,531
Total operating expenses
3,508,417
2,960,125
11,178,522
9,089,715
Income from operations
3,532,656
1,959,100
7,060,185
4,062,901
Other income (expense):
Change in fair value of derivative financial instruments - warrants
( 2,417,772 )
372,894
( 5,075,489 )
561,070
Change in fair value of stock-based liabilities
( 2,854,556 )
—
( 4,921,376 )
—
Interest expense and amortization of debt issuance costs
( 121,628 )
( 322,681 )
( 371,478 )
( 782,221 )
Gain from settlement agreements
1,761,792
—
1,761,792
—
Gain on sale of ANDA
—
1,000,000
—
1,000,000
Interest income
5,249
15
16,085
187
Other (expense) income, net
( 3,626,915 )
1,050,228
( 8,590,466 )
779,036
(Loss) income before income taxes
( 94,259 )
3,009,328
( 1,530,281 )
4,841,937
Income tax benefit (expense)
800,613
( 39,250 )
18,313,045
( 50,837 )
Net income attributable to common shareholders
$ 706,354
$ 2,970,078
$ 16,782,764
$ 4,791,100
Basic net income per share attributable to common shareholders
$ 0.00
$ 0.00
$ 0.02
$ 0.00
Diluted net income per share attributable to common shareholders
$ 0.00
$ 0.00
$ 0.02
$ 0.01
Basic weighted average Common Stock outstanding
1,014,768,071
1,013,915,081
1,014,265,162
1,012,480,115
Diluted weighted average Common Stock outstanding
1,024,448,445
1,013,915,081
1,019,511,813
1,012,480,115
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
F- 2
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY
(UNAUDITED)
Series J Preferred Stock
Common Stock
Additional
Paid-In
Treasury Stock
Accumulated
Total
Shareholders’
Shares
Amount
Shares
Amount
Capital
Shares
Amount
Deficit
Equity
Balance as of April 1, 2023
—
$ —
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
Net income
—
—
—
—
—
—
—
14,934,601
14,934,601
Non-cash compensation through the issuance of employee stock options
—
—
—
—
42,777
—
—
—
42,777
Balance at September 30, 2023
—
$ —
1,014,015,081
$ 1,014,019
$ 164,808,757
100,000
$ ( 306,841 )
$ ( 120,421,488 )
$ 45,094,447
Shares issued in satisfaction of accrued director salaries
—
—
1,642,971
1,643
250,224
—
—
—
251,867
Shares issued in satisfaction of accrued consultant fees
—
—
2,223,147
2,223
309,015
—
—
—
311,238
Net income
—
—
—
—
—
—
—
706,354
706,354
Non-cash compensation through the issuance of employee stock options
—
—
—
—
49,815
—
—
—
49,815
Balance at December 31, 2023
—
$ —
1,017,881,199
$ 1,017,885
$ 165,417,811
100,000
$ ( 306,841 )
$ ( 119,715,134 )
$ 46,413,721
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
F- 3
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY
(UNAUDITED)
Series J Preferred Stock
Common Stock
Additional Paid-In
Treasury Stock
Accumulated
Total Shareholders’
Shares
Amount
Shares
Amount
Capital
Shares
Amount
Deficit
Equity
Balance as of April 1, 2022
—
—
1,011,381,988
$ 1,011,385
$ 164,577,227
100,000
$ ( 306,841 )
$ ( 140,059,744 )
$ 25,222,027
Net income
—
—
—
—
—
—
—
305,883
305,883
Non-cash compensation through the issuance of employee stock options
—
—
—
—
5,322
—
—
—
5,322
Balance at June 30, 2022
—
$ —
1,011,381,988
$ 1,011,385
$ 164,582,549
100,000
$ ( 306,841 )
$ ( 139,753,861 )
$ 25,533,232
Net income
—
—
—
—
—
—
—
1,515,139
1,515,139
Non-cash compensation through the issuance of employee stock options
—
—
—
—
5,974
—
—
—
5,974
Shares issued in payment of director salaries
—
—
1,378,608
1,379
58,621
—
—
—
60,000
Shares issued in payment of consultant fees
—
—
1,254,485
1,255
75,807
—
—
—
77,062
Balance at September 30, 2022
—
$ —
1,014,015,081
$ 1,014,019
$ 164,722,951
100,000
$ ( 306,841 )
$ ( 138,238,722 )
$ 27,191,407
Balance
—
$ —
1,014,015,081
$ 1,014,019
$ 164,722,951
100,000
$ ( 306,841 )
$ ( 138,238,722 )
$ 27,191,407
Net income
—
—
—
—
—
—
—
2,970,078
2,970,078
Net income (Loss)
—
—
—
—
—
—
—
2,970,078
2,970,078
Non-cash compensation through the issuance of employee stock options
—
—
—
—
13,029
—
—
—
13,029
Balance at December 31, 2022
—
$ —
1,014,015,081
$ 1,014,019
$ 164,735,980
100,000
$ ( 306,841 )
$ ( 135,268,644 )
$ 30,174,514
Balance
—
$ —
1,014,015,081
$ 1,014,019
$ 164,735,980
100,000
$ ( 306,841 )
$ ( 135,268,644 )
$ 30,174,514
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
F- 4
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
For the Nine Months Ended December 31,
2023
2022
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income
$ 16,782,764
$ 4,791,100
Adjustments to reconcile net income to net cash (used in) provided by operating activities:
Depreciation and amortization
992,136
933,531
Bad debt expense
194,600
—
Amortization of operating leases - right-of-use assets
18,153
61,621
Non-cash compensation accrued
563,105
430,778
Change in fair value of derivative financial instruments - warrants
5,075,489
( 561,070 )
Change in fair value of stock-based liabilities
4,921,376
—
Gain on settlement of Common Stock to consultant
( 1,761,792 )
—
Non-cash compensation through the issuance of employee stock options
107,592
24,325
Non-cash rent expense and lease accretion
—
602
Deferred revenue
( 10,001 )
( 10,003 )
Change in operating assets and liabilities:
Accounts receivable
( 13,109,665 )
( 2,487,930 )
Inventory
( 4,774,325 )
( 1,860,688 )
Prepaid expenses and other current assets
40,908
( 581,113 )
Deferred income tax asset
( 18,061,782 )
—
Accounts payable, accrued expenses and other current liabilities
3,702,825
( 309,950 )
Interest expense of finance lease liability
( 2,915 )
—
Lease obligations - operating leases
( 20,005 )
( 61,182 )
Net cash (used in) provided by operating activities
( 5,341,537 )
370,021
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment
( 406,007 )
( 5,200,407 )
Net cash used in investing activities
( 406,007 )
( 5,200,407 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Payment of bond principal
( 125,000 )
( 115,000 )
Proceeds from related party loans payable
4,000,000
—
Proceeds from loans payable
—
14,550,001
Amortization of finance leases - right-of-use assets
6,923
—
Loan payments
( 134,850 )
( 230,770 )
Net cash provided by financing activities
3,747,073
14,204,231
Net change in cash and restricted cash
( 2,000,471 )
9,373,845
Cash and restricted cash, beginning of period
8,244,681
8,940,396
Cash and restricted cash, end of period
$ 6,244,210
$ 18,314,241
Supplemental disclosure of cash and non-cash transactions:
Cash paid for interest
$ 119,412
$ 782,221
Cash paid for income taxes
$ 292,000
$ 127,522
Stock issued in satisfaction of accrued directors salaries and consultant fees
$ 563,105
$ 137,067
Recognition of right of use asset and lease liabilities entered into
$ 272,620
$ —
Reconciliation of cash and restricted cash
Cash
$ 5,816,211
$ 17,909,077
Restricted cash - debt service for NJEDA bonds
427,999
405,164
Total cash and restricted cash shown in statement of cash flows
$ 6,244,210
$ 18,314,241
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
F- 5
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
NOTE
1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Overview
Elite
Pharmaceuticals, Inc. (the “Company” or “Elite”) was incorporated on October 1, 1997 under the laws of the State
of Delaware, and its wholly-owned subsidiary Elite Laboratories, Inc. (“Elite Labs”) was incorporated on August 23, 1990
under the laws of the State of Delaware. On January 5, 2012, Elite Pharmaceuticals was reincorporated under the laws of the State of
Nevada. Elite Labs engages primarily in researching, developing, licensing, manufacturing, and sales of generic, oral dose pharmaceuticals.
The Company is equipped to manufacture controlled-release products on a contract basis for third parties and itself, if and when the
product candidates are approved. These products include drugs that cover therapeutic areas for allergy, bariatric, attention deficit
and infection. Research and development activities are performed with an objective of developing product candidates that will secure
marketing approvals from the United States Food and Drug Administration (“FDA”), and thereafter, commercially exploiting
such products.
Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements of the Company are presented in conformity with accounting principles
generally accepted in the United States of America (“GAAP”) and pursuant to the rules and regulations of the SEC. The unaudited
condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, Elite Labs. All significant
intercompany accounts and transactions have been eliminated in consolidation. Certain information or footnote disclosures normally included
in condensed financial statements prepared in accordance with GAAP have been condensed or omitted, pursuant to the rules and regulations
of the SEC for interim financial reporting. Accordingly, they do not include all the information and footnotes necessary for a comprehensive
presentation of financial position, results of operations, or cash flows. In the opinion of management, the accompanying unaudited condensed
consolidated financial statements include all adjustments, consisting of a normal recurring nature, which are necessary for a fair presentation
of the financial position, operating results and cash flows for the periods presented. The accompanying unaudited condensed consolidated
financial statements should be read in conjunction with the Company’s Form 10-K as filed with the SEC on June 29, 2023. The interim
results for the nine months ended December 31, 2023 are not necessarily indicative of the results to be expected for the fiscal year
ending March 31, 2024 or for any future periods.
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.
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 unaudited consolidated financial statements. Please see Note 15 for further details.
F- 6
ELITE PHARMACEUTICALS,
INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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.
F- 7
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 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.
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. The table also includes a reconciliation of the disaggregated revenue with the reportable segments:
SCHEDULE
OF DISAGGREGATION OF REVENUE
For the Three Months Ended December 31,
For the Nine Months Ended December 31,
2023
2022
2023
2022
NDA:
Manufacturing fees
$ -
$ -
$ -
$ -
Licensing fees
$ —
$ —
$ —
$ —
Total NDA revenue
—
—
—
—
ANDA:
Manufacturing fees
$ 14,791,110
$ 7,798,159
$ 36,208,217
$ 21,312,663
Licensing fees
747,690
1,451,907
2,467,844
4,200,888
Total ANDA revenue
15,538,800
9,250,066
38,676,061
25,513,551
Total revenue
$ 15,538,800
$ 9,250,066
$ 38,676,061
$ 25,513,551
Selected
information on reportable segments and reconciliation of operating income by segment to income from operations before income taxes are
disclosed within Note 15.
F- 8
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Cash
Cash
consists of cash on deposit with banks and money market instruments. The Company places its cash with high-quality, U.S. financial institutions
and, to date has not experienced losses on any of its balances.
Restricted
Cash
As
of December 31, 2023, and March 31, 2023, the Company had $ 427,999 and $ 412,434 , of restricted cash, respectively, related to debt service
reserve in regard to the New Jersey Economic Development Authority (“NJEDA”) bonds (see Note 5).
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.
Prior
to April 1, 2023, trade receivables were presented net of allowance for expected credit losses based on the credit risk of specific clients,
past collection history, and management’s evaluation of other risks. Expected credit losses stemming from unbilled receivables
expected to be billed between March 31, 2024 and March 31, 2028 include additional risk premiums estimated based on factors such as projected
inflation, projected decreases in GDP, and projected unemployment.
Inventory
Inventory
is recorded at the lower of cost or net realizable value on specific identification by lot number basis.
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.
F- 9
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
During
the year ended March 31, 2023, the Company determined indicators of impairment occurred and recorded impairment expense of $ 292,807 on
its ANDAs and patents. There were no such impairments recorded during the period ended December 31, 2023. The Company notes that none
of its patents relate to any of the Company’s revenue producing activities.
The
following table summarizes the Company’s intangible assets as of and for the periods ended December 31, 2023 and March 31, 2023:
SCHEDULE
OF INTANGIBLE ASSETS
December 31, 2023
Estimated Useful Life
Gross Carrying Amount
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
March 31, 2023
Estimated Useful Life
Gross Carrying Amount
Impairment losses
Accumulated Amortization
Net Book Value
Patent application costs
*
$ 465,684
$ ( 176,645 )
$ —
$ 289,039
ANDA acquisition costs
Indefinite
6,168,351
( 116,162 )
—
6,052,189
$ 6,634,035
$ ( 292,807 )
$ —
$ 6,341,228
Research
and Development
Research
and development expenditures are charged to expenses as incurred.
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 December 31, 2023, the results
of such proceedings cannot be predicted with certainty, but the Company does not anticipate that the final outcome, if any, arising out
of any such matters will have a material adverse effect on its business, financial condition or results of operations.
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, 2016 and forward. The Company did not record
unrecognized tax positions for the nine months ended December 31, 2023.
Warrants
and Preferred Shares
The
accounting treatment of warrants and preferred share series issued is determined pursuant to the guidance provided by ASC 470, Debt ,
ASC 480, Distinguishing Liabilities from Equity , and ASC 815, Derivatives and Hedging , as applicable. Each feature of a
freestanding financial instrument including, without limitation, any rights relating to subsequent dilutive issuances, dividend issuances,
equity sales, rights offerings, forced conversions, optional redemptions, automatic monthly conversions, dividends and exercise is assessed
with determinations made regarding the proper classification in the Company’s financial statements.
F- 10
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Stock-Based
Compensation
The
Company accounts for stock-based compensation in accordance with ASC 718, Compensation-Stock Compensation . Under the fair value
recognition provisions, stock-based compensation cost is measured at the grant date based on the fair value of the award and is recognized
as an expense on a straight-line basis over the requisite service period, based on the terms of the awards. The cost of the stock-based
payments to nonemployees that are fully vested and non-forfeitable as at the grant date is measured and recognized at that date, unless
there is a contractual term for services in which case such compensation would be amortized over the contractual term. The Company accounts
for forfeitures as they occur.
In
accordance with the Company’s Director compensation policy and certain employment contracts, director’s fees and a portion
of employee’s salaries are to be paid via the issuance of shares of the Company’s Common Stock (“Common Stock”),
in lieu of cash, with the valuation of such share being calculated on a quarterly basis and equal to the average closing price of the
Company’s Common Stock. The Company records earned but unissued stock-based compensation in accrued expenses.
Sale
of ANDA
During
the quarter ended December 31, 2022, the Company entered into an agreement with Pyros Pharmaceuticals, Inc. (“Pyros”) pursuant
to which the Company sold to Pyros its rights in and to the Company’s approved abbreviated new drug applications (ANDAs) for its
generic Sabril drug (the “Sabril Product”). The Company sold its rights to Pyros for $ 1,000,000 , which was recorded as gain
on sale of ANDA during the year ended March 31, 2023. There is no further action required by the Company regarding the rights which would
affect future periods.
In
conjunction with the sale of its Sabril Product to Pyros, the Company executed a Manufacturing and Supply Agreement (the “Pyros
Agreement”) with Pyros. Under the terms of the Pyros Agreement, the Company will receive an agreed-upon price per drug for the
manufacturing and packaging of Sabril over a term of three years. Revenue per the Pyros Agreement will be recognized as control of the
manufactured and supplied drugs is transferred to Pyros (at the time of delivery).
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
and nine months ended December 31, 2023 and 2022 did not exceed the exercise price of th e
warrants, t he potential dilutio n from the warrants converting into
79,008,661 shares of Common Stock for all periods have been excluded from the number of shares used in calculating diluted net income
per share as their inclusion would have been antidilutive.
F- 11
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The
following is the computation of earnings per share applicable to common shareholders for the periods indicated:
SCHEDULE
OF EARNINGS (LOSS) PER SHARE APPLICABLE TO COMMON SHAREHOLDERS
For the Three Months Ended December 31,
For the Nine Months Ended December 31,
2023
2022
2023
2022
Numerator
Net income - basic
$ 706,354
$ 2,970,078
$ 16,782,764
$ 4,791,100
Effect of dilutive instrument on net income
—
372,894
—
561,070
Net income - diluted
$ 706,354
$ 3,342,972
$ 16,782,764
$ 5,352,170
Denominator
Weighted average shares of Common Stock outstanding - basic
1,014,768,071
1,013,915,081
1,014,265,162
1,012,480,115
Dilutive effect of stock options and convertible securities
9,680,374
—
5,246,651
—
Weighted average shares of Common Stock outstanding - diluted
1,024,448,445
1,013,915,081
1,019,511,813
1,012,480,115
Net income per share
Basic
$ 0.00
$ 0.00
$ 0.02
$ 0.00
Diluted
$ 0.00
$ 0.00
$ 0.02
$ 0.01
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.
F- 12
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Measured
on a Recurring Basis
The
following table presents information about our 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 April 1, 2023
$ 521,711
$ —
$ —
$ 521,711
Change in fair value of derivative financial instruments - warrants
5,075,489
—
—
5,075,489
Balance as of December 31, 2023
$ 5,597,200
$ —
$ —
$ 5,597,200
Fair Value Measurement
Amount at Fair Value
Level 1
Level 2
Level 3
Balance as of April 1, 2022
$ 936,837
$ —
$ —
$ 936,837
Change in fair value of derivative financial instruments - warrants
( 561,070 )
—
—
( 561,070 )
Balance as of December 31, 2022
$ 375,767
$ —
$ —
$ 375,767
See
Note 11 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 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.
Financial
Instruments — Credit Losses (ASU 2016-13)
In
June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (“CECL”). The amendments in this update introduce
a new accounting model to measure credit losses for financial assets measured at amortized cost. The FASB has also issued additional
ASUs to clarify the scope and provide additional guidance for ASU 2016-13. Credit losses for financial assets measured at amortized cost
should be determined based on the total current expected credit losses over the life of the financial asset or group of financial assets.
In effect, the financial asset or group of financial assets should be presented at the net amount expected to be collected. Credit losses
will no longer be recorded under the current incurred loss model for financial assets measured at amortized cost. The amendments also
modify the accounting for available-for-sale debt securities whereby credit losses will be recorded through an allowance for credit losses
rather than a write-down to the security’s cost basis, which allows for reversals of credit losses when estimated credit losses
decline. Credit losses for available-for-sale debt securities should be measured in a manner similar to current GAAP.
The
amendments were effective on April 1, 2023 for the Company, and must be applied using a modified retrospective approach with a cumulative-effect
adjustment through retained earnings as of the beginning of the fiscal year upon adoption as required. While the standard modifies the
measurement of the allowance for credit losses, it does not alter the credit risk of our trade or unbilled receivables.
The
impact of applying the CECL methodology upon adoption effective on April 1, 2023 was immaterial to the Company’s consolidated financial
statements.
The
Company’s quantitative allowance for credit loss estimates under CECL was determined using the loss rate method, which is impacted
by certain forecasted economic factors. In addition to the Company’s quantitative allowance for credit losses, the Company also
incorporates qualitative adjustments that may relate to unique risks, changes in current economic conditions that may not be reflected
in quantitatively derived results, or other relevant factors to further inform the Company’s estimate of the allowance for credit
losses.
F- 13
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Additionally,
due to the expansion of the time horizon over which the Company is required to estimate future credit losses, the Company may experience
increased volatility in its future provisions for credit losses. Factors that could contribute to such volatility include, but are not
limited to, changes in the composition and credit quality of customer base, economic conditions and forecasts, the allowance for credit
loss models that are used, the data that is included in the models, the associated qualitative allowance framework, and the Company’s
estimation techniques.
The
Company has had no recordable write offs for bad debts or uncollectible invoiced amounts during the for the nine months ended December
31, 2023 or the prior twelve months ended March 31, 2023. In applying the CECL methodology, the Company recorded an estimated allowance
of $ 194,600 for current estimated credit losses.
Treasury
Stock
The
Company records treasury stock at the cost to acquire it and includes treasury stock as a component of shareholders’ equity.
Recently
Issued Accounting Pronouncements
Management
has evaluated recently issued accounting pronouncements and does not believe that any of these pronouncements will have a significant
impact on our consolidated financial statements and related disclosures.
NOTE
2. INVENTORY
Inventory
consisted of the following:
SCHEDULE
OF INVENTORY
December 31, 2023
March 31, 2023
Finished goods
$ 5,544,848
$ 2,352,330
Work-in-progress
1,247,307
1,791,311
Raw materials
7,532,886
5,407,075
Inventory
$ 14,325,041
$ 9,550,716
NOTE
3. PROPERTY AND EQUIPMENT, NET
Property
and equipment consisted of the following:
SCHEDULE
OF PROPERTY AND EQUIPMENT
December 31, 2023
March 31, 2023
Land, building and improvements
$ 10,269,297
$ 10,768,181
Laboratory, manufacturing, warehouse and transportation equipment
14,518,570
13,364,512
Office equipment and software
373,601
395,563
Furniture and fixtures
512,032
484,237
Property and equipment, gross
25,673,500
25,012,493
Less: Accumulated depreciation
( 15,578,471 )
( 14,586,335 )
Property and equipment, net
$ 10,095,029
$ 10,426,158
Depreciation
expense was $ 336,614 and $ 314,610 for the three months ended December 31, 2023 and 2022, respectively, and $ 992,136 and $ 923,365 for
the nine months ended December 31, 2023 and 2022, respectively.
F- 14
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
NOTE
4. ACCRUED EXPENSES
As
of December 31, 2023 and March 31, 2023, the Company’s accrued expenses consisted of the following:
SUMMARY
OF ACCRUED EXPENSES
December 31, 2023
March 31, 2023
Salaries and fees payable in Common Stock inclusive of the change in fair value of Common stock underlying such liabilities
$ 6,934,812
$ 4,125,000
Income tax
—
414,989
Co-development profit split
3,389,949
—
Consultant contract fees
10,000
193,333
Audit fees
125,000
125,000
Director dues
22,500
70,000
Legal and professional expense
75,000
—
Employee bonuses
712,384
—
Other accrued expenses
615,000
119,404
Total accrued expenses
$ 11,884,645
$ 5,047,726
NOTE
5. NJEDA BONDS
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 unaudited 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
December 31, 2023
March 31, 2023
Gross bonds payable
NJEDA Bonds - Series A Notes
$ 1,120,000
$ 1,245,000
Less: Current portion of bonds payable (prior to deduction of bond offering costs)
( 130,000 )
( 125,000 )
Long-term portion of bonds payable (prior to deduction of bond offering costs)
$ 990,000
$ 1,120,000
Bond offering costs
$ 354,454
$ 354,454
Less: Accumulated amortization
( 259,930 )
( 249,294 )
Bond offering costs, net
$ 94,524
$ 105,160
Current portion of bonds payable - net of bond offering costs
Current portions of bonds payable
$ 130,000
$ 125,000
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
$ 110,822
Long term portion of bonds payable - net of bond offering costs
Long term portion of bonds payable
$ 990,000
$ 1,120,000
Less: Bond offering costs to be amortized subsequent to the next 12 months
( 80,346 )
( 90,982 )
Long term portion of bonds payable, net of bond offering costs
$ 909,654
$ 1,029,018
Amortization
expense was $ 3,540 and $ 3,544 for the three months ended December 31, 2023 and 2022, $ 10,636 and $ 10,629 for the nine months ended December
31, 2023 and 2022, respectively. Interest payable was $ 24,267 and $ 6,744 as of December 31, 2023 and March 31, 2023, respectively. Interest
expense was $ 18,200 and $ 20,231 for the three months ended December 31, 2023 and 2022, respectively, and $ 57,985 and $ 63,808 for the
nine months ended December 31, 2023 and 2022, respectively.
F- 15
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Maturities
of bonds for the next five years, exclusive of the nine months ended December 31, 2023 are as follows:
SCHEDULE
OF MATURITIES OF BONDS
Years ending March 31,
Amount
2024
$ —
2025
130,000
2026
140,000
2027
150,000
2028
160,000
Thereafter
540,000
Total
$ 1,120,000
NOTE
6. LOANS PAYABLE
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. The EWB
Term Loan bears interest at a rate of 9.73 % ( 1.73 % plus the prime rate (“Prime”)) and is repayable over five years , maturing
on May 1, 2027 . The EWB Revolver bears interest at a rate of ( 8.87 % ( 0.87 % plus Prime)) and matures on May 1, 2027 . The total transaction
costs associated with the EWB Term Loan incurred as of March 31, 2023, were $ 40,120 , which are being amortized on a monthly basis over
five years, beginning in April 2022. The EWB Loans are secured by a security interest in the personal property of the Company and Elite
Labs. The EWB Loan Agreement contains customary representations, warranties and covenants. These covenants include, but are not limited
to, maintaining maximum leverage ratios of 3.50 to 1.00, minimum liquidity of $5,000,000, minimum cash of $1,000,000, a fixed charge
coverage ratio of 1.25 to 1.00 and restrictions on mergers or sales of assets and debt borrowings . 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.
In
place of the EWB Term Loan, the Company has entered into a collateralized promissory note with individual lenders with rates comparable
to the EWB Term Loan but with less restrictive covenants (a “Promissory Note”). As of June 2, 2023, a Promissory Note was
placed with Nasrat Hakim, CEO and Chairman of the Board of Directors, for $ 3,000,000 . The Promissory Note has an interest rate of 9 %
for the first year and 10 % for an optional second year and the proceeds will be used for working capital and other business purposes.
Loans
payable consisted of the following:
SCHEDULE
OF LOANS PAYABLE
December 31, 2023
March 31, 2023
Mortgage loan payable 4.75 % interest and maturing June 2032
$ 2,438,958
$ 2,472,923
Equipment and insurance financing loans payable, between 7.10 % and 12.02 % interest and maturing between January 2024 and October 2025
158,726
259,611
Less: Current portion of loans payable
( 190,607 )
( 200,032 )
Long-term portion of loans payable
$ 2,407,077
$ 2,532,502
The
interest expense associated with the loans payable was $ 30,384 and $ 317,844 for the three months ended December 31, 2023 and 2022, and
$ 101,478 and $ 579,109 for the nine months ended December 31, 2023 and 2022, respectively.
F- 16
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Loan
principal payments for the next five years are as follows:
SCHEDULE
OF LOAN PRINCIPAL PAYMENTS
Future principal balances
Years ending March 31,
Amount
2024 (excluding the nine months ended December 31, 2023)
$ 44,535
2025
186,657
2026
120,748
2027
92,773
2028
94,433
2029 and thereafter
2,058,538
Total remaining principal balance
$ 2,597,684
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 will be used for working capital and other business purposes.
The original maturity date of the Hakim Promissory Note is June 2, 2024, with an optional second year extension. The second year extension
must be exercised by both parties 60 days prior to the original maturity date. As of the date of this filing, the Company does not expect
to exercise the second year extension. For the three and nine months ended December 31, 2023, interest expense on the Hakim Promissory
Note totaled $ 67,500 and $ 202,500 respectively, 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
July 1, 2022, the 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 the Wall Street Journal Prime Rate (“WSJP”) plus 0.5% with
floor rate of 4.5% . The total transaction costs associated with the EWB Mortgage Loan incurred as of December 31, 2023, 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 the date of this filing, the Company was in compliance with each financial
covenant .
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 is June 30, 2024,
with an optional second year extension. The second year extension must be exercised by both parties 60 days prior to the original maturity
date. As of the date of this filing, the Company does not expect to exercise the second year extension. For the three and nine months
ended December 31, 2023, interest expense on the Caskey Promissory Note totaled $ 22,500 and $ 67,500 respectively, 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.
NOTE
8. DEFERRED REVENUE
Deferred
revenues in the aggregate amount of $ 22,222 as of December 31, 2023, were comprised of a current component of $ 13,333 and a long-term
component of $ 8,889 . Deferred revenues in the aggregate amount of $ 32,223 as of March 31, 2023, were comprised of a current component
of $ 13,333 and a long-term component of $ 18,890 . These amounts represent the unamortized balance of a $ 200,000 advance payment received
for a TAGI Pharma licensing agreement with a fifteen-year term beginning in September 2010 and ending in August 2025 . These advance payments
were recorded as deferred revenue when received and are earned, on a straight-line basis over the life of the licenses. The current component
is equal to the amount of revenue to be earned during the 12-month period immediately subsequent to the balance sheet date and the long-term
component is equal to the amount of revenue to be earned thereafter.
F- 17
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
NOTE
9. COMMITMENTS AND CONTINGENCIES
Occasionally,
the Company may be involved in claims and legal proceedings arising from the ordinary course of its business. The Company records a provision
for a liability when it believes that it is both probable that a liability has been incurred, and the amount can be reasonably estimated.
If these estimates and assumptions change or prove to be incorrect, it could have a material impact on the Company’s 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 December 31, 2023, the results
of such proceedings cannot be predicted with certainty, but the Company does not anticipate that the final outcome, if any, arising out
of any such matters will have a material adverse effect on its business, financial condition or results of operations.
Operating
Leases
The
Company entered into an operating lease for a portion of a one-story warehouse, located at 135 Ludlow Avenue, Northvale, New Jersey (the
“Ludlow Ave. lease”) which began in 2010. On June 30, 2021, the Company exercised a renewal option, with such option including
a term that begins on January 1, 2022 and expires on December 31, 2026. The Ludlow Ave. lease was terminated on July 1, 2022, when the
Company purchased the underlying property.
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 Elite 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 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 an 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 Elite 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.
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 balance sheets as Finance lease - right-of-use asset
and Lease obligation - finance lease. The finance lease costs are split between Depreciation and amortization expense related to the
asset and Interest expense and amortization of debt issuance costs on the lease liability, using the effective rate charged by the lessor.
The Company has elected to account for lease and non-lease components separately.
F- 18
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Lease
assets and liabilities are classified as follows on the condensed consolidated balance sheet:
SCHEDULE
OF LEASE ASSETS AND LIABILITIES
Lease
Classification
December 31, 2023
Assets
Finance
Finance lease – right-of-use asset
$ 408,428
Operating
Operating lease – right-of-use asset
26,231
Total leased assets
$ 434,659
Liabilities
Current
Finance
Lease obligation – finance lease
$ 37,444
Operating
Lease obligation – operating lease
26,231
Long-term
Finance
Lease obligation – finance lease, net of current portion
200,939
Operating
Lease obligation – operating lease, net of current portion
—
Total lease liabilities
$ 264,614
Rent
expense is recorded on the straight-line basis. Rent expense under the 135 Ludlow Ave. modified lease was $ 0 for the three months ended
December 31, 2023 and 2022, respectively, and $ 0 and $ 58,248 for the nine months ended December 31, 2023 and 2022, respectively. Rent
expense under the Pompano Office Lease for the three months ended December 31, 2023 and 2022 was $ 7,565 and $ 6,456 , respectively, and
$ 20,603 and $ 19,116 for the nine months ended December 31, 2023 and 2022, respectively. Rent expense is recorded in general and administrative
expense in the unaudited condensed consolidated statements of operations.
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
2024 (excluding the nine months ended December 31, 2023)
$ 8,087
$ 16,286
$ 24,373
2025
18,870
65,145
84,015
2026
—
65,145
65,145
2027
—
65,145
65,145
2028
—
65,145
65,145
Thereafter
—
43,429
43,429
Less: interest
( 727 )
( 81,911 )
( 82,638 )
Present value of lease payments
$ 26,230
$ 238,384
$ 264,614
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
Lease Term and Discount Rate
December 31, 2023
Remaining lease term (years)
Operating leases
0.8
Finance leases
4.9
Discount rate
Operating leases
6.0 %
Finance leases
12.5 %
F- 19
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
NOTE
10. PREFERRED STOCK
Series
J convertible preferred stock
On
April 28, 2017, the Company created the Series J Convertible Preferred Stock (“Series J Preferred”) in conjunction with the
Certificate of Designations. A total of 50 shares of Series J Preferred were authorized, zero shares are issued and outstanding, with
a stated value of $ 1,000,000 per share and a par value of $ 0.01 .
NOTE
11. DERIVATIVE FINANCIAL INSTRUMENTS – WARRANTS
The
Company evaluates and accounts for its freestanding instruments in accordance with ASC 815, Accounting for Derivative Instruments
and Hedging Activities .
The
Company issued warrants, with a term of ten years, to affiliates in connection with an exchange agreement dated April 28, 2017, as further
described in this note below.
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 December 31, 2023 and March 31, 2023.
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.
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
December 31, 2023
March 31, 2023
Fair value of the Company’s Common Stock
$ 0.1393
$ 0.0290
Volatility
73.50 %
74.37 %
Initial exercise price
$ 0.1521
$ 0.1521
Warrant term (in years)
3.3
4.1
Risk free rate
4.01 %
3.55 %
The
changes in warrants (Level 3 financial instruments) measured at fair value on a recurring basis for the nine months ended December 31,
2023 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
5,075,489
Balance at December 31, 2023
$ 5,597,200
F- 20
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
NOTE
12. SHAREHOLDERS’ EQUITY
Lincoln
Park Capital Transaction - 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
Company did not issue any shares of its Common Stock pursuant to the 2020 LPC Purchase Agreement during the three and nine months ended
December 31, 2023 and 2022. In addition, there were no shares issued to Lincoln Park as additional commitment shares, pursuant to the
2020 LPC Purchase Agreement. The 2020 LPC Purchase Agreement expired on August 1, 2023.
Summary
of Common Stock Activity
On
November 22, 2023, the Company issued 1,642,971
shares of Common Stock in payment
of director fees to be paid via the issuance of common stock, with such shares having an aggregate value on the date of original accrual
of $ 60,000 and which were owed for periods prior to the current fiscal year and accrued as of the date of share issuance. The price
of the Company’s Common Stock on November 22, 2023, was $ 0.1533
per share. The aggregate value
of the shares on the date of their issuance was $ 251,867 .
On
December 29, 2023, the Company issued 2,223,147 shares
of Common Stock in payment of consultant fees to be paid via the issuance of common stock, with such shares having an aggregate
value on the date of original accrual of $ 153,333
and which were owed for periods prior to the
current fiscal year and accrued as of the date of share issuance. The price of the Company’s Common Stock on December 29,
2023, was $ 0.14 per
share. The aggregate value of the shares on the date of their issuance was $ 311,238 .
As
of December 31, 2023, there were 1,017,881,199 shares of Common Stock issued and 1,017,781,199 shares of Common Stock outstanding.
NOTE
13. STOCK-BASED COMPENSATION
Part
of the compensation paid by the Company to its Directors and employees consists of the issuance of Common Stock or via the granting of
options to purchase Common Stock.
Stock-based
Director Compensation
The
Company’s Director compensation policy, instituted in October 2009 and further revised in January 2016, includes provisions that
a portion of director’s fees are to be paid via the issuance of shares of the Company’s Common Stock, in lieu of cash, with
the valuation of such shares being calculated on quarterly basis and equal to the average closing price of the Company’s Common
Stock.
During
the nine months ended December 31, 2023, the Company accrued director’s fees totaling $ 22,500 , which will be paid via cash payments
totaling $ 22,500 . All of the accrued shares of common stock related to the Director’s compensation policy were paid out on December
29, 2023.
SCHEDULE
OF STOCK BASED COMPENSATION
Balance of common stock owed at April 1, 2023
$ 60,000
Awarded shares
—
Change in fair value of stock-based liabilities
191,867
Issuance of common stock on November 22, 2023
( 251,867 )
Balance of common stock owed at December 31, 2023
$ —
Stock-based
Employee/Consultant Compensation
Employment
contracts with the Company’s President and Chief Executive Officer and certain other employees and engagement contracts with certain
consultants include provisions for a portion of each employee’s salaries or consultant’s fees to be paid via the issuance
of shares of the Company’s Common Stock, in lieu of cash, with the valuation of such shares being calculated on a quarterly basis
and equal to the average closing price of the Company’s Common Stock.
SCHEDULE
OF STOCK BASED COMPENSATION
Balance of common stock owed at April 1, 2023
$ 4,278,333
Awarded shares
—
Change in fair value of stock-based liabilities
4,729,509
Common stock issued
( 311,238 )
Settlement of non-cash liability
( 1,761,792 )
Balance of common stock owed at December 31, 2023
$ 6,934,812
During
the nine months ended December 31, 2023, the Company accrued no additional salaries owed to the Company’s President, Chief Executive
Officer and certain other employees which will be paid via the issuance of shares of Common Stock. As of December 31, 2023, the total
obligation of $ 6,934,812 is outstanding which is recorded at fair value and is included in Accrued Expenses on the Condensed Consolidated
Balance Sheets.
F- 21
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
On
November 6, 2023, the Company entered into a Settlement Agreement with a former executive who was terminated on February 7, 2022.
The employment agreement with the former executive included annual compensation of $ 250,000
which was to be paid via the issuance
of shares of Common Stock. At the date of the former executive’s termination an aggregate of 14,892,580 shares
of Common Stock (the “Deferred Shares”) were due to the former executive, with such number of shares representing an
aggregate of $ 1,000,000
in compensation earned pursuant to the relevant employment agreement at an annual rate of $ 250,000 .
Pursuant to the Settlement Agreement, the former executive irrevocably elected to relinquish all rights and claims to the Deferred
Shares. The Company is released of any obligation to issue the Deferred Shares and further acknowledges that no Deferred Shares will
be issued to or received by the former employee. The price of the Company’s Common Stock on November 6, 2023 was $ 0.1183
per share and the value of the Deferred Shares on this date was $ 1,761,792 .
The Company recorded other income from gain on settlement agreement for this amount on the unaudited Condensed Consolidated
Statements of Operations.
On
December 29, 2023, the Company issued 2,223,147
shares of Common Stock in satisfaction of accrued consultant fees.
Options
Under
its 2014 Stock Option Plan and prior options plans, the Company may grant stock options to officers, selected employees, as well as members
of the Board of Directors and advisory board members. 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. The following assumptions were used
for the nine months ended December 31, 2023 and year ended March 31, 2023:
SCHEDULE
OF GRANT DATE FAIR VALUE OF OPTION AWARDS
December 31, 2023
March 31, 2023
Term (in years)
10
10
Exercise Price
$ 0.08 -$ 0.09
$ 0.03 -$ 0.04
Dividend Yield
—
—
Expected Volatility
80 %- 81 %
79 %- 80 %
Risk Free Rate
4.27 %- 4.69 %
2.99 %- 4.01 %
A
summary of the activity of Company’s 2014 Stock Option Plan for the nine months ended December 31, 2023 is as follows:
SCHEDULE
OF STOCK OPTION PLAN
Shares
Weighted
Weighted Average
Remaining Contractual
Aggregate
Underlying Options
Average
Exercise Price
Term (in years)
Intrinsic
Value
Outstanding at March 31, 2023
15,370,000
$ 0.07
7.4
$ —
Granted
4,100,000
$ 0.09
10.0
$ —
Expired and Forfeited
( 3,840,000 )
$ 0.07
1.8
$ —
Outstanding at December 31, 2023
15,630,000
$ 0.05
9.0
$ 1,429,822
Exercisable at December 31, 2023
343,334
$ 0.19
4.6
$ 6,850
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 December 31, 2023 of $ 0.14 for those awards with strike prices lower than the quoted price of the Company’s Common Stock as of December 31,
2023. As of December 31, 2023, there was $ 450,470
in unrecognized stock based compensation
expense that will be recognized over a weighted average 2.37
year period.
On
September 5, 2023, options were granted to the Chief Financial Officer pursuant to the 2014 Plan to purchase an aggregate of 3,000,000
shares of Common Stock. The options have an exercise price of $ 0.0898 per share, the fair market value of the Common Stock on the date
of grant. The options granted will vest one third for each of the next three years upon the anniversary date of the grant and have a
ten-year expiration date.
F- 22
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
On
September 19, 2023, options were granted to one employee pursuant to the 2014 Plan to purchase an aggregate of 1,000,000 shares of Common
Stock. The options have an exercise price of $ 0.0819 per share, the fair market value of the Common Stock on the date of grant. The options
granted will vest one third for each of the next three years upon the anniversary date of the grant and have a ten-year expiration date.
On
October 2, 2023, options were granted to one employee pursuant to the 2014 Plan to purchase an aggregate of 100,000 shares of Common
Stock. The options have an exercise price of $ 0.0938 per share, the fair market value of the Common Stock on the date of grant. The options
granted will vest one third for each of the next three years upon the anniversary date of the grant and have a ten-year expiration date.
The
weighted-average grant-date fair value of stock options granted during the nine months ended December 31, 2023 under the 2014 Plan was
$ 0.0754 .
NOTE
14. CONCENTRATIONS AND CREDIT RISK
Revenues
Two
customers accounted for approximately 57 % of the Company’s revenues for the nine months ended December 31, 2023. These three customers
accounted for approximately 30 %, and 27 %, of revenues each, respectively.
Two
customers accounted for approximately 96 % of the Company’s revenues for the nine months ended December 31, 2022. These two customers
accounted for approximately 85 % and 11 % of revenue each, respectively.
Accounts
Receivable
Two
customers accounted for approximately 77 % of the Company’s accounts receivable as of December 31, 2023. These two customers accounted
for approximately 45 % and 32 % of accounts receivable each, respectively.
One
customer accounted for approximately 89 % of the Company’s accounts receivable as of December 31, 2022.
Purchasing
Two
suppliers accounted for approximately 43 % of the Company’s purchases of raw materials for the nine months ended December 31, 2023.
These two customers accounted for approximately 30 %, and 13 %, of purchasing each, respectively.
One
supplier accounted for approximately 62 % of the Company’s purchases of raw materials for the nine months ended December 31, 2022.
NOTE
15. 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 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.
Asset
information by operating segment is not presented below since the chief operating decision maker does not review this information by
segment. The reporting segments follow the same accounting policies used in the preparation of the Company’s unaudited condensed
consolidated financial statements.
F- 23
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The
following represents selected information for the Company’s reportable segments:
SCHEDULE OF SELECTED INFORMATION FOR REPORTABLE SEGMENTS
2023
2022
2023
2022
For the Three Months Ended December 31,
For the Nine Months Ended December 31,
2023
2022
2023
2022
Operating Income by Segment
ANDA
$ 5,637,283
$ 3,828,493
$ 13,073,023
$ 7,947,118
Operating income by Segment
$ 5,637,283
$ 3,828,493
$ 13,073,023
$ 7,947,118
The
Company notes that there was no revenue related to the NDA segment for the three and nine months ended December 31, 2023 and 2022.
The
table below reconciles the Company’s operating income by segment to income before income taxes as reported in the Company’s
unaudited condensed consolidated statements of operations:
SCHEDULE
OF OPERATING INCOME BY SEGMENT TO INCOME FROM OPERATIONS
2023
2022
2023
2022
For the Three Months Ended December 31,
For the Nine Months Ended December 31,
2023
2022
2023
2022
Operating income by segment
$ 5,637,283
$ 3,828,493
$ 13,073,023
$ 7,947,118
Corporate unallocated costs
( 1,711,275 )
( 378,867 )
( 4,906,187 )
( 1,465,792 )
Interest income
5,249
15
16,085
187
Interest expense and amortization of debt issuance costs
( 121,628 )
( 322,681 )
( 371,478 )
( 782,221 )
Depreciation and amortization expense
( 343,537 )
( 317,685 )
( 999,059 )
( 933,531 )
Significant non-cash items
1,711,977
( 172,841 )
1,654,200
( 484,894 )
Change in fair value of derivative instruments
( 2,417,772 )
372,894
( 5,075,489 )
561,070
Change in fair value of stock-based liabilities
( 2,854,556 )
—
( 4,921,376 )
—
Income(Loss) before income taxes
$ ( 94,259 )
$ 3,009,328
$ ( 1,530,281 )
$ 4,841,937
NOTE
16. 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 December 31, 2023, the Company owes an aggregate of $ 3,389,949 to
Mikah in accordance with the agreements, with such amount being recorded as an accrued expense on the unaudited condensed
consolidated balance sheets.
Consultants
Agreements
Employment
contracts with certain consultants include provisions for a portion of the consultant’s fees to be paid via the issuance of shares
of the Company’s Common Stock, in lieu of cash, with the valuation of such shares being calculated on a quarterly basis and equal
to the average closing price of the Company’s Common Stock. On December 29, 2023, the Company issued 2,223,147
shares of Common Stock in satisfaction
of accrued consultant fees owed to one consultant.
F- 24
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
NOTE
17. INCOME TAXES
The
Company’s income tax benefit was $ 18.3 million and income tax expense was $ 0.05 million for the nine months ended December 31, 2023
and 2022, respectively.
The
Company’s income tax benefit was $ 0.8 million and income tax expense was $ 0.04 million for the three months ended December 31, 2023
and 2022, respectively.
During
the nine months ended December 31, 2023, the Company recorded a discrete tax benefit of $ 18.1 million
related to the Company’s release of the valuation allowance against deferred tax assets related to U.S. federal net operating
losses carryforwards and research and development tax credits, which are expected to be realized based on demonstrated current
profitability and its expectations of forecasted income. For the nine months ended December 31, 2023, the release in the
valuation allowance is the primary reason that the effective tax rate is different than the United States federal statutory rate of 21 %.
NOTE
18. SUBSEQUENT EVENTS
The
Company has evaluated subsequent events from the balance sheet date through February 14, 2024, and note the following subsequent events:
140 Ludlow Office Lease
The
Company entered into a five-year office lease agreement for a portion of a one-story warehouse, located at 140 Ludlow Avenue, Northvale,
New Jersey (the 140 Ludlow Ave. lease”) which began on January 22, 2024 and ends on December 31, 2028.
F- 25
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.