Item 1. Financial Statements
ITEM
1. FINANCIAL STATEMENTS
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
CONDENSED
CONSOLIDATED BALANCE SHEETS
June 30, 2023
March 31, 2023
ASSETS
Current assets:
Cash
$ 9,076,659
$ 7,832,247
Accounts receivable, net of allowance for expected credit losses of $ 100,000 and $ 0 as of June 30, 2023 and March 31, 2023, respectively
6,201,448
3,094,549
Inventory
11,168,431
9,550,716
Prepaid expenses and other current assets
998,058
1,032,785
Total current assets
27,444,596
21,510,297
Property and equipment, net of accumulated depreciation of $ 14,914,617 and $ 14,586,335 , respectively
10,097,876
10,426,158
Intangible assets, net of accumulated amortization of $-0-
6,341,228
6,341,228
Operating lease - right-of-use asset
7,528
13,062
Deferred income tax asset
2,171,821
2,171,821
Other assets:
Restricted cash - debt service for NJEDA bonds
415,430
412,434
Security deposits
21,018
21,018
Total other assets
436,448
433,452
Total assets
$ 46,499,497
$ 40,896,018
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$ 1,874,925
$ 2,446,810
Accrued expenses
5,929,353
5,047,726
Deferred revenue, current portion
13,333
13,333
Bonds payable, current portion, net of bond issuance costs
110,822
110,822
Loans payable, current portion
140,454
200,032
Related party loans payable (Note 7)
4,000,000
—
Lease obligation - operating lease, current portion
8,586
14,914
Total current liabilities
12,077,473
7,833,637
Long-term liabilities:
Deferred revenue, net of current portion
15,556
18,890
Bonds payable, net of current portion and bond issuance costs
1,032,568
1,029,018
Loans payable, net of current portion and loan costs
2,545,753
2,532,502
Derivative financial instruments - warrants
711,078
521,711
Total long-term liabilities
4,304,955
4,102,121
Total liabilities
16,382,428
11,935,758
Shareholders’ equity:
Common stock; par value $ 0.001 ; 1,445,000,000 shares authorized; 1,014,015,081 shares issued and 1,013,915,081 shares outstanding as of June 30, 2023; 1,014,015,081 shares issued and 1,013,915,081 shares outstanding as of March 31, 2023
1,014,019
1,014,019
Additional paid-in capital
164,765,980
164,750,980
Treasury stock; 100,000 shares as of June 30, 2023 and March 31, 2023, respectively, at cost
( 306,841 )
( 306,841 )
Accumulated deficit
( 135,356,089 )
( 136,497,898 )
Total shareholders’ equity
30,117,069
28,960,260
Total liabilities and shareholders’ equity
$ 46,499,497
$ 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)
2023
2022
For the Three Months Ended
June 30,
2023
2022
Revenue:
Manufacturing fees
$ 7,909,237
$ 6,327,141
Licensing fees
1,070,839
1,345,767
Total revenue
8,980,076
7,672,908
Cost of manufacturing
4,229,521
3,675,061
Gross profit
4,750,555
3,997,847
Operating expenses:
Research and development
1,143,545
955,443
General and administrative
1,661,704
1,718,104
Non-cash compensation through issuance of stock options
15,000
5,322
Depreciation and amortization
328,282
296,294
Total operating expenses
3,148,531
2,975,163
Income from operations
1,602,024
1,022,684
Other income (expense):
Change in fair value of derivative instruments
( 189,367 )
( 500,143 )
Interest expense and amortization of debt issuance costs
( 119,412 )
( 216,787 )
Interest income
3,516
129
Other expense, net
( 305,263 )
( 716,801 )
Income before income taxes
1,296,761
305,883
Income tax expense
( 154,952 )
—
Net income attributable to common shareholders
$ 1,141,809
$ 305,883
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
1,013,915,081
1,011,381,988
Diluted weighted average Common Stock outstanding
1,014,572,821
1,011,381,988
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
F- 2
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
CONDENSED
CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY
(UNAUDITED)
Shares
Amount
Shares
Amount
Capital
Shares
Amount
Deficit
Equity
Series J Preferred Stock
Common Stock
Additional Paid-In
Treasury Stock
Accumulated
Total Shareholders’
Shares
Amount
Shares
Amount
Capital
Shares
Amount
Deficit
Equity
Balance as of April 1, 2023
—
$ —
1,013,915,081
$ 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
—
$ —
1,013,915,081
$ 1,014,019
$ 164,765,980
100,000
$ ( 306,841 )
$ ( 135,356,089 )
$ 30,117,069
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
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
F- 3
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
2023
2022
For the Three Months Ended
June 30,
2023
2022
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income
$ 1,141,809
$ 305,883
Adjustments to reconcile net income to net cash used in operating activities:
Depreciation and amortization
328,282
296,294
Bad debt expense
100,000
—
Amortization of operating leases - right-of-use assets
5,534
51,013
Change in fair value of derivative financial instruments - warrants
189,367
500,143
Non-cash compensation through the issuance of employee stock options
15,000
5,322
Non-cash rent expense and lease accretion
192
602
Change in operating assets and liabilities:
Accounts receivable
( 3,206,899 )
( 907,196 )
Inventory
( 1,617,715 )
( 875,993 )
Prepaid expenses and other current assets
34,727
( 180,974 )
Accounts payable, accrued expenses and other current liabilities
309,550
299,968
Deferred revenue
( 3,334 )
( 3,337 )
Lease obligations - operating leases
( 6,328 )
( 49,241 )
Net cash used in operating activities
( 2,709,815 )
( 557,516 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment
—
( 94,597 )
Net cash used in investing activities
—
( 94,597 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from loans payable
—
12,000,000
Proceeds from related party loans payable
4,000,000
—
Loan payments
( 42,777 )
( 103,536 )
Net cash provided by financing activities
3,957,223
11,896,464
Net change in cash and restricted cash
1,247,408
11,244,351
Cash and restricted cash, beginning of period
8,244,681
8,940,396
Cash and restricted cash, end of period
$ 9,492,089
$ 20,184,747
Supplemental disclosure of cash and non-cash transactions:
Cash paid for interest
$ 119,412
$ 216,787
Cash paid for income taxes
$ 127,522
$ —
The accompanying notes are an integral part
of these unaudited condensed consolidated financial statements.
F- 4
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
NOTE
1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Overview
Elite
Pharmaceuticals, Inc. (the “Company” or “Elite”) was incorporated on October 1, 1997 under the laws of the State
of Delaware, and its wholly-owned subsidiary Elite Laboratories, Inc. (“Elite Labs”) was incorporated on August 23, 1990
under the laws of the State of Delaware. On January 5, 2012, Elite Pharmaceuticals was reincorporated under the laws of the State of
Nevada. Elite Labs engages primarily in researching, developing, licensing, manufacturing, and sales of generic, oral dose pharmaceuticals.
The Company is equipped to manufacture controlled-release products on a contract basis for third parties and itself, if and when the
product candidates are approved. These products include drugs that cover therapeutic areas for allergy, bariatric, attention deficit
and infection. Research and development activities are performed with an objective of developing product candidates that will secure
marketing approvals from the United States Food and Drug Administration (“FDA”), and thereafter, commercially exploiting
such products.
Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements of the Company are presented in conformity with accounting
principles generally accepted in the United States of America (“GAAP”) and pursuant to the rules and regulations of the
SEC. The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary,
Elite Labs. All significant intercompany accounts and transactions have been eliminated in consolidation. Certain information or
footnote disclosures normally included in condensed financial statements prepared in accordance with GAAP have been condensed or
omitted, pursuant to the rules and regulations of the SEC for interim financial reporting. Accordingly, they do not include all the
information and footnotes necessary for a comprehensive presentation of financial position, results of operations, or cash flows. In
the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments,
consisting of a normal recurring nature, which are necessary for a fair presentation of the financial position, operating results
and cash flows for the periods presented. The accompanying unaudited condensed consolidated financial statements should be read in
conjunction with the Company’s Form 10-K as filed with the SEC on June 29, 2023. The interim results for the three months
ended June 30, 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- 5
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.
F- 6
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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 June 30, 2023.
In
accordance with ASC 606-10-55-65, royalties are recognized when the subsequent sale of the customer’s products occurs.
c)
Direct Sales
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 direct sales of pharmaceutical products to distributors for pharmacies and institutions.
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
June 30,
2023
2022
ANDA:
Manufacturing fees
$ 7,909,237
$ 6,327,141
Licensing fees
1,070,839
1,345,767
Total ANDA revenue
8,980,076
7,672,908
Total revenue
$ 8,980,076
$ 7,672,908
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- 7
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 June 30, 2023, and March 31, 2023, the Company had $ 415,430 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. 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 February 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.
F- 8
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The
Company tests its intangible assets for impairment at least annually (as of March 31st) and whenever events or circumstances 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.
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 impairment recorded during the period ended June 30, 2023.
The
following table summarizes the Company’s intangible assets as of and for the periods ended June 30, 2023 and March 31,
2023:
SCHEDULE
OF INTANGIBLE ASSETS
June 30, 2023
Estimated
Gross
Useful
Carrying
Impairment
Accumulated
Net Book
Life
Amount
losses
Amortization
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
Gross
Useful
Carrying
Impairment
Accumulated
Net Book
Life
Amount
losses
Amortization
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.
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 .
F- 9
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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, 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 three months ended June 30, 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.
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. Such exercise price adjustment feature prohibits the Company from being able to conclude the warrants
are indexed to its own stock and thus such warrants are classified as liabilities and measured initially and subsequently at fair value.
The Series J Warrants also provide for other standard adjustments upon the happening of certain customary events.
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.
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 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 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 conversion of securities that would have an antidilutive
effect.
F- 10
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
2023
2022
For the Three Months Ended
June 30,
2023
2022
Numerator
Net income - basic 1
$ 1,141,809
$ 305,883
Effect of dilutive instrument on net income
—
—
Net income - basic and diluted
$ 1,141,809
$ 305,883
Denominator
Weighted average shares of Common Stock outstanding - basic
1,013,915,081
1,011,381,988
Dilutive effect of stock options and convertible securities
657,740
—
Weighted average shares of Common Stock outstanding - diluted
1,014,572,821
1,011,381,988
Net income per share
Basic
$ 0.00
$ 0.00
Diluted
$ 0.00
$ 0.00
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 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 instruments
189,367
—
—
189,367
Balance as of June 30, 2023
$ 711,078
$ —
$ —
$ 711,078
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 instruments
500,143
—
—
500,143
Balance as of June 30, 2022
$ 1,436,980
$ —
$ —
$ 1,436,980
1
No amounts are included in the calculation because their effects are anti-dilutive
F- 11
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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.
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 historical collections of customer payments averaging approximately 99.96 % as of June 30, 2023. The Company recorded revenue
during the three months ended June 30, 2023 of approximately $ 9.0 million and recorded an estimated allowance of $ 100,000 , which is approximately
1.2 % of total revenues during the three months ended June 30, 2023. The Company estimated the allowance using considerations such as
customer collections, and estimated credit losses. The Company believes the 1.2 % credit allowance is appropriate given its historical
customer collections.
F- 12
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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
June 30, 2023
March 31, 2023
Finished goods
$ 7,808,657
$ 2,352,330
Work-in-progress
90,922
1,791,311
Raw materials
3,268,852
5,407,075
Inventory
$ 11,168,431
$ 9,550,716
NOTE
3. PROPERTY AND EQUIPMENT, NET
Property
and equipment consisted of the following:
SCHEDULE
OF PROPERTY AND EQUIPMENT
June 30, 2023
March 31, 2023
Land, building and improvements
$ 10,771,997
$ 10,768,181
Laboratory, manufacturing, warehouse and transportation equipment
13,354,863
13,364,512
Office equipment and software
373,601
395,563
Furniture and fixtures
512,032
484,237
Property and equipment, gross
25,012,493
25,012,493
Less: Accumulated depreciation
( 14,914,617 )
( 14,586,335 )
Property and equipment, net
$ 10,097,876
$ 10,426,158
Depreciation
expense was $ 328,282 and $ 292,748 for the three months ended June 30, 2023 and 2022, respectively.
F- 13
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
NOTE
4. ACCRUED EXPENSES
As
of June 30, 2023 and March 31, 2023, the Company’s accrued expenses consisted of the following:
SUMMARY
OF ACCRUED EXPENSES
June 30, 2023
March 31, 2023
Salaries and fees payable in common stock
4,470,001
4,125,000
Income tax
564,985
414,989
Consultant contract fees
193,333
193,333
Audit fees
125,000
125,000
Director dues
107,500
70,000
Legal and professional expense
90,000
—
Employee bonuses
30,000
—
Other accrued expenses
348,534
119,404
Total accrued expenses
$ 5,929,353
$ 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
June 30, 2023
March 31, 2023
Gross bonds payable
NJEDA Bonds - Series A Notes
$ 1,245,000
$ 1,245,000
Less: Current portion of bonds payable (prior to deduction of bond offering costs)
( 125,000 )
( 125,000 )
Long-term portion of bonds payable (prior to deduction of bond offering costs)
$ 1,120,000
$ 1,120,000
Bond offering costs
$ 354,454
$ 354,454
Less: Accumulated amortization
( 252,842 )
( 249,294 )
Bond offering costs, net
$ 101,612
$ 105,160
Current portion of bonds payable - net of bond offering costs
Current portions of bonds payable
$ 125,000
$ 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
$ 110,822
$ 110,822
Long term portion of bonds payable - net of bond offering costs
Long term portion of bonds payable
$ 1,120,000
$ 1,120,000
Less: Bond offering costs to be amortized subsequent to the next 12 months
( 87,432 )
( 90,982 )
Long term portion of bonds payable, net of bond offering costs
$ 1,032,568
$ 1,029,018
Amortization
expense was $ 3,548 and $ 3,546 for the three months ended June 30, 2023 and 2022, respectively. Interest payable was $ 6,744 as of June
30, 2023 and March 31, 2023. Interest expense was $ 20,232 and $ 22,101 for the three months ended June 30, 2023 and 2022, respectively.
F- 14
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Maturities
of bonds for the next five years are as follows:
SCHEDULE
OF MATURITIES OF BONDS
Years ending March 31,
Amount
2024
$ 125,000
2025
130,000
2026
140,000
2027
150,000
Thereafter
700,000
Total
$ 1,245,000
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
June 30, 2023
March 31, 2023
Mortgage loan payable 4.75% interest and maturing June 2032
$ 2,471,304
$ 2,472,923
Equipment and insurance financing loans payable, between 7.10 % and 12.02 % interest and maturing between September 2023 and October 2025
214,903
259,611
Less: Current portion of loans payable
( 140,454 )
( 200,032 )
Long-term portion of loans payable
$ 2,545,753
$ 2,532,502
The
interest expense associated with the loans and mortgage payable was $ 77,238 and $ 177,579 for the three months ended June 30, 2023 and
2022, respectively.
Loan
and mortgage principal payments for the next five years are as follows:
SCHEDULE
OF LOAN PRINCIPAL PAYMENTS
Years ending March 31,
Amount
2024 (excluding the three months ended June 30, 2023)
$ 140,454
2025
380,210
2026
317,537
2027
292,652
2028
297,245
2029 and thereafter
1,258,109
Total remaining principal balance
$ 2,686,207
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 less 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.
F- 15
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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 June 30, 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.
NOTE
8. DEFERRED REVENUE
Deferred
revenues in the aggregate amount of $ 28,889 as of June 30, 2023, were comprised of a current component of $ 13,333 and a long-term component
of $ 15,556 . 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 line items represent the unamortized amounts 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.
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.
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.
F- 16
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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 has a term of three years, ending on October
31, 2023.
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.
Lease
assets and liabilities are classified as follows on the condensed consolidated balance sheet:
SCHEDULE
OF LEASE ASSETS AND LIABILITIES
Lease
Classification
As of
June 30, 2022
Assets
Operating
Operating lease – right-of-use asset
$ 7,528
Total leased assets
$ 7,528
Liabilities
Current
Operating
Lease obligation – operating lease
$ 8,586
Long-term
Operating
Lease obligation – operating lease, net of current portion
—
Total lease liabilities
$ 8,586
Rent
expense is recorded on the straight-line basis. Rent expense under the 135 Ludlow Ave. modified lease for the three months ended June
30, 2023 and 2022 was $0 and $ 58,248 , respectively. Rent expense under the Pompano Office Lease for the three months ended June
30, 2023 and 2022 was $ 6,519 and $ 6,330 , 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:
SCHEDULE
OF FUTURE MINIMUM RENTAL PAYMENTS
Years ending March 31,
Amount
2024 (excluding the three months ended June 30, 2023)
$ 8,694
Total future minimum lease payments
8,694
Less: interest
( 108 )
Present value of lease payments
$ 8,586
F- 17
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The
weighted-average remaining lease term and the weighted-average discount rate of our lease was as follows:
SCHEDULE
OF WEIGHTED -AVERAGE REMAINING TERM AND THE WEIGHTED-AVERAGE DISCOUNT RATE
Lease Term and Discount Rate
June 30, 2023
Remaining lease term (years)
Operating leases
0.3
Discount rate
Operating leases
6 %
NOTE
10. PREFERRED STOCK
Series
J convertible preferred stock
On
April 28, 2017, the Company created the Series J Convertible Preferred Stock (“Series J Preferred”) in conjunction with the
Certificate of Designations. A total of 50 shares of Series J Preferred were authorized, zero shares are
issued and outstanding, with a stated value of $ 1,000,000 per share and a par value of $ 0.01 .
F- 18
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
NOTE
11. DERIVATIVE FINANCIAL INSTRUMENTS – WARRANTS
The
Company evaluates and accounts for its freestanding instruments in accordance with ASC 815, Accounting for Derivative Instruments
and Hedging Activities .
The
Company issued warrants, with a term of ten years, to affiliates in connection with an exchange agreement dated April 28, 2017, 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, 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. 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. Such exercise price adjustment feature prohibits the Company from being able to conclude the warrants are indexed to
its own stock and thus such warrants are classified as liabilities and measured initially and subsequently at fair value. 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 instead of a Monte Carlo Simulation because the probability
with the shareholder approval provisions was no longer a factor. 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, 2023
March 31, 2023
Fair value of the Company’s Common Stock
$ 0.0383
$ 0.0290
Volatility
72.21 %
74.37 %
Initial exercise price
$ 0.1521
$ 0.1521
Warrant term (in years)
3.8
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 three months ended June 30, 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
189,367
Balance at June 30, 2023
$ 711,078
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.
F- 19
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The
Company did not issue any shares of its Common Stock pursuant to the 2020 LPC Purchase Agreement during the three months ended June 30,
2023 and 2022. In addition, there were no shares issued to Lincoln Park as additional commitment shares, pursuant to the 2020 LPC Agreement.
The 2020 LPC Purchase Agreement will expire on August 1, 2023.
Summary
of Common Stock Activity
During
the three months ended June 30, 2023 and 2022, the Company did not issue any shares of Common Stock.
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 three months ended June 30, 2023, the Company accrued director’s fees totaling $ 37,500 ,
which will be paid via cash payments totaling $ 7,500
and the issuance of shares of Common Stock.
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.
During
the three months ended June 30, 2023, the Company accrued salaries totaling $ 170,000
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 June 30, 2023, the
total obligation of $ 4,725,000
is outstanding.
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. A summary of the activity of Company’s 2014 Stock Option Plan
for the three months ended June 30, 2023 is as follows:
SCHEDULE
OF STOCK OPTION PLAN
Shares
Underlying
Options
Weighted
Average
Exercise Price
Weighted Average
Remaining Contractual
Term
(in years)
Aggregate Intrinsic
Value
Outstanding at March 31, 2023
15,370,000
$ 0.07
7.4
$ —
Outstanding at June 30, 2023
15,370,000
$ 0.05
7.2
$ —
Exercisable at June 30, 2023
4,182,000
$ 0.08
2.0
$ —
F- 20
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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, 2023 and March 31, 2023 of $ 0.04 and $ 0.03 , respectively. As
of June 30, 2023, there was $ 184,722 in unrecognized stock based compensation expense that will be recognized over a 1.3 year period.
NOTE
14. CONCENTRATIONS AND CREDIT RISK
Revenues
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 revenues each, respectively.
One
customer accounted for approximately 85 % of the Company’s revenues for the three months ended June 30, 2022.
Accounts
Receivable
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.
One
customer accounted for approximately 96 % the Company’s accounts receivable as of March 31, 2023.
Purchasing
One
supplier accounted for approximately 39 % of the Company’s purchases of raw materials for the three months ended June 30, 2023.
Two
suppliers accounted for approximately 66 % of the Company’s purchases of raw materials for the three months ended June 30, 2022.
These two suppliers accounted for approximately 56 % and 10 % of purchases each, respectively.
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.
The
following represents selected information for the Company’s reportable segments:
SCHEDULE
OF SELECTED INFORMATION FOR REPORTABLE SEGMENTS
2023
2022
For the Three Months Ended
June 30,
2023
2022
Operating Income by Segment
ANDA
$ 7,725,635
$ 8,068,073
Operating income by Segment
$ 7,725,635
$ 8,068,073
F- 21
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The
table below reconciles the Company’s operating income by segment to income 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
For the Three Months Ended
June 30,
2023
2022
Operating income by segment
$ 7,725,635
$ 8,068,073
Corporate unallocated costs
( 2,606,661 )
( 2,288,461 )
Interest income
3,516
129
Interest expense and amortization of debt issuance costs
( 119,412 )
( 126,376 )
Depreciation and amortization expense
( 328,282 )
( 908,297 )
Significant non-cash items
( 469,021 )
( 652,281 )
Change in fair value of derivative instruments
( 189,367 )
1,523,394
Income before income taxes
$ 4,016,408
$ 5,616,181
NOTE
16. RELATED PARTY AGREEMENTS WITH MIKAH PHARMA, LLC
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.
NOTE
17. INCOME TAXES
The
Company’s effective tax rate was 11.5 % and income tax expense for the three months ended June 30, 2023 was $ 154,952 . The Company’s
effective tax rate was 0.00 % and income tax expense was $— for the three months ended June 30, 2022. The Company has evaluated
its deferred tax assets, specifically its net operating loss carryovers, for realizability and has provided a valuation allowance on
the majority of its deferred tax assets. The change in valuation allowance is the reason that the effective tax rate and income tax expense are
different than the statutory rate of 21 %.
NOTE
18. SUBSEQUENT EVENTS
The Company has evaluated subsequent events from the balance sheet date through August 14, 2023 and note no material subsequent events were identified.
F- 22
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.