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”) which 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 and licensing proprietary orally administered, controlled-release
drug delivery systems and products with abuse deterrent capabilities and the manufacture 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 products are approved. These products include drugs that cover therapeutic areas for pain, allergy, bariatric and infection.
Research and development activities are done so with an objective of developing products that will secure marketing approvals from
the United States Food and Drug Administration (“FDA”), and thereafter, commercially exploiting such products.
Principles of Consolidation
The accompanying unaudited
condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the
United States (“GAAP”) and in conformity with the instructions on Form 10-Q and Rule 8-03 of Regulation S-X and the
related rules and regulations of the Securities and Exchange Commission (“SEC”). The unaudited condensed consolidated
financial statements include the accounts of the Company and its wholly owned subsidiary, Elite Laboratories, Inc. All significant
intercompany accounts and transactions have been eliminated in consolidation. The unaudited condensed consolidated financial statements
reflect all adjustments, consisting of normal recurring accruals, which are, in the opinion of management, necessary for a fair
presentation of such statements. The results of operations for the three and nine months ended December 31, 2019 are not necessarily
indicative of the results that may be expected for the entire year.
Going Concern
At December 31, 2019, the
Company had unrestricted cash balances totaling $1,870,080. The Company has incurred losses and negative cash flows from operations,
including operating income of $691,195 and loss of $2,637,130 for the three months ended December 31, 2019 and 2018, and operating
losses of $911,042 and $7,148,496 for the nine months ended December 31, 2019 and 2018, respectively. In addition, overall working
capital, defined as current assets minus current liabilities decreased by $654,482 as of December 31, 2019.
Based on the foregoing,
the Company has determined that there did appear to be evidence of substantial doubt of its ability to continue as a going concern.
To continue as a going concern, the Company will need to do some or all of the following, without limitation: obtain additional
financing, increase sales of existing products, bring additional products in the pipeline to market and/or reduce expenses. The
successful development of the Company’s contemplated plan of operations, and its transition, ultimately, to the attainment
of profitable operations are necessary for the Company to continue operations.
The accompanying financial
statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets
and the settlement of liabilities and commitments in the normal course of business. The financial statements included herein do
not reflect any adjustments relating to the recoverability and reclassification of assets and liabilities that might be necessary
if the Company is unable to continue as a going concern.
Segment Information
Financial Accounting
Standards Board (“FASB”) Accounting Standards Codification (“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.
ELITE PHARMACEUTICALS,
INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
(UNAUDITED)
The Company has determined
that its reportable segments are products whose marketing approvals were secured via an Abbreviated New Drug Applications (“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 unaudited condensed consolidated financial statements. Please see Note 15 for further details.
Revenue Recognition
The Company generates
revenue from the development of pain management products, manufacturing of a line of generic pharmaceutical products with approved
ANDA, commercialization of products either by license and the collection of royalties, or through the manufacture of formulations
and the development of new products and the expansion of licensing agreements with other pharmaceutical companies, including co-development
projects, joint ventures and other collaborations. The Company also generates revenue through its focus on the development of various
types of drug products, including branded drug products which require NDAs.
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 recognize 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 and products utilizing abuse deterrent technologies. The Company
also develops and markets (either on its own or by license to other companies) generic and proprietary controlled-release and abuse
deterrent 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.
Revenue on product are presented gross because 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.
ELITE PHARMACEUTICALS,
INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
(UNAUDITED)
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 not recognize revenue from the milestone until
there is not a high probability of a reversal of revenue, which typically occurs near or upon achievement of the event.
Significant management
judgment is required to determine the level of effort required under an arrangement and the period over which the Company expects
to complete its performance obligations under the arrangement. If the Company cannot reasonably estimate when its performance obligations
either are completed or become inconsequential, then revenue recognition is deferred until the Company can reasonably make such
estimates. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method.
When determining the
transaction price of a contract, an adjustment is made if payment from a customer occurs either significantly before or significantly
after performance, resulting in a significant financing component. Applying the practical expedient in ASC 606-10-32-18, the Company
does not assess whether a significant financing component exists if the period between when the Company performs its obligations
under the contract and when the customer pays is one year or less. None of the Company’s contracts contained a significant
financing component as of December 31, 2019.
In accordance with
ASC 606-10-55-65, royalties are recognized when the subsequent sale of the customer’s products occurs.
Disaggregation of revenue
In the following table,
revenue is disaggregated by type of revenue generated by the Company and timing of revenue recognition. The table also includes
a reconciliation of the disaggregated revenue with the reportable segments:
|
|
For the Three Months Ended
December 31,
|
|
|
For the Nine Months Ended
December 31,
|
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
NDA:
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing fees
|
|
$
|
250,000
|
|
|
$
|
250,000
|
|
|
$
|
750,000
|
|
|
$
|
750,000
|
|
Total NDA revenue
|
|
|
250,000
|
|
|
|
250,000
|
|
|
|
750,000
|
|
|
|
750,000
|
|
ANDA:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Manufacturing fees
|
|
$
|
3,754,721
|
|
|
$
|
2,108,487
|
|
|
$
|
10,851,425
|
|
|
$
|
4,456,832
|
|
Licensing fees
|
|
|
1,050,392
|
|
|
|
335,479
|
|
|
|
1,447,915
|
|
|
|
1,017,881
|
|
Total ANDA revenue
|
|
|
4,805,113
|
|
|
|
2,443,966
|
|
|
|
12,299,340
|
|
|
|
5,474,713
|
|
Total revenue
|
|
$
|
5,055,113
|
|
|
$
|
2,693,966
|
|
|
$
|
13,049,340
|
|
|
$
|
6,224,713
|
|
Collaborative Arrangements
Contracts are considered
to be collaborative arrangements when they satisfy the following criteria defined in ASC 808, Collaborative Arrangements:
|
●
|
The parties to the contract must actively participate in the joint operating activity; and,
|
|
|
|
|
●
|
The joint operating activity must expose the parties to the possibility of significant risk and rewards, based on whether or not the activity is successful.
|
ELITE PHARMACEUTICALS,
INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
(UNAUDITED)
The Company entered
into a sales and distribution licensing agreement with Epic Pharma LLC, (“Epic”) dated June 4, 2015 (the “2015
Epic License Agreement”), which has been determined to satisfy the criteria for consideration as a collaborative agreement,
and is accounted for accordingly, in accordance with GAAP.
The Company entered
into a Master Development and License Agreement with SunGen Pharma LLC dated August 24, 2016 (the “SunGen Agreement”),
which has been determined to satisfy the criteria for consideration as a collaborative agreement, and is accounted for accordingly,
in accordance with GAAP.
Cash
The Company considers
all highly liquid investments with an original maturity of three months or less to be cash equivalents. Cash and cash equivalents
consist of cash on deposit with banks and money market instruments. The Company places its cash and cash equivalents 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,
2019, and March 31, 2019, the Company had $403,575 and $398,125 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
Accounts receivable
are comprised of balances due from customers, net of estimated allowances for uncollectible accounts. In determining collectability,
historical trends are evaluated, and specific customer issues are reviewed on a periodic basis to arrive at appropriate allowances.
Inventory
Inventory is recorded
at the lower of cost or market 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.
As of December 31,
2019, the Company did not identify any indicators of impairment.
Please also see Note
4 for further details on intangible assets.
ELITE PHARMACEUTICALS,
INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
(UNAUDITED)
Research and Development
Research and development
expenditures are charged to expense 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.
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 instruments 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
are assessed with determinations made regarding the proper classification in the Company’s financial statements.
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, 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.
Earnings (Loss) Per Share Attributable
to Common Shareholders’
The Company follows
ASC 260, Earnings Per Share, which requires presentation of basic and diluted earnings (loss) per share (“EPS”)
on the face of the income statement for all entities with complex capital structures and requires a reconciliation of the numerator
and denominator of the basic EPS computation to the numerator and denominator of the diluted EPS computation. In the accompanying
financial statements, basic earnings (loss) per share is computed by dividing net income (loss) by the weighted average number
of shares of common stock outstanding during the period. Diluted EPS excluded all potential dilutive shares if their effect was
anti-dilutive.
ELITE PHARMACEUTICALS,
INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
(UNAUDITED)
The following is the
computation of earnings (loss) per share applicable to common shareholders for the periods indicated:
|
|
For the Three Months Ended
December 31,
|
|
|
For the Nine Months Ended
December 31,
|
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
Numerator
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to common shareholders – basic
|
|
$
|
(1,860,680
|
)
|
|
$
|
(2,344,318
|
)
|
|
$
|
(3,176,719
|
)
|
|
$
|
(6,615,616
|
)
|
Effect of dilutive instrument on net loss
|
|
|
-
|
|
|
|
(380,976
|
)
|
|
|
-
|
|
|
|
(807,347
|
)
|
Net loss attributable to common shareholders - diluted
|
|
$
|
(1,860,680
|
)
|
|
$
|
(2,725,924
|
)
|
|
$
|
(3,176,719
|
)
|
|
$
|
(7,422,963
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares of common stock outstanding - basic
|
|
|
829,394,203
|
|
|
|
819,412,807
|
|
|
|
828,446,951
|
|
|
|
811,603,678
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dilutive effect of stock options, warrants and convertible securities
|
|
|
-
|
|
|
|
56,074
|
|
|
|
-
|
|
|
|
56,074
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares of common stock outstanding – diluted
|
|
|
829,394,203
|
|
|
|
819,468,881
|
|
|
|
828,466,951
|
|
|
|
811,659,752
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share attributable to common shareholders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
(0.00
|
)
|
|
$
|
(0.00
|
)
|
|
$
|
(0.00
|
)
|
|
$
|
(0.01
|
)
|
Diluted
|
|
$
|
(0.00
|
)
|
|
$
|
(0.00
|
)
|
|
$
|
(0.00
|
)
|
|
$
|
(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.
|
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:
|
|
|
|
|
Fair Value Measurement Using
|
|
|
|
Amount at Fair Value
|
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
December 31 2019
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivative financial instruments – warrants
|
|
$
|
5,078,525
|
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
5,078,525
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivative financial instruments – warrants
|
|
$
|
2,487,830
|
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
2,487,830
|
|
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.
Treasury Stock
The Company records
treasury stock at the cost to acquire it and includes treasury stock as a component of shareholders’ deficit.
Recently Adopted Accounting Pronouncements
The Financial Accounting
Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-02, Leases (Topic 842)
in February 2016 and subsequent ASUs in 2018 and 2019 (collectively referred to as “Topic 842”) on the treatment of
leases, which guidance is effective for annual reporting periods beginning after December 15, 2019 and early adoption is
permitted. Under Topic 842, lessees will be required to recognize the following for all leases (with the exception of short-term
leases) at the commencement date: 1) a lease liability, which is a lessee’s obligation to make lease payments arising
from a lease, measured on a discounted basis, and 2) a right-of-use asset, which is an asset that represents the lessee’s
right to use, or control the use of, a specified asset for the lease term. Entities are allowed to apply Topic 842 using a modified
retrospective approach either (1) retrospectively to each reporting period presented in the financial statements with the cumulative
effect adjustment recognized at the beginning of the earliest comparative period; or (2) retrospectively at the beginning of the
period of adoption through a cumulative-effective adjustment. The modified retrospective approach includes a number of optional
practical expedients that entities may elect to apply.
On April 1, 2019, the
Company adopted Topic 842 using the modified retrospective basis with a cumulative-effect adjustment at the beginning of the period
of adoption and therefore did not revise prior period information or disclosure. Further, the Company elected the package of practical
expedients upon transition that allows the Company not to reassess the lease classification for expired and existing leases, whether
initial direct costs qualify for capitalization for any expired or existing leases or whether any expired contracts are or contain
leases. The adoption of ASU 2016-02 resulted in the recognition of operating leases and lease liabilities of approximately $0.6
million on the condensed consolidated balance sheet as of April 1, 2019. The operating leases and lease liabilities relate to a
real estate lease.
The impact of the adoption
of Topic 842 on the accompanying condensed consolidated balance sheet as of April 1, 2019 was as follows:
|
|
March 31,
2019
|
|
|
Adoption Adjustment
|
|
|
April 1,
2019
|
|
Operating lease - right of use
|
|
$
|
-
|
|
|
$
|
554,088
|
|
|
$
|
554,088
|
|
Deferred rent liability
|
|
$
|
13,022
|
|
|
$
|
(13,022
|
)
|
|
$
|
-
|
|
Lease obligation - operating lease
|
|
$
|
-
|
|
|
$
|
191,817
|
|
|
$
|
191,817
|
|
Lease obligation - operating lease, net of current portion
|
|
$
|
-
|
|
|
$
|
375,293
|
|
|
$
|
375,293
|
|
See additional lease
disclosures in Note 9.
ELITE PHARMACEUTICALS,
INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
(UNAUDITED)
Recently Issued Accounting Pronouncements
In November 2018,
the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808), Clarifying the Interaction between Topic 808 and Topic
606. The ASU clarifies when transactions between collaborative participants are in the scope of ASC 606. The ASU also provides
some guidance on presentation of transactions not in the scope of ASC 606. ASU 2018-18 is effective for fiscal years, and interim
periods within those years, beginning after December 15, 2019. Early adoption is permitted for fiscal years, and interim periods
within those years. The Company is currently evaluating the impact the standard will have on our condensed consolidated financial
statements.
In June 2016, the FASB
issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments
(“ASU 2016-13”). The standard changes the methodology for measuring credit losses on financial instruments and the
timing of when such losses are recorded. ASU 2016-13 is effective for fiscal years, and interim periods within those years, beginning
after December 15, 2019. Early adoption is permitted for fiscal years, and interim periods within those years, beginning after
December 15, 2018. The Company is currently evaluating the impact the standard will have on our condensed consolidated financial
statements. In November 2018, the FASB issued ASU 2018-19, Codification Improvements to Topic 326, Financial Instruments - Credit
Losses. The ASU changes the effective date of ASU 2016-13, Financial Instruments - Credit Losses, to fiscal years beginning
after December 15, 2019, including interim periods within those fiscal years. In May 2019, the FASB issued ASU 2019-05, Financial
Instruments - Credit Losses (Topic 326), Targeted Transition Relief. The ASU allows companies to elect, upon adoption of ASU
2016-13, the fair value option on financial instruments that were previously recorded at amortized cost and are within the scope
of ASC 326-20 if the instruments are eligible for the fair value option under ASC 825-10. The ASU is effective when the entity
adopts ASU 2016-13. In October 2019, the FASB issued ASU 2019-10, Financial Instruments – Credit Losses (Topic 326), Derivatives
and Hedging (Topic 815) and Leases (Topic 842). The ASU amends and defers the effective dates of credit losses, derivatives
and leases standards for certain companies. The ASU allows deferral of the credit losses standard to January 1, 2023 for SEC filers
considered small reporting companies. The ASU allows deferral of the derivatives and hedging and leasing standards to January 1,
2021 for non-public entities. In November 2019, the FASB issued ASU 2019-11, Codification Improvements to Topic 326, Financial
Instruments – Credit Losses. The ASU amends ASU 2016-13 and extends the recovery guidance to purchased financial assets
with credit deterioration. The ASU is effective when the entity adopts ASU 2016-13. The Company is currently evaluating the impact
the standard will have on our condensed consolidated financial statements.
Management has evaluated
other recently issued accounting pronouncements and does not believe that any of these pronouncements will have a significant impact
on our condensed consolidated financial statements and related disclosures.
NOTE 2. INVENTORY
Inventory consisted
of the following:
|
|
December 31,
2019
|
|
|
March 31,
2019
|
|
Finished goods
|
|
$
|
55,521
|
|
|
$
|
575,699
|
|
Work-in-progress
|
|
|
238,052
|
|
|
|
189,069
|
|
Raw materials
|
|
|
3,516,828
|
|
|
|
3,750,955
|
|
|
|
|
3,810,401
|
|
|
|
4,515,723
|
|
Less: Inventory reserve
|
|
|
-
|
|
|
|
-
|
|
|
|
$
|
3,810,401
|
|
|
$
|
4,515,723
|
|
ELITE PHARMACEUTICALS,
INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
(UNAUDITED)
NOTE 3. PROPERTY AND EQUIPMENT, NET
Property and equipment
consisted of the following:
|
|
December 31,
2019
|
|
|
March 31,
2019
|
|
Land, building and improvements
|
|
$
|
5,260,523
|
|
|
$
|
5,260,523
|
|
Laboratory, manufacturing, warehouse and transportation equipment
|
|
|
12,135,950
|
|
|
|
12,078,340
|
|
Office equipment and software
|
|
|
373,601
|
|
|
|
373,601
|
|
Furniture and fixtures
|
|
|
383,103
|
|
|
|
383,103
|
|
|
|
|
18,153,177
|
|
|
|
18,095,567
|
|
Less: Accumulated depreciation
|
|
|
(10,634,174
|
)
|
|
|
(9,651,718
|
)
|
|
|
$
|
7,519,003
|
|
|
$
|
8,443,849
|
|
Depreciation expense
was $326,908 and $317,618 for the three months, and $982,456 and $931,180 for the nine months, ended December 31, 2019 and 2018,
respectively.
NOTE 4. INTANGIBLE ASSETS
The following table
summarizes the Company’s intangible assets:
|
|
December 31 2019
|
|
|
Estimated
|
|
Gross
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Useful
|
|
Carrying
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
Net Book
|
|
|
|
Life
|
|
Amount
|
|
|
Additions
|
|
|
Reductions
|
|
|
Amortization
|
|
|
Value
|
|
Patent application costs
|
|
*
|
|
$
|
465,684
|
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
465,684
|
|
ANDA acquisition costs
|
|
Indefinite
|
|
|
6,168,351
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
6,168,351
|
|
|
|
|
|
$
|
6,634,035
|
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
6,634,035
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2019
|
|
|
Estimated
|
|
Gross
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Useful
|
|
Carrying
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
Net Book
|
|
|
|
Life
|
|
Amount
|
|
|
Additions
|
|
|
Reductions
|
|
|
Amortization
|
|
|
Value
|
|
Patent application costs
|
|
*
|
|
$
|
465,684
|
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
465,684
|
|
ANDA acquisition costs
|
|
Indefinite
|
|
|
7,247,317
|
|
|
|
-
|
|
|
|
(1,078,966
|
)
|
|
|
-
|
|
|
|
6,168,351
|
|
|
|
|
|
$
|
7,713,001
|
|
|
$
|
-
|
|
|
$
|
(1,078,966
|
)
|
|
$
|
-
|
|
|
$
|
6,634,035
|
|
Patent application
costs were incurred in relation to the Company’s abuse deterrent opioid technology. Amortization of the patent costs will
begin upon the issuance of marketing authorization by the FDA. Amortization will then be calculated on a straight-line basis through
the expiry of the related patent(s).
NOTE 5. NJEDA BONDS
During August 2005,
the Company refinanced a bond issue occurring in 1999 through the issuance of Series A and B Notes tax-exempt bonds (the “NJEDA
Bonds” and/or “Bonds”). During July 2014, the Company retired all outstanding Series B Notes, at par, along with
all accrued interest due and owed.
In relation to the
Series A Notes, the Company is required to maintain a debt service reserve. The debt serve reserve is classified as restricted
cash on the accompanying unaudited condensed consolidated balance sheets. The NJEDA Bonds require the Company to make an annual
principal payment on September 1st based on the amount specified in the loan documents and semi-annual interest payments
on March 1st and September 1st, equal to interest due on the outstanding principal. The annual interest rate
on the Series A Note is 6.5%. The NJEDA Bonds are collateralized by a first lien on the Company’s facility and equipment
acquired with the proceeds of the original and refinanced bonds.
ELITE PHARMACEUTICALS,
INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
(UNAUDITED)
The following tables
summarize the Company’s bonds payable liability:
|
|
December 31,
2019
|
|
|
March 31,
2019
|
|
Gross bonds payable
|
|
|
|
|
|
|
NJEDA Bonds - Series A Notes
|
|
$
|
1,575,000
|
|
|
$
|
1,670,000
|
|
Less: Current portion of bonds payable (prior to deduction of bond offering costs)
|
|
|
(105,000
|
)
|
|
|
(95,000
|
)
|
Long-term portion of bonds payable (prior to deduction of bond offering costs)
|
|
$
|
1,470,000
|
|
|
$
|
1,575,000
|
|
|
|
|
|
|
|
|
|
|
Bond offering costs
|
|
$
|
354,454
|
|
|
$
|
354,453
|
|
Less: Accumulated amortization
|
|
|
(203,221
|
)
|
|
|
(192,591
|
)
|
Bond offering costs, net
|
|
$
|
151,233
|
|
|
$
|
161,862
|
|
|
|
|
|
|
|
|
|
|
Current portion of bonds payable - net of bond offering costs
|
|
|
|
|
|
|
|
|
Current portions of bonds payable
|
|
$
|
105,000
|
|
|
$
|
95,000
|
|
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
|
|
$
|
90,822
|
|
|
$
|
80,822
|
|
|
|
|
|
|
|
|
|
|
Long term portion of bonds payable - net of bond offering costs
|
|
|
|
|
|
|
|
|
Long term portion of bonds payable
|
|
$
|
1,470,000
|
|
|
$
|
1,575,000
|
|
Less: Bond offering costs to be amortized subsequent to the next 12 months
|
|
|
(137,055
|
)
|
|
|
(147,685
|
)
|
Long term portion of bonds payable, net of bond offering costs
|
|
$
|
1,332,945
|
|
|
$
|
1,427,315
|
|
Amortization expense
was $3,545 and $3,544 for the three months, and $10,630 and $10,636 for the nine months, ended December 31, 2019 and 2018, respectively.
NOTE 6. LOANS PAYABLE
Loans payable consisted
of the following:
|
|
December 31,
2019
|
|
|
March 31,
2019
|
|
Equipment and insurance financing loans payable, between 3.5% and 12.73% interest and maturing between March 2019 and July 2024
|
|
$
|
886,817
|
|
|
$
|
1,272,298
|
|
Less: Current portion of loans payable
|
|
|
(356,137
|
)
|
|
|
(573,029
|
)
|
Long-term portion of loans payable
|
|
$
|
530,480
|
|
|
$
|
699,269
|
|
The interest expense
associated with the loans payable was $18,291 and $28,025 for the three months, and $63,170 and $86,765 for the nine months, ended
December 31, 2019 and 2018, respectively.
NOTE 7. RELATED PARTY SECURED PROMISSORY
NOTE WITH MIKAH PHARMA LLC
For consideration of
the assets acquired on May 15, 2017, the Company issued a Secured Promissory Note (the “Note”) to Mikah for the principal
sum of $1,200,000. The Note matures on December 31, 2020 in which the Company shall pay the outstanding principal balance of the
Note. Interest shall be computed on the unpaid principal amount at the per annum rate of ten percent (10%); provided, upon the
occurrence of an Event of Default as defined within the Note, the principal balance shall bear interest from the date of such occurrence
until the date of actual payment at the per annum rate of fifteen percent (15%). All interest payable hereunder shall be computed
on the basis of actual days elapsed and a year of 360 days. Installment payments of interest on the outstanding principal shall
be paid as follows: quarterly commencing August 1, 2017 and on November 1, February 1, May 1 and August 1 of each year thereafter.
No principal or interest payments have been made on the Note since its issuance. All unpaid principal and accrued but unpaid interest
shall be due and payable in full on the Maturity Date. The interest expense associated with the Note was $30,000 for the three
months and $90,000 for the nine months ended December 31, 2019 and 2018, respectively. Accrued interest due and owing on this note
was $315,000 and $225,000 as of December 31, 2019 and March 31, 2019, respectively.
ELITE PHARMACEUTICALS,
INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
(UNAUDITED)
NOTE 8. DEFERRED REVENUE
Deferred revenues in
the aggregate amount of $492,224 as of December 31, 2019, were comprised of a current component of $430,000 and a long-term component
of $62,224. Deferred revenues in the aggregate amount of $1,252,223 as of March 31, 2019, were comprised of a current component
of $1,013,333 and a long-term component of $238,890. These line items represent the unamortized amounts of a $200,000 advance payment
received for a TAGI licensing agreement with a fifteen-year term beginning in September 2010 and ending in August 2025 and the
$5,000,000 advance payment Epic Collaborative Agreement with a five-year term beginning in June 2015 and ending in May 2020. 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 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 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 – 135 Ludlow
Ave.
The Company entered
into an operating lease for a portion of a one-story warehouse, located at 135 Ludlow Avenue, Northvale, New Jersey (the “135
Ludlow Ave. lease”). The 135 Ludlow Ave. lease is for approximately 15,000 square feet of floor space and began on July 1,
2010. During July 2014, the Company modified the 135 Ludlow Ave. lease in which the Company was permitted to occupy the entire
35,000 square feet of floor space in the building (“135 Ludlow Ave. modified lease”).
The 135 Ludlow Ave.
modified lease includes an initial term, which expired on December 31, 2016 with two tenant renewal options of five years each,
at the sole discretion of the Company. On June 22, 2016, the Company exercised the first of these renewal options, with such option
including a term that begins on January 1, 2017 and expires on December 31, 2021.
The 135 Ludlow Ave.
property required significant leasehold improvements and qualifications, as a prerequisite, for its intended future use. Manufacturing,
packaging, warehousing and regulatory activities are currently conducted at this location. Additional renovations and construction
to further expand the Company’s manufacturing resources are in progress.
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 our 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 at December 31, 2019:
Lease
|
|
Classification
|
|
As of
December 31,
2019
|
|
Assets
|
|
|
|
|
|
Operating
|
|
Operating lease – right to use asset
|
|
$
|
412,063
|
|
Total leased assets
|
|
|
|
$
|
412,063
|
|
|
|
|
|
|
|
|
Liabilities
|
|
|
|
|
|
|
Current
|
|
|
|
|
|
|
Operating
|
|
Lease obligation – operating lease
|
|
$
|
203,984
|
|
|
|
|
|
|
|
|
Long-term
|
|
|
|
|
|
|
Operating
|
|
Lease obligation – operating lease, net of current portion
|
|
|
221,166
|
|
Total lease liabilities
|
|
|
|
$
|
425,150
|
|
Rent
expense is recorded on the straight-line basis. Rent expense under the 135 Ludlow Ave. modified lease for the three months ended
December 31, 2019 and 2018 was $18,296 and $54,909, and $128,072 and $164,757 for the nine months ended December 31, 2019 and 2018,
respectively. Rent expense is recorded in general and administrative expense in the unaudited condensed consolidated statements
of operations.
ELITE PHARMACEUTICALS,
INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
(UNAUDITED)
The
table below show the future minimum rental payments, exclusive of taxes, insurance and other costs, under the 135 Ludlow Ave. modified
lease:
Years ending March 31,
|
|
Amount
|
|
2020 — Remaining
|
|
$
|
55,986
|
|
2021
|
|
|
225,063
|
|
2022
|
|
|
171,315
|
|
Total future minimum lease payments
|
|
|
452,634
|
|
Less: interest
|
|
|
(27,214
|
)
|
Present value of lease payments
|
|
$
|
425,150
|
|
The weighted-average
remaining lease term and the weighted-average discount rate of our lease was as follows:
Lease Term and Discount Rate
|
|
December 31,
2019
|
|
Remaining lease term (years)
|
|
|
|
Operating leases
|
|
|
2.0
|
|
|
|
|
|
|
Discount rate
|
|
|
|
|
Operating leases
|
|
|
6
|
%
|
The Company has an
obligation for the restoration of its leased facility and the removal or dismantlement of certain property and equipment as a result
of its business operation in accordance with ASC 410, Asset Retirement and Environmental Obligations – Asset Retirement
Obligations. The Company records the fair value of the asset retirement obligation in the period in which it is incurred. The
Company increases, annually, the liability related to this obligation. The liability is accreted to its present value each period
and the capitalized cost is depreciated over the useful life of the related asset. Upon settlement of the liability, the Company
records either a gain or loss. As of December 31, 2019, and March 31, 2019, the Company had a liability of $34,916 and $33,383,
respectively, and recorded as a component of other long-term liabilities.
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 (“Series J COD”). A total of 50 shares of Series J Preferred were authorized, 24.0344 shares are issued
and outstanding, with a stated value of $1,000,000 per share and a par value of $0.01 as of December 31, 2019.
The shares were issued
pursuant to an Exchange Agreement with Nasrat Hakim, (“Hakim”) a related party and the Company’s President, CEO
and Chairman of the Board of Directors. Pursuant to the Exchange Agreement the Company exchanged 158,017,321 shares of Common Stock
for 24.0344 shares of Series J Preferred and warrants to purchase 79,008,661 shares of common stock at $0.1521 per share. The aggregate
stated value of the Series J Preferred issued was equal to the aggregate value of the shares of common stock exchanged, with such
value of each share of Common Stock exchanged being equal to the closing price of the Common Stock on April 27, 2017. In connection
with the Exchange Agreement, the Company also issued warrants to purchase 79,008,661 shares of common stock at $0.1521 per share,
and such warrants were classified as liabilities on the accompanying unaudited condensed consolidated balance sheet as of December
31, 2019 (See Note 11).
Each Series J Preferred
is convertible at the option of the holder into shares of common stock, that is the earlier of (i) the date that shareholder approval
is obtained, and the requisite corporate action has been effected regarding a Fundamental Transaction (as defined in the Series
J COD); or (ii) not less than three years subsequent to the Original Issue Date (the date of the first issuance of any shares of
the Series J Preferred Stock) (the “Conversion Date”). The number of common shares is calculated by dividing the Stated
Value of such share of Series J Preferred by the Conversion Price. The conversion price for the Series J Preferred shall equal
$0.1521, subject to adjustment as discussed below.
Based on the current
conversion price, the Series J Preferred is convertible into 158,017,321 shares of common stock. The conversion price is subject
to the following adjustments: (i) stock dividends and splits, (ii) sale or grant of shares below the conversion price, (iii) pro
rata distributions; or (iv) fundamental changes (merger, consolidation, or sale of all or substantially all assets).
ELITE PHARMACEUTICALS,
INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
(UNAUDITED)
If upon any Conversion
Date there is not a sufficient number of authorized shares of Common Stock (that are not issued, outstanding or reserved for issuance)
available to effect the entire conversion of the then outstanding shares of Series J Preferred Stock and the then outstanding common
stock purchase warrants issued in conjunction therewith (an “Authorized Share Deficiency”), such conversion shall not
exceed the Issuable Maximum (as defined in the Series J COD); however, the Company shall use its best efforts to obtain shareholder
approval within two (2) years of the date of first issuance of Series J Preferred Stock to permit the balance of the conversion.
If shareholder approval is not obtained due to an insufficient number of shareholder votes for passage, the Company shall continue
to solicit for shareholder approval annually thereafter. As of March 31, 2019, the Company does not have a sufficient number of
unreserved authorized shares to effect the entire conversion, notwithstanding that the earliest possible Conversion Date is April
28, 2020.
Solely during any period
of time during which an Authorized Share Deficiency exists commencing on or after the fourth anniversary of the Original Issue
Date (“Dividend Commencement Date” and collectively the “Dividend Entitlement Period”), holders of Series
J Preferred shall be entitled to receive, and the Company shall pay, dividends at the rate per share (as a percentage of the Stated
Value per share) of 20% per annum, payable quarterly, in arrears, on January 1, April 1, July 1 and October 1, in cash or duly
authorized, validly issued, fully paid and non-assessable shares of Series J Preferred, or a combination thereof (the amount to
be paid in shares of Series J Preferred, the “Dividend Share Amount”). The form of dividend payments to each holder
shall be made, at the option of the Holders, (i) in cash, to the extent that funds are legally available for the payment of dividends
in cash, (ii) in shares of Series J Preferred Stock, or (iii) a combination thereof. The Series J Preferred shall rank senior to
the common stock with respect to payment of dividends and pari passu to the common stock with respect to liquidation, dissolution
or winding up of the Company.
The holders of the
Series J Preferred shall have voting rights on any matter presented to the shareholders of the Company for their action or consideration
at any meeting of shareholders of the Company (or by written consent of shareholders in lieu of meeting). Each holder shall be
entitled to cast the number of votes equal to the number of whole shares of common stock into which the shares of Series J Preferred
held by the holder are convertible as of the record date for determining the shareholders entitled to vote on such matter regardless
of whether an Authorized Share Deficiency Exists.
The Company has determined
that the Series J Preferred host instrument was more akin to equity than debt and that the above identified conversion feature,
subject to adjustments, was clearly and closely related to the host instrument, and accordingly bifurcation and classification
of the conversion feature as a derivative liability was not required. The Company has accounted for the Series J Preferred as contingently
redeemable preferred stock for which redemption is not probable. Accordingly, the Series J Preferred is presented in mezzanine
equity based on their initial measurement amount (fair value), as required by ASC 480-10-S99, Distinguishing Liabilities from Equity
– SEC Materials. No subsequent adjustment of the initial measurement amounts for these contingently redeemable Series J Preferred
is necessary unless the redemption of the Series J Preferred becomes probable. Accordingly, the amount presented as temporary equity
for the contingently redeemable Series J Preferred outstanding is its issuance-date fair value. The Series J Preferred was initially
measured at its fair value, $13,903,960 at April 28, 2017.
The fair value of the
Series J Preferred issued by the Company pursuant to the exchange agreement was calculated using a Monte Carlo Simulation because
of the probability assumptions associated with the shareholder approval provisions; the following are the Monte Carlo inputs:
|
|
April 28, 2017
|
|
Fair value of the Company’s common stock
|
|
$
|
0.1521
|
|
Initial exercise price
|
|
$
|
0.1521
|
|
Number of Series J Preferred issued
|
|
|
24.0344
|
|
Fully diluted shares outstanding as of measurement date
|
|
|
923,392,780
|
|
Risk-free rate
|
|
|
2.30
|
%
|
Volatility
|
|
|
90.00
|
%
|
Shareholder approval threshold
|
|
$
|
0.1521
|
|
Probability of approval is ending stock price is greater than threshold - midpoint
|
|
|
82.50
|
%
|
Probability of approval is ending stock price is greater than threshold - midpoint
|
|
|
17.50
|
%
|
Trials
|
|
|
200,000
|
|
Authorized, issued
and outstanding shares, along with carrying value as of March 31, 2019 are as follows:
Shares authorized
|
|
|
50
|
|
Shares outstanding
|
|
|
24.0344
|
|
Par value
|
|
$
|
0.01
|
|
Stated value
|
|
$
|
1,000,000
|
|
Conversion price
|
|
$
|
0.1521
|
|
Common shares to be issued upon redemption
|
|
|
158,017,321
|
|
Carrying value of Series J convertible preferred stock
|
|
$
|
13,903,960
|
|
ELITE PHARMACEUTICALS,
INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
(UNAUDITED)
Increase in Authorized Shares
An amendment
to the Company’s Articles of Incorporation to increase the number of shares of common stock the Company is authorized to
issue from 995,000,000 shares to 1,445,000,000 shares was approved at the Company’s Annual Meeting of Shareholders held on
December 4, 2019. Prior to the approval of the increase in the number of authorized shares, there were insufficient authorized
shares if the Series J Preferred Stock were converted. As a result, the shares were classified in mezzanine equity. After the approval
of the increase in the number of authorized shares, there are now sufficient authorized shares if the Series J Preferred Stock
were converted. With the approval of the increase in the number of authorized shares, there is no longer the presumption that a
cash settlement will be required. Therefore, the Series J Preferred has been reclassified from mezzanine equity to permanent equity
at its current carrying amount of $13,903,960 on the accompanying condensed consolidated balance sheet.
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 seven years, to Nasrat Hakim, pursuant to the Exchange Agreement detailed below.
A summary of warrant
activity is as follows:
|
|
December 31 2019
|
|
|
March 31, 2019
|
|
|
|
Warrant Shares
|
|
|
Weighted Avg. Exercise Price
|
|
|
Warrant Shares
|
|
|
Weighted Avg. Exercise Price
|
|
Balance at beginning of period
|
|
|
79,008,661
|
|
|
$
|
0.1521
|
|
|
|
79,008,661
|
|
|
$
|
0.1521
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants granted pursuant to the issuance of Series J convertible preferred shares
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants exercised, forfeited and/or expired, net
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at end of period
|
|
|
79,008,661
|
|
|
$
|
0.1521
|
|
|
|
79,008,661
|
|
|
$
|
0.1521
|
|
On April 28, 2017,
the Company entered into an exchange agreement (the “Exchange Agreement”) with Nasrat Hakim, the Chairman of
the Board, President, and Chief Executive Officer of the Company, pursuant to which the Company issued to Mr. Hakim 23.0344 shares
of its newly designated Series J Convertible Preferred Stock (“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 Mr. Hakim, the “Securities”) in exchange for 158,017,321 shares of Common Stock owned by Mr. 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 on the earlier of (i) the date that Shareholder
Approval is obtained, and the requisite corporate action has been effected; or (ii) 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 Series J
Warrants are not exercisable during any period when an Authorized Share Deficiency exists and will expire on the expiry date, without
regards to the existence of an Authorized Shares Deficiency (see Note 10). As of March 31, 2019, the Company does not have a sufficient
number of unreserved authorized shares to effect the entire conversion of the Series J Preferred, therefore the Series J Warrants
are not currently exercisable. Please also see Note 10.
ELITE PHARMACEUTICALS,
INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
(UNAUDITED)
The fair value of the
warrants issued by the Company pursuant to the issuance of Series J convertible preferred shares (79,008,661 warrant shares) was
calculated using a Monte Carlo Simulation because of the probability assumptions associated with the Shareholder Approval provisions.
The following are the key assumptions used in the Monte Carlo Simulation:
|
|
March 31,
2019
|
|
Fair value of the Company’s common stock
|
|
$
|
0.9900
|
|
Initial exercise price
|
|
$
|
0.1521
|
|
Number of common warrants
|
|
|
79,008,661
|
|
Fully diluted shares outstanding as of measurement date
|
|
|
824,946,559
|
|
Warrant term (in years)
|
|
|
8.08
|
|
Risk-free rate
|
|
|
2.35
|
%
|
Volatility
|
|
|
90.00
|
%
|
Shareholder approval threshold
|
|
$
|
0.1580
|
|
Probability of approval is ending stock price is greater than threshold - midpoint
|
|
|
82.50
|
%
|
Probability of approval is ending stock price is greater than threshold - midpoint
|
|
|
17.50
|
%
|
Trials
|
|
|
100,000
|
|
Fair value of derivative financial instruments - warrants
|
|
$
|
2,487,830
|
|
The fair value of
the warrants issued by the Company pursuant to the issuance of Series J convertible preferred shares (79,008,661 warrant shares)
was calculated using a Black-Scholes model instead of a Monte 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 warrants issued by the Company pursuant to the issuance of Series J convertible preferred shares (79,008,661 warrant shares):
|
|
December 31,
2019
|
|
Fair value of the Company’s common stock
|
|
$
|
0.0925
|
|
Volatility
|
|
|
83.89
|
%
|
Initial exercise price
|
|
$
|
0.1521
|
|
Warrant term (in years)
|
|
|
7.3
|
|
Risk free rate
|
|
|
1.83
|
%
|
The changes in warrants
(Level 3 financial instruments) measured at fair value on a recurring basis for the nine months ended December 31, 2019 were as
follows:
Outstanding at March 31, 2019
|
|
$
|
2,487,830
|
|
Change in fair value of derivative financial instruments - warrants
|
|
|
2,590,695
|
|
Balance at December 31, 2019
|
|
$
|
5,078,525
|
|
NOTE 12. SHAREHOLDERS’ EQUITY
Lincoln Park Capital – April
10, 2014 Purchase Agreement
In April 2014, the
Company entered into a Purchase Agreement (the “Lincoln Park Purchase Agreement” and/or “Purchase Agreement”)
and a Registration Rights Agreement (the “Registration Rights Agreement”) with Lincoln Park Capital Fund, LLC
(“Lincoln Park”). Pursuant to the terms of the Purchase Agreement, Lincoln Park agreed to purchase from the
Company up to $40 million of common stock (subject to certain limitations) from time to time over a 36-month period that ended
June 1, 2017. Pursuant to the terms of the Registration Rights Agreement, the Company filed with the SEC registration statements
to register for resale under the Securities Act the shares that have been or may be issued to Lincoln Park under the Purchase Agreement.
Upon execution of the
Purchase Agreement, the Company issued 1,928,641 shares of common stock to Lincoln Park pursuant to the Purchase Agreement as consideration
for its commitment to purchase additional shares of common stock under that agreement and the Company was obligated to issue up
to an additional 1,928,641 commitment shares to Lincoln Park pro rata as up to $40.0 million of common stock purchased by Lincoln
Park.
ELITE PHARMACEUTICALS,
INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
(UNAUDITED)
The Purchase Agreement
expired on June 1, 2017. During the term of the Purchase Agreement, the Company sold an aggregate of 110.6 million shares to Lincoln
Park, for aggregate gross proceeds of approximately $27.0 million. In addition, the Company issued an aggregate of 3.2 million
commitment shares.
Lincoln Park Capital – May
1, 2017 Purchase Agreement
On May 1, 2017, the
Company entered into a purchase agreement (the “2017 LPC Purchase Agreement”), together with a registration
rights agreement (the “2017 LPC Registration Rights Agreement”), with Lincoln Park.
Under the terms and
subject to the conditions of the 2017 LPC Purchase Agreement, the Company has the right to sell to and Lincoln Park is obligated
to purchase up to $40 million in shares of common stock, subject to certain limitations, from time to time, over the 36-month period
commencing on June 5, 2017. The Company may direct Lincoln Park, at its sole discretion and subject to certain conditions, to purchase
up to 500,000 shares of common stock on any business day, provided that at least one business day has passed since the most recent
purchase, increasing to up to 1,000,000 shares, depending upon the closing sale price of the common stock (such purchases, “
Regular Purchases “). However, in no event shall a Regular Purchase be more than $1,000,000. The purchase price of
shares of common stock related to the future funding will be based on the prevailing market prices of such shares at the time of
sales. In addition, the Company may direct Lincoln Park to purchase additional amounts as accelerated purchases under certain circumstances.
In the case of both Regular Purchases and accelerated purchases, the purchase price per share will be equitably adjusted for any
reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction occurring during
the business days used to compute the purchase price. Sales of shares of common stock to Lincoln Park under the 2017 LPC Purchase
Agreement are limited to no more than the number of shares that would result in the beneficial ownership by Lincoln Park and its
affiliates, at any single point in time, of more than 4.99% of the then outstanding shares of common stock.
In connection with
the 2017 LPC Purchase Agreement, the Company issued to Lincoln Park 5,540,551 shares of common stock and is required to issue up
to 5,540,551 additional shares of Common Stock pro rata as the Company requires Lincoln Park to purchase shares under the 2017
LPC Purchase Agreement over the term of the agreement. Lincoln Park has represented to the Company, among other things, that it
is an “accredited investor” (as such term is defined in Rule 501(a) of Regulation D under the Securities Act of 1933,
as amended (the “Securities Act”)). The Company sold the securities in reliance upon an exemption from registration
contained in Section 4(a)(2) under the Securities Act. The securities sold may not be offered or sold in the United States absent
registration or an applicable exemption from registration requirements.
The 2017 LPC Purchase
Agreement and the 2017 LPC Registration Rights Agreement contain customary representations, warranties, agreements and conditions
to completing future sale transactions, indemnification rights and obligations of the parties. The Company has the right to terminate
the 2017 LPC Purchase Agreement at any time, at no cost or penalty. Actual sales of shares of common stock to Lincoln Park under
the 2017 LPC Purchase Agreement will depend on a variety of factors to be determined by us from time to time, including, among
others, market conditions, the trading price of the Common Stock and determinations by us as to the appropriate sources of funding
for us and our operations. There are no trading volume requirements or, other than the limitation on beneficial ownership discussed
above, restrictions under the 2017 LPC Purchase Agreement. Lincoln Park has no right to require any sales by the Company but is
obligated to make purchases from the Company as directed in accordance with the 2017 LPC Purchase Agreement. Lincoln Park has covenanted
not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of the Company’s shares.
The net proceeds received
by the Company under the 2017 LPC Purchase Agreement will depend on the frequency and prices at which the Company sells shares
of common stock to Lincoln Park. A registration statement on Form S-3 was filed with the SEC on May 10, 2017 and was declared
effective on June 5, 2017.
During the nine months
ended December 31, 2019, a total of 8,895,233 shares were sold to Lincoln Park pursuant to the 2017 LPC Agreement for net proceeds
totaling $806,987. In addition, 111,778 shares were issued to Lincoln Park as additional commitment shares, pursuant to the 2017
LPC Agreement. During the nine months ended December 31, 2018, a total of 17,642,083 shares were sold to Lincoln Park pursuant
to the 2017 LPC Agreement for net proceeds totaling $1,669,829. In addition, 231,295 shares were issued to Lincoln Park as additional
commitment shares, pursuant to the 2017 LPC Agreement.
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.
ELITE PHARMACEUTICALS,
INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
(UNAUDITED)
Stock-based Director Compensation
The Company’s
Director compensation policy was 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, 2019, the Company did not issue any shares of common stock to its Directors in payment of director’s fees.
During the nine months
ended December 31, 2019, the Company accrued director’s fees totaling 67,500, which will be paid via cash payments totaling
$22,500 and the issuance of 585,417 shares of Common Stock.
As of December 31,
2019, the Company owed its Directors a total of $60,000 in cash payments and 1,379,033 shares of Common Stock in payment of director
fees totaling $180,000 due and owing. The Company anticipates that these shares of Common Stock will be issued prior to the end
of the current fiscal year.
Stock-based Employee/Consultant Compensation
Employment contracts
with the Company’s President and Chief Executive Officer, Chief Financial 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 nine months
ended December 31, 2019, the Company did not issue any shares pursuant to employment contracts with the Company’s President
and Chief Executive Officer, Chief Financial Officer or certain other employees. During the nine months ended December 31, 2019,
the Company did not issue any shares pursuant to the engagement contracts with certain consultants.
As of December 31,
2019, the Company accrued salaries totaling $603,750 owed to the Company’s President and Chief Executive Officer, Chief Financial
Officer and certain other employees which will be paid via the issuance of 7,854,334 shares of Common Stock.
As of December 31,
2019, the Company owed its President and Chief Executive Officer, Chief Financial Officer and certain other employees’ salaries
totaling $2,110,000 which will be paid via the issuance of 22,536,856 shares of Common Stock.
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.
|
|
|
|
|
|
|
|
Weighted Average
|
|
|
|
|
|
|
Shares
|
|
|
Weighted
Average
|
|
|
Remaining Contractual
|
|
|
Aggregate
|
|
|
|
Underlying Options
|
|
|
Exercise
Price
|
|
|
Term (in years)
|
|
|
Intrinsic
Value
|
|
Outstanding at April 1, 2019
|
|
|
6,158,000
|
|
|
$
|
0.15
|
|
|
|
5.0
|
|
|
$
|
87,330
|
|
Forfeited and expired
|
|
|
(283,000
|
)
|
|
$
|
0.15
|
|
|
|
7.8
|
|
|
$
|
-
|
|
Outstanding at December 31, 2019
|
|
|
5,875,000
|
|
|
$
|
0.14
|
|
|
|
4.0
|
|
|
$
|
-
|
|
Exercisable at December 31 2019
|
|
|
5,541,668
|
|
|
$
|
0.14
|
|
|
|
4.0
|
|
|
$
|
67,500
|
|
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 common stock as of December 31, 2019 and March 31, 2019 of $0.0925 and $0.10, respectively.
ELITE PHARMACEUTICALS,
INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
(UNAUDITED)
NOTE 14. CONCENTRATIONS AND CREDIT RISK
Revenues
Three customers accounted
for approximately 94% of the Company’s revenues for the nine months ended December 31, 2019. These three customers accounted
for approximately 57%, 24%, and 13% of revenues each. The same three customers accounted for approximately 69%, 12%, and 13% of
revenues each, respectively, for the three months ended December 31, 2019.
Three customers accounted
for substantially all the Company’s revenues for the nine months ended December 31, 2018. These three customers accounted
for approximately 63%, 17%, and 16% of revenues each, respectively. The same three customers accounted for approximately 58%, 21%,
and 7% of revenues each, respectively, for the three months ended December 31, 2018.
Accounts Receivable
Three customers accounted
for approximately 90% the Company’s accounts receivable as of December 31, 2019. These three customers accounted for approximately
60%, 22% and 8% of accounts receivable each.
Four customers accounted
for substantially all the Company’s accounts receivable as of March 31, 2019. These four customers accounted for approximately
38%, 34%, 19%, and 4% of accounts receivable each.
Purchasing
Eight suppliers accounted
for more than 85% of the Company’s purchases of raw materials for the nine months ended December 31, 2019. Included in these
eight suppliers were three suppliers that accounted for approximately 34%, 25%, and 11% of purchases each.
Seven suppliers accounted
for more than 75% of the Company’s purchases of raw materials for the nine months ended December 31, 2018. Included in these
seven suppliers are two suppliers that accounted for approximately 40%, 16%, and 15% of purchases each.
NOTE 15. SEGMENT RESULTS
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:
|
|
For the Three Months Ended
December 31,
|
|
|
For the Nine Months Ended December 31,
|
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
Operating Income (Loss) by Segment
|
|
|
|
|
|
|
|
|
|
|
|
|
ANDA
|
|
$
|
2,431,906
|
|
|
$
|
(582,822
|
)
|
|
$
|
2,538,560
|
|
|
$
|
(1,129,324
|
)
|
NDA
|
|
|
135,500
|
|
|
|
(744,393
|
)
|
|
|
407,245
|
|
|
|
(1,250,420
|
)
|
|
|
$
|
2,567,406
|
|
|
$
|
(1,327,215
|
)
|
|
$
|
2,945,805
|
|
|
$
|
(2,379,744
|
)
|
ELITE PHARMACEUTICALS,
INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
(UNAUDITED)
The table below reconciles
the Company’s operating loss by segment to loss from operations before provision for income taxes as reported in the Company’s
unaudited condensed consolidated statements of operations.
|
|
For the Three Months Ended
December 31,
|
|
|
For the Nine Months Ended
December 31,
|
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
Operating income (loss) by segment
|
|
$
|
2,567,406
|
|
|
$
|
(1,327,215
|
)
|
|
$
|
2,945,805
|
|
|
$
|
(2,379,744
|
)
|
Corporate unallocated costs
|
|
|
(739,790
|
)
|
|
|
(667,002
|
)
|
|
|
(1,740,579
|
)
|
|
|
(3,111,346
|
)
|
Interest income
|
|
|
2,334
|
|
|
|
1,733
|
|
|
|
10,667
|
|
|
|
4,570
|
|
Interest expense
|
|
|
(94,515
|
)
|
|
|
(89,897
|
)
|
|
|
(283,649
|
)
|
|
|
(279,037
|
)
|
Depreciation and amortization expense
|
|
|
(323,368
|
)
|
|
|
(321,164
|
)
|
|
|
(986,001
|
)
|
|
|
(891,390
|
)
|
Non-cash items
|
|
|
(213,052
|
)
|
|
|
(321,749
|
)
|
|
|
(532,267
|
)
|
|
|
(766,016
|
)
|
Change in fair value of
derivative instruments – warrants
|
|
|
(3,059,695
|
)
|
|
|
380,976
|
|
|
|
(2,590,695
|
)
|
|
|
807,347
|
|
Loss from operations
|
|
$
|
(1,860,680
|
)
|
|
$
|
(2,344,318
|
)
|
|
$
|
(3,176,719
|
)
|
|
$
|
(6,615,616
|
)
|
NOTE 16. COLLABORATIVE AGREEMENT WITH
EPIC PHARMA LLC
On June 4, 2015, the
Company entered into the 2015 Epic License Agreement, which provides for the exclusive right to market, sell and distribute, by
Epic Pharma LLC (“Epic”) of SequestOx™, an abuse deterrent opioid which employs the Company’s proprietary
pharmacological abuse-deterrent technology. Epic will be responsible for payment of product development and pharmacovigilance costs,
sales, and marketing of SequestOx™, and Elite will be responsible for the manufacture of the product. Under the 2015 Epic
License Agreement, Epic will pay Elite non-refundable payments totaling $15 million, with such amount representing the cost of
an exclusive license to ELI-200, the cost of developing the product and certain filings and a royalty based on an amount equal
to 50% of profits derived from net product sales as defined in the 2015 Epic License Agreement. The initial term of the exclusive
right to product development sales and distribution is five years (“Epic Exclusivity Period”); the license is renewable
upon mutual agreement at the end of the initial term.
In June 2015, Elite
received non-refundable payments totaling $5.0 million from Epic for the exclusive right to product development sales and distribution
of SequestOx™ pursuant to the Epic Collaborative Agreement, under which it agreed to not permit marketing or selling of SequestOx™
within the United States of America to any other party. Such exclusive rights are considered a significant deliverable element
of the Epic Collaborative Agreement pursuant to ASC 605-25, Revenue Recognition – Multiple Element Arrangements. These
nonrefundable payments represent consideration for certain exclusive rights to ELI-200 and will be recognized ratably over the
Epic Exclusivity Period.
In addition, in January
2016, a New Drug Application for SequestOx™ was filed, thereby earning the Company a non-refundable $2.5 million milestone,
pursuant to the 2015 Epic License Agreement. The filing of this NDA represents a significant deliverable element as defined within
the Epic Collaborative pursuant to ASC 605-25, Revenue Recognition – Multiple Element Arrangements. Accordingly, the
Company has recognized the $2.5 million milestone, which was paid by Epic and related to this deliverable as income during the
year ended March 31, 2016.
To date, the Company
received payments totaling $7.5 million pursuant to the 2015 Epic License Agreement, with all amounts being non-refundable. An
additional $7.5 million is due upon approval by the FDA of the NDA filed for SequestOx™, and license fees based on commercial
sales of SequestOx™. Revenues relating to these additional amounts due under the 2015 Epic License Agreement will be recognized
as the defined elements are completed and collectability is reasonably assured.
Please note that on
July 15, 2016, the FDA issued a Complete Response Letter, or CRL, regarding the NDA. The CRL stated that the review cycle for the
SequestOx™ NDA is complete and the application is not ready for approval in its present form.
On July 7, 2017, the
Company reported topline results from a pivotal bioequivalence fed study for or SequestOx™. The mean Tmax (the amount of
time that a drug is present at the maximum concentration in serum) of SequestOx™ was 4.6 hr. with a range of 0.5 hr. to 12
hr. and the mean Tmax of the comparator, Roxicodone®, was 3.4 hr. with a range of 0.5 hr. to 12 hr. A key objective for the
study was to determine if the reformulated SequestOx™ had a similar Tmax to the comparator when taken with a high fat meal.
Based on these results, the Company paused clinical trials for this formulation of SequestOx™. On January 30, 2018, the Company
reported positive topline results from a pilot study conducted for a modified SequestOx™ wherein, based on the results of
this pilot study, the modified SequestOx™ formulation is expected to achieve bioequivalence with a Tmax range equivalent
to the reference product when conducted in a pivotal trial under fed conditions. The Company has provided the pilot data to the
FDA, requesting clarification as to the requirements for resubmission of the NDA. The FDA has provided guidance for repeated bio-equivalence
studies in order to bridge the new formulation to the original SequestOx™ studies and also extended our filing fee waiver
until July 2020. Due to the prohibitive cost of such repeated bio-equivalence studies, the Company has paused development of this
product.
ELITE PHARMACEUTICALS,
INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
(UNAUDITED)
The 2015 Epic License
Agreement expires on June 4, 2020, and Epic has previously advised the Company of their desire to extend this agreement. While
discussions are ongoing, they are directly correlated to the regulatory status of SequestOx™. Furthermore, there can be no
assurances that the parties will reach mutual agreement to extend the term of this agreement and no assurances that the terms and
conditions of the agreement will be similar in all material aspects in the event that the agreement is extended by mutual consent
of the parties. Non-receipt by the Company of the remaining $7.5 million milestone will have a material adverse effect on the Company’s
financial condition.
NOTE 17. COLLABORATIVE AGREEMENT WITH
SUNGEN PHARMA LLC
On August 24, 2016,
the Company entered into the SunGen Agreement. The SunGen Agreement provides that Elite and SunGen Pharma LLC will engage in the
research, development, sales, and marketing of four generic pharmaceutical products. Two of the products are classified as CNS
stimulants (the “CNS Products”) and two of the products are classified as beta blockers (the “Beta Blocker Products”).
Under the terms of
the SunGen Agreement, Elite and SunGen will share in the responsibilities and costs in the development of these products and will
share in the profits from sales of the Products. Upon approval, the know-how and intellectual property rights to the products will
be owned jointly by Elite and SunGen. SunGen shall have the exclusive right to market and sell the Beta Blocker Products using
SunGen’s label and Elite shall have the exclusive right to market and sell the CNS Products using Elite’s label. Elite
will manufacture and package all four products on a cost-plus basis.
On December 1, 2016
and July 24, 2017, Elite Labs and SunGen executed an amendment to the parties’ 2016 Development and License Agreement (the
“Amended Agreement”), to undertake and engage in the research, development, sales and marketing of four additional
generic pharmaceutical products bringing the total number of products under the amended agreement to eight. The product classes
for the additional four products include antidepressants, antibiotics, and antispasmodics.
Under the terms of
the Amended Agreement, Elite and SunGen will share in the responsibilities and costs in the development of these products and will
share substantially in the profits from sales of the products. Upon approval, the know-how and intellectual property rights to
the products will be owned jointly by Elite and SunGen. Three products will be owned jointly by Elite and SunGen; three shall be
owned by SunGen while Elite shall have the marketing rights once the products are approved by the FDA; and two shall be owned by
Elite while SunGen shall have the marketing rights once the products are approved by the FDA. Elite will manufacture and package
all eight products on a cost-plus basis.
On December 10, 2018,
the Company received approval from the FDA for an ANDA filed for a generic version of Adderall®, an immediate-release mixed
salt of a single entity amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine
Sulfate), with strengths of 5mg, 7.5mg. 10mg, 12.5mg, 15mg, 20mg, and 30mg tablets. The product is indicated for the treatment
of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. This approval represents the first FDA approval received for
a product co-developed with SunGen under the SunGen Agreement. The first commercial shipment of this product occurred in April
2019. The product is currently marketed by Lannett Company Inc. (“Lannett”) under license granted pursuant a strategic
marketing alliance dated March 6, 2019 (the “Lannett Alliance”).
On May 24, 2018, the
Company filed an ANDA with the FDA for a generic version of an extended release CNS stimulant. The ANDA represents the second filing
for a product co-developed with SunGen under the SunGen Agreement. This product will also be marketed by Lannett pursuant to the
Lannett Alliance.
On January 3, 2019,
the Company filed an ANDA with the FDA for a generic version of an antibiotic product. The ANDA represents the third filing for
a product co-developed with SunGen under the SunGen Agreement.
There can be no assurances
that any of these products, even those for which ANDAs have been filed, will receive marketing authorization and achieve commercialization
within a reasonable time period, or at all. In addition, even if marketing authorization is received, including the product for
which such marketing authorization has already been received, there can be no assurances that there will be future revenues of
profits, or that any such future revenues or profits would be in amounts that provide adequate return on the significant investments
made to secure these marketing authorizations.
ELITE PHARMACEUTICALS,
INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
(UNAUDITED)
NOTE 18. RELATED PARTY TRANSACTION AGREEMENTS WITH EPIC PHARMA
LLC
The Company has entered
into two agreements with Epic which constitute agreements with a related party due to the management of Epic including a member
on our Board of Directors at the time such agreements were executed.
On June 4, 2015, the
Company entered into the 2015 Epic License Agreement (please see Note 16 above). The 2015 Epic License Agreement includes milestone
payments totaling $10 million upon the filing with and approval of an NDA with the FDA. The Company has determined these milestones
to be substantive, with such assessment being made at the inception of the 2015 Epic License Agreement, and based on the following:
|
●
|
The Company’s performance is required to achieve each milestone; and
|
|
|
|
|
●
|
The milestones will relate to past performance, when achieved; and
|
|
|
|
|
●
|
The milestones are reasonable relative to all of the deliverables and payment terms within the 2015 Epic License Agreement
|
After marketing authorization
is received from the FDA, Elite will receive a license fee which is based on profits achieved from the commercial sales of ELI-200.
On January 14, 2016, the Company filed an NDA with the FDA for SequestOx™, thereby earning a $2.5 million milestone pursuant
to the 2015 Epic License Agreement. The Company has received payment of this amount from Epic. An additional $7.5 million is due
upon approval by the FDA of the NDA filed for SequestOx™. Please note that on July 15, 2016, the FDA issued a Complete Response
Letter, or CRL, regarding the NDA. The CRL stated that the review cycle for the SequestOx™ NDA is complete and the application
is not ready for approval in its present form. On December 21, 2016, the Company met with the FDA for an end-of-review meeting
to discuss steps that it could take to obtain approval of SequestOx™. Based on this and the meeting minutes received from
the FDA on January 23, 2017, the Company formulated a plan to address the issues cited by the FDA in the CRL, with such plan including,
without limitation, modifying the SequestOx™ formulation, conducting bioequivalence and bioavailability fed and fasted studies,
comparing the modified formulation to the original formulation. On July 7, 2017, the Company reported topline results from a pivotal
bioequivalence fed study for SequestOx™. This study resulted in a mean Tmax of 4.6 hours, with a range of 0.5 hour to 12
hours and a mean Tmax of the comparator, Roxicodone® of 3.4 hours with a range of 0.5 hour to 12 hours. A key objective
of this study was to determine if the reformulated SequestOx™ had a similar Tmax to the comparator when taken with a high
fat meal. Based on these results, the Company will pause, not proceed, with the rest of the clinical trials, and seek clarity from
the FDA before deciding on the next steps for immediate release SequestOx™. There can be no assurances of the success of
any future clinical trials, or if such trials are successful, there can be no assurances that an intended future resubmission of
the NDA product filing, if made, will be accepted by or receive marketing approval from the FDA, and accordingly, there can be
no assurances that the Company will earn and receive the additional $7.5 million or future license fees. If the Company does not
receive these payments or fees, it will materially and adversely affect our financial condition. In addition, even if marketing
authorization is received, there can be no assurances that there will be future revenues of profits, or that any such future revenues
or profits would be in amounts that provide adequate return on the significant investments made to secure this marketing authorization.
On October 2, 2013,
Elite executed the Epic Pharma Manufacturing and License Agreement (the “Epic Generic Agreement”). The Epic Generic
Agreement, which expired on October 2, 2018 granted rights to Epic to manufacture twelve generic products whose ANDA’s are
owned by Elite, and to market, in the United States and Puerto Rico, six of these products on an exclusive basis, and the remaining
six products on a non-exclusive basis. These products were to be manufactured at Epic, with Epic being responsible for the manufacturing
site transfer supplements that are a prerequisite to each product being approved for commercial sale. In addition, Epic was to
be responsible for all regulatory and pharmacovigilance matters, as well as all marketing and distribution activities. Elite has
no further obligations or deliverables under the Epic Generic Agreement.
Pursuant to the Epic
Generic Agreement, Elite was to receive $1.8 million, payable in increments that require the commercialization of all six exclusive
products if the full amount is to be received, plus license fees equal to a percentage that is not less than 50% and not greater
than 60% of profits achieved from commercial sales of the products, as defined in the Epic Generic Agreement. The Epic Generic
Agreement expired on October 2, 2018 with Epic launching four of the six exclusive products and Elite collecting $1.0 million of
the total $1.8 million fee.
The 2015 Epic License
Agreement contains license fees that will be earned and payable to the Company, after the FDA has issued marketing authorization(s)
for the related product(s). License fees are based on commercial sales of the products achieved by Epic and calculated as a percentage
of net sales dollars realized from such commercial sales. Net sales dollars consist of gross invoiced sales less those costs and
deductions directly attributable to each invoiced sale, including, without limitation, cost of goods sold, cash discounts, Medicaid
rebates, state program rebates, price adjustments, returns, short date adjustments, charge backs, promotions, and marketing costs.
The rate applied to the net sales dollars to determine license fees due to the Company is equal to an amount negotiated and agreed
to by the parties to each agreement, with the following significant factors, inputs, assumptions, and methods, without limitation,
being considered by either or both parties:
|
●
|
Assessment of the opportunity for each product in the market, including consideration of the following, without limitation: market size, number of competitors, the current and estimated future regulatory, legislative, and social environment for abuse deterrent opioids and the other generic products to which the underlying contracts are relevant;
|
ELITE PHARMACEUTICALS,
INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
(UNAUDITED)
|
●
|
Assessment of various avenues for monetizing SequestOx™ and the twelve ANDA’s owned by the Company, including the various combinations of sites of manufacture and marketing options;
|
|
●
|
Elite’s resources and capabilities with regards to the concurrent development of abuse deterrent opioids and expansion of its generic business segment, including financial and operational resources required to achieve manufacturing site transfers for twelve approved ANDA’s;
|
|
●
|
Capabilities of each party with regards to various factors, including, one or more of the following: manufacturing, marketing, regulatory and financial resources, distribution capabilities, ownership structure, personnel, assessments of operational efficiencies and entity stability, company culture and image;
|
|
●
|
Stage of development of SequestOx™ and manufacturing site transfer and regulatory requirements relating to the commercialization of the generic products at the time of the discussions/negotiations, and an assessment of the risks, probability, and time frames for achieving marketing authorizations from the FDA for each product.
|
|
●
|
Assessment of consideration offered; and
|
|
●
|
Comparison of the above factors among the various entities with whom the Company was engaged in discussions relating to the commercialization of SequestOx™ and the manufacture/marketing of the twelve generics related to the Epic Generic Agreement.
|
This transaction is
not to be considered as an arms-length transaction.
Please also note that,
effective April 7, 2016, all Directors on the Company’s Board of Directors that were also owners/managers of Epic had resigned
as Directors of the Company and all current members of the Company’s Board of Directors have no relationship to Epic. Accordingly,
Epic no longer qualifies as a party that is related to the Company.
NOTE 19. MANUFACTURING, LICENSE AND
DEVELOPMENT AGREEMENTS
The Company has entered into the following
active agreements:
|
●
|
License agreement with Precision Dose, dated September 10, 2010 (the “Precision Dose License Agreement”);
|
|
●
|
Development and License Agreement with SunGen (the “SunGen Agreement”);
|
|
●
|
Strategic Marketing Alliance with Glenmark Pharmaceuticals, Inc. USA dated May 22, 2018 (the “Glenmark Alliance”).
|
|
●
|
Strategic Marketing Alliance with Lannett Company. Inc. dated March 6, 2019 (the “Lannett-SunGen Product Alliance”)
|
|
●
|
Strategic Marketing Alliance with Lannett Company. Inc. dated April 9, 2019 (the “Lannett-Elite Product Alliance”)
|
The Precision Dose
Agreement provides for the marketing and distribution, by Precision Dose and its wholly owned subsidiary, TAGI Pharma, of Phentermine
37.5mg tablets (launched in April 2011), Phentermine 15mg capsules (launched in April 2013), Phentermine 30mg capsules (launched
in April 2013), Hydromorphone 8mg tablets (launched in March 2012), Naltrexone 50mg tablets (launched in September 2013) and certain
additional products that require approval from the FDA which has not been received. Precision Dose will have the exclusive right
to market these products in the United States and Puerto Rico and a non-exclusive right to market the products in Canada. Pursuant
to the Precision Dose License Agreement, Elite received $200k at signing, and is receiving milestone payments and a license fee
which is based on profits achieved from the commercial sale of the products included in the agreement.
Revenue from the $200k
payment made upon signing of the Precision Dose Agreement is being recognized over the life of the Precision Dose Agreement.
ELITE PHARMACEUTICALS,
INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
(UNAUDITED)
The milestones, totaling
$500k (with $405k already received), consist of amounts due upon the first shipment of each identified product, as follows: Phentermine
37.5mg tablets ($145k), Phentermine 15 & 30mg capsules ($45k), Hydromorphone 8mg ($125k), Naltrexone 50mg ($95k) and the balance
of $95k due in relation to the first shipment of generic products which still require marketing authorizations from the FDA, and
to which there can be no assurances of such marketing authorizations being granted and accordingly there can be no assurances that
the Company will earn and receive these milestone amounts. These milestones have been determined to be substantive, with such determination
being made by the Company after assessments based on the following:
|
●
|
The Company’s performance is required to achieve each milestone; and
|
|
●
|
The milestones will relate to past performance, when achieved; and
|
|
●
|
The milestones are reasonable relative to all of the deliverables and payment terms within the Precision Dose License Agreement.
|
The license fees provided
for in the Precision Dose Agreement are calculated as a percentage of net sales dollars realized from commercial sales of the related
products. Net sales dollars consist of gross invoiced sales less those costs and deductions directly attributable to each invoiced
sale, including, without limitation, cost of goods sold, cash discounts, Medicaid rebates, state program rebates, price adjustments,
returns, short date adjustments, charge backs, promotions, and marketing costs. The rate applied to the net sales dollars to determine
license fees due to the Company is equal to an amount negotiated and agreed to by the parties to the Precision Dose License Agreement,
with the following significant factors, inputs, assumptions, and methods, without limitation, being considered by either or both
parties:
|
●
|
Assessment of the opportunity for each generic product in the market, including consideration of the following, without limitation: market size, number of competitors, the current and estimated future regulatory, legislative, and social environment for each generic product, and the maturity of the market;
|
|
●
|
Assessment of various avenues for monetizing the generic products, including the various combinations of sites of manufacture and marketing options;
|
|
●
|
Capabilities of each party with regards to various factors, including, one or more of the following: manufacturing resources, marketing resources, financial resources, distribution capabilities, ownership structure, personnel, assessment of operational efficiencies and stability, company culture and image;
|
|
●
|
Stage of development of each generic product, all of which did not have FDA approval at the time of the discussions/negotiations and an assessment of the risks, probability, and time frame for achieving marketing authorizations from the FDA for the products;
|
|
●
|
Assessment of consideration offered by Precision and other entities with whom discussions were conducted; and
|
|
|
|
|
●
|
Comparison of the above factors among the various entities with whom the Company was engaged in discussions relating to the commercialization of the generic products.
|
The SunGen Agreement
provides for the research, development, sales and marketing of eight generic pharmaceutical products. Two of the products are classified
as CNS stimulants (the “CNS Products”), two of the products are classified as beta blockers and the remaining four
products consist of antidepressants, antibiotics and antispasmodics. To date, the Company has filed ANDAs with the FDA for the
two CNS Products and one antibiotic identified in the SunGen Agreement. The Company received FDA approval of the ANDA filed for
the first CNS Product in December 2018 and achieved commercial launch in April 2019, with such product being marketed pursuant
to the Lannett Alliance.
Under the terms of
the SunGen Agreement, Elite and SunGen will share in the responsibilities and costs in the development of these products and will
share substantially in the profits from sales. Upon approval, the know-how and intellectual property rights to the products will
be owned jointly by Elite and SunGen. Three of the eight products will be jointly owned, three products will be owned by SunGen,
with Elite having exclusive marketing rights and the remaining two products will be owned by Elite, with SunGen having exclusive
marketing rights. Elite will manufacture and package all eight products on a cost-plus basis.
ELITE PHARMACEUTICALS,
INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
(UNAUDITED)
The Glenmark Alliance,
provides for the manufacture by Elite and marketing by Glenmark of identified generic products under license from Elite. In addition
to the purchase prices for the products, Elite will receive license fees well in excess of 50% of gross profits. Gross profit is
defined as net sales less the price paid to Elite for the products, distribution fees (less than 10%) and shipping costs. Glenmark
will have semi-exclusive marketing rights to the ANDA approved generic product, phendimetrazine 35mg tablets, and exclusive marketing
rights to generic Methadone HCl. Collectively, the brand products and their generic equivalents had total annual sales of approximately
$33.6 million in 2017, according to Quintiles IMS Health data. The Agreement has an initial term of three years and automatically
renews for one-year periods absent prior written notice of non-renewal. In addition to customary termination provisions, the Agreement
permits Glenmark to terminate with regard to a product on at least three months’ prior written notice if it determines to
stop marketing and selling such product, and it permits Elite to terminate with regard to a product if at any time after the first
twelvemonths from the first commercial sale, the average license fee paid by Glenmark for such product is less than $100,000 for
a six-month sales period.
Pursuant to Lannett-SunGen
Product Alliance with Lannett Company Inc. (“Lannett”), Lannett will be the exclusive U.S. marketer and distributor
for two generic products co-developed and co-owned by Elite and SunGen – Amphetamine IR Tablets and a second product which
is an extended release CNS stimulant that is currently under review by the FDA. Elite will manufacture and Lannett will purchase
the products from Elite and then sell and distribute them. In addition to the purchase prices for the products, Elite will receive
license fees in excess of 50% of net profits, which will be shared equally with SunGen, pursuant to the SunGen Agreement. The Lannett-SunGen
Product Alliance has an initial term of three years and automatically renews for one-year periods absent prior written notice of
non-renewal. In addition to customary termination provisions, the Agreement permits Lannett to terminate with regard to a product
on at least six months’ prior written notice, and it permits Elite or Lannett to terminate with regard to a product if at
any time after the first twelve months from the first commercial sale, the average license fee paid by Lannett for such product
is less than $300,000 for a six month sales period. In addition to manufacturing fees and license fees, Lannett will also pay a
milestone, of $750,000 upon commercial launch of the extended release CNS stimulant product that is currently under review by the
FDA. This milestone payment will be shared equally by Elite and SunGen, pursuant to the SunGen Agreement.
The first commercial
shipment of Amphetamine IR Tablets, a generic version of Adderall®, with strengths of 5mg, 7.5mg, 10mg, 12.5mg,
15mg, 20mg and 30mg, pursuant to the Lannett-SunGen Product Alliance occurred in April 2019.
Pursuant to the Lannett-Elite
Product Alliance, Lannett will be the exclusive U.S. marketer and distributor for Dantrolene Capsules. Elite will manufacture and
Lannett will purchase Dantrolene Capsules from Elite and then sell and distribute them. In addition to the purchase prices for
the products, Elite will receive license fees in excess of 50% of net profits. Net profits is defined as net sales less the price
paid to Elite for the products, distribution fees (less than 10%) and shipping costs. The Lannett-Elite Product Alliance has an
initial term of three years and automatically renews for one-year periods absent prior written notice of non-renewal. In addition
to customary termination provisions, the Agreement permits Lannett to terminate with regard to a product on at least six months’
prior written notice and it permits Elite or Lannett to terminate with regard to a product if at any time after the first twelve
months from the first commercial sale, the average license fee paid by Lannett for such product is less than $300,000 for a six
month sales period.
NOTE 20. RELATED PARTY AGREEMENTS WITH MIKAH PHARMA LLC
Pursuant to an asset
acquisition, on May 17, 2017, Elite Labs, executed an assignment agreement with Mikah, pursuant to which the Company acquired all
rights, interests, and obligations under a supply and distribution agreement (the “Reddy’s Distribution Agreement”)
with Dr. Reddy’s Laboratories, Inc. (“Dr. Reddy’s”) originally entered into by Mikah on May 7, 2017 and
relating to the supply, sale and distribution of generic Trimipramine Maleate Capsules 25mg, 50mg and 100mg (“Trimipramine”).
On May 22, 2017, the
Company executed an assignment agreement with Mikah, pursuant to which the Company acquired all rights, interests and obligations
under a manufacturing and supply agreement with Epic originally entered into by Mikah on June 30, 2015 and relating to the manufacture
and supply of Trimipramine (the “Epic Trimipramine Manufacturing Agreement”). Pursuant to this agreement, Epic manufactured
Trimipramine under license from Elite. In September 2018, Elite successfully transferred manufacturing of Trimipramine to the Northvale
Facility, resulting in the irrelevance of the Epic Trimipramine Manufacturing Agreement. Trimipramine is currently manufactured
by Elite.
Mikah is owned by Nasrat
Hakim, the CEO, President and Chairman of the Board of the Company.
The Reddy’s Distribution
Agreement was concluded by mutual consent in August 2018.
Trimipramine is one
of the products included in the Glenmark Strategic Alliance and is currently marketed and distributed by Glenmark.
On December 3, 2018,
the Company executed a development agreement with Mikah, pursuant to which Mikah and the Company will collaborate to develop and
commercialize generic products including formulation development, analytical method development, bioequivalence studies and manufacture
of development batches of generic products.
ELITE PHARMACEUTICALS,
INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
(UNAUDITED)
The Company received
a total of $480,000 from Mikah, $150,000 and $330,000 in January and September of 2019, respectively, as an advance payment for
the purchase of pharmaceutical materials relating to future product development conducted pursuant to this agreement. This amount
was recorded as a deposit and contained within the customer deposits financial statement line item on the condensed consolidated
balance sheet. As of the date of this report, the Company has purchased raw materials with an aggregate cost of $452,348 pursuant
to this agreement. As of December 31, 2019, the balance of the customer deposit from Mikah was $55,653 and was included in the
financial statement line of customer deposits on the accompanying condensed consolidated balance sheet.
NOTE 21. OTHER INCOME – PROCEEDS FROM SALE OF ANDAs
Sale of ANDAs
for Oxycodone Hydrochloride and Acetaminophen, USP CII (generic version of Percocet®)
Approved ANDAs for
a generic version of Percocet® (oxycodone hydrochloride and acetaminophen, USP CII) 5mg, 7.5mg and 10mg tablets
with 325mg of acetaminophen were sold to Nostrum Laboratories Inc. (“Nostrum”) for cash consideration totaling $300,000.
The three related approved ANDA’s were developed by Elite, with the costs of such development being charged to expense in
the periods incurred, in accordance with generally accepted accounting principles.
Sale of ANDAs
for Hydrocodone bitartrate and acetaminophen tablets USP CII (generic version of Norco)
Approved ANDAs for
a generic version of Norco® (hydrocodone bitartrate and acetaminophen tablets USP CII) 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg
and 10mg/325mg tablets were sold to Nostrum for cash consideration totaling $300,000.
The four related approved ANDA’s were developed by Elite, with the costs of such development being charged to expense in
the periods incurred, in accordance with generally accepted accounting principles.
NOTE 22. SUBSEQUENT EVENTS
The Company has evaluated
subsequent events from the condensed consolidated balance sheet date through February 10, 2020. The following are material subsequent
events:
Common Stock issued and sold pursuant
to the Lincoln Park Purchase Agreement
Subsequent to December
31, 2019 and up to February 4, 2020 (the latest practicable date), a total of 5,337,102 shares of Common Stock were issued to Lincoln
Park, with such shares consisting of 5,265,484 purchase shares and 71,618 additional commitment shares. Total proceeds from these
transactions was $517,037.
Sale of ANDA for Hydromorphone HCl
oral tablet – 8mg
On February 3, 2020,
Elite sold the ANDA for generic Hydromorphone HCl 8mg tablet to Nostrum for cash consideration totaling $300,000. The carrying
value for the asset related to the ANDA was $0.