Item 5. Market for Registrant’s Common Equity
ITEM 5. MARKET FOR COMPANY’S
COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
Market Information
Our Common Stock is quoted
on the Over-the-Counter Bulletin Board under the ticker symbol “ELTP”. The following table shows, for the periods indicated,
the high and low bid prices per share of our Common Stock as by OTC Bulletin Board. Over-the-counter market quotations reflect inter-dealer
prices, without retail mark-up, mark-down or commission and may not necessarily represent actual transactions.
Quarter Ended
High
Low
Fiscal Year Ending March 31, 2021
March 31, 2021
$ 0.09
$ 0.05
December 31, 2020
$ 0.09
$ 0.05
September 30, 2020
$ 0.09
$ 0.07
June 30, 2020
$ 0.10
$ 0.07
Fiscal Year Ending March 31, 2020
March 31, 2020
$ 0.11
$ 0.05
December 31, 2019
$ 0.11
$ 0.08
September 30, 2019
$ 0.14
$ 0.04
June 30, 2019
$ 0.10
$ 0.03
As of June 7, 2021, the last reported
sale price of our Common Stock, as reported by the OTCBB, was $0.60.
Holders
As of June 7, 2021, there
were, respectively, approximately 116 holders of record of our Common Stock.
Dividends
We have never paid cash dividends
on our Common Stock. We currently anticipate that we will retain all available funds for use in the operation and expansion of our business.
Recent Sales of Unregistered Securities
None.
48
Securities Authorized for Issuance under Equity Compensation Plans
The following table sets
forth certain information regarding Elite’s equity compensation plans as of March 31, 2021:
Plan Category
Number of
securities to be
issued upon
exercise of
outstanding
options,
warrants
and rights
(a)
Weighted-
average
exercise
price per share
of outstanding
options,
warrants and
rights
(b)
Number of securities
remaining available
for future issuance
under equity
compensation plans
(excluding securities
reflected in column
(a))
Equity compensation plans approved by security holders (1)
—
—
2,150,000
(1) Represents
securities reserved and available for grant under the 2014 Equity Incentive Plan
2014 Equity Incentive Plan
Our 2014 Equity Incentive
Plan (the “ 2014 Plan ”) was adopted by the Board on March 17, 2014, to attract, motivate and retain officers, employees,
consultants, and directors by issuing common stock-based incentives to directors, officers, employees, and consultants who are selected
for participation. By relating incentive compensation to increases in shareholder value, it is hoped that these individuals will both
continue in the long-term service of the Company and be motivated to experience a heightened interest and participate in the future success
of Company operations. An aggregate of 3,000,000 shares of Common Stock are reserved for grant and issuance pursuant to the 2014 Plan.
The 2014 Plan is administered and interpreted by our Compensation Committee (the “ Administrator ”). Awards under the
2014 Plan may be granted in any one or all of the following forms: (i) incentive stock options (“ISOs”) intended to qualify
under Section 422 of the Internal Revenue Code of 1986, as amended (the “Code”); (ii) non-qualified stock options (“NSOs”);
(iii) stock appreciation rights, which may be granted in tandem with options or on a stand-alone basis; (iv) shares of restricted stock;
(v) shares of unrestricted stock; (vi) performance shares, and (vii) performance units.
Options may not be granted
under the 2014 Plan at an exercise price of less than the fair market value of the common stock on the date of grant and the term of
options cannot exceed ten years. ISOs may only be granted to persons who are employees of the Company. The exercise price of an ISO granted
to a holder of more than 10% of the common stock must be at least 110% of the fair market value of the common stock on the date of grant,
and the term of these options cannot exceed five years.
The Administrator also may
grant stock appreciation rights. Stock appreciation rights represent the right to receive upon exercise an amount payable in cash or
common stock equal to (A) the number of shares with respect to which the stock appreciation right is being exercised multiplied by (B)
the excess of (i) the fair market value of a share of common stock on the date the award is exercised over (ii) the exercise price specified
in the award agreement.
Under the performance award
component of the 2014 Plan, participants may be granted an award denominated in shares of common stock or in dollars. Achievement of
the performance targets, or multiple performance targets established by the Administrator relating to corporate, group, unit or individual
performance based upon standards set by the Administrator shall entitle the participant to payment at the full amount or a portion of
the amount specified with respect to the award, at the discretion of the Administrator based on its evaluation of the performance of
the target goals applicable to such award. Payment may be made in cash, common stock or any combination thereof, as determined by the
Administrator, and shall be adjusted in the event the participant ceases to be an employee of the Company before the end of a performance
cycle by reason of death, disability, or retirement.
Under the stock component
of the 2014 Plan, the Administrator may, in selected cases, grant to a plan participant a given number of shares of restricted stock
or unrestricted stock. Restricted stock under the 2014 Plan is common stock restricted as to sale pending fulfilment of such vesting
schedule and employment requirements as the Administrator shall determine. Prior to the lifting of the restrictions, the participant
will nevertheless be entitled to receive distributions in liquidation and dividends on, and to vote the shares of, the restricted stock.
The 2014 Plan provides for forfeiture of restricted stock for breach of conditions of grant.
The 2014 Plan also permits
the board of directors (and not the Compensation Committee) to grant awards of NSOs, restricted stock or unrestricted stock to non-employee
directors. The board may authorize individual grants or adopt one or more formulas for grants of awards to the non-employee directors.
All options granted to non-employee directors must have an exercise price equal to the fair market value at the date of grant.
49
The exercise price of awards
may be paid in cash, in shares of common stock (valued at fair market value at the date of exercise), by delivery of a notice of exercise
together with irrevocable instructions to a broker to deliver to the Company the proceeds of the sale of common stock or of a loan from
the broker sufficient to pay the exercise price, by having the Company withhold from shares being exercised the number of shares having
a fair market value equal to the exercise price for all shares being exercised, or by a combination of the foregoing means of payment,
as may be determined by the Administrator.
Issuer Purchases of Equity Securities
None.
ITEM 6. SELECTED FINANCIAL
DATA
Not Applicable.
ITEM 7 MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION
Management’s Discussion
and Analysis of Financial Condition and Results of Operations, or MD&A, is intended to provide a reader of our consolidated financial
statements with a narrative from the perspective of our management on our financial condition, results of operations, liquidity and certain
other factors that may affect our future results. You should read the following discussion and analysis of our financial condition and
results of operations together with our financial statements and the related notes and other financial data included elsewhere in this
Annual Report. Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report, including
information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties.
You should review Item 1A of this Annual Report for a discussion of important factors that could cause actual results to differ materially
from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.
Results of Operations:
Years Ended March 31, 2021 and 2020
Revenue, Cost of revenue and Gross profit:
For the Years Ended
March 31,
Change
2021
2020
Dollars
Percentage
Manufacturing fees
$ 20,997,310
$ 14,526,048
$ 6,471,262
45 %
Licensing fees
4,383,439
3,468,591
914,848
26 %
Total revenue
25,380,749
17,994,639
7,386,110
41 %
Cost of manufacturing
13,513,611
10,015,855
3,497,756
35 %
Gross profit
$ 11,867,138
$ 7,978,784
$ 3,888,354
49 %
Gross profit - percentage
47 %
44 %
Total revenues for the year
ended March 31, 2021 increased by $7.4 million or 41%, to $25.4 million, as compared to $18.0 million for the prior year, primarily due
to revenues earned from Amphetamine ER Capsules, which were launched during the current fiscal year, increased revenues from Amphetamine
IR Tablets, as compared to the prior year, offset by decreases in license fee revenues resulting from the full amortization of SequestOx™
milestone revenues occurring in June 2020 and accordingly providing partial year contribution to revenues during the year ended March
31, 2021, while contributing a full year of revenues to the prior year.
50
Manufacturing fees increased
by $6.5 million, or 45%, primarily due to manufacturing revenues earned from Amphetamine ER Capsules, which were launched during the
current fiscal year, and increased sales of Amphetamine IR Tablets, as compared to the prior year.
Licensing fees increased by
$0.9 million, or 26%.This increase is primarily due to licensing fees earned from the sale of Amphetamine ER Capsules, which were launched
during the current fiscal year, and increased licensing revenues earned from the sale of Amphetamine IR Tablets and Isradipine Capsules,
as compared to the prior year.
Costs of revenue consists
of manufacturing and assembly costs. Our costs of revenue increased by $3.5 million or 35%, to $13.5 million as compared to $10.0 million
for the prior fiscal year. This increase was due in large part to increased manufacturing activities and related manufacturing revenues
during the year ended March 31, 2021, as compared to the prior year, and also due to there being a strong positive correlation of costs
of revenue to manufacturing revenues.
Our gross profit margin was
47% during the year ended March 31, 2021 as compared to 44% during the comparable prior fiscal year.
Operating expenses:
For the Years Ended
March 31,
Change
2021
2020
Dollars
Percentage
Operating expenses:
Research and development
$
5,112,542
$
5,532,462
$
(419,920
)
(8
)%
General and administrative
3,323,045
3,349,837
(26,792)
(1)
%
Non-cash compensation
13,181
62,098
(48,917
)
(79)
%
Depreciation and amortization
1,313,847
1,319,795
(5,948
)
0
%
Total operating expenses
$
9,762,615
$
10,264,192
$
(501,577
)
(5)
%
Operating expenses consist
of research and development costs, general and administrative, non-cash compensation and depreciation and amortization expenses. Operating
expenses for the year ended March 31,2021 decreased by $0.5 million or 5% to $9.8 million, as compared to $10.3 million for the prior
year.
Research and development
costs for the year ended March 31,2021 were $5.1 million, a decrease of $0.4 million, or 8%, from $5.5 million of such costs for the
prior year. The decrease was a result of the timing and nature of product development activities during the year ended March 31,2021
as compared to the prior year.
General and administrative
expenses for the year ended March 31,2021 were $3.32 million, a decrease of less than $0.1 million or 1%, from $3.35 million of such costs
for the prior year. The decrease was due in large part to savings achieved from ongoing cost reduction and control initiatives.
Non-cash compensation expense
for the years ended March 31, 2021 and 2020 was less than $0.1 million.
Depreciation and amortization
expenses for the year ended March 31, 2021 were $1.3 million, and remained consistent related to such costs for the prior year.
As a result of the foregoing,
our income from operations for the year ended March 31, 2021 was $2.1 million, compared to an operating loss of $2.3 million for the prior
year.
Other income (expense):
For the Years Ended
March 31,
Change
2021
2020
Dollars
Percentage
Other income (expense):
Change in fair value of derivative instruments
$ 1,237,132
$ (1,111,548 )
$ 2,348,680
-211 %
Interest expense and amortization of debt issuance costs
(259,598 )
(355,874 )
96,276
-27 %
Gain on sale of fixed assets
48,463
—
48,463
n/a
Gain on transfer/discontinuance of intangible assets
—
1,502,500
(1,502,500 )
-100 %
Interest income
514
11,979
(11,465 )
-96 %
PPP Loan Forgiveness
1,013,480
—
1,013,480
n/a
Other income, net
$ 2,039,991
$ 47,057
$ 1,992,934
4,235 %
51
Other income, net for the
year ended March 31, 2021 was $2.0 million, an increase in other income, net of $1.9 million from other income of $0.1 million for the
prior year. The increase in other income (expense), net was due to an increase in income relating to changes in the fair value of our
outstanding derivative warrants, as compared to the prior fiscal year, PPP loan forgiveness which occurred during the current fiscal
year and not during the prior fiscal year, offset by gains on transfer/discontinuance of intangible assets which were recognized during
the prior fiscal year and not during the current fiscal year. Please note that the change in the fair value of derivative instruments
is determined in large part by the change in the closing price of the Company’s Common Stock as of the end of the period, as compared
to the closing price at the beginning of the period, with a strong inverse relationship between the fair value of our derivatives instruments
and decreases in the closing price of the Company’s Common Stock.
As a result of the foregoing,
our income before income taxes for the year ended March 31,2021 was $4.3 million, compared to a loss before income taxes of $2.2 million
for the prior year.
Liquidity and Capital Resources
Capital Resources
March 31,
2021
March 31,
2020
Change
Current assets
$
12,194,667
$
10,251,279
$
1,943,388
Current liabilities
$
5,812,531
$
8,639,548
$
(2,827,017
)
Working capital
$
6,382,136
$
1,611,731
$
4,770,405
The Company considers cash
and working capital balances as several of the factors the Company uses in evaluating its performance. As of March 31, 2021, the
Company had cash on hand of $3.2 million and accounts receivable to be collected within expected operating cycles of $3.5 million. The
Company believes that such resources, combined with the working capital surplus of $6.4 million and the continuation of ongoing operations
are sufficient to fund operations through the current operating cycle. For the year ended March 31, 2021, the Company had income
from operations totaling $2.1 million, net other income totaling $2.0 million and a net income of $5.1 million. The Company’s other
income and net income (loss) available to common shareholders are significantly influenced by the fluctuations in the fair value of warrant
derivatives with such fair value bearing a strong inverse correlation to the market share price of the Company’s Common Stock.
Our working capital (total
current assets less total current liabilities) increased by $4.8 million from $1.6 million as of March 31, 2020 to $6.4 million
as of March 31, 2021, with such increase being primarily related to the net income of $5.1 million and a net positive cash flow
of $2.1 million achieved during the year ended March 31, 2021
Summary of Cash Flows:
For the Years Ended
March 31,
2021
2020
Net cash provided by (used in) operating activities
$ 3,193,861
$ (1,793,821 )
Net cash used in investing activities
$ (262,781 )
$ (34,953 )
Net cash (used in) provided by financing activities
$ (869,829 )
$ 689,536
Net cash provided by operating
activities for the year ended March 31, 2021 was $3.2 million, which included net income of $5.1 million and increases in non-cash expenses
totaling $0.2 million, offset by net increases in assets and decreases in liabilities totaling $2.1 million.
Net cash used in investing
activities for the year ended March 31, 2021 was comprised of purchases of purchases of property and equipment of $0.3 million offset
by proceeds from the sale of property and equipment of less than $0.1 million.
Net cash used in financing
activities was $0.9 million for the year ended March 31, 2021 which consisted primarily of proceeds from the payroll protection program
loan offset by loan payments.
Lincoln Park Capital
July 8, 2020 Purchase Agreement
On July 8, 2020, Elite Pharmaceuticals,
Inc., a Nevada corporation (the “Company”), entered into a purchase agreement (the “2020 LPC Purchase Agreement”),
and a registration rights agreement (the “Registration Rights Agreement”), with Lincoln Park Capital Fund, LLC (“Lincoln
Park”), pursuant to which Lincoln Park has committed to purchase up to $25.0 million of the Company’s common stock, $0.001
par value per share (the “Common Stock”), from time to time over the term of the Purchase Agreement, at the Company’s
direction.
52
During the year ended March
31, 2021 the Company issued an aggregate of 5,975,857 shares of Common Stock in the amount of $469,105 to Lincoln Park as initial commitment
shares. The Company sold 640,543 shares of its Common Stock pursuant to the 2020 LPC Purchase Agreement during the year ended March 31,
2021 for net proceeds totaling $42,223. In addition, 10,094 shares were issued to Lincoln Park as additional commitment shares, pursuant
to the 2020 LPC Agreement.
NJEDA Bonds
On August 31, 2005, the Company
successfully completed a refinancing of a prior 1999 bond issue through the issuance of new tax-exempt bonds (the “Bonds”).
The refinancing involved borrowing $4,155,000, evidenced by a 6.5% Series A Note in the principal amount of $3,660,000 maturing on September
1, 2030 and a 9% Series B Note in the principal amount of $495,000 maturing on September 1, 2012. The net proceeds, after payment of
issuance costs, were used (i) to redeem the outstanding tax-exempt Bonds originally issued by the Authority on September 2, 1999, (ii)
refinance other equipment financing and (iii) for the purchase of certain equipment to be used in the manufacture of pharmaceutical products.
As of March 31, 2016, all of the proceeds were utilized by the Company for such stated purposes.
Interest is payable semi-annually
on March 1 and September 1 of each year. The Bonds are collateralized by a first lien on the Company’s facility and equipment acquired
with the proceeds of the original and refinanced Bonds. The related Indenture requires the maintenance of a Debt Service Reserve Fund
of $366,000 in relation to the Series A Notes.
Bond issue costs of $354,454
were paid from the bond proceeds and are being amortized over the life of the bonds. Amortization of bond issuance costs amounted to
$14,178 for the fiscal year ended March 31, 2021.
The NJEDA Bonds require the
Company to make an annual principal payment on September 1st of varying amounts as specified in the loan documents and semi-annual interest
payments on March 1st and September 1st, equal to interest due on the outstanding principal at the applicable rate for the semi-annual
period just ended.
As of the date of filing
of this Annual Report on Form 10-K, there are no interest or principal amounts in arrears. The Series B Notes were retired, at par in
July 2014.
Off-Balance Sheet Arrangements
We have not entered into
any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition,
changes in financial condition, revenues, or expenses, results of operations, liquidity, capital expenditures, or capital resources that
would be considered material to investors.
Effects of Inflation
We are subject to price risks
arising from price fluctuations in the market prices of the products that we sell. Management does not believe that inflation risk is
material to our business or our consolidated financial position, results of operations, or cash flows.
Critical Accounting Policies and Estimates
Our significant accounting
policies are disclosed in Note 1 of our Consolidated Financial Statements included elsewhere in this Annual Report on Form 10-K. The
following discussion addresses our most critical accounting policies, which are those that are both important to the portrayal of our
financial condition and results of operations and that require significant judgment or use of complex estimates.
Segment Information
Financial Accounting Standards
Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 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 U.S. GAAP when making
decisions about allocating resources and assessing performance of the Company.
The Company has determined
that its reportable segments are products whose marketing approvals were secured via an Abbreviated New Drug 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.
53
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 audited
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 recognizes revenues following the five-step model prescribed under ASC 606: (i) identify contract(s) with a customer; (ii) identify
the performance obligation(s) in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance
obligation(s) in the contract; and (v) recognize revenues when (or as) the Company satisfies a performance obligation. The Company only
applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange
for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope
of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations
and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction
price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Sales, value add,
and other taxes collected on behalf of third parties are excluded from revenue.
Nature of goods and services
The following is a description
of the Company’s goods and services from which the Company generates revenue, as well as the nature, timing of satisfaction of
performance obligations, and significant payment terms for each, as applicable:
a) Manufacturing Fees
The Company is equipped to
manufacture controlled-release products on a contract basis for third parties, if and when the products are approved. These products
include products using controlled-release drug technology 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.
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.
54
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 March
31, 2020.
In accordance with ASC 606-10-55-65,
royalties are recognized when the subsequent sale of the customer’s products occurs.
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.
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.
Accounts Receivable
Accounts receivable are comprised
of balances due from customers, net of estimated allowances for uncollectible accounts, if any. 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 a 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.
55
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.
Research and Development
Research and development expenditures
are charged to expense as incurred.
Leases
Lease agreements are evaluated
to determine if they are capital leases meeting any of the following criteria at inception: (a) transfer of ownership; (b) bargain purchase
option; (c) the lease term is equal to 75 percent or more of the estimated economic life of the leased property; or (d) the present value
at the beginning of the lease term of the minimum lease payments, excluding that portion of the payments representing executory costs
such as insurance, maintenance, and taxes to be paid by the lessor, including any profit thereon, equals or exceeds 90 percent of the
excess of the fair value of the leased property to the lessor at lease inception over any related investment tax credit retained by the
lessor and expected to be realized by the lessor.
If at its inception a lease
meets any of the four lease criteria above, the lease is classified by the Company as a capital lease; and if none of the four criteria
are met, the lease is classified by the Company as an operating lease.
Contingencies
Occasionally, the Company
may be involved in claims and legal proceedings arising from the ordinary course of its business. The Company records a provision for
a liability when it believes that it is both probable that a liability has been incurred, and the amount can be reasonably estimated.
If these estimates and assumptions change or prove to be incorrect, it could have a material impact on the Company’s consolidated
financial statements. Contingencies are inherently unpredictable, and the assessments of the value can involve a series of complex judgments
about future events and can rely heavily on estimates and assumptions.
Income Taxes
Income taxes are accounted
for under the asset and liability method. Deferred tax assets and liabilities are recognized for the estimated future tax consequences
attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective
tax bases. Deferred tax assets and liabilities are measured using enacted tax rates in effect for the year in which those temporary differences
are expected to be recovered or settled. Where applicable, the Company records a valuation allowance to reduce any deferred tax assets
that it determines will not be realizable in the future.
The Company recognizes the
benefit of an uncertain tax position that it has taken or expects to take on income tax returns it files if such tax position is more
likely than not to be sustained on examination by the taxing authorities, based on the technical merits of the position. These tax benefits
are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate resolution.
The Company operates in multiple
tax jurisdictions within the United States of America. The Company remains subject to examination in all tax jurisdiction until the applicable
statutes of limitation expire. As of March 31, 2021, a summary of the tax years that remain subject to examination in our major tax jurisdictions
are: United States – Federal, 2015 and forward, and State, 2011 and forward. The Company did not have any unrecognized tax positions
for the years ended March 31, 2021 and 2020.
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.
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Stock-Based Compensation
The Company accounts for
stock-based compensation in accordance with ASC Topic 718, Compensation-Stock Compensation . Under the fair value recognition provisions
of this topic, 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 simple average closing price of the Company’s common stock for each trading day of the quarter
then ended.
Earnings (Loss) Per Share Applicable 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 dilutive potential shares if their effect was anti-dilutive.
Fair Value of Financial Instruments
ASC Topic 820, Fair Value
Measurements and Disclosures (“ ASC Topic 820 ”) provides a framework for measuring fair value in accordance with
generally accepted accounting principles.
ASC Topic 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 Topic 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
Topic 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.
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’ equity (deficit).
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Recently Adopted Accounting Standards
In
August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (ASC 820): Disclosure Framework-Changes to the Disclosure Requirements
for Fair Value Measurement . ASU 2018-13 removes certain disclosures, modifies certain disclosures and adds additional disclosures.
The ASU is effective for annual periods, including interim periods within those annual periods, beginning after December 15, 2019. Early
adoption is permitted. The Company adopted the guidance as of April 1, 2020. The Company is not materially impacted by the implementation
of this pronouncement.
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 adopted the
guidance as of April 1, 2020. The Company is not materially impacted by the implementation of this pronouncement.
In March 2020, the FASB issued
ASU 2020-03, Codification Improvements to Financial Instruments . The ASU clarifies disclosure guidance for fair value options,
adds clarifications to the subsequent measurement of fair value, clarifies disclosure for depository and lending institutions, clarifies
the line-of-credit or revolving-debt arrangements guidance, and the interaction of Financial Instruments - Credit Losses (Topic 326) with
Leases (Topic 842) and Transfers and Servicing-Sales of Financial Assets (Subtopic 860-20). In accordance with ASU 2020-03, the Company
adopted the guidance as of April 1, 2020. The Company is not materially impacted by the implementation of this pronouncement.
Recently Issued Accounting Pronouncements
In June 2016, the FASB issued
ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. This update requires
immediate recognition of management’s estimates of current expected credit losses (“CECL”). Under the prior model,
losses were recognized only as they were incurred. The new model is applicable to all financial instruments that are not accounted for
at fair value through net income. The standard is effective for fiscal years beginning after December 15, 2022 for public entities qualifying
as smaller reporting companies. Early adoption is permitted. The Company is currently assessing the impact of this update on the consolidated
financial statements and does not expect a material impact on the 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 consolidated financial statements and related disclosures.
ITEM 7A QUANTITATIVE AND QUALITATIVE DISCLOSURES
ABOUT MARKET RISK
Not Applicable.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Attached hereto and filed
as a part of this Annual Report on Form 10-K are our Consolidated Financial Statements, beginning on page F-1.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH
ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
None.