Item 9A. Controls and Procedures
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and
Procedures
The
term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act, refers to controls
and procedures that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits
under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and
forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required
to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s
management, including its principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding
required disclosure. As required by Rules 13a-15(b) and 15d-15(b) of the Exchange Act, our management, with the participation of our
Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of the
end of the period covered by this Annual Report on Form 10-K. Based on that evaluation, our Chief Executive Officer and our Chief Financial
Officer concluded that our disclosure controls and procedures were effective as of March 31, 2021 at the reasonable assurance level.
58
Management’s Report on Internal
Control Over Financial Reporting
Internal
control over financial reporting refers to the process designed by, or under the supervision of, our Chief Executive Officer and Chief
Financial Officer, and effected by our board of directors, management and other personnel, to provide reasonable assurance regarding
the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally
accepted accounting principles, and includes those policies and procedures that: (1) pertain to the maintenance of records that in reasonable
detail accurately and fairly reflect the transactions and dispositions of our assets; (2) provide reasonable assurance that transactions
are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles,
and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and (3)
provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the company’s
assets that could have a material effect on the financial statements.
Internal
control over financial reporting may not prevent or detect all errors and all fraud. A control system, no matter how well conceived and
operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are achieved. Further, the design
of a control system must be balanced against resource constraints, and therefore the benefits of controls must be considered relative
to their costs. Given the inherent limitations in all systems of controls, no evaluation of controls can provide absolute assurance all
control issues and instances of fraud, if any, within a company have been detected. These inherent limitations include the realities
that judgments in decision making can be faulty and that breakdowns can occur because of a simple error or mistake. Additionally, controls
can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the controls.
The design of any system of controls is also based in part upon certain assumptions about the likelihood of future events, and there
can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls
may become inadequate because of changes in conditions or the degree of compliance with policies or procedures may deteriorate. Accordingly,
given the inherent limitations in a cost-effective system of internal control, financial statement misstatements due to error or fraud
may occur and may not be detected. Our disclosure controls and procedures are designed to provide reasonable, not absolute, assurance
of achieving their objectives. We conduct periodic evaluations of our systems of controls to enhance, where necessary, our control policies
and procedures.
Management
is responsible for establishing and maintaining adequate internal control over our financial reporting, as such term is defined in Rules
13a-15(f) and 15d-15(f) under the Exchange Act. Under the supervision and with the participation of our management, including our Chief
Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness of our internal control over financial
reporting. Management has used the framework set forth in the report entitled “Internal Control—Integrated Framework (2013)”
published by the Committee of Sponsoring Organizations of the Treadway Commission to evaluate the effectiveness of our internal control
over financial reporting. Based on its evaluation, management has concluded that our internal control over financial reporting was effective
as of March 31, 2021 at the reasonable assurance level.
Changes in internal control
over financial reporting
There were no changes in
our internal control over financial reporting identified in management’s evaluation pursuant to Rules 13a-15(d) or 15d-15(d) of
the Exchange Act during the fiscal quarter ended March 31, 2021 that materially affected, or are reasonably likely to materially affect,
our internal control over financial reporting.
ITEM 9B. OTHER INFORMATION
None.
59
PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND
CORPORATE GOVERNANCE
The following sets forth
biographical information about each of our directors and executive officers as of the date of this report:
Name
Age
Position
Director/Officer
Since
Director
Tier
Nasrat Hakim
60
President, Chief Executive Officer and Director
August 2013
III
Barry Dash, Ph. D.
90
Director
April 2005
II
Jeffrey Whitnell
65
Director
October 2009
III
Davis Caskey
73
Director
April 2016
I
Marc Bregman
50
Chief Financial Officer, Secretary and Treasurer
May 2021
Douglas Plassche
58
Executive Vice President of Operations
August 2013
The principal occupations
and employment of each Director during the past five years is set forth below. In each instance in which dates are not provided in connection
with a director’s business experience, such nominee has held the position indicated for at least the past five years.
Each director currently holds
office until the expiration of his Tier (each for three years) or until such director’s death, resignation, or removal. Pursuant
to our recently amended and restated bylaws, our Board of Directors is now classified into three separate tiers of directors, with each
respective tier to serve a three-year term and until their successors are duly elected and qualified.
Nasrat Hakim
Nasrat Hakim has served
as a Director, President, and Chief Executive officer since August 2013. He has been a member of the Audit Committee, member and chairman
of the nominating Committee and member of the Compensation Committee since September 2016. Mr. Hakim has more than 30 years of pharmaceutical
and medical industry experience in Quality Assurance, Analytical Research and Development, Technical Services, and Regulatory Compliance.
He brings with him proven management experience, in-depth knowledge of manufacturing systems, development knowledge in immediate and
extended release formulations and extensive regulatory experience of GMP and FDA regulations. From 2004 to 2013, Mr. Hakim was employed
by Actavis, Watson and Alpharma in various senior management positions. Most recently, Mr. Hakim served as International Vice President
of Quality Assurance at Actavis, overseeing 25 sites with more than 3,000 employees under his leadership. Mr. Hakim also served as Corporate
Vice President of Technical Services, Quality and Regulatory Compliance for Actavis U.S., Global Vice President, Quality, and Regulatory
Compliance for Alpharma, as well as Executive Director of Quality Unit at TheraTech, overseeing manufacturing and research and development.
In 2009, Mr. Hakim founded Mikah Pharma, LLC, a virtual, fully functional pharmaceutical company. Mr. Hakim holds a Bachelor in Chemistry/Bio-Chemistry
and Masters of Science in Chemistry from California State University at Sacramento, Sacramento, CA; a Masters in Law with Graduate Certification
in U.S. and International Taxation from St. Thomas University, School of Law, Miami, FL.; and a Graduate Certification in Regulatory
Affairs (RAC) from California State University at San Diego, San Diego, CA. Mr. Hakim’s leadership experience (consisting of extensive
experience in senior management positions, responsible for 25 global manufacturing/regulatory sites with more than 3,000 employees under
his leadership), industry experience (comprising more than 30 years of pharmaceutical and medical industry experience served in various
quality assurance, analytical research and development/technical services and compliance positions) and academic experience (including
Bachelor degrees in Chemistry and Bio-Chemistry, Masters degrees in Chemistry and Law, with Graduate Certification in U.S. and International
Taxation, and a Graduate Certification in Regulatory Affairs) led to the conclusion that he is qualified to serve as a director.
Barry Dash, Ph.D.
Dr. Barry Dash has
served as a Director since April 2005, member of the Audit Committee since April 2005, member of the Nominating Committee since April
2005 and member and Chairman of the Compensation Committee since June 2007. Dr. Dash has been, since 1995, President and Managing Member
of Dash Associates, L.L.C., an independent consultant to the pharmaceutical and health industries. From 1983 to 1996 he was employed
by Whitehall-Robins Healthcare, a division of American Home Products Corporation (now known as Wyeth), initially as Vice President of
Scientific Affairs, then as Senior Vice President of Scientific Affairs and then as Senior Vice President of Advanced Technologies, during
which time he personally supervised six separate departments: Medical and Clinical Affairs, Regulatory Affairs, Technical Affairs, Research
and Development, Analytical R&D and Quality Management/Q.C. Dr. Dash had been employed by the Whitehall Robins Healthcare from 1960
to 1976, during which time he served as Director of Product Development Research, Assistant Vice President of Product Development and
Vice President of Scientific Affairs. Dr. Dash had been employed by J.B. Williams Company (Nabisco Brands, Inc.) from 1978 to 1982. From
1976 to 1978 he was Vice President and Director of Laboratories of the Consumer Products Division of American Can Company. Dr. Dash holds
a Ph.D. from the University of Florida and M.S. and B.S. degrees from Columbia University where he was Assistant Professor at the College
of Pharmaceutical Sciences from 1956 to 1960. He is a member of the American Pharmaceutical Association, the American Association for
the Advancement of Science and the Society of Cosmetic Chemist, American Association of Pharmaceutical Scientists, Drug Information Association,
American Foundation for Pharmaceutical Education, and Diplomate American Board of Forensic Examiners. He is the author of scientific
publications and patents in the pharmaceutical field. Dr. Dash’s extensive education in pharmaceutical sciences and his experience
in the development of scientific products, including his experience in regulatory affairs, led to the conclusion that he is qualified
to serve as a director.
60
Jeffrey Whitnell
Jeffrey Whitnell has
served as a Director since October 23, 2009, Chairman of the Audit Committee, member of the Compensation Committee since October 2009
and designated by the Board as an “ audit committee financial expert ” as defined under applicable rules under the Exchange
Act. Since April 2015, Mr. Whitnell has provided financial advisory services, primarily to the healthcare industry, including LifeWatch
Services, where he served as the Vice President, Finance & Controller. From June2010 to March 2015, Mr. Whitnell was the Chief Financial
Officer for ReliefBand Medical Technologies, a medical device company. From June 2009 to June 2010, Mr. Whitnell provided financial advisory
services to various healthcare companies, including ReliefBand Medical Technologies. From June 2004 to June 2009, Mr. Whitnell was Chief
Financial Officer and Senior Vice President of Finance at Akorn, Inc. From June 2002 to June 2004, Mr. Whitnell was Vice President of
Finance and Treasurer for Ovation Pharmaceuticals. From 1997 to 2001, Mr. Whitnell was Vice President of Finance and Treasurer for MediChem
Research. Prior to 1997, Mr. Whitnell held various finance positions at Akzo Nobel and Motorola. Mr. Whitnell began his career as an
auditor with Arthur Andersen & Co. He is a certified public accountant and holds an M.B.A. in Finance from the University of Chicago
Booth School of Business and a B.S. in Accounting from the University of Illinois. Mr. Whitnell’s qualifications as an accounting
and audit expert provide specific experience to serve as a director for the Company.
Davis Caskey
Davis Caskey has served
as a Director since April 2016, and a member of the Audit Committee, the nominating Committee and the Compensation Committee since September
2016. He brings more than 40 years of pharmaceutical industry experience to this position. Mr. Caskey is currently President & CEO
of Caskey LLC, which he formed in 2013 to serve as an umbrella to manage his pharmaceutical consulting and other business interests.
From 1990 to 2013, Davis served as the operating officer of ECR Pharmaceuticals, of which he was a founding member. HiTech Pharmacal
acquired the privately held ECR in 2009 and Mr. Caskey continued in his role until retiring in 2013. At ECR, Mr. Caskey was credited
with the establishment of the company’s sales and marketing structure, its product distribution format, and the development and management
of the firm’s internal organization. His responsibilities included the oversight of drug development and regulatory filings, product
acquisitions, and acquisition of other companies. A primary focus was to conceive and develop, with the assistance of key strategic partners,
unique dosage forms and extended release formulations of products which enhance patient compliance and safety. Prior to ECR, Mr. Caskey
was employed by A.H. Robins for 18 years in various field and home office management positions. His experience brings critical insight
into the marketing and distribution of pharmaceutical products in a rapid and ever-changing competitive marketplace. Mr. Caskey attended
the University of Texas (Austin) and Lamar University, and holds bachelor’s and master’s degrees.
Marc Bregman
Marc Bregman has served
as Chief Financial Officer, Secretary and Treasurer of the Company since May 17, 2021. Prior to joining the Company, from February 2015
to May 2021, Mr. Bregman served as Controller of Langan Engineering. From 2013 to 2015, Mr. Bregman served as financial controller at
Chemtrade Logistics. From 2009 to 2013, Mr. Bregman held corporate finance positions at Chemetall. From 1999 to 2009, Mr. Bregman held
multiple corporate finance positions at National Starch and Chemical Company. Mr. Bregman began his career as a certified public accountant
in the audit department of Ernst & Young, LLP. Mr. Bregman is a Certified Public Accountant (“CPA”), and holds a Master
in Business degree from the New Jersey Institute of Technology, Newark, NJ and Bachelor of Science in Accounting from William Paterson
College, Wayne, NJ. Mr. Bregman’s experience and expertise in the areas of finance, financial planning & analysis, Sarbanes
Oxley compliance, financial auditing and manufacturing accounting, provides the qualifications, attributes, and skills to serve as an
officer for the Company.
Douglas Plassche
Douglas Plassche has
served as Executive Vice President of Operations since August 2013. Prior to joining the Company, from 2009 to 2013, Mr. Plassche served
as the Managing Director of the New Jersey Solid Oral Dose Operations of Actavis, overseeing 450 employees and the production of more
than 100 products. From 2007 to 2009, Mr. Plassche was the Senior Director of Manufacturing for PAR Pharmaceuticals, overseeing 200 employees
and the production of more than 70 products. From 1990 – 2007, Mr. Plassche was employed by Schering-Plough, progressing steadily
through multiple disciplines, locations, and technical operations sectors with increasing levels of responsibility. Mr. Plassche has
a bachelor’s degree in Economics from Rochester University.
There are no family relationships
between any of our directors and executive officers.
61
Committees of the Board
The Board of Directors has
an Audit Committee, a Compensation Committee, and a Nominating Committee.
Audit Committee
During Fiscal 2021, the members
of the Audit Committee were Jeffrey Whitnell (Chairman of the Audit Committee), Dr. Barry Dash, Davis Caskey and Nasrat Hakim. We deem
Messrs. Whitnell, Dash, and Caskey to be independent and Mr. Whitnell to be qualified as an audit committee financial expert. The Board
of Directors has determined that Messrs. Whitnell, Dash and Caskey are independent directors as (i) defined in Rule 10A-3(b)(1)(ii) under
the Exchange Act and (ii) under Sections 803A(2) and 803B(2)(a) of the NYSE American LLC Company Guide (although our securities are not
listed on the NYSE American LLC or any other national exchange).
Nominating Committee
During Fiscal 2021, the members
of the Nominating Committee were Nasrat Hakim (Chairman of the Nominating Committee), Dr. Barry Dash, and Davis Caskey. There were no
material changes to the procedures by which security holders may recommend nominees to our Board of Directors since the filing of our
last Annual Report on Form 10-K.
Compensation Committee
During Fiscal 2021, the members
of the Compensation Committee were Dr. Barry Dash (Chairman of the Compensation Committee), Jeffrey Whitnell, Davis Caskey and Nasrat
Hakim.
Code of Conduct and Ethics
At the first meeting of the
Board of Directors following the annual meeting of stockholders held on June 22, 2004, and as further updated effective July 2009, the
Board of Directors adopted a Code of Business Conduct and Ethics that is applicable to the Company’s directors, officers, and employees.
A copy of the Code of Business Conduct and Ethics is available on our website at www.elitepharma.com, under Investor Relations.
Delinquent Section 16(a) Reports
Section 16(a) of the Exchange
Act requires our directors and executive officers and persons who beneficially own more than ten percent of our common stock to report
their ownership of, and transactions in, our stock in filings with the SEC. Copies of these reports are also required to be supplied
to VPG. VPG believes, based solely on a review of the copies of such reports received, that our directors and executive officers and
persons who beneficially own more than ten percent of our common stock complied with all applicable Section 16(a) reporting requirements
during the year ended March 31, 2021, except that Mr. Plassche filed one late Form 4 reporting the award of salary shares.
62
ITEM 11 EXECUTIVE COMPENSATION
Role of the Compensation Committee
The Company formed the Compensation
Committee in June 2007. Since the formation of the Compensation Committee all elements of the executives’ compensation are determined
by the Compensation Committee, which currently is comprised of three independent non-employee directors, and one director who is also
the Company’s Chief Scientific Officer. However, the Compensation Committee’s decisions concerning the compensation of the
Company’s Chief Executive Officer are subject to ratification by the independent directors of the Board of Directors. The members
of the Compensation Committee are Dr. Barry Dash (Chairman of the Compensation Committee), Jeffrey Whitnell, Davis Caskey and Nasrat Hakim.
The Committee operates pursuant to a charter. Under the Compensation Committee charter, the Compensation Committee has authority to retain
compensation consultants, outside counsel, and other advisors that the committee deems appropriate, in its sole discretion, to assist
it in discharging its duties, and to approve the terms of retention and fees to be paid to such consultants. During the fiscal year ended
March 31, 2021, the Compensation Committee did not engage any advisors.
Named Executive Officers
The named executive officers
for the fiscal year ended March 31, 2021 were:
●
Nasrat Hakim, Chief Executive Officer, and President for the full year;
●
Carter J. Ward, Chief Financial Officer, Secretary, and Treasurer for
the full year;
●
Douglas Plassche, Executive Vice President for the full year.
These individuals are referred
to collectively as the “ Named Executive Officers ”.
Our executive compensation program
Overview
Our approach to executive
compensation, one of the most important and complex aspects of corporate governance, is influenced by our belief in rewarding people for
consistently strong execution and performance. We believe that the ability to attract and retain qualified executive officers and other
key employees is essential to our long-term success. Our plan to obtain and retain highly skilled employees is to provide significant
incentive compensation opportunities and market competitive salaries. We strive to link individual employee objectives with overall company
strategies and results, and to reward executive officers and significant employees for their individual contributions to those strategies
and results. Furthermore, we believe that equity ownership serves to align the interests of our executives with those of our stockholders.
As such, equity is a key component of our compensation program.
The primary elements of our
executive compensation program are base salary, incentive cash and stock bonus opportunities and equity incentives typically in the form
of stock option grants or stock awards. Although we provide other types of compensation, these three elements are the principal means
by which we provide the Named Executive Officers with compensation opportunities.
Elements of our executive compensation program
Base Salary
We pay a base salary to certain
of the Named Executive Officers, with such payments being made in either cash, Common Stock or a combination of cash and Common Stock.
In general, base salaries for the Named Executive Officers are determined by evaluating the responsibilities of the executive’s
position, the executive’s experience, and the competitive marketplace. Base salary adjustments are considered and take into account
changes in the executive’s responsibilities, the executive’s performance, and changes in the competitive marketplace. We
believe that the base salaries of the Named Executive Officers are appropriate within the context of the compensation elements provided
to the executives and because they are at a level which remains competitive in the marketplace.
In the section below entitled
“ Agreements with Named Executive Officers ”, we describe the breakdown between compensation paid in cash and in equity
for each Named Executive Officer during the fiscal year ended March 31, 2021.
Bonuses
Named Executive Officers may
earn discretionary bonuses, which are awarded by the Compensation Committee in its discretion after the end of a fiscal year based on
its assessment of factors including Company and individual performance. Pursuant to his employment agreement, Mr. Hakim was eligible to
earn a discretionary bonus for the fiscal year ended March 31, 2021 up to 100% of his base salary ($500,000 for fiscal 2021), which he
earned in full. In addition, as described in the section below entitled “Agreements with Named Executive Officers,” Mr. Plassche
was guaranteed a $75,000 annual bonus for the fiscal year ended March 31, 2021. Mr. Ward was awarded a $25,000 discretionary bonus for
his service during fiscal 2021.
63
Equity
As noted above, certain components of our Named Executive
Officers’ fiscal year 2021 base salary and bonuses were payable in shares of Common Stock. In addition, Messrs. Ward and
Plassche are each entitled to an annual grant of restricted shares of Common Stock, as described in the section entitled
“ Agreements with Named Executive Officers ” below. During the fiscal year ended 2021, this amount was $25,000
worth of fully vested restricted shares for Mr. Ward and $30,000 worth of fully vested restricted shares for Mr. Plassche.
From time to time, we also
grant stock options to our Named Executive Officers which generally vest over time, obtainment of a corporate goal or a combination of
the two. We did not grant any stock options to our named executive officers in fiscal year 2021.
Retirement Benefits
We maintain a tax-qualified
retirement plan under Section 401(k) of the Code. The plan allows employees to defer compensation on a pre-tax basis subject to certain
limits; however, Elite does not provide a matching contribution to its participants.
Perquisites
Mr. Hakim receives a monthly
car allowance of up to $1,500 pursuant to the terms of his employment agreement. Mr. Plassche receives a monthly car allowance of up to
$500. Mr. Hakim is also entitled to a monthly housing allowance up to $5,000. These perquisites represent a small fraction of the total
compensation of each such Named Executive Officer. The value of the perquisites we provide are taxable to the Named Executive Officers
and the incremental cost to us of providing these perquisites is reflected in the Summary Compensation Table. The Board of Directors believes
that the perquisites provided are reasonable and appropriate. The Company generally covers life insurance premiums for its employee population,
including its Named Executive Officers. For more information on perquisites provided to the Named Executive Officers, please see the “ All
Other Compensation ” column of the Summary Compensation Table.
Agreements with Named Executive Officers
Nasrat Hakim
Pursuant to his August 2013
employment agreement, as amended on January 12, 2016 (the “ Hakim Employment Agreement ”), Mr. Hakim receives an annual
salary of $500,000 per year. The Salary is paid in shares of the Company’s Common Stock pursuant to the Company’s current
procedures for paying Company executives in Stock. He also is entitled to an annual performance bonus equal to up to 100% of his annual
salary, payable in shares of Common Stock as well. The Board may also award discretionary bonuses in its sole discretion. Mr. Hakim is
entitled to employee benefits (e.g., health, vacation, employee benefit plans and programs) consistent with other Company employees of
his seniority and a car allowance of up to $1,500 per month. The Hakim Employment Agreement contains restrictive covenants including a
confidentiality provision and a one year post-termination non-solicit provision.
Mr. Hakim’s employment
is terminable by the Company for cause (as defined below). The Hakim Employment Agreement also may be terminated by the Company upon at
least 30 days written notice due to disability (as defined below) or without cause. Mr. Hakim can terminate the Hakim Employment Agreement
by resigning, provided he gives notice at least 60 days prior to the effective resignation date.
If Mr. Hakim is terminated
for cause or he resigns, he only is entitled to accrued and unpaid annual salary, accrued vacation time and any reasonable and necessary
business expenses, all through the date of termination and payable in stock (“Basic Termination Benefits”). If Mr. Hakim is
terminated because of disability or death, in addition to Basic Termination Benefits, he is entitled to a pro rata annual bonus through
the date of termination (payable in Stock), payable in a lump sum. In addition, in the event of the termination of Mr. Hakim’s employment
due to his disability, he will be entitled to a lump sum payment within 60 days of the termination date equal to one year of his base
salary (payable in Stock), subject to his execution of a release. If the Company terminates Mr. Hakim without cause, in addition to Basic
Termination Benefits, Mr. Hakim is entitled to his pro rata annual bonus through the date of termination and an amount equal to two years’
annual salary (all payable in Stock in a lump sum within 60 days of the termination date), and 12 months of continued health insurance
continuation under the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended (“COBRA”), at active employee rates,
subject to his execution of a release and his continued compliance with applicable restrictive covenants.
64
Upon a termination of employment
in connection with a Change of Control (as defined below), in addition to Basic Termination Benefits, Mr. Hakim is entitled to a pro rata
annual bonus and payment in an amount equal to two year’s base annual salary in effect upon the Date of Termination, less applicable
deductions, and withholdings, payable in Stock in a lump sum within 60 days, and two years of health care continuation benefits. In addition,
all outstanding unvested equity held by Mr. Hakim will then vest.
Under the Hakim Employment
Agreement:
“Cause” means
(1) Mr. Hakim’s failure or refusal to perform the services required under the agreement, (2) the material breach by Mr. Hakim of
any of the terms of the agreement, or (3) Mr. Hakim’s conviction of a crime that results in imprisonment or involves embezzlement,
dishonest or activities injurious to the Company or its reputation.
“Change of Control”
means generally (1) an acquisition or merger resulting in the holders of the Company’s voting stock immediately prior to the transaction
holding less than fifty (50%) percent of the combined voting power after the transaction; (2) the sale of all or substantially all of
the assets or capital stock of the Company; or (3) the securities of the Company representing greater than fifty (50%) percent of the
combined voting power of the Company’s then outstanding voting securities are acquired in a single transaction or series of related
transactions.
“Disability” means
that Mr. Hakim is prevented by illness, accident or other disability (mental or physical) from performing the essential functions of his
position for one or more periods cumulatively totaling 3 months during any consecutive 12 month period.
Carter J. Ward
On November 12, 2009, the
Company entered into an employment agreement with Mr. Carter J. Ward (the “ Ward Employment Agreement ”) which superseded
his prior agreement with the Company. Pursuant to the terms of the Ward Employment Agreement, Mr. Ward continues as an at-will employee
of the Company as its Chief Financial Officer. Under the Ward Employment Agreement, Mr. Ward was entitled to an initial base salary of
$125,000 in accordance with the Company’s payroll practices and an additional $25,000 per annum paid by the issuance of restricted
shares of Common Stock. The Common Stock component of Mr. Ward’s compensation is to be computed on a quarterly basis, with the number
of shares issued equal to the quotient of the quarterly amount due of $6,250 divided by the average daily closing price of the Company’s
Common Stock for the quarter just ended.
On April 1, 2020, Mr. Ward’s
compensation was adjusted to include a total compensation of $200,529, consisting of $170,529 being paid in cash in accordance with the
Company’s payroll practices and $30,000 being paid by the issuance of restricted shares of Common Stock.
On March 1, 2021, Mr. Ward’s
compensation was adjusted to include a total compensation of $208,543, consisting of $178,543 being paid in accordance with the Company’s
payroll practices and $30,000 being paid by the issuance of restricted shares of Common Stock.
Mr. Ward subsequently
resigned as CFO of the Company, effective May 14, 2021.
Douglas Plassche
On July 20, 2013, the Company
entered into an employment agreement with Mr. Douglas Plassche (the “ Plassche Employment Agreeme nt”). Pursuant to the
Plassche Employment Agreement, Mr. Plassche serves as an at-will employee, in the position of Vice President of Operations, commencing
on August 12, 2013. The Plassche Employment Agreement includes an initial base salary of $205,000 being paid in accordance with the Company’s
payroll practices and an additional $25,000 being paid by the issuance of restricted shares of Common Stock. The Common Stock component
of Mr. Plassche’s compensation is to be computed on an annual basis, with the number of shares issued being equal to the quotient
of the annual amount due, divided by the average daily closing price of the Company’s Common Stock for the calendar year just ended.
Mr. Plassche is also eligible
for an annual bonus in cash and/or equity-based awards for up to an equivalent of 30% of base salary, with such annual bonus being granted
based upon the achievement of agreed milestones and at the discretion of the Company and its Chief Executive Officer. In addition, pursuant
to the Plassche Employment Agreement, he was initially granted options to purchase 3,000,000 shares of Common Stock, at a price of $ 0.07
per share, (the closing price of the Common Stock on the date of the Plassche Employment Agreement). The options were issued pursuant
to the 2004 Employee Stock Option Plan and vested over a period of three years with the vesting period commencing one year from the date
of issuance.
Mr. Plassche’s employment
is terminable by either party. If the Company terminates Mr. Plassche without cause, Mr. Plassche is entitled to an amount equal to six
months of base annual salary in effect upon the date of termination.
Throughout his tenure, Mr.
Plassche’s compensation was increased from time to time by the Board.
On June 21, 2019, Mr. Plassche
entered into a retention agreement with the Company (the “Plassche Retention Agreement”), as an in incentive for his continued
employment and cooperating during a transitional period for the Company. Pursuant to the Plassche Retention Agreement, Mr. Plassche is
entitled to a lump sum retention payment of $253,552 as of June 30, 2021, provided Mr. Plassche remains continuously employed by the Company
through such date. In addition, Mr. Plassche was paid a one-time $30,000 relocation payment during fiscal year 2020. Under the Plassche
Retention Agreement, the Company also guaranteed Mr. Plassche a salary of $253,552 and an annual bonus of $75,000 during the two year
period following the agreement date.
65
On April 1, 2020, Mr. Plassche’s
compensation was adjusted to include a total base compensation package of $272,530, consisting of $247,530 being paid in accordance with
the Company’s payroll practices and $25,000 being paid by the issuance of restricted shares of Common Stock.
On March 1, 2021, Mr. Plassche’s
compensation was adjusted to include a total base compensation package of $278,606, consisting of $253,606 being paid in accordance with
the Company’s payroll practices and $25,000 being paid by the issuance of restricted shares of Common Stock.
Potential Payments Upon Termination or Change
of Control
Messrs. Hakim and Plassche
are entitled to certain benefits upon a termination event (and in the case of Mr. Hakim, in connection with a change of control), as described
in the section entitled “ Agreements with Named Executive Officers ” above. We do not presently provide the Named Executive
Officers with any plan or arrangement, other than those that may be contained in the employment contracts disclosed above, in connection
with any termination, including, without limitation, through retirement, resignation, severance, or constructive termination (including
a change in responsibilities) of such Named Executive Officer’s employment with the Company.
As part of the Company’s
efforts to ensure the retention and continuity of key employees, officers, and directors in the event of a change of control of the ownership
of the Company, unless otherwise stated in applicable employment contracts, key executives would receive an amount not to exceed twelve
months of such executive’s salary, and certain Directors and managers would receive an amount equal to six months of such Director’s
or manager’s fees or salaries, as applicable. In addition, any outstanding and unvested options would immediately vest, in the event
of a change of control.
Hedging Policy
We do not permit the Named
Executive Officers to “hedge” ownership by engaging in short sales or trading in any options contracts involving securities.
Summary Compensation Table
Name and Principal Position
Fiscal Year
Salary
($)
Bonus
($)
Stock
Awards
($)
All Other
Compensation
($)
Total
($)
Nasrat Hakim, President, Chief Executive Officer and Chairman of the Board of Directors
2021
500,000
(1)
500,000
(2)
—
78,000
(3)
1,078,000
2020
500,000
500,000
—
78,000
1,078,000
Carter J. Ward, Chief Financial Officer
2021
201,197
(4)
25,000
(5)
—
—
226,197
2020
192,816
30,000
—
—
222,816
Douglas Plassche, Executive Vice President
2021
267,536
(6)
75,000
(7)
—
6,000
(8)
348,536
2020
253,552
75,000
—
36,000
364,552
(1) Represents
salary earned by Mr. Hakim pursuant to the Hakim Employment Agreement for Fiscal 2021, with such amounts to be paid via the issuance
of Common Stock in lieu of cash.
No shares of Common Stock have been issued
to Mr. Hakim in payment of salaries due for Fiscal 2021. A total of 7,388,707 shares of Common Stock are due and owing to Mr. Hakim
in payment of salaries earned during Fiscal 2021. A total of 6,305,856 shares of Common Stock are due and owing to Mr. Hakim in payment
of salaries earned during Fiscal 2020. In aggregate, a total of $2,125,000 is accrued, due and owing to Mr. Hakim for salaries earned
during Fiscal 2021, Fiscal 2020, and the thirty-six months ended March 31, 2019, but not paid. This amount is to be paid via the
issuance of 24,342,733 shares of Common Stock, with the date of such issuance of shares of Common Stock being undetermined.
(2)
The bonus earned by Mr. Hakim for fiscal 2021.
Bonuses earned by Mr. Hakim during Fiscal
2021 were paid in accordance with the Company’s payroll practices during Fiscal 2021.
Mr. Hakim was also paid $437,500 during Fiscal 2021 for bonuses earned
and accrued during the twelve months ended March 31, 2018, and not paid previously. Mr. Hakim was also paid $312,500 during Fiscal 2021
for bonuses earned and accrued during the twelve months ended March 31, 2019, and not previously paid. Mr. Hakim accordingly was paid
a total of $1,250,000 during Fiscal 2021, with such amount representing bonuses earned during Fiscal 2021 and the twenty-four month period
ending March 31, 2019, and not previously paid.
A total of $125,000 of bonus earned by Mr.
Hakim during Fiscal 2020 was paid in accordance with the Company’s payroll practices. A total of $375,000 of bonus earned by
Mr. Hakim during Fiscal 2020 was accrued and is owing to Mr. Hakim.
As of March 31, 2021, Mr. Hakim is owed $562,500 in bonuses earned
during the twenty-four-month period ending March 31, 2020. Pursuant to the Hakim Employment Agreement, these bonuses are to be paid in
accordance with the Company’s payroll practices.
66
(3)
Represents $18,000 amounts paid for auto allowance and $60,000 for housing allowances.
(4)
Represents salaries earned by Mr. Ward pursuant to the Ward Employment Agreement.
Fiscal 2021 salaries consist of $171,197 being
paid in accordance with the Company’s payroll practices and $30,000 being accrued, due, owing and to be paid via the issuance of
443,355 shares of Common Stock.
In aggregate, salaries totaling $97,500 are accrued,
due and owing to Mr. Ward for salaries earned and not paid during Fiscal 2021, Fiscal 2020 and the twenty-four month period ended March
31, 2019, with such accrued amount being paid via the issuance of 1,218,536 shares of Common Stock during May 2021.
(5)
Represents the bonus earned by Mr. Ward for fiscal 2021.
(6)
Represents salaries earned by Mr. Plassche pursuant to the Plassche Employment Agreement.
Fiscal 2021 salaries consist of $242,536 being
paid in accordance with the Company’s payroll practices and $25,000 being accrued, due, owing and to be paid via the issuance of
369,462 shares of Common Stock.
In aggregate, salaries totaling $25,000 are accrued,
due and owing to Mr. Plassche for salaries earned and not paid during Fiscal 2021, with such accrued amount to be paid via the issuance
of 369,462 shares of Common Stock, with the date of such issuance of shares of Common Stock being undetermined.
(7)
Represents the bonus earned by Mr. Plassche for fiscal 2021 pursuant to the Plassche Employment Agreement.
(8)
Represents amounts paid for auto allowances.
Outstanding Equity Awards at March 31, 2021
Option Awards
Name
Number of
securities
underlying
unexercised
options
Exercisable
(#)
Number of
securities
underlying
unexercised
options
Unexercisable
(#)
Equity Incentive Plan
Awards:
Number of securities
underlying unexercised
unearned options
(#)
Options
Exercise
Price
($)
Option
Expiration
Date
Nasrat Hakim
Carter Ward
150,000
-
-
0.12
6/19/2022
Douglas Plassche
3,000,000
-
-
0.07
7/23/2023
67
Director Compensation
The following table sets forth
information concerning director compensation for the year ended March 31, 2021:
Name
Fees
Earned or
Paid In
Cash (1)
($)
Stock
Awards (1)
($)
Option
Awards
($)
All Other
Compensation
($)
Total
($)
Barry Dash
10,000 (2)
20,000 (3)
-
-
-
-
30,000
Jeffrey Whitnell
10,000 (2)
20,000 (3)
-
-
-
-
30,000
Davis Caskey
10,000 (2)
20,000 (3)
-
-
-
-
30,000
(1)
Please refer to the section below titled “ Director
Fee Compensation ” for details on the Company’s director fee compensation policy. No directors held unexercised or unvested stock awards as of March 31, 2021.
(2)
Amounts represent Director fees earned during the
fiscal year ended March 31, 2021 which are to be paid in cash. These fees were accrued and unpaid as of March 31, 2021, with a payment
date being undetermined. In aggregate, Directors fees totaling $30,000 ($10,000 for each of the Company’s three non-employee
Directors) is accrued, due and owing for Director fees earned during Fiscal 2021. This amount is to be paid in cash, with the date
of such payment being undetermined.
(3)
Director equity compensation for the fiscal year ended March 31, 2021 consists of an entitlement to 295,570 shares of Common Stock for each of Dr. Dash, Mr. Whitnell and Mr. Caskey each receiving 295,570 shares of Common Stock. Payment of this amount due via share issuance will be made at an as yet undetermined date.
Director Fee Compensation
The Company’s policy
regarding director fees is as follows: (i) Directors who are employees or consultants of the Company (and/or any of its subsidiaries)
receive no additional remuneration for serving as directors or members of committees of the Board; (ii) all Directors are entitled to
reimbursement for out-of-pocket expenses incurred by them in connection with their attendance at the Board or committee meetings; (iii)
Directors who are not employees or consultants of the Company (and/or any of its subsidiaries) receive a $30,000 annual retainer fee,
with $20,000 of this amount being paid via the issuance of restricted Common Stock, and the remaining $10,000 being paid in cash; (iv)
Directors and the Chairman do not receive any additional compensation for attendance at or chairing of any meetings.
Director Equity Compensation
As described above, members
of the Board of Directors and the Chairman are paid a portion of their annual retainer fees via the issuance of restricted shares of Common
Stock of the Company. The number of shares to be issued to each Director and the Chairman is equal to the quotient of the quarterly amount
due to each Director and the Chairman, respectively, divided by the average daily closing price of the Company’s stock for the quarter
just ended.
Members of the Board of Directors
during the fiscal year ended March 31, 2021 did not receive any options or equity compensation for serving as directors other than shares
of Common Stock earned in lieu of cash in relation to Director fees due.
Other
The Company’s Articles
of Incorporation provide for the indemnification of each of the Company’s directors to the fullest extent permitted under Nevada
General Corporation Law.
68
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL
OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The following table sets forth
certain information, as of June 7, 2021 (except as otherwise indicated), regarding beneficial ownership of our Common Stock by (i) each
person who is known by us to own beneficially more than 5% of each such class, (ii) each of our directors, (iii) each of our executive
officers and (iv) all our directors and executive officers as a group. As of June 7, 2021, we had 1,009,176,752 shares of Common Stock
outstanding (exclusive of 0.1 million treasury shares). On any matter presented to the holders of our Common Stock for their action or
consideration at any meeting of our Shareholders, each share of Common Stock entitles the holder to one vote.
As used in the table below
and elsewhere in this report, the term beneficial ownership with respect to a security consists of sole or shared voting power, including
the power to vote or direct the vote, and/or sole or shared investment power, including the power to dispose or direct the disposition,
with respect to the security through any contract, arrangement, understanding, relationship, or otherwise, including a right to acquire
such power(s) during the 60 days immediately following June 7, 2021. Except as otherwise indicated, the Shareholders listed in the table
have sole voting and investment powers with respect to the shares indicated.
Name and Address of Beneficial
Owner of Common Stock
Common
Stock
Percent (%)
of
Voting Securities
Beneficially
Owned
Nasrat Hakim, President, Chief Executive Officer
and Chairman of the Board of Directors*
273,166,287 (1)
24.4 %
Barry Dash, Director*
2,228,362 (2)
** %
Jeffrey Whitnell, Director*
2,179,827 (3)
** %
Davis Caskey, Director*
1,042,243 (4)
** %
Carter J. Ward, Former Chief Financial Officer
5,185,023 (5)
** %
Douglas Plassche, Executive Vice President *
4,503,394 (6)
** %
All Directors and Officers as a group
283,120,113 (7)
25.3 %
* The
address is c/o Elite Pharmaceuticals Inc., 165 Ludlow Avenue, Northvale, NJ 07647.
** Less
than 1%
(1)
Includes 169,814,882 shares of Common Stock held and 24,342,744 shares
of Common Stock due and owing to Mr. Hakim as of March 31, 2021 (the latest practicable date) for compensation earned pursuant to Mr.
Hakim’s employment agreement with the Company and 79,008,661 shares of Common Stock issuable upon cash exercise of the Series J
Warrants with an exercise price of $0.1521 per share.
(2)
Includes 1,932,792 shares of Common Stock held and
295,570 shares of Common Stock due and owing to Dr. Dash as of March 31, 2021 (the latest practicable date) for Directors fees accrued
as of such date.
(3)
Includes 1,884,257 shares of Common Stock held and
295,570 shares of Common Stock due and owing to Mr. Whitnell as of March 31, 2021 (the latest practicable date) for Directors fees
accrued as of such date.
(4)
Includes 746,673 shares of Common Stock held and 295,570
shares of Common Stock due and owing to Mr. Caskey as of March 31, 2021 (the latest practicable date) Date for Directors fees accrued
as of such date.
(5)
Mr. Ward resigned on May 14, 2021. Address
is c/o Enveric Biosciences Inc., 4851 Tamiami Trail N, Naples FL 34103.
Includes 3,771,919 shares of Common Stock
held and 1,263,104 shares of Common Stock due and owing to Mr. Ward as of May 14, 2021. for salaries earned pursuant to Mr. Ward’s
employment agreement with the Company, with such shares being issued to Mr. Ward during May 2021, and vested options to purchase
150,000 shares of Common Stock.
(6)
Includes 1,133,932 shares of Common Stock held 369,462
shares of Common Stock due and owing to Mr. Plassche as of March 31, 2021 (the latest practicable date) for salaries earned pursuant
to Mr. Plassche’s employment agreement with the Company, and shares of Common Stock issuable upon cash exercise of vested options
to purchase 3,000,000 shares of Common Stock.
(7)
Relates only to current directors and officers. Includes
175,512,536 shares of Common Stock held, 25,598,916 shares of Common Stock due and owing as of March 31, 2021 (the latest practicable
date) for director’s fees and salaries accrued as of such date, 3,000,000 shares of Common Stock issuable upon cash exercise
of vested options and 79,008,661 shares of Common Stock issuable upon cash exercise of warrants at an exercise price of $0.1521 per
share of Common Stock.
69
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE
Certain Related Person Transactions
In May 2020, SunGen, under
an asset purchase agreement, assigned its rights and obligations under the SunGen Agreement for Amphetamine IR and Amphetamine ER to
Mikah Pharmaceuticals. The ANDAs for Amphetamine IR and Amphetamine ER are now registered under Elite’s name. Mikah will now be
Elite’s partner with respect to Amphetamine IR and ER and will assume all the rights and obligations for these products from SunGen.
Mikah Pharmaceuticals was founded in 2009 by Nasrat Hakim.
Director Independence
All related person transactions
are reviewed and, as appropriate, may be approved or ratified by the Board of Directors. If a Director is involved in the transaction,
he or she may not participate in any review, approval, or ratification of such transaction. Related person transactions are approved
by the Board of Directors only if, based on all of the facts and circumstances, they are in, or not inconsistent with, our best interests
and the best interests of our stockholders, as the Board of Directors determines in good faith. The Board of Directors takes into account,
among other factors it deems appropriate, whether the transaction is on terms generally available to an unaffiliated third-party under
the same or similar circumstances and the extent of the related person’s interest in the transaction. The Board of Directors may
also impose such conditions as it deems necessary and appropriate on us or the related person in connection with the transaction.
In the case of a transaction
presented to the Board of Directors for ratification, the Board of Directors may ratify the transaction or determine whether rescission
of the transaction is appropriate.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
The Company’s independent
registered public accounting firm for the fiscal year ending March 31, 2022 is Buchbinder Tunick & Company LLP (“ Buchbinder ”).
The following table presents
fees, including reimbursements for expenses, for professional audit services rendered by Buchbinder, for the audits of our financial
statements and interim reviews of our quarterly financial statements.
Fiscal
2021
Fiscal
2020
Audit Fees
$ 120,000
$ 120,000
Audit-Related Fees
—
—
Tax Fees
8,000
8,000
Audit Fees
Represents fees for professional
services provided for the audit of our annual financial statements, services that are performed to comply with generally accepted auditing
standards, and review of our financial statements included in our quarterly reports and services in connection with statutory and regulatory
filings.
Audit-Related Fees
Represents the fees for assurance
and related services that were reasonably related to the performance of the audit or review of our financial statements.
Tax Fees
Represents preparation of
Federal, State and Local income tax returns.
The Audit Committee has determined
that Buchbinder’s rendering of these audit-related services was compatible with maintaining auditor’s independence. The Board
of Directors considered Buchbinder to be well qualified to serve as our independent public accountants. The Committee also pre-approved
the charges for services performed in Fiscal 2021.
Pre-Approval Procedures
The Audit Committee pre-approves
all audit and tax services and the terms thereof (which may include providing comfort letters in connection with securities underwriting)
and non-audit services (other than non-audit services prohibited under Section 10A(g) of the Exchange Act or the applicable rules of
the SEC or the Public Company Accounting Oversight Board) to be provided to us by the independent auditor; provided, however, the pre-approval
requirement is waived with respect to the provisions of non-audit services for us if the “de minimus” provisions of Section
10A (i)(1)(B) of the Exchange Act are satisfied. This authority to pre-approve non-audit services may be delegated to one or more members
of the Audit Committee, who shall present all decisions to pre-approve an activity to the full Audit Committee at its first meeting following
such decision.
70
PART IV
ITEM 15. EXHIBITS, FINANCIAL STATEMENTS AND SCHEDULES
(a)
The following are filed as part of this Annual Report on
Form 10-K
(1)
The financial statements and schedules required to be filed by Item
8 of this Annual Report on Form 10-K and listed in the Index to Consolidated Financial Statements.
(2)
The Exhibits required by Item 601 of Regulation S-K and listed below
in the “ Index to Exhibits required by Item 601 of Regulation S- K.”
(b)
The Exhibits are filed with or incorporated by reference
in this Annual Report on Form 10-K
(c)
None
71
Index to Exhibits required by Item 601 of Regulation S-K.
Exhibit
No.
Description
3.1(a)
Articles
of Incorporation of Elite-Nevada, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed with the SEC on
January 9, 2012.
3.1(b)
Certificate
of Designations of the Series G Convertible Preferred Stock as filed with the Secretary of State of the State of Nevada on April
18, 2013, incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K, dated April 18, 2013 and filed with the SEC
on April 22, 2013.
3.1(c)
Certificate
of Designation of the Series H Junior Participating Preferred Stock, incorporated by reference to Exhibit 2 (contained in Exhibit
1) to the Registration Statement on Form 8-A filed with the SEC on November 15, 2013.
3.1(d)
Certificate
of Designations of the Series I Convertible Preferred Stock as filed with the Secretary of State of the State of Nevada on February
6, 2014, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K, dated February 6, 2014 and filed with the SEC
on February 7, 2014.
3.1(e)
Certificate
of Designations of the Series J Convertible Preferred Stock as filed with the Secretary of State of the State of Nevada on May 3,
2017, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K, dated April 28, 2017 and filed with the SEC on
April 28, 2017.
3.1(f)
Certificate
of Amendment to Articles of Incorporation, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K, dated June
24, 2020 and filed with the SEC on June 24, 2020.
3.2(a)
Amended
and Restated By-Laws of the Company, incorporated by reference to Exhibit 3.2 to the Current Report on Form 8-K dated April 23, 2020
and filed with the SEC on April 23, 2020.
4.1
Form
of specimen certificate for Series G Convertible Preferred Stock of the Company, incorporated by reference to Exhibit 4.2 to the
Current Report on Form 8-K, dated April 18, 2013 and filed with the SEC on April 22, 2013.
4.2
Form
of specimen certificate for Series I Convertible Preferred Stock of the Company, incorporated by reference to Exhibit 4.2 to the
Current Report on Form 8-K, dated February 6, 2014 and filed with the SEC on February 7, 2014.
4.3
Rights
Agreement, dated as of November 15, 2013, between the Company and American Stock Transfer & Trust Company, LLC., incorporated
by reference to Exhibit 1 to the Registration Statement on Form 8-A filed with the SEC on November 15, 2013.
4.4
Form
of Series H Preferred Stock Certificate, incorporated by reference to Exhibit 1 to the Registration Statement on Form 8-A filed with
the SEC on November 15, 2013.
4.5
Warrant
to purchase shares of Common Stock issued to Nasrat Hakim dated April 28, 2017 incorporated by reference to Exhibit 4.1 to the Current
Report on Form 8-K, dated April 28, 2017, and filed with the SEC on April 28, 2017.
72
4.6
Description
of Common Stock, incorporated by reference to Exhibit 4.6 to the Report 10-K filed in June 2020.
10.1
Elite
Pharmaceuticals, Inc. 2014 Equity Incentive Plan, incorporated by reference to Appendix B to the Company’s Definitive Proxy
Statement for its Annual Meeting of Shareholders, filed with the SEC on April 3, 2014.
10.2
Form
of Confidentiality Agreement (corporate), incorporated by reference to Exhibit 10.7 to the Form SB-2.
10.3
Form
of Confidentiality Agreement (employee), incorporated by reference to Exhibit 10.8 to the Form SB-2.
10.4
Loan
Agreement, dated as of August 15, 2005, between New Jersey Economic Development Authority (“NJEDA”) and the Company,
incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K, dated August 31, 2005 and filed with the SEC on September
6, 2005.
10.5
Series
A Note in the aggregate principal amount of $3,660,000.00 payable to the order of the NJEDA, incorporated by reference to Exhibit
10.2 to the Current Report on Form 8-K, dated August 31, 2005 and filed with the SEC on September 6, 2005.
10.6
Series
B Note in the aggregate principal amount of $495,000.00 payable to the order of the NJEDA, incorporated by reference to Exhibit 10.3
to the Current Report on Form 8-K, dated August 31, 2005 and filed with the SEC on September 6, 2005.
10.7
Mortgage
from the Company to the NJEDA, incorporated by reference to Exhibit 10.4 to the Current Report on Form 8-K, dated August 31, 2005
and filed with the SEC on September 6, 2005.
10.8
Indenture
between NJEDA and the Bank of New York as Trustee, dated as of August 15, 2005, incorporated by reference to Exhibit 10.5 to the
Current Report on Form 8-K, dated August 31, 2005 and filed with the SEC on September 6, 2005.
10.13
Employment
Agreement, dated as of November 13, 2009, by and between the Company and Carter J. Ward, incorporated by reference to Exhibit 10.2
to the Quarterly Report on Form 10-Q, for the period ending September 30, 2009 and filed with the SEC on November 16, 2009.+
10.15
License
Agreement, dated as of September 10, 2010, by and among Precision Dose Inc. and the Company, incorporated by reference to Exhibit
10.8 to the Quarterly Report on Form 10-Q, for the period ended September 30, 2010 and filed with the SEC on November 15, 2010 (Confidential
Treatment granted with respect to portions of the Agreement).
10.16
Manufacturing
and Supply Agreement, dated as of September 10, 2010, by and among Precision Dose Inc. and the Company, incorporated by reference
to Exhibit 10.9 to the Quarterly Report on Form 10-Q, for the period ended September 30, 2010 and filed with the SEC on November
15, 2010 (Confidential Treatment granted with respect to portions of the Agreement).
10.17
August
1, 2013 Employment Agreement with Nasrat Hakim, incorporated by reference to Exhibit 10.4 to the Current Report on Form 8-K, dated
August 1, 2013 and filed with the SEC on August 5, 2013.+
10.18
August
1, 2013 Mikah LLC Asset Purchase Agreement, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K/A, dated
August 1, 2013 and filed with the SEC on August 30, 2018. (Confidential Treatment granted with respect to portions of the Agreement).
10.19
August
1, 2013 Secured Convertible Note from the Company to Mikah Pharma LLC., incorporated by reference to Exhibit 10.2 to the Current
Report on Form 8-K, dated August 1, 2013 and filed with the SEC on August 5, 2013.
10.20
August
1, 2013 Security Agreement from the Company to Mikah Pharma LLC., incorporated by reference to Exhibit 10.3 to the Current Report
on Form 8-K, dated August 1, 2013 and filed with the SEC on August 5, 2013.
10.21
October
15, 2013 Hakim Credit Line Agreement, incorporated by reference to Exhibit 10.16 to the Quarterly Report on Form 10-Q for the period
ended September 30, 2013.
10.22
October
2, 2013 Manufacturing and Licensing Agreement with Epic Pharma LLC, incorporated by reference to Exhibit 10.17 to the Amended Quarterly
Report on Form 10-Q/A for the period ended September 30, 2013 and filed with the SEC on April 25, 2014. Confidential Treatment granted
with respect to portions of the Agreement.
10.23
February
7, 2014 Amendment to Secured Convertible Note from the Company to Mikah, incorporated by reference to Exhibit 10.1 to the Current
Report on Form 8-K, dated February 7, 2014 and filed with the SEC on February 7, 2014.
73
10.24
Employment
Agreement with Dr. G. Kenneth Smith, dated October 20, 2014, incorporated by reference to Exhibit 10.82 to the Quarterly Report on
Form 10-Q for the period ended September 30, 2014 and filed with the SEC on November 14, 2014.+
10.25
January
28, 2015 First Amendment to the Loan Agreement between Nasrat Hakim and Elite Pharmaceuticals dated October 15, 2013, incorporated
by reference to Exhibit 10.83 to the Quarterly Report on Form 10-Q for the period ended December 31, 2014 and filed with the SEC
on February 17, 2015.
10.26
January
28, 2015 Termination of Development and License Agreement for Mikah-001 between Elite Pharmaceuticals, Inc. and Mikah Pharma LLC
and Transfer of Payment, incorporated by reference to Exhibit 10.84 to the Quarterly Report on Form 10-Q for the period ended December
31, 2014 and filed with the SEC on February 17, 2015.
10.28
Amendment
No. 1 to Hakim Employment Agreement, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the SEC
on January 29, 2016.
10.29
August
24, 2016 Master Development and License Agreement between Elite and SunGen Pharma LLC. incorporated by reference to Exhibit 10.44
to the Quarterly Report on Form 10-Q for the period ended September 30, 2016 and filed with the SEC on November 9, 2016. (Confidential
Treatment granted with respect to portions of the Agreement).
10.30
Purchase Agreement between the Company and Lincoln Park Capital LLC dated July 8, 2020, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K, dated July 9, 2020 and filed with the SEC on July 9, 2020.
10.31
Registration
Rights Agreement between the Company and Lincoln Park Capital LLC dated July 8, 2020, incorporated by reference to Exhibit 10.2 to
the Current Report on Form 8-K, dated July 9, 2020 and filed with the SEC on July 9, 2020.
10.33
May
2017 Trimipramine Acquisition Agreement from Mikah Pharma, incorporated by reference to Exhibit 10.50 to the Annual Report on Form
10-K, for the period ended March 31, 2017 and filed with the SEC on June 14, 2017.
10.34
May
2017 Secured Promissory Note from the Company to Mikah Pharma, incorporated by reference to Exhibit 10.51 to the Annual Report on
Form 10-K, for the period ended March 31, 2017 and filed with the SEC on June 14, 2017.
10.35
May
2017 Security Agreement between the Company to Mikah Pharma, incorporated by reference to Exhibit 10.52 to the Annual Report on Form
10-K, for the period ended March 31, 2017 and filed with the SEC on June 14, 2017.
10.36
May
2017 Assignment of Supply and Distribution Agreement between Dr. Reddy’s Laboratories and Mikah Pharma, incorporated by reference
to Exhibit 10.53 to the Annual Report on Form 10-K, for the period ended March 31, 2017 and filed with the SEC on June 14, 2017.
10.37
May
2017 Assignment of Manufacturing and Supply Agreement between Epic and Mikah Pharma, incorporated by reference to Exhibit 10.54 to
the Annual Report on Form 10-K, for the period ended March 31, 2017 and filed with the SEC on June 14, 2017.
10.38
Supply
and Distribution Agreement between Dr. Reddy’s Laboratories and Mikah Pharma, incorporated by reference to Exhibit 10.55 to
the Annual Report on Form 10-K, for the period ended March 31, 2017 and filed with the SEC on June 14, 2017. (Confidential Treatment
granted with respect to portions of the Agreement).
10.39
Manufacturing
and Supply Agreement between Epic and Mikah Pharma, incorporated by reference to Exhibit 10.56 to the Annual Report on Form 10-K,
for the period ended March 31, 2017 and filed with the SEC on June 14, 2017. (Confidential Treatment granted with respect to portions
of the Agreement).
10.40
Master
Development and License Agreement For Products Between Elite Pharmaceuticals, Inc. And SunGen dated July 6, 2017, incorporated by
reference to Exhibit 10.57 to the Quarterly Report on Form 10-Q for the period ended June 30, 2017 and filed with the SEC on August
9, 2017. (Confidential Treatment granted with respect to portions of the Agreement).
10.41
First
Amendment to Master Development And License Agreement For Products Between Elite Pharmaceuticals, Inc. and SunGen Pharma, LLC, incorporated
by reference to Exhibit 10.59 to the Quarterly Report on Form 10-Q for the period ended June 30, 2017 and filed with the SEC on August
9, 2017. (Confidential Treatment granted with respect to portions of the Agreement).
10.42
Second
Amendment to Master Development And License Agreement For Products Between Elite Pharmaceuticals, Inc. and SunGen Pharma, LLC, incorporated
by reference to Exhibit 10.58 to the Quarterly Report on Form 10-Q for the period ended June 30, 2017 and filed with the SEC on August
9, 2017. (Confidential Treatment granted with respect to portions of the Agreement).
74
10.45
License,
Supply And Distribution Agreement effective March 6, 2019 by and between Elite Pharmaceuticals, Inc., and Elite Laboratories, Inc.
and Lannett Company, Inc., USA, incorporated by reference to Exhibit 10.45 to the Quarterly Report on Form 10-Q, for the period ended
December 31, 2019 and filed with the SEC on February 10, 2020. (Portions of this Agreement have been redacted in compliance with
Regulation S-K Item 601(b)(10)).
10.46
License,
Supply and Distribution Agreement effective April 9, 2019 by and between Elite Pharmaceuticals, Inc., and Elite Laboratories, Inc.
and Lannett Company, Inc., USA, incorporated by reference to Exhibit 10.49 to the Annual Report on Form 10-K for the period ended
March 31, 2019 and filed with the SEC on June 21, 2019 (portions of this Agreement have been redacted in compliance with Regulation
S-K Item 601(b)(10)).
10.47
License,
Supply and Distribution Agreement effective March 6, 2019 by and between Elite Pharmaceuticals, Inc., and Elite Laboratories, Inc.
and Lannett Company, Inc., USA, incorporated by reference to Exhibit 10.50 to the Annual Report on Form 10-K for the period ended
March 31, 2019 and filed with the SEC on June 21, 2019 (portions of this Agreement have been redacted in compliance with Regulation
S-K Item 601(b)(10)).
10.48
Development
Agreement effective December 3, 2018 by and between Mikah Pharma LLC and Elite Laboratories, Inc., incorporated by reference to Exhibit
10.51 to the Annual Report on Form 10-K for the period ended March 31, 2019 and filed with the SEC on June 21, 2019 (portions of
this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)).
10.49
Asset
Purchase Agreement dated November 13, 2019 by and between the Company and Nostrum Laboratories Inc. , incorporated by reference to
Exhibit 10.49 to the Quarterly Report on Form 10-Q, for the period ended December 31, 2019 and filed with the SEC on February 10,
2020.
10.50
January
2, 2020 Amendment to the Glenmark Pharmaceuticals Inc. USA License, Supply and Distribution Agreement, incorporated by reference
to Exhibit 10.50 to the Quarterly Report on Form 10-Q, for the period ended December 31, 2019 and filed with the SEC on February
10, 2020. (Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)).
10.51
Asset
Purchase Agreement executed January 16, 2020 by and between the Company and Nostrum Laboratories Inc., incorporated by reference
to Exhibit 10.49 to the Quarterly Report on Form 10-Q, for the period ended December 31, 2019 and filed with the SEC on February
10, 2020.
10.52
Employment Agreement with Douglas Plassche *+
10.53
June 21, 2019 Retention Agreement with Douglas Plassche.* +
10.54
July 29, 2019 Amendment To The License, Supply And Distribution Agreement Between Elite Pharmaceuticals, Inc./Elite Laboratories, Inc. And Lannett Company, Inc. (Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)).*
21
Subsidiaries
of the Company, incorporated by reference to Exhibit 21 to the Annual Report on Form 10-K, for the period ended March 31, 2019 and
filed with the SEC on June 21, 2019.
75
23.1
Consent of Buchbinder Tunick & Company LLP, Independent Registered Public Accounting Firm*
31.1
Certification of Chief Executive Officer pursuant to Exchange Act Rule 13a-14(a) and Rule 15d-14(a)*
31.2
Certification of Chief Financial Officer pursuant to Exchange Act Rule 13a-14(a) and Rule 15d-14(a)*
32.1
Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*
32.2
Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*
101.INS*
XBRL Instance Document
101.SCH*
XBRL Taxonomy Schema Document
101.CAL*
XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF*
XBRL Taxonomy Extension Definition Linkbase Document
101.LAB*
XBRL Taxonomy Extension Label Linkbase Document
101.PRE*
XBRL Taxonomy Extension Presentation Linkbase Document
104
Cover Page Interactive Data File
* Filed
herewith.
** Furnished
herewith.
+
Indicates management contract or compensatory plan or arrangement.
ITEM 16. FORM 10-K SUMMARY
None.
76
SIGNATURES
Pursuant to the requirements of Section 13 or
15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned,
thereunto duly authorized.
ELITE PHARMACEUTICALS, INC.
By:
/s/ Nasrat Hakim
Nasrat Hakim
Chief Executive Officer
Dated: June 14, 2021
By:
/s/ Marc Bregman
Marc Bregman
Chief Financial Officer
Dated: June 14, 2021
Pursuant to the requirements of the Securities
Exchange Act of 1934, this report has been signed by the following persons on behalf of the registrant and in the capacities and on the
dates indicated.
Signature
Title
Date
/s/
Nasrat Hakim
Chief Executive Officer,
President and Chairman of the
June
14, 2021
Board of Directors (Principal Executive Officer)
/s/
Marc Bregman
Chief Financial Officer, Treasurer, Secretary (Principal
June 14, 2021
Financial Officer and Principal Accounting Officer)
/s/
Barry Dash
Director
June 14, 2021
/s/
Jeffrey Whitnell
Director
June 14, 2021
/s/ Davis
Caskey
Director
June 14, 2021
78
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED MARCH 31, 2021 AND 2020
TABLE OF CONTENTS
PAGE
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
FIRM
F-2
CONSOLIDATED BALANCE SHEETS
F-3
CONSOLIDATED STATEMENTS OF OPERATIONS
F-5
CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY
F-6
CONSOLIDATED STATEMENTS OF CASH FLOWS
F-7
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
F-8
F- 1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
FIRM
To the Board of Directors and
Stockholders of Elite Pharmaceuticals, Inc., and Subsidiary
Opinion on the Financial Statements
We have audited the accompanying
consolidated balance sheets of Elite Pharmaceuticals, Inc. and Subsidiary (the Company) as of March 31, 2021 and 2020, and the related
consolidated statements of operations, stockholders’ equity, and cash flows for each of the years in the two-year period ended March
31, 2021, and the related notes (collectively referred to as the consolidated financial statements). In our opinion, the consolidated
financial statements present fairly, in all material respects, the financial position of the Company as of March 31, 2021 and 2020 and
the results of its operations and its cash flows for each of the years in the two-year period ended March 31, 2021 in conformity with
accounting principles generally accepted in the United States of America.
Basis for Opinion
These consolidated financial statements
are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated
financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board
(United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities
laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance
with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether
the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were
we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an
understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the
Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess
the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated
financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management,
as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable
basis for our opinion.
Critical Audit Matter
The critical audit matter communicated
below is a matter arising from the current-period audit of the financial statements that was communicated or required to be communicated
to the audit committee and that (1) relates to accounts or disclosures that are material to the financial statements and (2) involved
our especially challenging, subjective, or complex judgments. The communication of the critical audit matter does not alter in any way
our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing
separate opinions on the critical audit matter or on the accounts or disclosures to which they relate.
Indefinite-Lived Intangible Assets Impairment
Assessments of ANDAs and Patents — Refer to Notes 1, 4 and 15 to the financial statements
Critical Audit Matter Description
As of March 31,
2021, the Company has capitalized costs of $6,168,351 for ANDAs and $465,684 for patents. The Company evaluates its intangible assets
for impairment annually during the fourth quarter in accordance with ASC Topic 350, Intangibles Goodwill and Other, and between annual
evaluations if events occur or circumstances change that would more likely than not reduce the fair value of the assets carrying amount.
Management evaluates qualitative
factors to determine whether it is more likely than not that the fair value of the intangible assets is less than its carrying amount.
The qualitative factors management considers include, but are not limited to, the current project status, expected future cash flows,
decline in the Company’s stock price, legal and regulatory factors and industry and market considerations.
We identified the impairment evaluation
of the intangibles as a critical audit matter because of the significant judgements made by management to estimate the fair value of the
intangible assets.
Our audit procedures related to impairment
of indefinite lived intangible assets included review of management’s analysis and testing the significant assumptions used by management.
/s/ Buchbinder Tunick & Company LLP
Buchbinder Tunick & Company LLP
We have served as the Company’s auditor since 2010.
Little Falls, New Jersey 07424
June 14, 2021,
F- 2
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS
(AUDITED)
March 31,
2021
March 31,
2020
ASSETS
Current assets:
Cash
$ 3,192,768
$ 1,131,728
Accounts receivable, net of allowance for doubtful accounts
of $-0-, respectively
3,496,376
4,106,846
Inventory
5,012,902
4,142,472
Prepaid expenses and other current
assets
492,621
870,233
Total current assets
12,194,667
10,251,279
Property and equipment, net of accumulated
depreciation of $12,153,626 and $10,957,334, respectively
6,649,365
7,227,648
Intangible assets, net of accumulated
amortization of $-0-, respectively
6,634,035
6,634,035
Operating lease - right-of-use asset
214,674
363,282
Other assets:
Restricted cash - debt service for NJEDA bonds
405,013
404,802
Security deposits
91,738
75,534
Total other assets
496,751
480,336
Total assets
$ 26,189,492
$ 24,956,580
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$ 929,690
$ 1,577,860
Accrued expenses
4,270,600
4,821,132
Deferred revenue, current portion
13,333
180,000
Bonds payable, current portion, net of bond issuance costs
95,822
90,822
Loans payable, current portion
314,996
561,550
Lease obligation - operating lease, current portion
188,090
208,184
Senior secured promissory note -
related party, current portion
—
1,200,000
Total current liabilities
5,812,531
8,639,548
Long-term liabilities:
Deferred revenue, net of current portion
45,558
58,891
Bonds payable, net of current portion and bond issuance
costs
1,240,668
1,336,489
Loans payable, net of current portion
500,066
463,902
Lease obligation - operating lease, net of current portion
38,866
167,109
Derivative financial instruments - warrants
2,362,246
3,599,378
Other long-term liabilities
37,628
35,442
Total long-term liabilities
4,225,032
5,661,211
Total liabilities
10,037,563
14,300,759
The accompanying notes are an integral part
of these audited consolidated financial statements.
F- 3
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS
(continued)
March 31,
2021
March 31,
2020
Shareholders’ equity:
Series J convertible preferred stock; par
value of $0.01; 50 shares authorized; 0 issued and outstanding as of March 31, 2021 and 24.0344 issued and outstanding as of March
31, 2020
—
13,903,960
Common Stock; par value $0.001; 1,445,000,000 shares authorized; 1,009,276,752
shares issued and 1,009,176,752 shares outstanding as of March 31, 2021; 840,504,367 shares issued and 840,404,367 shares outstanding
as of March 31, 2020
1,009,279
840,507
Additional paid-in capital
164,407,480
150,264,605
Treasury stock; 100,000 shares as of March 31, 2021 and March 31, 2020;
at cost
(306,841 )
(306,841 )
Accumulated deficit
(148,957,989 )
(154,046,410 )
Total shareholders’
equity
16,151,929
10,655,821
Total liabilities
and shareholders’ equity
$ 26,189,492
$ 24,956,580
The accompanying notes are an integral part
of these audited consolidated financial statements.
F- 4
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF OPERATIONS
(AUDITED)
For the Years Ended
March 31,
2021
2020
Revenue:
Manufacturing fees
$ 20,997,310
$ 14,526,048
Licensing fees
4,383,439
3,468,591
Total revenue
25,380,749
17,994,639
Cost of manufacturing
13,513,611
10,015,855
Gross profit
11,867,138
7,978,784
Operating expenses:
Research and development
5,112,542
5,532,462
General and administrative
3,323,045
3,349,837
Non-cash compensation through issuance of stock options
13,181
62,098
Depreciation and amortization
1,313,847
1,319,795
Total operating expenses
9,762,615
10,264,192
Income (loss) from operations
2,104,523
(2,285,408 )
Other income (expense):
Change in fair value of derivative instruments
1,237,132
(1,111,548 )
Interest expense and amortization of debt issuance costs
(259,598 )
(355,874 )
Gain on sale of fixed assets
48,463
—
Gain on transfer/discontinuance of intangible assets
—
1,502,500
Interest income
514
11,979
PPP loan forgiveness
1,013,480
—
Other income, net
2,039,991
47,057
Income (loss) from operations before income taxes
4,144,514
(2,238,351 )
Income tax benefit (expense)
943,907
(2,000 )
Net income (loss) attributable to common shareholders
$ 5,088,421
$ (2,240,351 )
Basic net income (loss) per share attributable to common shareholders
$ 0.01
$ (0.00 )
Diluted net income (loss) per share attributable to common shareholders
$ 0.01
$ (0.00 )
Basic weighted average Common Stock outstanding
942,997,875
832,326,965
Diluted weighted average Common Stock outstanding
942,997,875
993,260,953
The accompanying notes are an integral part
of these audited consolidated financial statements.
F- 5
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY
(AUDITED)
Series J
Preferred Stock
Common Stock
Additional
Paid-In
Treasury Stock
Accumulated
Total
Shareholders’
Equity
Shares
Amount
Shares
Amount
Capital
Shares
Amount
Deficit
(Deficit )
Balance as of March 31, 2019
—
$ —
824,946,559
$ 824,949
$ 148,780,087
100,000
$ (306,841 )
$ (151,806,059 )
$ (2,507,864 )
Net loss
—
—
—
—
—
—
—
(2,240,351 )
(2,240,351 )
Common Stock sold pursuant to the Lincoln Park purchase
agreement
—
—
15,358,627
15,359
1,422,620
—
—
—
1,437,979
Common Stock issued as additional commitment shares pursuant
to the LPC purchase agreement
—
—
199,181
199
20,111
—
—
—
20,310
Costs associated with raising capital
—
—
—
—
(20,311 )
—
—
—
(20,311 )
Non-cash compensation through the issuance of employee
stock options
—
—
—
—
62,098
—
—
—
62,098
Reclassification of mezzanine equity
to permanent equity
24
13,903,960
—
—
—
—
—
—
13,903,960
Balance at March 31, 2020
24
$ 13,903,960
840,504,367
$ 840,507
$ 150,264,605
100,000
$ (306,841 )
$ (154,046,410 )
$ 10,655,821
Net income
—
—
—
—
—
—
—
5,088,421
5,088,421
Conversion of Preferred Stock to Common Stock
(24 )
(13,903,960 )
158,017,321
158,017
13,745,943
—
—
—
—
Initial commitment shares issued pursuant to the 2020
Lincoln Park purchase agreement
—
—
5,975,857
5,976
463,129
—
—
—
469,105
Common Stock sold pursuant to the Lincoln Park purchase
agreement
—
—
640,543
641
41,582
—
—
—
42,223
Common Stock issued as additional commitment shares pursuant
to the LPC purchase agreement
—
—
10,094
10
722
—
—
—
732
Costs associated with raising capital
—
—
—
—
(469,837 )
—
—
—
(469,837 )
Non-cash compensation through the issuance of employee
stock options
—
—
—
—
13,181
—
—
—
13,181
Shares issued in payment of Director fees
—
—
1,550,343
1,551
133,449
—
—
—
135,000
Shares issued in payment of salaries
—
—
646,336
645
55,605
—
—
—
56,250
Shares issued in payment of consulting
fees
—
—
1,931,891
1,932
159,101
—
—
—
161,033
Balance at March 31, 2021
—
$ —
1,009,276,752
$ 1,009,279
$ 164,407,480
100,000
$ (306,841 )
$ (148,957,989 )
$ 16,151,929
The accompanying notes are an integral part
of these audited consolidated financial statements.
F- 6
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(AUDITED)
For the Years Ended
March 31,
2021
2020
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income (loss)
$ 5,088,421
$ (2,240,351 )
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
Depreciation and amortization
1,313,847
1,319,795
Amortization of operating leases - right-of-use assets
210,744
190,806
Gain on the disposal of property and equipment
(48,463 )
—
Change in fair value of derivative financial instruments - warrants
(1,237,132 )
1,111,548
PPP loan forgiveness
(1,013,480 )
—
Non-cash compensation accrued
922,443
966,655
Non-cash compensation from issuances of options
13,181
62,098
Non-cash rent expense and lease accretion
2,186
2,081
Change in operating assets and liabilities:
Accounts receivable
610,470
(2,785,041 )
Inventory
(870,430 )
373,251
Prepaid expenses and other current assets
361,408
216,091
Accounts payable, accrued expenses and other current liabilities
(1,768,862 )
344,395
Deferred revenue and customer deposits
(180,000 )
(1,163,332 )
Lease obligations - operating leases
(210,472 )
(191,817 )
Net cash provided by (used in) operating activities
3,193,861
(1,793,821 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment
(329,981 )
(34,953 )
Proceeds from disposal of property and equipment
67,200
—
Net cash used in investing activities
(262,781 )
(34,953 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from the issuance of Common Stock
42,223
1,437,978
Proceeds from PPP loan
1,013,480
—
Payment of related party note payable
(1,200,000 )
—
Payment of bond principal
(105,000 )
(95,000 )
Other loan payments
(620,532 )
(653,442 )
Net cash (used in) provided by financing activities
(869,829 )
689,536
Net change in cash and restricted cash
2,061,251
(1,139,238 )
Cash and restricted cash, beginning of year
1,536,530
2,675,768
Cash and restricted cash, end of year
$ 3,597,781
$ 1,536,530
Supplemental disclosure of cash and non-cash transactions:
Cash paid for interest
$ 176,179
$ 240,785
Financing of equipment purchases and insurance renewal
$ 410,141
$ 54,462
Stock issued in payment of Directors fees, salaries and consulting expenses
$ 352,283
$ —
Commitment shares issued to Lincoln Park Capital
$ 722
$ 20,311
Conversion of preferred stock to Common Stock
$ 13,903,960
$ —
Supplemental non-cash amounts of lease liabilities arising from obtaining right of use assets
$ —
$ 554,088
F- 7
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Overview
Elite Pharmaceuticals, Inc.
(the “Company” or “Elite”) was incorporated on October 1, 1997 under the laws of the State of Delaware, and its
wholly-owned subsidiary Elite Laboratories, Inc. (“Elite Labs”) was incorporated on August 23, 1990 under the laws of the
State of Delaware. On January 5, 2012, Elite Pharmaceuticals was reincorporated under the laws of the State of Nevada. Elite Labs engages
primarily in researching, developing, licensing and 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 allergy, bariatric, attention deficit and infection. Research and development activities are performed
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 audited
consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States
(“GAAP”). The audited 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 audited consolidated
financial statements reflect all adjustments, consisting of normal recurring items, which are, in the opinion of management, necessary
for a fair presentation of such statements.
Segment Information
Financial Accounting Standards
Board (“FASB”) Accounting Standards Codification 280 (“ASC 280”), Segment Reporting , establishes standards
for reporting information about operating segments. Operating segments are defined as components of an enterprise about which separate
financial information is available that is evaluated regularly by the chief operating decision maker, or decision-making group, in deciding
how to allocate resources and in assessing performance.
The Company’s chief
operating decision maker is the Chief Executive Officer, who reviews the financial performance and the results of operations of the segments
prepared in accordance with GAAP when making decisions about allocating resources and assessing performance of the Company.
The Company has determined
that its reportable segments are products whose marketing approvals were secured via an Abbreviated New Drug 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 audited
consolidated financial statements. Please see Note 15 for further details.
Revenue Recognition
The Company generates revenue
primarily from manufacturing and licensing fees. Manufacturing fees include the development of pain management products, manufacturing
of a line of generic pharmaceutical products with approved ANDA, through the manufacture of formulations and the development of new products.
Licensing fees include the commercialization of products either by license and the collection of royalties, or the expansion of licensing
agreements with other pharmaceutical companies, including co-development projects, joint ventures and other collaborations.
Under ASC 606, Revenue
from Contacts with Customers (“ASC 606”), the Company recognizes revenue when the customer obtains control of promised
goods or services, in an amount that reflects the consideration which is expected to be received in exchange for those goods or services.
The Company recognizes revenues following the five-step model prescribed under ASC 606: (i) identify contract(s) with a customer; (ii)
identify the performance obligation(s) in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to
the performance obligation(s) in the contract; and (v) recognize revenues when (or as) the Company satisfies a performance obligation.
The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled
to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within
the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance
obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the
transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Sales,
value add, and other taxes collected on behalf of third parties are excluded from revenue.
F- 8
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Nature of goods and services
The following is a description
of the Company’s goods and services from which the Company generates revenue, as well as the nature, timing of satisfaction of
performance obligations, and significant payment terms for each, as applicable:
a) Manufacturing Fees
The Company is equipped to
manufacture controlled-release products on a contract basis for third parties, if, and when, the products are approved. These products
include products using controlled-release drug technology. The Company also develops and markets (either on its own or by license to
other companies) generic and proprietary controlled-release pharmaceutical products.
The Company recognizes revenue
when the customer obtains control of the Company’s product based on the contractual shipping terms of the contract. The Company
is primarily responsible for fulfilling the promise to provide the product, is responsible to ensure that the product is produced in
accordance with the related supply agreement and bears risk of loss while the inventory is in-transit to the commercial partner. Revenue
is measured as the amount of consideration the Company expects to receive in exchange for transferring products to a customer.
b) License Fees
The Company enters into licensing
and development agreements, which may include multiple revenue generating activities, including milestones payments, licensing fees,
product sales and services. The Company analyzes each element of its licensing and development agreements in accordance with ASC 606
to determine appropriate revenue recognition. The terms of the license agreement may include payment to the Company of licensing fees,
non-refundable upfront license fees, milestone payments if specified objectives are achieved, and/or royalties on product sales.
If the contract contains
a single performance obligation, the entire transaction price is allocated to the single performance obligation. Contracts that contain
multiple performance obligations require an allocation of the transaction price based on the estimated relative standalone selling prices
of the promised products or services underlying each performance obligation. The Company determines standalone selling prices based on
the price at which the performance obligation is sold separately. If the standalone selling price is not observable through past transactions,
the Company estimates the standalone selling price taking into account available information such as market conditions and internally
approved pricing guidelines related to the performance obligations.
The Company recognizes revenue
from non-refundable upfront payments at a point in time, typically upon fulfilling the delivery of the associated intellectual property
to the customer. For those milestone payments which are contingent on the occurrence of particular future events (for example, payments
due upon a product receiving FDA approval), the Company determined that these need to be considered for inclusion in the calculation
of total consideration from the contract as a component of variable consideration using the most-likely amount method. As such, the Company
assesses each milestone to determine the probability and substance behind achieving each milestone. Given the inherent uncertainty of
the occurrence of future events, the Company will recognize revenue from the milestone when there is not a high probability of a reversal
of revenue, which typically occurs near or upon achievement of the event.
Significant management judgment
is required to determine the level of effort required under an arrangement and the period over which the Company expects to complete
its performance obligations under the arrangement. If the Company cannot reasonably estimate when its performance obligations either
are completed or become inconsequential, then revenue recognition is deferred until the Company can reasonably make such estimates. Revenue
is then recognized over the remaining estimated period of performance using the cumulative catch-up method.
When determining the transaction
price of a contract, an adjustment is made if payment from a customer occurs either significantly before or significantly after performance,
resulting in a significant financing component. Applying the practical expedient in ASC 606-10-32-18, the Company does not assess whether
a significant financing component exists if the period between when the Company performs its obligations under the contract and when
the customer pays is one year or less. None of the Company’s contracts contained a significant financing component as of March 31,
2021.
F- 9
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
In accordance with ASC 606-10-55-65,
royalties are recognized when the subsequent sale of the customer’s products occurs.
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. The 2015 Epic License Agreement expired on June 4, 2020 without renewal.
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. On April 3,
2020, Elite and SunGen mutually agreed to discontinue any further joint product development activities.
Disaggregation of revenue
In the following table, revenue
is disaggregated by type of revenue generated by the Company. The table also includes a reconciliation of the disaggregated revenue with
the reportable segments:
For the Years Ended March 31,
2021
2020
NDA:
Licensing fees
$ 166,167
$ 1,000,000
Total NDA revenue
166,167
1,000,000
ANDA:
Manufacturing fees
$ 20,997,310
$ 14,526,048
Licensing fees
4,217,272
2,468,591
Total ANDA revenue
25,214,582
16,994,639
Total revenue
$ 25,380,749
$ 17,994,639
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 March 31, 2021
and March 31, 2020, the Company had restricted cash of $405,013 and $404,802, 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.
F- 10
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
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 March 31, 2021,
the Company did not identify any indicators of impairment.
Please also see Note 4 for
further details on intangible assets.
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 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, 2016 and forward, and State, 2012 and forward. The Company did not record unrecognized
tax positions for the years ended March 31, 2021 and 2020.
F- 11
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Warrants and Preferred Shares
The accounting treatment
of warrants and preferred share series issued is determined pursuant to the guidance provided by ASC 470, Debt , ASC 480, Distinguishing
Liabilities from Equity , and ASC 815, Derivatives and Hedging , as applicable. Each feature of a freestanding financial instrument
including, without limitation, any rights relating to subsequent dilutive issuances, dividend issuances, equity sales, rights offerings,
forced conversions, optional redemptions, automatic monthly conversions, dividends and exercise is assessed with determinations made
regarding the proper classification in the Company’s financial statements.
Stock-Based Compensation
The Company accounts for
stock-based compensation in accordance with ASC 718, Compensation-Stock Compensation . Under the fair value recognition provisions,
stock-based compensation cost is measured at the grant date based on the fair value of the award and is recognized as an expense on a
straight-line basis over the requisite service period, based on the terms of the awards. The cost of the stock-based payments to nonemployees
that are fully vested and non-forfeitable as at the grant date is measured and recognized at that date, unless there is a contractual
term for services in which case such compensation would be amortized over the contractual term.
In accordance with the Company’s
Director compensation policy and certain employment contracts, director’s fees and a portion of employee’s salaries are to
be paid via the issuance of shares of the Company’s Common Stock (“Common Stock”), in lieu of cash, with the valuation
of such shares 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 just ended.
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. The computation of diluted net income (loss) per share does not include the conversion of securities that would have
an antidilutive effect.
The following is the computation
of earnings (loss) per share applicable to common shareholders for the periods indicated:
For the Years Ended March 31,
2021
2020
Numerator
Net income (loss) - basic
$ 5,088,421
$ (2,240,351 )
Effect of dilutive instrument on net income
—
1,111,548
Net income (loss) - diluted
$ 5,088,421
$ (1,128,803 )
Denominator
Weighted average shares of Common Stock outstanding - basic
942,997,875
832,326,965
Dilutive effect of stock options and convertible securities
—
160,933,988
Weighted average shares of Common Stock outstanding - diluted
942,997,875
993,260,953
Net income (loss) per share
Basic
$ 0.01
$ (0.00 )
Diluted
$ 0.01
$ (0.00 )
F- 12
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
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:
Amount at
Fair
Value Measurement Using
Fair Value
Level
1
Level
2
Level
3
March 31, 2021
Liabilities
Derivative financial instruments
- warrants
$
2,362,246
$
—
$
—
$
2,362,246
March 31, 2020
Liabilities
Derivative financial instruments - warrants
$
3,599,378
$
—
$
—
$
3,599,378
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.
F- 13
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Treasury Stock
The Company records treasury
stock at the cost to acquire it and includes treasury stock as a component of shareholders’ equity.
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.
NOTE 2. INVENTORY
Inventory consisted of the
following:
March
31, 2021
March
31, 2020
Finished goods
$
274,603
$
138,981
Work-in-progress
781,350
677,824
Raw materials
3,956,949
3,325,667
$
5,012,902
$
4,142,472
F- 14
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 3. PROPERTY AND EQUIPMENT, NET
Property and equipment consisted
of the following:
March
31, 2021
March
31, 2020
Land, building and improvements
$
5,456,523
$
5,260,524
Laboratory, manufacturing, warehouse and transportation
equipment
12,580,457
12,167,754
Office equipment and software
373,601
373,601
Furniture and fixtures
392,410
383,103
18,802,991
18,184,982
Less: Accumulated depreciation
(12,153,626
)
(10,957,334
)
$
6,649,365
$
7,227,648
Depreciation expense was
$1,299,668 and $1,305,616 for the years ended March 31, 2021 and 2020, respectively.
NOTE 4. INTANGIBLE ASSETS
The following table summarizes
the Company’s intangible assets:
March
31, 2021
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, 2020
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
*
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).
F- 15
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 5. NJEDA BONDS
During August 2005, the Company
refinanced a bond issue occurring in 1999 through the issuance of Series A and B Notes tax-exempt bonds (the “NJEDA Bonds”
and/or “Bonds”). During July 2014, the Company retired all outstanding Series B Notes, at par, along with all accrued interest
due and owed.
In relation to the Series
A Notes, the Company is required to maintain a debt service reserve. The debt service reserve is classified as restricted cash on the
accompanying consolidated balance sheets. The NJEDA Bonds require the Company to make an annual principal payment on September 1st based
on the amount specified in the loan documents and semi-annual interest payments on March 1st and September 1st, equal to interest due
on the outstanding principal. The annual interest rate on the Series A Note is 6.5%. The NJEDA Bonds are collateralized by a first lien
on the Company’s facility and equipment acquired with the proceeds of the original and refinanced bonds.
The following tables summarize
the Company’s bonds payable liability:
March
31, 2021
March
31, 2020
Gross bonds payable
NJEDA Bonds -
Series A Notes
$
1,470,000
$
1,575,000
Less: Current portion of
bonds payable (prior to deduction of bond offering costs)
(110,000
)
(105,000
)
Long-term portion of bonds
payable (prior to deduction of bond offering costs)
$
1,360,000
$
1,470,000
Bond offering costs
$
354,454
$
354,454
Less: Accumulated amortization
(220,944
)
(206,765
)
Bond offering costs, net
$
133,510
$
147,689
Current portion of bonds payable - net of bond offering
costs
Current portions of bonds
payable
$
110,000
$
105,000
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
$
95,822
$
90,822
Long term portion of bonds payable - net of bond
offering costs
Long term portion of bonds
payable
1,360,000
$
1,470,000
Less: Bond offering costs
to be amortized subsequent to the next 12 months
(119,332
)
(133,511
)
Long term portion of bonds
payable, net of bond offering costs
$
1,240,668
$
1,336,489
Amortization expense was
$14,179 and $14,174 for the year ended March 31, 2021 and 2020, respectively. As of March 31, 2021 and 2020, interest payable was $7,963
and $8,531, respectively.
Maturities of bonds for the next five years are
as follows:
Years ending March 31,
Amount
2022
110,000
2023
115,000
2024
125,000
2025
130,000
Thereafter
990,000
$ 1,470,000
F- 16
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 6. LOANS PAYABLE
Loans payable consisted of
the following:
March
31, 2021
March
31, 2020
Equipment and insurance financing
loans payable, between 3.5% and 12.73% interest and maturing between January 2021 and October 2026
$
815,062
$
1,025,452
Less: Current portion of loans payable
(314,996
)
(561,550
)
Long-term portion of loans payable
$
500,066
$
463,902
The interest expense associated
with the loans payable was $77,218 and $79,870 for the years ended March 31, 2021 and 2020, respectively.
Loan principal payments for
the next five years are as follows:
Years ending March 31,
Amount
2022
$ 314,996
2023
245,405
2024
129,275
2025
96,117
Thereafter
29,269
$ 815,062
2020 Paycheck Protection
Program Term Note
In April 2020, the Company
entered into a Paycheck Protection Program Term Note (the “PPP Note”) with TD Bank, NA in the amount of $1,013,480. The PPP
Note was issued to the Company pursuant to the Coronavirus, Aid, Relief, and Economic Security Act’s (the “CARES Act”)
(P.L. 116-136) Paycheck Protection Program (the “Program”). Under the Program, all or a portion of the PPP Note may be forgiven
in accordance with the Program requirements.
On January 12, 2021, the
Company received notification that the United States Small Business Administration (“SBA”), had approved, in full, the Company’s
application for forgiveness of amounts received pursuant to the CARES Act and the Program.
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 “Mikah Note”) to Mikah Pharma, LLC (“Mikah”)
for the principal sum of $1,200,000. Mikah was founded in 2009 by Nasrat Hakim (“Hakim”), a related party and, the Company’s
President, Chief Executive Officer and Chairman of the Board. The Mikah Note matured on December 31, 2020 and was retired at par in March
2021. The principal amount of $1,200,000 was repaid by the Company at maturity.
Interest expense associated with the Note was $90,000 and $120,000
for the years ended March 31, 2021 and 2020, respectively. A total of $435,000 in accrued interest expense, representing interest expense
accrued during the life of the Mikah Note was due and owing as of the maturity date of the Note. Of the $435,000 accrued interest due
at maturity, $238,451 of accrued interest was satisfied by offset against amounts due from Mikah pursuant to the development agreement
between the Company and Mikah, dated December 3, 2018 (see Note 16). The balance of $196,549 of accrued interest expense owing in relation
to the Mikah Note is recorded as a non-interest bearing, general liability of the Company.
F- 17
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 8. DEFERRED REVENUE
Deferred revenues in the
aggregate amount of $58,891 as of March 31, 2021, were comprised of a current component of $13,333 and a long-term component of
$45,558. Deferred revenues in the aggregate amount of $238,891 as of March 31, 2020, were comprised of a current component of $180,000
and a long-term component of $58,891. These line items represent the unamortized amounts of a $200,000 advance payment received for a
TAGI Pharma (“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
sheet date and the long-term component is equal to the amount of revenue to be earned thereafter.
NOTE 9. COMMITMENTS AND CONTINGENCIES
Occasionally, the Company may be involved in claims and legal proceedings
arising from the ordinary course of its business. The Company records a provision for a liability when it believes that 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.
Operating Leases
The Company entered into
an operating lease for a portion of a one-story warehouse, located at 135 Ludlow Avenue, Northvale, New Jersey (the “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. modified
lease 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 plans to exercise
the second option pursuant to the 135 Ludlow Ave. Modified Lease in June 2021. This option includes a term that begins on January 1, 2022
and expires on December 31, 2026. Minimum lease payments required during the five year term of this option total $1,212,480.
In October 2020, the Company
entered into an operating lease for office space in Pompano Beach, Florida (the “Pompano Office Lease”). The Pompano Office
Lease is for approximately 1,275 square feet of office space, with Elite taking occupancy on November 1, 2020. The Pompano Office includes
a 3 month abatement from November 2020 through February 2021 and has a term of three years, ending on October 31, 2023.
The Company assesses whether
an arrangement is a lease or contains a lease at inception. For arrangements considered leases or that contain a lease that is accounted
for separately, the Company determines the classification and initial measurement of the right-of-use asset and lease liability at the
lease commencement date, which is the date that the underlying asset becomes available for use. The Company has elected to account for
non-lease components associated with its leases and lease components as a single lease component.
The Company recognizes a
right-of-use asset, which represents the Company’s right to use the underlying asset for the lease term, and a lease liability,
which represents the present value of the Company’s obligation to make payments arising over the lease term. The present value
of the lease payments is calculated using either the implicit interest rate in the lease or an incremental borrowing rate.
F- 18
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Lease assets and liabilities are classified as follows on the consolidated
balance sheet:
Lease
Classification
As
of March 31, 2021
Assets
Operating
Operating lease – right-of-use
asset
$
214,674
Total leased assets
$
214,674
Liabilities
Current
Operating
Lease obligation – operating lease
$
188,090
Long-term
Operating
Lease
obligation – operating lease, net of current portion
38,866
Total lease liabilities
$
226,956
Rent expense is recorded on the straight-line basis. Rent expense under
the 135 Ludlow Ave. Modified lease for the years ended March 31, 2021 and 2020, is $219,638 and $220,650, respectively. Rent expense under
the Pompano Office Lease for the years ended March 31, 2021 and 2020, is $9,544 and $0, respectively. Rent expense is recorded in general
and administrative expense in the audited consolidated statements of operations.
The table below show the
future minimum rental payments, exclusive of taxes, insurance and other costs, in aggregate, under the 135 Ludlow Ave. modified lease
and the Pompano Office Lease:
Years ending
March 31,
Amount
2022
$
195,331
2023
25,638
2024
15,214
2025
---
2026
---
Subsequent to March 31, 2026
---
Total future minimum lease
payments
236,183
Less: interest
(9,227
)
Present value of lease payments
$
226,956
The weighted-average remaining
lease term and the weighted-average discount rate of our lease was as follows:
Lease Term and Discount Rate
March 31, 2021
Remaining lease term (years)
Operating leases
2.6
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 March 31,
2021, and March 31, 2020, the Company had a liability of $37,628 and $35,442, respectively, recorded as a component of other long-term
liabilities.
F- 19
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
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, zero shares are outstanding, with a stated
value of $1,000,000 per share and a par value of $0.01 as of March 31, 2021.
On April 27, 2017, a total of 24.0344 shares of Series J Preferred
were issued pursuant to an exchange agreement (the “Exchange Agreement”) with Nasrat Hakim (“Mr. Hakim”), a related
party and the Company’s President, Chief Executive Officer and Chairman of the Board of Directors. The Exchange Agreement provided
for Hakim to exchange 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 are classified as liabilities on the accompanying consolidated balance sheet as
of March 31, 2021 (See Note 11).
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 in the event of a full conversion of Series J Preferred Stock. 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 was reclassified from mezzanine equity to permanent equity at its carrying amount of $13,903,960 on the consolidated balance
sheet as of March 31, 2020.
On June 23, 2020, the Company
held a Special Meeting of Shareholders, with such including a proposal for shareholders to again vote on the above referenced amendment
to the Company’s Articles of Incorporation. This proposal was also passed by shareholder vote.
On August 24, 2020, Hakim
converted the 24.0344 shares of Series J Preferred into 158,017,321 shares of Common Stock at a conversion price of $0.1521 per share.
F- 20
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 11. DERIVATIVE FINANCIAL INSTRUMENTS
– WARRANTS
The Company evaluates and
accounts for its freestanding instruments in accordance with ASC 815, Accounting for Derivative Instruments and Hedging Activities .
The Company issued warrants,
with a term of ten years, to affiliates in connection with an exchange agreement dated April 28, 2017, as further described in this note
below.
A summary of warrant activity
is as follows:
March
31, 2021
March
31, 2020
Warrant
Shares
Weighted
Average Exercise Price
Warrant
Shares
Weighted
Average 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 with
Mr. Hakim, the Chairman of the Board, President, and Chief Executive Officer of the Company, pursuant to which the Company issued to Hakim
24.0344 shares of its Series J Preferred and warrants to purchase an aggregate of 79,008,661 shares of its Common Stock (the “Series
J Warrants” and, along with the Series J Preferred issued to 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 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, other than shares issued pursuant to the 2020LPC Purchase
Agreement (as defined below), at an effective price below the then exercise price. Such exercise price adjustment feature prohibits the
Company from being able to conclude the warrants are indexed to its own stock and thus such warrants are classified as liabilities and
measured initially and subsequently at fair value. The Series J Warrants also provide for other standard adjustments upon the happening
of certain customary events.
The fair value of the Series
J Warrants was calculated using a Black-Scholes model. The following assumptions were used in the Black-Scholes model to calculate the
fair value of the Series J Warrants:
March
31, 2021
March
31, 2020
Fair value of the Company’s Common
Stock
$
0.0610
$
0.0720
Volatility
75.18
%
83.81
%
Initial exercise price
$
0.1521
$
0.1521
Warrant term (in years)
6.1
7.1
Risk free rate
1.40
%
0.55
%
F- 21
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The changes in warrants (Level
3 financial instruments) measured at fair value on a recurring basis for the years ended March 31, 2021 were as follows:
Balance at March 31, 2019
$
2,487,830
Change in fair value of derivative financial instruments
- warrants
1,111,548
Balance at March 31, 2020
3,599,378
Change in fair value of derivative financial instruments
- warrants
(1,237,132
)
Balance at March 31, 2021
$
2,362,246
NOTE 12. SHAREHOLDERS’ EQUITY
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 had the right to sell to and Lincoln Park was 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 that commenced on June 5, 2017. The 2017 LPC Purchase Agreement
expired on July 1, 2020.
During the year ended March
31, 2021, there were no shares sold to Lincoln Park pursuant to the 2017 LPC Purchase Agreement. In addition, there were no shares issued
to Lincoln Park as additional commitment shares, pursuant to the 2017 LPC Purchase Agreement. During the year ended March 31, 2020, a
total of 15,358,627 shares were sold to Lincoln Park pursuant to the 2017 LPC Purchase Agreement for net proceeds totaling $15,359. In
addition, 199,181 shares were issued to Lincoln Park as additional commitment shares, pursuant to the 2017 LPC Purchase Agreement.
Lincoln Park Capital Transaction - July
8, 2020 Purchase Agreement
On July 8, 2020, Elite Pharmaceuticals,
Inc., a Nevada corporation (the “Company”), entered into a purchase agreement (the “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.
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.
F- 22
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Summary of Common Stock Activity
During the years ended March
31, 2021 and 2020, the Company issued 168,772,385 and 15,557,808 shares of Common Stock, respectively, with such issuances of Common
Stock being summarized as follows:
March
31,
2021
2020
Common
Stock issued as of March 31, 2021 and 2020, respectively
840,504,367
824,946,559
Common
stock converted from Preferred Stock
158,017,321
—
Common
Stock sold pursuant to the Lincoln Park Capital Purchase Agreements, with net proceeds of such shares totaling $42,223 and $1,437,978
for the years ended March 31, 2021 and 2020, respectively.
640,543
15,358,627
Common
Stock issued as initial and additional commitment shares pursuant to the Lincoln Park Capital Purchase Agreements
5,985,951
199,181
Common
Stock issued in payment of Directors fees, salaries and consulting fees
4,128,570
—
Common
Stock issued during the fiscal year
168,772,385
15,557,808
Common
Stock issued as of March 31, 2021 and 2020, respectively
1,009,276,752
840,504,367
NOTE 13. STOCK-BASED COMPENSATION
Part of the compensation
paid by the Company to its Directors and employees consists of the issuance of Common Stock or via the granting of options to purchase
Common Stock.
Stock-based Director Compensation
The Company’s Director
compensation policy, instituted in October 2009 and further revised in January 2016, includes provisions that a portion of director’s
fees are to be paid via the issuance of shares of the Company’s Common Stock, in lieu of cash, with the valuation of such shares
being calculated on quarterly basis and equal to the average closing price of the Company’s Common Stock.
During the year ended March
31, 2021, the Company issued 1,550,343 shares of Common Stock to its Directors in payment of director’s fees totaling an aggregate of
$135,000 and with such aggregate director’s fees being earned and accrued over the twenty-seven month period beginning on January 1,
2018 and ending on March 31, 2020. In addition, the Company made cash payments totaling an aggregate of $67,500 in payment of director’s
fees earned over the same twenty-seven month period.
During the year ended March 31, 2021, the Company
accrued director’s fees totaling $60,000, which will be paid via cash payments totaling $30,000 and the issuance of 886,710 shares
of Common Stock.
As of March 31, 2021,
the Company owed its Directors a total of $30,000 in cash payments and 886,710 shares of Common Stock in payment of director fees totaling
$60,000 due and owing. The Company anticipates that these shares of Common Stock will be issued prior to the end of the subsequent 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 year ended March
31, 2021, the Company issued 646,336 shares of Common Stock in payment of salaries totaling $56,250 pursuant to the employment contract
of the Company’s Executive Vice President of Operations and with such salaries being earned and accrued over the thirty-month period
beginning on January 1, 2018 and ending on June 30, 2020.
F- 23
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
During the year ended March
31, 2021, the Company accrued salaries totaling $748,750 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 11,250,185 shares of Common Stock.
As of March 31, 2021,
the Company owed its President and Chief Executive Officer, Chief Financial Officer and certain other employees’ salaries totaling
$3,060,000 which will be paid via the issuance of 36,085,114 shares of Common Stock.
During the year ended March
31, 2021, the Company issued 1,931,891 shares of Common Stock in payment of consulting fees totaling $161,033, pursuant to engagement
contracts with a certain consultant, and with such consulting expenses being earned and accrued over the twenty seven month period beginning
on January 1, 2018 and ending March 31, 2020.
Options
Under its 2014 Stock Option
Plan and prior options plans, the Company may grant stock options to officers, selected employees, as well as members of the Board of
Directors and advisory board members. All options have generally been granted at a price equal to or greater than the fair market value
of the Company’s Common Stock at the date of the grant. Generally, options are granted with a vesting period of up to three years
and expire ten years from the date of grant. A summary of the activity of Company’s 2014 Stock Option Plan for the years ended March
31, 2021and 2020 is as follows:
Weighted
Average
Shares
Weighted
Average
Remaining
Contractual
Aggregate
Underlying
Options
Exercise
Price
Term
(in years)
Intrinsic
Value
Outstanding at March 31, 2019
6,158,000
$
0.15
5.0
$
87,330
Granted
115,000
0.10
9.5
Forfeited and expired
(898,000
)
Outstanding at March 31, 2020
5,375,000
0.14
4.1
6,000
Granted
600,000
0.06
9.7
Forfeited and expired
(75,000
)
Outstanding at March 31, 2021
5,900,000
$
0.13
3.7
$
6,000
Exercisable at March 31, 2021
5,246,667
$
0.13
3.7
$
6,000
The aggregate intrinsic value
for outstanding options is calculated as the difference between the exercise price of the underlying awards and the quoted price of the
Company’s Common Stock as of March 31, 2021 and March 31, 2020 of $0.06 and $0.07, respectively.
NOTE 14. CONCENTRATIONS AND CREDIT RISK
Revenues
Two customers accounted for
approximately 92% of the Company’s revenues for the year ended March 31, 2021. These two customers accounted for approximately
77% and 15% of revenues each, respectively.
Three customers accounted
for approximately 92% of the Company’s revenues for the year ended March 31, 2020. These three customers accounted for approximately
55%, 24%, and 13% of revenues each, respectively.
Accounts Receivable
Three customers accounted
for approximately 99% of the Company’s accounts receivable as of March 31, 2021. These three customers accounted for approximately
73%, 15% and 11% of accounts receivable each, respectively.
Four customers accounted
for substantially all the Company’s accounts receivable as of March 31, 2020. These four customers accounted for approximately
73%, 13%, 8%, and 5% of accounts receivable each, respectively.
F- 24
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Purchasing
Four suppliers accounted
for approximately 78% of the Company’s purchases of raw materials for the year ended March 31, 2021. These four suppliers accounted
for approximately 54%, 13%, 6% and 5% of purchases each, respectively.
Three suppliers accounted
for more than 71% of the Company’s purchases of raw materials for the year ended March 31, 2020. These three suppliers accounted
for approximately 41%, 23%, and 7% of purchases each, respectively.
NOTE 15. SEGMENT RESULTS
FASB ASC 280-10-50 requires
use of the “management approach” model for segment reporting. The management approach is based on the way a company’s
management organized segments within the company for making operating decisions and assessing performance. Reportable segments are based
on products and services, geography, legal structure, management structure, or any other manner in which management disaggregates a company.
The Company has determined
that its reportable segments are ANDAs for generic products and NDAs for branded products. The Company identified its reporting segments
based on the marketing authorization relating to each and the financial information used by its chief operating decision maker to make
decisions regarding the allocation of resources to and the financial performance of the reporting segments.
Asset information by operating
segment is not presented below since the chief operating decision maker does not review this information by segment. The reporting segments
follow the same accounting policies used in the preparation of the Company’s consolidated financial statements. Disaggregated revenue
by reportable segments is disclosed in Note 1.
The following represents
selected information for the Company’s reportable segments:
For the Years Ended March 31,
2021
2020
Operating Income by Segment
ANDA
$ 6,512,632
$ 3,579,047
NDA
142,812
580,414
$ 6,655,444
$ 4,159,461
The table below reconciles
the Company’s operating income by segment to income (loss) from operations before provision for income taxes as reported in the
Company’s consolidated statements of operations.
For the Years Ended March 31,
2021
2020
Operating income by segment
$ 6,655,444
$ 4,159,461
Corporate unallocated costs
(2,252,983 )
(2,721,103 )
Interest income
514
11,980
Interest expense and amortization of debt issuance costs
(259,598 )
(355,874 )
Depreciation and amortization expense
(1,313,847 )
(1,319,795 )
Significant non-cash items
(935,628 )
(901,472 )
PPP loan forgiveness
1,013,480
---
Change in fair value of derivative instruments
1,237,132
(1,111,548 )
Income (loss) from operations before income taxes
$ 4,144,514
$ (2,238,351 )
NOTE 16. RELATED PARTY AGREEMENTS WITH MIKAH PHARMA, LLC
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. As of the date of this report, the Company has incurred costs which are $238,451 in excess of advanced payments
received to date from Mikah. This balance due from Mikah was offset, in full, against accrued interest due and owing to Mikah pursuant
to the Mikah Note (see Note 7).
F- 25
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
In May 2020, SunGen Pharma LLC (“SunGen”), under an asset
purchase agreement, assigned its rights and obligations under the SunGen Agreement for Amphetamine IR and Amphetamine ER to Mikah Pharmaceuticals.
The ANDAs for Amphetamine IR and Amphetamine ER are now registered under Elite’s name. Mikah will now be Elite’s partner with
respect to Amphetamine IR and ER and will assume all the rights and obligations for these products from SunGen. Mikah Pharmaceuticals
was founded in 2009 by Nasrat Hakim.
NOTE 17. INCOME TAXES
The components of the income
taxes benefit (expense) are as follows:
Year
Ended March 31,
2021
2020
Federal
Current
—
—
Deferred
—
—
State
Current
—
—
Deferred
—
—
Benefit from sale of state net operating loss credits
904,528
—
Net benefit from sale of state net operating loss credits
$
904,528
$
—
The major components of deferred
tax assets and liabilities as of March 31, 2021 and 2020 are as follows (amounts in thousands of dollars):
Year Ended March 31,
2021
2020
Federal
Net operating loss carry forward
20,890
21,360
Valuation allowance
(20,890 )
(21,360 )
$ —
$ —
State
Net operating loss carry forward
841
2,258
Valuation Allowance
(841 )
(2,258 )
$ —
$ —
At March 31, 2021 and
2020 a 100% valuation allowance is provided, as it is uncertain if the deferred tax assets will provide any future benefits because of
the uncertainty about the Company’s ability to generate the future taxable income necessary to use the net operating loss carry
forwards. Absent the above mentioned allowance, at March 31, 2021, the Company’s federal and state income taxes due were $0.4 million
and $0.2 million, respectively. Absent the above mentioned allowance, at March 31, 2020, the Company’s federal and state income
taxes due were $0.2 million and $0.1 million, respectively.
The company believes that
temporary timing differences between accrual and payment of income taxes are not material to the financial position of the Company.
As of March 31, 2021,
Elite has a federal net operating loss carry forward of $99.5 million, which do not expire and net operating loss carry forward in state
tax jurisdictions of $9.3 million some of which will began to expire in 2021.
F- 26
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Sale of New Jersey Net Operating Loss
In April 2020, Elite Laboratories
Inc., a wholly owned subsidiary of Elite Pharmaceuticals Inc., received final approval from the New Jersey Economic Development Authority
for the sale of net tax benefits of $607,635 relating to New Jersey net operating losses and net tax benefits of $338,772, relating to
R&D tax credits. The Company sold the net tax benefits approved for sale for total proceeds of $946,407.
NOTE 18. COVID-19 UPDATE
In December 2019, the Novel
Corona Virus, COVID-19 was reported to have emerged in Wuhan, China. In March 2020, the World Health Organization (“WHO”)
declared the COVID-19 outbreak a global pandemic. Governments at the national, state and local level in the United States, and globally,
have implemented aggressive actions to reduce the spread of the virus, with such actions including, without limitation, lockdown and
shelter in place orders, limitations on non-essential gatherings of people, suspension of all non-essential travel, and ordering certain
businesses and governmental agencies to cease non-essential operations at physical locations. Under current and applicable laws and regulations,
the Company’s business is deemed essential and it has continued to operate in all aspects of its pharmaceutical manufacturing,
distribution, product development, regulatory compliance and other activities. The Company’s management has developed and implemented
a range of measures to address the risks, uncertainties, and operational challenges associated with operating in a COVID-19 environment.
The Company is closely monitoring the rapidly evolving and changing situation and are implementing plans intended to limit the impact
of COVID-19 on our business so that the Company can continue to manufacture those medicines used by end user patients. Actions the Company
has taken to date are, without limitation, further described below.
Workforce
The Company has taken and
will continue to take, proactive measures to provide for the well-being of its workforce while continuing to safely produce pharmaceutical
products. The Company has implemented alternative working practices, which include, without limitation, modified schedules, shift rotation
and work at home abilities for appropriate employees to best ensure adequate social distancing. In addition, the Company increased its
already thorough cleaning protocols throughout its facilities and has prohibited visits from non-essential visitors. Certain of these
measures have resulted in increased costs.
Manufacturing and Supply Chain
During the year ended March
31, 2021, the Company has not experienced material, detrimental issues related to COVID-19 in its manufacturing, supply chain, quality
assurance and regulatory compliance activities, and has been able to operate without interruption. The Company has taken, and plans to
continue to take, commercially practical measures to keep its facilities open. The Company’s supply chains remain intact and operational,
and the Company is in regular communications with its suppliers and third-party partners. A prolonging of the current situation relating
to COVID-19 may result in an increased risk of interruption in the Company supply chain in the future, with no assurances given as the
materiality of such future interruption on the Company’s business, financial condition, results of operations and cash flows.
NOTE 19. SUBSEQUENT EVENTS
Sale of New Jersey Net Operating Loss and
Research and Development Tax Credit
In April 2021, Elite Laboratories
Inc., a wholly owned subsidiary of Elite Pharmaceuticals Inc. received final approval from the New Jersey Economic Development Authority
for the sale of net tax benefits of $798,889 relating to New Jersey net operating losses and net tax benefits of $58,490, relating to
research and development tax credits. The Company sold the net tax benefits approved for sale at a transfer price equal to ninety three
and one half cents for every benefit dollar and incurred transaction fees of $12,861, resulting in net proceeds to the Company of $788,789.
F-27