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, 2022 at the reasonable assurance level.
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, 2022 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, 2022 that materially affected, or are reasonably likely to
materially affect, our internal control over financial reporting.
ITEM
9B. OTHER INFORMATION
None.
ITEM
9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS.
None.
61
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
Class
Nasrat
Hakim
61
President,
Chief Executive Officer and Director
August
2013
III
Barry
Dash, Ph. D.
91
Director
April
2005
II
Jeffrey
Whitnell
66
Director
October
2009
III
Davis
Caskey
74
Director
April
2016
I
Robert
Chen
63
Chief
Financial Officer, Secretary and Treasurer
May
2022
Douglas
Plassche
58
Executive
Vice President of Operations
August
2013
The
principal occupations and employment of each Director and executive officer during the past five years is set forth below. In
each instance in which dates are not provided in connection with an individual’s business experience, such individual
has held the position indicated for at least the past five years.
Pursuant
to our recently amended and restated bylaws, our Board of Directors is now classified into three separate classes of directors.
Each director currently holds office until the expiration of the term of his class (each for three years) and until his successor
is duly elected and qualified, or until such director’s death, resignation, or removal.
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.
62
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.
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 2017, Mr. Whitnell has provided financial advisory services, primarily to the healthcare industry, including
Southside Master, where he served as Chief Financial Officer from September 2018 to present. In 2016, Mr. Whitnell served as Vice President,
Finance and Controller for LifeWatch Services and other Private Equity-backed portfolio companies. From June 2010 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 led to the conclusion that he is qualified to serve as a director.
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,
and this experience led to the conclusion that he is qualified to serve as a director. Mr. Caskey attended the University of Texas
(Austin) and Lamar University, and holds bachelor’s and master’s degrees.
63
Robert
Chen
Robert
Chen has served as Chief Financial Officer, Secretary, and Treasurer of the Company since May 5, 2022. Mr. Chen joins Elite with
broad experience in financial and operational leadership for life science companies, both private and public, ranging from preclinical
development to commercial operations. Before joining Elite, Mr. Chen served as Vice President for KBP Biosciences from December
2020 to February 2022. From July 2019 to October 2020, Mr. Chen was the Chief Financial Officer at Victory Commercial Management.
During 2019, Mr. Chen served as Sr. Director of Finance for WuXi Advanced Therapies. From 2014 to 2019, Mr. Chen was the Sr. Director
of Finance at Taiho Oncology. Mr. Chen held various other financial positions in the life sciences sector with increasing responsibilities.
Mr. Chen is a certified public accountant and began his career with Price Waterhouse and served as an Industrial Financial Analyst. Mr.
Chen brings with him extensive and diversified financial leadership background in the areas of financial reporting, including manufacturing,
financial and cost accounting, SEC, GAAP and IFRS, as well as financial planning and analysis, and this experience led to the conclusion
that he is qualified to serve as a director. Mr. Chen has a Bachelor of Science in Business Administration, Accounting, and a Master
of Professional Accountancy degree from the University of Southern Mississippi. He is a Certified Public Accountant (CPA).
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.
Committees
of the Board
The
Board of Directors has an Audit Committee, a Compensation Committee, and a Nominating Committee.
Audit
Committee
During
the year ended March 31, 2022, the members of the Audit Committee were Jeffrey Whitnell (Chairman of the Audit Committee), Dr. Barry
Dash, Davis Caskey and Nasrat Hakim. The Board of Directors has determined that 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
the year ended March 31, 2022, 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
the year ended March 31, 2022, the members of the Compensation Committee were Dr. Barry Dash (Chairman of the Compensation Committee),
Jeffrey Whitnell, Davis Caskey and Nasrat Hakim.
Delinquent
Section 16 Reports
Section
16(a) of the Exchange Act requires the Company’s officers and directors, and persons who own more than ten percent of a registered
class of the Company’s stock, to file reports of ownership and changes in ownership with the SEC. Officers, directors and greater
than ten percent stockholders are required by SEC regulation to furnish the Company with copies of all Section 16(a) reports they file.
Based
solely on its review of copies of such reports and upon written representations from each of the Company’s officers and directors,
the Company believes that, for the year ended March 31, 2022, all Section 16(a) filing requirements applicable to the Company’s
officers, directors and greater than ten percent stockholders were complied with on a timely basis, except for one Form 4 filed on July
7, 2021 to report an award of options to Marc Bregman on May 17, 2021 that was late due to an administrative error.
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.
64
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 Executive 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, 2022, the Compensation Committee did not engage any advisors.
Named
Executive Officers
The
named executive officers for the fiscal year ended March 31, 2022 were:
●
Nasrat
Hakim, Chief Executive Officer, and President for the full year;
●
Marc
Bregman, Chief Financial Officer, Secretary, and Treasurer from May 17, 2021 through April 29, 2022;
●
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.
65
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, 2022.
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 an annual bonus for the fiscal year ended March 31, 2022 up to 100% of his base salary ($500,000
for fiscal 2022), which he earned in full. In addition, as described in the section below entitled “ Agreements with Named Executive
Officers ,” Mr. Plassche was entitled to earn an annual bonus for the fiscal year ended March 31, 2022 up to 30% of his base
salary $78,493 for fiscal 2022. Mr. Plassche was awarded an $83,600 bonus for the fiscal year ended March 31, 2022. Mr. Bregman
was entitled to earn an annual bonus for the fiscal year ended March 31, 2022 up to 20% of his base salary $37,400 for fiscal
2022, which he earned in full.
Equity
As
noted above, certain components of our Named Executive Officers’ fiscal year 2022 base salary and bonuses were payable in shares
of Common Stock. In addition, Mr. Plassche is entitled to an annual grant of shares of Common Stock, as described in the section entitled
“ Agreements with Named Executive Officers ” below. During the fiscal year ended March 31, 2022, this amount was
$18,750 worth of fully vested shares for Mr. Plassche, which he elected to take as a cash bonus payment. Mr. Plassche’s annual
grant of shares of Common Stock in lieu of salary was terminated on December 31, 2021.
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. Mr. Bregman was granted stock options to purchase 300,000 shares of Common Stock with the strike price
being closing price of the Company’s stock as traded on the OTC Bulletin Board (symbol ELTP) on the first day of employment. The
options were to vest over a three-year period commencing one year from the date of issuance. Mr. Bregman resigned prior to any of the
options vesting. We did not grant any other stock options to our named executive officers during the fiscal year ended March
31, 2022.
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. The value of the perquisites we
provide are taxable to the Named Executive Officers and the incremental cost to us of providing these perquisites are 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.
66
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 bonus equal to up to 100% of his annual salary,
payable in accordance with the Company’s payroll practices. 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 confidentiality,
non-competition and other standard restrictive covenants.
Mr.
Hakim’s employment is terminable by the Company for cause (as defined in the Hakim Employment Agreement). The Hakim Employment
Agreement also may be terminated by the Company upon at least 30 days written notice due to disability (as defined in the Hakim Employment
Agreement) 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.
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.
Marc
Bregman
On
April 26, 2021, the Company entered into an employment agreement with Mr. Marc Bregman (the “Bregman Employment Agreement”).
Pursuant to the terms of the Bregman Employment Agreement, Mr. Bregman served as an at-will employee of the Company as its Chief Financial
Officer. Mr. Bregman received a base salary of $187,000, payable in accordance with the Company’s payroll practices. He was
also eligible for an annual bonus, equal to up to 20% of his base salary.
67
Mr. Bregman was granted
stock options to purchase 300,000 shares of Common Stock. The options were to vest over a three-year period, commencing one year from
the date of issuance.
Mr.
Bregman was entitled generally to the same employee benefits offered to other employees of the Company, subject to applicable
eligibility requirements.
Mr.
Bregman subsequently resigned as CFO of the Company, effective April 29, 2022.
Douglas
Plassche
On
July 20, 2013, the Company entered into an employment agreement with Mr. Douglas Plassche (the “Plassche Employment Agreement”).
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 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 awarded 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, Mr. Plassche 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 is
entitled to a monthly automobile allowance of $500.
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
April 1, 2020, Mr. Plassche’s compensation was adjusted to include a total base compensation of $272,530, consisting of $247,530
being paid in cash in accordance with the Company’s payroll practices and $25,000 being paid by the issuance of shares of Common Stock in lieu of cash.
Mr.
Plassche is party to two retention agreements with the Company. On June 21, 2019, he entered into an agreement as an incentive for his
continued employment and cooperation during a transitional period for the Company, which provided a retention bonus of $253,552, subject
to his continued employment through June 30, 2021. This amount was earned during fiscal 2022 and is reflected in the Summary Compensation
Table below.
On
February 18, 2022, Mr. Plassche entered into a subsequent retention agreement with the Company (the “Plassche Retention
Agreement”), also as an incentive for his continued employment and cooperation during a transitional period for the Company.
Pursuant to the Plassche Retention Agreement, Mr. Plassche is entitled to a $150,000 retention payment on each of October 31,
2022 and June 30, 2023, subject in each case to his continued employment through such date.
On
March 1, 2022, Mr. Plassche’s compensation was adjusted to include a total base compensation package of $300,000 payable in accordance
with the Company’s payroll practices.
68
Potential
Payments Upon Termination or Change of Control
Messrs.
Hakim and Plassche are entitled to certain benefits upon a termination event (and in the case of Mr. Hakim, in connection with a change
of control), as described in the section entitled “Agreements with Named Executive Officers” above. We do not presently provide
the Named Executive Officers with any plan or arrangement, other than those that may be contained in the employment contracts disclosed
above, in connection with any termination, including, without limitation, through retirement, resignation, severance, or constructive
termination (including a change in responsibilities) of such Named Executive Officer’s employment with the Company.
As
part of the Company’s efforts to ensure the retention and continuity of key employees, officers, and directors in the event of
a change of control of the ownership of the Company, unless otherwise stated in applicable employment contracts, key executives would
receive an amount not to exceed twelve months of such executive’s salary, and certain Directors and managers would receive an amount
equal to six months of such Director’s or manager’s fees or salaries, as applicable. In addition, any outstanding and unvested
options would immediately vest, in the event of a change of control.
Hedging
Policy
We
do not permit the Named Executive Officers to “hedge” ownership by engaging in short sales or trading in any options contracts
involving securities.
Summary
Compensation Table
Name and Principal Position
Fiscal Year
Salary ($)
Bonus ($)
Option Awards
($)
All Other Compensation ($)
Total ($)
Nasrat Hakim, President, Chief Executive Officer and Chairman of the Board of Directors
2022
500,000 1
500,000 2
—
78,000 3
1,078,000
2021
500,000
500,000
—
78,000
1,078,000
Marc Bregman, Chief Financial Officer
2022
187,000 4
37,400 5
—
—
224,400
2021
—
—
—
—
—
Douglas Plassche, Executive Vice President
2022
261,644 6
393,902 7
—
6,000 8
661,546
2021
267,536
75,000
—
6,000
348,536
1 Represents
salary earned by Mr. Hakim pursuant to the Hakim Employment Agreement for Fiscal 2022, 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 2022.
A total of 11,570,858 shares of Common Stock are due and owing to Mr. Hakim in payment of salaries earned during Fiscal 2022. 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. In
aggregate, a total of $2,625,000 is accrued, due and owing to Mr. Hakim for salaries earned during Fiscal 2022, Fiscal 2021, and the
forty-eight months ended March 31, 2020, but not paid. This amount is to be paid via the issuance of 35,913,602 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 2022. Bonuses earned by Mr. Hakim during Fiscal 2022 were paid in accordance with the
Company’s payroll practices during Fiscal 2022. Mr. Hakim was also paid $187,500 during Fiscal 2022 for bonuses earned and
accrued during the twelve months ended March 31, 2019, and not paid previously. Mr. Hakim was also paid $375,000 during Fiscal 2022
for bonuses earned and accrued during the twelve months ended March 31, 2020, and not previously paid. Mr. Hakim accordingly was
paid a total of $1,062,000 during Fiscal 2022, with such amount representing bonuses earned during Fiscal 2022 and the twenty-four
month period ending March 31, 2020, and not previously paid. A total of $500,000 of bonus earned by Mr. Hakim during Fiscal 2021 was
paid in accordance with the Company’s payroll practices. Mr. Hakim was also paid a total of $750,000 of bonuses earned and
accrued during the twenty-four month period ending March 31, 2019 and not previously paid.
3
Represents $18,000 amounts paid for auto allowance and $60,000 for housing allowances.
4
Represents salaries earned by Mr. Bregman pursuant to the Bregman Employment Agreement.
5
Represents bonus earned by Mr. Bregman during fiscal 2022.
6 Represents
salaries earned by Mr. Plassche pursuant to the Plassche Employment Agreement. Fiscal 2022 salaries consist of $261,644 being paid
in accordance with the Company’s payroll practices.
7
Represents the bonus of $83,600 earned by Mr. Plassche for fiscal 2022 pursuant to the Plassche Employment Agreement, $18,750
of salaries earned during Fiscal 2022 which Mr. Plassche has elected to receive in cash instead of the issuance of common stock, and
$291,552 as retention bonus under the June 2019 retention agreement.
8
Represents amounts paid for auto allowances.
69
Outstanding
Equity Awards at March 31, 2022
Name
Number of
securities
underlying
unexercised
options
Exercisable
(#)
Number of
securities
underlying
unexercised
options
Unexercisable
(#)
Equity Incentive Plan
Awards:
Number of securities
underlying unexercised
unearned options
(#)
Options
Exercise
Price
($)
Option
Expiration
Date
Douglas Plassche
3,000,000
—
—
0.07
7/23/2023
Director
Compensation
The
following table sets forth information concerning director compensation for the year ended March 31, 2022:
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, 2022.
(2)
Amounts
represent Director fees earned during the fiscal year ended March 31, 2022 which are to be paid in cash. These fees were accrued
and unpaid as of March 31, 2022, 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 2022.
(3)
Director
equity compensation for the fiscal year ended March 31, 2022 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.
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 Common Stock, and the remaining $10,000 being paid in
cash; (iv) Directors 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 are paid a portion of their annual retainer fees via the issuance
of shares of Common Stock of the Company. The number of shares to be issued to each Director is equal to
the quotient of the quarterly amount due to each Director, 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, 2022 did not receive any additional equity compensation for serving
as directors.
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.
70
ITEM
12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The
following table sets forth certain information, as of June 23, 2022 (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 23, 2022, we had
1,011,281,988 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 23, 2022. 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*
284,737,145 (1)
28.2 %
Barry Dash, Director*
2,723,718 (2)
** %
Jeffrey Whitnell, Director*
2,675,363 (3)
** %
Davis Caskey, Director*
1,537,779 (4)
** %
Douglas Plassche, Executive Vice President *
4,491,484 (5)
** %
All Directors and Officers as a group
296,165,489 (6)
29.3 %
*
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 35,913,602 shares of Common Stock due and owing to Mr. Hakim as of March 31, 2022 (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
2,228,182 shares of Common Stock held and 495,536 shares of Common Stock due and owing to Dr. Dash as of March 31, 2022 (the latest
practicable date) for Directors fees accrued as of such date.
(3)
Includes
2,179,827 shares of Common Stock held and 495,536 shares of Common Stock due and owing to Mr. Whitnell as of March 31, 2022 (the
latest practicable date) for Directors fees accrued as of such date.
(4)
Includes
1,042,243 shares of Common Stock held and 495,536 shares of Common Stock due and owing to Mr. Caskey as of March 31, 2022 (the latest
practicable date) Date for Directors fees accrued as of such date.
(5)
Includes
1,133,932 shares of Common Stock held 357,552 shares of Common Stock due and owing to Mr. Plassche as of March 31, 2022 (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.
(6)
Relates
only to current directors and officers. Includes 176,399,066 shares of Common Stock held, 37,757,762 shares of Common Stock
due and owing as of March 31, 2022 (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.
71
ITEM
13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
Certain
Related Person Transactions
In
May 2020, Praxgen , under an asset purchase agreement, assigned its rights and obligations
under the Praxgen Agreement for Amphetamine IR and Amphetamine ER to Mikah. The ANDAs
for Amphetamine IR and Amphetamine ER are now registered under Elite’s name. Mikah is now Elite’s partner with respect
to Amphetamine IR and ER and Mikah will assume all the rights and obligations for these products from Praxgen .
Mikah 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, 2023 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 2022
Fiscal 2021
Audit Fees
$ 122,000
$ 120,000
Audit-Related Fees
$ —
$ —
Tax Fees
$ 8,500
$ 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 2022.
Pre-Approval
Procedures
The
Audit Committee pre-approves all audit related 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.
72
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
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 4.1 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
29, 2020 and filed with the SEC on June 29, 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.
4.6
Description
of Common Stock, incorporated by reference to Exhibit 4.6 to the Annual Report on Form 10-K, filed with the SEC on June 29, 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.
73
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.
10.19
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.
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.
10.27
June 4, 2015 License Agreement with Epic Pharma LLC, incorporated by reference to Exhibit 10.85 to Amendment No. 1 to the Annual Report on Form 10-K for the fiscal year ended March 31, 2015 and filed with the SEC on June 15, 2015. (Confidential Treatment granted with respect to portions of the Agreement).
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 May 1, 2017, incorporated by reference to Exhibit 10.1 to the Current
Report on Form 8-K, dated May 2, 2017 and filed with the SEC on May 2, 2017.
10.31
Registration
Rights Agreement between the Company and Lincoln Park Capital LLC dated May 1, 2017, incorporated by reference to Exhibit 10.2 to
the Current Report on Form 8-K, dated May 2, 2017 and filed with the SEC on May 2, 2017.
10.32
April
28, 2017 Exchange Agreement between the Company and Nasrat Hakim, incorporated by reference to Exhibit 10.1 to the Current Report
on Form 8-K, dated April 28, 2017 and filed with the SEC on April 28. 2017.
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.
74
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).
10.43
May
22, 2018 License, Manufacturing and Supply Agreement with Glenmark Pharmaceuticals Inc. USA, incorporated by reference to Exhibit
10.60 to the Annual Report on Form 10-K for the fiscal year ended March 31, 2018 and filed with the SEC on June 14, 2018. (Confidential
treatment granted with respect to portions of the Agreement).
10.44
August 1, 2018 Amendment to the Glenmark Pharmaceuticals Inc. USA License, Supply and Distribution Agreement, incorporated by reference to Exhibit 10.44 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)).of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)).
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, incorporated by reference to Exhibit 10.52 to the Annual Report on Form 10-K, filed with the SEC on June 14, 2021.
10.53
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)), incorporated by reference to Exhibit 10.54 to the Annual Report on Form 10-K, filed with the SEC on June 14, 2021.
75
10.54
Master Development and License Agreement for Products Between Elite Pharmaceuticals, Inc. and Mikah Pharma LLC, effective as of June 10, 2021.(Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10), incorporated by reference to the 10-Q for the period ended June 30, 2021 and filed with the SEC on August 16, 2021.
10.55
License, Supply, and Distribution Agreement by and between Elite Pharmaceuticals, Inc. and Lannett Company, Inc, dated October 18, 2021.*
10.56
License, Supply, and Distribution Agreement by and between Elite Pharmaceuticals, Inc. and Lannett Company, Inc, dated October 18, 2021.*
10.57
License and Distribution Agreement by and between Elite Pharmaceuticals, Inc. and Dexcel Ltd. (Or Akiva, Israel), dated December 6, 2021.*
10.58
February 18, 2022 Retention Agreement with Douglas Plassche.*
10.59
License, Supply, and Distribution
Agreement by and between Elite Pharmaceuticals and Lannett, Inc., dated July 20, 2021*
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.
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*
Inline
XBRL Instance Document
101.SCH*
Inline
XBRL Taxonomy Schema Document
101.CAL*
Inline
XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF*
Inline
XBRL Taxonomy Extension Definition Linkbase Document
101.LAB*
Inline
XBRL Taxonomy Extension Label Linkbase Document
101.PRE*
Inline
XBRL Taxonomy Extension Presentation Linkbase Document
104
Cover Page Interactive Data File (embedded within the
Inline XBRL document)
*
Filed
herewith.
**
Furnished
herewith.
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 29, 2022
By:
/s/
Robert Chen
Robert
Chen
Chief
Financial Officer
Dated:
June 29, 2022
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 Board of Directors (Principal Executive Officer)
June
29, 2022
/s/
Robert Chen
Chief
Financial Officer, Secretary, and Treasurer
June
29, 2022
/s/
Barry Dash
Director
June
29, 2022
/s/
Jeffrey Whitnell
Director
June
29, 2022
/s/
Davis Caskey
Director
June
29, 2022
77
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONSOLIDATED
FINANCIAL STATEMENTS
FOR
THE YEARS ENDED MARCH 31, 2022 AND 2021
TABLE
OF CONTENTS
PAGE
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM (Buchbinder Tunick & Company # 6189 )
F-2
CONSOLIDATED BALANCE SHEETS
F-4
CONSOLIDATED STATEMENTS OF OPERATIONS
F-6
CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY
F-7
CONSOLIDATED STATEMENTS OF CASH FLOWS
F-8
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
F-9
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, 2022 and 2021, 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, 2022,
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, 2022 and 2021 and
the results of its operations and its cash flows for each of the years in the two year period ended March 31, 2022 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.
Intangible Assets — Refer to Notes 1 and 4 to
the consolidated financial statements
Critical Audit Matter Description
As described in Note 1 and 4 to
the consolidated financial statements, 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 whenever events or circumstances change that indicate impairment may have occurred.
F- 2
Management performs a qualitative assessment of each
intangible assets prior to performing a quantitative impairment test. Qualitative factors management considers include, the current project
status, cost factors of raw material and labor, current cash flows, legal and regulatory factors and industry and market considerations.
If the qualitative assessment indicates the fair value is more likely than not less than the carrying value a quantitative test is performed.
The management performed a quantitative test on certain intangible assets using a discounted cash flow methodology and market approach.
The methods used to estimate the fair value of intangible assets involve significant assumptions. The significant assumptions applied
by management in estimating the fair value of intangible assets included income projections and discount rates. Due to the significant
estimates and assumptions management is required to make, we identified the fair value of intangible assets as a critical audit matter.
Performing audit procedures to evaluate the reasonableness of these estimates and assumptions required a high degree of auditor judgment
and an increased extent of effort.
How We Addressed the Matter in Our Audit
The primary procedures we performed to address this
critical audit matter included:
We obtained an understanding and evaluated
the design and implementation of controls over the intangible valuation process. This included management’s review over the assessment
of the methodology, significant inputs and assumptions included in the fair value estimate, as well as management’s review around
the completeness, accuracy and reasonableness of the data used in this estimate.
Our audit procedures assessed whether the
valuation methodology used was appropriate and tested the mathematical accuracy of the valuation model.
We evaluated whether the assumptions used
were reasonable by considering the past performance, and discount rates, and whether such assumptions were consistent with evidence obtained
in other areas of the audit.
/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 29, 2022
F- 3
ELITE PHARMACEUTICALS,
INC. AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS
(AUDITED)
March 31, 2022
March 31, 2021
ASSETS
Current assets:
Cash
$ 8,535,357
$ 3,192,768
Accounts receivable, net of allowance for doubtful accounts of $- 0 -, respectively
3,057,913
3,496,376
Inventory
6,741,170
5,012,902
Prepaid expenses and other current assets
526,949
492,621
Total current assets
18,861,389
12,194,667
Property and equipment, net of accumulated depreciation of
$ 13,348,565
and $ 12,153,626 ,
respectively
5,952,992
6,649,365
Intangible assets
6,634,035
6,634,035
Operating lease - right-of-use asset
1,031,884
214,674
Deferred income tax asset
2,171,821
—
Other assets:
Restricted cash - debt service for NJEDA bonds
405,039
405,013
Security deposits
91,738
91,738
Total other assets
496,777
496,751
Total assets
$ 35,148,898
$ 26,189,492
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$ 1,430,985
$ 929,690
Accrued expenses
4,693,142
4,270,600
Deferred revenue, current portion
13,333
13,333
Bonds payable, current portion, net of bond issuance costs
100,822
95,822
Loans payable, current portion
253,006
314,996
Lease obligation - operating lease, current portion
202,953
188,090
Total current liabilities
6,694,241
5,812,531
Long-term liabilities:
Deferred revenue, net of current portion
32,226
45,558
Bonds payable, net of current portion and bond issuance costs
1,139,848
1,240,668
Loans payable, net of current portion
249,046
500,066
Lease obligation - operating lease, net of current portion
835,893
38,866
Derivative financial instruments - warrants
936,837
2,362,246
Other long-term liabilities
38,780
37,628
Total long-term liabilities
3,232,630
4,225,032
Total liabilities
9,926,871
10,037,563
The
accompanying notes are an integral part of these consolidated financial statements.
F- 4
ELITE PHARMACEUTICALS,
INC. AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS
(AUDITED)
(continued)
March 31, 2022
March 31, 2021
Shareholders’ equity:
Common stock; par value $ 0.001 ; 1,445,000,000 shares authorized; 1,011,381,988 shares issued and 1,011,281,988 shares outstanding as of March 31, 2022; 1,009,276,752 shares issued and 1,009,176,752 shares outstanding as of March 31, 2021
1,011,385
1,009,279
Additional paid-in capital
164,577,227
164,407,480
Treasury stock; 100,000 shares as of March 31, 2022 and March 31, 2021; at cost
( 306,841 )
( 306,841 )
Accumulated deficit
( 140,059,744 )
( 148,957,989 )
Total shareholders’ equity
25,222,027
16,151,929
Total liabilities and shareholders’ equity
$ 35,148,898
$ 26,189,492
The
accompanying notes are an integral part of these consolidated financial statements.
F- 5
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
CONSOLIDATED
STATEMENTS OF OPERATIONS
(AUDITED)
2022
2021
For the Years Ended March 31,
2022
2021
Revenue:
Manufacturing fees
$ 26,951,863
$ 20,997,310
Licensing fees
5,310,254
4,383,439
Total revenue
32,262,117
25,380,749
Cost of manufacturing
17,466,763
13,513,611
Gross profit
14,795,354
11,867,138
Operating expenses:
Research and development
4,051,349
5,112,542
General and administrative
4,464,003
3,323,045
Non-cash compensation through issuance of stock options
14,353
13,181
Depreciation and amortization
1,194,939
1,313,847
Total operating expenses
9,724,644
9,762,615
Income from operations
5,070,710
2,104,523
Other income, net:
Change in fair value of derivative instruments
1,425,409
1,237,132
Interest expense and amortization of debt issuance costs
( 191,816 )
( 259,598 )
Gain on sale of fixed assets
—
48,463
Interest income
126
514
PPP loan forgiveness
—
1,013,480
Other income, net
1,233,719
2,039,991
Income from operations before income taxes
6,304,429
4,144,514
Income tax benefit
1,736,437
Net benefit for sale of state net operating losses and credits
857,379
943,907
Net income attributable to common shareholders
$ 8,898,245
$ 5,088,421
Basic net income per share attributable to common shareholders
$ 0.01
$ 0.01
Diluted net income per share attributable to common shareholders
$ 0.01
$ 0.00
Basic weighted average Common Stock outstanding
1,010,607,713
942,997,875
Diluted weighted average Common Stock outstanding
1,010,607,713
942,997,875
The
accompanying notes are an integral part of these consolidated financial statements.
F- 6
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
CONSOLIDATED
STATEMENTS OF SHAREHOLDERS’ EQUITY
(AUDITED)
Shares
Amount
Shares
Amount
Capital
Shares
Amount
Deficit
Equity
Series
J
Preferred Stock
Common
Stock
Additional
Paid-In
Treasury
Stock
Accumulated
Total Shareholders’
Shares
Amount
Shares
Amount
Capital
Shares
Amount
Deficit
Equity
Balance as of 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 2020 Lincoln Park purchase agreement
—
—
640,543
641
41,582
—
—
—
42,223
Common Stock issued as additional commitment shares pursuant to the 2020
Lincoln Park 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 expenses
—
—
1,931,891
1,932
159,101
—
—
—
161,033
Balance as of March 31, 2021
—
$ —
1,009,276,752
$ 1,009,279
$ 164,407,480
100,000
$ ( 306,841 )
$ ( 148,957,989 )
$ 16,151,929
Beginning balance
—
—
1,009,276,752
$ 1,009,279
$ 164,407,480
100,000
$ ( 306,841 )
$ ( 148,957,989 )
$ 16,151,929
Net income
—
—
—
—
—
—
—
8,898,245
8,898,245
Non-cash compensation through the issuance of employee stock options
—
—
—
—
14,353
—
—
—
14,353
Shares issued in payment of salaries
—
—
2,105,236
2,106
155,394
—
—
—
157,500
Balance at March 31, 2022
—
$ —
1,011,381,988
$ 1,011,385
$ 164,577,227
100,000
$ ( 306,841 )
$ ( 140,059,744 )
$ 25,222,027
Ending balance
—
$ —
1,011,381,988
$ 1,011,385
$ 164,577,227
100,000
$ ( 306,841 )
$ ( 140,059,744 )
$ 25,222,027
The
accompanying notes are an integral part of these consolidated financial statements.
F- 7
ELITE PHARMACEUTICALS,
INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF CASH FLOWS
(AUDITED)
2022
2021
For the Years Ended March 31,
2022
2021
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income
$ 8,898,245
$ 5,088,421
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization
1,209,119
1,313,847
Amortization of operating leases - right-of-use assets
225,590
210,744
Gain on sale of fixed assets
—
( 48,463 )
Change in fair value of derivative financial instruments - warrants
( 1,425,409 )
( 1,237,132 )
PPP loan forgiveness
—
( 1,013,480 )
Deferred income tax asset
( 2,171,821 )
—
Non-cash compensation accrued
767,122
922,443
Non-cash compensation through the issuance of employee stock options
14,353
13,181
Non-cash rent expense and lease accretion
1,152
2,186
Change in operating assets and liabilities:
Accounts receivable
438,463
610,470
Inventory
( 1,728,268 )
( 870,430 )
Prepaid expenses and other current assets
209,796
361,408
Accounts payable, accrued expenses and other current liabilities
314,214
( 1,768,862 )
Deferred revenue and customer deposits
( 13,332 )
( 180,000 )
Lease obligations - operating leases
( 230,910 )
( 210,472 )
Net cash provided by operating activities
6,508,314
3,193,861
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment
( 498,566 )
( 329,981 )
Proceeds from disposal of property and equipment
—
67,200
Net cash used in investing activities
( 498,566 )
( 262,781 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from PPP loan
—
1,013,480
Proceeds from the issuance of Common Stock
—
42,223
Payment of related party note payable
—
( 1,200,000 )
Payment of bond principal
( 110,000 )
( 105,000 )
Other loan payments
( 557,133 )
( 620,532 )
Net cash used in financing activities
( 667,133 )
( 869,829 )
Net change in cash and restricted cash
5,342,615
2,061,251
Cash and restricted cash, beginning of period
3,597,781
1,536,530
Cash and restricted cash, end of period
$ 8,940,396
$ 3,597,781
Supplemental disclosure of cash and non-cash transactions:
Cash paid for interest
$ 177,636
$ 176,179
Financing of equipment purchases and insurance renewal
$ 244,124
$ 410,141
Stock issued in payment of Directors fees, salaries and consulting expenses
$ 157,500
$ 352,283
Supplemental non-cash amounts of lease liabilities arising from obtaining right of use assets
$ 1,042,800
$ —
Commitment shares issued to Lincoln Park Capital
$ —
$ 722
Conversion of preferred stock to Common Stock
$ —
$ 13,903,960
Reconciliation of cash and restricted cash
Cash
$ 8,535,357
$ 3,192,768
Restricted cash - debt service for NJEDA bonds
405,039
405,013
Total cash and restricted cash shown in statement of cash flows
$ 8,940,396
$ 3,597,781
The
accompanying notes are an integral part of these consolidated financial statements.
F- 8
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 Labs. All significant intercompany accounts and transactions have been eliminated in consolidation.
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.
F- 9
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Under
ASC 606, Revenue from Contacts with Customers (“ASC 606”), the Company recognizes revenue when the customer obtains
control of promised goods or services, in an amount that reflects the consideration which is expected to be received in exchange for
those goods or services. The Company recognizes revenues following the five-step model prescribed under ASC 606: (i) identify contract(s)
with a customer; (ii) identify the performance obligation(s) in the contract; (iii) determine the transaction price; (iv) allocate the
transaction price to the performance obligation(s) in the contract; and (v) recognize revenues when (or as) the Company satisfies a performance
obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration
it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined
to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that
are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the
amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is
satisfied. Sales, value add, and other taxes collected on behalf of third parties are excluded from revenue.
Nature
of goods and services
The
following is a description of the Company’s goods and services from which the Company generates revenue, as well as the nature,
timing of satisfaction of performance obligations, and significant payment terms for each, as applicable:
a)
Manufacturing Fees
The
Company is equipped to manufacture controlled-release products on a contract basis for third parties, if, and when, the products are
approved. These products include products using controlled-release drug technology. The Company also develops and markets (either on
its own or by license to other companies) generic and proprietary controlled-release pharmaceutical products.
The
Company recognizes revenue when the customer obtains control of the Company’s product based on the contractual shipping terms of
the contract. The Company is primarily responsible for fulfilling the promise to provide the product, is responsible to ensure that the
product is produced in accordance with the related supply agreement and bears risk of loss while the inventory is in-transit to the commercial
partner. Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring products to a
customer.
b)
License Fees
The
Company enters into licensing and development agreements, which may include multiple revenue generating activities, including milestones
payments, licensing fees, product sales and services. The Company analyzes each element of its licensing and development agreements in
accordance with ASC 606 to determine appropriate revenue recognition. The terms of the license agreement may include payment to the Company
of licensing fees, non-refundable upfront license fees, milestone payments if specified objectives are achieved, and/or royalties on
product sales.
If
the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation.
Contracts that contain multiple performance obligations require an allocation of the transaction price based on the estimated relative
standalone selling prices of the promised products or services underlying each performance obligation. The Company determines standalone
selling prices based on the price at which the performance obligation is sold separately. If the standalone selling price is not observable
through past transactions, the Company estimates the standalone selling price taking into account available information such as market
conditions and internally approved pricing guidelines related to the performance obligations.
The
Company recognizes revenue from non-refundable upfront payments at a point in time, typically upon fulfilling the delivery of the associated
intellectual property to the customer. For those milestone payments which are contingent on the occurrence of particular future events
(for example, payments due upon a product receiving FDA approval), the Company determined that these need to be considered for inclusion
in the calculation of total consideration from the contract as a component of variable consideration using the most-likely amount method.
As such, the Company assesses each milestone to determine the probability and substance behind achieving each milestone. Given the inherent
uncertainty of the occurrence of future events, the Company will recognize revenue from the milestone when there is not a high probability
of a reversal of revenue, which typically occurs near or upon achievement of the event.
F- 10
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
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, 2022.
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 Praxgen, formerly known
as 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 Praxgen
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:
SCHEDULE
OF DISAGGREGATION OF REVENUE
For the Years Ended March 31,
2022
2021
NDA:
Manufacturing fees
$ 26,951,863
$ 20,997,310
Licensing fees
$ —
$ 166,167
Total NDA revenue
—
166,167
ANDA:
Manufacturing fees
$ 26,951,863
$ 20,997,310
Licensing fees
5,310,254
4,217,272
Total ANDA revenue
32,262,117
25,214,582
Total revenue
$ 32,262,117
$ 25,380,749
Selected
information on reportable segments and reconciliation of operating income by segment to income (loss) from operations before income taxes
are disclosed within Note 15.
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.
F- 11
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Restricted
Cash
As
of March 31, 2022, and March 31, 2021, the Company had $ 405,039 and $ 405,013 , of restricted cash, respectively, related to debt service
reserve in regard to the New Jersey Economic Development Authority (“NJEDA”) bonds (see Note 5).
Accounts
Receivable
Accounts
receivable are comprised of balances due from customers, net of estimated allowances for uncollectible accounts. In determining collectability,
historical trends are evaluated, and specific customer issues are reviewed on a periodic basis to arrive at appropriate allowances.
Inventory
Inventory
is recorded at the lower of cost or market on specific identification by lot number basis.
Long-Lived
Assets
The
Company periodically evaluates the fair value of long-lived assets, which include property and equipment and intangibles, whenever events
or changes in circumstances indicate that its carrying amounts may not be recoverable.
Property
and equipment are stated at cost. Depreciation is provided on the straight-line method based on the estimated useful lives of the respective
assets which range from three to forty years . Major repairs or improvements are capitalized. Minor replacements and maintenance and repairs
which do not improve or extend asset lives are expensed currently.
Upon
retirement or other disposition of assets, the cost and related accumulated depreciation are removed from the accounts and the resulting
gain or loss, if any, is recognized in income.
Intangible
Assets
The
Company capitalizes certain costs to acquire intangible assets; if such assets are determined to have a finite useful life they are amortized
on a straight-line basis over the estimated useful life. Costs to acquire indefinite lived intangible assets, such as costs related to
ANDAs are capitalized accordingly.
The
Company tests its intangible assets for impairment at least annually (as of March 31st) and whenever events or circumstances change that
indicate impairment may have occurred. A significant amount of judgment is involved in determining if an indicator of impairment has
occurred. Such indicators may include, among others and without limitation: a significant decline in the Company’s expected future
cash flows; a sustained, significant decline in the Company’s stock price and market capitalization; a significant adverse change
in legal factors or in the business climate of the Company’s segments; unanticipated competition; and slower growth rates.
As
of March 31, 2022, 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.
F- 12
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Contingencies
Occasionally,
the Company may be involved in claims and legal proceedings arising from the ordinary course of its business. The Company records a provision
for a liability when it believes that it is both probable that a liability has been incurred, and the amount can be reasonably estimated.
If these estimates and assumptions change or prove to be incorrect, it could have a material impact on the Company’s condensed
consolidated financial statements. Contingencies are inherently unpredictable, and the assessments of the value can involve a series
of complex judgments about future events and can rely heavily on estimates and assumptions.
Income
Taxes
Income
taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the estimated future
tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and
their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates in effect for the year in which
those temporary differences are expected to be recovered or settled. Where applicable, the Company records a valuation allowance to reduce
any deferred tax assets that it determines will not be realizable in the future.
The
Company recognizes the benefit of an uncertain tax position that it has taken or expects to take on income tax returns it files if such
tax position is more likely than not to be sustained on examination by the taxing authorities, based on the technical merits of the position.
These tax benefits are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate resolution .
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, 2022, 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, 2013 and forward. The
Company did not record unrecognized tax positions for the years ended March 31, 2022 and 2021.
F- 13
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 share being calculated on a quarterly basis and equal to the average closing price of the
Company’s Common Stock.
Earnings
Per Share Attributable to Common Shareholders’
The
Company follows ASC 260, Earnings Per Share, which requires presentation of basic and diluted earnings per share (“EPS”)
on the face of the income statement for all entities with complex capital structures and requires a reconciliation of the numerator and
denominator of the basic EPS computation to the numerator and denominator of the diluted EPS computation. In the accompanying financial
statements, basic earnings per share is computed by dividing net income by the weighted average number of shares of Common Stock outstanding
during the period. The computation of diluted net income per share does not include the conversion of securities that would have an antidilutive
effect.
F- 14
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The
following is the computation of earnings per share applicable to common shareholders for the periods indicated:
SCHEDULE
OF EARNINGS (LOSS) PER SHARE APPLICABLE TO COMMON SHAREHOLDERS
2022
2021
For the Years Ended March 31,
2022
2021
Numerator
Net income - basic
$ 8,898,245
$ 5,088,421
Effect of dilutive instrument on net income
( 1,425,409 )
( 1,237,132 )
Net income - diluted
$ 7,472,836
$ 3,851,289
Denominator
Weighted average shares of Common Stock outstanding - basic
1,010,607,713
942,997,875
Dilutive effect of stock options and convertible securities
—
—
Weighted average shares of Common Stock outstanding - diluted
1,010,607,713
942,997,875
Net income per share
Basic
$ 0.01
$ 0.01
Diluted
$ 0.01
$ 0.00
Fair
Value of Financial Instruments
ASC
820, Fair Value Measurements and Disclosures (“ASC 820”) provides a framework for measuring fair value in accordance
with generally accepted accounting principles.
ASC
820 defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction
between market participants at the measurement date. ASC 820 establishes a fair value hierarchy that distinguishes between (1) market
participant assumptions developed based on market data obtained from independent sources (observable inputs) and (2) an entity’s
own assumptions about market participant assumptions developed based on the best information available in the circumstances (unobservable
inputs).
The
fair value hierarchy consists of three broad levels, which gives the highest priority to unadjusted quoted prices in active markets for
identical assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3). The three levels of the fair value
hierarchy under ASC 820 are described as follows:
●
Level
1 – Unadjusted quoted prices in active markets for identical assets or liabilities that are accessible at the measurement date.
●
Level
2 – Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly
or indirectly. Level 2 inputs include quoted prices for similar assets or liabilities in active markets; quoted prices for identical
or similar assets or liabilities in markets that are not active; inputs other than quoted prices that are observable for the asset
or liability; and inputs that are derived principally from or corroborated by observable market data by correlation or other means.
●
Level
3 – Inputs that are unobservable for the asset or liability.
F- 15
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Measured
on a Recurring Basis
The
following table presents information about our liabilities measured at fair value on a recurring basis, aggregated by the level in the
fair value hierarchy within which those measurements fell:
SCHEDULE
OF LIABILITIES MEASURED AT FAIR VALUE ON A RECURRING BASIS
Amount at
Fair Value Measurement Using
Fair Value
Level 1
Level 2
Level 3
March 31, 2022
Liabilities
Derivative financial instruments - warrants
$ 936,837
$ —
$ —
$ 936,837
March 31, 2021
Liabilities
Derivative financial instruments - warrants
$ 2,362,246
$ —
$ —
$ 2,362,246
See
Note 11 for specific inputs used in determining fair value.
The
carrying amounts of the Company’s financial assets and liabilities, such as cash, accounts receivable, prepaid expenses and other
current assets, accounts payable and accrued expenses, approximate their fair values because of the short maturity of these instruments.
Based upon current borrowing rates with similar maturities the carrying value of long-term debt approximates fair value.
Non-Financial
Assets that are Measured at Fair Value on a Non-Recurring Basis
Non-financial
assets such as intangible assets, and property and equipment are measured at fair value only when an impairment loss is recognized. The
Company did not record an impairment charge related to these assets in the periods presented.
Treasury
Stock
The
Company records treasury stock at the cost to acquire it and includes treasury stock as a component of shareholders’ equity.
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:
SCHEDULE
OF INVENTORY
March 31, 2022
March 31, 2021
Finished goods
$ 159,808
$ 274,603
Work-in-progress
1,203,204
781,350
Raw materials
5,378,158
3,956,949
Inventory,
net
$ 6,741,170
$ 5,012,902
F- 16
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE
3. PROPERTY AND EQUIPMENT, NET
Property
and equipment consisted of the following:
SCHEDULE
OF PROPERTY AND EQUIPMENT
March 31, 2022
March 31, 2021
Land, building and improvements
$ 5,456,524
$ 5,456,523
Laboratory, manufacturing, warehouse and transportation equipment
13,017,731
12,580,457
Office equipment and software
373,601
373,601
Furniture and fixtures
453,701
392,410
19,301,557
18,802,991
Less: Accumulated depreciation
( 13,348,565 )
( 12,153,626 )
$ 5,952,992
$ 6,649,365
Depreciation
expense was $ 1,194,939 and $ 1,299,668 for the years ended March 31, 2022 and 2021, respectively.
NOTE
4. INTANGIBLE ASSETS
The
following table summarizes the Company’s intangible assets:
SCHEDULE OF INTANGIBLE ASSETS
March 31, 2022
Estimated Useful Life
Gross Carrying Amount
Additions
Reductions
Accumulated Amortization
Net Book 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, 2021
Estimated Useful Life
Gross Carrying Amount
Additions
Reductions
Accumulated Amortization
Net Book 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).
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 audited 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.
F- 17
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The
following tables summarize the Company’s bonds payable liability:
SCHEDULE
OF BONDS PAYABLE LIABILITY
March 31, 2022
March 31, 2021
Gross bonds payable
NJEDA Bonds - Series A Notes
$ 1,360,000
$ 1,470,000
Less: Current portion of bonds payable (prior to deduction
of bond offering costs)
( 115,000 )
( 110,000 )
Long-term portion of bonds payable (prior to deduction of
bond offering costs)
$ 1,245,000
$ 1,360,000
Bond offering costs
$ 354,454
$ 354,454
Less: Accumulated amortization
( 235,124 )
( 220,944 )
Bond offering costs, net
$ 119,330
$ 133,510
Current portion of bonds payable - net of bond offering costs
Current portions of bonds payable
$ 115,000
$ 110,000
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
$ 100,822
$ 95,822
Long term portion of bonds payable - net of bond offering costs
Long term portion of bonds payable
1,245,000
$ 1,360,000
Less: Bond offering costs to be amortized subsequent to the
next 12 months
( 105,152 )
( 119,332 )
Long term portion of bonds payable, net of bond offering
costs
$ 1,139,848
$ 1,240,668
Amortization
expense was $ 14,180 and $ 14,179 for the years ended March 31, 2022 and 2021, respectively. As of March 31, 2022 and March 31, 2021, interest
payable was $ 7,367 and $ 7,963 , respectively.
Maturities
of bonds for the next five years are as follows:
SCHEDULE OF MATURITIES OF BONDS FOR THE NEXT FIVE YEARS
Years ending March 31,
Amount
2023
115,000
2024
125,000
2025
130,000
2026
140,000
Thereafter
850,000
Total
$ 1,360,000
NOTE
6. LOANS PAYABLE
Loans
payable consisted of the following:
SCHEDULE OF LOANS PAYABLE
March 31, 2022
March 31, 2021
Equipment and insurance financing loans payable, between 3.30 % and 12.02 % interest and maturing between October 2022 and October 2025
$ 502,052
$ 815,062
Less: Current portion of loans payable
( 253,006 )
( 314,996 )
Long-term portion of loans payable
$ 249,046
$ 500,066
F- 18
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The
interest expense associated with the loans payable was $ 62,845 and $ 77,218 for the years ended March 31, 2022 and 2021, respectively.
Loan
principal payments for the next five years are as follows:
SCHEDULE OF LOAN PRINCIPAL PAYMENTS
Years ending March 31,
Amount
2023
253,006
2024
129,275
2025
96,117
2026
23,654
Total
$ 502,052
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 for the year ended March 31, 2021. 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 Mikah Note. Of the $ 435,000
accrued interest due at maturity, $ 435,000 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).
F- 19
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE
8. DEFERRED REVENUE
Deferred
revenues in the aggregate amount of $ 45,559 as of March 31, 2022, were comprised of a current component of $ 13,333 and a long-term component
of $ 32,226 . 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 . 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 .
These advance payments were recorded as deferred revenue when received and are earned, on a straight-line basis over the life of the
licenses. The current component is equal to the amount of revenue to be earned during the 12-month period immediately subsequent to the
balance sheet date and the long-term component is equal to the amount of revenue to be earned thereafter.
NOTE
9. COMMITMENTS AND CONTINGENCIES
Occasionally,
the Company may be involved in claims and legal proceedings arising from the ordinary course of its business. The Company records a provision
for a liability when it believes that it is both probable that a liability has been incurred, and the amount can be reasonably estimated.
If these estimates and assumptions change or prove to be incorrect, it could have a material impact on the Company’s condensed
consolidated financial statements. Contingencies are inherently unpredictable, and the assessments of the value can involve a series
of complex judgments about future events and can rely heavily on estimates and assumptions.
Operating
Leases – 135 Ludlow Ave.
The
Company entered into an operating lease for a portion of a one-story warehouse, located at 135 Ludlow Avenue, Northvale, New Jersey (the
“135 Ludlow Ave. lease”). The 135 Ludlow Ave. lease is for approximately 15,000 square feet of floor space and began on July
1, 2010. During July 2014, the Company modified the 135 Ludlow Ave. lease in which the Company was permitted to occupy the entire 35,000
square feet of floor space in the building (“135 Ludlow Ave. modified lease”).
The
135 Ludlow Ave. modified lease includes an initial term, which expired on December 31, 2016 with two tenant renewal options of five years
each, at the sole discretion of the Company. On June 22, 2016, the Company exercised the first of these renewal options, with such option
including a term that begins on January 1, 2017 and expires on December 31, 2021. On June 30, 2021, the Company exercised the second
of the renewal options, with such option including a term that begins on January 1, 2022 and expires on December 31, 2026 .
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.
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- 20
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Lease
assets and liabilities are classified as follows on the condensed consolidated balance sheet:
SCHEDULE OF LEASE ASSETS AND LIABILITIES
Lease
Classification
As of March 31, 2022
Assets
Operating
Operating lease – right-of-use asset
$ 1,031,884
Total leased assets
$ 1,031,884
Liabilities
Current
Operating
Lease obligation – operating lease
$ 202,953
Long-term
Operating
Lease obligation – operating lease, net of current portion
835,893
Total lease liabilities
$ 1,038,846
Rent
expense is recorded on the straight-line basis. Rent expense under the 135 Ludlow Ave. modified lease for the years ended March 31, 2022
and 2021 was $ 229,563 and $ 219,636 , respectively. Rent expense under the Pompano Office Lease for the year ended March 31, 2022 was $ 23,430 .
There was no rent expense under the Pompano Office lease for the year ended March 31, 2021 as there was a rent abatement period from
November 2020 through February 2021. Rent expense is recorded in general and administrative expense in the audited consolidated statements
of operations.
The
table below shows the future minimum rental payments, exclusive of taxes, insurance and other costs, under the 135 Ludlow Ave. modified
lease and the Pompano Office Lease:
SCHEDULE
OF FUTURE MINIMUM RENTAL PAYMENTS
Years ending March 31,
Amount
2023
259,794
2024
254,050
2025
243,612
2026
248,484
Thereafter
189,144
Total future minimum lease payments
1,195,084
Less: interest
( 156,238 )
Present value of lease payments
$ 1,038,846
The
weighted-average remaining lease term and the weighted-average discount rate of our lease was as follows:
SCHEDULE OF WEIGHTED-AVERAGE
REMAINING LEASE TERM AND THE WEIGHTED-AVERAGE DISCOUNT RATE
Lease Term and Discount Rate
March 31, 2022
Remaining lease term (years)
Operating leases
7
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, 2022, and March 31, 2021, the Company had a liability of $ 38,780 and $ 37,628 , respectively, recorded as a component
of other long-term liabilities.
F- 21
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
issued and outstanding, with a stated value of $ 1,000,000 per share and a par value of $ 0.01 as of March 31, 2022.
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 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
audited consolidated balance sheet as of March 31, 2022 (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 sheets as of March 31, 2022 and 2021.
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- 22
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:
SCHEDULE OF WARRANT ACTIVITY
March 31, 2022
March 31, 2021
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 Hakim, the Chairman of the Board, President, and Chief Executive
Officer of the Company, pursuant to which the Company issued to Hakim 24.0344 shares of its Series J Preferred and warrants to purchase
an aggregate of 79,008,661 shares of its Common Stock (the “Series J Warrants” and, along with the Series J Preferred issued
to Hakim, the “Securities”) in exchange for 158,017,321 shares of Common Stock owned by Hakim. The fair value of the Series
J Warrants was determined to be $ 6,474,674 upon issuance at April 28, 2017.
The
Series J Warrants are exercisable for a period of 10 years from the date of issuance, commencing April 28, 2020. The initial exercise
price is $ 0.1521 per share and the Series J Warrants can be exercised for cash or on a cashless basis. The exercise price is subject
to adjustment for any issuances or deemed issuances of Common Stock or Common Stock equivalents at an effective price below the then
exercise price. Such exercise price adjustment feature prohibits the Company from being able to conclude the warrants are indexed to
its own stock and thus such warrants are classified as liabilities and measured initially and subsequently at fair value. The Series
J Warrants also provide for other standard adjustments upon the happening of certain customary events.
The
fair value of the Series J Warrants was calculated using a Black-Scholes model instead of a Monte Carlo Simulation because the probability
with the shareholder approval provisions was no longer a factor. The following assumptions were used in the Black-Scholes model to calculate
the fair value of the Series J Warrants:
SCHEDULE
OF FAIR VALUE OF WARRANTS ISSUED
March 31, 2022
March 31, 2021
Fair value of the Company’s Common Stock
$ 0.0350
$ 0.0610
Volatility
76.55 %
75.18 %
Initial exercise price
$ 0.1521
$ 0.1521
Warrant term (in years)
5.1
6.1
Risk free rate
2.40 %
1.40 %
F- 23
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 year ended March 31, 2022 were
as follows:
SCHEDULE OF CHANGES IN WARRANTS MEASURED AT FAIR VALUE ON A RECURRING BASIS
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
Change in fair value of derivative financial instruments - warrants
( 1,425,409 )
Balance at March 31, 2022
$ 936,837
NOTE
12. SHAREHOLDERS’ EQUITY
Lincoln
Park Capital Transaction - July 8, 2020 Purchase Agreement
On
July 8, 2020, the Company entered into a purchase agreement (the “2020 LPC Purchase Agreement”), and a registration rights
agreement (the “2020 LPC Registration Rights Agreement”), with Lincoln Park Capital Fund, LLC (“Lincoln Park”),
pursuant to which Lincoln Park has committed to purchase up to $ 25.0 million of the Company’s Common Stock, $ 0.001 par value per
share, from time to time over the term of the 2020 LPC Purchase Agreement, at the Company’s direction.
The
Company did not issue any shares of its Common Stock pursuant to the 2020 LPC Purchase Agreement during the year ended March 31, 2022.
In addition, there were no shares issued to Lincoln Park as additional commitment shares, pursuant to the 2020 LPC Agreement.
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- 24
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Summary
of Common Stock Activity
During
the years ended March 31, 2022 and 2021, the Company issued 2,105,236 and 168,772,385 shares of Common Stock, respectively, with such
issuances of Common Stock being summarized as follows:
SCHEDULE OF COMMON STOCK ACTIVITY
2022
2021
March 31,
2022
2021
Common Stock issued as of March 31, 2021 and 2020, respectively
1,009,276,752
840,504,367
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 $ - and $ 42,223 for the years ended March 31, 2022 and 2021, respectively.
—
6,616,400
Common Stock issued as initial and additional commitment shares pursuant to the Lincoln Park Capital Purchase Agreements
—
10,094
Common Stock issued in payment of Directors fees, salaries and consulting fees
2,105,236
4,128,570
Common Stock issued during the fiscal year
2,105,236
168,772,385
Common Stock issued as of March 31, 2022 and 2021, respectively
1,011,381,988
1,009,276,752
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, 2022, the Company accrued director’s fees totaling $ 90,000 , which will be paid via cash payments totaling
$ 30,000 and the issuance of 1,378,608 shares of Common Stock.
As
of March 31, 2022, the Company owed its Directors a total of $ 30,000 in cash payments and 1,378,608 shares of Common Stock in payment
of director fees totaling $ 90,000 due and owing. The Company anticipates that these shares of Common Stock will be issued prior to the
end of the current fiscal year.
Stock-based
Employee/Consultant Compensation
Employment
contracts with the Company’s President and Chief Executive Officer 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, 2022, the Company issued 1,218,526 shares of Common Stock in payment of salaries totaling $ 97,500 pursuant to
the employment contract of the Company’s former Chief Financial Officer, with such salaries being earned and accrued over the forty
one month period beginning on October 1, 2018 and ending on March 31, 2021.
F- 25
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
During
the year ended March 31, 2022, the Company accrued salaries totaling $ 84,000 owed
to a certain other employees which will be paid via the issuance of 14,105,665 shares
of Common Stock.
As
of March 31, 2022, the Company owed its President and Chief Executive Officer and certain other employees’ salaries totaling $ 3,625,000
which will be paid via the issuance of 50,190,779 shares of Common Stock.
Options
Under
its 2014 Stock Option Plan and prior options plans, the Company may grant stock options to officers, selected employees, as well as members
of the Board of Directors and advisory board members. All options have generally been granted at a price equal to or greater than the
fair market value of the Company’s Common Stock at the date of the grant. Generally, options are granted with a vesting period
of up to three years and expire ten years from the date of grant. A summary of the activity of Company’s 2014 Stock Option Plan
for the years ended March 31, 2022 and 2021 is as follows:
SCHEDULE OF STOCK OPTION PLAN
Shares
Underlying
Options
Weighted
Average
Exercise Price
Weighted Average
Remaining Contractual Term (in years)
Aggregate Intrinsic
Value
Outstanding at March 31, 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
Granted
500,000
$ 0.05
Forfeited and expired
( 750,000 )
-
Outstanding at March 31, 2022
5,650,000
$ 0.14
2.8
$ —
Exercisable at March 31, 2022
4,530,001
$ 0.16
2.3
$ —
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, 2022 and March 31, 2021 of $ 0.10 and $ 0.06 , respectively. As
of March 31, 2022, there was $ 25,328 in unrecognized stock-based compensation expense that will be recognized over a 3 year period.
NOTE
14. CONCENTRATIONS AND CREDIT RISK
Revenues
Two
customers accounted for approximately 95 % of the Company’s revenues for the year ended March 31, 2022. These two customers accounted
for approximately 84 % and 11 % of revenues each, respectively.
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.
Accounts
Receivable
Two
customers accounted for approximately 91 % of the Company’s accounts receivable as of March 31, 2022. These two customers accounted
for approximately 78 % and 13 % of accounts receivable each, respectively.
Three
customers accounted for substantially all the Company’s accounts receivable as of March 31, 2021. These three customers accounted
for approximately 73 %, 15 % and 10 % of accounts receivable each, respectively.
F- 26
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Purchasing
Four
suppliers accounted for approximately 69 % of the Company’s purchases of raw materials for the year ended March 31, 2022. These
four suppliers accounted for approximately 51 %, 7 %, 6 % and 5 % of purchases each, respectively.
Four
suppliers accounted for more than 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.
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 audited consolidated
financial statements.
The
following represents selected information for the Company’s reportable segments:
SCHEDULE OF SELECTED INFORMATION FOR REPORTABLE SEGMENTS
2022
2021
For the Years Ended March 31,
2022
2021
Operating Income by Segment
ANDA
10,744,005
6,512,632
NDA
—
142,812
Operating Income by Segment
$ 10,744,005
$ 6,655,444
The
table below reconciles the Company’s operating income by segment to income from operations before provision for income taxes as
reported in the Company’s audited consolidated statement of operations:
SCHEDULE OF OPERATING LOSS BY SEGMENT TO (LOSS) INCOME FROM OPERATIONS
2022
2021
For the Years Ended March 31,
2022
2021
Operating income by segment
$ 10,744,005
$ 6,655,444
Corporate unallocated costs
( 3,696,881 )
( 2,252,983 )
Interest income
126
514
Interest expense and amortization of debt issuance costs
( 191,816 )
( 259,598 )
Depreciation and amortization expense
( 1,194,939 )
( 1,313,847 )
Significant non-cash items
( 781,475 )
( 935,628 )
PPP loan forgiveness
—
1,013,480
Change in fair value of derivative instruments
1,425,409
1,237,132
Income from operations before income taxes
$ 6,304,429
$ 4,144,514
F- 27
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
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 March 31, 2021, 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).
In
May 2020, Praxgen , pursuant to an asset purchase agreement, assigned its rights and
obligations under the Praxgen 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 Praxgen .
Mikah Pharmaceuticals was founded in 2009 by Nasrat Hakim, a related party and the Company’s President, Chief Executive Officer
and Chairman of the Board.
In
June 2021, the Company entered into a development and license agreement with Mikah Pharma LLC, pursuant to which Mikah Pharma LLC will
engage in the research, development, sales and licensing of generic pharmaceutical products. In addition, Mikah Pharma LLC will collaborate
to develop and commercialize generic products including formulation development, analytical method development, manufacturing, sales
and marketing of generic products. Initially two generic products were identified for the parties to develop.
NOTE
17. INCOME TAXES
The
components of the income taxes benefit (expense) are as follows:
SCHEDULE
OF COMPONENTS OF CREDIT FOR INCOME TAXES
2022
2021
Year Ended March 31,
2022
2021
Federal
Current
$ —
$ —
Deferred
2,171,821
—
State
Current
( 435,384 )
—
Deferred
—
—
Income tax benefit
$ 1,736,437
$ —
Benefit from sale of state net operating loss credits
$ 857,379
$ 943,907
Net benefit from sale of state net operating loss credits
$ 857,379
$ 943,907
The
major components of deferred tax assets and liabilities as of March 31, 2022 and 2021 are as follows (amounts in thousands of dollars):
SCHEDULE OF COMPONENTS OF DEFERRED TAX ASSETS AND LIABILITIES
2022
2021
Year Ended March 31,
2022
2021
Federal
Net operating loss carry forward
$ 21,180
$ 20,890
Tax credits
4,764
—
Valuation allowance
( 23,772 )
( 20,890 )
Deferred tax assets and
liabilities
$ 2,172
$ —
State
Net operating loss carry forward
$ 747
$ 841
Valuation Allowance
( 747 )
( 841 )
Deferred tax assets and
liabilities
$ —
$ —
F- 28
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
At
March 31, 2022 and 2021 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.
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, 2022, Elite has a federal net operating loss carry forward of $ 100.8
million, which do not expire and net operating
loss carry forward in state tax jurisdictions of $ 8.4
million some of which will begin to expire
in 2022 . During 2022, the Company was able
to release a portion of its valuation allowance as it determined future profits will offset a portion of its valuation allowance. During
2022, the Company recorded a tax benefit of $ 2.2
million as a result of this change in
judgment. Absent the above mentioned allowance, at March 31, 2022, the Company’s federal and state income taxes due were $ 0.0
million and $ 0.4
million, respectively.
Sale
of New Jersey Net Operating Loss
In
April 2020, Elite Labs 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 during the year ended March 31, 2021.
Sale
of New Jersey Net Operating Loss and Research and Development Tax Credit
In
April 2021, Elite Labs received final approval from the New Jersey Economic Development Authority for the sale of net tax benefits of
$ 796,860 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 $ 857,379 , during the year ended March 31,
2022.
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, 2022, and as of the date of this Annual Report on Form 10-K, 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
On
April 2, 2022, the Company entered into a loan and security agreement with East West Bank, pursuant to which the Company was granted
by the Bank a term loan of $ 12,000,000 for
a duration of five
years and an asset-based Revolving Line of
Credit up to $ 2,000,000 .
The Company has received the proceeds of $ 11,959,880 out
of the term loan net of applicable professional changes, and it will be used for general working capital purpose. In return for the term loan, the Company is required to meet certain financial terms and
conditions.
On April 8, 2022, the Company
entered into an Asset Purchase Agreement to purchase the building located at 135-137 Ludlow Avenue in Northvale NJ and is currently in
escrow. The Company has leased the entire 35,000 square feet of floor space since 2014. This property is occupied by the Company’s
Quality Assurance department, commercial manufacturing, packaging, and warehouse. The closing date is expected to take place in July
2022.
On June 27, 2022, the Company
received notification from the US Food and Drug Administration (FDA) for the approval of the Company’s Abbreviated New Drug Application
(ANDA) for a generic version of Sabril® (Vigabatrin USP) 500 mg powder for solution packet. Lannett
Company, Inc. has an exclusive license to market and distribute the product in the U.S. and territories. Elite will exclusively manufacture
and package the product for sale for an agreed-upon transfer price. The companies will share in product net profits.
F- 29