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 based on the
criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission on Internal Control (“COSO”),
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 not effective as of March 31, 2026 to ensure that
information required to be disclosed by the Company in reports that it files or submits under the Exchange Act is recorded, processed,
summarized and reported within the time periods specified in Securities and Exchange Commission rules and forms and such information
is accumulated and communicated to management as appropriate to allow timely decisions regarding required disclosures.
A
material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a
reasonable possibility that a misstatement of our annual or interim financial statements will not be prevented or detected on a timely
basis. As of March 31, 2026, we identified the following control deficiencies that we believe constituted individually, and in the aggregate,
material weaknesses in the design and operation components of our internal controls within the COSO framework:
● We
were unable to formalize and implement revised controls, policies and procedure documentation
to evidence a system of internal controls, including testing of such revised controls, that
was consistent with available personnel and resources;
● We
failed to maintain effective control activities over our control environment, risk assessment and response, information technology
and communication, objective setting, event identification, control activities and monitoring components and;
● We
had insufficient segregation of duties, oversight of work performed and lack of compensating
controls in our finance and accounting functions due to limited personnel and resources.
Management’s
Annual 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: (i) pertain to the maintenance of records that in reasonable
detail accurately and fairly reflect the transactions and dispositions of our assets; (ii) 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 (iii)
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 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.
54
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, utilizing those criteria, management has determined that, as of March 31, 2026, because
of the material weaknesses described below, our internal control over financial reporting was not effective.
A
material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a
reasonable possibility that a misstatement of our annual or interim financial statements will not be prevented or detected on a timely
basis. As of March 31, 2026, we identified the following control deficiencies that we believe constituted individually, and in the aggregate,
material weaknesses in the design and operation components of our internal controls within the COSO framework:
The
deficiencies in our internal controls over financial reporting and disclosure controls and procedures are described above and our efforts
to remediate these deficiencies are described below. Please also see Item 1A-Risk Factors: “ We have identified material weaknesses
in our internal control over financial reporting which could, if not remediated, adversely affect our ability to report our financial
condition, cash flows and results of operations in a timely and fairly stated manner and/or increase the risk of future misstatements,
which could have a material adverse effect on our business, financial condition, cash flows and results of operations and could cause
the market value of our common shares and/or debt securities to decline.”
Changes
in Internal Controls Over Financial Reporting
During
the fiscal year ended March 31, 2025, as a result of reviews and assessments of internal controls over financial reporting conducted
by the Company’s CFO, the Company identified material weaknesses in internal controls over financial reporting as further detailed
above and began remediation efforts which are detailed below, with such activities expected to result in further changes in internal
control over financial reporting as necessary to remediate the identified material weaknesses.
Remediation
efforts to address material weaknesses in internal controls over financial report ing
We
are in the process of revising and expanding control environment documentation and increasing personnel resources needed to support
the Company’s growth. We have begun designing and implementing controls, policies and procedure documentation that are
consistent with current and planned personnel, resources and capabilities, with significant focus on controls relating to financial
oversight, management, analysis and reporting of operations emanating from the Company’s manufacturing, marketing and
distribution of its Elite Label product line as well as enhanced segregation of duties and testing of control procedures. Please
note that these material weaknesses cannot be considered remediated until the applicable remedial controls operate for a sufficient
period of time, allowing management, through testing, to reach a conclusion on such controls design and operational
effectiveness.
Item
9B. OTHER INFORMATION .
During
the fiscal year ended March 31, 2026, none of the Company’s directors or officers (as defined in Rule 16a-1(f) of the Securities
Exchange Act of 1934, as amended) adopted or terminated a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement (as
such terms are defined in Item 408 of Regulation S-K of the Securities Act of 1933, as amended).
ITEM
9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS.
None.
55
PART
III
ITEM
10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The
following sets forth biographical information about each of our directors and executive officers as of the date of this report:
Name
Age
Position
Director/Officer
Since
Director
Class
Nasrat
Hakim
65
Chairman
of the Board of Directors
August
2013
III
Barry
Dash, Ph. D.
95
Director
April
2005
II
Jeffrey
Whitnell
70
Director
October
2009
III
Davis
Caskey
78
Director
April
2016
I
Kirko
Kirkov
58
Chief
Commercial Officer
September
2022
Douglas
Plassche
62
Executive
Vice President of Operations
August
2013
Carter
Ward
62
Chief
Financial Officer
September
2023
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 amended and restated bylaws, our Board of Directors is 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.
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.
56
Jeffrey
Whitnell
Jeffrey
Whitnell has served as a Director since October 23, 2009, Chairman of the Audit Committee, member of the Compensation Committee since
October 2009 and designated by the Board as an “audit committee financial expert” as defined under applicable rules under
the Exchange Act. Since April 2015, Mr. Whitnell has provided financial advisory services, primarily to the healthcare industry. He worked
for Southside Master, a specialty pharmacy company from September 2018 to June 2022, where he served as Chief Financial Officer. From
April 2015 to August 2018, Mr. Whitnell provided financial advisory services to various Private Equity portfolio companies, including
Lifewatch Services (acquired by BioTelemetry), where he served as Vice President, Finance & Controller. Mr. Whitnell was the Chief
Financial Officer for ReliefBand Medical Technologies, a medical device company, from June 2010 to March 2015. From July 2009 to May
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., a specialty pharmaceuticals
company. From 2002 to 2004, Mr. Whitnell was Vice President of Finance and Treasurer for Ovation Pharmaceuticals (acquired by Lundbeck).
From 1997 to 2001, Mr. Whitnell was Vice President of Finance and Treasurer for MediChem Research (acquired by deCODE genetics). Prior
to 1997, Mr. Whitnell held various finance positions with 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 (“ECR”), 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.
Kirko
Kirkov
Mr.
Kirkov joined Elite in September 2022, as an accomplished and multi-faceted leader with more than twenty years of in-depth business
development skills across international pharmaceutical organizations. Before joining Elite, Mr. Kirkov served as General Manager of Vertice
Pharma, a specialty generics pharmaceutical company, from February 2020 to August 2022. From April 2008 to February 2020, Mr. Kirkov
was employed by Sandoz and served in positions of increasing responsibilities beginning with Country Head & Managing Director of
Bulgaria from 2008 to 2011. From 2011 to 2013, Mr. Kirkov served as Sandoz’s Business Unit Head, Branded Prescription Generics
in Russia, and most recently, from January 2013 to February 2020, served as Sandoz’s Executive Director, Commercial Operations.
Mr. Kirkov brings with him a broad range of experience in the areas of business development, operationalization of commercial strategy,
and implementation of retail and wholesale channel sales operations, having overseen sales portfolios consisting of 400+ product families,
and 1,500+ SKUs covering both generic and branded products.
57
Mr.
Kirkov has a Bachelor of Science in Mechanical Engineering/Engineering Management from the University of Ottawa, two Masters of Science
degrees in Naval Architecture and Ocean Systems Management, respectively, from the Massachusetts Institute of Technology, a Master of
Science in Applied Positive Psychology and Coaching from the University of East London, and an MBA from the University of Durham.
Douglas
Plassche
Douglas
Plassche has served as the Company’s 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.
Carter
Ward
Carter
Ward has served as Chief Financial Officer, Secretary and Treasurer of the Company since September 5, 2023. This is Mr. Ward’s
second tenure with the Company, previously serving in the same positions from July 2009 through May 2021. In between Mr. Ward’s
roles with the Company, he served as Chief Financial Officer of Mirror Biologics, a privately held biotech organization from September
2022 to July 2023 and as CFO of Enveric Biosciences, a NASDAQ listed biotech company, from May 2021 to September 2022. Prior to initially
joining the Company, from July 2005 to April 2009, Mr. Ward filled multiple finance and supply chain leadership roles with the Actavis
Group and its U.S. subsidiary, Amide Pharmaceuticals. From September 2004 to June 2005, Mr. Ward was a consultant, mainly engaged in
improving internal controls and supporting Sarbanes Oxley compliance of Centennial Communications, Inc, a NASDAQ listed wireless communications
provider. Mr. Ward began his career as a certified public accountant in the audit department of KPMG. Mr. Ward holds a B.S. in Accounting
from Long Island University from where he graduated summa cum laude.
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
The
members of the Audit Committee are Mr. Jeffrey Whitnell (Chairman of the Audit Committee), Dr. Barry Dash, Mr. Davis Caskey and Mr. Nasrat
Hakim. The Board of Directors has determined that Messrs. Whitnell, Caskey and Dr. Dash are independent and Mr. Whitnell is qualified
as an audit committee financial expert. The Board of Directors has determined that Messrs. Whitnell, Caskey and Dr. Dash 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
The
members of the Nominating Committee are Mr. Nasrat Hakim (Chairman of the Nominating Committee), Dr. Barry Dash, and Mr. 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
The
members of the Compensation Committee are 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, 2026, 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.
58
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.
Insider
trading policy
The
Company has adopted insider trading policies and procedures governing the purchase, sale and/or other dispositions of its securities
by directors, officers and employees of the Company, that are reasonably designed to promote compliance with insider trading laws, rules
and regulations and any listing standards applicable to the Company. Such policies are described in our Code of Business Conduct and
Ethics filed as Exhibit 14.1 to this Annual Report on Form 10-K.
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 and equity awards are subject to ratification by the full Board of Directors.
The members of the Compensation Committee are Dr. Barry Dash (Chairman of the Compensation Committee), and Messrs Jeffrey Whitnell,
Davis Caskey and Nasrat Hakim. The Compensation 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, 2026, the Compensation Committee did not engage any advisors.
Named
Executive Officers
The
named executive officers for the fiscal year ended March 31, 2026 were:
● Nasrat
Hakim, Chief Executive Officer and President for the full year;
● Douglas
Plassche, Executive Vice President for the full year and;
● Carter
Ward, Chief Financial Officer 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 is driven 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. 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 each of the Named Executive Officers. 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.
59
In
the section below titled “ 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, 2026.
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. For the fiscal year ended March 31, 2026,
Mr. Plassche received a discretionary cash bonus of $178,482 and Mr. Ward received a discretionary cash bonus of $141,625. Mr. Hakim
was awarded a discretionary cash bonus of $5,000,000 that was accrued and owing as of March 31, 2026 and paid subsequent to March 31,
2026.
In the section below titled “Agreements with Named Executive Officers,” we describe Mr. Ward’s guaranteed annual bonus.
Equity
In
addition to cash compensation, our Named Executive Officers from time to time are granted stock options. All Options granted
typically include vesting periods consisting of one-third of total options granted vesting on each of the first, second and third
anniversaries of the grant date, with current employment being a requisite for all vesting. Options granted expire the earlier of
ten years from the grant date or 90 days subsequent to the employee’s last date of employment. There were no stock options
granted to our Named Executive Officers during the fiscal year ended March 31, 2026.
Although
we do not have a formal policy regarding the timing of awards of stock options, stock appreciation rights (“SARs”) and/or
similar option-like instruments grants to our Named Executive Officers, we do not make these awards or any other form of equity compensation
in anticipation of the release of material, non-public information. Similarly, we do not time the release of material, non-public information
based on stock option, SARs or other equity award grant dates for the purpose of affecting the value of any Named Executive Officer award.
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. 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 aggregate incremental cost to us for 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.
Agreements
with Named Executive Officers
Nasrat
Hakim
Pursuant
to his August 1, 2013 employment agreement, as amended on January 12, 2016 and September 13, 2023 (the “Hakim Employment
Agreement”), as of April 1, 2023, Mr. Hakim receives an annual salary of $1,000,000 per year 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, a car allowance of $1,500 per month and housing allowance of $5,000 per month, respectively. 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. The Hakim Employment Agreement shall also automatically terminate upon Mr. Hakim’s death. 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
reimbursement of any reasonable and necessary business expenses, all through the date of termination, payable in stock (“Basic
Termination Benefits”). 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, 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
an amount equal to two years’ annual base salary, payable in stock as a lump sum within 60 days of the termination date, and
12 months of partial health benefits continuation under the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended
(“COBRA”) equal to amounts the Company paid immediately prior to his separation of employment, subject to his timely
election of COBRA coverage, execution of a release and continued compliance with applicable restrictive covenants.
60
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 discretionary bonus and payment in an amount equal to two year’s annual base salary in effect upon
the date of termination, less applicable deductions, and withholdings, 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.
Douglas
Plassche
On
July 20, 2013, the Company entered into an employment agreement with Mr. Douglas Plassche (as modified by the retention agreement
dated February 18, 2022, 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.
Throughout
his tenure, Mr. Plassche’s compensation has been increased from time to time by the Board and the annual stock award has been
removed. On March 1, 2026, Mr. Plassche’s compensation was adjusted to include an annual salary of $374,812, payable in
accordance with the Company’s payroll practices. In addition, Mr. Plassche is entitled to a monthly automobile allowance of
$500 and an annual bonus based upon the achievement of agreed milestones and at the discretion of the Company and its Chief
Executive Officer.
The
Plassche Employment Agreement also provides for the granting of 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 expired, unexercised, ten years from the date of issuance, in accordance with the terms and
conditions of the option agreement.
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 his then current base annual salary.
Carter
Ward
On
September 5, 2023, the Company entered into an employment agreement with Mr. Carter Ward, effective as of September 5, 2023 to serve
as the Company’s Chief Financial Officer (the “Ward Employment Letter”). Pursuant to the Ward Employment Letter, Mr.
Ward receives an annual base salary of $275,000, guaranteed annual bonus equal to 20% of annual base salary and is eligible to receive
additional performance bonuses of up to 30% of annual base salary as determined from time to time by the Company’s Board of Directors.
In addition and also pursuant to the Ward Employment Letter, the Company’s Board of Directors approved the grant of options to
purchase 3,000,000 shares of Common Stock at a price equal to the closing price of the Company’s Common Stock on the first date
of Mr. Ward’s employment pursuant to the Ward Employment Letter.
61
The
Ward Employment Agreement will remain in effect until terminated by either party with at least 60 days advance written notice. In addition,
the Ward Employment Agreement is subject to early termination by Mr. Ward or the Company in accordance with the terms of the Ward Employment
Agreement.
Pursuant
to the Ward Agreement, if Mr. Ward’s employment is terminated by the Company without cause, then the Company must pay Mr.
Ward, in addition to any then-accrued and unpaid obligations owed to him, severance payments equal to two months of his then-current
base salary for each year of service, up to a maximum of 12 months, and 12 months of continued health insurance continuation under
COBRA equal to amounts the Company paid immediately prior to his separation of employment, at active employee rates, in each case, subject to his execution of a release and his compliance with applicable restrictive
covenants.
The
Ward Employment Agreement also contains covenants restricting Mr. Ward from soliciting the Company’s employees or customers during
his employment and for a period of 12 months after the termination of Mr. Ward’s employment with the Company and prohibiting him
from disclosing confidential information regarding the Company at any time.
Throughout
his tenure, Mr. Ward’s compensation has been increased from time to time by the Board. On March 1, 2026, Mr. Ward’s compensation
was adjusted to include an annual salary of $297,413, payable in accordance with the Company’s payroll practices.
Potential
Payments Upon Termination or Change of Control
Messrs.
Hakim, Plassche and Ward are entitled to certain benefits upon a termination event (and in the case of Mr. Hakim, in connection with
a change of control), as described in the section entitled “Agreements with Named Executive Officers” above. We do not presently
provide the Named Executive Officers with any plan or arrangement, other than those that may be contained in the employment contracts
disclosed above, in connection with any termination, including, without limitation, through retirement, resignation, severance, or constructive
termination (including a change in responsibilities) of such Named Executive Officer’s employment with the Company.
As
part of the Company’s efforts to ensure the retention and continuity of key employees, officers, and directors in the event of
a change of control of the Company, unless otherwise stated in applicable employment contracts, key executives would receive an amount
not to exceed twelve months of such executive’s salary, and certain managers would receive an amount equal to six
months of such Director’s or manager’s fees or salaries, as applicable. In addition, any outstanding and unvested options
would immediately vest, in the event of a change of control.
Summary
Compensation Table
Name and Principal Position
Fiscal Year
Salary
($)
Bonus
($)
All Other Compensation
($)
Total
($)
Nasrat Hakim, President, Chief Executive Officer and Chairman of the Board of Directors
2026
1,000,000 1
5,000,000 3
78,000 2
6,078,000
2025
1,000,000 1
—
78,000 2
1,078,000
Douglas Plassche, Executive Vice President
2026
355,348 4
178,482 4
6,000 6
539,830
2025
347,434 4
173,284 4
6,000 6
526,718
Carter Ward, Chief Financial Officer
2026
281,968 7
141,625 8
—
423,593
2025
275,687 7
137,500 8
—
413,187
1
Represents
salary earned by Mr. Hakim pursuant to the Hakim Employment Agreement for the fiscal years ended March 31, 2026 and 2025 and paid
in accordance with the Company’s payroll practices.
2
Represents
annual auto and housing allowances of $18,000 and $60,000, respectively.
3
Represents
discretionary cash bonus awarded to Mr. Hakim by the Board for fiscal year 2026.
62
4
Represents
salary earned by Mr. Plassche pursuant to the Plassche Employment Agreement and paid in accordance with the Company’s payroll
practices.
5
Represents
discretionary cash bonus earned pursuant to the Plassche Employment Agreement and paid in accordance with the Company’s payroll
practices.
6
Represents
annual auto allowance.
7
Represents
salary earned by Mr. Ward pursuant to the Ward Employment Agreement and paid in accordance with the Company’s payroll practices.
8
Represents cash bonuses earned pursuant to the Ward Employment Agreement and paid in accordance with the Company’s payroll
practices.
Outstanding
Equity Awards as of March 31, 2026
Option Awards
Name
Number
of
securities
underlying
unexercised
options
Exercisable
(#)
Number
of
securities
underlying
unexercised
options
Unexercisable
(#)
Options
Exercise
Price
($)
Option
Expiration
Date
Douglas Plassche
—
—
Carter Ward
2,000,000
1,000,000 1
$ 0.0898
9/5/2033
Nasrat Hakim
—
—
1
The remaining portion of this option grant is scheduled to
vest on September 5, 2026, subject to Mr. Ward’s continued employment through the vest date.
Director
Fee Compensation
The
Company’s policy regarding director fees is as follows: (i) Directors who are employees or consultants of the Company (and/or any
of its subsidiaries), including Mr. Hakim, 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 $30,000 annual retainer fee, payable in cash (iv) Directors do not receive any additional compensation for attendance at or
chairing of any meetings.
Director
Compensation
The
following table sets forth information concerning director compensation for the year ended March 31, 2026:
Name
Fees
Earned
or
Paid
In
Cash
1
($)
Total
($)
Barry Dash
30,000 2
30,000
Jeffrey Whitnell
30,000 2
30,000
Davis Caskey
30,000 2
30,000
1
Please
refer to the section above titled “Director Fee Compensation” for details on the Company’s director fee compensation
policy. No directors held unexercised or unvested stock or option awards as of March 31, 2026.
2
Amounts
represent Director fees earned during the fiscal year ended March 31, 2026 payable in cash.
63
ITEM
12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The
following table sets forth certain information, as of June 29, 2026 (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 29, 2026 we had 1,077,096,442
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 29, 2026. 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*
300,581,058 (1)
26.0 %
Barry Dash, Director*
3,235,555 (2)
** %
Jeffrey Whitnell, Director*
3,187,020 (3)
** %
Davis Caskey, Director*
2,049,436 (4)
** %
Douglas Plassche, Executive Vice President *
6,000,000 (5)
** %
Carter Ward, Chief Financial Officer
6,990,445 (6)
** %
All Directors and Officers as a group
322,043,514 (7)
27.9 %
*
The address is c/o Elite
Pharmaceuticals Inc., 165 Ludlow Avenue, Northvale, NJ 07647.
**
Less than 1%
(1) Includes
219,349,250 shares of Common Stock held by Mr. Hakim and 2,223,147 shares of Common Stock
held by Mr. Hakim’s spouse 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
3,235,555 shares of Common Stock held by Dr. Dash
(3) Includes
3,187,020 shares of Common Stock held by Mr. Whitnell
(4) Includes
2,049,436 shares of Common Stock held by Mr. Caskey.
(5) Includes
6,000,000 shares of Common Stock held by Mr. Plassche.
(6) Includes
4,990,445 shares of Common Stock held by Mr. Ward and shares of Common Stock issuable upon
cash exercise of vested options to purchase 2,000,000 shares of Common Stock and excludes
1,000,000 shares issuable upon exercise of options not vested or not exercisable within the
next 60 days.
(7) Relates
only to current directors and officers. Includes 241,034,853 shares of Common Stock held,
2,000,000 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, and excludes 1,000,000 shares issuable upon exercise of options
not vested or not exercisable within the next 60 days.
64
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 has assumed all the rights and obligations for these products from
Praxgen. Mikah was founded in 2009 by Nasrat Hakim, the Company’s President, Chief Executive Officer and Chairman of the Board
of Directors.
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 years ending March 31, 2026 and 2025 is Forvis Mazars LLP
(“ Forvis Mazars ”).
The
following table presents fees, including reimbursements for expenses, for professional audit services rendered by Forvis Mazars, for the fiscal years ended March 31, 2026 and 2025 for the audits of our financial statements and interim reviews of our
quarterly financial statements.
Fiscal 2026
Fiscal 2025
Audit Fees - Forvis Mazars, LLP
$ 792,000
$ 369,500
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.
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.
65
PART
IV
ITEM
15. EXHIBITS, FINANCIAL STATEMENTS AND SCHEDULES
(a)
The following are filed as
part of this Annual Report on Form 10-K
(1)
The financial statements and schedules required to be filed by Item 8 of this Annual Report on Form 10-K and listed in the Index to Consolidated
Financial Statements.
(2)
The Exhibits required by Item 601 of Regulation S-K and listed below in the “Index to Exhibits required by Item 601 of Regulation
S-K.”
(b)
The Exhibits are filed with
or incorporated by reference in this Annual Report on Form 10-K
(c)
None
Index
to Exhibits required by Item 601 of Regulation S-K.
Exhibit
No.
Description
3.1(a)
Articles of Incorporation of Elite-Nevada, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed with the SEC on January 9, 2012.
3.1(b)
Certificate of Designations of the Series G Convertible Preferred Stock as filed with the Secretary of State of the State of Nevada on April 18, 2013, incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K, dated April 18, 2013 and filed with the SEC on April 22, 2013.
3.1(c)
Certificate of Designation of the Series H Junior Participating Preferred Stock, incorporated by reference to Exhibit 2 (contained in Exhibit 1) to the Registration Statement on Form 8-A filed with the SEC on November 15, 2013.
3.1(d)
Certificate of Designations of the Series I Convertible Preferred Stock as filed with the Secretary of State of the State of Nevada on February 6, 2014, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K, dated February 6, 2014 and filed with the SEC on February 7, 2014.
3.1(e)
Certificate of Designations of the Series J Convertible Preferred Stock as filed with the Secretary of State of the State of Nevada on May 3, 2017, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K, dated April 28, 2017 and filed with the SEC on April 28, 2017.
3.1(f)
Certificate of Amendment to Articles of Incorporation, incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K, dated June 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. Restated 2014 Equity Incentive Plan , incorporated by reference to Exhibit 10.1 to the Annual Report on Form 10-K, filed with the SEC on July 1, 2024.
10.2
Form
of Confidentiality Agreement (corporate), incorporated by reference to Exhibit 10.7 to the Form SB-2.
10.3
Form
of Confidentiality Agreement (employee), incorporated by reference to Exhibit 10.8 to the Form SB-2.
10.4
Loan Agreement, dated as of August 15, 2005, between New Jersey Economic Development Authority (“NJEDA”) and the Company, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K, dated August 31, 2005 and filed with the SEC on September 6, 2005.
10.5
Series A Note in the aggregate principal amount of $3,660,000.00 payable to the order of the NJEDA, incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K, dated August 31, 2005 and filed with the SEC on September 6, 2005.
10.6
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.
10.7
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).
10.8
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.
10.9
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 thereof).
66
10.10
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 thereof).
10.11
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 thereof).
10.12
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)).
10.13
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.
10.14
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.
10.15
License and Distribution Agreement by and between Elite Pharmaceuticals, Inc. and Dexcel Ltd. (Or Akiva, Israel), dated December 6, 2021, incorporated by reference to Exhibit 10.57 to the Annual Report on Form 10-K for the period ended March 31, 2022, filed with the SEC on June 29, 2022.
10.16
February 18, 2022 Retention Agreement with Douglas Plassche, incorporated by reference to Exhibit 10.58 to the Annual Report on Form 10-K for the period ended March 31, 2022, filed with the SEC on June 29, 2022.
10.17
Agreement for Sale and Purchase of Real Estate, dated April 8, 2022, by and between Clyde Wesp and Margaret Wesp as trustees of the Wesp Family Joint Living Trust UTD November 19, 2015 and the Company, incorporated by reference to Exhibit 10.2 to the Quarterly Report on Form 10-Q, for the period ended June 30, 2022 and filed with the SEC on August 15, 2022.
10.18
Loan and Security Agreement, dated April 1, 2022, by and among East West Bank, Elite Pharmaceuticals, Inc. and Elite Laboratories, Inc., incorporated by reference to Exhibit 10.3 to the Quarterly Report on Form 10-Q, for the period ended June 30, 2022 and filed with the SEC on August 15, 2022.
10.19
Employment Agreement, dated September 5, 2022, between Elite Pharmaceuticals, Inc. and Kirko Kirkov, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the SEC on September 7, 2022.
10.20
Employment Agreement, dated April 27, 2023, between Elite Pharmaceuticals, Inc. and Mark Pellegrino, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the SEC on May 3, 2023
10.21
Employment Agreement, dated September 5, 2023, between Elite Pharmaceuticals, Inc. and Carter Ward, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the SEC on September 7, 2023.
10.22
Elite Pharmaceuticals, Inc. 2024 Equity Incentive Plan, incorporated by reference to Exhibit 99.1 to the Form S-8 filed with the SEC on March 28, 2024.
10.23
Asset Purchase Agreement, dated June 17, 2024, by and between the Company and Nostrum Laboratories Inc. incorporated by reference to Exhibit 10.59 to the Annual Report on Form 10-K, filed with the SEC on July 1, 2024
10.24
Amendment to Hakim Employment Agreement, dated September 13, 2023 incorporated by reference to Exhibit 10.24 to the Annual Report of Form 10-K, filed with the SEC on June 30, 2025.
10.25
License Agreement, dated as of September 10, 2010, by and among Precision Dose Inc. and the Company, incorporated by reference to Exhibit 10.8 to the Quarterly Report on Form 10-Q filed with the SEC on November 15, 2010 (Confidential Treatment granted with respect to portions thereof).
14.1*
Code of Business Conduct and Ethics of Elite Pharmaceuticals, Inc.
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 Forvis Mazars LLP, Independent Registered Public Accounting Firm*
31.1*
Certification of Chief Executive Officer pursuant to Exchange Act Rule 13a-14(a) and Rule 15d-14(a)*
31.2*
Certification of Chief Financial Officer pursuant to Exchange Act Rule 13a-14(a) and Rule 15d-14(a)*
32.1**
Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.**
32.2**
Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.**
101.INS*
XBRL
Instance Document
101.SCH*
XBRL
Taxonomy Schema Document
101.CAL*
XBRL
Taxonomy Extension Calculation Linkbase Document
101.DEF*
XBRL
Taxonomy Extension Definition Linkbase Document
101.LAB*
XBRL
Taxonomy Extension Label Linkbase Document
101.PRE*
XBRL
Taxonomy Extension Presentation Linkbase Document
*
Filed herewith.
**
Furnished herewith.
ITEM
16. FORM 10-K SUMMARY
None.
67
SIGNATURES
Pursuant
to the requirements 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.
6/29/2026
By:
/s/
Nasrat Hakim
Nasrat
Hakim
Chief
Executive Officer, President and Chairman of the Board of Directors
(Principal
Executive Officer)
6/29/2026
By:
/s/
Carter Ward
Carter
Ward
Chief
Financial Officer
(Principal
Accounting Officer and Principal Financial Officer)
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
June
29, 2026
Nasrat
Hakim
(Principal
Executive Officer)
/s/
Carter Ward
Chief
Financial Officer
June
29, 2026
Carter
Ward
(Principal
Accounting Officer and Principal Financial Officer)
/s/
Barry Dash
Director
June
29, 2026
Barry
Dash
/s/
Jeffrey Whitnell
Director
June
29, 2026
Jeffrey
Whitnell
/s/
Davis Caskey
Director
June
29, 2026
Davis
Caskey
68
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONSOLIDATED
FINANCIAL STATEMENTS
FOR
THE YEARS ENDED MARCH 31, 2026 AND 2025
TABLE
OF CONTENTS
PAGE
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM ( Forvis Mazars, LLP , Iselin, NJ # 686 )
F-1
CONSOLIDATED BALANCE SHEETS
F-2
CONSOLIDATED STATEMENTS OF OPERATIONS
F-3
CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY
F-4
CONSOLIDATED STATEMENTS OF CASH FLOWS
F-5
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
F-6
69
Report
of Independent Registered Public Accounting Firm
To
the Shareholders, Board of Directors, and Audit Committee
Elite
Pharmaceuticals, Inc.
Opinion
on the Consolidated Financial Statements
We
have audited the accompanying consolidated balance sheets of Elite Pharmaceuticals, Inc. (the “Company”) as of March 31,
2026 and 2025, the related consolidated statements of operations, shareholders’ equity, and cash flows for each of the
years in the two-year period ended March 31, 2026, and the related notes (collectively referred to as the “financial
statements”). In our opinion, the financial statements referred to above present fairly, in all material
respects, the financial position of the Company as of March 31, 2026 and 2025, and the results of its operations and its cash flows
for each of the years in the two-year period ended March 31, 2026, in conformity with accounting principles generally accepted in
the United States of America.
Basis
for Opinion
These
financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s
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 include examining, on a test basis, evidence regarding
the amounts and disclosures in the 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 financial statements. We believe that our audits
provides 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 a 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 a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Chargeback
Reserve
As
described in Note 1 to the financial statements, the Company recognizes revenue from the sale of generic pharmaceutical products under
the Elite label at their net realizable value, which includes reductions for variable consideration such as chargebacks. A chargeback
represents the difference between the price the wholesaler pays and the price that the wholesaler’s end-customer pays for a product.
The Company provides for chargebacks to wholesalers for sales to various end-customers, including hospitals, group purchasing organizations,
institutions, and pharmacies. The Company’s estimate for chargebacks is developed based on management’s assumptions regarding
anticipated product returns, other rebates, and historical information.
We
identified the chargeback reserve as a critical audit matter due to the subjectivity involved in management’s assumptions used
to estimate the reserve, including the reliance on historical chargeback data and the variability in the wholesaler’s end-customer
pricing arrangements. These factors required a high degree of auditor judgment in evaluating the reasonableness of the estimate.
The
primary procedures we performed to address this critical audit matter included:
● Obtaining
an understanding of management’s process for developing the chargeback reserve, including
the methods and assumptions used;
● Testing
the completeness and accuracy of the underlying data used in the estimate, including historical
chargeback activity and customer arrangements;
● Developing
an independent expectation of the chargeback reserve using relevant historical chargeback
data to assess the reasonableness of management’s estimate;
● Assessed
the relevance and reliability of the data from external sources utilized in determination
of the independent expectation of the chargeback reserve.
/s/
Forvis Mazars, LLP
We
have served as the Company’s auditor since 2024.
Iselin,
New Jersey
June
29, 2026
F- 1
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
CONSOLIDATED
BALANCE SHEETS
March 31, 2026
March 31, 2025
ASSETS
Current assets:
Cash
$ 29,797,800
$ 11,315,385
Accounts receivable, net of allowance for expected credit losses of $ 1,441,523 and $ 387,533 respectively
59,715,676
29,207,028
Inventory
21,259,898
16,240,376
Prepaid expenses and other current assets
1,333,177
976,358
Total current assets
112,106,551
57,739,147
Property and equipment, net of accumulated depreciation of $ 18,100,243 and $ 17,028,700 respectively
10,181,328
10,327,245
Intangible assets
4,790,790
5,637,802
Finance lease - right-of-use asset, net of accumulated amortization of $ 984,801 and $ 508,470 , respectively
1,295,163
1,771,494
Operating lease - right-of-use asset
1,529,468
2,000,284
Deferred income tax asset
7,823,039
18,365,748
Other assets:
Restricted cash - debt service for NJEDA bonds
471,520
453,776
Security deposits
91,981
91,981
Total other assets
563,501
545,757
Total assets
$ 138,289,840
$ 96,387,477
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$ 6,053,444
$ 2,957,584
Accrued expenses
10,194,222
3,795,227
Deferred revenue
—
5,556
Bonds payable, current portion, net of bond issuance costs
135,822
125,822
Loans payable, current portion
92,774
120,744
Related party loans payable (Note 8)
—
4,000,000
Lease obligation - finance lease, current portion
378,775
363,112
Lease obligation - operating lease, current portion
536,427
472,390
Total current liabilities
17,391,464
11,840,435
Long-term liabilities:
Bonds payable, net of current portion and bond issuance costs
651,559
787,381
Loans payable, net of current portion and loan costs
2,152,969
2,245,743
Lease obligation - finance lease, net of current portion
851,640
1,247,621
Lease obligation - operating lease, net of current portion
1,015,647
1,552,075
Derivative financial instruments - warrants
17,343,586
25,199,193
Total long-term liabilities
22,015,401
31,032,013
Total liabilities
39,406,865
42,872,448
Commitments and Contingencies (Note 9)
-
-
Shareholders’ equity:
Common Stock; par value $ 0.001 ; 1,445,000,000 shares authorized; 1,077,196,442 and 1,068,463,108 shares issued as of March 31, 2026 and March 31, 2025, respectively; 1,077,096,442 and 1,068,363,108 shares outstanding as of March 31, 2026 and March 31, 2025, respectively
1,077,200
1,068,467
Additional paid-in capital
173,943,856
173,457,329
Treasury stock; 100,000 shares as of both March 31, 2026 and March 31, 2025, at cost
( 306,841 )
( 306,841 )
Accumulated deficit
( 75,831,240 )
( 120,703,926 )
Total
shareholders’ equity
98,882,975
53,515,029
Total liabilities and shareholders’ equity
$ 138,289,840
$ 96,387,477
The
accompanying notes are an integral part of these consolidated financial statements.
F- 2
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
CONSOLIDATED
STATEMENTS OF OPERATIONS
2026
2025
For the Years Ended March 31,
2026
2025
Revenue:
Manufacturing fees
$ 147,810,122
$ 81,986,079
Licensing fees
1,059,997
2,057,850
Total revenue
148,870,119
84,043,929
Cost of manufacturing
73,845,784
43,957,274
Gross profit
75,024,335
40,086,655
Operating expenses:
Research and development
5,742,955
7,964,837
General and administrative
17,596,803
9,001,930
Non-cash compensation through issuance of stock options
176,507
227,565
Impairment of intangible assets
847,012
1,603,426
Depreciation and amortization
1,547,874
1,688,429
Total operating expenses
25,911,151
20,486,187
Income from operations
49,113,184
19,600,468
Other income (expense):
Change in fair value of derivative financial instruments - warrants
7,855,607
( 18,901,185 )
Interest expense and amortization of debt issuance costs
( 396,664 )
( 772,367 )
Interest income
207,857
20,944
Other income
34,500
—
Other income (expense), net
7,701,300
( 19,652,608 )
Income (loss) before income taxes
56,814,484
( 52,140 )
Income tax expense
( 11,941,798 )
( 4,262,519 )
Net income (loss)
$ 44,872,686
$ ( 4,314,659 )
Basic net income (loss) per share
$ 0.04
$ ( 0.00 )
Diluted net income (loss) per share
$ 0.03
$ ( 0.00 )
Basic weighted average common stock outstanding
1,072,837,856
1,068,290,368
Diluted weighted average common stock outstanding
1,138,368,235
1,068,290,368
The accompanying notes are an integral part of
these consolidated financial statements.
F- 3
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
CONSOLIDATED
STATEMENTS OF SHAREHOLDERS’ EQUITY
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, 2024
—
$ —
1,068,373,108
$ 1,068,377
$ 173,210,549
100,000
$ ( 306,841 )
$ ( 116,389,267 )
$ 57,582,818
Net loss
—
—
—
—
—
—
—
( 4,314,659 )
( 4,314,659 )
Non-cash compensation through the issuance of employee stock options
—
—
—
—
227,565
—
—
—
227,565
Shares issued in payment of consultants
—
—
90,000
90
19,215
—
—
—
19,305
Balance as of March 31, 2025
—
$ —
1,068,463,108
$ 1,068,467
$ 173,457,329
100,000
$ ( 306,841 )
$ ( 120,703,926 )
$ 53,515,029
Balance
—
$ —
1,068,463,108
$ 1,068,467
$ 173,457,329
100,000
$ ( 306,841 )
$ ( 120,703,926 )
$ 53,515,029
Net income
—
—
—
—
—
—
—
44,872,686
44,872,686
Net income (loss)
—
—
—
—
—
—
—
44,872,686
44,872,686
Non-cash compensation through the issuance of employee stock options
—
—
—
—
176,507
—
—
—
176,507
Shares issued pursuant to exercise of employee stock options
—
—
8,733,334
8,733
310,020
—
—
—
318,753
Balance as of March 31, 2026
—
$ —
1,077,196,442
$ 1,077,200
$ 173,943,856
100,000
$ ( 306,841 )
$ ( 75,831,240 )
$ 98,882,975
Balance
—
$ —
1,077,196,442
$ 1,077,200
$ 173,943,856
100,000
$ ( 306,841 )
$ ( 75,831,240 )
$ 98,882,975
The accompanying notes
are an integral part of these consolidated financial statements.
F- 4
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
CONSOLIDATED
STATEMENTS OF CASH FLOWS
2026
2025
For the Years Ended March 31,
2026
2025
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income (loss)
$ 44,872,686
$ ( 4,314,659 )
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
Depreciation and amortization
1,071,543
1,226,399
Provision for losses on accounts receivable
1,053,990
151,258
Impairment of intangible assets
847,012
1,603,426
Amortization of operating leases - right-of-use assets
470,816
433,914
Amortization of finance leases - right-of-use assets
476,331
462,030
Amortization of debt discount - bonds offering costs
14,178
14,178
Loss on asset disposal
—
121,481
Change in fair value of derivative financial instruments - warrants
( 7,855,607 )
18,901,185
Deferred tax expense
10,542,709
3,795,147
Non-cash compensation through the issuance of employee stock options
176,507
227,565
Change in operating assets and liabilities:
Accounts receivable
( 31,562,638 )
( 9,904,985 )
Inventory
( 5,019,522 )
( 3,309,912 )
Prepaid expenses and other current assets
( 356,819 )
( 253,739 )
Security deposits
—
2,259
Accounts payable
3,095,860
243,278
Accrued expenses
6,398,995
( 1,506,520 )
Deferred revenue
( 5,556 )
( 13,333 )
Lease obligations - operating leases
( 472,391 )
( 423,333 )
Net cash provided by operating activities
23,748,094
7,455,639
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment
( 925,626 )
( 1,625,082 )
Purchase of intangible assets
—
( 900,000 )
Proceeds from disposition of property and equipment
—
125,250
Net cash used in investing activities
( 925,626 )
( 2,399,832 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Payment of bond principal
( 140,000 )
( 130,000 )
Payments of related party loans payable
( 4,000,000 )
—
Payments on principal on finance lease obligations
( 380,318 )
( 336,189 )
Proceeds from exercise of stock options
318,753
19,305
Loan payments
( 120,744 )
( 378,856 )
Net cash used in financing activities
( 4,322,309 )
( 825,740 )
Net change in cash and restricted cash
18,500,159
4,230,067
Cash and restricted cash, beginning of period
11,769,161
7,539,094
Cash and restricted cash, end of period
$ 30,269,320
$ 11,769,161
Supplemental disclosure of cash and non-cash transactions:
Cash paid for interest
$ 246,118
$ 672,409
Cash paid for income taxes
$ 1,150,785
$ 612,085
Finance directors and officers insurance premium
$ —
$ 198,457
Recognition of finance lease right of use asset and lease liabilities entered into
$ —
$ 153,870
Recognition of operating lease right of use asset and lease liabilities entered into
$ —
$ 78,997
Reconciliation of cash and restricted cash
Cash
$ 29,797,800
$ 11,315,385
Restricted cash - debt service for NJEDA bonds
471,520
453,776
Total cash and restricted cash shown in statement of cash flows
$ 30,269,320
$ 11,769,161
The accompanying notes
are an integral part of these consolidated financial statements.
F- 5
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, manufacturing, and sales of generic, oral dose pharmaceuticals.
The Company is equipped to manufacture controlled-release products on a contract basis for third parties and itself, if and when the
product candidates are approved. These products include drugs that cover therapeutic areas for allergy, bariatric, attention deficit
and infection. Research and development activities are performed with an objective of developing product candidates that will secure
marketing approvals from the United States Food and Drug Administration (“FDA”), and thereafter, commercially exploiting
such products.
Basis
of Presentation
The
accompanying audited consolidated financial statements have been prepared in accordance with generally accepted accounting principles
in the United States (“GAAP”) and pursuant to the rules and regulations of the SEC. 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. The preparation of financial statements in accordance with GAAP requires management to make certain
estimates and assumptions affecting amounts reported in the Company’s consolidated financial statements.
Use
of Estimates
The
preparation of consolidated financial statements in conformity with GAAP requires management to make certain estimates and assumptions.
These estimates and assumptions affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities
at the date of the consolidated financial statements, as well as reported amounts of revenues and expenses during the reporting period.
Such management estimates and assumptions include, but are not limited to, chargeback liabilities related to revenue recognition, valuation
of intangible assets, the useful life of property and equipment and identifiable intangible assets, stock-based compensation expense,
and income taxes. The Company continuously evaluates its estimates, which are based on the information that is currently available to
the Company and on various other assumptions that it believes to be reasonable under the circumstances. Actual results could differ from
those estimates.
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 (“CODM”),
or decision-making group, in deciding how to allocate resources and in assessing performance.
The
Company’s CODM 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 previously determined that its reportable segments were products whose marketing approvals were secured via an Abbreviated New
Drug Application (“ANDA”) and products whose marketing approvals were secured via a New Drug Application (“NDA”).
ANDA products are referred to as generic pharmaceuticals and NDA products are referred to as branded pharmaceuticals. The Company identifies
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. The
Company has paused further development of NDAs and has not engaged in business activities for several years, and does not intend to engage
in business activities related to the development of NDAs for the foreseeable future. Therefore, as of March 31, 2026, the Company has
determined that it operates in a 1 single operating and reportable segment.
Asset
information by operating segment is not presented below since the chief operating decision maker does not review this information by
segment. The ANDA segment follows the same accounting policies used in the preparation of the Company’s consolidated financial
statements. Please see Note 14 for further details.
Revenue
Recognition
The
Company generates revenue from manufacturing and licensing fees and direct sales to pharmaceutical distributors for pharmacies and institutions.
Manufacturing fees include the development of pain management products, manufacturing of a line of generic pharmaceutical products with
approved ANDA, through the manufacture of formulations and the development of new products. Licensing fees include the commercialization
of products either by license and the collection of royalties, or the expansion of licensing agreements with other pharmaceutical companies,
including co-development projects, joint ventures and other collaborations.
F- 6
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Under
ASC 606, Revenue from Contracts 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 manufacturing fees related to revenue generated from wholesale customers and from direct sale customers. Wholesalers
represent customers that purchase the Company’s products and sell them to end customers such as hospitals, group purchasing organizations,
institutions, and pharmacies. Direct sales customers purchase products directly from the Company.
The
Company provides for chargebacks to wholesalers for sales to various end-customers to include, but not limited to, hospitals, group purchasing
organizations, and pharmacies. Chargebacks represent the difference between the price the wholesaler pays and the price that the end-customer
pays for a product. The Company’s estimate for chargebacks is developed based upon management’s assumption of anticipated
claims as well as historical information. Chargebacks represent variable consideration within the Company’s contracts and therefore
as such, revenue recognized is limited to the amount for which a significant reversal of revenue related to this variable consideration
is not probable.
The
Company recognizes revenue when the customer obtains control of the Company’s product based on the contractual shipping terms of
the contract, at which time the performance obligation is deemed to be completed. The Company is primarily responsible for ensuring that
the product is produced in accordance with the related supply agreement, and fulfilling the promise to deliver the product and bearing
the risk of loss while the inventory is in-transit to the purchaser or commercial partner. Revenue is measured as the amount of consideration
the Company expects to receive from the sale of its products, including Elite-labeled pharmaceutical products, and is recorded at net
realizable value which consists of gross amounts invoiced reduced by contractual reductions, including, without limitation, chargebacks,
discounts and program rebates, as applicable.
b)
License Fees
The
Company enters into licensing and development agreements, which may include multiple revenue generating activities, including milestones
payments, licensing fees, product sales and services. The Company analyzes each element of its licensing and development agreements in
accordance with ASC 606 to determine appropriate revenue recognition. The terms of the license agreement may include payment to the Company
of licensing fees, non-refundable upfront license fees, milestone payments if specified objectives are achieved, and/or royalties on
product sales.
If
the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation.
Contracts that contain multiple performance obligations require an allocation of the transaction price based on the estimated relative
standalone selling prices of the promised products or services underlying each performance obligation. The Company determines standalone
selling prices based on the price at which the performance obligation is sold separately. If the standalone selling price is not observable
through past transactions, the Company estimates the standalone selling price taking into account available information such as market
conditions and internally approved pricing guidelines related to the performance obligations.
F- 7
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
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.
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, 2026.
In
accordance with ASC 606-10-55-65, royalties are recognized when the subsequent sale of the customer’s products occurs.
Disaggregation
of revenue
In
the following table, revenue is disaggregated by type of revenue generated by the Company. The Company recognizes revenue at a point
in time for all performance obligations. During the fiscal years ended March 31, 2026 and 2025, the Company has paused further development
of NDAs and has not engaged in business activities in that segment. Accordingly during the fiscal years ended March 31, 2026 and 2025,
the Company has only engaged in business activities in a single operating segment.
Selected
information on reportable segments and the reconciliation of operating income by segment to income from operation and to income (loss)
before income taxes are disclosed within Note 14.
The
Company disaggregates manufacturing fees revenue by sales channel, consisting of revenues from direct and indirect wholesalers, which
have different cash flows and contract economics as margins generated differ between direct and indirect revenues. Additionally, although
the underlying arrangements are substantially similar, pricing to direct wholesalers yields higher margins than pricing to indirect wholesalers,
while the timing and uncertainty of cash flows do not differ materially. The following table summarizes manufacturing fees by sales channel
for the fiscal years ended March 31, 2026 and 2025:
SCHEDULE OF DISAGGREGATION OF REVENUE
2026
2025
For the Years Ended March 31,
2026
2025
Direct sales to Wholesalers
$ 65,273,763
$ 48,008,986
Indirect sales to Wholesalers
82,536,359
33,977,093
Total Manufacturing Fees
$ 147,810,122
$ 81,986,079
The
Company’s revenue-generating products consist of two categories: (i) products containing an active ingredient listed by the United
States Drug Enforcement Agency as a scheduled substance under the Controlled Substances Act of 1970 (“Scheduled Products”)
and (ii) products not containing such a scheduled active ingredient (“Unscheduled Products”). The following table summarizes
the breakdown of revenues by product category for the fiscal years ended March 31, 2026 and 2025:
2026
2025
For the Years Ended March 31,
2026
2025
Scheduled Products – Manufacturing Fees
$ 141,465,975
$ 74,756,506
Scheduled Products – Licensing Fees
465,511
248,789
Unscheduled Products – Manufacturing Fees
6,344,147
7,229,573
Unscheduled Products – Licensing Fees
594,486
1,809,061
Total Revenue
$ 148,870,119
$ 84,043,929
F- 8
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Cash
Cash
consists of cash on deposit with banks and money market instruments. The Company places its cash with high-quality, U.S. financial institutions
and, to date has not experienced losses on any of its balances.
Restricted
Cash
As
of March 31, 2026 and 2025, the Company had $ 471,520 and $ 453,776 , of restricted cash, respectively, related to debt service reserve
in regard to the New Jersey Economic Development Authority (“NJEDA”) bonds (see Note 6).
Accounts
Receivable and Allowance for Expected Credit Losses
Accounts
receivable are comprised of balances due from customers, net of estimated allowances for expected credit losses, and other contractual
deductions, including, without limitation, chargebacks, discounts and program rebates. In determining collectability, historical trends
are evaluated, and specific customer issues are reviewed on a periodic basis to arrive at appropriate allowances.
The
allowance for expected credit losses is based on the probability of future collection under the current expected credited loss (“CECL”)
impairment model under Accounting Standards Update (“ASU”) 2016-13, Financial Instruments - Credit Losses (Topic 326),
Measurement of Credit Losses on Financial Assets . Under the CECL impairment model, the Company determines its allowance by applying
a loss-rate method based on an aging schedule using the Company’s historical loss rate. The Company also considers reasonable and
supportable current information in determining its estimated loss rates, such as external forecasts, macroeconomic trends or other factors
including customers’ credit risk and historical loss experience. The adequacy of the allowance is evaluated on a regular basis.
Account balances are written off after all means of collection are exhausted and the balance is deemed uncollectible. Subsequent recoveries
are credited to the allowance. Changes in the allowance are recorded as adjustments to credit losses in the period incurred.
The
Company’s quantitative allowance for credit loss estimates under CECL was determined using the loss rate method, which is impacted
by certain forecasted economic factors. In addition to the Company’s quantitative allowance for credit losses, the Company also
incorporates qualitative adjustments that may relate to unique risks, changes in current economic conditions that may not be reflected
in quantitatively derived results, or other relevant factors to further inform the Company’s estimate of the allowance for credit
losses.
Additionally,
due to the expansion of the time horizon over which the Company is required to estimate future credit losses, the Company may experience
increased volatility in its future provisions for credit losses. Factors that could contribute to such volatility include, but are not
limited to, changes in the composition and credit quality of customer base, economic conditions and forecasts, the allowance for credit
loss models that are used, the data that is included in the models, the associated qualitative allowance framework, and the Company’s
estimation techniques.
During
the fiscal years ended March 31, 2026 and 2025, the Company incurred bad debt expenses of $ 1,053,990 and $ 151,258 , respectively. As of
March 31, 2026 and 2025, the Company’s allowance for credit losses was $ 1,441,523 and $ 387,533 , respectively.
Inventory
Inventory
is recorded at the lower of cost or net realizable value on specific identification by lot number basis.
Long-Lived
Assets
The
Company periodically evaluates the fair value of long-lived assets, which include property and equipment and intangibles, whenever events
or changes in circumstances indicate that its carrying amounts may not be recoverable.
Property
and equipment are stated at cost. Depreciation is provided on the straight-line method based on the estimated useful lives of the respective
assets which range from 3 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.
F- 9
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
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. Judgment is involved in determining if an indicator of impairment has occurred. Such indicators
may include, among others and without limitation: a significant decline in the Company’s expected future cash flows; a sustained,
significant decline in the Company’s stock price and market capitalization; a significant adverse change in legal factors or in
the business climate of the Company’s segments; unanticipated competition; and slower growth rates.
Research
and Development
Research
and development expenditures are charged to expenses as incurred.
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, 2026, a summary of the tax years that remain subject
to examination in the Company’s major tax jurisdictions are: United States – Federal, 2022 and forward, and State, 2021 and
forward. The Company did not have any unrecognized tax positions for the years ended March 31, 2026 and 2025.
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. The Company accounts
for forfeitures as they occur.
Earnings
(Loss) Per Share
The
Company follows ASC 260, Earnings Per Share , which requires presentation of basic and diluted income (loss) per share (“EPS”)
on the face of the income statement for all entities with complex capital structures and requires a reconciliation of the numerator and
denominator of the basic EPS computation to the numerator and denominator of the diluted EPS computation. In the accompanying financial
statements, basic income (loss) per share is computed by dividing net income (loss) by the weighted average number of shares of Common
Stock outstanding during the period. The computation of diluted net income (loss) per share includes the assumed exercise of options
and warrants if the effect is dilutive. The assumed exercise of the Series J Warrants was dilutive for the year ended March 31, 2026,
and is therefore included in the diluted EPS calculation for that period.
F- 10
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
As
the Company was in a net loss position for the year ended March 31, 2025, the potential dilution from the Series J Warrants converting
into 79,008,661 shares of Common Stock and the stock options being exercised for 15,640,000 shares of Common Stock for these periods
have been excluded from the number of shares used in calculating diluted net income (loss) per share as their inclusion would have been
antidilutive.
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
2026
2025
For the Years Ended March 31,
2026
2025
Numerator
Net income (loss) - basic
$ 44,872,686
$ ( 4,314,659 )
Effect of dilutive instrument on net income - warrants
( 7,855,607 )
—
Net income (loss) - diluted
$ 37,017,079
$ ( 4,314,659 )
Denominator
Weighted average shares of Common Stock outstanding - basic
1,072,837,856
1,068,290,368
Dilutive effect of stock options and convertible securities
65,530,379
—
Weighted average shares of Common Stock outstanding - diluted
1,138,368,235
1,068,290,368
Net income (loss) per share
Basic
$ 0.04
$ ( 0.00 )
Diluted
$ 0.03
$ ( 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.
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, and related party loans payable approximates
fair value.
F- 11
ELITE
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
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.
See
Note 4 for additional information for the impairment loss recorded in relation to the Company’s intangible assets.
Treasury
Stock
The
Company records treasury stock at the cost to acquire it and includes treasury stock as a component of shareholders’ equity.
Right-of-Use
Asset and Lease Liability
The
Company accounts for leases in accordance with ASC 842, Leases (Topic 842) (“ASC 842”).
A
lessee should recognize the lease liability to make lease payments and the right-of-use asset representing its right to use the underlying
asset for the lease term. For operating leases and finance leases, a right-of-use asset and a lease liability are initially measured
at the present value of the lease payments by discount rates. The Company’s lease discount rates are generally based on its incremental
borrowing rate, as the discount rates implicit in the Company’s leases is readily determinable. Operating leases are included in
operating lease right-of-use assets and lease liabilities in the consolidated balance sheets. Finance leases are included in property
and equipment and lease liability in the Company’s consolidated balance sheets. Lease expense for operating expense payments is
recognized on a straight-line basis over the lease term. Interest and amortization expenses are recognized for finance leases on a straight-line
basis over the lease term.
For
the leases with a term of twelve months or less, a lessee is permitted to make an accounting policy election by class of underlying asset
not to recognize lease assets and lease liabilities. If a lessee makes this election, it should recognize lease expense for such leases
generally on a straight-line basis over the lease term.
Recently
Adopted Accounting Pronouncements
In
December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures , which requires public
entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income
taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption
permitted. The Company adopted ASU 2023-09 for the year ended March 31, 2026, and applied the new disclosure requirements prospectively
to the current annual period. Prior period disclosures have not been adjusted to reflect the new disclosure requirements. See Note 16
Income Taxes in the accompanying notes to the consolidated financial statements for further detail.
Recently
Issued Accounting Pronouncements
In
November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures
(Subtopic 220-40): Disaggregation of Income Statement Expenses. In January 2025, the FASB issued ASU No. 2025-01, Income Statement
- Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40), Clarifying the Effective Date (“ASU-2024-03”).
ASU 2024-03 requires public companies to disclose, in interim and reporting periods, additional information about certain expenses in
the financial statements. ASU 2024-03, as clarified by ASU 2025-01, is effective for public entities for annual periods beginning after
December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted and is effective on either
a prospective basis or retrospective basis. The Company is currently evaluating the impact that the updated standard will have on the
Company’s disclosures within the consolidated financial statements.
In
May 2025, the FASB issued ASU 2025-04, Compensation-Stock Compensation (Topic 718) and Revenue from Contracts with Customers (Topic
606): Clarifications to Share-Based Consideration Payable to a Customer to reduce diversity in practice and improve the decision
usefulness and operability of the guidance for share-based consideration payable to a customer in conjunction with selling goods or services.
The ASU is effective for fiscal years beginning after December 15, 2026 with updates to be applied on a retrospective or modified retrospective
basis. Early adoption is permitted. The Company is evaluating the impact that this standard will have on the Company’s consolidated
financial statements.
In
July 2025, the FASB issued ASU 2025-05, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses for Accounts
Receivable and Contract Assets . The ASU introduces a practical expedient and an accounting policy election to simplify the estimation
of expected credit losses for current accounts receivable and current contract assets arising from transactions accounted for under ASC
606. The practical expedient allows entities to assume that conditions at the balance sheet date remain unchanged for the asset’s
remaining life when preparing forecasts as part of estimating expected credit losses. The ASU is effective for fiscal years beginning
after December 15, 2025, and is to be adopted on a prospective basis. Early adoption is permitted. The Company is currently evaluating
the impact of this standard on its consolidated financial statements.
In
December 2025, the FASB issued ASU 2025-11, Interim Reporting (Topic 270)—Narrow-Scope Improvements . The ASU clarifies the
scope of interim reporting guidance, reorganizes disclosure requirements for ease of navigation, and introduces a principle requiring
disclosure of material events occurring after the last annual reporting period but before interim financial statements are issued. The
ASU does not create new disclosure requirements but improves clarity and consistency in presentation. The ASU is effective for interim
periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The Company is currently evaluating the impact
this standard will have on the Company’s consolidated financial statements.
F- 12
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Management
has evaluated recently issued accounting pronouncements outside of those mentioned above and does not believe that any of these pronouncements
will have a significant impact on the Company’s consolidated financial statements and related disclosures.
NOTE
2. INVENTORY
Inventory
consisted of the following:
SCHEDULE OF INVENTORY
March 31, 2026
March 31, 2025
Finished goods
$ 5,389,291
$ 4,816,458
Work-in-progress
3,267,705
1,422,005
Raw materials
12,602,902
10,001,913
Inventory
$ 21,259,898
$ 16,240,376
NOTE
3. PROPERTY AND EQUIPMENT, NET
Property
and equipment consisted of the following:
SCHEDULE OF PROPERTY AND EQUIPMENT
March 31, 2026
March 31, 2025
Land, building and improvements
$ 11,649,918
$ 11,649,918
Laboratory, manufacturing, warehouse and transportation equipment
15,701,634
14,776,008
Office equipment and software
373,601
373,601
Furniture and fixtures
556,418
556,418
Property and equipment, gross
28,281,571
27,355,945
Less: Accumulated depreciation
( 18,100,243 )
( 17,028,700 )
Property and equipment, net
$ 10,181,328
$ 10,327,245
Depreciation
expense was $ 1,071,543 and $ 1,226,399 for the years ended March 31, 2026 and 2025, respectively.
NOTE
4. INTANGIBLE ASSETS
The
following table summarizes the Company’s intangible assets as of and for the periods ended March 31, 2026 and 2025:
SCHEDULE OF INTANGIBLE ASSETS
March 31, 2026
Estimated
Useful Life
Gross Carrying
Amount
Additions
Impairment
losses
Accumulated
Amortization
Net Book
Value
Patent application costs
- *
$ 289,039
$ —
$ ( 289,039 )
$ —
$ —
ANDA acquisition costs
Indefinite
5,348,763
-
( 557,973 )
—
4,790,790
$ 5,637,802
$ —
$ ( 847,012 )
$ —
$ 4,790,790
March 31, 2025
Estimated
Useful Life
Gross Carrying
Amount
Additions
Impairment
losses
Accumulated
Amortization
Net Book
Value
Patent application costs
- *
$ 289,039
$ —
$ —
$ —
$ 289,039
ANDA acquisition costs
Indefinite
6,052,189
900,000
( 1,603,426 )
—
5,348,763
$ 6,341,228
$ 900,000
$ ( 1,603,426 )
$ —
$ 5,637,802
* Patent application costs were incurred in relation to the Company’s abuse deterrent
opioid technology. Amortization of the patent costs would have begun upon the issuance of marketing authorization by the FDA. During
the year ended March 31, 2026, these costs were impaired in full as discussed above.
On
June 17, 2024, the Company and Nostrum Laboratories Inc. (“Nostrum”) entered into an Asset Purchase Agreement (the “Asset
Purchase Agreement”), pursuant to which Nostrum was obligated to (i) sell to the Company all of its rights in and to the approved
abbreviated new drug applications (ANDAs) for generic Norco® (Hydrocodone Bitartrate and Acetaminophen tablets, USP CII), generic
Percocet® (Oxycodone Hydrochloride and Acetaminophen, USP CII), and generic Dolophine® (Methadone Hydrochloride tablets), each
a “Product”, and (ii) grant to the Company a royalty-free, non-exclusive perpetual license to use the manufacturing technology,
proprietary information, processes, techniques, protocols, methods, know-how, and improvements necessary or used to manufacture each
Product in accordance with the applicable ANDA, in exchange for $ 900,000 in cash (the “Transaction”). The Asset Purchase
Agreement includes customary representations and warranties and various customary covenants. The closing of the Transaction occurred
on June 21, 2024.
F- 13
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
During
the year ended March 31, 2026, the Company determined indicators of impairment occurred related to the Loxapine intangible asset, an
ANDA product, and recorded impairment expense of $ 557,973 . Additionally, the patent related to the Company’s abuse deterrent opioid
technology expired during the year ended March 31, 2026, before marketing authorization was obtained from the FDA, and as such the Company
impaired this intangible asset in full in the amount of $ 289,039 .
During
the year ended March 31, 2025, the Company determined indicators of impairment occurred related to the Dantrolene and Phentermine intangible
assets, both ANDA products, and recorded impairment expense of $ 1,603,426 .
*
Patent application costs were incurred in relation to the Company’s abuse deterrent opioid technology. Amortization of the patent
costs would have begun upon the issuance of marketing authorization by the FDA. During the year ended March 31, 2026, these costs were
impaired in full as discussed above.
NOTE
5. ACCRUED EXPENSES
Accrued
expenses consisted of the following:
SCHEDULE OF ACCRUED EXPENSES
March 31, 2026
March 31, 2025
Co-development profit split
$ 2,616,950
$ 2,617,210
Income tax
594,181
340,614
Employee bonuses
5,285,256
121,885
Audit fees
500,000
75,000
Legal and professional expense
282,672
55,000
Director dues
22,500
22,500
Salaries and fees payable
273,059
172,655
Accrued interest - related parties
—
100,000
Other accrued expenses
619,604
290,363
Total accrued expenses
$ 10,194,222
$ 3,795,227
NOTE
6. NJEDA BONDS
During
August 2005, the Company refinanced a prior 1999 bond issue occurring in 1999 through the issuance of Series A and B Notes new tax-exempt
bonds (the “NJEDA Bonds”). The refinancing involved borrowing $ 4,155,000 , evidenced by a 6.5 % Series A Note in the principal
amount of $ 3,660,000 maturing on September 1, 2030 and a 9 % Series B Note in the principal amount of $ 495,000 maturing on September 1,
2012 . During July 2014, the Company retired all the 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 fund. The debt service reserve is classified
as restricted cash on the accompanying consolidated balance sheets. The NJEDA Bonds require the Company to make an annual principal payment
on September 1st based on the amount specified in the loan documents and semi-annual interest payments on March 1st and September 1st,
equal to interest due on the outstanding principal. The annual interest rate on the Series A Note is 6.5 %. The NJEDA Bonds are collateralized
by a first lien on the Company’s facility and equipment acquired with the proceeds of the original and refinanced bonds. The bonds
mature on September 1, 2030.
F- 14
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, 2026
March 31, 2025
Gross bonds payable
NJEDA Bonds - Series A Notes
$ 850,000
$ 990,000
Less: Current portion of bonds payable (prior to deduction of bond offering costs)
( 150,000 )
( 140,000 )
Long-term portion of bonds payable (prior to deduction of bond offering costs)
$ 700,000
$ 850,000
Bond offering costs
$ 354,454
$ 354,454
Less: Accumulated amortization
( 291,835 )
( 277,657 )
Bond offering costs, net
$ 62,619
$ 76,797
Current portion of bonds payable - net of bond offering costs
Current portions of bonds payable
$ 150,000
$ 140,000
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
$ 135,822
$ 125,822
Long term portion of bonds payable - net of bond offering costs
Long term portion of bonds payable
$ 700,000
$ 850,000
Less: Bond offering costs to be amortized subsequent to the next 12 months
( 48,441 )
( 62,619 )
Long term portion of bonds payable, net of bond offering costs
$ 651,559
$ 787,381
Amortization
expense was $ 14,178 and $ 14,178 for the years ended March 31, 2026 and 2025, respectively. Interest payable was $ 4,604 and $ 5,363 as
of March 31, 2026 and 2025, respectively. Interest expense was $ 59,042 and $ 67,871 for the years ended March 31, 2026 and 2025, respectively.
Maturities
of bonds for the next five years are as follows:
SCHEDULE OF MATURITIES OF BONDS
Years ending March 31,
Amount
2027
$ 150,000
2028
160,000
2029
170,000
2030
180,000
2031
190,000
Total
$ 850,000
NOTE
7. LOANS PAYABLE
On
July 1, 2022, the East West Bank (“EWB”) provided a mortgage loan (“EWB Mortgage Loan”) in the amount of $ 2.55
million for the purchase of the property at 135-137 Ludlow Avenue, which was formerly a lease held by the Company. The EWB Mortgage Loan
matures in 10 years and bears interest at a rate of 4.75% fixed for 5 years then adjustable at the Wall Street Journal Prime Rate (“WSJP”)
plus 0.5% with floor rate of 4.5%. The EWB Mortgage Loan contains customary representations, warranties and covenants. These covenants
include maintaining a minimum debt coverage ratio of 1.50 to 1.00 tested annually and a minimum trailing 12-month debt coverage ratio
of 1.50 to 1.00. As of the date of this filing, the Company was in compliance with each financial covenant.
The
Company has entered into a collateralized promissory note with individual lenders (a “Promissory Note”). As of June 2, 2023,
a Promissory Note was placed with Nasrat Hakim, CEO and Chairman of the Board of Directors, for $ 3,000,000 . Refer to Note 8 for information
regarding the Promissory Note.
Loans
payable consisted of the following:
SCHEDULE OF LOANS PAYABLE
March 31, 2026
March 31, 2025
Mortgage loan payable 4.75 % interest and maturing June 2032
$ 2,245,743
$ 2,334,163
Equipment and insurance financing loans payable, between 5.99 % and 12.02 % interest and maturing between April 2025 and October 2025
—
32,324
Less: Current portion of loans payable
( 92,774 )
( 120,744 )
Long-term portion of loans payable
$ 2,152,969
$ 2,245,743
F- 15
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The
interest expense associated with the loans payable was $ 111,361 and $ 128,234 for the years ended March 31, 2026 and 2025, respectively.
Loan
principal payments for the next five years are as follows:
SCHEDULE OF LOAN PRINCIPAL PAYMENTS
Future principal balances
Years ending March 31,
Amount
2027
$ 92,774
2028
94,433
2029
98,447
2030
103,817
2031
109,482
Thereafter
1,746,790
Total remaining principal balance
$ 2,245,743
NOTE
8. RELATED PARTY LOANS PAYABLE
The
Company has entered into a collateralized promissory note with individual lenders with rates comparable to the mortgage loan, dated July
1, 2022, provided by East West Bank to the Company but with fewer covenants. These covenants include filing timely tax returns and financial
statements, and an agreement not to sell, lease, or transfer a substantial portion of the Company’s assets during the term of the
Hakim Promissory Note. On June 2, 2023, the Company entered into a Promissory Note with Nasrat Hakim, President, Chief Executive Officer
and Chairman of the Board of Directors of the Company (the “Board”), pursuant to which the Company borrowed funds in the
aggregate principal amount of $ 3,000,000 (the “Hakim Promissory Note”). The Hakim Promissory Note had an interest rate of
9 % for the first year and 10 % for an optional second year and the proceeds were used for working capital and other business purposes.
The original maturity date of the Hakim Promissory Note was June 2, 2024, with an optional second year extension. The second year extension
was exercised pursuant to the terms of the Hakim Promissory Note. For the years ended March 31, 2026 and 2025, interest expense on the
Hakim Promissory Note totaled $ 50,000 and $ 292,500 , respectively, recorded on the Consolidated Statements of Operations in interest expense
and amortization of debt issuance costs. On June 2, 2025, the Hakim Promissory Note was paid in full and no balance was outstanding as
of this date.
On
June 30, 2023, the Company entered into a collateralized promissory note with Davis Caskey (the “Caskey Promissory Note”).
The Caskey Promissory Note has a principal balance of $ 1,000,000 and an interest rate of 9 % for the first year and 10 % for an optional
second year. The Caskey Promissory Note is subject to the same covenants as are contained in the Hakim Promissory Note. The proceeds
will be used for working capital and other business purposes. The original maturity date of the Caskey Promissory Note was June 30, 2024,
with an optional second year extension. The second year extension was exercised pursuant to the terms of the Caskey Promissory Note.
For the years ended March 31, 2026 and 2025, interest expense on the Caskey Promissory Note totaled $ 25,000 and $ 100,000 , respectively,
recorded on the Consolidated Statements of Operations in interest expense and amortization of debt issuance costs. On June 26, 2025,
the Caskey Promissory Note was paid in full and no balance was outstanding as of this date.
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 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.
On
August 17, 2023, Elite filed a paragraph IV certification with its ANDA to generic OxyContin ® and after Elite got acceptance
of the ANDA by the FDA on September 19, 2023, Elite sent the patentee and NDA holder a Notice Letter as required under the Hatch-Waxman
Act. On November 14, 2023, a patent infringement suit was filed in the District Court of New Jersey by Purdue Pharma. The Parties agreed to a stipulated dismissal of the case and the judge signed the order dismissing the case on June
12, 2026.
F- 16
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Elite’s
launch of a generic OxyContin ® will depend on the approval by the FDA and the outcome of various litigation involving
Purdue or the expiry of the patents listed on the Orange Book.
Operating
Leases
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 was for approximately 1,275 square feet of office space, with the Company taking occupancy on November 1, 2020.
The Pompano Office Lease had a term of three years , ending on October 31, 2023 . The Pompano Office Lease was extended for one additional
year to October 31, 2024. Accordingly, the Pompano Office Lease expired at the end of the renewal term on October 31, 2024.
The
Company entered into an operating lease for office space in North Bay Village, Pompano FL (the “NBV Pompano Office Lease”).
The Company took occupancy on October 1, 2024. The NBV Pompano Office Lease has a term of three years , ending on September 30, 2027 .
The
Company entered into a lease agreement for a portion of a one-story warehouse, located at 144 Ludlow Avenue, Northvale, New Jersey (the
“144 Ludlow Ave. Lease”). The lease agreement began on January 22, 2024, and has a term of five years . The 144 Ludlow Ave.
Lease will expire on December 31, 2028.
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. Operating leases are included in operating lease right-of-use assets and lease liabilities in the consolidated balance sheets.
Lease expense for operating expense payment is recognized on a straight-line basis over the lease term.
Finance
Leases
In
November 2023, the Company entered into a finance lease for equipment (the “Waters Equipment Lease”). The Waters Equipment
Lease is related to lab equipment with an acquisition cost of $ 499,775 , with the Company taking ownership of the asset on December 1,
2023. The Waters Equipment Lease has a term of five years , ending on November 29, 2028 . The Company also has the option to purchase the
asset at the end of the lease term for the amount of $ 1 , which is probable to be exercised.
In
February 2024, the Company entered into a finance lease for warehouse equipment (the “Warehouse Equipment Lease”). The Warehouse
Equipment Lease is related to warehouse equipment with an acquisition cost of $ 37,500 , with the Company taking ownership of the asset
during February 2024. The Warehouse Equipment Lease had a term of two years , which ended in February 2026 . The Company had the option
to purchase the asset at the end of the lease term for the amount of $ 1 , which the Company exercised.
In
February 2024, the Company entered into a finance lease for equipment (the “February 2024 Equipment Lease”). The February
2024 Equipment Lease is related to manufacturing equipment with an acquisition cost of $ 455,000 , with the Company taking ownership of
the asset during February 2024. The February 2024 Equipment Lease has a term of five years , ending in February 2029 . The Company will
retain ownership of the equipment at lease termination.
In
March 2024, the Company entered into three separate finance leases for manufacturing assets (the “March 2024 Equipment Leases”).
The March 2024 Equipment Leases are related to manufacturing equipment and vault installed at the Company’s facility located at
144 Ludlow Avenue, Northvale NJ with an aggregate acquisition cost of $ 1,085,177 . Each of the separate leases included in the March 2024
Equipment Leases have a term of five years , ending in March 2029 . The Company will retain ownership of all related assets at lease termination.
In
July 2024, the Company entered into two separate finance leases for manufacturing assets (the “July 2024 Equipment Leases”).
The July 2024 Equipment Leases are related to warehouse and laboratory equipment with an aggregate acquisition cost of $ 153,745 . One
of the July 2024 Equipment Leases has a term of five years , ending in July 2029 , and the other lease has a term of two years , ending
in July 2026 . The Company will retain ownership of all related assets at lease terminations.
F- 17
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
A
lease is classified as a finance lease if any of the following criteria are met: (i) ownership of the underlying asset transfers to the
Company by the end of the lease term; (ii) the lease contains an option to purchase the underlying asset that the Company is reasonably
expected to exercise; (iii) the lease term is for a major part of the remaining economic life of the underlying asset; (iv) the present
value of the sum of lease payments and any residual value guaranteed by the Company equals or exceeds substantially all of the fair value
of the underlying asset; or (v) the underlying asset is of a specialized nature that it is expected to have no alternative use to the
lessor at the end of the lease term. A lease that does not meet any of the criteria to be classified as a finance lease is classified
as an operating lease. As the Company expects to exercise the option to purchase the asset at the end of the lease term, the Waters equipment
lease was determined to be a finance lease. The finance lease is included on the consolidated balance sheets as Finance lease - right-of-use
asset and Lease obligation - finance lease. The finance lease costs are split between Depreciation and amortization expense related to
the asset and interest expense on the lease liability, using the effective rate charged by the lessor. The Company has elected to account
for lease and non-lease components separately.
Rent
expense is recorded on the straight-line basis and is recorded in cost of manufacturing and general and administrative expense in the
consolidated statements of operations. Rent expense is as follows:
SCHEDULE OF RENT EXPENSE STRAIGHT-LINE BASIS
Lease
2026
2025
For the Years Ended March 31,
Lease
2026
2025
Ludlow-144
$ 633,269
$ 610,409
Pompano-2311
—
18,870
NBV-610
18,249
14,605
Rent expense
18,249
14,605
The
table below shows the future minimum rental payments, exclusive of taxes, insurance and other costs:
SCHEDULE OF FUTURE MINIMUM RENTAL PAYMENTS
Years ending March 31,
Operating Lease Amount
Financing Lease Amount
Total
2027
667,307
484,151
1,151,458
2028
666,207
479,337
1,145,544
2029
440,159
438,045
878,204
2030
—
13,740
13,740
Less: interest
( 221,599 )
( 184,858 )
( 406,457 )
Present value of lease payments
$ 1,552,074
$ 1,230,415
$ 2,782,489
The
weighted-average remaining lease term and the weighted-average discount rate of the Company’s leases were as follows:
SCHEDULE OF WEIGHTED -AVERAGE REMAINING TERM AND THE WEIGHTED-AVERAGE DISCOUNT RATE
For the Years Ended March 31,
Lease Term and Discount Rate
2026
2025
Remaining lease term (years)
Operating leases
2.6
3.6
Finance leases
2.9
3.8
Discount rate
Operating leases
10.0 %
10.0 %
Finance leases
9.5 %
9.5 %
NOTE
10. PREFERRED STOCK
Series
J convertible preferred stock
On
April 28, 2017, the Company created the Series J Convertible Preferred Stock (“Series J Preferred”) in conjunction with the
Certificate of Designations. A total of 50 shares of Series J Preferred were authorized, zero shares are issued and outstanding, with
a stated value of $ 1,000,000 per share and a par value of $ 0.01 .
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.
F- 18
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The
Company has 79,008,661 total warrants to purchase shares of Common Stock outstanding with a weighted average exercise price of $ 0.1521
as of March 31, 2026 and 2025.
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, including a provision within that
provides the holder a choice of net cash settlement or settlement in shares upon a cashless exercise. The net cash settlement amount
is the cash value obtained by subtracting the then exercise price from the closing price of the Company’s Common Stock (provided
such closing price is higher than the exercise price) and multiplying the difference by the number of shares exercised. As this event
is at the holder’s option, it is considered outside of the Company’s control. As a result of the net cash settlement at the
option of the holder, such warrants are classified as liabilities and measured initially and subsequently at fair value.
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. The Series J Warrants also provide for other standard adjustments upon the happening of certain
customary events.
The
fair value of the Series J Warrants was calculated using a Black-Scholes model. The following assumptions were used in the Black-Scholes
model to calculate the fair value of the Series J Warrants:
SCHEDULE OF FAIR VALUE OF WARRANTS ISSUED
March 31, 2026
March 31, 2025
Fair value of the Company’s Common Stock
$ 0.3601
$ 0.4350
Volatility
63.96 %
82.80 %
Initial exercise price
$ 0.1521
$ 0.1521
Warrant term (in years)
1.1
2.1
Risk free rate
3.47 %
3.89 %
The
changes in warrants (Level 3 financial instruments) measured at fair value on a recurring basis were as follows:
SCHEDULE OF CHANGES IN WARRANTS MEASURED AT FAIR VALUE ON A RECURRING BASIS
Balance at March 31, 2024
$ 6,298,008
Change in fair value of derivative financial instruments - warrants
18,901,185
Balance at March 31, 2025
$ 25,199,193
Change in fair value of derivative financial instruments - warrants
( 7,855,607 )
Balance at March 31, 2026
$ 17,343,586
Measured
on a Recurring Basis
The
following table presents information about the Company’s 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
Level 1
Level 2
Level 3
Balance as of March 31, 2025
$ 25,199,193
$ —
$ —
$ 25,199,193
Change in fair value of derivative financial instruments - warrants
( 7,855,607 )
—
—
( 7,855,607 )
Balance as of March 31, 2026
$ 17,343,586
$ —
$ —
$ 17,343,586
Amount at Fair Value
Level 1
Level 2
Level 3
Balance as of March 31, 2024
$ 6,298,008
$ —
$ —
$ 6,298,008
Change in fair value of derivative financial instruments - warrants
18,901,185
—
—
18,901,185
Balance as of March 31, 2025
$ 25,199,193
$ —
$ —
$ 25,199,193
F- 19
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE
12. STOCK-BASED COMPENSATION
Under
its 2014 Equity Incentive Plan and its 2024 Equity Incentive Plan, the Company did grant and may grant stock options to officers, selected
employees, as well as members of the Board of Directors and advisory board members. On July 1, 2024 the Company restated the 2014 Equity
Incentive Plan to increase the shares reserved under the option plan by 12,730,000 . Under the 2024 Equity Incentive Plan, 80,000,000
options are available for grant. 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.
The
fair value of option awards is estimated on the date of grant using the Black-Scholes option-pricing model. The exercise price of each
award is generally not less than the per share fair value in effect as of that award date. The determination of fair value using the
Black-Scholes model is affected by the Company’s share fair value as well as assumptions regarding a number of complex and subjective
variables, including expected price volatility, risk-free interest rate and projected employee share option exercise behaviors. The Company
estimates its expected volatility by using a combination of historical share price volatilities of similar companies within the Company’s
industry. The expected term of the Company’s stock options for employees has been determined utilizing the “simplified”
method for awards, since the Company does not have sufficient exercise history to estimate term of its historical option awards. The
risk-free interest rate is determined by reference to the U.S. Treasury yield curve. Expected dividend yield is zero based on the fact
that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future.
A
summary of the activity of Company’s 2024 Equity Incentive plan and prior equity incentive plans for the year ended March 31, 2026
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, 2025
15,640,000
$ 0.05
7.8
$ 6,000,552
Granted
—
—
—
$ —
Exercised
( 8,733,334 )
0.04
—
$ —
Expired and Forfeited
—
—
—
$ —
Outstanding at March 31, 2026
6,906,666
$ 0.07
6.8
$ 2,002,996
Exercisable at March 31, 2026
5,440,000
$ 0.06
6.6
$ 1,610,856
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, 2026 of $ 0.36 for those awards with strike prices lower than
the quoted price of the Company’s Common Stock as of March 31, 2026. As of March 31, 2026, there was $ 51,659 in unrecognized stock
based compensation expense that will be recognized over a weighted average 0.49 year period.
The
total intrinsic value of options exercised during the year ended March 31, 2026 was $ 2,826,120 .
NOTE
13. CONCENTRATIONS AND CREDIT RISK
Revenues
Two
customers accounted for approximately 74 % of the Company’s revenues for the year ended March 31, 2026. These two customers accounted
for approximately 64 % and 10 % of revenues each, respectively.
Two
customers accounted for approximately 58 % of the Company’s revenues for the year ended March 31, 2025. These two customers accounted
for approximately 39 % and 19 % of revenue each, respectively.
F- 20
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Accounts
Receivable
One
customer accounted for approximately 69 % of the Company’s accounts receivable as of March 31, 2026.
Three
customers accounted for approximately 75 % of the Company’s accounts receivable as of March 31, 2025. These three customers accounted
for approximately 46 %, 19 %, and 10 % of accounts receivable each, respectively.
Purchasing
Three
suppliers accounted for approximately 73 % of the Company’s purchases of raw materials for the year ended March 31, 2026. These
three customers accounted for approximately 36 %, 24 %, and 13 % of purchasing each, respectively.
Three
suppliers accounted for approximately 69 % of the Company’s purchases of raw materials for the year ended March 31, 2025. These
three customers accounted for approximately 43 %, 13 %, and 13 %, of purchasing each, respectively.
NOTE
14. 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.
Consolidated
income from operations, which is reported in the accompanying consolidated statements of operations, is the measure of segment profit
or loss that is regularly reviewed by the CODM. This enables the CODM to assess the overall level of available resources and determine
how best to deploy these resources across research and development projects in line with the long-term company-wide strategic goals.
There are no significant segment expenses or other segment items that are separately provided to the CODM beyond research and development
and general and administrative expenses. The CODM does not receive segment level information related to depreciation, amortization, capital
expenditures, or other non-cash items, and therefore such items are excluded. The ANDA segment follows the same accounting policies used
in the preparation of the Company’s consolidated financial statements.
The
following represents selected information for the Company’s reportable segment:
SCHEDULE OF SELECTED INFORMATION FOR REPORTABLE SEGMENTS
2026
2025
For the Years Ended March 31,
2026
2025
Operating Income by Segment
ANDA
$ 69,281,380
$ 32,121,818
Operating income by Segment
$ 69,281,380
$ 32,121,818
The
table below reconciles the Company’s operating income by segment to income from operations and to income (loss) before income taxes
as reported in the Company’s consolidated statements of operations:
SCHEDULE OF OPERATING INCOME BY SEGMENT TO INCOME FROM OPERATIONS
2026
2025
For the Years Ended March 31,
2026
2025
Operating income by segment
$ 69,281,380
$ 32,121,818
Corporate unallocated costs
( 17,596,803 )
( 9,001,930 )
Impairment of intangible assets
( 847,012 )
( 1,603,426 )
Depreciation and amortization expense
( 1,547,874 )
( 1,688,429 )
Significant non-cash items
( 176,507 )
( 227,565 )
Income from operations
49,113,184
19,600,468
Change in fair value of derivative instruments
7,855,607
( 18,901,185 )
Interest expense and amortization of debt issuance costs
( 396,664 )
( 772,367 )
Interest income
207,857
20,944
Other income
34,500
—
Income (loss) before income taxes
$ 56,814,484
$ ( 52,140 )
F- 21
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE
15. RELATED PARTY AGREEMENTS
Mikah
Pharma, LLC Agreements
In
May 2020, Praxgen (formerly known as SunGen Pharma LLC), pursuant to an asset purchase agreement, assigned its rights and obligations
under the Praxgen Agreement for Amphetamine IR and Amphetamine ER to Mikah Pharma LLC (“Mikah”). The ANDAs for Amphetamine
IR and Amphetamine ER are now registered under Elite’s name. Mikah will now be Elite’s partner with respect to Amphetamine
IR and ER and will assume all the rights and obligations for these products from Praxgen. Mikah was founded in 2009 by Nasrat Hakim,
a related party and the Company’s President, Chief Executive Officer and Chairman of the Board.
In
June 2021, the Company entered into a development and license agreement with Mikah, pursuant to which Mikah will engage in the research,
development, sales and licensing of generic pharmaceutical products. In addition, Mikah will collaborate to develop and commercialize
generic products including formulation development, analytical method development, manufacturing, sales and marketing of generic products.
Initially two generic products were identified for the parties to develop.
As
of March 31, 2026 and 2025, the Company owed an aggregate of $ 2,616,950 and $ 2,617,210 , respectively, to Mikah in accordance with the
agreements, with such amounts being recorded as an accrued expense on the consolidated balance sheets.
NOTE
16. INCOME TAXES
The
earnings (loss) before income taxes for the years ended March 31, 2026 and 2025 were $ 56.8 million and $ ( 0.1 ) million, respectively.
Components
of the provision for income taxes were (amounts in thousands):
SCHEDULE OF PROVISION FOR INCOME TAXES
For the Year Ended March 31 (in thousands)
2026
2025
Current provision (benefit):
Federal
$ —
$ —
State and local
1,399
468
Total current provision
1,399
468
Deferred provision (benefit):
Federal
10,335
3,871
State and local
208
( 76 )
Total deferred provision
10,543
3,795
Provision for income taxes
$ 11,942
$ 4,263
F- 22
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
A
reconciliation between the Company’s effective tax rate and the federal statutory rate for the year ended March 31, 2026 is as
follows (amounts in thousands of dollars):
SCHEDULE OF EFFECTIVE INCOME TAX RATE RECONCILIATION
Amount
Percent
2026
Amount
Percent
U.S. Federal Statutory Tax Rate
$ 11,682
21.00 %
State and Local Income Taxes, Net of Federal Income Tax Effect (a)
1,313
2.36 %
Foreign Tax Effects
—
— %
Effect of Changes in Tax Law or Rates Enacted in the Current Period
—
— %
Effect of Cross-Border Tax Laws
—
— %
Tax Credits
—
— %
Federal R&D Credits
( 360 )
( 0.65 )%
Prior year deferred true-up
Changes in Valuation Allowance
—
— %
Nontaxable or Nondeductible Items
—
— %
Non-deductible change in fair value of derivative financial instruments
( 1,650 )
( 2.96 )%
Non-deductible change in fair value of stock-based liabilities
Officer’s compensation
1,143
2.05 %
Other
( 186 )
( 0.33 )%
Other permanent items
Changes in Unrecognized Tax Benefits
—
— %
Other Adjustments
—
— %
Other
—
— %
Effective Tax Rate
$ 11,942
21.47 %
(a) State taxes in
New Jersey and Florida made up the majority (greater than 50 percent) of the tax effect in this category.
A
reconciliation between the Company’s effective tax rate and the federal statutory rate for the year ended March 31, 2025 is as
follows:
For the Year Ended March 31 (in thousands)
2025
Federal income tax rate
$ ( 11 )
U.S. Federal Statutory Tax Rate
$ ( 11 )
State and local taxes, net of federal benefit
293
State and Local Income Taxes, Net of Federal Income Tax Effect
293
Non-deductible change in fair value of derivative financial instruments
3,969
Non-deductible change in fair value of stock-based liabilities
—
Other permanent items
17
Prior year deferred true-up
110
Tax credits
( 115 )
Federal R&D Credits
( 115 )
Change in valuation allowance
—
Changes in Valuation Allowance
—
Effective tax rate
$ 4,263
Effective Tax Rate
$ 4,263
F- 23
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The
major components of deferred tax assets and liabilities as of March 31, 2026 and 2025 are as follows (amounts in thousands of dollars):
SCHEDULE OF COMPONENTS OF DEFERRED TAX ASSETS AND LIABILITIES
As of March 31 (in thousands)
2026
2025
Deferred tax assets:
Lease Liability
$ 659
$ 865
Sec. 174 R&E Capitalization
123
3,104
Allowance for Expected Credit Losses
352
92
Net Operating Loss
2,489
10,664
R&D Credit
5,708
5,348
Deferred tax assets
9,331
20,073
Deferred tax liabilities:
Fixed Assets
( 218 )
( 98 )
Right of Use Asset
( 669 )
( 898 )
Intangible Assets
( 621 )
( 711 )
Deferred tax liabilities
( 1,508 )
( 1,707 )
Net deferred tax asset
$ 7,823
$ 18,366
The
Company’s income tax expense was $ 11.9 million and $ 4.3 million for the years ended March 31, 2026 and 2025, respectively.
As
of March 31, 2026, the Company has a federal net operating loss carry forward of $ 11.9 million of which $ 10 million can be carried forward
indefinitely with limitation of 80% of taxable income and the remaining $ 1.9 million will expire in 2037 and has no limitation . As of
March 31, 2026, the Company’s has a federal research credits carryforward of $ 5.7 million which will begin to expire in 2032 . As
of March 31, 2026, the Company’s federal and state income taxes due were $ 0 and $ 1.4 million, respectively.
The
Company’s policy for recording interest and penalties associated with unrecognized tax benefits is to record such interest and
penalties as a component of income tax expense. There were no amounts accrued for interest or penalties for the year ended March 31,
2026. Management does not expect any material changes in its unrecognized tax benefits in the next year.
There
are currently no federal or state income tax examinations underway. The Company’s federal tax returns are open to examination from
2022 and its state tax returns are open to examination from 2021.
On
July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted in the United States. The OBBBA permanently extends certain
provisions of the Tax Cuts and Jobs Act, modifies aspects of the international tax framework, and restores favorable tax treatment for
certain business provisions, including the immediate expensing of domestic research and development expenditures. resulting in a decrease
in our deferred tax assets of approximately $ 3.1 million, primarily due to the immediate expensing of domestic research and development
expenditures.
The
amounts of cash income taxes paid by the Company were as follows:
SCHEDULE
OF INCOME TAXES PAID
(in thousands)
March 31, 2026
Federal
$ —
State and Local:
Florida
435
New Jersey
575
New York
108
All Other States
33
Income taxes, net of amounts refunded
$ 1,151
NOTE
17. SUBSEQUENT EVENTS
On
April 2, 2026, the Company announced the commercial launch of our generic methadone hydrochloride 5 mg and 10 mg tablets. The product
is marketed and sold under the Elite Labs label.
On
June 1, 2026, the Company reported that it had filed an Abbreviated New Drug Application with the US Food and Drug Administration for
a generic version of an undisclosed drug product in the class of medications called anticoagulants.
On June 12, 2026, pursuant
to a stipulated dismissal agreed to by both parties, the District Court of New Jersey signed an order dismissing the patent infringement
suit filed by Purdue Pharma against the Company in November 2023.
F- 24
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.