What changed in this filing

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Item 1A. Risk Factors

2024-07-01 compared with 2023-06-29 · 509 added, 340 removed, 1079 unchanged (44% of the section changed)

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may fail to successfully identify, develop, and commercialize new products.

operations could be disrupted by failure of our information systems or cyber-attacks.

of generic equivalents of our products by competitors.

operations could be disrupted by failure of our information systems or cyber-attacks and artificial.

intelligence based platforms my present new risks and challenges to our business.

in product development may result in failure to achieve adequate return on investment.

business is dependent on market perceptions, social and political pressures, including public concern over the abuse of opioids.

business is dependent on market acceptance of our products, social and political pressures, including public concern over the abuse of certain products, including opioids..

economic conditions may adversely affect our business.

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collaboration or licensing arrangements could limit revenues and product development.

portion of revenues is derived from a limited number of products.

depend to a large extent on third-party suppliers and distributors for the raw materials for our products.

related to incorrect or inadequate provision for price adjustments and sales allowances

and Liquidity Related Risks

have identified material weaknesses in our internal controls over financial reporting

have a relatively limited operating history and our operating results could fluctuate significantly.

ability to fund operations is uncertain and we may require additional financing to meet objectives.

most likely will require additional financing to meet our business objectives.

have substantial indebtedness which may adversely affect our financial condition.

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of generics may be limited through legislative, regulatory or efforts of pharmaceutical companies.

revenues and profits from generic products may decline as a result of changes in regulatory policy.

tariffs and evolving trade policy between the US and other countries may adversely affect our business.

DEA could limit the availability of active ingredients used in many of our products.

in FDA approval requirements may prevent or delay approval of new products.

received a CRL from the FDA indicating that the SequestOx™ NDA is not ready for approval.

received a Complete Response Letter (“CRL”) from the FDA indicating that the SequestOx™ NDA is not ready for approval.

factors may cause us to be unable to manufacture products or face interruptions in our manufacturing process.

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States and Internationally.

reporting and payment obligations under the Medicaid rebate program.

Investigations

and litigation concerning the calculation of average wholesale prices may adversely affect our business

and Liability Related Risks

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distribution and third party sale of counterfeit versions of our products could have a detrimental effect on our reputation and business.

and Organizational Risks

of our Articles of Incorporation could deter a change of management and discourage offers to acquire us.

or other third parties may allege that we are infringing upon their IP.

Property Related Risks

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effectively, which could impair our ability to implement our business model.

Competitive factors faced include, without limitation, product

development, safety, efficacy, commercialization, marketing, promotion, product quality, cost-effectiveness, reputation, service, patient

convenience, access to scientific and technical information, and ability to manage operations in an economic environment that has been severely

impacted by the COVID-19 pandemic.

In addition, the pharmaceutical industry is undergoing rapid and significant technological

change, and we expect competition to intensify as technical advances in each field are made and become more widely known.

An increasing

number of pharmaceutical companies have been or are becoming interested in the development and commercialization of products incorporating

advanced or novel drug delivery systems.

We expect that competition in the field of drug delivery will increase in the future as other

specialized research and development companies begin to concentrate on this aspect of the business.

Some of the major pharmaceutical

companies have invested and are continuing to invest significant resources in the development of their own drug delivery systems and

technologies and some have invested funds in specialized drug delivery companies.

Many of our competitors have longer operating histories

and, they, and future competitors, may have greater financial, research and development, marketing, and other resources than we do.

recent trends in this industry include market consolidation, which may further concentrate financial, technical, market and other strengths

and resources with the result being a further increase competitive pressures existent in this industry.

Such companies may develop new

formulations and products, or may improve existing ones, more efficiently than we can.

Our success, if any, will depend in part on our

ability to keep pace with the changing technology in the fields in which we operate.

we expand our presence in the generic pharmaceuticals market our product candidates may face intense competition from brand-name companies

that have taken aggressive steps to thwart competition from generic companies.

In particular, brand-name companies continue to sell or

license their products directly or through licensing arrangements or strategic alliances with generic pharmaceutical companies (so-called

“authorized generics”).

No significant regulatory approvals are required for a brand-name company to sell directly or through

a third party to the generic market, and brand-name companies do not face any other significant barriers to entry into such market.

addition, such companies continually seek to delay generic introductions and to decrease the impact of generic competition, using tactics

which include, without limitation:

Competitive factors faced include, without limitation:

of other generic drug manufacturers’ products in direct competition with our generic drug products;

of authorized generic drug products in direct competition with our products, particularly during any period of exclusivity;

ability of generic drug product competitors to quickly enter the market after the expiration of patents or exclusivity periods, diminishing

the amount and duration of significant profits;

Consolidation

among distribution outlets through mergers and acquisitions and the formation of buying groups;

willingness of generic drug customer, including, without limitation, wholesale and retail customers, to switch among products of

different generic pharmaceutical manufacturers;

pressures by competitors and customers, even if similar price savings are not passed on to consumers;

company’s reputation as a manufacturer and distributor of quality generic pharmaceutical products;

company’s level of service, including, without limitation, maintaining sufficient inventory levels for deliveries consistent

with customer expectations;

company’s ability to use and integrate technology, including the use and integration of artificial intelligence;

appearance and labeling;

company’s breadth of product offerings;

and significant technological change;

and commercialization of advanced or novel drug delivery systems;

of greater financial resources to fund research and development, marketing, human resources and other operational and overhead resources

and capabilities;

of new formulations and products, or improvement of existing ones, at higher levels of efficiency;

depend on third party suppliers and distributors for the raw materials for our products.

success, if any, will depend in part on our ability to successfully keep pace with these factors.

we expand our presence in the generic pharmaceuticals market our products may face intense competition from brand-name companies that

have taken aggressive steps to thwart competition from generic companies.

In particular, brand-name companies continue to sell or license

their products directly or through licensing arrangements or strategic alliances with generic pharmaceutical companies (so-called “authorized

No significant regulatory approvals are required for a brand-name company to sell directly or through a third party

to the generic market, and brand-name companies do not face any other significant barriers to entry into such market.

In addition, such

companies continually seek to delay generic introductions and to decrease the impact of generic competition, using tactics which include,

without limitation:

new patents on drugs whose original patent protection is about to expire;

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disasters could cause closures of our facilities and disrupt our operations.

the occurrence of one or more unexpected events, including fires, tornadoes, tsunamis, hurricanes, earthquakes, floods, and other

forms of severe hazards in the United States or in other countries in which we or our suppliers operate or are located could

adversely affect our operations and financial performance.

We have lost power or had to shut down operations as a result of extreme

weather and natural disasters, most notably Superstorm Sandy.

These types of unexpected events could result in physical damage to

and complete or partial closure of one or more of distribution centers or manufacturing facilities, or the temporary or long-term

disruption in the supply of products, and/or disruption of our ability to deliver products to customers.

Further, the long-term

effects of climate change on general economic conditions and the pharmaceutical manufacturing and distribution industry in

particular are unclear, and changes in the supply, demand or available sources of energy and the regulatory and other costs

associated with energy production and delivery may affect the availability or cost of goods and services, including natural

resources, necessary to run our businesses.

Existing insurance arrangements may not provide protection for the costs that may arise

from such events, particularly if such events are catastrophic in nature or occur in combination.

Any long-term disruption in our

ability to service our customers from one or more distribution centers or outsourcing facilities could have a material adverse

the occurrence of one or more unexpected events, including fires, tornadoes, tsunamis, hurricanes, earthquakes, floods, and other forms

of severe hazards in the United States or in other countries in which we or our suppliers operate or are located could adversely affect

our operations and financial performance.

We have lost power or had to shut down operations as a result of extreme weather and natural

These types of unexpected events could result in physical damage to and complete or partial closure of one or more of distribution

centers or manufacturing facilities, or the temporary or long-term disruption in the supply of products, and/or disruption of our ability

to deliver products to customers.

Further, the long-term effects of climate change on general economic conditions and the pharmaceutical

manufacturing and distribution industry in particular are unclear, and changes in the supply, demand or available sources of energy and

the regulatory and other costs associated with energy production and delivery may affect the availability or cost of goods and services,

including natural resources, necessary to run our businesses.

Existing insurance arrangements may not provide protection for the costs

that may arise from such events, particularly if such events are catastrophic in nature or occur in combination.

Any long-term disruption

in our ability to service our customers from one or more distribution centers or outsourcing facilities could have a material adverse

effect on our operations, our business, results of operations and stock price.

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in operations at our sole facility could have a material adverse effect on our business.

our manufacturing facility or the facilities of any of our suppliers fail to comply with regulatory requirements or encounter other

manufacturing difficulties, it could adversely affect our ability to manufacture and supply products.

All facilities and

manufacturing processes used for the manufacture of pharmaceutical products are subject to inspection by regulatory agencies at any

time and must be operated in conformity with current good manufacturing practice (“cGMP”) and, in the case of controlled

substances, DEA regulations.

Compliance with the FDA’s cGMP and DEA requirements applies to both drug products seeking

regulatory approval and to approved drug products.

In complying with cGMP requirements, pharmaceutical manufacturing facilities must

continually expend significant time, money and effort in production, recordkeeping, quality assurance and quality control so that

their products meet applicable specifications and other requirements for product safety, efficacy and quality.

Failure to comply

with applicable legal requirements subjects us, our manufacturing facilities and the facilities of our third-party suppliers to

possible legal or regulatory action, including, without limitation, shutdown, which may adversely affect our ability to supply the

Additionally, our manufacturing facilities, and those of our third party suppliers may face other significant disruptions

due to labor strikes, failure to reach acceptable agreement with labor unions, infringement of intellectual property rights,

vandalism, natural disaster, pandemics, storm or other environmental damage, civil or political unrest, export or import

restrictions or other events.

Were we not able to manufacture products at our manufacturing facilities or were our third party

suppliers unable to manufacture products at their facilities because of regulatory, business or any other reasons, the manufacture

our manufacturing facility or the facilities of any of our suppliers fail to comply with regulatory requirements or encounter other manufacturing

difficulties, it could adversely affect our ability to manufacture and supply products.

All facilities and manufacturing processes used

for the manufacture of pharmaceutical products are subject to inspection by regulatory agencies at any time and must be operated in conformity

with current good manufacturing practice (“cGMP”) and, in the case of controlled substances, DEA regulations.

with the FDA’s cGMP and DEA requirements applies to both drug products seeking regulatory approval and to approved drug products.

In complying with cGMP requirements, pharmaceutical manufacturing facilities must continually expend significant time, money and effort

in production, recordkeeping, quality assurance and quality control so that their products meet applicable specifications and other requirements

for product safety, efficacy and quality.

Failure to comply with applicable legal requirements subjects us, our manufacturing facilities

and the facilities of our third-party suppliers to possible legal or regulatory action, including, without limitation, shutdown, which

may adversely affect our ability to supply the product.

Additionally, our manufacturing facilities, and those of our third party suppliers

may face other significant disruptions due to labor strikes, failure to reach acceptable agreement with labor unions, infringement of

intellectual property rights, vandalism, natural disaster, pandemics, storm or other environmental damage, civil or political unrest,

export or import restrictions or other events.

Were we not able to manufacture products at our manufacturing facilities or were our third

party suppliers unable to manufacture products at their facilities because of regulatory, business or any other reasons, the manufacture

and marketing of these products would be interrupted.

This could have a material adverse impact on our business, results of

operation, financial condition, cash flows, competitive position and ability to operate.

This could have a material adverse impact on our business, results of operation,

financial condition, cash flows, competitive position and ability to operate.

all of our manufacturing operations are conducted at the Northvale Facility and any delays or unanticipated expenses in connection with

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product pipeline, including the paused development of its abuse deterrent opioid products, are in various stages of development.

to commercialization, product development must be completed that could include scale-up, clinical studies, regulatory filing, regulatory

review, approval by the FDA, and/or other development steps.

to commercialization, product development must be completed that could include scale-up, clinical studies, bioequivalence studies, regulatory

filing, regulatory review, approval by the FDA, and/or other development steps.

Development is subject to risks.

We cannot assure you that development will

be successful, or that during development unexpected delays might occur or additional costs might be incurred.

order to obtain FDA approval to market a new drug product, we must demonstrate proof of safety and effectiveness in humans.

To meet these

requirements, we must conduct extensive preclinical testing and “adequate and well-controlled” clinical trials.

clinical trials is a lengthy, time-consuming, and expensive process.

Completion of necessary clinical trials may take several years or

Delays associated with product candidates for which we are directly conducting preclinical or clinical trials may cause us to incur additional

operating expenses.

The commencement and rate of completion of clinical trials may be delayed by many factors, including, without limitation,

We cannot assure you

that development will be successful, or that during development unexpected delays might occur or additional costs might be incurred.

order to obtain FDA approval to market a new drug product, we must demonstrate proof of safety and effectiveness in humans or bioequivalence

to the reference listed drug.

To meet these requirements, we must conduct extensive preclinical testing and “adequate and well-controlled”

clinical trials and/or bioequivalence studies.

Conducting clinical trials and bioequivalence studies is a lengthy, time-consuming, and

expensive process.

Completion of necessary clinical trials may take several years or more.

Delays associated with product candidates

for which we are directly conducting preclinical or clinical trials may cause us to incur additional operating expenses.

The commencement

and rate of completion of clinical trials may be delayed by many factors, including, without limitation, for example:

Ineffectiveness

of our product candidate or perceptions by physicians that the product candidate is not safe or effective for a particular indication;

to manufacture sufficient quantities of the product candidate for use in clinical trials;

to manufacture sufficient quantities of the product candidate for use in clinical trials or bioequivalence studies;

or failure in obtaining approval of our clinical trial protocols from the FDA or institutional review boards;

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or regulatory delays;

trial costs that are greater than we currently anticipate.

if we achieve positive interim results in clinical trials, these results do not necessarily predict final results, and positive results

in early trials may not be indicative of success in later trials.

A number of companies in the pharmaceutical industry have suffered

significant setbacks in advanced clinical trials, even after achieving promising results in earlier trials.

Negative or inconclusive

results or adverse medical events during a clinical trial could cause us to repeat or terminate a clinical trial or require us to conduct

additional trials.

We do not know whether our existing or any future clinical trials will demonstrate safety and efficacy sufficiently

to result in marketable products.

Our clinical trials may be suspended at any time for a variety of reasons, including if the FDA or

we believe the patients participating in our trials are exposed to unacceptable health risks or if the FDA finds deficiencies in the

conduct of these trials.

or perceived failures in our clinical trials will directly delay our product development and regulatory approval process, damage our

business prospects, make it difficult for us to establish collaboration and partnership relationships, and negatively affect our reputation

and competitive position in the pharmaceutical community.

trial or bioequivalence costs that are greater than we currently anticipate.

if we achieve positive interim results in clinical trials and bioequivalence studies, these results do not necessarily predict final

results, and positive results in early trials and studies may not be indicative of success in later trials and studies.

A number of companies

in the pharmaceutical industry have suffered significant setbacks in advanced clinical trials, even after achieving promising results

in earlier trials.

Negative or inconclusive results or adverse medical events during a clinical trial could cause us to repeat or terminate

a clinical trial or require us to conduct additional trials.

We do not know whether our existing or any future clinical trials or bioequivalence

studies will demonstrate safety and efficacy, or bioequivalence to the reference listed drug, sufficiently to result in marketable products.

Our clinical trials may be suspended at any time for a variety of reasons, including if the FDA or we believe the patients participating

in our trials are exposed to unacceptable health risks or if the FDA finds deficiencies in the conduct of these trials.

or perceived failures in our clinical trials or bioequivalence studies will directly delay our product development and regulatory approval

process, damage our business prospects, make it difficult for us to establish collaboration and partnership relationships, and negatively

affect our reputation and competitive position in the pharmaceutical community.

ability to sustain current operations, engender business growth, achieve current and future revenues and profitability, significantly

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process of developing and obtaining regulatory approvals for new products is time-consuming, costly and inherently unpredictable.

are direct, indirect, known and unknown risks inherent in the development of pharmaceuticals, including, without limitation, product candidates

which initially show promise in preliminary pharmacological or marketing studies, but fail to yield the positive results consistent with

initial indications.

Product candidates we may develop may not receive the marketing authorizations necessary for us to market them and, if approved,

we may be unable to successfully commercialize them on a timely basis or at all, or if commercialized, revenues and profits achieved

from the sale of such products might not reach levels that provide sufficient return on those costs incurred during the commercialization

are direct, indirect, known and unknown risks inherent in the development of pharmaceuticals, including, without limitation, product

candidates which initially show promise in preliminary pharmacological or marketing studies, but fail to yield the positive results consistent

with initial indications.

Product candidates we may develop may not receive the marketing authorizations necessary for us to market them

and, if approved, we may be unable to successfully commercialize them on a timely basis or at all, or if commercialized, revenues and

profits achieved from the sale of such products might not reach levels that provide sufficient return on those costs incurred during

the commercialization process.

successful commercialization of a product is subject to a number of factors, including:

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and results of operations may be materially harmed.

our competitors introduce their own generic equivalents of our generic drug products, our revenues and gross margin from such products

generally decline, often rapidly.

and gross margin derived from generic pharmaceutical products often follow a pattern based on regulatory and competitive factors that

we believe are unique to the generic pharmaceutical industry.

As the patent(s) for a brand name product or any statutory period of marketing

exclusivity expires, the first generic manufacturer to receive regulatory approval for a generic equivalent of the product is often able

to capture a substantial share of the market.

However, as other generic manufacturers receive regulatory approvals for their own generic

versions, that market share, and the price of the that product, will typically decline depending on several factors, including, without

limitation, the number of competitors, the price of the branded product and the pricing strategy of the new competitors.

competition in the generic pharmaceutical marketplace is not uncommon with one result of such being significant decline in revenue and

gross margins.

There can be no assurances of our ability to continue to develop new products or that the number of competitors for any

given product will not increase to such an extent that we may stop marketing a generic drug product for which we previously obtained

approval, resulting in a material adverse effect on our business, financial condition, results of operations, cash flow, ability to operate

and stock price.

operations could be disrupted by failure of our information systems or cyber-attacks.

operations could be disrupted if our information systems fail, if we are unsuccessful in implementing necessary upgrades or if we are

subject to cyber-attacks.

Our business depends on the efficient and uninterrupted operation of our computer and communications systems

and networks, hardware and software systems and our other information technology.

We collect and maintain information, which includes

confidential and proprietary information as well as personal information regarding our customers and employees, in digital form.

maintained in digital form is subject to risk of cyber-attacks, which are increasing in frequency and sophistication.

Cyber-attacks could

include the deployment of harmful malware, viruses, worms, and other means to affect service reliability and threaten data confidentiality,

integrity and availability.

Despite our efforts to monitor and safeguard our systems to prevent data compromise, the possibility of a

future data compromise cannot be eliminated entirely, and risks associated with intrusion, tampering, and theft remain.

we do not have insurance coverage with respect to system failures or cyber- attacks.

A failure of our systems, or an inability to successfully

expand the capacity of these systems, or an inability to successfully integrate new technologies into our existing systems could have

a material adverse effect on our business, results of operations, financial condition, and cash flows.

also have outsourced significant elements of our information technology infrastructure to third parties, some of which may be outside

Accordingly, significant elements of our information technology infrastructure, require our management of multiple independent

vendor relationships with third parties who may or could have access to our confidential information.

The size and complexity of our

information technology systems, and those of our third-party vendors with whom we contract, make such systems potentially vulnerable

to service interruptions.

The size and complexity of our and our vendors’ systems and the large amounts of confidential information

that is present on them also makes them potentially vulnerable to security breaches from inadvertent or intentional actions by our employees,

partners, or vendors, or from attacks by malicious third parties.

Company and its vendors’ sophisticated information technology operations are spread across multiple, sometimes inconsistent, platforms,

which pose difficulties in maintaining data integrity across systems.

The ever-increasing use and evolution of technology, including

cloud-based computing, creates opportunities for the unintentional or improper dissemination or destruction of confidential information

stored in the Company’s systems.

breach of our security measures or the accidental loss, inadvertent disclosure, unapproved dissemination, misappropriation or misuse

of trade secrets, proprietary information or other confidential information, whether as a result of theft, hacking, fraud, trickery or

other forms of deception, or for any other cause, could enable others to produce competing products, use our proprietary technology or

information and/or adversely affect our business position.

Further, any such interruption, security breach, loss or disclosure of confidential

information could result in financial, legal, business and reputational harm to our company and could have a material adverse effect

on our business, financial condition, results of operations, cash flows and stock price.

disruptions to our IT systems or breaches of information security could adversely affect our business.

In the ordinary course of business,

we collect, store and transmit what we consider to be large amounts of confidential information, and it is critical that we do so in

a secure manner to maintain the confidentiality and integrity of such information.

Additionally, our IT systems are critical to our ability

to store electronic and financial information and to manage a variety of business processes and activities, including, without limitation,

manufacturing, financial, logistics, sales, marketing and administrative functions.

We depend on our IT infrastructure to communicate

internally and externally with employees, customers, suppliers and others.

We also use IT networks and systems to comply with regulatory,

legal and tax requirements.

We have outsourced significant elements of our IT infrastructure.

As a result, we manage independent vendor

relationships with third-parties who are responsible for maintaining significant elements of our IT systems and infrastructure and who

may or could have access to our confidential information.

The size and complexity of our IT systems, and those of our third-party vendors,

make such systems potentially vulnerable to service interruptions and security breaches from inadvertent or intentional actions by our

employees, partners or vendors.

These systems are also vulnerable to attacks by malicious third parties, such as phishing or ransomware

attacks, and may be susceptible to intentional or accidental physical damage to the infrastructure maintained by us or by third parties,

including, without limitation, as a result of extreme weather events, such as fires, floods, hurricanes or tornadoes or as the result

of the use of AI or other new technologies.

the secrecy of confidential, proprietary, and/or trade secret information is important to our competitive business position.

We continually

assess these threats and make investments to increase internal protection, detection, and response capabilities, as well as ensure our

third-party providers have required capabilities and controls, to address these risks.

Like other public companies, our computer systems

and those of our third-party vendors and service providers are regularly subject to, and will continue to be the target of, computer

viruses, malware or other malicious code (including ransomware), unauthorized access, cyber-attacks or other computer-related penetrations,

which have caused, and may continue to cause, disruptions to our operations.

Over time, the sophistication of these threats continues

Our reliance on unsupported and vulnerable operating systems and other software in certain cases may increase both the likelihood

and potential severity of cyber incidents.

The preventative actions we take to reduce the risk of cyber incidents and protect our information

may be insufficient.

Our efforts may not prevent service interruptions or security breaches in our systems or the unauthorized or inadvertent

wrongful use or disclosure of confidential information that could adversely affect our business operations or result in the loss, dissemination,

or misuse of critical or sensitive information.

A breach of our security measures or the accidental loss, inadvertent disclosure, unapproved

dissemination, misappropriation or misuse of trade secrets, proprietary information, or other confidential information, whether as a

result of theft, hacking, fraud, trickery or other forms of deception, or for any other cause, could enable others to produce competing

products, use our proprietary technology or information, and/or adversely affect our business position.

Further, any such interruption,

security breach, loss or disclosure of confidential information could result in financial, legal, business, and reputational harm to

us and could have a material adverse effect on our business, financial condition, results of operations, cash flow, ability to operate

and stock price.

intelligence based platforms may present new risks and challenges to our business.

technologies may exacerbate existing risks, including risks associated with data privacy, cybersecurity, IP, healthcare fraud and abuse,

drug development and manufacturing, and risks to patients or human subjects in clinical trials.

AI also introduces new risks, due to

the autonomous nature of the technology, which, in some cases, may be deployed to perform tasks, inform decisions, automate decisions,

and make predictions.

AI may amplify biased and discriminatory decision making, perform unreliably and malfunction, generate insights

which are difficult to interpret and explain, and cause direct harm to individuals or groups.

are proposing, adopting, and implementing new AI laws and regulations.

We may be required to change our business practices and policies

as a result of such laws and regulations and may incur substantial compliance-related costs.

are also using existing laws and regulations to take enforcement actions related to the deployment of AI in ways that result in non-compliance

with current laws and regulations.

If we fail to comply with AI laws and regulations, we may be subject to sanctions, fines, and reputational

damage, orders to stop certain processing of personal data, orders to delete certain data or destroy AI algorithms derived from data

collects, legal action on behalf of impacted individuals or other enforcement or other actions.

If we fail to take steps to protect our

confidential data, trade secrets, IP and personal data, we may be subject to legal, regulatory, financial, and reputational risks.

technologies present significant opportunities and risks to our business.

Harnessing AI’s transformative potential may enable us

to speed up the discovery and development of new drugs, optimize our manufacturing processes, and drive efficiencies.

Our failure to

use AI technologies in a way that maintains trust, quality and control in our business activities and to capitalize on opportunities

presented by AI may also place us at a competitive disadvantage.

Failure to address AI risks will reduce our ability to deliver strategic

Also, investments in AI may not realize the benefits that were anticipated.

in generic product development may result in failure to achieve adequate return on investment.

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marketing our product other than as an OTC drug, in which case revenues could be substantially less than we anticipated.

business is dependent on market perceptions, social and political pressures, including public concern over the abuse of opioids.

business is dependent on market acceptance of our products, social and political pressures, including public concern over the abuse of opiods.

acceptance of our products among physicians, patients, health care payors and the medical community, is a key component of commercial

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concern over the abuse of opioid medications, including increased legal and regulatory action, could also negatively affect our business.

While Elite has de-emphasized its programs with respect to opioids and will continue to focus on products other than opioids, certain

governmental and regulatory agencies, as well as state and local jurisdictions, are focused on the abuse of opioid medications in the

United States.

Certain governmental and regulatory agencies, as well as state and local jurisdictions, are focused on the abuse of opioid medications

in the United States.

State and local governmental agencies may investigate us as a manufacturer and/or distributor of medicines containing

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During the year ended March 31, 2020, we disposed

of four approved ANDA’s for opioid products.

As of March 31, 2023, we continue to hold one approved ANDA for an opioid product

that, while approved by the FDA, has not been launched commercially.

Further, defense against any such opioid related lawsuits could

be cost-prohibitive resulting in an adverse material effect on our business, financial condition, results of operations, cash flows and

Similar allegations made against us, even without litigation, could also negatively affect our business in various ways,

including through increased costs and harm to our reputation.

In addition, an adverse resolution of any lawsuit or investigation could

also have a material adverse effect on our business, results of operations, cash flows and stock price.

of four approved ANDAs for opioid products.

As of March 31, 2024, we continue to hold one approved ANDA for an opioid product that, while

approved by the FDA, has not been launched commercially.

Subsequent to March 31, 2024, the Company acquired three approved ANDAs for

opioid products, and plans on commercially launching these three products, in addition to the one approved ANDA for an opioid product

previously held within a timeframe that is beneficial to the Company’s interests.

Further, defense against any such opioid related

lawsuits could be cost-prohibitive resulting in an adverse material effect on our business, financial condition, results of operations,

cash flows and stock price.

Similar allegations made against us, even without litigation, could also negatively affect our business in

various ways, including through increased costs and harm to our reputation.

In addition, an adverse resolution of any lawsuit or investigation

could also have a material adverse effect on our business, results of operations, cash flows and stock price.

perceptions of our business are important to us, especially market perceptions of the safety and quality of our products.

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economic conditions may adversely affect our business.

global economy has undergone a period of significant volatility, especially during the ongoing COVID-19 pandemic, which has led to diminished

credit availability, declines in consumer confidence, and increases in unemployment rates.

There remains caution about the stability

economy, and we cannot assure that further deterioration in the financial markets will not occur.

These economic conditions

have resulted in, and could lead to further, reduced consumer spending related to healthcare in general and pharmaceutical products in

global economy has undergone a period of significant volatility, which has led to diminished credit availability, declines in consumer

confidence, and increases in unemployment rates.

There remains caution about the stability of the U.S.

economy, and we cannot assure

that further deterioration in the financial markets will not occur.

These economic conditions have resulted in, and could lead to further,

reduced consumer spending related to healthcare in general and pharmaceutical products in particular.

addition, we have exposure to many different industries and counterparties, including our partners under our alliance and collaboration

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ability to operate and stock price.

substantial portion of our total revenues is expected to be derived from sales of a limited number of products to a limited number of

expect that we will continue to derive a substantial portion of our revenue from sales of a limited number of products.

For the twelve

months ended March 31, 2024, our significant product families (defined as the top four products based on active pharmaceutical ingredient)

accounted for in excess of 90% of allocated revenues (defined as gross revenues less chargebacks and government rebates processed).

sale of our products may be significantly influenced by market conditions, as well as regulatory actions.

We may experience decreases

in the sale of our products in the future as a result of actions taken by our competitors, such as price reductions, or as a result of

regulatory actions, such as changes in quota, related to our products or to competing products, which could result in a material adverse

on our business, financial condition, results of operations, cash flow, ability to operate and stock price.

also expect that we will continue to derive a substantial portion of our revenue from sales to a limited number of customers.

twelve months ended March 31, 2024, our six largest customers accounted for in excess of 80% of revenues.

The loss of any one or more

of these customers, without replacement by a customer of similar significance, or the substantial reduction in orders from any one or

more of these customers, without replacement of orders of a similar magnitude from other customers, could result in a material adverse

on our business, financial condition, results of operations, cash flow, ability to operate and stock price.

depend to a large extent on third-party suppliers and distributors for the raw materials for our products, particularly the chemical

compounds comprising the active pharmaceutical ingredients (“API’s”) that we use to manufacture our products, as well

as for certain finished goods.

purchase the bulk of the raw materials essential to our manufacturing business from third parties.

If we experience supply interruptions

or delays, or if a supplier discontinues the sale of certain products, we may have to obtain substitute materials or products, which

in turn would require us to obtain amended or additional regulatory approvals, subjecting us to additional expenditures of significant

time and resources.

In addition, changes in our raw material suppliers could result in significant delays in production, higher raw material

costs and loss of sales and customers, because regulatory authorities must generally approve raw material sources for pharmaceutical

products, which may be time consuming.

For example, it may take as long as 18 months to find and qualify a new sole-source supplier.

If we receive less than one year’s termination notice from a sole-source supplier that intends to cease supplying raw materials,

it could result in disruption of our ability to produce the drug involved.

Any significant interruption could result in a material adverse

on our business, financial condition, results of operations, cash flow, ability to operate and stock price.

issue price adjustments and other sales allowances to our customers.

Although we may establish reserves based on our estimates of these

amounts, if estimates are incorrect and the reserves are inadequate, it may result in adjustments to these liabilities that may have

a material adverse effect on our financial position and results of operations.

on estimates, we establish liabilities for sales allowances, including, without limitation, sales discounts, returns, chargebacks, sales

volume rebates, shelf stocks, cash discounts and Medicaid rebate obligations at each reporting period.

Although we believe our liabilities

are adequate as of the date of this report, there can be no assurances given by us that our reserves will ultimately prove to be adequate.

Increases in such sales allowances may exceed our estimates for a variety of reasons, including, without limitation, unanticipated competition,

an unexpected change in one or more contractual relationships or changes in ratios in contractual sales volumes as compared to historical

We will continue to evaluate the relevant factors upon which our estimates and reserves are calculated and record appropriate

adjustments if and when deemed necessary.

Any failure to establish adequate liabilities with respect to these sales allowances could

result in a material adverse effect on our business, financial position, results of operations, cash flows, ability to operate and cash

and Liquidity Risks

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.

management is responsible for establishing and maintaining adequate internal control over our financial reporting, as defined in Rule

13a-15(f) under the Exchange Act.

Based on reviews conducted by management and specific guidance from third party subject matter experts

engaged by the Company, we have concluded that material weaknesses in the Company’s internal controls over financial reporting

A material weakness is a deficiency, or a combination of deficiencies, in internal controls over financial reporting such that

there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or

detected on a timely basis.

Company has identified certain remediation actions and is in the process of implementing them, but such efforts are not complete, most

likely require the retention of additional personnel or consultants, both of which are further subject to the Company’s financial

condition and financial ability to retain such resources.

Although no material misstatement of historical financial statements was identified,

if we are unable to complete our remediation in a timely manner or if our remedial measures are insufficient to address the material

weaknesses, or if additional material weaknesses in our internal controls are discovered or occur in the future, it may adversely affect

our ability to report our financial condition and results of operations in a timely and accurate manner and there will continue to be

an increased risk of future misstatements.

In our periodic review and evaluation of internal control systems to allow management to assess

the effectiveness of our internal controls over financial reporting, we may discover additional weaknesses in our internal controls over

financial reporting or disclosure controls and procedures.

The next time we evaluate our internal controls over financial reporting and

disclosure controls and procedures, if we identify one or more new material weaknesses or have been unable to timely remediate our existing

material weaknesses, we would be unable to conclude that our internal controls over financial reporting or disclosure controls and procedures

are effective.

If we are unable to conclude that our internal controls over financial reporting or our disclosure controls and procedures

are effective or, if required to issue such an opinion, our independent registered public accounting firm expresses an opinion that our

internal controls over financial reporting is ineffective, we may not be able to report our financial condition and results of operations

in a timely and accurate manner, 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 to decline.

In addition, any potential future restatements could

subject us to additional adverse consequences, including sanctions by the SEC, shareholder litigation and other adverse actions.

we may be the subject of further negative publicity focusing on such financial statement adjustments and resulting restatement and negative

reactions from our shareholders, creditors or others with whom we do business.

The occurrence of any of the foregoing 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 to decline.

Please see Item 9A “Controls and Procedures” in Part II.

have a relatively limited operating history and our operating results could fluctuate significantly.

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Variations may result from one or more factors, including, without limitation:

of a global pandemic or similar situation, including, without limitation the COVID-19 pandemic that emerged in 2020, with such effects

to include actions taken by the Company, its suppliers, partners, competitors, other entities involved in the industry, other entities,

and any laws, regulations, executive orders or other governmental/regulatory actions taken in relation to such a pandemic or similar

circumstance;

of approval of applications filed with the FDA;

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and respond to competitive developments.

operations during a global pandemic or similar situation, such as the COVID-19 global pandemic first identified in 2020.

we do not effectively address the risks we face, our business model may become unworkable and we may not achieve or sustain profitability

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to significant risks and uncertainties.

We rely on cash generated by operations as well as access to financial markets, such as the equity

line with Lincoln Park and equipment financings, to fund our commercial, product development and other operations, maintain liquidity

and meet our financial obligations.

Amounts available under the equity line with Lincoln Park have a strong and direct correlation to

the Company’s publicly traded price per share and volumes.

There can be no assurances of our traded price per share and volumes

being at sufficient levels to provide adequate funding from the equity line with Lincoln Park.

In addition, there can be no assurances

of our ability to secure equipment financing, resulting in an increased risk of our inability to achieve critical or necessary facility

We rely on cash generated by operations as well as access to financial markets and equipment

financings, to fund our commercial, product development and other operations, maintain liquidity and meet our financial obligations.

There can be no assurances of our ability to secure equipment financing, resulting in an increased risk of our inability to achieve critical

or necessary facility upgrades.

operations are also subject to many significant risks and uncertainties, as described, without limitation, in this “ Risk Factors ”

section, including, without limitation, those risks related to the effects of a global pandemic such as or similar to the COVID-19 pandemic,

competition in the markets in which we operate, litigation risks, government investigations, including those related to our sale, marketing

and/or distribution of prescription opioid medications in prior periods, and others.

Any negative development or outcome in connection

with any or all of these risks and uncertainties could result in significant consequences, including, without limitation, one or more

of the following:

section, including, without limitation, competition in the markets in which we operate, litigation risks, government investigations,

including those related to our sale, marketing and/or distribution of prescription opioid medications in prior periods, and others.

negative development or outcome in connection with any or all of these risks and uncertainties could result in significant consequences,

including, without limitation, one or more of the following:

dedication of a substantial portion of our cash flows from operations to the payment of legal or related expenses, resulting in these

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for development or currently in development.

of March 31, 2023, we had cash on hand of approximately $7.8 million and a working capital surplus of $13.7 million, and, for the fiscal

year ended March 31, 2023, we generated income from operations totaling $3.7 million, net other income totaling $0.3 million and net

income of $3.6 million.

July 8, 2020, we entered into another purchase agreement (the “ 2020 LPC Purchase Agreement ”), together with a registration

rights agreement (the “ 2020 LPC Registration Rights Agreement ”), with Lincoln Park.

Under the terms and subject to

the conditions of the 2020 LPC Purchase Agreement, we have the right to sell to and Lincoln Park is obligated to purchase up to $25 million

in shares of our common stock, subject to certain limitations, from time to time, over the 36-month period commencing on July 27, 2020

and expiring on August 1, 2023.

of March 31, 2024, we had cash on hand of approximately $7.1 million and a working capital surplus of $27.0 million, as of March 31,

2024, we generated income from operations totaling $10.8 million, net other expenses totaling $10.3 million and a net tax benefit of

$19.6 million, resulting in net income of $20.1 million.

growth in our current generic product line, consisting of Phentermine Tablets, Phentermine Capsules, Phendimetrazine Tablets, Naltrexone

Tablets, Isradipine Capsules, Trimipramine Capsules, Loxapine capsules, Amphetamine IR Tablets, Amphetamine ER Capsules and Dantrolene Capsules, and successful commercialization of other products in our product development pipeline,

may lead to eventual profitability, there can be no assurances of Elite becoming profitable.

Furthermore, there can be no assurances

of the continuation revenues being earned from the current generic product line, no assurances of Elite’s successful commercialization

of other products in our development pipeline, and no assurances of Elite’s ability to continue as a going concern.

there can be no assurances of Elite being able to raise additional funds in a timely manner, on acceptable terms, if needed to support

commercial operations resulting in a material detrimental effect on Elite’s ability to become profitable and accordingly being

a material factor to the detriment of Elite’s ability to continue as a going concern as well as having a material adverse effect

on our business, results of operations, financial condition, and cash flow and ability to operate in the future.

Tablets, Isradipine Capsules, Trimipramine Capsules, Loxapine capsules, Amphetamine IR Tablets, Amphetamine ER Capsules and Dantrolene

Capsules, and successful commercialization of other products in our product development pipeline, may lead to increased profitability,

there can be no assurances of Elite increasing profits or achieving profitable operations in the future.

Furthermore, there can be no

assurances of the continuation of revenues being earned from the current generic product line, no assurances of Elite’s successful

commercialization of other products in our development pipeline.

In addition, there can be no assurances of Elite being able to raise additional funds in a timely manner, on acceptable terms, if needed

to support commercial operations resulting in a material detrimental effect on Elite’s operations and profits as well as having a material adverse

effect on our business, results of operations, financial condition, and cash flow and ability to operate in the future.

sustain operations and meet our business objectives we must be able to commercialize our products and other products or pipeline opportunities.

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to grow our business, take advantage of business opportunities, or respond to competitive pressures..

also see the risk factor titled “ Global pandemic and natural disasters ”.

have substantial indebtedness which may adversely affect our financial condition.

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Total liabilities as of March 31, 2024, were $26.1 million, with such amount including, without

limitation, $3.9 million in various loans, leases, and bonds payable, $0.5 million in derivative liabilities, and $7.5 million in current

payables and accruals.

limitation, $11.7 million in various loans, leases, bonds payable and deferred revenues, $6.3 million in derivative liabilities and $8.0

million in current payables and accruals.

The consequences of this substantial indebtedness could include:

increase in our vulnerability to general economic and industry conditions, including recessions, depressions, effects of global pandemics

such as the COVID-19 pandemic, significant inflation and other financial market volatility;

to the risk of increased interest rates;

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effect on our business, financial condition, results of operations, cash flows and stock price.

During the year ended March 31, 2023, we determined that circumstances indicated that the value of our intangible

assets may not be recoverable.

During the year ended March 31, 2023, we recorded impairment of approximately $0.3 million of our ANDA

and patent intangible assets.

During the year ended March 31, 2023,

we determined that circumstances indicated that the value of our intangible assets may not be recoverable.

During the years ended March

31, 2024 and 2023, we recorded impairment of approximately $0.0 million, and $0.3 million respectively, of our ANDA and patent intangible

requires estimates, judgements and assumptions which inherently contain uncertainties.

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costs to their employees.

Job losses, or other economic hardships, especially, but not limited to those hardships resulting from the

effects of the COVID-19 global pandemic, may also result in reduced levels of coverage for some individuals, potentially resulting in

lower healthcare coverage for themselves or their families.

Furthermore, increased instability in the insurance marketplace or an increase

in uninsured Americans or others living and working in the USA may result from the Tax Cuts and Jobs Act of 2017 elimination of the Patient

Protection and Affordable Care Act (PPACA)’s requirement that individuals maintain health insurance or incur a financial penalty

and other steps taken by various governmental and other organizations to limit or end subsidies to such individuals at comparatively

lower income levels.

These economic conditions may affect an individual’s ability to afford healthcare as a result of increased

premiums, co-pay or deductible obligations, greater cost sensitivity to existing co-pay or deductible obligations, lost healthcare coverage

or for other reasons.

It is possible that such conditions could lead to changes in patient behavior and spending patterns that could

negatively affect prescription and usage of certain or all of our products, including, without limitation, delaying of treatment, rationing

of prescription medications, non-filling of prescriptions, reduction in the frequency of visits to healthcare facilities, utilizing alternative

therapies or foregoing healthcare insurance coverage altogether.

Such changes may result in the reduced demand for any or all of our

products, which could have a material adverse effect on our business, results of operations, financial condition, cash flows and ability

to operate as a going concern.

Job losses, or other economic hardships may also result in reduced levels of coverage for some individuals,

potentially resulting in lower healthcare coverage for themselves or their families.

Furthermore, increased instability in the insurance

marketplace or an increase in uninsured Americans or others living and working in the USA may result from the Tax Cuts and Jobs Act of

2017, elimination of the Tax Cuts and Jobs Act of 2017, elimination of the Patient Protection and Affordable Care Act (PPACA)’s

requirement that individuals maintain health insurance or incur a financial penalty and other steps taken by various governmental and

other organizations to limit or end subsidies to such individuals at comparatively lower income levels.

These economic conditions may

affect an individual’s ability to afford healthcare as a result of increased premiums, co-pay or deductible obligations, greater

cost sensitivity to existing co-pay or deductible obligations, lost healthcare coverage or for other reasons.

It is possible that such

conditions could lead to changes in patient behavior and spending patterns that could negatively affect prescription and usage of certain

or all of our products, including, without limitation, delaying of treatment, rationing of prescription medications, non-filling of prescriptions,

reduction in the frequency of visits to healthcare facilities, utilizing alternative therapies or foregoing healthcare insurance coverage

Such changes may result in the reduced demand for any or all of our products, which could have a material adverse effect

on our business, results of operations, financial condition, cash flows and ability to operate as a going concern.

our ability to commercialize and generate revenues and profit splits relating to the sale of our products depends, in part, on the extent

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both coverage and the level of reimbursement (including adjusting co-pays) for drugs, (ii) refusing, in some cases, to provide any coverage

for certain uses for drugs and (iii) requiring or encouraging, through more favorable reimbursement levels or otherwise, the substitution

of generic alternatives to branded drugs.

For example, government agencies or third-party payers could attempt to reduce reimbursement

for physician administered products through their interpretation of complex government price reporting obligations and payment and reimbursement

coding rules, and could attempt to reduce reimbursement for separate physician administered products that share an active ingredient

by requiring the blending of sales and pricing information in the same payment and reimbursement code.

for certain uses for drugs, (iii) requiring rebates, in the case of government healthcare programs, for net sales amounts above statutorily

defined ceilings, with such ceilings being potentially below production costs and (iv) requiring or encouraging, through more favorable

reimbursement levels or otherwise, the substitution of generic alternatives to branded drugs.

For example, government agencies or third-party

payers could attempt to reduce reimbursement for physician administered products through their interpretation of complex government price

reporting obligations and payment and reimbursement coding rules, and could attempt to reduce reimbursement for separate physician administered

products that share an active ingredient by requiring the blending of sales and pricing information in the same payment and reimbursement

unavailability of, or reduction in, the reimbursement of our products could have a material adverse effect on our business, ability to

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adverse effect on our results of operations, financial condition, cash flows and our ability to operate.

revenues and profits from generic products may decline as a result of changes in regulatory policy.

The IRA contains substantial drug pricing reforms, including the establishment of a drug

price negotiation program within the U.S.

Department of Health and Human Services that would require manufacturers to charge a negotiated

“maximum fair price” for certain selected drugs or pay an excise tax for noncompliance, the establishment of rebate payment

requirements on manufacturers of certain drugs payable under Medicare Parts B and D to penalize price increases that outpace inflation,

and requires manufacturers to provide discounts on Part D drugs.

Substantial penalties can be assessed for noncompliance with the drug

pricing provisions.

with an available generic or biosimilar, certain drugs that represent a limited portion of Medicare program spending, drugs with an orphan

designation as their only FDA approved indication, and all plasma-derived products are exempt from direct negotiation.

The number of

negotiated products will be phased in between 2026 and 2029, and the law sets a maximum fair price the manufacturer can charge based

on the number of years the product has been on the market.

The law allows HHS to levy an excise and civil monetary penalties against

non-compliant manufacturers or those who refuse to negotiate.

IRA also imposes rebate requirements on manufacturers of single-source generics and other drugs covered under Medicare Part B and Part

D where the price of the drug increases faster than inflation.

Multisource generics and all products with an average manufacturer’s

price less than $100 per year, per individual, are exempt from rebate requirements.

Beginning on October 1, 2022 for Part D products

and on January 1, 2023 for Part B products, CMS will monitor for products with price increases higher than the rate of inflation on a

quarterly basis.

Rebates will be calculated as the total number of units sold by the amount the product exceeds the inflation-adjusted

price, with 2021 as the base year to measure cumulative changes relative to inflation.

Noncompliant manufacturers will be subject to

a civil monetary penalty of at least 125% of the calculated rebate amount.

effect of the IRA on our business, generic manufacturers, and the pharmaceutical industry in general is not

tariffs and evolving trade policy between the US and other countries may adversely affect our business.

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such action could have an adverse effect on the Company’s business, operations and financial condition.

reporting and payment obligations under the Medicaid rebate program and other governmental purchasing and rebate programs are complex

and may involve subjective decisions.

Any determination that we have failed to comply with those obligations could subject us to penalties

and sanctions which could have a material adverse effect on our business.

regulations applicable to us regarding reporting and payment obligations with respect to Medicaid reimbursement and rebates and other

governmental programs are complex.

Our calculations and methodologies are subject to review and challenge by the applicable governmental

agencies, and it is possible that such reviews could adversely affect us and our business.

In addition, because our processes for these

calculations and the judgments involved in making these calculations involve, and will continue to involve, subjective decisions and

complex methodologies, these calculations are subject to the risk of error and misjudgment.

Any governmental agencies that have commenced

(or that may commence) an investigation of us could impose, based on a claim of violation of anti - fraud and false claims laws

or otherwise, civil and/or criminal sanctions, including fines, penalties and possible exclusion from federal health care programs (including

Medicaid and Medicare).

Some of the applicable laws may impose liability even in the absence of specific intent to defraud.

should there be ambiguity with respect to how to properly calculate and report payments, and even in the absence of any such ambiguity,

a governmental authority may take a position contrary to a position that we have taken and may impose civil and/or criminal sanctions

Any such penalties, sanctions, or exclusion from federal health care programs could have a material adverse effect on our business,

financial position, results of operation, ability to operate and stock price.

Investigations

and litigation concerning the calculation of average wholesale prices may adversely affect our business

government and third-party payers, including Medicare, Medicaid, HMOs and others, reimburse doctors and others for the purchase of certain

prescription drugs based on a drug’s average wholesale price (“AWP”).

In the past several years, state and federal

government agencies have conducted ongoing investigations of manufacturers’ reporting practices with respect to AWP, as a result

of which certain agencies have suggested that reporting of inflated AWPs by manufacturers has led to excessive payments for prescription

Numerous pharmaceutical companies have been named as defendants in actions brought by various State Attorneys General and have

faced state law qui tam actions brought on behalf of various states, alleging generally that the defendants defrauded state Medicaid

systems by purportedly reporting or causing the reporting of AWP and/or “Wholesale Acquisition Costs” that exceeded the actual

selling price of the defendants’ prescription drugs.

These cases generally seek some combination of actual damages, and/or double

damages, treble damages, compensatory damages, statutory damages, civil penalties, disgorgement of excessive profits, restitution, disbursements,

counsel fees and costs, litigation expenses, investigative costs, injunctive relief, punitive damages, imposition of a constructive trust,

accounting of profits or gains derived through the alleged conduct, expert fees, interest and other relief that the court may have deemed

can give no assurance that we will be able to settle current or future actions on terms that we deem reasonable, or that such settlements

or adverse judgments, if entered, will not exceed the amount of any liability we have recorded.

Accordingly, such actions could adversely

affect us and may have a material adverse effect on our business, results of operations, financial condition, cash flows ability to operate

and stock price.

and Liability Related Risks

may not be able to obtain or maintain adequate insurance coverages.

cost of insurance, including directors and officer insurance, workers compensation, product liability, truck and general liability insurance

have increase significantly in recent years and may continue to increase in the future.

We have increased deductibles and/or decreased

coverages to mitigate some of these costs.

These insurance premium increases, as well as our increased risk due to reduced coverage and

increased deductibles could have an adverse material effect on our business, financial condition, results of operations, cash flows and

cost of insurance, including directors and officer insurance, workers compensation, product liability for products containing opioids

and products not containing opioids, truck and general liability insurance have increase significantly in recent years and may continue

to increase in the future.

We have increased deductibles and/or decreased coverages to mitigate some of these costs.

These insurance

premium increases, as well as our increased risk due to reduced coverage and increased deductibles could have an adverse material effect

on our business, financial condition, results of operations, cash flows and stock price.

may not have and may be unable to obtain or maintain in the future insurance, on acceptable terms, that provide adequate coverage against

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any reason, regardless of the merits, success or failure of such claim.

In the past year, as a result of product liability and securities

In past years, as a result of product liability and securities

litigation in the general marketplace, and a threatened claim of action against us in relation to the shareholder vote conducted in December

2019, our insurance premiums have increased significantly, while also providing no greater, and in most cases, lower levels of coverage.

The significant premium increases experienced were prior to, and accordingly did not consider, the impact of the COVID-19 global pandemic

on the legal and litigation environment in which we and all other companies operate.

amount of our insurance coverage is accordingly limited by our financial resources and greatly impacted by the significant premium increases

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civil False Claims Act (which can be enforced through “qui tam,” or whistleblower actions, by private citizens on

behalf of the federal government), prohibits any person from, among other things, knowingly presenting, or causing to be presented

false or fraudulent claims for payment of government funds or knowingly making, using or causing to be made or used, a false record

or statement material to an obligation to pay money to the government or knowingly and improperly avoiding, decreasing or concealing

an obligation to pay money to the U.S.

behalf of the federal government and impose civil and criminal penalties), prohibits any person from, among other things, knowingly

presenting, or causing to be presented false or fraudulent claims for payment of government funds or knowingly making, using or causing

to be made or used, a false record or statement material to an obligation to pay money to the government or knowingly and improperly

avoiding, decreasing or concealing an obligation to pay money to the U.S.

federal government;

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intent to violate it in order to have committed a violation;

as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and its implementing regulations,

which also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission

of individually identifiable health information without appropriate authorization by covered entities subject to the rule, such as

health plans, healthcare clearinghouses and healthcare providers as well as their business associates and their subcontractors that

perform certain services for or on their behalf involving the use or disclosure of individually identifiable health information;

laws and regulations, including state anti-kickback and false claims laws, that may apply to our business practices, including but

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REMS programs could increase the cost, burden and liability associated with the commercialization of certain products.

FDA has imposed a class-wide REMS on all IR, ER and long acting (“LA”) opioid drug products (known as the Opioid Analgesic

The FDA continually evaluates whether the REMS program is meeting its goal of ensuring that the benefit of these drugs continue

to outweigh their risks, and whether the goals or elements of the program should be modified.

If the FDA determines that additional measures

are necessary, the modification of the Opioid Analgesic REMS to impose additional or more burdensome requirements could increase the

costs associated with marketing opioid products and/or reduce the willingness of healthcare providers to prescribe those products, both

which would have a material adverse effect on the ability to successfully commercializing, or to generate sufficient revenue from, such

FDA has imposed a class-wide REMS on all IR, ER and long acting opioid drug products (known as the Opioid Analgesic REMS).

The FDA continually

evaluates whether the REMS program is meeting its goal of ensuring that the benefit of these drugs continue to outweigh their risks,

and whether the goals or elements of the program should be modified.

If the FDA determines that additional measures are necessary, the

modification of the Opioid Analgesic REMS to impose additional or more burdensome requirements could increase the costs associated with

marketing opioid products and/or reduce the willingness of healthcare providers to prescribe those products, both which would have a

material adverse effect on the ability to successfully commercializing, or to generate sufficient revenue from, such products.

distribution and third party sale of counterfeit versions of our products could have a detrimental effect on our reputation and business.

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on our business, results of operations and financial condition.

and Organizational Risks

of our Articles of Incorporation could deter a change of management and discourage offers to acquire us.

of our Articles of Incorporation and By-Laws law may make it more difficult for someone to acquire control of us or for our shareholders

to remove existing management and might discourage a third party from offering to acquire us, even if a change in control or in Management

would be beneficial to our shareholders.

For example, as discussed above, our Articles of Incorporation allows us to issue shares of

preferred stock without any vote or further action by our shareholders.

Our Board of Directors has the authority to fix and determine

the relative rights and preferences of preferred stock.

Our Board of Directors also has the authority to issue preferred stock without

further shareholder approval.

As a result, our Board of Directors could authorize the issuance of a series of preferred stock that would

grant to holders the preferred right to our assets upon liquidation, the right to receive dividend payments before dividends are distributed

to the holders of common stock and the right to the redemption of the shares, together with a premium, prior to the redemption of our

common stock.

In this regard, on November 15, 2013, we entered into a Shareholder Rights Plan and, under the Rights Plan, our Board of

Directors declared a dividend distribution of one Right for each outstanding share of our common stock and one right for each share of

Common Stock into which any of our outstanding Preferred Stock is convertible, to shareholders of record at the close of business on

Each Right entitles the registered holder to purchase from us one “Unit” consisting of one one-millionth (1/1,000,000)

of a share of Series H Junior Participating preferred stock, at a purchase price of $2.10 per Unit, subject to adjustment, and may be

redeemed prior to November 15, 2023, the expiration date, at $0.000001 per Right, unless earlier redeemed by the Company.

generally are not transferable apart from the common stock and will not be exercisable unless and until a person or group acquires or

commences a tender or exchange offer to acquire, beneficial ownership of 15% or more of our common stock.

However, for Mr.

Chief Executive Officer, the Rights Plan’s the 15% threshold excludes shares beneficially owned by him as of November 15, 2013

and all shares issuable to him pursuant to his employment agreement and the Mikah Note.

Our By-Laws provide for the classification of

our Board of Directors into three classes.

competitors or other third parties may allege that we are infringing upon their intellectual property (“IP”), forcing us

to expend substantial resources in litigation, the outcome of which is uncertain.

Any unfavorable outcome of such litigation, including,

without limitation, losses related to “at-risk” product launches, could have a material effect our business, financial position

and results of operations.

that produce branded pharmaceutical products routinely bring litigation against ANDA filers or similar applicants that seek regulatory

approval to manufacture and market generic forms of their branded products alleging patent infringement or other violations of IP rights.

Patent holders may also bring patent infringement suits against companies that are currently marketing and selling approved generic products.

Litigation often involves significant expense and can delay or prevent introduction or sale of our generic and/or biosimilar products.

If valid and enforceable patents are infringed by our products, we would need to delay selling the infringing generic product unless

we could obtain a license from the patent holder, and, if we were already selling the infringing product, cease selling and potentially

destroy existing product stock.

may be situations in which we may make business and legal judgments to market and sell products that are subject to claims of alleged

patent infringement prior to final resolution of those claims by the courts, based upon our belief that such patents are invalid, unenforceable,

or are not infringed by our marketing and sale of such products.

This is referred to in the pharmaceutical industry as an “at-risk”

The risk involved in an at-risk launch can be substantial because, if a patent holder ultimately prevails against us, the remedies

available to such holder may include, among other things, damages measured by the profits lost by the patent holder or treble damages,

which can be significantly higher than the profits we make from selling the generic version of the product.

We may also be harmed by

the loss of any value of such inventory that we are unable to market or sell.

Any or all of the above could have a material adverse effect

on our business, financial condition, results of operations, cash flow, ability to operate as a going concern and stock price.

Property Related Risks

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to protect our intellectual property adequately, competitors may manufacture and market products similar to ours.

currently hold six patents.

We intend to file further patent applications in the future.

We cannot be certain that our pending patent

applications will result in the issuance of patents.

currently hold three patents and we may intend to file further patent applications in the future.

We cannot be certain that any further

patent applications will result in the issuance of patents.

If patents are issued, third parties may sue us to challenge our patent protection,

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Related to our Common Shares

from issuance of shares to Lincoln Park, Directors, Employees, Consultants or upon exercise of warrants and options or the perception

that dilution may occur could cause the price per share of common stock to fall.

July 8, 2020, we entered into the Purchase Agreement with Lincoln Park, pursuant to which Lincoln Park has committed to purchase up to

$25,000,000 of our common stock.

Concurrently with the execution of the Purchase Agreement, we issued 5,975,857 shares of our common

stock to Lincoln Park as an initial fee for its commitment to purchase shares of our common stock under the Purchase Agreement.

for each additional purchase by Lincoln Park, additional commitment shares in commensurate amounts up to a total of 5,975,857 shares

will be issued based upon the relative proportion of the aggregate amount of $25,000,000 purchased by Lincoln Park.

The purchase shares

that may be sold pursuant to the Purchase Agreement may be sold by us to Lincoln Park at our discretion from time to time over a 36-month

period commencing after July 27, 2020 and expiring on August 1, 2023.

The purchase price for the shares that we may sell to Lincoln Park

under the Purchase Agreement will fluctuate based on the price of our common stock.

Depending on market liquidity at the time, sales

of such shares may cause the trading price of our common stock to fall.

generally have the right to control the timing and amount of any sales of our shares to Lincoln Park.

Additional sales of our common

stock, if any, to Lincoln Park will depend upon market conditions and other factors to be determined by us.

Lincoln Park may ultimately

purchase all, some, or none of the shares of our common stock that may be sold pursuant to the Purchase Agreement and, after it has acquired

shares, Lincoln Park may sell all, some or none of those shares.

addition, as of March 31, 2023, there were outstanding warrants to purchase an aggregate of approximately 79 million shares of Common

Stock at a cash exercise price of $0.1521 per share, vested options to purchase an aggregate of approximately 15.4 million shares at a

weighted average cash exercise price of $0.07.

Additional shares of Common Stock may be issuable as a result of anti-dilution provisions

in the outstanding warrants, with such provisions excluding any shares issued to Lincoln Park from consideration .

from issuance of shares to Directors, Employees, Consultants or upon exercise of warrants and options or the perception that dilution

may occur could cause the price per share of common stock to fall.

of March 31, 2024, there were outstanding warrants to purchase an aggregate of approximately 79.0 million shares of Common Stock at a

cash exercise price of $0.1521 per share, vested options to purchase an aggregate of approximately 15.7 million shares at a weighted

average cash exercise price of $0.05.

Additional shares of Common Stock may be issuable as a result of anti-dilution provisions in the

outstanding warrants.

We may also issue shares from time to time to our directors, officers, employees, and consultants.

a result of the above discussed potential issuance of securities, such issuances by us could result in substantial dilution to the interests

of other holders of our common stock.

Additionally, the sale of a substantial number of shares of our common stock to Lincoln Park or

pursuant to the conversion or exercise of outstanding shares of warrants, or the anticipation of such issuances, could make it more difficult

for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect sales.

pursuant to the Company’s policies relating to the compensation of Directors, 2/3 of all director fees are paid via the issuance

of shares of Common Stock, with such shares being valued at the simple average of the closing price of the Company’s Common Stock

for each day in the period for which the director fees were incurred.

In addition, members of the Company’s management, certain

employees and consultants receive a portion of their salaries or compensation via the issuance of shares Common Stock, with such shares

being valued by the same method as that used for the shares issued in payment of director fees.

issuance of these shares is dilutive to holders of our Common Stock, and the subsequent sale of these shares, or the perception that

the sale of these shares may occur, could cause the price of our common stock to fall.

of other holders of our common stock, and the subsequent sale of these shares, or the perception that the sale of these shares may occur,

could cause the price of our common stock to fall.

Additionally, the conversion or exercise of outstanding shares of warrants, or the

anticipation of such issuances, could make it more difficult for us to sell equity or equity-related securities in the future at a time

and at a price that we might otherwise wish to effect sales.

common stock is a penny stock, quoted on the OTC bulletin board, with rules in place that could limit trading and liquidity of our shares,

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and will increase transaction costs for sales and purchases of our Common Stock as compared to other securities.

addition, our Common stock is quoted on the Venture Market (the “OTCQB”) which is a regulated quotation

service that displays real-time quotes, last sale prices and volume limitations in over-the-counter securities.

Because trades and quotations

on the OTCQB involve a manual process, the market information for such securities cannot be guaranteed.

In addition, quote information,

or even firm quotes, may not be available.

The manual execution process may delay order processing and intervening price fluctuations

may result in the failure of a limit order to execute or the execution of a market order at a significantly different price.

of trades, execution reporting and the delivery of legal trade confirmations may be delayed significantly.

Consequently, one may not

be able to sell shares of our Common Stock at the optimum trading prices.

addition, our Common stock is quoted on the Venture Market (the “OTCQB”) which is a regulated quotation service that displays

real-time quotes, last sale prices and volume limitations in over-the-counter securities.

Because trades and quotations on the OTCQB

involve a manual process, the market information for such securities cannot be guaranteed.

In addition, quote information, or even firm

quotes, may not be available.

The manual execution process may delay order processing and intervening price fluctuations may result in

the failure of a limit order to execute or the execution of a market order at a significantly different price.

Execution of trades, execution

reporting and the delivery of legal trade confirmations may be delayed significantly.

Consequently, one may not be able to sell shares

of our Common Stock at the optimum trading prices.

fewer shares of a security are being traded on the OTCQB, volatility of prices may increase, and price movement may outpace the ability

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to conduct share repurchases either currently or in the foreseeable future.

UNRESOLVED STAFF COMMENTS

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors