What changed in this filing

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Item 1A. Risk Factors

2024-03-19 compared with 2023-03-23 · 389 added, 301 removed, 1335 unchanged (34% of the section changed)

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ability to attract customers and increase sales of current and future products

ability to obtain marketing approval and ongoing expense associated with it for any of our drug candidates, including those we own

royalty rights of;

ability to obtain marketing approval and ongoing expense associated with it for any of our drug candidates, including those for which

we own royalty rights

reliance on third parties for manufacturing certain components, FDA approved drugs and to conduct clinical trials

exposure to liabilities and reputation harm if our products give rise to defects, recalls, patient injury or death

potential adverse impact of health epidemics, including the COVID-19 pandemic;

information technology systems exposure to cyberattack or information security breach could significantly compromise the confidentiality,

integrity and availability of our information technology systems

Related to Government Regulations and Third-Party Policies

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burden operations or narrow the market for our products

sales depend on coverage and reimbursement from government and commercial third-party payers, and pricing and reimbursement pressures

sales depend on coverage and reimbursement from government and commercial third-party payors, and pricing and reimbursement pressures

have affected, and are likely to continue to affect, our profitability

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may not be successful in obtaining market exclusivity for our product candidates

Related to Our Notes

ability pay the interest and debt service payments associated with the Notes;

Notes are unsecured, effectively subordinated to any secured indebtedness, with limited protection for its holders;’

Related to the Notes

ability to pay the interest and debt service payments associated with the Notes

Notes are unsecured, effectively subordinated to any secured indebtedness, with limited protection for holders of the Notes

Notes are subject to various market factors, including market interest rates, trading activity, third-party ratings and other factors

Related to Our Common Stock

of the price of our common stock

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Our business,

financial condition, results of operations and stock price could be materially adversely affected by any of these risks.

financial condition, results of operations, and prices of our common stock and Notes could be materially adversely affected by any of

Related to Economic Conditions and Operations of Our Business.

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success of our product acquisitions will depend on, among other things, our ability to successfully integrate the products into our commercial

platform, transfer the products NDAs, maintain payer reimbursement coverage, maintain an adequate supply of the products, market the

platform, transfer the products NDAs, maintain payor reimbursement coverage, maintain an adequate supply of the products, market the

products to our existing customers and re-introduce TRIESENCE to the ophthalmic market.

If we experience difficulties with the implementation

of plans with respect to our acquisitions, the anticipated benefits of the recent or future acquisition may not be realized fully or

at all, or may take longer to realize than expected.

of plans with respect to our acquisitions, the anticipated benefits of recent or future acquisitions may not be realized fully or at

all, or may take longer to realize than expected.

Integration efforts will also divert management’s attention and resources.

These matters could have an adverse effect during any transition period and for an undetermined period after completion of the acquisitions.

matters could have an adverse effect during any transition period and for an undetermined period after completion of the acquisitions.

may not be able to correctly estimate our future operating expenses, which could lead to cash shortfalls.

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a result of changes to our business model and strategy, our termination of efforts to pursue FDA approval of a drug candidate in November

2013, our acquisitions of compounding facilities and various product and corporate development opportunities since 2014, and the expenses

in developing our pharmacy facilities into outsourcing facilities and registering them as such with the FDA.

We may not accurately estimate

the potential revenues and expenses of our operations.

If we are unable to correctly estimate the amount of cash necessary to fund our

business, we could spend our available financial resources much faster than we expect.

If we do not have sufficient funds to continue

to operate and develop our business, we could be required to seek additional financing earlier than we expect, which may not be available

when needed or at all, or be forced to delay, scale back or eliminate some or all of our proposed operations.

we do not successfully identify and acquire rights to potential formulations and successfully integrate them into our operations, our

growth opportunities may be limited.

plan to pursue the development of new proprietary compounded formulations in the ophthalmology and/or other therapeutic areas, which

may include continued activities to develop and commercialize current assets or, if and as opportunities arise, potential acquisitions

of new intellectual property rights and assets.

We also intend to seek opportunities to FDA approved products and drug candidates.

we expect acquisitions of compounding pharmacies to provide us with only limited research and development support and access to additional

novel compounded formulations.

We have historically relied, and we expect to continue to rely, primarily upon third parties to provide

us with additional development opportunities.

We may seek to enter into acquisition agreements or licensing arrangements to obtain rights

to develop new formulations and FDA approved products in the future, but only if we are able to identify attractive products and formulations

and negotiate acquisition or license agreements on terms acceptable to us, which we may not be able to do.

Moreover, we have limited

resources to acquire additional potential product development assets and integrate them into our business.

Acquisition opportunities

may involve competition among several potential purchasers, which could include large multi-national pharmaceutical companies and other

competitors that have access to greater financial resources than we do.

If we are unable to obtain rights to development and commercial

opportunities from third parties and we are unable to rely upon our compounding pharmacies and current and future relationships with

pharmacists, physicians and other inventors to provide us with additional development opportunities, our growth and prospects could be

product development strategy is to focus on a ophthalmology and eye care related products and formulations in which we believe there

is broad market potential, large unmet needs and/or unique value to physicians and patients and to develop and offer formulations and

products within these therapeutic areas that could afford us with gross and operating margins consistent with our current and historical

However, our expectations and assumptions about market potential and patient needs may prove to be wrong, and we may invest

capital and other resources on products, drug candidates, and formulations that do not generate sufficient revenues for us to recoup

our investment.

2013, our acquisitions of compounding facilities and various product and corporate development opportunities since 2014, the expenses

associated with developing our pharmacy facilities into outsourcing facilities and registering them as such with the FDA and our recent

strategic shift to develop and commercialize FDA approved products.

We may not accurately estimate the potential revenues and expenses

of our operations.

If we are unable to correctly estimate the amount of cash necessary to fund our business, we could spend our available

financial resources much faster than we expect.

If we do not have sufficient funds to continue to operate and develop our business, we

could be required to seek additional financing earlier than we expect, which may not be available when needed or at all, or be forced

to delay, scale back or eliminate some or all of our proposed operations.

we do not successfully identify and acquire rights to new products and drug candidates and successfully integrate them into our operations,

our growth opportunities may be limited.

plan to pursue the development of new FDA approved products and drug candidates which may include continued activities to develop and

commercialize current assets or, if and as opportunities arise, potential acquisitions of new intellectual property rights and assets.

We have historically relied, and we expect to continue to rely, primarily upon third parties to provide us with additional development

opportunities.

We may seek to enter into acquisition agreements or licensing arrangements to obtain rights to develop new formulations

and FDA approved products in the future, but only if we are able to identify attractive products and formulations and negotiate acquisition

or license agreements on terms acceptable to us, which we may not be able to do.

Moreover, we have limited resources to acquire additional

potential product development assets and integrate them into our business.

Acquisition opportunities may involve competition among several

potential purchasers, which could include large multi-national pharmaceutical companies and other competitors that have access to greater

financial resources than we do.

If we are unable to obtain rights to development and commercial opportunities from third parties and

we are unable to rely upon our compounding pharmacies and current and future relationships with pharmacists, physicians and other inventors

to provide us with additional development opportunities, our growth and prospects could be limited.

product development strategy is to focus on ophthalmology and eye care related products and formulations for which we believe there is

broad market potential, large unmet needs and/or unique value to physicians and patients and to develop and offer formulations and products

within these therapeutic areas that could afford us with gross and operating margins consistent with our current and historical figures.

However, our expectations and assumptions about market potential and patient needs may prove to be wrong, and we may invest capital and

other resources on products, drug candidates, and formulations that do not generate sufficient revenues for us to recoup our investment.

may be unable to successfully develop and commercialize our proprietary formulations or any other assets we may acquire.

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more rapidly than anticipated and could require us to seek additional financing earlier than we expect to support our operations.

have raised over $200,000,000 in funds through equity and debt financings since 2021.

We may seek to obtain additional capital through

equity or debt financings, funding from corporate partnerships or licensing arrangements, sales of assets or other financing transactions.

If we issue additional equity or convertible debt securities to raise funds, our existing stockholders may experience substantial dilution,

and the newly issued equity or debt securities may have more favorable terms or rights, preferences and privileges senior to those of

our existing stockholders.

If we raise additional funds through collaboration and licensing arrangements or sales of assets, we may have

to relinquish potentially valuable rights to our drug candidates or proprietary technologies, or grant licenses on terms that are not

favorable to us.

If we raise funds by incurring additional debt, we may be required to pay significant interest expenses and our leverage

relative to our earnings or to our equity capitalization may increase.

Obtaining commercial loans, assuming those loans would be available,

would increase our liabilities and future cash commitments and may impose restrictions on our activities, such as the financial and operating

Further, we may incur substantial costs in pursuing future capital and/or financing transactions, including investment banking

fees, legal fees, accounting fees, printing and distribution expenses and other costs.

We may also be required to recognize non-cash

expenses in connection with certain securities we may issue, such as options, convertible notes and warrants, which would adversely impact

our financial results.

have in the past and may in the future participate in strategic transactions that could impact our liquidity, increase our expenses and

distract our management.

have raised over $285,000,000 in gross proceeds through equity and debt financings since 2021.

We may seek to obtain additional capital

through equity or debt financings, funding from corporate partnerships or licensing arrangements, sales of assets or other financing

transactions.

If we issue additional equity or convertible debt securities to raise funds, our existing stockholders may experience substantial

dilution, and the newly issued equity or debt securities may have more favorable terms or rights, preferences and privileges senior to

those of our existing stockholders.

If we raise additional funds through collaboration and licensing arrangements or sales of assets,

we may have to relinquish potentially valuable rights to our drug candidates or proprietary technologies, or grant licenses on terms

that are not favorable to us.

If we raise funds by incurring additional debt, we may be required to pay significant interest expenses

and our leverage relative to our earnings or to our equity capitalization may increase.

Obtaining commercial loans, assuming those loans

would be available, would increase our liabilities and future cash commitments and may impose restrictions on our activities, such as

the financial and operating covenants.

Further, we may incur substantial costs in pursuing future capital and/or financing transactions,

including investment banking fees, legal fees, accounting fees, printing and distribution expenses and other costs.

We may also be required

to recognize non-cash expenses in connection with certain securities we may issue, such as options, convertible notes and warrants, which

would adversely impact our financial results.

have in the past participated and may in the future participate in strategic transactions that could impact our liquidity, increase our

expenses and distract our management.

time to time, we consider engaging in strategic transactions, such as out-licensing or in-licensing of compounds, drug candidates, drug

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liabilities that may arise.

COVID-19 pandemic had an adverse effect on our business and results of operations and could have future adverse effects, which could

be material, on our business, results of operations, financial condition, liquidity, and capital investments.

March 11, 2020, the World Health Organization declared the COVID-19 outbreak a global pandemic.

The COVID-19 pandemic has negatively

impacted the global economy, disrupted supply chains and created significant volatility in financial markets.

We have implemented business

policies intended to protect our employees from the spread of COVID-19.

Those policies included employees working from home when possible

and employees in our facilities increasing physical distancing.

March 18, 2020, CMS released guidance for U.S.

healthcare providers to limit all elective medical procedures in order to conserve personal

protective equipment and limit exposure to COVID-19 during the pendency of the pandemic.

Many of our customers use our products in procedures

impacted by the guidance.

In addition to limiting medical procedures, many hospitals and other healthcare providers strictly limited

access to their facilities during the pandemic.

While we believe our business has mostly recovered from the impact of the pandemic, if

conditions worsen, we believe future impact of the pandemic to our business could include, but is not limited to:

revenues from our customers, including our major customers, whose products are impacted by CMS guidance to limit elective medical

ability or willingness of third parties to market, distribute and sell our products, due to reduced demand from, or lack of access

to, healthcare facilities and providers;

ability, or inability, to complete clinical trials and other activities required to achieve regulatory clearance of our products

under development due to lack of access to healthcare facilities, healthcare providers and patients;

or lost access to third-party service providers that we use in our research and development or marketing efforts;

cash flow from our operations due to reductions in revenues or collections from our customers and increases in operating costs related

to actions we have taken in response to the pandemic;

business productivity due to inefficiencies in employees working from home or increasing physical distancing and other pandemic response

protocols in our production facilities;

susceptibility to the risk of information technology security breaches and other disruptions due to increased volumes of remote access

to our information systems from our employees working at home;

to source sufficient components used in our products due to disruptions in supply chains;

ability to identify, evaluate and acquire, or effectively integrate, complementary businesses, products, materials or technologies

due to travel restrictions, physical distancing protocols, and lack of access to third-party service providers related to our development

of manufacturing capacity, which could lead to failures to meet product delivery commitments, or increased operating costs if one

of our facilities were to experience a COVID-19 outbreak;

in assessing and securing intellectual property rights due to lack of access to, or delayed responsiveness of, third-party service

providers or governmental agencies;

ability to retain personnel over concerns about workplace exposure to COVID-19, or to hire and effectively train new personnel, due

to physical distancing protocols;

of goodwill or other assets due to reductions in the fair value of our reporting units.

and other factors relating to, or arising from, the pandemic could have material adverse effects on our business, results of operations,

cash flows, financial condition, and capital investments.

disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.

operations, and those of contract research organizations (“CROs”), contractors and consultants, could be subject to power

shortages, telecommunications failures, wildfires, water shortages, floods, earthquakes, hurricanes, typhoons, fires, extreme weather

conditions, medical epidemics, such as the COVID-19 pandemic, and other natural or man-made disasters or business interruptions for which

we are predominantly self-insured.

The occurrence of any of these business disruptions could seriously harm our operations and financial

condition and increase our costs and expenses.

Our ability to obtain clinical supplies of our product candidates could be disrupted if

the operations of our contract manufacturers or the contract manufacturers of our development partners are affected by a man-made or

natural disaster or other business interruption.

operations, and those of CROs, contractors and consultants, could be subject to power shortages, telecommunications failures, wildfires,

water shortages, floods, earthquakes, hurricanes, typhoons, fires, extreme weather conditions, public health crises, and other natural

or man-made disasters or business interruptions for which we are predominantly self-insured.

The occurrence of any of these business

disruptions could seriously harm our operations and financial condition and increase our costs and expenses.

Our ability to obtain clinical

supplies of our product candidates could be disrupted if the operations of our contract manufacturers or the contract manufacturers of

our development partners are affected by a man-made or natural disaster or other business interruption.

sell our proprietary formulations primarily through pharmaceutical compounding facilities we own, but we may not be successful in our

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of operations and financial condition.

August 2017, the FDA issued a MedWatch notification regarding our curcumin emulsion and two adverse events that had been associated

with the use of these emulsions by prescribing physicians.

We issued a press release on August 7, 2017, clarifying certain facts

regarding the notice which outlined our belief that the adverse events associated with the two patients occurred due to an allergic

reaction caused by the products being inappropriately administered and obtained by the prescribing physician, and our use of

curcumin and excipients in our curcumin emulsion formulation met regulatory standards required for dispensing of the curcumin

In September 2017, the FDA released a letter confirming that the alleged misuse of certain ingredients in our curcumin

emulsions were due to mislabeling by the underlying supplier, and not of our own misdoing.

We no longer compound curcumin emulsion

Separately, in December 2017, we were issued a warning letter from the FDA alleging that, in their interpretation of our

public communications, we had made false or misleading claims and omitted risk and side effect information regarding certain of our

ophthalmology focused compounded medications.

We immediately performed a full review of our public communications referenced in the

warning letter and responded to the FDA in January 2018, notwithstanding our continued belief that our public communications were

not in fact false and misleading, we have been in communication with the FDA and took steps to address the items outlined in the FDA

The Company received another warning letter from the FDA related to our alleged marketing activities;

we immediately

responded to this warning letter received and the FDA sent the Company notice in January 2023 that our corrective actions appear

In June 2019, our outsourcing facility was issued a warning letter related to an April 2017 inspection and our use of

certain active pharmaceutical ingredients in our compounded medications.

During September 2020 through January 2021, our New Jersey

based outsourcing facility was inspected by the FDA (the “2020 Inspection”) and certain observations were made by the

FDA in a Form 483.

Five observations made during the 2020 Inspection were considered repeat observations from a 2017 FDA inspection.

In addition, during the 2020 Inspection, the FDA noted that we were compounding drugs for which there is no change that produces for

an individual patient a clinical difference, as determined by a prescribing practitioner between a compounded drug and the

comparable approved drug.

August 2017, the FDA issued a MedWatch notification regarding our curcumin emulsion and two adverse events that had been associated with

the use of these emulsions by prescribing physicians.

We issued a press release on August 7, 2017, clarifying certain facts regarding

the notice which outlined our belief that the adverse events associated with the two patients occurred due to an allergic reaction caused

by the products being inappropriately administered and obtained by the prescribing physician, and our use of curcumin and excipients

in our curcumin emulsion formulation met regulatory standards required for dispensing of the curcumin emulsion.

In September 2017, the

FDA released a letter confirming that the alleged misuse of certain ingredients in our curcumin emulsions were due to mislabeling by

the underlying supplier, and not of our own misdoing.

We no longer compound curcumin emulsion products.

Separately, in December 2017,

we were issued a warning letter from the FDA alleging that, in its interpretation of our public communications, we had made false or

misleading claims and omitted risk and side effect information regarding certain of our ophthalmology focused compounded medications.

We immediately performed a full review of our public communications referenced in the warning letter and responded to the FDA in January

2018, notwithstanding our continued belief that our public communications were not in fact false and misleading, we remained in communication

with the FDA and took steps to address the items outlined in the FDA letter.

The Company received another warning letter from the FDA

in June 2022 related to our alleged marketing activities.

We immediately responded to the warning letter and the FDA sent the Company

notice in January 2023 that our corrective actions appear adequate.

In June 2019, our outsourcing facility was issued a warning letter

related to an April 2017 inspection and our use of certain active pharmaceutical ingredients in our compounded medications.

During September

2020 through January 2021, our New Jersey based outsourcing facility was inspected by the FDA (the “2020 Inspection”) and

certain observations were made by the FDA in a Form 483.

Five observations made during the 2020 Inspection were considered repeat observations

from a 2017 FDA inspection.

In addition, during the 2020 Inspection, the FDA noted that we were compounding drugs for which there is

no change that produces for an individual patient a clinical difference, as determined by a prescribing practitioner between a compounded

drug and the comparable approved drug.

We have responded to the FDA regarding all of their observations from the 2020 Inspection, including

providing documentation from prescribing clinicians that indicate a clinical difference between our compounded drugs and the

comparable approved drugs, while also committing to amend our order process to collect “medical necessity/clinical

difference” information for each order of our compounded drugs on a go-forward basis.

Our pharmacy was inspected in August

2022, and received a Form 483 with several observations from FDA.

We have responded to these observations and continue to dialogue

with the FDA related to this 483.

providing documentation from prescribing clinicians that indicate a clinical difference between our compounded drugs and the comparable

approved drugs, while also committing to amend our order process to collect “medical necessity/clinical difference” information

for each order of our compounded drugs on a go-forward basis.

Our pharmacy was inspected in August 2022, and received a Form 483 with

several observations from the FDA.

In May 2023, our pharmacy received a warning letter related to the inspection that occurred in August

The warning letter indicated that our corrective actions from the inspection had appeared to be adequate;

however, the FDA could

not fully evaluate the adequacy of our actions because we did not include sufficient information or supporting documentation.

As an example,

we stated that smoke studies related to airflow in our laminar airflow hoods had been redone to satisfy FDA requirements, however, we

did not provide the FDA with supporting documentation (such as smoke study protocol, updated detailed report and/or videos).

responded to this warning letter and provided the FDA with additional information requested.

have worked and communicated, and will continue to work and communicate, with the FDA to assure that all allegations in the warning letters

and 483s have been addressed.

We believe, to date, we have addressed all of the material items of concern in the FDA’s 483, warning

letters and those related to the MedWatch notification (and any other requirements observed by the FDA and noted to us), and we do not

believe there will be any further action taken by the FDA in these matters.

We believe this is evidenced by the FDA registration for

our outsourcing facility which was most recently renewed in November 2022.

Nonetheless, these items increased further scrutiny and negative

publicity on us as a company.

As part of our commitment to actively work with regulators, at times, we have become aware of concerns

related to certain formulations, and as a result, discontinued compounding certain drug formulations in an attempt to help mitigate potential

regulatory risk.

As a result of the MedWatch notice, warning letters and other regulatory notifications, some physicians may be hesitant

to prescribe and some patients may be hesitant to purchase and use non-FDA-approved compounded formulations, particularly when an FDA-approved

potential alternative is available.

For other reasons, physicians may be unwilling to prescribe or patients may be unwilling to use our

proprietary compounded formulations, including the following:

legal prohibitions on our ability to discuss the efficacy or safety of

our formulations with potential users to the extent applicable data is available;

our pharmacy operations are primarily operating on

a cash-pay basis and reimbursement may or may not be available from third-party payors, including the government Medicare and Medicaid

and certain formulations are not required to be prepared and are not presently being prepared in a manufacturing facility governed

by cGMP requirements.

Any failure by physicians, patients and/or third-party payors to accept and embrace compounded formulations could

substantially limit our market and cause our operations to suffer.

and Form 483s have been addressed.

We believe, to date, we have addressed all of the material items of concern in the FDA’s Form

483, warning letters and those related to the MedWatch notification (and any other requirements observed by the FDA and noted to us),

and we do not believe there will be any further action taken by the FDA in these matters.

We believe this is evidenced by the FDA registration

for our outsourcing facility which was most recently renewed in November 2022.

Nonetheless, these items increased further scrutiny and

negative publicity on us as a company.

As part of our commitment to actively work with regulators, at times, we have become aware of

concerns related to certain formulations, and as a result, discontinued compounding certain drug formulations in an attempt to help mitigate

potential regulatory risk.

As a result of the MedWatch notice, warning letters and other regulatory notifications, some physicians may

be hesitant to prescribe and some patients may be hesitant to purchase and use non-FDA-approved compounded formulations, particularly

when an FDA-approved potential alternative is available.

For other reasons, physicians may be unwilling to prescribe or patients may

be unwilling to use our proprietary compounded formulations, including, but not limited to, the following:

legal prohibitions on our

ability to discuss the efficacy or safety of our formulations with potential users to the extent applicable data is available;

operations are primarily operating on a cash-pay basis and reimbursement may or may not be available from third-party payors, including

the government Medicare and Medicaid programs;

and certain formulations are not required to be prepared and are not presently being prepared

in a manufacturing facility governed by cGMP requirements.

Any failure by physicians, patients and/or third-party payors to accept and

embrace compounded formulations could substantially limit our market and cause our operations to suffer.

breakdown of our information technology systems, or a cyberattack or information security breach could significantly compromise the confidentiality,

integrity and availability of our information technology systems, network-connected control systems and/or our data, interrupt the operation

of our business and/or affect our reputation.

achieve our business objectives, we rely on sophisticated information technology systems, including hardware, software, technology infrastructure,

online sites and networks for both internal and external operations, mobile applications, cloud services and network-connected control

systems, some of which are managed, hosted, provided or serviced by third parties.

Internal or external events that compromise the confidentiality,

integrity and availability of our systems and data may significantly interrupt the operation of our business, result in significant costs

and/or adversely affect our reputation.

information technology systems are highly integrated into our business, including our customer service infrastructure, R&D efforts,

clinical and commercial manufacturing processes and product sales and distribution processes.

Further, as the large part of our employees

work remotely for some portion of their jobs, our reliance on our third-party information technology systems has increased substantially

and is expected to continue to increase.

Remote and hybrid working arrangements can increase cybersecurity risks due to the challenges

associated with managing remote computing assets and security vulnerabilities that are present in many non-corporate and home networks.

The complexity and interconnected nature of software, hardware and our systems make them vulnerable to breakdown or other service interruptions,

and to software errors or defects, misconfiguration and other security vulnerabilities.

Upgrades or changes to our systems or the software

that we use have resulted and we expect, in the future, will result in the introduction of new cybersecurity vulnerabilities and risks.

Our systems are also subject to frequent perimeter network reconnaissance and scanning, phishing and other cyberattacks.

As the cyber-threat

landscape evolves, these attacks are growing in frequency, sophistication, and intensity, and are becoming increasingly difficult to

detect and increasingly sophisticated in using techniques and tools—including artificial intelligence—that circumvent security

controls, evade detection and remove forensic evidence.

Such attacks could include the use of harmful and virulent malware, including

ransomware or other denials of service, which can be deployed through various means, including the software supply chain, e-mail, malicious

websites and/or the use of social engineering/phishing.

have experienced attacks against our network, although none that have had a material adverse impact to our business.

There can be no

assurance that our efforts to guard against the wide and growing variety of potential attack techniques will be successful.

as those experienced by government entities (including those that approve and/or regulate our products) and other multi-national companies,

including some of our peers, could leave us unable to utilize key business systems or access or protect important data, and could have

a material adverse effect on our ability to operate our business, including developing, gaining regulatory approval for, manufacturing,

selling and/or distributing our products.

For example, in 2017, a pharmaceutical company experienced a cyberattack involving virulent

malware that significantly disrupted its operations, including its research and sales operations and the production of some of its medicines

and vaccines.

As a result of the cyberattack, its orders and sales for certain products were negatively affected.

In late 2020, SolarWinds

Corporation, a leading provider of software for monitoring and managing information technology infrastructure, disclosed that it had

suffered a cybersecurity incident whereby attackers had inserted malicious code into legitimate software updates for its products that

were installed by myriad private and government customers, enabling the attackers to access a backdoor to such systems.

In 2022, Okta,

Inc., a provider of software that helps companies manage user authentication, disclosed that several hundred of its corporate customers

were vulnerable to a security breach that allowed attackers to access Okta’s internal network.

Although this breach did not have

a significant effect on our business, there can be no assurance that a similar future breach would not result in a material adverse effect

on our business or results of operations.

systems contain and use a high volume of sensitive data, including intellectual property, trade secrets and other proprietary business

information, financial information, regulatory information, strategic plans, sales trends and forecasts, litigation materials and/or

personal identifiable information belonging to us, our staff, our patients, customers and/or other parties.

In some cases, we utilize

third-party service providers to collect, process, store, manage or transmit such data, which have increased our risk.

Intentional or

inadvertent data privacy or security breaches (including cyberattacks) resulting from attacks or lapses by employees, service providers

(including providers of information technology-specific services), business partners, nation states (including groups associated with

or supported by foreign intelligence agencies), organized crime organizations, “hacktivists” or others, create risks that

our sensitive data may be exposed to unauthorized persons, our competitors or the public.

System vulnerabilities and/or cybersecurity

breaches experienced by our third-party service providers constitute a substantial share of the information security risks to our business.

There can be no assurance that a cybersecurity incident would not result in a material adverse effect on our business or results of operations.

Further, the timeliness of our awareness of a cybersecurity incident affects our ability to respond to and work to mitigate the severity

of such events.

Cyberattackers

are also increasingly exploiting vulnerabilities in commercially available software from shared or open-source code.

We rely on third

party commercial software that have had and may have such vulnerabilities, but as use of open-source code is frequently not disclosed,

our ability to fully assess this risk to our systems is limited.

There can be no assurances that a vulnerability in the software and

services that we use would not result in a material adverse effect on our business or results of operations.

and global government regulators, our business partners, suppliers with whom we do business, companies that provide us or our

partners with business services and companies we have acquired or may acquire face similar risks.

Security breaches of their systems

or service outages have adversely affected systems and could, in the future, affect our systems and security, leave us without

access to important systems, products, raw materials, components, services or information, or expose our confidential data or

sensitive personal information.

An extended service outage affecting these or other vendors, particularly where such vendor is the

single source from which we obtain the services, could have a material adverse effect on our business or results of operations.

example, in February 2024, UnitedHealth Group announced that a suspected nation-state associated cyber security threat actor had

gained access to some of the Change Healthcare (“Change”) information technology systems.

Change is the largest

clearinghouse for medical claims in the U.S.

While Harrow was not directly impacted by this cybersecurity incident, it was reported

that as a reaction to the cybersecurity incident, Change temporarily disconnected over 100 related payment systems and Change was

unable to process medical claims through its primary platforms.

This resulted in the delays to the revenue and cash collection cycle

for several ASCs and physician offices, putting a strain on their cash resources.

While temporary, the cash constraints for these

ASCs and physician offices, we believe, impacted sales of some of our products, such as IHEEZO, during this disrupted period of

In addition, we distribute our products in the United States primarily through three pharmaceutical wholesalers, and a

security breach that impairs the distribution operations of our wholesalers could significantly impair our ability to deliver our

products to healthcare providers and patients.

There can be no assurance that our cybersecurity risk management program and

processes, including our policies, controls, or procedures, will be effective in protecting our information technology systems and

sensitive data.

will continue to experience varying degrees of cyberattacks and other incidents in the future.

Even though we continue to invest in the

monitoring, protection and resilience of our critical and/or sensitive data and systems, there can be no assurances that our efforts

will detect, prevent or fully recover systems or data from all breakdowns, service interruptions, attacks and/or breaches of our systems

that could adversely affect our business and operations and/or result in the loss or exposure of critical, proprietary, private, confidential

or otherwise sensitive data, which could result in material financial, legal business or reputational harm to us or negatively affect

our stock price.

While we maintain cyber-liability insurance, our insurance is not sufficient to cover us against all losses that could

potentially result from a service interruption, breach of our systems or loss of our critical or sensitive data.

are also subject to various laws and regulations globally regarding privacy and data protection, including laws and regulations relating

to the collection, storage, handling, use, disclosure, transfer and security of personal data.

The legislative and regulatory environment

regarding privacy and data protection is continuously evolving and developing and the subject of significant attention globally.

example, we are subject to the CCPA, which became effective in January 2020, which can result in substantial penalties for noncompliance.

The CCPA was amended in late 2020, to create the California Privacy Rights Act to create opt in requirements for the use of sensitive

personal data and the formation of a new dedicated agency for the enforcement of the law, the California Privacy Protection Agency.

consumer privacy laws went into effect in Virginia, Colorado, Utah, Connecticut and Florida in 2023.

Consumer privacy laws were also

passed in 11 other states, with the earliest effective dates later this year, and proposed in three additional states.

Failure to comply

with these current and future laws could result in significant penalties and reputational harm and could have a material adverse effect

on our business and results of operations.

Related to Government Regulations and Third-Party Policies

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is not required in order to market and sell our compounded formulations.

We own, we are pursuing FDA approval to market and sell drug

candidates, both owned by us and by Melt and Surface, FDA approval of those drug candidates, along with the marketing and sale of FDA-approved

drugs and compounded formulations is subject to and must comply with extensive state and federal statutes and regulations governing those

products and compounding pharmacies.

These compounding statutes and regulations include, among other things, restrictions on compounding

for office use or in advance of receiving a patient-specific prescription or, for outsourcing facilities, requirements regarding preparation,

such as regular FDA inspections and cGMP requirements, prohibitions on compounding drugs that are essentially copies of FDA-approved

drugs, limitations on the volume of compounded formulations that may be sold across state lines, and prohibitions on wholesaling or reselling.

These and other restrictions on the activities of compounding pharmacies and outsourcing facilities may significantly limit the market

available for compounded formulations, compared to the market available for FDA-approved drugs.

We are pursuing FDA approval to market and sell drug candidates.

The marketing and sale of those drug candidates, FDA-approved drugs and compounded formulations are subject to and must comply with extensive

state and federal statutes and regulations governing those products and compounding pharmacies.

These compounding statutes and regulations

include, among other things, restrictions on compounding for office use or in advance of receiving a patient-specific prescription or,

for outsourcing facilities, requirements regarding preparation, such as regular FDA inspections and cGMP requirements, prohibitions on

compounding drugs that are essentially copies of FDA-approved drugs, limitations on the volume of compounded formulations that may be

sold across state lines, and prohibitions on wholesaling or reselling.

These and other restrictions on the activities of compounding

pharmacies and outsourcing facilities may significantly limit the market available for compounded formulations, compared to the market

available for FDA-approved drugs.

pharmacy business is impacted by federal and state laws and regulations governing the following:

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October 27, 2020, the FDA announced availability of a final Memorandum of Understanding, Addressing Certain Distributions of Compounded

Human Drug Products Between the State Board of Pharmacy or Other Appropriate State Agency and the Food and Drug Administration (the “Final

The Final MOU describes the responsibilities of a state board of pharmacy, or other appropriate state agency that chooses

to sign the Final MOU, in investigating and responding to complaints related to drug products compounded in such state and distributed

outside such state and in addressing the interstate distribution of inordinate amounts of compounded human drug products.

Additionally,

as part of the Final MOU, the FDA refined the definition of “inordinate amount,” a threshold for certain information identification

and sharing which does not place a limit on the distribution of compounded human drug products interstate by a pharmacy located in a

state that has entered into the Final MOU.

Section 503A of the FDCA sets a 5% limit on compounded drugs distributed outside the state

by a pharmacist, pharmacy or physician located in a state that has not entered into the Final MOU.

Human Drug Products Between the State Board of Pharmacy or Other Appropriate State Agency and the Food and Drug Administration (the

“Final MOU”).

The Final MOU describes the responsibilities of a state board of pharmacy, or other appropriate state agency

that chooses to sign the Final MOU, in investigating and responding to complaints related to drug products compounded in such state and

distributed outside such state and in addressing the interstate distribution of inordinate amounts of compounded human drug products.

Additionally, as part of the Final MOU, the FDA refined the definition of “inordinate amount,” a threshold for certain information

identification and sharing which does not place a limit on the distribution of compounded human drug products interstate by a pharmacy

located in a state that has entered into the Final MOU.

Section 503A of the FDCA sets a 5% limit on compounded drugs distributed outside

the state by a pharmacist, pharmacy or physician located in a state that has not entered into the Final MOU.

February 2022, the FDA said it would suspend implementation of the Final MOU and engage in a formal rulemaking process.

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Additionally, the permanent injunction

entered on July 22, 2019, by the United States District Court of the Central District of California in the Allergan litigation (also

referenced in Item.

3 Legal Proceedings), enjoins the Company from engaging in activities that are inconsistent with current FDA guidelines

for 503A and 503B operations.

While the Company believes its operations fully comply with the injunction, if the Court were to find the

Company to be in violation of the injunction, further sanctions, including fines and limitations on the pharmacies’ operations,

entered on July 22, 2019, by the United States District Court of the Central District of California (the “Court”) in the

Allergan litigation (also referenced in Item.

3 Legal Proceedings), enjoins the Company from engaging in activities that are inconsistent

with current FDA guidelines for 503A and 503B operations.

While the Company believes its operations fully comply with the injunction,

if the Court were to find the Company to be in violation of the injunction, further sanctions, including fines and limitations on the

pharmacies’ operations, could occur.

we market any of our drug candidates in a manner that violates healthcare fraud and abuse laws, or if we violate government price reporting

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is possible that some of our business activities could be subject to challenge under one or more of these laws.

sales depend on coverage and reimbursement from government and commercial third-party payers, and pricing and reimbursement pressures

sales depend on coverage and reimbursement from government and commercial third-party payors, and pricing and reimbursement pressures

have affected, and are likely to continue to affect, our profitability.

of our branded products depend on the availability and extent of coverage and reimbursement from third-party payers, including government

of our branded products depend on the availability and extent of coverage and reimbursement from third-party payors, including government

healthcare programs and private insurance plans.

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the consequences to our business if, enacted and implemented.

However, to the extent that payer actions further decrease or modify the

However, to the extent that payor actions further decrease or modify the

coverage or reimbursement available for our products, require that we pay increased rebates or shift other costs to us, limit or affect

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Six states (Colorado, Maine, New Hampshire,

Maryland, Oregon and Washington) have enacted laws that establish Prescription Drug Affordability Boards (PDABs) to study drug prices

and identify drugs that pose affordability challenges, and in three states (Colorado, Maryland and Washington) include authority for

the state PDAB to set upper payment limits on certain drugs in state regulated plans.

Maryland, Oregon and Washington) have enacted laws that establish Prescription Drug Affordability Boards (“PDABs”) to study

drug prices and identify drugs that pose affordability challenges, and in three states (Colorado, Maryland and Washington) include authority

for the state PDABs to set upper payment limits on certain drugs in state regulated plans.

Other states may consider implementing similar

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a material adverse effect on our product sales, business and results of operations.

commercial payer actions have affected and may continue to affect access to and sales of our products

commercial payor actions have affected and may continue to affect access to and sales of our products

including healthcare insurers, pharmacy benefit managers (“PBMs”), integrated healthcare delivery systems (vertically-integrated

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This high degree of consolidation among insurers and

PBMs and other payers, including through integrated healthcare delivery systems and/or with specialty or mail-order pharmacies and pharmacy

PBMs and other payors, including through integrated healthcare delivery systems and/or with specialty or mail-order pharmacies and pharmacy

retailers, has increased the negotiating leverage such entities have over us and other biopharmaceutical manufacturers and has resulted

in greater price discounts, rebates and service fees realized by those payers from our business.

in greater price discounts, rebates and service fees realized by those payors from our business.

CVS, Express Scripts and United Health

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Ultimately, additional discounts, rebates, fees, coverage changes, plan changes, restrictions or exclusions

imposed by these commercial payers could have a material adverse effect on our product sales, business and results of operations.

imposed by these commercial payors could have a material adverse effect on our product sales, business and results of operations.

reforms advanced by Congress or the Biden administration that refine the role of PBMs in the U.S.

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groups, insurance carriers, physicians’ groups, private health and science foundations and organizations involved in various diseases

also publish guidelines and recommendations to healthcare providers, administrators and payers, as well as patient communities.

also publish guidelines and recommendations to healthcare providers, administrators and payors, as well as patient communities.

Recommendations

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private organizations that publish their findings and offer recommendations relating to the products’ reimbursement by government

and private payers.

Some companies and payers have announced pricing and payment decisions based in part on the assessments of private

and private payors.

Some companies and payors have announced pricing and payment decisions based in part on the assessments of private

organizations.

In addition, government health technology assessment organizations in many countries make reimbursement recommendations

to payers in their jurisdictions based on the clinical effectiveness, cost-effectiveness and service effects of new, emerging and existing

to payors in their jurisdictions based on the clinical effectiveness, cost-effectiveness and service effects of new, emerging and existing

medicines and treatments.

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See “- Our sales depend on coverage and reimbursement from government

and commercial third-party payers, and pricing and reimbursement pressures have affected, and are likely to continue to affect, our profitability.”

and commercial third-party payors, and pricing and reimbursement pressures have affected, and are likely to continue to affect, our profitability.”

Such recommendations or guidelines may affect our reputation, and any recommendations or guidelines that result in decreased use,

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compete have been approved for marketing and sale by the FDA and are required to be manufactured in facilities compliant with cGMP standards.

Although we prepare our compounded formulations in accordance with the standards provided by USP chapter <795> and USP chapter

<797> and applicable state and federal law, our proprietary compounded formulations are not required to be, and have not been,

approved for marketing and sale by the FDA.

As a result, some physicians may be unwilling to prescribe, and some patients may be unwilling

to use, our formulations.

Additionally, under federal and state laws applicable to our current compounding pharmacy operations, we are

not permitted to prepare significant amounts of a specific formulation in advance of a prescription, compound quantities for office use

or utilize a wholesaler for distribution of our formulations;

instead, our compounded formulations must be prepared and dispensed in

connection with a physician prescription for an individually identified patient.

Pharmaceutical companies, on the other hand, are able

to sell their FDA-approved products to large pharmaceutical wholesalers, which can in turn sell to and supply hospitals and retail pharmacies.

Even if we are successful in registering certain of our facilities as outsourcing facilities, our business may not be scalable on the

scope available to our competitors that produce FDA-approved drugs, which may limit our potential for profitable operations.

of our operations may subject our business to limitations our competitors with FDA-approved drugs may not face.

November 2022, USP published finalized revisions to USP chapters <795> and <797>, which had been previously proposed for

public comment in September 2021.

The revisions include limitations on beyond use dating of sterile and preservative-free products and

batch sizes, among other changes.

USP expects the published revisions to become effective November 1, 2023, however, regulatory bodies

such as state boards of pharmacy may adopt these changes at that time, or on different dates, on a case-by-case basis.

While USP has

no role in enforcement, we believe the revisions to USP chapter <797> in particular will likely cause two changes to our business,

which in the aggregate should have a neutral to positive revenue impact on Harrow:

(i) we expect a reduction in revenues generated from

sales of formulations compounded by our 503A pharmacy, and (ii) we expect an increase in revenues from sales of formulations compounded

in our 503B facility.

Further, we believe the changes to USP chapter <797> will likely cause a reduction in the ability of local

503A pharmacies to produce compounded formulations to serve local markets, and that these changes in policy affecting sterile compounded

formulations, if adopted by the various states, may increase demand for compounded formulations from larger vendors such as Harrow and

cause further consolidation in the market for compounded formulations as smaller 503A pharmacies see a reduction in revenues from certain

segments of their formularies affected by these changes.

Although we prepare our compounded formulations in accordance with the standards provided by USP <795> and USP <797> and

applicable state and federal law, our proprietary compounded formulations are not required to be, and have not been, approved for marketing

and sale by the FDA.

As a result, some physicians may be unwilling to prescribe, and some patients may be unwilling to use, our formulations.

Additionally, under federal and state laws applicable to our current compounding pharmacy operations, we are not permitted to prepare

significant amounts of a specific formulation in advance of a prescription, compound quantities for office use or utilize a wholesaler

for distribution of our formulations;

instead, our compounded formulations must be prepared and dispensed in connection with a physician

prescription for an individually identified patient.

Pharmaceutical companies, on the other hand, are able to sell their FDA-approved

products to large pharmaceutical wholesalers, which can in turn sell to and supply hospitals and retail pharmacies.

Even if we are successful

in registering certain of our facilities as outsourcing facilities, our business may not be scalable on the scope available to our competitors

that produce FDA-approved drugs, which may limit our potential for profitable operations.

These facets of our operations may subject

our business to limitations our competitors with FDA-approved drugs may not face.

November 2022, USP published finalized revisions to USP <795> and USP <797>, which had been previously proposed for public

comment in September 2021.

The revisions include limitations on beyond use dating of sterile and preservative-free products and batch

sizes, among other changes.

USP expects the published revisions to become effective November 1, 2023, however, regulatory bodies such

as state boards of pharmacy may adopt these changes at that time, or on different dates, on a case-by-case basis.

While USP has no role

in enforcement, we believe the revisions to USP <797> in particular will likely cause two changes to our business, which in the

aggregate should have a neutral to positive revenue impact on Harrow:

(i) a reduction in revenues generated from sales of formulations

compounded by our 503A pharmacy, and (ii) an increase in revenues from sales of formulations compounded in our 503B facility.

we believe the changes to USP <797> will likely cause a reduction in the ability of local 503A pharmacies to produce compounded

formulations to serve local markets, and that these changes in policy affecting sterile compounded formulations, if adopted by the various

states, may increase demand for compounded formulations from larger vendors such as Harrow and cause further consolidation in the market

for compounded formulations as smaller 503A pharmacies see a reduction in revenues from certain segments of their formularies affected

by these changes.

future success depends in large part on our ability to maintain a competitive position with respect to biotechnology and related pharmaceutical

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Concentration

of sales at certain of our wholesaler distributors and consolidation of private payers may negatively affect our business.

of our distributors, customers and payers have substantial purchasing leverage, due to the volume of our products they purchase or the

of sales at certain of our wholesaler distributors and consolidation of private payors may negatively affect our business.

of our distributors, customers and payors have substantial purchasing leverage, due to the volume of our products they purchase or the

number of patient lives for which they provide coverage.

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that a small number of PBMs now oversee a substantial percentage of total covered lives in the United States.

sales depend on coverage and reimbursement from government and commercial third-party payers, and pricing and reimbursement pressures

sales depend on coverage and reimbursement from government and commercial third-party payors, and pricing and reimbursement pressures

have affected, and are likely to continue to affect, our profitability.” The three largest PBMs in the United States are now

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by our competitors, or that the rights granted thereunder will provide competitive advantages to us.

also rely on unpatented trade secrets and know-how and continuing technological innovation in order to develop our formulations, which

we seek to protect, in part, by confidentiality agreements with our employees, consultants, collaborators and others, including certain

service providers.

In certain instances, we have acquired

products that are patented and have been subject to prior litigation challenging the validity of certain patents related to those products.

In some situations, the litigation resulted in settlement agreements that have allowed generic manufacturers to license the patent rights

related to certain products and allowing the generic manufacturer to enter the market prior to patent expiration associated with the

branded product.

also rely on unpatented trade secrets and know-how and continuing technological innovation in order to develop our products, formulations,

which we seek to protect, in part, by confidentiality agreements with our employees, consultants, collaborators and others, including

certain service providers.

We also have invention or patent assignment agreements with our current employees and certain consultants.

our employees and consultants may breach these agreements, and we may not have adequate remedies for the breach.

Our trade secrets may

otherwise become known or be independently discovered by competitors or could be developed by a person not bound by an invention assignment

agreement with us, in which case we may have no rights to use the applicable invention.

Nonetheless, our employees and consultants may breach these agreements, and we may not have adequate remedies for the breach.

secrets may otherwise become known or be independently discovered by competitors or could be developed by a person not bound by an invention

assignment agreement with us, in which case we may have no rights to use the applicable invention.

may face additional competition outside of the U.S.

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rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business.

proprietary formulations and technologies could potentially conflict with the rights of others.

preparation or sale of our proprietary formulations and use of our technologies may infringe on the patent or other intellectual property

rights of others.

If our products infringe or conflict with the patent or other intellectual property rights of others, third parties

could bring legal actions against us claiming damages and seeking to enjoin our manufacturing and marketing of our affected products.

products, drug candidates and compounded formulations and technologies could potentially conflict with the rights of others.

preparation or sale of our products, drug candidates and compounded formulations and use of our technologies may infringe on the patent

or other intellectual property rights of others.

If our products infringe or conflict with the patent or other intellectual property

rights of others, third parties could bring legal actions against us claiming damages and seeking to enjoin our manufacturing and marketing

of our affected products.

Patent litigation is costly and time consuming and may divert management’s attention and our resources.

We may not have sufficient

resources to bring any actions to a successful conclusion.

If we are not successful in defending against these legal actions should they

arise, we may be subject to monetary liability or be forced to alter our products, cease some or all of our operations relating to the

affected products, or seek to obtain a license in order to continue manufacturing and marketing the affected products, which may not

be available on acceptable terms or at all.

We may not have sufficient resources to bring any actions to a successful conclusion.

If we are not successful in defending against these

legal actions should they arise, we may be subject to monetary liability or be forced to alter our products, cease some or all of our

operations relating to the affected products, or seek to obtain a license in order to continue manufacturing and marketing the affected

products, which may not be available on acceptable terms or at all.

are dependent on our Chief Executive Officer, Mark L.

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Baum, along with other key persons, including, but not limited to, our Chief Financial Officer, Andrew

Boll, and Chief Commercial Officer, John P.

Saharek, have played a primary role in creating and developing our current business model.

We are highly dependent on these executives for the implementation of our business plan and the future development of our assets and

our business, and the loss of their services and leadership could materially adversely impact our Company.

Boll, and Chief Executive Officer of ImprimisRx and Chief Commercial Officer, John P.

Saharek, have played a primary role in creating

and developing our current business model.

We are highly dependent on these executives for the implementation of our business plan and

the future development of our assets and our business, and the loss of their services and leadership could materially adversely impact

we are unable to attract and retain key personnel and consultants, we may be unable to maintain or expand our business.

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In addition, any staffing interruptions resulting

from geopolitical actions, including war and terrorism, adverse public health developments such as the COVID-19 pandemic, or natural

disasters including earthquakes, typhoons, floods and fires, could have a material adverse effect on our business.

from geopolitical actions, including war and terrorism, adverse public health developments, or natural disasters including earthquakes,

typhoons, floods and fires, could have a material adverse effect on our business.

Related to Product Development, Regulatory Approval, Manufacturing and Commercialization

we seek FDA approval to market and sell any of our proprietary formulations, such as drug candidates that we have royalty interests in

that are being developed by Melt and Surface, and MAQ-100, we may be unable to demonstrate the necessary safety and efficacy to obtain

such FDA approval.

we seek FDA approval to market and sell any of our drug candidates we may be unable to demonstrate the necessary safety and efficacy

to obtain such FDA approval.

recent years, we have sought, and in the future, we, alone or with project partners, intend to seek, FDA regulatory approval to market

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In addition, manufacturers of drug products and their facilities

are subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance with current cGMP,

are subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance with current cGMPs,

requirements relating to quality control, quality assurance and corresponding maintenance of records and documents.

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Medicaid Drug Rebate Program, the Federal

Supply Schedule of the U.S.

Department of Veterans Affairs, or other government drug programs, we will be subject to complex laws and

regulations regarding reporting and payment obligations.

Supply Schedule of the VA, or other government drug programs, we will be subject to complex laws and regulations regarding reporting

and payment obligations.

All of these activities are also potentially subject to U.S.

federal and state

consumer protection and unfair competition laws.

federal and state consumer protection and unfair

competition laws.

Similar requirements exist in many of these areas in other countries.

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If we are unable to generate revenues from our drug candidates, our ability to create stockholder value

will be limited.

may be limited.

drug candidates are in various stages of clinical development.

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to generate revenue will be materially impaired.

and maintaining regulatory approval of our drug candidates in one jurisdiction does not mean that we will be successful in obtaining

regulatory approval of our drug candidates in other jurisdictions.

and maintaining regulatory approval of our products and drug candidates in one jurisdiction does not mean that we will be successful

in obtaining regulatory approval of our products or drug candidates in other jurisdictions.

and maintaining regulatory approval of our drug candidates in one jurisdiction does not guarantee that we will be able to obtain or maintain

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we rely on third parties to supply the raw materials needed to manufacture our existing and potential products.

interruptions resulting from geopolitical actions, including war and terrorism, adverse public health developments such as the outbreak

of the COVID-19 coronavirus, or natural disasters including earthquakes, typhoons, floods and fires, could affect our supply chain.

Any reliance on suppliers may involve several risks, including a potential inability to obtain critical materials and reduced control

over production costs, delivery schedules, reliability and quality.

Any unanticipated disruption to a future contract manufacturer caused

by problems at suppliers could delay shipment of any of our drug candidates, increase our cost of goods sold and result in lost sales.

interruptions resulting from geopolitical actions, including war and terrorism, adverse public health developments, or natural disasters

including earthquakes, typhoons, floods and fires, could affect our supply chain.

Any reliance on suppliers may involve several

risks, including a potential inability to obtain critical materials and reduced control over production costs, delivery schedules, reliability

Any unanticipated disruption to a future contract manufacturer caused by problems at suppliers could delay shipment of any

of our drug candidates, increase our cost of goods sold and result in lost sales.

cannot guarantee that our future manufacturing and supply partners will be able to reduce the costs of commercial scale manufacturing

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for any expedited review procedure does not ensure that we will ultimately obtain regulatory approval for such drug candidate.

Related to the Senior Notes

Related to the Notes

have incurred significant indebtedness, which will require substantial cash to service and which subjects us to certain financial requirements

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to sell them.

Notes are quoted on Nasdaq under the symbols “HROWL” and “HROWM”.

Although the Notes are quoted, we cannot provide

Notes are listed on Nasdaq under the symbols “HROWL” and “HROWM”.

Although the Notes are listed, we cannot provide

any assurances that an active trading market will be maintained for the Notes or that a holder will be able to sell the Notes.

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may disproportionately influence the market price of our common stock.

A consistently active and liquid trading market in our securities

may never develop or be sustained.

A consistently active and liquid trading market in our common

stock may never develop or be sustained.

stock price may be volatile.

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an economic downturn, which could directly affect our ability to attain our operating goals on schedule and on budget.

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