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Item 1A. Risk Factors

2021-11-10 compared with 2021-08-11 · 557 added, 540 removed, 668 unchanged (62% of the section changed)

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This summary does not address all of the risks that we face.

Additional discussion of the risks summarized

in this risk factor summary, and other risks that we face, can be found below under the heading “Risk Factors” and should be carefully considered, together with other information in this Form 10-K and our other filings with the SEC, before making

an investment decision regarding our common stock.

To date, we have generated limited product revenues, have a history of losses and will need to raise additional capital to operate our business, which may not be available on favorable terms, if at all.

Additional discussion of the risks

summarized in this risk factor summary, and other risks that we face, can be found below under the heading “Risk Factors” and should be carefully considered, together with other information in this Form 10-K and our other filings with the SEC,

before making an investment decision regarding our common stock.

We have a history of losses and will need to raise additional capital to operate our business, which may not be available on favorable terms, if at all.

Our auditor’s report contains a going concern statement.

We are currently not profitable and may never become profitable.

The COVID-19 pandemic and efforts to reduce its spread has significantly affected worldwide economic conditions, and could have a material adverse impact on our business, liquidity, financial condition and results of operations, as well

as a change to the overall market size and potential for our products.

well as a change to the overall market size and potential for our products.

We contract with third parties for the filling, packaging, testing and labeling of the drug substance we manufacture.

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manner or according to our specifications, which could delay the availability of our finished drug product and could adversely affect our commercialization efforts and our revenues.

The estimates of market opportunity and forecasts of market and revenue growth included in our filings may prove to be inaccurate, and even if the markets in which we compete achieve the forecasted growth, our business could fail to grow

at similar rates, if at all.

grow at similar rates, if at all.

Both of our business segments and our facilities are subject to periodic inspections by the FDA, which, depending on the outcome of such inspection, could result in certain FDA actions, including the issuance of observations, notices,

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If we do not obtain and maintain the necessary U.S.

or international regulatory approvals to commercialize a product candidate, we will not be able to sell that product candidate, which would make it difficult for us to recover the costs

of researching and developing such product candidate.

Although we have received approval from the FDA to market ASCENIV as a treatment for PIDD, our ability to market or seek approval for ASCENIV for alternative indications could be limited and FDA could require clinical trials beyond what

we may deem to be reasonable.

or international regulatory approvals to commercialize a product candidate, we will not be able to sell that product candidate, which would make it difficult for us to recover the

costs of researching and developing such product candidate.

what we may deem to be reasonable.

Unless additional clinical trials are successfully conducted and the FDA approves a BLA or other required submission for review, we may not be authorized to market ASCENIV for any other indication.

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We may be unable to successfully expand our manufacturing processes to fulfill demand for our products or increase our production capabilities through the addition of new equipment, including if we do not obtain requisite approval from

Our products, and any additional products for which we may obtain marketing approval in the future, could be subject to post-marketing restrictions or withdrawal from the market and we could be subject to substantial penalties if we fail

to comply with regulatory requirements or if we experience unanticipated problems with our products following approval.

fail to comply with regulatory requirements or if we experience unanticipated problems with our products following approval.

Historically, a few customers have accounted for a significant amount of our total revenue and accounts receivable and the loss of any of these customers could have a material adverse effect on our business, results of operations and

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The Perceptive Credit Facility is subject to acceleration in specified circumstances, which may result in Perceptive taking possession and disposing of any collateral.

If we are unable to protect our patents, trade secrets or other proprietary rights, if our patents are challenged or if our provisional patent applications do not get approved, our competitiveness and business prospects may be materially

materially damaged.

Cyberattacks and other security breaches could compromise our proprietary and confidential information, which could harm our business and reputation.

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Also, the risks that we now foresee might affect us to a greater or different degree than expected.

Certain risks and uncertainties, including ones that we currently deem immaterial or that

are similar to those faced by other companies in our industry or business in general, may also affect our business.

If any of the risks described below actually occur, our business, financial condition or results of operations could be materially

and adversely affected.

Certain risks and uncertainties, including ones that we currently deem immaterial or

that are similar to those faced by other companies in our industry or business in general, may also affect our business.

If any of the risks described below actually occur, our business, financial condition or results of operations could be

materially and adversely affected.

You should carefully consider the following risk factors and the section entitled “Special Note Regarding Forward-Looking Statements” before you decide to invest in our securities.

Risks Relating to our Business

To date, we have generated limited product revenues, have a history of losses and will need to raise additional capital to operate our business, which may not be available on favorable terms, if at

To date, we have generated limited product revenues, have a history of losses and will need to raise additional capital to operate our business, which may not be available on favorable terms, if

Our long-term liquidity depends upon our ability to grow our commercial programs, expand our commercial operations at the Boca Facility, improve our supply-chain capabilities, improve production yields, provide more

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potentially longer, requiring substantial investments in raw material plasma and other manufacturing materials.

We currently anticipate, based upon our projected revenue and expenditures, that our current cash, cash equivalents and accounts receivable will be sufficient to fund our operations into the fourth quarter of 2021.

This time frame may change based upon how quickly we are able to execute on our commercialization efforts and operational initiatives.

However, if the assumptions underlying our estimated revenues and expenses prove to be incorrect, we may have to

raise additional capital sooner than we currently expect.

We anticipate that we will not be able to generate a sufficient amount of product revenue to achieve profitability until the beginning of 2024 and, as a result, we anticipate that we will

need to continue to finance our operations through additional equity or debt financings or corporate collaboration and licensing arrangements.

If we are unable to raise additional capital as needed, we will have to delay, curtail or eliminate our

commercialization efforts as well as product development activities.

Even if we are able to raise additional capital, such financings may only be available on unattractive terms, resulting in significant dilution of stockholders’ interests and, in

such event, the value and potential future market price of our common stock may decline.

In addition, if we raise additional funds through license arrangements or through the disposition of any of our assets, it may be necessary to relinquish

potentially valuable rights to our product candidates or assets or grant licenses on terms that are not favorable to us.

We currently anticipate, based upon our projected revenue and expenditures, that our current cash, cash equivalents and accounts receivable, including the proceeds received on October 25, 2021 from our most recent

underwritten public offering, will be sufficient to fund our operations, as currently conducted, through the first half of 2022.

In order to have sufficient cash to fund our operations thereafter, we will need to raise additional capital during

the second half of 2022, which includes our plans to refinance and expand upon, our existing debt facility.

We believe that a refinancing and expansion of our current debt facility, combined with the proceeds received from the October 25, 2021

public offering, will be sufficient to fund our operations into the first quarter of 2024, at which time we believe our operations will be cash flow positive.

This time frame may change based upon how quickly we are able to execute on our

commercialization efforts and operational initiatives.

However, if the assumptions underlying our estimated revenues and expenses prove to be incorrect, we may have to raise additional capital sooner than we currently expect.

evaluating a variety of strategic and financing alternatives and have engaged Morgan Stanley as a financial advisor in connection with certain of those strategic alternatives.

We anticipate that we will not be able to generate a sufficient amount

of product revenue to achieve profitability until the beginning of 2024 and, as a result, we anticipate that we will need to continue to finance our operations through additional equity or debt financings or corporate collaboration and licensing

arrangements.

If we are unable to raise additional capital as needed, we will have to delay, curtail or eliminate our commercialization efforts as well as product development activities.

Even if we are able to raise additional capital, such

financings may only be available on unattractive terms, resulting in significant dilution of stockholders’ interests and, in such event, the value and potential future market price of our common stock may decline.

In addition, if we raise

additional funds through license arrangements or through the disposition of any of our assets, it may be necessary to relinquish potentially valuable rights to our product candidates or assets or grant licenses on terms that are not favorable to

In addition, the auditor’s report on our financial statements for the year ended December 31, 2020 includes a going concern paragraph.

To date, our products have not generated significant revenue.

As a result, we have

suffered recurring losses and require significant additional cash resources to execute our business plan.

As a result, we

have suffered recurring losses and require significant additional cash resources to execute our business plan.

These losses are expected to continue for an extended period of time.

These factors raise substantial doubt about our ability to continue as a

going concern beyond one year from the date of filing this Quarterly Report on Form 10-Q.

The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of

liabilities in the normal course of business.

The financial statements do not include any adjustments relating to the recoverability and classification of asset amounts or the classification of liabilities that might be necessary should we be

unable to continue as a going concern within one year after the date the financial statements are issued.

We recognize that we will need to raise additional capital in order to continue to execute our business plan in the future.

Historically, the major source of our cash has been from proceeds from various public and

private offerings of our common stock.

These factors raise substantial doubt about our ability to

continue as a going concern beyond one year from the date of filing this Quarterly Report on Form 10-Q.

The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the

satisfaction of liabilities in the normal course of business.

The financial statements do not include any adjustments relating to the recoverability and classification of asset amounts or the classification of liabilities that might be necessary

should we be unable to continue as a going concern within one year after the date the financial statements are issued.

Historically, the major source of our cash has been from proceeds from various public and private offerings of our common stock.

The actual amount of cash that we will need is subject to many factors.

There can be no assurances that additional financing will be available when needed or that management will be able to obtain financing on

terms acceptable to us or that we will become profitable and generate positive operating cash flow.

If we are unable to raise sufficient additional funds, we will have to scale back our operations.

There can be no

assurances that additional financing will be available when needed or that management will be able to obtain financing on terms acceptable to us or that we will become profitable and generate positive operating cash flow.

If we are unable to

raise sufficient additional funds, we will have to scale back our operations.

We are currently not profitable and may never become profitable.

We have a history of losses and expect to incur substantial losses and negative operating cash flows into fiscal 2023, and we may never achieve or maintain profitability.

For the six months ended June 30, 2021 and

2020, we incurred net losses of $37.3 million and $39.4 million, respectively, and for the years ended December 31, 2020 and 2019, we incurred net losses of $75.7 million and $48.3 million, respectively.

From our inception in 2004 through June 30,

2021, we have incurred an accumulated deficit of $377.8 million.

We expect that we will not be able to generate a sufficient amount of product revenue to achieve profitability until the beginning of 2024 and, as a result, we expect that we will

need to continue to finance our operations through additional equity or debt financings or corporate collaboration and licensing agreements.

We also expect to continue to incur significant operating and capital expenditures and anticipate that our

operating expenses will increase substantially in the foreseeable future as we:

For the nine months ended September 30, 2021

and 2020, we incurred net losses of $55.0 million and $56.3 million, respectively, and for the years ended December 31, 2020 and 2019, we incurred net losses of $75.7 million and $48.3 million, respectively.

From our inception in 2004 through

September 30, 2021, we have incurred an accumulated deficit of $395.5 million.

We expect that we will not be able to generate a sufficient amount of product revenue to achieve profitability until the beginning of 2024

and, as a result, we expect that we will need to continue to finance our operations through additional equity or debt financings or corporate collaboration and licensing agreements.

We also expect to continue to incur significant operating and

capital expenditures and anticipate that our operating expenses will increase substantially in the foreseeable future as we:

expand commercialization and marketing efforts;

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Our failure to achieve or maintain profitability could negatively impact the value of our securities.

The COVID-19 pandemic and efforts to reduce its spread has significantly affected worldwide economic conditions, and could have a material adverse impact on our business,

liquidity, financial condition and results of operations

The COVID-19 pandemic and efforts to reduce its spread has significantly affected worldwide economic conditions, caused supply chain disruptions and could have a material

adverse impact on our business, liquidity, financial condition and results of operations

The COVID-19 pandemic, including the Delta variant and other resistant strains of the coronavirus, has the potential to adversely impact several aspects of each of our business segments, our commercial manufacturing

operations and plasma collection facilities, including but not limited to potential disruptions to our supply-chain operations, including procurement of raw materials and packaging materials, a portion of which are sourced internationally, and the

testing of finished drug product that is required prior to its availability for commercial sale.

the testing of finished drug product that is required prior to its availability for commercial sale.

Such testing has historically been performed by contract laboratories outside the United States.

While we do not believe that the COVID-19 pandemic

has significantly affected operations and immunoglobulin production at our Boca Facility or our ADMA BioCenters plasma collection operations at this time, we may experience adverse effects in the future, particularly in light of the recent increase

in COVID-19 cases in the State of Florida.

For example, our employees becoming ill, the imposition of additional mandatory remote working environments and federal, state and local responses to the pandemic could materially affect the efficiency and

pace of our operations and manufacturing at our Boca Facility.

While we do not believe that the COVID-19

pandemic has significantly affected operations and immunoglobulin production at our Boca Facility or our ADMA BioCenters plasma collection operations at this time, we may experience adverse effects in the future, particularly in light of the

recent increase in COVID-19 cases in the State of Florida.

For example, our employees becoming ill, the imposition of additional mandatory remote working environments and federal, state and local responses to the pandemic could materially affect

the efficiency and pace of our operations and manufacturing at our Boca Facility.

Employee or donor illness, if not properly managed, could also impact the quality of our products and product candidates.

In addition, travel and other restrictions that have been

implemented in the United States could impact our commercial efforts with respect to any of our products, including BIVIGAM and ASCENIV, as trade shows, industry and medical conferences and other events we had been planning to utilize and exhibit

and attend with our staff to increase awareness of our products by physicians and payers are subject to limitations, rescheduling or outright cancellation in response to the pandemic.

Also, due to a combination of previous state and local

“shelter-in-place” orders, as well as government stimulus packages, persisting social distancing measures and varying roll-outs of vaccinations by state, we have experienced, and may experience in the future, lower than expected donor collections

at our FDA-licensed plasma collection centers.

We were also subject to delays in shipments of source plasma from our contracted third-party suppliers, as well as delays in deliveries for personal protective equipment, reagents and other non-plasma

raw materials and supplies used in the manufacture and distribution of our products.

We have also experienced supply chain delays as a result of significant resources being diverted towards the rapid development and distribution of COVID-19

vaccines, which could result in our need to carry more inventory that we have in the past, which would put an additional strain on our cash resources.

In addition, travel and other restrictions

that have been implemented in the United States could impact our commercial efforts with respect to any of our products, including BIVIGAM and ASCENIV, as trade shows, industry and medical conferences and other events we had been planning to

utilize and exhibit and attend with our staff to increase awareness of our products by physicians and payers are subject to limitations, rescheduling or outright cancellation in response to the pandemic.

Also, due to a combination of previous

state and local “shelter-in-place” orders, as well as government stimulus packages, persisting social distancing measures and varying roll-outs of vaccinations by state, we have experienced, and may experience in the future, lower than expected

donor collections at our FDA-licensed plasma collection centers.

We were also subject to delays in shipments of source plasma from our contracted third-party suppliers, as well as delays in deliveries for personal protective equipment, reagents

and other non-plasma raw materials and supplies used in the manufacture and distribution of our products.

We have also experienced supply chain delays as a result of significant resources being diverted towards the rapid development and

distribution of COVID-19 vaccines, which could result in our need to carry more inventory that we have in the past, which would put an additional strain on our cash resources.

In the future we may continue to experience pandemic-related challenges with respect to obtaining and manufacturing a sufficient amount of supplies, raw materials, and finished product to meet our need for commercial

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By example, the pandemic may result in slower enrollment,

the need to suspend enrollment into studies, patient withdrawals, postponement of planned clinical or preclinical studies, redirection of site resources from studies, study modification, suspension, or termination, the introduction of remote study

procedures and modified informed consent procedures, study site changes, direct delivery of investigational products to patient homes requiring state licensing, study deviations or noncompliance, and changes or delays in site monitoring.

foregoing may require that we consult with relevant review and ethics committees, IRBs, and the FDA.

study procedures and modified informed consent procedures, study site changes, direct delivery of investigational products to patient homes requiring state licensing, study deviations or noncompliance, and changes or delays in site monitoring.

The foregoing may require that we consult with relevant review and ethics committees, IRBs, and the FDA.

The foregoing may also impact the integrity of our study data.

The effects of the COVID-19 pandemic may also increase the need for clinical trial

patient monitoring and regulatory reporting of adverse effects.

The pandemic could further impact our ability to interact with the FDA or other regulatory authorities and may result in delays in the conduct of inspections or review of pending

applications or submissions.

During the second quarter of 2021, we were notified by the FDA that our submission for the approval of our in-house fill-finish process utilizing our Vanrx SA25 Workcell aseptic filling machine will require a site

inspection, either in person or virtually.

Although the inspection was completed in July of 2021, the FDA’s review of our regulatory filing with respect to our in-house fill-finish process and new aseptic filling machine remains ongoing.

we anticipate receiving regulatory approval of this submission in the second half of 2021, no assurances can be provided as to the timing for completion of this FDA review or any other regulatory submissions or applications that may be impacted by

restrictions related to COVID-19 or other circumstances unknown to us presently or that are out of our direct control.

Due to the potential impact of the COVID-19 outbreak on clinical trials, drug development, and manufacturing, the FDA issued a

number of guidances specifically concerning COVID-19, including guidances with respect to blood and blood components.

The FDA’s guidance is continually evolving.

Since the onset of the COVID-19 pandemic, there has been a noticeable decline in certain medical prescriptions attributed to lower incident rates for illnesses, fewer RSV, influenza and other respiratory viral

pathogen-infected patients, hospital admissions and a reduction in doctor visits.

In addition, physical and social distancing guidelines issued by public health authorities and the resulting global changes in human behavior have resulted in an

The effects of the COVID-19 pandemic may also increase the need for clinical

trial patient monitoring and regulatory reporting of adverse effects.

The pandemic could further impact our ability to interact with the FDA or other regulatory authorities and may result in delays in the conduct of inspections or review of

pending applications or submissions.

site inspection, either in person or virtually.

Although the inspection was completed in July of 2021 and FDA approval our in-house fill-finish process and new aseptic filling machine was received in September 2021, no assurances can be provided

as to the timing for completion of any other regulatory submissions or applications that may be impacted by restrictions related to COVID-19 or other circumstances unknown to us presently or that are out of our direct control.

potential impact of the COVID-19 outbreak on clinical trials, drug development, and manufacturing, the FDA issued a number of guidances specifically concerning COVID-19, including guidances with respect to blood and blood components.

guidance is continually evolving.

Subsequent to the onset of the COVID-19 pandemic, there had been a noticeable decline in certain medical prescriptions attributed to lower incident rates for illnesses, fewer RSV, influenza and other respiratory

viral pathogen-infected patients, hospital admissions and a reduction in doctor visits.

In addition, physical and social distancing guidelines issued by public health authorities and the resulting global changes in human behavior resulted in an

observed reduction in infection transmission rates and spread of bacterial and viral infections, resulting in lower rates of infection across all patient populations, which, if continued, could potentially negatively impact the use of our IVIG

products by patients.

While COVID-19-related requirements vary across the United States, there are recent reports of increasing rates of other viral infections in certain locations and geographic regions of the country and as such may impact the

usage and/or demand for our IVIG products.

Additionally, the previous guidelines that were issued by public health authorities or any new or changing recommendations or guidelines may still impact the demand or usage of our IVIG products.

The COVID-19 pandemic may also result in changes in laws and regulations.

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various provisions regarding FDA drug shortage reporting requirements, as well as provisions regarding supply chain security, such as risk management plan requirements, and the promotion of supply chain redundancy and domestic manufacturing.

and any future changes in law may require that we change our internal processes and procedures to ensure continued compliance.

This and any future changes in law may require that we change our internal processes and procedures to ensure continued compliance.

The ultimate impact of the COVID-19 pandemic is highly uncertain and subject to change.

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fill/finish services could have a material and adverse effect on our business, financial condition and results from operations.

Although we have built our own fill/finish suite within the Boca Facility, we also intend to continue to utilize third parties to supplement our fill/finish process for final drug substance.

addition, our recently completed fill/finish suite has yet to be validated and approved by the FDA.

Although we have received FDA approval for the fill/finish suite we built at the Boca Facility, we also intend to continue to utilize third parties to supplement our fill/finish process for final

drug substance.

Our anticipated reliance on a limited number of third-party manufacturers exposes us to the following risks:

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contract manufacturers may not be able to execute our inspection procedures and required tests appropriately;

contract manufacturers are subject to ongoing periodic unannounced inspection by the FDA and corresponding state agencies to ensure strict compliance with cGMP and other government regulations, and we do not have control over third-party

providers’ compliance with these regulations;

third-party providers’ compliance with these regulations;

our third-party fill/finishers could breach or terminate their agreements with us;

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assurance and qualified personnel.

Each of these risks could delay or prevent the completion of our finished drug product and the release of finished drug product by the FDA, which could result in higher costs or adversely impact the

commercialization of our products.

Each of these risks could delay or prevent the completion of our finished drug product and the release of finished drug product by the

FDA, which could result in higher costs or adversely impact the commercialization of our products.

These risks could also result in the delay in obtaining clinical supply, which would delay our development programs.

In addition, our contract fill/finishers and our other third-party vendors may source their

materials and supplies globally, and are therefore subject to supply disruptions in the event of fire, weather related events such as hurricanes, wind and rain, other acts of God or force majeure events or global health occurrences and

emergencies, including the COVID-19 pandemic.

In addition, our contract

fill/finishers and our other third-party vendors may source their materials and supplies globally, and are therefore subject to supply disruptions in the event of fire, weather related

events such as hurricanes, wind and rain, other acts of God or force majeure events or global health occurrences and emergencies, including the COVID-19 pandemic.

The estimates of market opportunity and forecasts of market and revenue growth included in our filings may prove to be inaccurate, and even if the markets in which we compete

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As a result, we may not be able to accurately forecast or predict revenue.

For these reasons, the estimates and forecasts in our filings relating to

revenue generation and growth may prove to be inaccurate.

For these reasons, the estimates and forecasts in our filings relating

to revenue generation and growth may prove to be inaccurate.

Even if the markets in which we compete meet our size estimates and forecasted growth, our business could fail to grow at similar rates, if at all.

Both of our business segments and our facilities, as well as our suppliers and contractors, are subject to periodic inspections by the FDA, which, depending on the outcome of such inspection, could

result in certain FDA actions, including the issuance of observations, notices, citations or warning letters.

We and our suppliers and contractors may be unable to comply with our specifications, cGMP requirements and with other FDA, state, and foreign regulatory requirements for commercial

and clinical supply.

The FDA is authorized to perform inspections of our and our suppliers’ facilities, including the Boca Facility.

The FDA also must inspect and approve our and our third-parties’ facilities before they may be used for

commercial production.

At the end of such an inspection, the FDA could issue a Form 483 Notice of Inspectional Observations, which could cause us to modify certain activities identified during the inspection and may not approve the use of the

Following such inspections, the FDA may issue an untitled letter as an initial correspondence that cites violations that do not meet the threshold of regulatory significance of a warning letter.

FDA guidelines also provide for the

issuance of warning letters for violations of “regulatory significance” for which the failure to adequately and promptly achieve correction may be expected to result in an enforcement action.

FDA also may issue warning letters and untitled letters

in connection with events or circumstances unrelated to an FDA inspection.

Both of our business segments and our facilities, as well as our suppliers and contractors, are subject to periodic inspections by the FDA, which, depending on the outcome of such inspection,

could result in certain FDA actions, including the issuance of observations, notices, citations or warning letters.

We and our suppliers and contractors may be unable to comply with our specifications, cGMP requirements and with

other FDA, state, and foreign regulatory requirements for commercial and clinical supply.

The FDA is authorized to perform inspections of our and our suppliers’ facilities, including the

Boca Facility.

The FDA also must inspect and approve our and our third-parties’ facilities before they may be used for commercial production.

At the end of such an inspection, the FDA could issue a Form 483 Notice of Inspectional Observations,

which could cause us to modify certain activities identified during the inspection and may not approve the use of the facility.

Following such inspections, the FDA may issue an untitled letter as an initial correspondence that cites violations

that do not meet the threshold of regulatory significance of a warning letter.

FDA guidelines also provide for the issuance of warning letters for violations of “regulatory significance” for which the failure to adequately and promptly achieve

correction may be expected to result in an enforcement action.

FDA also may issue warning letters and untitled letters in connection with events or circumstances unrelated to an FDA inspection.

We may not be able to timely resolve concerns raised by the FDA as a result of an inspection or without expending significant resources.

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resulting in costly clean-up and liabilities under applicable laws and regulations governing the use, storage, handling and disposal of these materials and specified waste products.

Although we believe that the safety procedures utilized internally

and by our third-party manufacturers for handling and disposing of these materials generally comply with the standards prescribed by these laws and regulations, we cannot guarantee that this is the case or eliminate the risk of accidental

contamination or injury from these materials.

In such an event, we may be held liable for any resulting damages and such liability could exceed our resources and state or federal or other applicable authorities may curtail our use of certain

materials and/or interrupt our business operations.

Although we believe that the safety procedures utilized

internally and by our third-party manufacturers for handling and disposing of these materials generally comply with the standards prescribed by these laws and regulations, we cannot guarantee that this is the case or eliminate the risk of

accidental contamination or injury from these materials.

In such an event, we may be held liable for any resulting damages and such liability could exceed our resources and state or federal or other applicable authorities may curtail our use of

certain materials and/or interrupt our business operations.

Furthermore, environmental laws and regulations are complex, change frequently and have tended to become more stringent.

We cannot predict the impact of such changes and cannot be certain of our

future compliance.

We cannot predict the impact of such changes and cannot be

certain of our future compliance.

In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations.

These current or future laws and regulations may impair our commercial manufacturing,

research and development, or production efforts.

These current or future laws and regulations may impair our commercial

manufacturing, research and development, or production efforts.

Failure to comply with these laws and regulations also may result in substantial fines, penalties, or other sanctions.

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policies are subject to the insurance carriers’ final determination of compensation to us and we may not have adequate coverage if we need to rebuild or replace our inventory, infrastructure, business income or our entire facility.

our disaster recovery plans for our facilities may not be adequate and we do not have an alternative manufacturing facility or contractual arrangements with other manufacturers in the event of a casualty to or destruction of any of our facilities.

If we are required to rebuild or relocate any of our facilities, a substantial investment in improvements and equipment would be necessary.

We carry only a limited amount of business interruption insurance, which may not sufficiently compensate us

for losses that may occur.

We carry only a limited amount of business interruption insurance, which may not sufficiently

compensate us for losses that may occur.

As a result, any significant business interruption could adversely affect our business and results of operations.

If we are unsuccessful in obtaining regulatory approval for any of our product candidates or if any of our product candidates do not provide positive results, we may be required to delay or abandon

development of such product, which would have a material adverse impact on our business.

If we are unsuccessful in obtaining regulatory approval for any of our product candidates or if any of our product candidates do not provide positive results, we may be required to delay or

abandon development of such product, which would have a material adverse impact on our business.

Product candidates require extensive clinical data analysis and regulatory review and may require additional testing.

Clinical trials and data analysis can be very expensive, time-consuming and difficult to design and

Clinical trials and data analysis can be very expensive, time-consuming and difficult to design

and implement.

The conduct of preclinical studies and clinical trials is subject to numerous risks and results of the studies and trials are highly uncertain.

Human clinical trials are very

expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements.

Human clinical trials are

very expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements.

The clinical trial process is also time-consuming.

Furthermore, delays or setbacks can occur at any stage of the process, and we

could encounter problems that cause us to abandon our product development programs and related INDs or BLAs, or to repeat clinical trials.

The evolving COVID-19 pandemic may directly or indirectly affect the pace of enrollment in clinical trials as

patients may be restricted in traveling to and accessing healthcare facilities and physicians’ offices.

Additionally, such healthcare facilities and offices have their limited resources directed towards treating patients with COVID-19 symptoms.

commencement and completion of clinical trials for any current or future development product candidate may be delayed by several factors, including:

Furthermore, delays or setbacks can occur at any stage of the process,

and we could encounter problems that cause us to abandon our product development programs and related INDs or BLAs, or to repeat clinical trials.

The evolving COVID-19 pandemic may directly or indirectly affect the pace of enrollment in clinical

trials as patients may be restricted in traveling to and accessing healthcare facilities and physicians’ offices.

Additionally, such healthcare facilities and offices have their limited resources directed towards treating patients with COVID-19

The commencement and completion of clinical trials for any current or future development product candidate may be delayed by several factors, including:

unforeseen safety issues;

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adequate and well-controlled clinical trials.

However, if the FDA or an equivalent foreign regulatory authority determines that our Phase 3 clinical trial results do not demonstrate a statistically significant, clinically meaningful benefit with an

acceptable safety profile, or if a relevant regulator requires us to conduct additional Phase 3 clinical trials in order to gain approval, we will incur significant additional development costs and commercialization of these products would be

However, if the FDA or an equivalent foreign regulatory authority determines that our Phase 3 clinical trial results do not demonstrate a statistically significant, clinically meaningful benefit with

an acceptable safety profile, or if a relevant regulator requires us to conduct additional Phase 3 clinical trials in order to gain approval, we will incur significant additional development costs and commercialization of these products would be

prevented or delayed and our business would be adversely affected.

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The clinical trial process may fail to demonstrate that our product candidates are safe for humans and effective for indicated uses.

This failure would cause us to abandon a product candidate and may delay development

of other product candidates.

This failure would cause us to abandon a product candidate and may delay

development of other product candidates.

Any delay in, or termination of, our clinical trials will delay our ability to commercialize our product candidates and generate product revenues.

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Regulators may require us to perform additional or unanticipated clinical trials to obtain approval or we may be subject to additional post-marketing testing, surveillance, or REMS requirements to maintain regulatory approval;

Our third-party contractors may fail to comply with regulatory requirements or the clinical trial protocol, or meet their contractual obligations to us in a timely manner, or at all, or we may be required to engage in additional clinical

trial site monitoring;

clinical trial site monitoring;

The cost of clinical trials of our product candidates may be greater than we anticipate or we may have insufficient funds for a clinical trial or to pay the substantial user fees required by FDA upon the filing of a marketing

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it difficult for us to recover the costs of researching and developing such product candidate.

If we are not be able to generate revenue from our products and product candidates, our sources of revenue may continue to be from a product mix consisting only of plasma collection and sales revenues, revenues

If we are not able to generate revenue from our products and product candidates, our sources of revenue may continue to be from a product mix consisting only of plasma collection and sales revenues, revenues

generated from sales of our FDA-approved commercial products, revenues generated from ongoing contract manufacturing for third parties and revenues generated from the sales of manufacturing intermediates.

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studies, as well as human tests, referred to as clinical trials.

Satisfaction of the FDA’s regulatory requirements typically takes many years, depends upon the type, complexity and novelty of the product candidate and requires substantial resources

for research, development and testing.

Satisfaction of the FDA’s regulatory requirements typically takes many years, depends upon the type, complexity and novelty of the product candidate and requires substantial

resources for research, development and testing.

We cannot predict whether our research and clinical approaches will result in products that the FDA considers safe for humans and effective for indicated uses.

The FDA has substantial discretion in the product

approval process and may require us to conduct additional preclinical and clinical testing or to perform post-marketing studies or may require additional CMC or other data and information, and the development and provision of this data and

information may be time-consuming and expensive.

The approval process may also be delayed by changes in government regulation, future legislation, diversion of resources for FDA review during the ongoing COVID-19 pandemic or administrative action

or changes in FDA policy that occur prior to or during our regulatory review.

The FDA has substantial discretion in

the product approval process and may require us to conduct additional preclinical and clinical testing or to perform post-marketing studies or may require additional CMC or other data and information, and the development and provision of this

data and information may be time-consuming and expensive.

The approval process may also be delayed by changes in government regulation, future legislation, diversion of resources for FDA review during the ongoing COVID-19 pandemic or

administrative action or changes in FDA policy that occur prior to or during our regulatory review.

Delays in obtaining regulatory approvals may:

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The FDA and other governmental authorities strictly regulate and monitor marketing, labeling, advertising and promotion of prescription drugs.

These regulations include standards and restrictions for direct-to-consumer

advertising, industry-sponsored scientific and educational activities, promotional activities involving the Internet and off-label promotion.

The FDA generally does not allow drugs to be promoted for “off-label” uses — that is, uses that are not

described in the product’s labeling and that differ from those that were approved by the FDA.

These regulations include standards and restrictions for

direct-to-consumer advertising, industry-sponsored scientific and educational activities, promotional activities involving the Internet and off-label promotion.

The FDA generally does not allow drugs to be promoted for “off-label” uses — that is,

uses that are not described in the product’s labeling and that differ from those that were approved by the FDA.

The FDA limits approved uses to those studied by a company in its clinical trials.

In addition to the FDA approval required for new formulations, any new

indication for an approved product also requires FDA approval.

Although we have received approval from the FDA to market ASCENIV as a treatment for PIDD, we cannot be sure whether we will be able to obtain FDA approval for any desired future

indications for ASCENIV.

In addition to the FDA approval required for new

formulations, any new indication for an approved product also requires FDA approval.

Although we have received approval from the FDA to market ASCENIV as a treatment for PIDD, we cannot be sure whether we will be able to obtain FDA approval for

any desired future indications for ASCENIV.

While physicians in the U.S.

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approved by the regulatory authorities, our ability to promote our products is narrowly limited to those indications that are specifically approved by the FDA.

“Off-label” uses are common across medical specialties and may constitute an appropriate

treatment for some patients in varied circumstances.

“Off-label” uses are common across medical specialties and may constitute an

appropriate treatment for some patients in varied circumstances.

Regulatory authorities in the U.S.

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In addition, our failure to follow FDA rules and guidelines related to promotion and advertising may cause the FDA to issue warning letters or untitled letters, bring an enforcement action against us, suspend or withdraw an approved

product from the market, require a recall or institute fines or civil fines, or could result in disgorgement of money, operating restrictions, injunctions or criminal prosecution, among other consequences, any of which could harm our reputation and

our business.

and our business.

With the approval of ASCENIV, there can be no assurance that we will be successful in developing and expanding commercial operations or balancing our research and development activities with our

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In addition, we may be required to spend significant funds on building out our commercial operations.

There can be no assurance that after the expenditure of substantial funds and efforts, we will successfully develop and

commercialize any of our product candidates, generate any significant revenues or ever achieve and maintain a substantial level of sales of our products.

There can be no assurance that after the expenditure of substantial funds and efforts, we will successfully develop

and commercialize any of our product candidates, generate any significant revenues or ever achieve and maintain a substantial level of sales of our products.

We depend on third-party researchers, developers and vendors to develop, manufacture or test products and product candidates, as well as for other pre-and-post approval services, and such parties

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consultants to conduct our preclinical activities, clinical trials, CMC testing and other activities under agreements with us.

These collaborators are not our employees and we cannot control the amount or timing of resources that they devote to our

programs or the impact that the ongoing COVID-19 pandemic will have on such third parties.

These collaborators are not our employees and we cannot control the amount or timing of resources that they devote to

our programs or the impact that the ongoing COVID-19 pandemic will have on such third parties.

These investigators may not assign as great a priority to our programs or pursue them as diligently as we would if we were undertaking such programs

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any of our vendors may impede our ability to receive approval for our product candidates.

We may be unable to successfully expand our manufacturing processes to fulfill demand for our products or increase our production capabilities through the addition of new equipment, including if we

do not obtain requisite approval from the FDA.

We may be unable to successfully expand our manufacturing processes to fulfill demand for our products or

increase our production capabilities through the addition of new equipment, including if we do not obtain requisite approval from the FDA.

We currently anticipate expanding the manufacturing capacity of our Boca Facility by approximately 50% or more.

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Following the expansion of any of our manufacturing processes or the addition of new equipment, such as our fill-finish machine, we will need to validate the expanded facility and equipment and have it inspected by the FDA.

Given the significant delays that may result during the validation process, including due to any diverted FDA attention during the COVID-19 pandemic, we may experience a significant supply shortage of our products or our production capabilities may

be limited until completion of and validation of our facility expansion and new manufacturing equipment.

may be limited until completion of and validation of our facility expansion and new manufacturing equipment.

Our products, and any additional products for which we may obtain marketing approval in the future, could be subject to post-marketing restrictions or

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refusal to permit the import or export of products;

FDA debarment, suspension and debarment from government contracts, and refusal of orders under existing government contracts, exclusion from healthcare programs, consent decrees, or corporate integrity agreements;

FDA debarment, suspension and debarment from government contracts, and refusal of orders under existing government contracts, exclusion from healthcare programs, consent decrees, or

corporate integrity agreements;

product seizure or detention;

injunctions or the imposition of civil or criminal penalties.

Historically, a few customers have accounted for a significant amount of our total revenue and accounts receivable and the loss of any of these customers could have a material adverse effect on our

business, results of operations and financial condition.

For the six months ended June 30, 2021, five customers, BioCare, Biolife, Reliance, Curascript and AmerisourceBergen, represented an aggregate of 85% of our consolidated revenues.

Historically, a few customers have accounted for a significant amount of our total revenue and accounts receivable and the loss of any of these customers could have a material adverse effect on

our business, results of operations and financial condition.

For the nine months ended September 30, 2021, four customers, BioCare, Reliance, Curascript and AmerisourceBergen, represented an aggregate of 74% of our consolidated revenues.

For the year ended December 31, 2020,

three customers, BioCare, Reliance and Biolife, represented an aggregate of 82% of our consolidated revenues.

As of June 30, 2021, six customers, Curascript, BioCare, 1 ST America Infusion Services, LLC, Reliance, Biolife and AmerisourceBergen,

represented a total of 94% of our consolidated accounts receivable.

As of December 31, 2020, three customers, BioCare, Reliance and Curascript, represented a total of 92% of our consolidated accounts receivable.

As of September 30, 2021, six customers, Curascript, BioCare, Healix Infusion Therapy LLC, Reliance, Biolife and AmerisourceBergen, represented a total of 94% of our consolidated accounts receivable.

As of December

31, 2020, three customers, BioCare, Reliance and Curascript, represented a total of 92% of our consolidated accounts receivable.

The loss of any key customers or a material change in the revenue generated by any of these customers could have a material adverse effect on our business, results of operations and financial condition.

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Our future success depends on our ability to maintain and continuously improve our quality management program.

A quality or safety issue may result in failure to obtain product approval, adverse inspection reports, warning

letters, product recalls or seizures, monetary sanctions, injunctions to halt manufacture and distribution of products, civil or criminal sanctions, costly litigation, refusal of a government to grant approvals and licenses, restrictions on

operations or withdrawal of existing approvals and licenses.

An inability to address a quality or safety issue by us or by a third-party vendor in an effective and timely manner may also cause negative publicity or a loss of customer confidence in

us or our current or future products, which may result in the loss of sales and difficulty in successfully commercializing our current products and launching new products.

A quality or safety issue may result in failure to obtain product approval, adverse inspection reports,

warning letters, product recalls or seizures, monetary sanctions, injunctions to halt manufacture and distribution of products, civil or criminal sanctions, costly litigation, refusal of a government to grant approvals and licenses, restrictions

on operations or withdrawal of existing approvals and licenses.

An inability to address a quality or safety issue by us or by a third-party vendor in an effective and timely manner may also cause negative publicity or a loss of customer

confidence in us or our current or future products, which may result in the loss of sales and difficulty in successfully commercializing our current products and launching new products.

In addition, as a manufacturer of biological products, we are subject to the risks inherent in biological production, which could include normal course losses and failures inherent in the manufacturing process.

biologics production levels increase, there may be normal course inventory losses or write-downs as we ensure product quality and compliance with cGMP, FDA, state and local regulations, or due to testing results not meeting specifications.

result, our operating results are subject to potentially significant variability from one reporting period to the next should such normal course losses occur in any given period.

our biologics production levels increase, there may be normal course inventory losses or write-downs as we ensure product quality and compliance with cGMP, FDA, state and local regulations, or due to testing results not meeting specifications.

a result, our operating results are subject to potentially significant variability from one reporting period to the next should such normal course losses occur in any given period.

If physicians, payers and patients do not accept and use our current products or our future product candidates, our ability to generate revenue from these products will be materially impaired.

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Pneumoniae hyperimmune IG.

We have initiated small scale preclinical activities to potentially expand our current portfolio through new product development efforts or to in-license or acquire additional products and product candidates.

we are not successful in developing or acquiring additional products and product candidates, we will have to depend on our ability to successfully commercialize ASCENIV, as well as our ability to generate revenue from Nabi-HB, BIVIGAM, contract

manufacturing, intermediate fractions and plasma attributable to the operations of ADMA BioCenters, to support our operations.

We have initiated small scale preclinical activities to potentially expand our current portfolio through new product development efforts or to in-license or acquire additional products and product

If we are not successful in developing or acquiring additional products and product candidates, we will have to depend on our ability to successfully commercialize ASCENIV, as well as our ability to generate revenue from Nabi-HB,

BIVIGAM, contract manufacturing, intermediate fractions and plasma attributable to the operations of ADMA BioCenters, to support our operations.

Our ADMA BioCenters operations collect information from donors in the U.S.

that subjects us to consumer and health privacy laws, which could create enforcement and litigation exposure if we fail to

meet their requirements.

that subjects us to consumer and health privacy laws, which could create enforcement and litigation exposure if we fail

to meet their requirements.

Consumer privacy is highly protected by federal and state law.

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Health plans/insurers, healthcare providers engaging in standard transactions (insurance/health

plan claims and encounters, payment and remittance advice, claims status, eligibility, enrollment/disenrollment, referrals and authorizations, coordination of benefits and premium payments), and healthcare clearinghouses (switches that convert data

between standard and non-standard data sets) are covered entities.

A “business associate” provides services to covered entities (directly or as subcontractors to other business associates) involving arranging, creating, receiving, maintaining, or

transmitting protected health information (“PHI”) on a covered entity’s behalf.

In order to legally provide access to PHI to service providers, covered entities and business associates must enter into a “business associate agreement” (“BAA”) with

the service provider PHI recipient.

Among other things, HITECH made certain aspects of the HIPAA’s rules (notably the Security Rule) directly applicable to business associates – independent contractors or agents of covered entities that receive or

obtain protected health information in connection with providing a service on behalf of a covered entity.

HITECH also created four new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to

business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal court to enforce the federal HIPAA laws and seek attorney’s fees and costs associated with pursuing federal civil

data between standard and non-standard data sets) are covered entities.

A “business associate” provides services to covered entities (directly or as subcontractors to other business associates) involving arranging, creating, receiving,

maintaining, or transmitting protected health information (“PHI”) on a covered entity’s behalf.

In order to legally provide access to PHI to service providers, covered entities and business associates must enter into a “business associate

agreement” (“BAA”) with the service provider PHI recipient.

Among other things, HITECH made certain aspects of the HIPAA’s rules (notably the Security Rule) directly applicable to business associates – independent contractors or agents of covered

entities that receive or obtain protected health information in connection with providing a service on behalf of a covered entity.

HITECH also created four new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties

directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal court to enforce the federal HIPAA laws and seek attorney’s fees and costs associated with

pursuing federal civil actions.

The HHS Office of Civil Rights (“OCR”) has increased its focus on compliance and continues to train state attorneys general for enforcement purposes.

OCR has recently increased both its efforts to audit HIPAA compliance and its level of

enforcement, with one recent penalty exceeding $5.0 million.

OCR has recently increased both its efforts to audit HIPAA

compliance and its level of enforcement, with one recent penalty exceeding $5.0 million.

While we are not a covered entity or business associate subject to HIPAA, even when HIPAA does not apply, according to the U.S.

Federal Trade Commission (the “FTC”), failing to take appropriate steps to keep consumers’

personal information secure constitutes unfair acts or practices in or affecting commerce in violation of Section 5(a) of the Federal Trade Commission Act, 15 U.S.C § 45(a).

The FTC expects a company’s data security measures to be reasonable and

appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexity of its business, and the cost of available tools to improve security and reduce vulnerabilities.

Medical data is considered sensitive data

that merits stronger safeguards.

Federal Trade Commission (the “FTC”), failing to take appropriate steps to keep

consumers’ personal information secure constitutes unfair acts or practices in or affecting commerce in violation of Section 5(a) of the Federal Trade Commission Act, 15 U.S.C § 45(a).

The FTC expects a company’s data security measures to be

reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexity of its business, and the cost of available tools to improve security and reduce vulnerabilities.

Medical data is

considered sensitive data that merits stronger safeguards.

The FTC’s guidance for appropriately securing consumers’ personal information is similar to what is required by the HIPAA Security Rule.

In addition, states impose a variety of laws protecting consumer information,

with certain sensitive information such as HIV/Sexually Transmitted Disease status subject to heightened standards.

In addition, federal and state privacy, data security, and breach notification laws, rules and regulations, and other laws apply to

the collection, use and security of personal information, including social security number, driver’s license numbers, government identifiers, credit card and financial account numbers.

Some state privacy and security laws apply more broadly than

HIPAA and associated regulations.

For example, California recently enacted legislation – the California Consumer Privacy Act, or CCPA – which went into effect January 1, 2020, and will be amended by the California Privacy Rights Act, effective

January 1, 2023.

The CCPA, among other things, creates new data privacy obligations for covered companies and provides new privacy rights to California residents, including the right to opt out of certain disclosures of their information.

also creates a private right of action with statutory damages for certain data breaches, thereby potentially increasing risks associated with a data breach.

It remains unclear what, if any, modifications will be made to this legislation or how it

will be interpreted.

In addition, states impose a variety of laws

protecting consumer information, with certain sensitive information such as HIV/Sexually Transmitted Disease status subject to heightened standards.

In addition, federal and state privacy, data security, and breach notification laws, rules and

regulations, and other laws apply to the collection, use and security of personal information, including social security number, driver’s license numbers, government identifiers, credit card and financial account numbers.

Some state privacy and

security laws apply more broadly than HIPAA and associated regulations.

For example, California recently enacted legislation – the California Consumer Privacy Act, or CCPA – which went into effect January 1, 2020, and will be amended by the

California Privacy Rights Act, effective January 1, 2023.

The CCPA, among other things, creates new data privacy obligations for covered companies and provides new privacy rights to California residents, including the right to opt out of certain

disclosures of their information.

The CCPA also creates a private right of action with statutory damages for certain data breaches, thereby potentially increasing risks associated with a data breach.

It remains unclear what, if any, modifications

will be made to this legislation or how it will be interpreted.

We could be subject to enforcement action and litigation exposure if we fail to adhere to these data privacy and security laws.

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On February 11, 2019 (the “Perceptive Closing Date”), we entered into the Perceptive Credit Agreement with Perceptive Credit Holdings II, LP, as the lender and administrative agent (“Perceptive”).

The Perceptive Credit

Agreement, as amended, currently provides for a senior secured term loan facility in the principal amount of $100.0 million (the “Perceptive Credit Facility”), comprised of (i) a term loan made on the Perceptive Closing Date in the principal amount

of $45.0 million, as evidenced by our issuance of a promissory note in favor of Perceptive on the Perceptive Closing Date (the “Perceptive Tranche I Loan”), (ii) a term loan in the principal amount of $27.5 million evidenced by our issuance of a

promissory note in favor of Perceptive on May 3, 2019 (the “Perceptive Tranche II Loan”), (iii) a term loan in the principal amount of $12.5 million evidenced by our issuance of a promissory note in favor of Perceptive on March 20, 2020, (the

“Perceptive Tranche III Loan”);

and (iv) a term loan in the principal amount of $15 million evidenced by our issuance of a promissory note in favor of Perceptive on December 8, 2020 (the “Perceptive Tranche IV Loan,” and together with the

Perceptive Tranche I Loan, the Perceptive Tranche II Loan and the Perceptive Tranche III Loan, the “Perceptive Loans”).

The Perceptive Loans each have a maturity date of March 1, 2024, subject to acceleration pursuant to the Perceptive Credit

Agreement, including upon an Event of Default (as defined in the Perceptive Credit Agreement).

The Perceptive

Credit Agreement, as amended, currently provides for a senior secured term loan facility in the principal amount of $100.0 million (the “Perceptive Credit Facility”), comprised of (i) a term loan made on the Perceptive Closing Date in the

principal amount of $45.0 million, as evidenced by our issuance of a promissory note in favor of Perceptive on the Perceptive Closing Date (the “Perceptive Tranche I Loan”), (ii) a term loan in the principal amount of $27.5 million evidenced by

our issuance of a promissory note in favor of Perceptive on May 3, 2019 (the “Perceptive Tranche II Loan”), (iii) a term loan in the principal amount of $12.5 million evidenced by our issuance of a promissory note in favor of Perceptive on March

20, 2020, (the “Perceptive Tranche III Loan”);

with the Perceptive Tranche I Loan, the Perceptive Tranche II Loan and the Perceptive Tranche III Loan, the “Perceptive Loans”).

The Perceptive Loans each have a maturity date of March 1, 2024, subject to acceleration pursuant to the Perceptive

Credit Agreement, including upon an Event of Default (as defined in the Perceptive Credit Agreement).

The Perceptive Loans are secured by substantially all of our assets, including our intellectual property.

Events of Default include, among others,

non-payment of principal, interest, or fees, violation of covenants, inaccuracy of representations and warranties, bankruptcy and insolvency events, material judgments, cross-defaults to material contracts and events constituting a change of

In addition to an increase in the rate of interest on the Perceptive Loans of 4% per annum, the occurrence of an Event of Default could result in, among other things, the termination of commitments under the Perceptive Credit Facility, the

declaration that all outstanding Loans are immediately due and payable in whole or in part, and Perceptive taking immediate possession of, and selling, any collateral securing the Perceptive Loans.

Events of Default include, among

others, non-payment of principal, interest, or fees, violation of covenants, inaccuracy of representations and warranties, bankruptcy and insolvency events, material judgments, cross-defaults to material contracts and events constituting a change

Facility, the declaration that all outstanding Loans are immediately due and payable in whole or in part, and Perceptive taking immediate possession of, and selling, any collateral securing the Perceptive Loans.

Developments by competitors may render our products or technologies obsolete or non-competitive.

The biotechnology and pharmaceutical industries are intensely competitive and subject to rapid and significant technological change.

Our current products and any future product we may develop will have to compete with

other marketed therapies.

Our current products and any future product we may develop will have to compete

with other marketed therapies.

In addition, other companies may pursue the development of pharmaceuticals that target the same diseases and conditions that we are targeting.

We face competition from pharmaceutical and biotechnology companies in the U.S.

We face competition from pharmaceutical and biotechnology companies in

In addition, companies pursuing different but related fields represent substantial competition.

Many of these organizations competing with us have substantially greater financial resources, larger research and development staffs and

facilities, longer product development history in obtaining regulatory approvals and greater manufacturing and marketing capabilities than we do.

These organizations also compete with us to attract qualified personnel and parties for acquisitions,

joint ventures or other collaborations.

Many of these organizations competing with us have substantially greater financial resources, larger research and development

staffs and facilities, longer product development history in obtaining regulatory approvals and greater manufacturing and marketing capabilities than we do.

These organizations also compete with us to attract qualified personnel and parties for

acquisitions, joint ventures or other collaborations.

If we are unable to protect our patents, trade secrets or other proprietary rights, if our patents are challenged or if our provisional patent applications do not get approved, our competitiveness

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There can be no assurance that the confidentiality, nondisclosure and non-competition

agreements with employees, consultants and other parties with access to our proprietary information to protect our trade secrets, proprietary technology, processes and other proprietary rights, or any other security measures relating to such trade

secrets, proprietary technology, processes and proprietary rights, will be adequate, will not be breached, that we will have adequate remedies for any breach, that others will not independently develop substantially equivalent proprietary

trade secrets, proprietary technology, processes and proprietary rights, will be adequate, will not be breached, that we will have adequate remedies for any breach, that others will not independently develop substantially equivalent proprietary

information or that third parties will not otherwise gain access to our trade secrets or proprietary knowledge.

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Market exclusivity for our products is based upon patent rights and certain regulatory forms of exclusivity.

The scope of our patent rights may vary from country to country and may also be dependent on the availability

of meaningful legal remedies in a country.

The scope of our patent rights may vary from country to country and may also be dependent on the

availability of meaningful legal remedies in a country.

The failure to obtain patent and other intellectual property rights, or limitations on the use or loss of such rights, could be material to us.

In some countries, basic patent protections for our products

may not exist because certain countries did not historically offer the right to obtain specific types of patents and/or we (or our licensors) did not file in those markets.

In addition, the patent environment can be unpredictable and the validity

and enforceability of patents cannot be predicted with certainty.

In some countries, basic patent protections

for our products may not exist because certain countries did not historically offer the right to obtain specific types of patents and/or we (or our licensors) did not file in those markets.

In addition, the patent environment can be unpredictable

and the validity and enforceability of patents cannot be predicted with certainty.

Absent relevant patent protection for a product, once the data exclusivity period expires, generic versions can be approved and marketed.

Patent rights covering our products may become subject to patent litigation.

In some cases, manufacturers may seek regulatory approval by submitting their own clinical trial data to obtain marketing approval or choose

to launch a generic product “at risk” before the expiration of our patent rights/or before the final resolution of related patent litigation.

Enforcement of claims in patent litigation can be very costly, time-consuming and no assurance can be

given that we will prevail.

In addition, any such litigation may divert our management’s attention from our core business and reduce the resources available for our clinical development, manufacturing and marketing activities, and consequently have

a material and adverse effect on our business and prospects, regardless of the outcome.

There is no assurance that ASCENIV, or any other of our products for which we are issued a patent, will enjoy market exclusivity for the full time period of the

respective patent.

Third parties could obtain patents that may require us to negotiate licenses to conduct our business, and there can be no assurance that the required licenses would be available on reasonable terms

In some cases, manufacturers may seek regulatory approval by submitting their own clinical trial data to obtain marketing approval or

choose to launch a generic product “at risk” before the expiration of our patent rights/or before the final resolution of related patent litigation.

Enforcement of claims in patent litigation can be very costly, time-consuming and no assurance

can be given that we will prevail.

consequently have a material and adverse effect on our business and prospects, regardless of the outcome.

There is no assurance that ASCENIV, or any other of our products for which we are issued a patent, will enjoy market exclusivity for the full time period of the respective patent.

Third parties could obtain patents that may require us to negotiate licenses to conduct our business, and there can be no assurance that the required licenses would be available on reasonable

terms or at all.

We may not be able to operate our business without infringing third-party patents.

Numerous U.S.

and foreign patents and pending patent applications owned by third parties exist in fields that relate to the development

and commercialization of IG.

and foreign patents and pending patent applications owned by third parties exist in fields that relate to the

development and commercialization of IG.

In addition, many companies have employed intellectual property litigation as a way to gain a competitive advantage.

It is possible that infringement claims may occur as the number of products and competitors in our

market increases.

It is possible that infringement claims may occur as the number of products and

competitors in our market increases.

In addition, to the extent that we gain greater visibility and market exposure as a public company, we face a greater risk of being the subject of intellectual property infringement claims.

We cannot be certain that the conduct of

our business does not and will not infringe intellectual property or other proprietary rights of others in the U.S.

certain that the conduct of our business does not and will not infringe intellectual property or other proprietary rights of others in the U.S.

and in foreign jurisdictions.

If our products, methods, processes and other technologies are found to infringe third-party patent

rights, we could be prohibited from manufacturing and commercializing the infringing technology, process or product unless we obtain a license under the applicable third-party patent and pay royalties or are able to design around such patent.

may be unable to obtain a license on terms acceptable to us, or at all, and we may not be able to redesign our products or processes to avoid infringement.

Even if we are able to redesign our products or processes to avoid an infringement claim,

our efforts to design around the patent could require significant time, effort and expense and ultimately may lead to an inferior or more costly product and/or process.

Any claim of infringement by a third party, even those without merit, could

cause us to incur substantial costs defending against the claim and could distract our management from our business.

Furthermore, if any such claim is successful, a court could order us to pay substantial damages, including compensatory damages for

any infringement, plus prejudgment interest and could, in certain circumstances, treble the compensatory damages and award attorney fees.

These damages could be substantial and could harm our reputation, business, financial condition and operating

A court also could enter orders that temporarily, preliminarily or permanently prohibit us, our licensees, if any, or our customers from making, using, selling, offering to sell or importing one or more of our products or practicing our

proprietary technologies or processes, or could enter an order mandating that we undertake certain remedial activities.

Any of these events could seriously harm our business, operating results and financial condition.

If our products, methods, processes and other technologies are found to

infringe third-party patent rights, we could be prohibited from manufacturing and commercializing the infringing technology, process or product unless we obtain a license under the applicable third-party patent and pay royalties or are able to

design around such patent.

We may be unable to obtain a license on terms acceptable to us, or at all, and we may not be able to redesign our products or processes to avoid infringement.

Even if we are able to redesign our products or processes to

avoid an infringement claim, our efforts to design around the patent could require significant time, effort and expense and ultimately may lead to an inferior or more costly product and/or process.

Any claim of infringement by a third party, even

those without merit, could cause us to incur substantial costs defending against the claim and could distract our management from our business.

Furthermore, if any such claim is successful, a court could order us to pay substantial damages,

including compensatory damages for any infringement, plus prejudgment interest and could, in certain circumstances, treble the compensatory damages and award attorney fees.

These damages could be substantial and could harm our reputation,

business, financial condition and operating results.

A court also could enter orders that temporarily, preliminarily or permanently prohibit us, our licensees, if any, or our customers from making, using, selling, offering to sell or importing

one or more of our products or practicing our proprietary technologies or processes, or could enter an order mandating that we undertake certain remedial activities.

Any of these events could seriously harm our business, operating results and

financial condition.

If we are unable to successfully manage our growth, our business may be harmed.

Our success will depend on the expansion of our commercial and manufacturing activities, supply of plasma and overall operations and the effective management of our growth, which will place a significant strain on our

management and on our administrative, operational and financial resources.

our management and on our administrative, operational and financial resources.

To manage this growth, we must expand our facilities, augment our operational, financial and management systems and hire and train additional qualified personnel.

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In the ordinary course of our business, we generate, collect and store proprietary information, including intellectual property and business information.

The secure storage, maintenance, and transmission of and access

to this information is important to our operations and reputation.

Computer hackers may attempt to penetrate our computer systems and, if successful, misappropriate our proprietary and confidential information including e-mails and other electronic

communications.

Further, while many of our employees and certain suppliers with whom we do business operate in a remote working environment during the COVID-19 pandemic, the risk of cybersecurity attacks and data breaches, particularly through

phishing attempts, may be increased as we and third parties with whom we interact leverage our IT infrastructure in unanticipated ways during the ongoing COVID-19 pandemic.

In addition, an employee, contractor, or other third party with whom we do

business may attempt to obtain such information, and may purposefully or inadvertently cause a breach involving such information.

While we have certain safeguards in place to reduce the risk of and detect cyberattacks, including a Company-wide

cybersecurity policy, our information technology networks and infrastructure may be vulnerable to unpermitted access by hackers or other breaches, or employee error or malfeasance.

Any such compromise of our data security and access to, or public

disclosure or loss of, confidential business or proprietary information could disrupt our operations, damage our reputation, provide our competitors with valuable information and subject us to additional costs, which could adversely affect our

The secure storage, maintenance, and transmission of and

access to this information is important to our operations and reputation.

Computer hackers may attempt to penetrate our computer systems and, if successful, misappropriate our proprietary and confidential information including e-mails and other

electronic communications.

through phishing attempts, may be increased as we and third parties with whom we interact leverage our IT infrastructure in unanticipated ways during the ongoing COVID-19 pandemic.

In addition, an employee, contractor, or other third party with

whom we do business may attempt to obtain such information, and may purposefully or inadvertently cause a breach involving such information.

While we have certain safeguards in place to reduce the risk of and detect cyberattacks, including a

Company-wide cybersecurity policy, our information technology networks and infrastructure may be vulnerable to unpermitted access by hackers or other breaches, or employee error or malfeasance.

Any such compromise of our data security and access

to, or public disclosure or loss of, confidential business or proprietary information could disrupt our operations, damage our reputation, provide our competitors with valuable information and subject us to additional costs, which could adversely

affect our business.

If we are unable to hire and retain a substantial number of qualified personnel, our ability to sustain and grow our business may be harmed.

Our success depends in part on our ability to attract, motivate, and retain a sufficient number of qualified employees across various areas of our operations, such as research and development, manufacturing operations,

and sales, who understand and appreciate our strategy and culture and are able to contribute to our mission.

We will need to hire additional qualified personnel with expertise in commercialization, sales, marketing, medical affairs, reimbursement,

government regulation, formulation, quality control, manufacturing and finance and accounting.

In particular, over the next 12-24 months, we expect to hire several new employees devoted to commercialization, sales, marketing, medical and scientific

affairs, regulatory affairs, quality control, finance and general and operational management.

operations, and sales, who understand and appreciate our strategy and culture and are able to contribute to our mission.

We will need to hire additional qualified personnel with expertise in commercialization, sales, marketing, medical affairs,

reimbursement, government regulation, formulation, quality control, manufacturing and finance and accounting.

In particular, over the next 12-24 months, we expect to hire several new employees devoted to commercialization, sales, marketing,

medical and scientific affairs, regulatory affairs, quality control, finance and general and operational management.

Qualified individuals of the requisite caliber and number needed to fill these positions may be in short supply in some areas.

We compete for qualified

individuals with numerous biopharmaceutical companies, universities and other research institutions.

Competition for such individuals is intense, and we cannot assure you that our search for such personnel will be successful, particularly if the

COVID-19 pandemic causes significant changes in the competitive market for such personnel or travel restrictions related to COVID-19 prevent qualified personnel from applying for employment.

If we are unable to hire and retain personnel capable of

consistently performing at a high level, our business and operations could be materially adversely affected.

Additionally, any material increases in existing employee turnover rates or increases in labor costs could have a material adverse effect

on our business, financial condition or operating results.

We currently collect human blood plasma at our ADMA BioCenters facilities, and if we cannot maintain FDA approval for these facilities or obtain FDA approval for additional facilities that we create

or acquire rights to, we may be adversely affected and may not be able to sell or use this human blood plasma for future commercial purposes.

compete for qualified individuals with numerous biopharmaceutical companies, universities and other research institutions.

Competition for such individuals is intense, and we cannot assure you that our search for such personnel will be

successful, particularly if the COVID-19 pandemic causes significant changes in the competitive market for such personnel or travel restrictions related to COVID-19 prevent qualified personnel from applying for employment.

If we are unable to

hire and retain personnel capable of consistently performing at a high level, our business and operations could be materially adversely affected.

Additionally, any material increases in existing employee turnover rates or increases in labor costs

could have a material adverse effect on our business, financial condition or operating results.

We currently collect human blood plasma at our ADMA BioCenters facilities, and if we cannot maintain FDA approval for these facilities or obtain FDA approval for additional facilities that we

create or acquire rights to, we may be adversely affected and may not be able to sell or use this human blood plasma for future commercial purposes.

We intend to maintain FDA approval of our ADMA BioCenters collection facilities for the collection of human blood plasma and we may seek other governmental and regulatory approvals for these facilities.

We also plan to

grow through the building and licensing of additional ADMA BioCenters facilities in various regions of the U.S.

to grow through the building and licensing of additional ADMA BioCenters facilities in various regions of the U.S.

Collection facilities are subject to FDA and potentially other governmental and regulatory inspections and extensive regulation,

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enforcement actions, such as adverse inspection reports, warning or untitled letters, product recalls or seizures, monetary sanctions, injunctions to halt manufacture and distribution of products, civil or criminal sanctions, costly litigation,

refusal of regulatory authority approvals and licenses, restrictions on operations or withdrawal of existing approvals and licenses, any of which may significantly delay or suspend our operations for these locations, potentially having a materially

adverse effect on our ability to manufacture our products or offer for sale plasma collected at the affected sites.

materially adverse effect on our ability to manufacture our products or offer for sale plasma collected at the affected sites.

We manufacture our current marketed products, pipeline products, and products for third parties in our manufacturing and testing facilities, and if we or our vendors cannot maintain appropriate

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Many of our business practices are subject to scrutiny by federal and state regulatory authorities, as well as to lawsuits brought by private citizens under federal and state laws.

Failure to comply

with applicable law or an adverse decision in lawsuits may result in adverse consequences to us.

comply with applicable law or an adverse decision in lawsuits may result in adverse consequences to us.

The laws governing our conduct in the U.S.

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This places constraints on the marketing and promotion of products and on common business

arrangements, such as discounted terms and volume incentives for customers in a position to recommend or choose products for patients, such as physicians and hospitals, and these practices can result in substantial legal penalties, including, among

others, exclusion from the Medicare and Medicaid programs.

Arrangements with referral sources such as purchasers, group purchasing organizations, physicians and pharmacists must be structured with care to comply with applicable requirements.

among others, exclusion from the Medicare and Medicaid programs.

Arrangements with referral sources such as purchasers, group purchasing organizations, physicians and pharmacists must be structured with care to comply with applicable

requirements.

Legislators and regulators may seek to further restrict the scope of financial relationships that are considered appropriate.

For example, HHS recently promulgated a regulation that is effective in two phases.

First, the regulation excludes from

the definition of “remuneration” limited categories of (a) PBM rebates or other reductions in price to a plan sponsor under Medicare Part D or a Medicaid Managed Care Organization plan reflected in point-of sale reductions in price and (b) PBM

service fees.

Second, effective January 1, 2023, the regulation expressly provides that rebates to plan sponsors under Medicare Part D either directly to the plan sponsor under Medicare Part D, or indirectly through a pharmacy benefit manager will

not be protected under the anti-kickback discount safe harbor.

Also, certain business practices, such as payments of consulting fees to healthcare providers, sponsorship of educational or research grants, charitable donations, interactions with healthcare providers that prescribe

products for uses not approved by the FDA and financial support for continuing medical education programs, must be conducted within narrowly prescribed and controlled limits to avoid any possibility of wrongfully influencing healthcare providers to

prescribe or purchase particular products or as a reward for past prescribing.

Under the Patient Protection and Affordable Care Act (“ACA”) and the companion Health Care and Education Reconciliation Act, which together are referred to as the

“Healthcare Reform Law,” payments and transfers of value by pharmaceutical manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with

certain exceptions) to or at the request of covered recipients, such as, but limited to, physicians, physician assistants, nurse practitioners, clinical nurse specialists and certified registered nurse anesthetists and teaching hospitals, must be

tracked and reported to CMS, and are publicly disclosed.

First, the regulation

excludes from the definition of “remuneration” limited categories of (a) PBM rebates or other reductions in price to a plan sponsor under Medicare Part D or a Medicaid Managed Care Organization plan reflected in point-of sale reductions in price

and (b) PBM service fees.

benefit manager will not be protected under the anti-kickback discount safe harbor.

prescribe products for uses not approved by the FDA and financial support for continuing medical education programs, must be conducted within narrowly prescribed and controlled limits to avoid any possibility of wrongfully influencing healthcare

providers to prescribe or purchase particular products or as a reward for past prescribing.

Under the Patient Protection and Affordable Care Act (“ACA”) and the companion Health Care and Education Reconciliation Act, which together are referred

to as the “Healthcare Reform Law,” payments and transfers of value by pharmaceutical manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance

Program (with certain exceptions) to or at the request of covered recipients, such as, but limited to, physicians, physician assistants, nurse practitioners, clinical nurse specialists and certified registered nurse anesthetists and teaching

hospitals, must be tracked and reported to CMS, and are publicly disclosed.

Such “applicable manufacturers” are also required to report certain ownership interests held by physicians and their immediate family members.

A number of states have similar laws in place.

A number of states have

similar laws in place.

Additional and stricter prohibitions could be implemented by federal and state authorities.

Where such practices have been found to be improper incentives to use such products, government investigations and assessments of penalties against

manufacturers have resulted in substantial damages and fines.

Where such practices have been found to be improper incentives to use such products, government investigations and assessments of

penalties against manufacturers have resulted in substantial damages and fines.

Many manufacturers have been required to enter into consent decrees or orders that prescribe allowable corporate conduct.

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activities are prohibited, it may harm demand for our products.

Promotion of unapproved drugs or devices or unapproved indications for a drug or device is a violation of the Federal Food, Drug, and Cosmetic Act and subjects us to civil and criminal

Furthermore, sanctions under the Federal False Claims Act have recently been brought against companies accused of promoting off-label uses of drugs, because such promotion induces the use and subsequent claims for reimbursement under

Medicare and other federal programs.

Promotion of unapproved drugs or devices or unapproved indications for a drug or device is a violation of the Federal Food, Drug, and Cosmetic Act and subjects us to civil and

criminal sanctions.

reimbursement under Medicare and other federal programs.

Similar actions for off-label promotion have been initiated by several states for Medicaid fraud.

The Healthcare Reform Law significantly strengthened provisions of the Federal False Claims Act, the

Anti-Kickback Statute that applies to Medicare and Medicaid, and other healthcare fraud provisions, leading to the possibility of greatly increased qui tam suits by relators for perceived violations.

Violations or allegations of violations of the

foregoing restrictions could materially and adversely affect our business.

We are required to report detailed pricing information, net of included discounts, rebates and other concessions, to CMS for the purpose of calculating national reimbursement levels, certain federal prices and certain

federal and state rebate obligations.

The Healthcare Reform Law significantly strengthened provisions of the Federal False Claims

Act, the Anti-Kickback Statute that applies to Medicare and Medicaid, and other healthcare fraud provisions, leading to the possibility of greatly increased qui tam suits by relators for perceived violations.

Violations or allegations of

violations of the foregoing restrictions could materially and adversely affect our business.

certain federal and state rebate obligations.

Inaccurate or incomplete reporting of pricing information could result in liability under the False Claims Act, the federal Anti-Kickback Statute and various other laws, rules and regulations.

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considerable time after the receipt of marketing approval for a product.

To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our product candidate to

other available therapies.

To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our product candidate

to other available therapies.

Such trials may be time-consuming and expensive and may not show an advantage in efficacy for our products.

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has increasingly focused on regulating the conduct by U.S.

businesses occurring outside of the U.S., generally prohibiting remuneration to foreign officials

for the purpose of obtaining or retaining business.

To enhance compliance with applicable healthcare laws, and mitigate potential liability in the event of noncompliance, regulatory authorities such as the HHS Office of Inspector General (the

“OIG”) have recommended the adoption and implementation of a comprehensive healthcare compliance program that generally contains the elements of an effective compliance and ethics program described in Section 8B2.1 of the U.S.

Sentencing Commission

Guidelines Manual.

businesses occurring outside of the U.S., generally prohibiting remuneration to foreign

officials for the purpose of obtaining or retaining business.

To enhance compliance with applicable healthcare laws, and mitigate potential liability in the event of noncompliance, regulatory authorities such as the HHS Office of Inspector

General (the “OIG”) have recommended the adoption and implementation of a comprehensive healthcare compliance program that generally contains the elements of an effective compliance and ethics program described in Section 8B2.1 of the U.S.

Sentencing Commission Guidelines Manual.

Increasing numbers of U.S.-based pharmaceutical companies have such programs.

We will need to adopt healthcare compliance and ethics programs that would incorporate the OIG’s recommendations and train our employees.

program may be expensive and may not provide assurance that we will avoid compliance issues.

We are also required to comply with the applicable laws, rules, regulations and permit requirements of the various states in which our business operates, including the State of Florida where our manufacturing facility

We will need to adopt healthcare compliance and ethics programs that would incorporate the OIG’s recommendations and train our

Such a program may be expensive and may not provide assurance that we will avoid compliance issues.

facility is located.

These regulations and permit requirements are not always in concert with applicable federal laws, rules and regulations regulating our business.

Although compliant with applicable federal requirements, we may be required to comply

with additional state laws, rules, regulations and permits.

Failure to appropriately comply with such state requirements could result in temporary or long-term cessation of our manufacturing operations, as well as fines and other sanctions.

such penalties may have a material adverse effect on our business and results of operations.

Although compliant with applicable federal requirements, we may be required to

comply with additional state laws, rules, regulations and permits.

Failure to appropriately comply with such state requirements could result in temporary or long-term cessation of our manufacturing operations, as well as fines and other

Any such penalties may have a material adverse effect on our business and results of operations.

We are subject to extensive and rigorous governmental regulation, including the requirement of FDA and other federal, state and local business regulatory approval

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budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes.

Average review times at the FDA and other federal, state and local business regulatory agencies

have fluctuated in recent years as a result.

In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political

process, which is inherently fluid and unpredictable.

Disruptions at the FDA and other agencies may also slow the time necessary for products and product candidate submissions to be reviewed and/or approved by necessary government agencies, which

would adversely affect our business.

Average review times at the FDA and other federal, state and local business regulatory

agencies have fluctuated in recent years as a result.

In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the

political process, which is inherently fluid and unpredictable.

Disruptions at the FDA and other agencies may also slow the time necessary for products and product candidate submissions to be reviewed and/or approved by necessary government

agencies, which would adversely affect our business.

For example, over the last several years, including in December 2018 and January 2019, the U.S.

government has shut down several times and certain regulatory agencies, such as the FDA and SEC, have had to

furlough critical employees and stop critical activities.

If a prolonged government shutdown reoccurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions and other reporting requirements

which could have a material adverse effect on our business.

Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

government has shut down several times and certain regulatory agencies, such as the FDA and SEC,

have had to furlough critical employees and stop critical activities.

If a prolonged government shutdown reoccurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions and other reporting

requirements which could have a material adverse effect on our business.

Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our

The manufacturing processes for plasma-based biologics are complex and involve biological intermediates that are susceptible to contamination and impurities.

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process steps.

We may detect instances in which an unreleased product was produced without adherence to our manufacturing procedures or plasma used in our production process was not collected or stored in a compliant manner consistent with our cGMP

or other regulations.

cGMP or other regulations.

Such an event of noncompliance would likely result in our determination that the implicated products should not be released or maybe replaced or withdrawn from the market and therefore should be destroyed.

Once manufactured,

our plasma-derived products must be handled carefully and kept at appropriate temperatures.

Our failure, or the failure of third parties that supply, test, ship or distribute our products or product components to properly care for our products, may

require that those products be destroyed.

manufactured, our plasma-derived products must be handled carefully and kept at appropriate temperatures.

Our failure, or the failure of third parties that supply, test, ship or distribute our products or product components to properly care for

our products, may require that those products be destroyed.

Even if handled properly, biologics may form or contain particulates or have other issues or problems after storage which may require products to be destroyed or recalled.

While we expect to write off small

amounts of work-in-progress in the ordinary course of business due to the complex nature of plasma, our processes and our products, unanticipated events may lead to write-offs and other costs materially in excess of our expectations and the

reserves we have established for these purposes.

expect to write off small amounts of work-in-progress in the ordinary course of business due to the complex nature of plasma, our processes and our products, unanticipated events may lead to write-offs and other costs materially in excess of our

expectations and the reserves we have established for these purposes.

Such write-offs and other costs could cause material fluctuations in our results of operations.

Product or component quality issues may also result in regulatory enforcement actions, liability,

corrective actions and recalls, among other actions, as described elsewhere in this annual report.

Product or component quality issues may also result in regulatory enforcement

actions, liability, corrective actions and recalls, among other actions, as described elsewhere in this annual report.

Furthermore, contamination of our products could cause investors, consumers, or other third parties with whom we conduct business to lose confidence in the reliability of our manufacturing procedures, which could

adversely affect our revenues.

In addition, faulty or contaminated products that are unknowingly distributed could result in patient harm, threaten the reputation of our products and expose us to product liability damages and claims from companies

for whom we do contract manufacturing.

Our ability to continue to produce safe and effective products depends on the safety of our plasma supply, testing by third parties and the timing of receiving the testing results, and manufacturing

processes against transmittable diseases.

companies for whom we do contract manufacturing.

Our ability to continue to produce safe and effective products depends on the safety of our plasma supply, testing by third parties and the timing of receiving the testing results, and

manufacturing processes against transmittable diseases.

Despite overlapping safeguards, including the screening of donors and other steps to remove or inactivate viruses and other infectious disease-causing agents, the risk of transmissible disease through blood plasma

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sensitive and specific than a direct test as a means of identifying potentially contaminated plasma units.

During the early phase of an outbreak of a new infectious disease, our ability to manufacture safe products would depend on the manufacturing

process’ capacity to inactivate or remove the infectious agent.

To the extent that a product’s manufacturing process is inadequate to inactivate or remove an infectious agent, our ability to manufacture and distribute that product would be

If a new infectious disease were to emerge in the human population, such as COVID-19, or if there were a reemergence of an infectious disease, the regulatory and public health authorities could impose precautions to limit the transmission

of the disease that would impair our ability to procure plasma, manufacture our products or both.

Such precautionary measures could be taken before there is conclusive medical or scientific evidence that a disease poses a risk for plasma-derived

During the early phase of an outbreak of a new infectious disease, our ability to manufacture safe products would depend on the

manufacturing process’ capacity to inactivate or remove the infectious agent.

To the extent that a product’s manufacturing process is inadequate to inactivate or remove an infectious agent, our ability to manufacture and distribute that product

would be impaired.

transmission of the disease that would impair our ability to procure plasma, manufacture our products or both.

Such precautionary measures could be taken before there is conclusive medical or scientific evidence that a disease poses a risk for

plasma-derived products.

In recent years, new testing and viral inactivation methods have been developed that more effectively detect and inactivate infectious viruses in collected plasma.

There can be no assurance, however, that such new testing and inactivation

methods will adequately screen for, and inactivate, infectious agents in the plasma used in the production of our products.

We could become supply-constrained and our financial performance would suffer if we cannot obtain adequate quantities of FDA-approved source plasma with proper specifications or other necessary raw

There can be no assurance, however, that such new testing

and inactivation methods will adequately screen for, and inactivate, infectious agents in the plasma used in the production of our products.

We could become supply-constrained and our financial performance would suffer if we cannot obtain adequate quantities of FDA-approved source plasma with proper specifications or other necessary

raw materials.

In order for plasma to be used in the manufacturing of our products, the individual centers at which the plasma is collected must generally be licensed by the FDA and approved by the regulatory authorities of any

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When we open a new plasma center, and on an ongoing basis after licensure, it must be inspected by the FDA for compliance with cGMP and other regulatory requirements.

Therefore, even if we

are able to construct new plasma collection centers to complement our current plasma collection facilities, an unsatisfactory inspection could prevent a new center from being licensed or risk the suspension or revocation of an existing license,

among other enforcement actions.

Therefore, even if

we are able to construct new plasma collection centers to complement our current plasma collection facilities, an unsatisfactory inspection could prevent a new center from being licensed or risk the suspension or revocation of an existing

license, among other enforcement actions.

We do not and will not have adequate plasma to manufacture our products.

Therefore, we are reliant on the purchase of plasma from third parties to manufacture our products.

We can give no assurances that appropriate

plasma will be available to us on commercially reasonable terms, or at all, to manufacture our products.

Further, the COVID-19 pandemic has resulted in, and may continue to result in, significant constraints in raw material supply across various

different industries, including the supply of plasma.

It is possible that in the future, the COVID-19 pandemic and government responses thereto will have an adverse effect on our ability to source plasma from donors in quantity and quality

sufficient for our manufacturing processes.

We can give no assurances that

appropriate plasma will be available to us on commercially reasonable terms, or at all, to manufacture our products.

Further, the COVID-19 pandemic has resulted in, and may continue to result in, significant constraints in raw material supply

across various different industries, including the supply of plasma.

It is possible that in the future, the COVID-19 pandemic and government responses thereto will have an adverse effect on our ability to source plasma from donors in quantity and

quality sufficient for our manufacturing processes.

In order to maintain a plasma center’s license, its operations must continue to conform to cGMP and other regulatory requirements.

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compliance with cGMP and other applicable regulatory requirements, we may be unable to use and may ultimately destroy plasma collected from that center, which would be recorded as a charge to cost of product revenue.

Additionally, if non-compliance

in the plasma collection process is identified after the impacted plasma has been pooled with compliant plasma from other sources, entire plasma pools, in-process intermediate materials and final products could be impacted.

Consequently, we could

experience significant inventory impairment provisions and write-offs which could adversely affect our business and financial results.

We plan to increase our supplies of plasma for use in the manufacturing processes through increased purchases of

plasma from third-party suppliers as well as collections from our existing ADMA BioCenters plasma collection facilities.

This strategy is dependent upon our ability to maintain a cGMP compliant environment at our plasma collection facilities and to

expand production and attract donors to our facilities.

There is no assurance that the FDA will inspect and license any of our current or future unlicensed plasma collection facilities in a timely manner consistent with our production plans.

misjudge the readiness of a center for an FDA inspection, we may lose credibility with the FDA and cause the FDA to more closely examine all of our operations.

Such additional scrutiny could materially hamper our operations and our ability to

increase plasma collections.

Our ability to expand production and increase our plasma collection facilities to more efficient production levels may be affected by changes in the economic environment and population in selected regions where ADMA

BioCenters operates its current or future plasma facilities, by the entry of competitive plasma centers into regions where ADMA BioCenters operates such centers, by misjudging the demographic potential of individual regions where ADMA BioCenters

expects to expand production and attract new donors, by unexpected facility related challenges, or by unexpected management challenges at selected plasma facilities held by us from time to time.

Additionally, if

non-compliance in the plasma collection process is identified after the impacted plasma has been pooled with compliant plasma from other sources, entire plasma pools, in-process intermediate materials and final products could be impacted.

Consequently, we could experience significant inventory impairment provisions and write-offs which could adversely affect our business and financial results.

We plan to increase our supplies of plasma for use in the manufacturing processes

through increased purchases of plasma from third-party suppliers as well as collections from our existing ADMA BioCenters plasma collection facilities.

This strategy is dependent upon our ability to maintain a cGMP compliant environment at our

plasma collection facilities and to expand production and attract donors to our facilities.

There is no assurance that the FDA will inspect and license any of our current or future unlicensed plasma collection facilities in a timely manner

consistent with our production plans.

If we misjudge the readiness of a center for an FDA inspection, we may lose credibility with the FDA and cause the FDA to more closely examine all of our operations.

Such additional scrutiny could materially

hamper our operations and our ability to increase plasma collections.

Our ability to expand production and increase our plasma collection facilities to more efficient production levels may be affected by changes in the economic environment and

population in selected regions where ADMA BioCenters operates its current or future plasma facilities, by the entry of competitive plasma centers into regions where ADMA BioCenters operates such centers, by misjudging the demographic potential of

individual regions where ADMA BioCenters expects to expand production and attract new donors, by unexpected facility related challenges, or by unexpected management challenges at selected plasma facilities held by us from time to time.

Our ability to commercialize our products, alone or with collaborators, will depend in part upon the extent to which reimbursement will be available from governmental agencies, health

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reimbursement status of newly approved healthcare products, as well as to the timing, language, specifications and other details pertaining to the approval of such products.

Healthcare payers, including Medicare, are challenging the prices charged

for medical products and services.

Healthcare payers, including Medicare, are challenging the prices

charged for medical products and services.

Government and other healthcare payers increasingly attempt to contain healthcare costs by limiting both coverage and the level of reimbursement for products.

Even if one of our product candidates is approved by

the FDA, insurance coverage may not be available, and reimbursement levels may be inadequate, to cover such product.

If government and other healthcare payers do not provide adequate coverage and reimbursement levels for one of our products, once

approved, market acceptance of such product could be reduced.

Prices in many countries, including many in Europe, are subject to local regulation and certain pharmaceutical products, such as plasma-derived products, are subject to price controls in

several of the world’s principal markets, including many countries within the European Union.

In the U.S., where pricing levels for our products are substantially established by third-party payers, including Medicare, if payers reduce the amount of

reimbursement for a product, it may cause groups or individuals dispensing the product to discontinue administration of the product, to administer lower doses, to substitute lower cost products or to seek additional price-related concessions.

actions could have a negative effect on our financial results, particularly in cases where our products command a premium price in the marketplace, or where changes in reimbursement induce a shift in the site of treatment.

The existence of direct

and indirect price controls and pressures over our products could materially adversely affect our financial prospects and performance.

Even if one of our product candidates is

approved by the FDA, insurance coverage may not be available, and reimbursement levels may be inadequate, to cover such product.

If government and other healthcare payers do not provide adequate coverage and reimbursement levels for one of our

products, once approved, market acceptance of such product could be reduced.

Prices in many countries, including many in Europe, are subject to local regulation and certain pharmaceutical products, such as plasma-derived products, are subject to

price controls in several of the world’s principal markets, including many countries within the European Union.

In the U.S., where pricing levels for our products are substantially established by third-party payers, including Medicare, if payers

reduce the amount of reimbursement for a product, it may cause groups or individuals dispensing the product to discontinue administration of the product, to administer lower doses, to substitute lower cost products or to seek additional

price-related concessions.

These actions could have a negative effect on our financial results, particularly in cases where our products command a premium price in the marketplace, or where changes in reimbursement induce a shift in the site of

The existence of direct and indirect price controls and pressures over our products could materially adversely affect our financial prospects and performance.

The new biosimilar pathway established as part of healthcare reform may make it easier for competitors to market biosimilar products.

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A biological product may be demonstrated to

be “biosimilar” if data shows that, among other things, the product is “highly similar” to an already-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from

the reference product.

The law provides that a biosimilar application may be submitted as soon as four years after the reference product is first licensed, and that the FDA may not make approval of an application effective until 12 years after the

reference product was first licensed.

from the reference product.

after the reference product was first licensed.

Since the enactment of the law, the FDA has issued several guidance documents to assist sponsors of biosimilar products in preparing their approval applications.

Moreover, in an effort to increase competition

in the biologic product marketplace, Congress, the executive branch, and the FDA have taken certain legislative and regulatory steps.

Moreover, in an effort to increase

competition in the biologic product marketplace, Congress, the executive branch, and the FDA have taken certain legislative and regulatory steps.

For example, in 2020 the FDA finalized a guidance to facilitate biologic product importation.

The 2020 Further

Consolidated Appropriations Act included provisions requiring that sponsors of approved biologic products provide samples of the approved products to persons developing biosimilar products within specified timeframes, in sufficient quantities, and

on commercially reasonable market-based terms The FDA approved the first biosimilar product in 2015 and has since approved a number of biosimilars.

As a result of the biosimilar pathway in the U.S., we expect in the future to face greater

competition from biosimilar products, including a possible increase in patent challenges.

2020 Further Consolidated Appropriations Act included provisions requiring that sponsors of approved biologic products provide samples of the approved products to persons developing biosimilar products within specified timeframes, in sufficient

quantities, and on commercially reasonable market-based terms The FDA approved the first biosimilar product in 2015 and has since approved a number of biosimilars.

As a result of the biosimilar pathway in the U.S., we expect in the future to

face greater competition from biosimilar products, including a possible increase in patent challenges.

The implementation of the Healthcare Reform Law in the U.S.

may adversely affect our business.

Through the March 2010 adoption of the Healthcare Reform Law in the U.S., substantial changes are being made to the current system for paying for healthcare in the U.S., including programs to extend medical benefits to

millions of individuals who currently lack insurance coverage.

This reform establishes significant cost-saving measures with respect to several government healthcare programs, including Medicaid and Medicare Parts B and D, that may cover the cost

of our future products, and these efforts could have a material adverse impact on our future financial prospects and performance.

to millions of individuals who currently lack insurance coverage.

This reform establishes significant cost-saving measures with respect to several government healthcare programs, including Medicaid and Medicare Parts B and D, that may cover the

cost of our future products, and these efforts could have a material adverse impact on our future financial prospects and performance.

For example, in order for a manufacturer’s products to be reimbursed by federal funding under Medicaid, the

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rebates paid by manufacturers for single source and innovator multiple source (brand name) drug products from a minimum of 15.1% to a minimum of 23.1% of AMP, subject to certain exceptions.

For non-innovator multiple source (generic) products, the

rebate percentage was increased from a minimum of 11.0% to a minimum of 13.0% of AMP.

For non-innovator multiple source (generic) products,

the rebate percentage was increased from a minimum of 11.0% to a minimum of 13.0% of AMP.

In 2010, the Healthcare Reform Law also newly extended this rebate obligation to prescription drugs covered by Medicaid managed care organizations.

increases in required rebates may adversely affect our future financial prospects and performance.

In order for a pharmaceutical product to receive federal reimbursement under the Medicare Part B and Medicaid programs or to be sold directly to U.S.

In order for a pharmaceutical product to receive federal reimbursement under the Medicare Part B and Medicaid programs or to be sold directly to

government agencies, the manufacturer must extend discounts to entities eligible to participate in the 340B drug pricing program.

The required 340B discount on a given product is calculated based on the AMP and Medicaid rebate amounts reported by

the manufacturer.

The required 340B discount on a given product is calculated based on the AMP and Medicaid rebate amounts

reported by the manufacturer.

As the 340B drug pricing is determined based on AMP and Medicaid rebate data, the revisions to the Medicaid rebate formula and AMP definition described above could cause the required 340B discount to increase.

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The Healthcare Reform Law also created new rebate obligations for our products under Medicare Part D, a partial, voluntary prescription drug benefit created by the U.S.

federal government primarily for persons 65 years

old and over.

federal government primarily for persons 65

years old and over.

The Part D drug program is administered through private insurers that contract with CMS.

Beginning in 2011, the Healthcare Reform Law generally requires that in order for a drug manufacturer’s products to be reimbursed under Medicare

Part D, the manufacturer must enter into a Medicare Coverage Gap Discount Program agreement with the Secretary of HHS, and reimburse each Medicare Part D plan sponsor an amount now equal to 70% savings for the manufacturer’s brand name drugs and

biologics which the Part D plan sponsor has provided to its Medicare Part D beneficiaries who are in the “donut hole” (or a gap in Medicare Part D coverage for beneficiaries who have expended certain amounts for drugs).

The Part D plan sponsor is

responsible for calculating and providing the discount directly to its beneficiaries and for reporting these amounts paid to CMS’s contractor, which notifies drug manufacturers of the rebate amounts it must pay to each Part D plan sponsor.

rebate requirement could adversely affect our future financial performance, particularly if contracts with Part D plans cannot be favorably renegotiated or the Part D plan sponsors fail to accurately calculate payments due in a manner that

overstates our rebate obligation.

Regarding access to our products, the Healthcare Reform Law established and provided significant funding for a Patient-Centered Outcomes Research Institute to coordinate and fund Comparative Effectiveness Research

While the stated intent of CER is to develop information to guide providers to the most efficacious therapies, outcomes of CER could influence the reimbursement or coverage for therapies that are determined to be less cost-effective than

Should any of our products be determined to be less cost effective than alternative therapies, the levels of reimbursement for these products, or the willingness to reimburse at all, could be impacted, which could materially impact our

future financial prospects and results.

There have been repeated attempts by Congress to repeal or change the Healthcare Reform Law and there are ongoing legal challenges, including at the Supreme Court, which may contribute to the uncertainty of the ongoing

implementation and impact of the law and also underscores the potential for additional reform going forward.

We cannot assure that the law, as currently enacted or as amended in the future, will not adversely affect our business and financial

results and we cannot predict how future federal or state legislative or administrative changes relating to healthcare reform will affect our business.

Certain provisions of enacted or proposed legislative changes may negatively impact coverage

and reimbursement of, or rebates paid by manufacturers for, healthcare items and services.

Beginning in 2011, the Healthcare Reform Law generally requires that in order for a drug manufacturer’s products to be reimbursed under

Medicare Part D, the manufacturer must enter into a Medicare Coverage Gap Discount Program agreement with the Secretary of HHS, and reimburse each Medicare Part D plan sponsor an amount now equal to 70% savings for the manufacturer’s brand name

drugs and biologics which the Part D plan sponsor has provided to its Medicare Part D beneficiaries who are in the “donut hole” (or a gap in Medicare Part D coverage for beneficiaries who have expended certain amounts for drugs).

The Part D plan

sponsor is responsible for calculating and providing the discount directly to its beneficiaries and for reporting these amounts paid to CMS’s contractor, which notifies drug manufacturers of the rebate amounts it must pay to each Part D plan

The rebate requirement could adversely affect our future financial performance, particularly if contracts with Part D plans cannot be favorably renegotiated or the Part D plan sponsors fail to accurately calculate payments due in a

manner that overstates our rebate obligation.

Regarding access to our products, the Healthcare Reform Law established and provided significant funding for a Patient-Centered Outcomes Research Institute to coordinate and fund Comparative

Effectiveness Research (“CER”).

less cost-effective than others.

materially impact our future financial prospects and results.

ongoing implementation and impact of the law and also underscores the potential for additional reform going forward.

We cannot assure that the law, as currently enacted or as amended in the future, will not adversely affect our business and

financial results and we cannot predict how future federal or state legislative or administrative changes relating to healthcare reform will affect our business.

Certain provisions of enacted or proposed legislative changes may negatively impact

coverage and reimbursement of, or rebates paid by manufacturers for, healthcare items and services.

We will continue to evaluate the effect that the Healthcare Reform Law and any potential changes may have on our business.

Corporate responsibility, specifically related to environmental, social and governance (“ESG”) matters, may impose additional costs and expose us to new risks.

Public ESG and sustainability reporting is becoming more broadly expected by investors, stockholders and other third parties.

Certain organizations that provide corporate governance

and other corporate risk information to investors and stockholders have developed, and others may in the future develop, scores and ratings to evaluate companies and investment funds based upon ESG or “sustainability” metrics.

Many investment

funds focus on positive ESG business practices and sustainability scores when making investments and may consider a company’s ESG or sustainability scores as a reputational or other factor in making an investment decision.

In addition, investors,

particularly institutional investors, use these scores to benchmark companies against their peers and if a company is perceived as lagging, these investors may engage with such company to improve ESG disclosure or performance and may also make

voting decisions, or take other actions, to hold these companies and their boards of directors accountable.

Board diversity is an ESG topic that is, in particular, receiving heightened attention by investors, stockholders, lawmakers and listing

Public ESG and sustainability reporting is becoming more broadly expected by investors, stockholders and other third

Certain organizations that provide corporate governance and other corporate risk information to investors and stockholders have developed, and others may in the future develop, scores and ratings to evaluate companies and investment

funds based upon ESG or “sustainability” metrics.

Many investment funds focus on positive ESG business practices and sustainability scores when making investments and may consider a company’s ESG or sustainability scores as a reputational or

other factor in making an investment decision.

In addition, investors, particularly institutional investors, use these scores to benchmark companies against their peers and if a company is perceived as lagging, these investors may engage with

such company to improve ESG disclosure or performance and may also make voting decisions, or take other actions, to hold these companies and their boards of directors accountable.

Board diversity is an ESG topic that is, in particular,

receiving heightened attention by investors, stockholders, lawmakers and listing exchanges.

Certain states have passed laws requiring companies to meet certain gender and ethnic diversity requirements on their boards of directors.

We may face reputational damage in the event our corporate responsibility initiatives or

objectives, including with respect to board diversity, do not meet the standards set by our investors, stockholders, lawmakers, listing exchanges or other constituencies, or if we are unable to achieve an acceptable ESG or sustainability rating

from third-party rating services.

A low ESG or sustainability rating by a third-party rating service could also result in the exclusion of our common stock from

consideration by certain investors who may elect to invest with our competition instead.

reputational damage in the event our corporate responsibility initiatives or objectives, including with respect to board diversity, do not meet the standards set by our investors, stockholders, lawmakers, listing exchanges or other

constituencies, or if we are unable to achieve an acceptable ESG or sustainability rating from third-party rating services.

A low ESG or sustainability rating by a third-party rating service could also result in the exclusion of our common stock from consideration by certain investors who may elect to invest with our competition

Ongoing focus on corporate responsibility matters by investors and other parties as described above may impose additional costs or expose us to new risks.

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Our operations have consumed substantial amounts of cash since inception.

For the six months ended June 30, 2021 and 2020, we had negative cash flows from operations of $65.5 million and $45.9 million, respectively,

and for the years ended December 31, 2020 and 2019, we had negative cash flows from operations of approximately $102.0 million and $76.2 million, respectively.

We expect to continue to spend substantial amounts on procurement of raw material plasma

and other raw materials necessary to scale up our manufacturing operations, commercial product launches, capacity expansion at the Boca Facility, building additional plasma collection facilities, product development, quality assurance, regulatory

affairs and conducting clinical trials for our product candidates and purchasing clinical trial materials, some of which may be required by the FDA.

In addition, our end-to-end production cycle from procurement of raw materials to commercial

release of finished product can take between seven and 12 months or potentially longer, requiring substantial investments in raw material plasma and other manufacturing materials.

We expect that we will not be able to generate a sufficient amount

of product revenue to achieve profitability until the beginning of 2024 and, as a result, we expect that we will need to continue to finance our operations through additional equity or debt financings or corporate collaboration and licensing

In order to have sufficient cash to fund our operations thereafter, we will need to raise additional equity or debt financing before the end of the fourth quarter of 2021.

This time frame may change based upon how quickly we are able to

execute on our operational initiatives and the various financing options that may be available to us in 2021.

However, if the assumptions underlying our estimated expenses prove to be incorrect, we may have to raise additional capital sooner than

we currently expect.

Until such time, if ever, as we can generate a sufficient amount of product revenue to achieve profitability, we expect to continue to finance our operations through additional equity or debt financings or corporate

collaboration and licensing arrangements.

If we are unable to raise additional capital as needed, including due to widespread liquidity constraints or significant market instability that could result from the COVID-19 pandemic, we will have to

delay, curtail or eliminate our commercialization efforts or our product development activities.

For the nine months ended September 30, 2021 and 2020, we had negative cash flows from operations of $78.9 million and $69.8 million,

respectively, and for the years ended December 31, 2020 and 2019, we had negative cash flows from operations of approximately $102.0 million and $76.2 million, respectively.

We expect to continue to spend substantial amounts on procurement of raw

material plasma and other raw materials necessary to scale up our manufacturing operations, commercial product launches, capacity expansion at the Boca Facility, building additional plasma collection facilities, product development, quality

assurance, regulatory affairs and conducting clinical trials for our product candidates and purchasing clinical trial materials, some of which may be required by the FDA.

In addition, our end-to-end production cycle from procurement of raw

materials to commercial release of finished product can take between seven and 12 months or potentially longer, requiring substantial investments in raw material plasma and other manufacturing materials.

We expect that we will not be able to

generate a sufficient amount of product revenue to achieve profitability until the beginning of 2024 and, as a result, we expect that we will need to continue to finance our operations through additional equity or debt financings or corporate

collaboration and licensing agreements.

offering, will be sufficient to fund our operations, as currently conducted, through the first half of 2022.

In order to have sufficient cash to fund our operations thereafter, we will need to raise additional equity or debt financing during the

second half of 2022, which includes our plans to refinance and expand upon, our existing debt facility.

This time frame may change based upon how quickly we are able to execute on our operational initiatives and the various financing options that

may be available to us.

However, if the assumptions underlying our estimated expenses prove to be incorrect, we may have to raise additional capital sooner than we currently expect.

Until such time, if ever, as we can generate a sufficient amount

of product revenue to achieve profitability, we expect to continue to finance our operations through additional equity or debt financings or corporate collaboration and licensing arrangements.

If we are unable to raise additional capital as

needed, including due to widespread liquidity constraints or significant market instability that could result from the COVID-19 pandemic, we will have to delay, curtail or eliminate our commercialization efforts or our product development

We may not have cash available to us in amounts sufficient to enable us to make interest or principal payments on our indebtedness when due.

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Facility has a maturity date of March 1, 2024, subject to acceleration pursuant to the Perceptive Credit Agreement, including upon an Event of Default.

All of our obligations under the Perceptive Credit Facility are secured by a first-priority lien

and security interest in substantially all of our and our subsidiaries’ tangible and intangible assets, including intellectual property, and all of the equity interests in our subsidiaries.

All of our obligations under the Perceptive Credit Facility are secured by a first-priority

lien and security interest in substantially all of our and our subsidiaries’ tangible and intangible assets, including intellectual property, and all of the equity interests in our subsidiaries.

Our current cash, cash equivalents and accounts receivable will not be sufficient to repay all of our current outstanding debt obligations as they mature.

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To the extent that we raise additional capital by issuing equity securities, the share ownership of existing stockholders will be diluted.

Any future debt financing may involve covenants that, among other restrictions,

limit our ability to incur liens or additional debt, pay dividends, redeem or repurchase our common stock, make certain investments or engage in certain merger, consolidation or asset sale transactions.

In addition, if we raise additional funds

through licensing arrangements or the disposition of any of our assets, it may be necessary to relinquish potentially valuable rights to our product candidates or grant licenses on terms that are not favorable to us.

Any future debt financing may involve covenants that, among other

restrictions, limit our ability to incur liens or additional debt, pay dividends, redeem or repurchase our common stock, make certain investments or engage in certain merger, consolidation or asset sale transactions.

In addition, if we raise

additional funds through licensing arrangements or the disposition of any of our assets, it may be necessary to relinquish potentially valuable rights to our product candidates or grant licenses on terms that are not favorable to us.

Our cash and cash equivalents could be adversely affected if the financial institutions in which we hold our cash and cash equivalents fail.

We regularly maintain cash balances at third-party financial institutions in excess of the Federal Deposit Insurance Corporation insurance limit.

While we monitor the cash balances in our operating accounts on a daily

basis and adjust the balances as appropriate, these balances could be impacted, and there could be a material adverse effect on our business, if one or more of the financial institutions with which we deposit cash fails or is subject to other

adverse conditions in the financial or credit markets.

While we monitor the cash balances in our operating accounts on a

daily basis and adjust the balances as appropriate, these balances could be impacted, and there could be a material adverse effect on our business, if one or more of the financial institutions with which we deposit cash fails or is subject to

other adverse conditions in the financial or credit markets.

To date, we have experienced no loss or lack of access to our invested cash or cash equivalents;

however, we can provide no assurance that access to our invested cash and cash equivalents will

not be impacted by adverse conditions in the financial and credit markets.

however, we can provide no assurance that access to our invested cash and cash

equivalents will not be impacted by adverse conditions in the financial and credit markets.

If we fail to maintain proper and effective internal control over financial reporting in the future, our ability to produce accurate and timely financial statements could be impaired, which could

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As of December 31, 2020, we had federal and state NOLs of $239.8 million and $172.6 million, respectively.

Federal and State NOLs of approximately $115.8 million

and $90.0 million, respectively, will begin to expire at various dates beginning in 2027, if not limited by triggering events prior to such time.

Under the provisions of the Internal Revenue Code of 1986, as amended (the “Code”), changes in our

ownership, in certain circumstances, will limit the amount of federal NOLs that can be utilized annually in the future to offset taxable income.

In particular, Section 382 of the Code imposes limitations on a company’s ability to use NOLs upon

certain changes in such ownership.

Federal and State NOLs of approximately $115.8

million and $90.0 million, respectively, will begin to expire at various dates beginning in 2027, if not limited by triggering events prior to such time.

Under the provisions of the Internal Revenue Code of 1986, as amended (the “Code”), changes

in our ownership, in certain circumstances, will limit the amount of federal NOLs that can be utilized annually in the future to offset taxable income.

In particular, Section 382 of the Code imposes limitations on a company’s ability to use NOLs

upon certain changes in such ownership.

If we are limited in our ability to use our NOLs in future years in which we have taxable income, we will pay more taxes than if we were able to fully utilize our NOLs.

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2017 resulted in a change in ownership of ADMA under Section 382 and, as a result, we were required to write off $57.6 million of federal NOLs.

We may experience ownership changes in the future as a result of subsequent changes in our stock ownership

that we cannot predict or control that could result in further limitations being placed on our ability to utilize our federal NOLs.

We may experience ownership changes in the future as a result of subsequent changes in our stock

ownership that we cannot predict or control that could result in further limitations being placed on our ability to utilize our federal NOLs.

Risks Associated with our Common Stock

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Sales of a substantial number of shares of our common stock, or the perception that such sales may occur, may adversely affect the market price of our common stock.

As of August 6, 2021, most of our 132,769,471 outstanding shares of common stock, as well as a substantial number of shares of our common stock underlying outstanding warrants, were available for sale in the public

As of November 5, 2021, most of our 195,813,817 outstanding shares of common stock, as well as a substantial number of shares of our common stock underlying outstanding warrants, were available for sale in the public

market, subject to certain restrictions with respect to sales of our common stock by our affiliates, either pursuant to Rule 144 under the Securities Act, or under effective registration statements.

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Amended and Restated Bylaws (the “Bylaws”) and Delaware law might discourage, delay or prevent a change in control of our Company or changes in our management and, therefore, depress the trading price of our common stock.

As of June 30, 2021, Perceptive, our directors and executive officers and their affiliates beneficially owned approximately 18% of the outstanding shares of our common stock.

As of September 30, 2021, Perceptive, our directors and executive officers and their affiliates beneficially owned approximately 15% of the outstanding shares of our common stock.

Provisions of our Certificate of

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authorization of the issuance of “blank check” preferred stock, with such designation rights and preferences as may be determined from time to time by the Board, without any need for action by stockholders.

In addition, Section 203 of the Delaware General Corporation Law prohibits a publicly-held Delaware corporation from engaging in a business combination with an interested stockholder, generally a person which together

with its affiliates owns, or within the last three years, has owned 15% of our voting stock, for a period of three years after the date of the transaction in which the person became an interested stockholder, unless the business combination is

approved in a prescribed manner.

together with its affiliates owns, or within the last three years, has owned 15% of our voting stock, for a period of three years after the date of the transaction in which the person became an interested stockholder, unless the business

combination is approved in a prescribed manner.

The existence of the foregoing provisions and anti-takeover measures could limit the price that investors might be willing to pay in the future for shares of our common stock.

They could also deter potential

acquirers of our company, thereby reducing the likelihood that you could receive a premium for your common stock in an acquisition.

In addition, as a result of the concentration of ownership of our shares of common stock, our stockholders may, from

time to time, observe instances where there may be less liquidity in the public markets for our securities.

They could also deter

potential acquirers of our company, thereby reducing the likelihood that you could receive a premium for your common stock in an acquisition.

In addition, as a result of the concentration of ownership of our shares of common stock, our

stockholders may, from time to time, observe instances where there may be less liquidity in the public markets for our securities.

Our Board also recently adopted a short-term stockholder rights agreement with an expiration date of December 15, 2021 and an ownership trigger threshold of 10%.

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We have never paid cash dividends on any of our capital stock and we currently intend to retain future earnings, if any, to fund the development and growth of our business.

In addition, the terms of existing and future

debt agreements may preclude us from paying dividends.

In addition, the terms of existing and

future debt agreements may preclude us from paying dividends.

For example, the Perceptive Credit Agreement prohibits us from paying dividends.

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stockholders’ equity, our stock may be delisted.

This could potentially impair the liquidity of our securities not only in the number of shares that could be bought and sold at a given price, which may be depressed by the relative illiquidity, but

also through delays in the timing of transactions and the potential reduction in media coverage.

This could potentially impair the liquidity of our securities not only in the number of shares that could be bought and sold at a given price, which may be depressed by the relative illiquidity,

but also through delays in the timing of transactions and the potential reduction in media coverage.

As a result, an investor might find it more difficult to dispose of our common stock.

We believe that current and prospective investors would view an

investment in our common stock more favorably if it continues to be listed on Nasdaq.

Any failure at any time to meet the Nasdaq continued listing requirements could have an adverse impact on the value and trading activity of our common stock.

We believe that current and prospective investors would

view an investment in our common stock more favorably if it continues to be listed on Nasdaq.

Any failure at any time to meet the Nasdaq continued listing requirements could have an adverse impact on the value and trading activity of our common

Although we currently satisfy the listing criteria for Nasdaq, if our stock price declines dramatically, we could be at risk of failing to meet the Nasdaq continued listing criteria.

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investment objectives forming the basis for the broker-dealer’s suitability determination are accurately stated in such written agreement.

Unless an exception is available, the regulations require the delivery, prior to any transaction involving a

penny stock, of a disclosure schedule explaining the penny stock market and the associated risks.

Unless an exception is available, the regulations require the delivery, prior to any transaction involving

a penny stock, of a disclosure schedule explaining the penny stock market and the associated risks.

The additional burdens imposed upon broker-dealers by these requirements could discourage broker-dealers from effecting transactions in our common

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Currently, our Certificate of Incorporation authorizes the issuance of up to 300,000,000 shares of common stock.

As of June 30, 2021, there were 151,054,617 shares remaining available for issuance, after giving effect to 12,997,322 shares of our

common stock that were subject to outstanding stock options, Restricted Stock Units and warrants as of June 30, 2021 that may be issued by us without stockholder approval, as well as an additional 4,076,035 shares reserved for the future issuance

of awards under our equity compensation plans.

As of September 30, 2021, there were 144,641,489 shares remaining available for issuance, after giving effect to 16,828,915 shares of

our common stock that were subject to outstanding stock options, RSUs and warrants as of September 30, 2021 that may be issued by us without stockholder approval, as well as an additional 215,779 shares reserved for the future issuance of awards

under our equity compensation plans.

Unregistered Sales of Equity Securities and Use of Proceeds.

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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-Q

Item 1A. Risk Factors