What changed in this filing

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Item 1. Business

2023-03-23 compared with 2022-03-24 · 357 added, 1551 removed, 866 unchanged (69% of the section changed)

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commercial sales in August 2019;

(ii) ASCENIV (Immune Globulin Intravenous, Human – slra 10% Liquid), an IVIG product indicated for the treatment of PI, for which we received FDA approval on April 1, 2019 and commenced first commercial sales in

October 2019;

(ii) ASCENIV (Immune Globulin Intravenous, Human – slra 10% Liquid), an IVIG product indicated for the treatment of PI in adults and adolescents, for which we received FDA approval on April 1, 2019 and commenced

first commercial sales in October 2019;

and (iii) Nabi-HB (Hepatitis B Immune Globulin, Human), which is indicated for the treatment of acute exposure to blood containing HBsAg and other listed exposures to Hepatitis B.

We seek to develop a pipeline of plasma-derived

therapeutics, including a product based on our most recently approved patent application under U.S.

We seek to develop a

pipeline of plasma-derived therapeutics, including a product based on our most recently approved patent application under U.S.

10,259,865 related to methods of treatment and prevention of S.

pneumonia infection for an

immunoglobulin manufactured to contain standardized antibodies to numerous serotypes of S.

Our products and product candidates are intended to be used by physician specialists focused on

caring for immune-compromised patients with or at risk for certain infectious diseases.

infection for an immunoglobulin manufactured to contain standardized antibodies to numerous serotypes of S.

Our products and product candidates are intended to be used by physician specialists

focused on caring for immune-compromised patients with or at risk for certain infectious diseases.

We manufacture these products at our FDA-licensed, plasma fractionation and purification facility located in Boca Raton, Florida with a peak annual processing capability of up to 600,000 liters (the “Boca Facility”).

Based on current production yields, our ongoing supply chain enhancements and capacity expansion initiatives, we believe this facility has the potential to produce sufficient quantities of our immune globulin (“IG”) products representing more

than $250 million in annual revenue beginning in 2024 and potentially in excess of $300 million of annual revenue thereafter, as well as achieving profitability during the first quarter of 2024, as we ramp-up production over the next two to four

Through our ADMA BioCenters subsidiary, we currently operate FDA-licensed source plasma collection facilities in the U.S.

This business unit, which we refer to as our Plasma Collection Centers business segment,

provides us with a portion of our blood plasma for the manufacture of our products and product candidates, and also allows us to sell certain quantities of source plasma to customers for further manufacturing.

As a part of our planned supply

chain robustness initiative, we have opened five new plasma collection centers during the past 18 months, and we now have ten plasma collection centers in various stages of approval and development, including six that are operational and

collecting plasma.

With respect to our operational plasma collection centers, five plasma collection centers currently hold FDA licenses.

In addition, one of our FDA-approved plasma collection centers also has approvals from the Korean Ministry

of Food and Drug Safety (“MFDS”), as well as FDA approval to operate a Hepatitis B immunization program.

After giving effect to the progress we made in 2020 and 2021 with our plasma collection network expansion, we believe we remain on track to

achieve our goal of having 10 plasma collection centers licensed by the FDA by the end of 2023.

A typical plasma collection center, such as those operated by ADMA BioCenters, can collect approximately 30,000 to 50,000 liters of source plasma

annually, which may be sold for different prices depending upon the type of plasma, quantity of purchase and market conditions at the time of sale.

Plasma collected from ADMA BioCenters’ facilities that is not used to manufacture our products or

product candidates is sold to third-party customers in the U.S.

revenues of $210 million or more in 2023, more than $250 million in annual revenue in 2024 and potentially in excess of $300 million of annual revenue thereafter, as well as achieving profitability during the first quarter of 2024.

revenue levels, ADMA forecasts achieving consolidated gross margins in the range of 40-50% and net income margins in the range of 20-30%.

These assumptions translate to potential annual gross profit and net income in the range of $100-150 million

and $50-100 million, respectively, during the 2024-2025 time period and beyond.

Through our ADMA BioCenters subsidiary, we currently operate ten source plasma collection facilities in the U.S.

This business unit, which we refer to as our Plasma Collection Centers business segment, provides us

with a portion of our blood plasma for the manufacture of our products, and also allows us to sell certain quantities of source and hyperimmune plasma to third-party customers for further manufacturing.

With respect to our operational plasma

collection centers, eight plasma collection centers currently hold FDA licenses, with the remaining plasma collection centers anticipated to receive FDA approvals throughout 2023.

In addition, three of our FDA-approved plasma collection centers

also have approvals from the Korean Ministry of Food and Drug Safety (“MFDS”), as well as FDA approval to operate a Hepatitis B immunization program.

After giving effect to the supply chain robustness initiatives undertaken in 2021 and 2022 as it

pertains to our plasma collection network expansion, we remain on track to achieve our goal of having 10 FDA-licensed plasma collection centers by the end of 2023.

A typical plasma collection center, such as those operated by ADMA BioCenters, can

collect approximately 30,000 to 50,000 liters of source plasma annually, which may be sold for different prices depending upon the type of plasma, quantity of purchase and market conditions at the time of sale.

Plasma collected from ADMA

BioCenters’ facilities that is not used to manufacture our products is sold to third-party customers in the U.S.

and in other locations outside the U.S.

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In addition, from time to time we provide contract

manufacturing and testing services for certain third-party clients.

We also provide laboratory contracting services to certain customers and anticipate providing contract filling, labeling and packing services in light of the recent FDA approval

of our in-house fill-finish capabilities.

manufacturing services for certain third-party clients.

We also provide laboratory contracting services to certain customers and anticipate providing contract filling, labeling and packing services utilizing our FDA-approved in-house fill-finish

capabilities.

BIVIGAM is a plasma-derived IVIG that contains a broad range of antibodies similar to those found in normal human plasma.

These antibodies are directed against bacteria and viruses,

and help to protect PI patients against serious infections.

These antibodies are directed against bacteria and viruses, and

help to protect PI patients against serious infections.

BIVIGAM is a purified, sterile, ready-to-use preparation of concentrated human Immunoglobulin G antibodies indicated for the treatment of PI, a group of genetic disorders.

includes, but is not limited to, the humoral immune defect in common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome and severe combined immunodeficiency.

These PIs are a group of

genetic disorders.

This includes,

but is not limited to, the humoral immune defect in common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome and severe combined immunodeficiency.

These PIs are a group of genetic

Based on recent estimates, these disorders are no longer considered to be very rare, with as many as one in every 1,200 people in the United States having some form of PI.

On May 9, 2019, the FDA approved the Prior Approval Supplement (the “PAS”) for the use of our IVIG manufacturing process, thereby enabling us to re-launch and commercialize this product in the

United States.

On May 9, 2019, the FDA approved the Prior Approval Supplement (the “PAS”) for the use of our IVIG manufacturing process (known as fractionation), thereby enabling us to re-launch and commercialize

this product in the U.S.

We resumed production of BIVIGAM during the fourth quarter of 2017 and commercial production is ongoing, using our FDA-approved IVIG manufacturing process under U.S.

Department of Health and Human Services (“HHS”) License No.

Department of Health and Human Services (“HHS”) License

The commercial re-launch and first commercial sales for this product commenced in August of 2019.

On April 28, 2021, we announced that the FDA granted approval for our expanded plasma pool production scale process, allowing for a 4,400-liter plasma pool for the manufacture of our BIVIGAM IVIG product.

increased IVIG plasma pool scale, which allows us to produce BIVIGAM at an expanded capacity utilizing the same equipment, release testing assays and labor force, has begun to have a favorable impact on our gross margins and operating results,

beginning in the third quarter of 2021.

increased IVIG plasma pool scale, which allows us to produce BIVIGAM at an expanded capacity utilizing the same equipment, release testing assays and labor force, has had a favorable impact on our gross margins, manufacturing efficiencies and

operating results since the beginning of the third quarter of 2021.

ASCENIV is a plasma-derived IVIG that contains naturally occurring polyclonal antibodies, which are proteins that are used by the body’s immune system to neutralize microbes, such as bacteria and

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than 10% of the total donor collection samples we test.

ASCENIV is approved for the treatment of Primary Immune Deficiency Disorder (“PIDD”), a class of inherited genetic disorders that causes a deficient or absent immune system in adults and

adolescents (12 to 17 years of age).

Our pivotal Phase 3 clinical trial in 59 PIDD patients met the primary endpoint of no Serious Bacterial Infections reported during 12 months of treatment.

Secondary efficacy endpoints further demonstrated the

benefits of ASCENIV in the low incidence of infection, therapeutic antibiotic use, days missed from work/school/daycare and unscheduled medical visits and hospitalizations.

We believe this clinical data together with the FDA approval for the

treatment of PIDD better positions ADMA to further evaluate ASCENIV in immune-compromised patients infected with or at-risk for RSV infection or potentially other respiratory viral pathogens.

Due to the COVID-19 pandemic, our plans have been

In the future however, we may elect to work with the FDA and the immunology and infectious disease community to potentially design an appropriate clinical trial to evaluate the use of ASCENIV in this patient population.

Commercial sales

of ASCENIV commenced in October of 2019 and the product is currently available to U.S.-based healthcare professionals for prescription and use in U.S.-based patients.

ASCENIV is approved for the treatment of PIDD or PI, a class of inherited genetic disorders that causes a deficient or absent immune system in adults and adolescents (12 to 17 years of age).

pivotal Phase 3 clinical trial in 59 PIDD patients met the primary endpoint of no Serious Bacterial Infections (“SBI”) reported during 12 months of treatment.

Secondary efficacy endpoints further demonstrated the benefits of ASCENIV in the low

incidence of infection, therapeutic antibiotic use, days missed from work/school/daycare and unscheduled medical visits and hospitalizations.

We believe this clinical data together with the FDA approval for the treatment of PIDD better positions

ADMA to further evaluate ASCENIV in immune-compromised patients infected with or at-risk for RSV infection or potentially other respiratory viral pathogens.

Due to the COVID-19 pandemic, our plans have been delayed.

In the future however, we may

elect to work with the FDA and the immunology and infectious disease community to potentially design an appropriate clinical trial to evaluate the use of ASCENIV in this patient population.

Commercial sales of ASCENIV commenced in October of 2019

and the product is currently available to U.S.-based healthcare professionals for prescription and use in U.S.-based patients.

Nabi-HB is a hyperimmune globulin that is rich in antibodies to the Hepatitis B virus.

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It is a major global health problem.

It can cause chronic infection and puts people at

high risk of death from cirrhosis and liver cancer.

It can cause chronic infection and places people

at high risk of death from cirrhosis and liver cancer.

Nabi-HB has a well-documented record of long-term safety and effectiveness since its initial market introduction.

The FDA approved Nabi-HB on March 24, 1999.

Production of Nabi-HB at the Boca

Facility has continued under our leadership since the third quarter of 2017.

Production of Nabi-HB at the

Boca Facility has continued under our leadership since the third quarter of 2017.

In early 2018, we received authorization from the FDA for the release of our first commercial batch of Nabi-HB for commercial distribution in the U.S.

and we continue to

manufacture Nabi-HB under HHS License No.

continue to manufacture Nabi-HB under HHS License No.

Evaluation of ASCENIV in PIDD Patients

PIDD or PI, a genetic disorder that causes a deficient or absent immune system, is caused by hereditary or genetic defects and can affect anyone regardless of age or gender.

PIDD patients are more vulnerable to

infections and more likely to suffer complications from these infections.

PIDD or PI, also known as Inborn Errors of Immunity, are genetic disorders that causes a deficient or absent immune system, is caused by hereditary or genetic defects and can affect anyone regardless of age or

PIDD patients are more vulnerable to infections and more likely to suffer complications from these infections.

IVIG is a plasma-derived product that is used to prevent serious infections in patients with PIDD.

It is comprised of polyclonal antibodies, which are proteins produced by

B-cells that are used by the body’s immune system to neutralize foreign objects such as bacteria and viruses.

It is estimated that there are about 250,000 diagnosed PIDD patients in the U.S., approximately half of whom are treated with IVIG

It is comprised of

polyclonal antibodies, which are proteins produced by B-cells that are used by the body’s immune system to neutralize foreign objects such as bacteria and viruses.

It is estimated that there are about 250,000 diagnosed PIDD patients in the U.S.,

approximately half of whom are treated with IVIG regularly.

As reported in industry journals, the U.S.

sales of immune and hyperimmune globulin products for all its uses were reported to be approximately $9.5 billion in 2020 and are expected to reach approximately $17 billion by 2027 based

upon an anticipated compounded annual growth rate of approximately 9%.

sales of immune and hyperimmune globulin products for all its uses were reported to be approximately $9.6 billion in 2021 and are expected to

exceed $17 billion by 2027 based upon an anticipated compounded annual growth rate of approximately 9%.

ASCENIV, formerly known as RI-002, contains polyclonal antibodies against various infectious agents, such as streptococcus pneumoniae, H.

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were enrolled in nine treatment centers in the U.S.

The pivotal Phase III primary endpoint followed published FDA industry guidance, which provides for a reduction in the incidence of serious infections to less than one per year in each subject

receiving IVIG.

The pivotal Phase III primary endpoint followed published FDA industry guidance, which provides for a reduction in the incidence of SBI to less than one per year in each subject receiving IVIG.

The secondary outcome was safety and included other pharmacokinetic (“PK”) data collection points including antibody titers for certain agents, including RSV antibody levels at various time points after infusion.

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events to 59 patients in nine treatment centers throughout the U.S.

These results, included in our Biologics License Application (“BLA”), exceed the requirement specified by FDA guidance of ≤ 1 SBI per patient-year.

These results, included in our Biologics License Application (“BLA”), exceed the requirement specified by FDA guidance of ≤ 1 serious infection per patient-year.

On February 22, 2015, at the 2015 American Academy of Allergy, Asthma & Immunology Annual Meeting, scientific investigators reported on the secondary outcomes that included:

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Both children were treated with ASCENIV under an

emergency United States Food and Drug Administration (“FDA”) Investigational New Drug protocol.

emergency FDA Investigational New Drug protocol.

We previously conducted a randomized, double-blind, placebo-controlled Phase II clinical trial to evaluate RI-001, RI-002’s predecessor product candidate, in immune-compromised, RSV-infected patients.

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Data from our Phase II clinical trial, compassionate use experience and data obtained from the evaluation of RI-002 in the infected cotton rat animal model has

been presented at various conferences the past several years.

been presented at various conferences over the past several years.

Based on these results, we may elect to evaluate ASCENIV for the treatment of RSV or other respiratory viral pathogens in immunocompromised patients or other appropriate patient populations.

Due to the COVID-19

pandemic, our plans to commence such evaluation have been delayed.

Plasma Collection Operations

ADMA BioCenters has a total of ten source plasma collection facilities in various stages of operations or development.

We are actively operating and collecting plasma at six source plasma collection facilities

located in the U.S., five of which have an FDA license (of which one facility has received approvals from MFDS and FDA approval to implement a Hepatitis B immunization program), while a BLA for one of our other facilities is pending FDA approval.

In addition to our six currently operational plasma collection facilities, we have four additional plasma collection facilities that are under various stages of construction and development.

Source plasma that is collected from our FDA-licensed

facilities provides us with a portion of our blood plasma for the manufacture of our products and product candidates.

After giving effect to the progress we made in 2020 and 2021 with our plasma collection network expansion, we believe we remain

on track to achieve our goal of having 10 plasma collection centers licensed by the FDA by the end of 2023.

A typical plasma collection center, such as those operated by ADMA BioCenters, can collect approximately 30,000 to 50,000 liters of source

plasma annually, which may be sold for different prices depending upon the type of plasma, quantity of purchase, and market conditions at the time of sale.

Plasma collected from ADMA BioCenters’ facilities that is not used to manufacture our

products or product candidates are sold to third-party customers in the U.S.

ADMA BioCenters has a total of ten source plasma U.S.

based collection facilities, all of which are actively operating and collecting plasma.

Currently, eight of our plasma collection facilities have an FDA license

(of which three facilities have also received approvals from MFDS and FDA approval to implement a Hepatitis B immunization program), with two remaining centers expected to receive FDA approval during 2023.

Source plasma that is collected from our

FDA-licensed facilities provides us with a portion of our blood plasma for the manufacture of our products.

After giving effect to our supply chain robustness initiatives made in 2021 and 2022 as it pertains to our plasma collection network

expansion, we remain on track to achieve our stated goal of having ten plasma collection centers FDA-licensed by the end of 2023.

A typical plasma collection center, such as those operated by ADMA BioCenters, can collect approximately 30,000 to

50,000 liters of source plasma annually, which may be sold for different prices depending upon the type of plasma, quantity of purchase, and market conditions at the time of sale.

Plasma collected from ADMA BioCenters’ facilities that is not used

to manufacture our products or product candidates are sold to third-party customers in the U.S.

and other international locations where we are approved under supply agreements or in the open “spot” market.

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We also anticipate staffing our Company with additional personnel for

patient support, medical affairs, quality assurance, quality control, inventory management, regulatory affairs, scientific affairs production and third-party reimbursement.

We currently use and may continue to partner with a network of

national distributors to fulfill orders for BIVIGAM and ASCENIV.

We have implemented and continue to implement virtual customer engagement programs to adapt and change with the current restrictions in place due to COVID-19, as well as

continue with our in-person presence with customers and healthcare professionals and attend appropriate trade-related and scientific medical conferences as COVID-19 restrictions ease in various geographic regions of the country.

patient support, medical affairs, quality assurance, quality control, inventory management, regulatory affairs, scientific affairs and third-party reimbursement.

We currently use and may continue to partner with a network of national

distributors to fulfill orders for BIVIGAM and ASCENIV.

We have implemented and continue to implement virtual customer engagement programs to adapt to restrictions in place due to COVID-19, as well as continue with our in-person presence

with customers and healthcare professionals and attend appropriate trade-related and scientific medical conferences as COVID-19 restrictions ease in various geographic regions of the country.

Increase marketing efforts around Nabi-HB.

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treatment of RSV or other potential respiratory viral pathogens, as well as in other patient populations we may believe are appropriate.

Improve the Boca Facility’s operating efficiencies and gross margins.

During 2022, we plan to execute on the capacity optimization efforts we put in place during 2021 to increase the Boca

Facility’s manufacturing capacity throughput, look for operating efficiencies and gross margin improvements.

We also plan to strengthen our supply chain capabilities to potentially unlock efficiencies, improve production yields and

provide more control and visibility for timing of commercial product releases for all of our FDA-approved commercial products.

During 2021, we received FDA approvals for our 4,400L expanded IVIG production scale, as well as our in-house

fill-finish and related operations production line using our aseptic filling machine.

Improve the Boca Facility’s and ADMA BioCenters’ operating efficiencies, yields and gross margins.

During 2023, we plan to continue to execute on the capacity optimization efforts we put in

place during 2021 to increase the Boca Facility’s manufacturing capacity throughput, while seeking additional operating efficiencies and gross margin improvements.

We also plan to strengthen our supply chain capabilities to potentially

unlock efficiencies, improve production yields and provide more control and visibility for timing of commercial product releases for all of our FDA-approved commercial products.

During 2021, we received FDA approvals for our 4,400L

expanded IVIG production scale, as well as our in-house fill-finish and related operations production line using our aseptic filling machine.

In 2023, ADMA commenced manufacturing ASCENIV at the 4,400 Liter production scale for the first

time in corporate history.

We expect that this expansion should meaningfully improve the product’s margin profile and increase plant production capacity as fewer batches will be needed to support revenue goals.

The Company’s successful

experience in ramping up BIVIGAM to this production scale over the last two years lends confidence to its ability to leverage these same processes for ASCENIV.

We believe these benefits could be realized as early as the second half of

Label expansion.

The ongoing post-marketing clinical studies may provide label expansion opportunities for both BIVIGAM and ASCENIV to include pediatric-aged PI patients as well as additional

publications supporting product safety.

Expand and develop our pipeline with additional specialty plasma and/or hyperimmune immunoglobulin products .

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market for IG in 2021 was

$9.5 billion and is expected to grow to $17 billion by 2027 based upon a compounded annual growth rate of 9%.

$9.6 billion and is expected to exceed $17 billion by 2027 based upon a compounded annual growth rate of 9%.

As most patients with PIDD present with infections, the differential diagnosis and initial investigations for an underlying immune defect are typically guided by the clinical presentation.

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process is time consuming and complex.

The time for collection, manufacturing and release of a batch of IG is estimated at 7 to 12 months, which is not unique to just ADMA as other fractionators report similar production timelines.

The time for collection, manufacturing and release of a batch of IG is estimated at seven to 12 months, which is not unique to just ADMA as other fractionators report similar production timelines.

The proteins in human plasma fall into four categories:

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As reported in industry journals, the U.S.

sales of immune and hyperimmune globulin products for all its uses were reported to be approximately $9.5 billion in 2020 and are expected to reach approximately $17 billion

in 2027 based upon an anticipated compounded annual growth rate of approximately 9%.

IVIG products are used to treat primary immune deficiencies, certain autoimmune diseases, and other illnesses for immune-compromised patients and certain

neuropathy indications.

sales of immune and hyperimmune globulin products for all its uses were reported to be approximately $9.6 billion in 2021 and are expected to exceed $17 billion in 2027

based upon an anticipated compounded annual growth rate of approximately 9%.

IVIG products are used to treat primary immune deficiencies, certain autoimmune diseases, and other illnesses for immune-compromised patients and certain neuropathy

New research and data, secondary immune deficiencies, additional labeled indications, an aging population and emerging countries with new markets are all adding to the worldwide demand and growth of IVIG utilization.

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which ensures that our products comply with the requirements of the FDA and are safe and efficacious.

Once our drug-substance is produced in the Boca Facility, the product is further processed by certain third- party fill-finish providers as well as through labeling, packaging and DSCSA serialization requirements.

The end-to-end production cycle can take approximately seven to 12 months for a batch of FDA released drug product.

During 2020, we successfully implemented several manufacturing and supply chain enhancements, including the purchase and

installation of a new aseptic filling machine and the manufacturing of four conformance batches of BIVIGAM at an increased scale.

These initiatives are designed to reduce operating costs, improve margins and provide for faster production cycle

turnaround time, ultimately providing increased control and independence from third-party vendors and contractors.

ADMA submitted the appropriate applications to the FDA during the fourth quarter of 2020 and received FDA approval for both the

increased production scale and the in-house fill-finish line, including utilization of the Vanrx filling machine, during the second half of 2021.

ADMA BioCenters operates five FDA-licensed source plasma collection facilities located in the U.S.

which provides us with a portion of our blood plasma for the manufacture of our current products and product

We also have one other plasma collection facility where we currently collect plasma for which a BLA is pending with the FDA.

In addition, we have four additional plasma collection facilities that are under various stages of

construction and development.

After giving effect to the progress we made in 2020 and 2021 with our plasma collection network expansion, we believe we remain on track to achieve our goal of having 10 FDA-approved plasma collection centers by the

In addition, we intend to enter into additional third-party contracts to procure normal source and high-titer plasma.

Once our drug-substance is produced in the Boca Facility, the product is further processed by certain third- party fill-finish providers or through our own in-house fill finish process which was approved by the FDA

in the second half of 2021, as well as through labeling, packaging and Drug Supply Chain Security Act (“DSCSA”) serialization requirements.

The end-to-end production cycle can take approximately seven to 12 months for a batch of FDA released

drug product.

Since 2020, we have successfully implemented several manufacturing and supply chain enhancements, including the purchase and installation of a new aseptic filling machine and the manufacturing of four conformance batches of BIVIGAM

at an increased scale.

These initiatives are designed to reduce operating costs, improve margins and provide for faster production cycle turnaround time, ultimately providing increased control and independence from third-party vendors and

ADMA BioCenters has a total of ten source plasma collection facilities in its network.

We anticipate all ten collection facilities will be FDA-approved by the end of 2023 and should allow the Company to be

essentially self-sufficient for its raw material source plasma supply to produce its commercial IG product portfolio.

Eight of our operational ADMA BioCenters plasma collection facilities are currently licensed by the FDA and three facilities

have approvals from the South Korean MFDS and the FDA for the collection and sale of Hepatitis B hyperimmune plasma obtained from immunized donors.

At the present time, the Company does not plan to build additional plasma collection facilities

beyond the existing 10, but continues to have third-party supply contracts in place to augment our vertically integrated plasma collections.

Pursuant to the terms of a plasma purchase agreement with BPC, dated as of November 17, 2011 (the “2011 Plasma Purchase Agreement”), we have agreed to purchase from BPC an annual minimum volume of source plasma

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Unless terminated earlier, the 2011 Plasma Purchase Agreement expires in June 2027, after which it may be renewed for two additional five-year periods if agreed to by the parties.

As part of the closing

of the Biotest Transaction, we amended the 2011 Plasma Purchase Agreement to extend the initial term through the ten-year anniversary of the closing date of the Biotest Transaction.

On December 10, 2018, BPC assigned its rights and obligations

under the 2011 Plasma Purchase Agreement to Grifols Worldwide Operations Limited (“Grifols”) as its successor-in-interest, effective January 1, 2019.

On December 10, 2018,

BPC assigned its rights and obligations under the 2011 Plasma Purchase Agreement to Grifols Worldwide Operations Limited (“Grifols”) as its successor-in-interest, effective January 1, 2019.

On June 6, 2017, we entered into a Plasma Supply Agreement with BPC pursuant to which BPC supplies, on an exclusive basis subject to certain exceptions, to ADMA BioManufacturing an annual minimum volume of

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obligations under the Plasma Supply Agreement to Grifols, effective January 1, 2019.

On June 6, 2017, we entered into a Plasma Purchase Agreement with BPC (the “2017 Plasma Purchase Agreement”), pursuant to which ADMA BioManufacturing purchases normal source plasma from BPC at agreed upon annual

quantities and prices.

The 2017 Plasma Purchase Agreement has an initial term of five years after which the 2017 Plasma Purchase Agreement may be renewed for two additional terms of two years each upon the mutual written consent of the parties.

On July 19, 2018, we entered into an amendment to the 2017 Plasma Purchase Agreement with BPC to, among other things, provide agreed upon amounts of normal source plasma to be supplied by BPC to ADMA BioManufacturing in calendar year 2019 at a

specified price per liter, provided that ADMA BioManufacturing delivers a valid purchase order to BPC.

Additionally, pursuant to the amendment to the 2017 Plasma Purchase Agreement, BPC agrees that, for calendar years 2020 and 2021, it shall

supply no less than a high double-digit percentage of ADMA BioManufacturing’s requested NSP amounts, provided that such requested normal source plasma amounts are within an agreed range, at a price per liter to be mutually determined.

Furthermore, pursuant to the amendment to the 2017 Plasma Purchase Agreement, in the event BPC fails to supply ADMA BioManufacturing with at least a high double-digit percentage of ADMA BioManufacturing’s requested normal source plasma amounts,

BPC shall promptly reimburse ADMA BioManufacturing the difference in price ADMA BioManufacturing incurs due to BPC’s election not to supply NSP to ADMA BioManufacturing in such amounts as requested.

On December 10, 2018, BPC assigned its rights

and obligations under the Plasma Purchase Agreement to Grifols, effective January 1, 2019.

Effective as of May 12, 2021, the Company and Grifols amended the foregoing 2017 Plasma Purchase Agreement whereby, among other things, the term of the agreement was extended through December 31, 2022, while certain

historical provisions were deleted.

In order to maintain a reliable supply of raw material plasma thereafter, the Company has executed additional agreements with multiple third-party suppliers of NSP to supplement the 2017 Plasma Purchase

Agreement, and the Company has also increased its number of planned plasma collection center buildouts and is continuing to increase its plasma collection capabilities at its ADMA BioCenters plasma collection centers business segment.

On June 6, 2017, we entered into a Plasma Purchase Agreement with BPC (the “2017 Plasma Purchase

Agreement”), pursuant to which ADMA BioManufacturing purchases normal source plasma from BPC at agreed upon annual quantities and prices.

The 2017 Plasma Purchase Agreement had an initial term of five years after which the 2017 Plasma Purchase

Agreement could be renewed for two additional terms of two years each upon the mutual written consent of the parties.

On December 10, 2018, BPC assigned its rights and obligations under the Plasma Purchase Agreement to Grifols, effective January

were deleted.

The 2017 Plasma Purchase Agreement expired on December 31, 2022 and was not renewed.

In order to maintain a reliable supply of raw material plasma thereafter, we have executed additional agreements with multiple third-party

suppliers of NSP and we continue to increase our plasma collection capabilities at our ADMA BioCenters Plasma Collection Centers business segment.

Sales and Commercialization of Our Products

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which have significant patient populations for PIDD, suitable for treatment with ASCENIV.

We are in the process of expanding our current specialty sales force consisting of account managers, medical science liaisons and other normal and customary scientific, medical and detail representatives.

Our management and Board have substantial

prior direct marketing, sales and distribution experience with plasma-derived drugs, specialty immune globulins and other biological products.

As is customary in the plasma products industry, we may also use a network of national distribution

organizations that have specialty divisions that focus on plasma products to fulfill orders for ASCENIV.

Subject to restrictions surrounding the COVID-19 pandemic, commercialization efforts to generate increased market awareness for Nabi-HB include attending and presenting at medical conferences, as well as sponsoring

medical education symposiums.

We have also hired a small, specialty sales force to market BIVIGAM and ASCENIV to hospitals, physician offices/clinics, and other specialty treatment organizations as applicable.

In addition, we have been staffing

our Company with additional personnel for patient support, medical affairs, quality assurance, regulatory affairs, scientific affairs, third-party reimbursement, inventory and logistics, human resources and financial and operational management.

We may also use a network of national and regional distributors to assist with order fulfillment for BIVIGAM and ASCENIV for use by healthcare professionals and hospitals

Our management and Board have substantial prior direct marketing, sales and distribution experience with plasma-derived drugs, specialty immune globulins and other biological products.

As is customary in the plasma products industry, we may also

use a network of national distribution organizations that have specialty divisions that focus on plasma products to fulfill orders for ASCENIV.

Subject to restrictions surrounding the COVID-19 pandemic, efforts to generate increased market awareness for Nabi-HB include attending and presenting scientific information at medical conferences, as well as

sponsoring medical education symposiums.

We have also hired a specialty sales force consisting of account managers, medical science liaisons and other customary scientific, medical and detail representatives to market BIVIGAM and ASCENIV to

hospitals, physician offices/clinics, and other specialty treatment organizations as applicable.

In addition, we have expanded staffing efforts with additional personnel for patient support, medical affairs, quality assurance, regulatory affairs,

scientific affairs, third-party reimbursement, inventory and logistics, human resources and financial and operational management.

We may also use a network of national and regional distributors to assist with order fulfillment for BIVIGAM and

ASCENIV for use by healthcare professionals and hospitals.

Pursuant to our Manufacturing, Supply and License Agreement effective as of January 21, 2017, we granted Biotest an exclusive license to market and sell ASCENIV in Europe and in selected countries in North Africa and

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regulatory approval for ASCENIV in the Territory.

As consideration for the license, Biotest provided us with certain services at no charge and also compensated us with cash payments upon the completion of certain milestones.

Biotest was also

obligated to pay us an adjustable royalty based on a percentage of revenues from the sale of ASCENIV in the Territory for 20 years from the date of first commercial sale.

As consideration for the license, Biotest provided us with certain in-kind services and also compensated us with cash payments upon the completion of certain milestones.

Biotest is also obligated

to pay us an adjustable royalty based on a percentage of revenues from the sale of ASCENIV in the Territory for 20 years from the date of first commercial sale.

Major Customers

For the year ended December 31, 2021, four customers, BioCARE, Inc.

(“BioCare”), Reliance Life Sciences Pvt Limited (“Reliance”), AmerisourceBergen Corporation (“AmerisourceBergen) and Priority Healthcare

Distribution, Inc.

For the year ended December 31, 2022, two customers, BioCARE, Inc.

(“BioCare”) and Priority Healthcare Distribution, Inc.

(“Curascript”), represented an aggregate of 74% of our consolidated revenues.

The plasma products industry is highly competitive.

We face, and will continue to face, intense competition from both U.S.

based and foreign producers of plasma products, some of which have lower cost structures,

We face, and will continue to face, intense competition from both U.S.-based and foreign producers of plasma products, some of which have lower cost structures,

greater access to capital, greater resources for research and development, and sophisticated marketing capabilities.

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consisting of:

Grifols Biologicals, Takeda and ADMA Biologics.

Grifols, Takeda and ADMA Biologics.

In addition to competition from other large worldwide plasma products providers, we face competition in local areas from smaller entities.

In Europe, where the industry is highly regulated and

healthcare systems vary from country to country, local companies may have greater knowledge of local healthcare systems, more established infrastructures and existing regulatory approvals or a better understanding of the local regulatory process,

allowing them to market their products more quickly.

In Europe, where the industry is highly regulated and healthcare

systems vary from country to country, local companies may have greater knowledge of local healthcare systems, more established infrastructures and existing regulatory approvals or a better understanding of the local regulatory process, allowing

them to market their products more quickly.

Moreover, plasma therapy generally faces competition from non-plasma products and other courses of treatments.

For example, recombinant Factor VIII products compete with plasma-derived products

in the treatment of Hemophilia A.

For example, recombinant Factor VIII products compete with plasma-derived products in the

treatment of Hemophilia A.

New technologies are being developed by biotech and pharmaceutical companies which may impact physician prescription and patient usage of IVIG.

One such recently approved FDA therapy is an FcRn inhibitor (neonatal

Fc receptor, IgG receptor) which is a protein in humans responsible for maintaining IgG levels.

This recently FDA approved FcRn is for the treatment of generalized Myasthenia Gravis that may impact a subset of overall general IVIG usage.

such FcRn potential targeted indications in development that may disrupt general IVIG usage may include but are not limited to:

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (“CIDP”), a rare type of autoimmune disorder, Immune

Thrombocytopenic Purpura (“ITP”), a blood disorder characterized by a decrease in the number of platelets in the blood and Pemphigus Vulgaris (“PV”), a rare type of autoimmune disorder.

One such recently approved FDA therapy is an anti-FcRn inhibitor

(neonatal Fc receptor, IgG receptor) which is a protein in humans responsible for maintaining IgG levels.

This recently FDA approved anti-FcRn is for the treatment of generalized Myasthenia Gravis that may impact a subset of overall general IVIG

Other such FcRn potential targeted indications in development that may disrupt general IVIG usage may include but are not limited to:

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (“CIDP”), a rare type of autoimmune disorder,

Immune Thrombocytopenic Purpura (“ITP”), a blood disorder characterized by a decrease in the number of platelets in the blood and Pemphigus Vulgaris (“PV”), a rare type of autoimmune disorder.

Intellectual Property

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research, development, approval and post-approval monitoring and reporting, manufacturing, labeling, storage, recordkeeping, advertising, promotion, import, export, marketing sales and distribution of our products and product candidates.

not comply with applicable requirements, we may be fined, the government may refuse to approve our marketing applications or allow us to manufacture or market our products and we may be criminally prosecuted.

These requirements are continually

By example, in light of the COVID-19 pandemic, the FDA has issued a number of guidance documents to assist companies navigating pre-commercialization, commercialization, manufacturing and development concerns raised by COVID-19 and

with respect to products intended for COVID-19.

not comply with applicable requirements, we may be fined, the government may refuse to approve our marketing applications or allow us to manufacture or market our products, we may be criminally prosecuted and we may be excluded from participation

in government healthcare programs.

These requirements are continually evolving.

By example, in light of the COVID-19 pandemic, the FDA has issued a number of guidance documents to assist companies navigating pre-commercialization,

commercialization, manufacturing and development concerns raised by COVID-19 and with respect to products intended for COVID-19.

We and our manufacturers may also be subject to regulations under other federal, state and local laws.

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This requires sterile processes to be applied from initial manufacturing steps.

In the U.S., the FDA regulates biologic products under the FDCA, the PHS Act, related federal regulations

under Title 21 of the Code of Federal Regulations (CFR), as well as other federal, state, and local statutes and regulations.

The process required by the FDA before our product candidates may be marketed in the U.S.

generally involves the

following (although the FDA is given wide discretion to impose different or more stringent requirements on a case-by-case basis):

completion of extensive preclinical laboratory tests, preclinical animal studies and formulation studies performed in accordance with the FDA’s Good Laboratory Practice (“GLP”) regulations and other applicable laws and regulations;

In the U.S., the FDA regulates biologic products under the FDCA, the PHS Act and related federal

regulations under Title 21 of the Code of Federal Regulations (“CFR”).

Biologics are also regulated under other federal, state, and local statutes and regulations by other regulatory authorities.

The process required by the FDA before our product

candidates may be marketed in the U.S.

generally involves the following (although the FDA is given wide discretion to impose different or more stringent requirements on a case-by-case basis):

completion of extensive preclinical laboratory tests, preclinical, nonclinical and formulation studies performed in accordance with the FDA’s Good Laboratory Practice (“GLP”) regulations and other applicable laws and regulations;

submission to the FDA of an Investigational New Drug (“IND”) application which must become effective before clinical trials may begin;

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Pre-Clinical Studies

Prior to commencing the first clinical trial at a United States investigational site, we must submit manufacturing and analytical data, pre-clinical data from studies conducted in accordance with GLPs, and clinical

trial plans, among other information, to the FDA as part of an IND application.

Subject to certain exceptions, an IND becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, issues a clinical hold to

delay a proposed clinical investigation due to concerns or questions about the product or the conduct of the clinical trial, including concerns that human research subjects will be exposed to unreasonable health risks.

In such a case, the IND

sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin.

Prior to commencing the first clinical trial at a United States investigational site, we must submit manufacturing and analytical data, pre-clinical or nonclinical data from studies conducted in accordance with GLPs,

and clinical trial plans, among other information, to the FDA as part of an IND application.

Subject to certain exceptions, an IND becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, issues a

clinical hold to delay a proposed clinical investigation due to concerns or questions about the product or the conduct of the clinical trial, including concerns that human research subjects will be exposed to unreasonable health risks.

case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin.

Clinical holds also may be imposed by the FDA at any time before or during trials due to safety concerns or non-compliance.

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requirements for each medical center proposing to conduct the clinical trial must review and approve the plan for any clinical trial before it commences at that center and it must monitor the safety of the study and study subjects until

The FDA, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk.

Clinical testing also must satisfy

extensive GCP requirements and regulations for informed consent, and must be conducted with product meeting cGMPs.

Special clinical trial ethical considerations also must be taken into account if a study involves children.

The FDA, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the

subjects or patients are being exposed to an unacceptable health risk.

Clinical testing also must satisfy extensive GCP requirements and regulations for informed consent and must be conducted with product meeting cGMPs.

Clinical Trials

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In 2012, the Food and Drug Administration Safety and Innovation Act amended the FDCA to require that a sponsor who is planning to submit such an application submit an initial

Pediatric Study Plan (“PSP”) within 60 days of an end-of-phase 2 meeting or as may be agreed between the sponsor and the FDA.

The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of data or full or

partial waivers.

Pediatric Study Plan (“PSP”) within 60 days of an end-of-Phase II meeting or as may be agreed between the sponsor and the FDA.

The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of data or full

or partial waivers.

The FDA and the sponsor must reach agreement on the PSP.

More recently, Congress also passed legislation that will require that sponsors submit to FDA a diversity action plan for Phase III or other pivotal studies, unless such

requirement is waived by FDA.

In some cases, the FDA may condition continued approval of a BLA on the sponsor’s agreement to conduct additional clinical trials, or other commitments.

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Biologics License Applications

The results of product candidate development, preclinical testing and clinical trials, together with, among other things, detailed information on the manufacture and composition of the product and proposed labeling,

and the payment of a user fee, are submitted to the FDA as part of a BLA.

Under the Prescription Drug User Fee Act (“PDUFA”), the fees payable to the FDA for reviewing an original BLA, as well as annual program fees for approved products can be

substantial, subject to certain limited deferrals, waivers and reductions that may be available.

The results of product candidate development, preclinical and nonclinical testing and clinical trials, together with, among other things, detailed information on the manufacture and composition of the product and

proposed labeling, and the payment of a user fee, are submitted to the FDA as part of a BLA.

Under the Prescription Drug User Fee Act (“PDUFA”), the fees payable to the FDA for reviewing an original BLA, as well as annual program fees for

approved products can be substantial, subject to certain limited deferrals, waivers and reductions that may be available.

Following submission, the FDA has 60 days to review all BLAs to determine if they are substantially complete before it accepts them for filing.

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FDA may not complete its review or approve a BLA within these established goal review times.

Moreover, this review period may change as the PDUFA statute must be reauthorized by Congress by September 2022.

Before approving a marketing application, the FDA typically will inspect the facility or facilities where the product is manufactured, referred to as a Pre-Approval Inspection, as well as one or more clinical trial

The FDA will not approve a product candidate unless cGMP compliance is satisfactory.

During its review of a BLA, the FDA may refer the application to an advisory committee of experts for their review, evaluation and recommendation as to

whether the application should be approved, which information is taken into consideration along with the FDA’s own review findings.

After the FDA conducts its in-depth review of the application and after the inspection of the manufacturing facilities and clinical trial sites, the FDA issues either an approval letter or a Complete Response Letter

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surveillance programs to monitor the effect of approved products that have been commercialized, and the FDA has the power to prevent or limit further marketing of a product based on the results of these post-marketing programs.

Even if the FDA approves a product, it may limit the approved indications or populations for use of the product, require that contraindications, warnings, or precautions be included in the product labeling, including

a boxed warning, require testing and surveillance programs to monitor the product after commercialization, or impose other conditions, including distribution restrictions or other risk management mechanisms under a Risk Evaluation and Mitigation

Strategy (“REMS”).

including a boxed warning, require testing and surveillance programs to monitor the product after commercialization, or impose other conditions, including distribution restrictions or other risk management mechanisms under a Risk Evaluation and

Mitigation Strategy (“REMS”).

If the FDA concludes a REMS is needed, the sponsor of the BLA must submit a proposed REMS;

the FDA will not approve the BLA without a REMS, if required.

A REMS could include medication guides, physician communication plans or

elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools.

Any of these limitations on approval or marketing can materially affect the potential market and profitability of the

could include medication guides, physician communication plans or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools.

Any of these limitations on approval or marketing can

materially affect the potential market and profitability of the product.

The FDA may also not approve label statements that are necessary for successful commercialization and marketing.

Products may be marketed only for the FDA-approved indications and in accordance with the FDA-approved label.

not allow drugs to be promoted for “off-label” uses – that is, uses that are not described in the product’s approved labeling and that differ from those that were approved by the FDA.

Furthermore, the FDA generally limits approved uses to those

studied in clinical trials.

If there are any modifications to the product, including changes in indications, other labeling changes, or manufacturing processes or facilities, we may be required to submit and obtain FDA approval of a new BLA or

BLA supplement, which may require us to develop additional data or conduct additional preclinical studies and clinical trials, and/or require additional manufacturing data.

The FDA does not allow drugs to be promoted for “off-label” uses – that is, uses that are not described in the product’s approved

labeling and that differ from those that were approved by the FDA.

Furthermore, the FDA generally limits approved uses to those studied in clinical trials.

If there are any modifications to the product, including changes in indications, other

labeling changes, or manufacturing processes or facilities, we may be required to submit and obtain FDA approval of a new BLA or BLA supplement, which may require us to develop additional data or conduct additional preclinical studies and

clinical trials, and/or require additional manufacturing data.

Satisfaction of the FDA regulations and approval requirements or similar requirements of foreign regulatory agencies typically takes many years, and the actual time required may vary substantially based upon the

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Failure to comply with the statutory and regulatory requirements can subject a manufacturer to possible legal or regulatory action, such as refusal to approve pending

applications, license suspension or revocation, withdraw approval of a BLA, imposition of a clinical hold or termination of clinical trials, warning letters, untitled letters, suspension of manufacturing, sales or use, product seizures or

applications, license suspension or revocation, withdrawal of approval of a BLA, imposition of a clinical hold or termination of clinical trials, warning letters, untitled letters, suspension of manufacturing, sales or use, product seizures or

recalls, import restrictions, injunctive action or possible fines and other penalties.

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Manufacturers and certain other entities involved in the manufacturing and distribution of approved products are required to register their establishments with the FDA and certain state agencies, list the

manufactured products to the FDA, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP and other laws.

The cGMP requirements apply to all stages of the manufacturing process, including

the production, processing, sterilization, packaging, labeling, storage and shipment of the product.

Manufacturers must establish validated systems to ensure that products meet specifications and regulatory standards, and test each product batch

or lot prior to its release.

The information that must be submitted to FDA regarding manufactured products was expanded through the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act to include the volume of drugs produced during the

manufactured products to the FDA, and are subject to periodic unannounced inspections or remote regulatory assessments by the FDA and certain state agencies for compliance with cGMP and other laws.

The cGMP requirements apply to all stages of the

manufacturing process, including the production, processing, sterilization, packaging, labeling, storage and shipment of the product.

Manufacturers must establish validated systems to ensure that products meet specifications and regulatory

standards and test each product batch or lot prior to its release.

The information that must be submitted to FDA regarding manufactured products was expanded through the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act to include the

volume of drugs produced during the prior year.

For biologics products subject to lot release, for each product lot the applicant must submit materials related to that lot to the FDA prior to that lot being released for distribution.

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control to maintain cGMP compliance.

The commercial distribution of prescription drugs (including biological drug products) is subject to the Drug Supply Chain Security Act (“DSCSA”), which regulates the distribution of the products at the federal

level, and sets certain standards for federal or state registration and compliance of entities in the supply chain (manufacturers and repackagers, wholesale distributors, third-party logistics providers, and dispensers).

The DSCSA preempts

previously enacted state pedigree laws and the pedigree requirements of the Prescription Drug Marketing Act (“PDMA”).

Trading partners within the drug supply chain must now ensure certain product tracing requirements are met, and are required to

exchange transaction information, transaction history, and transaction statements.

Further, the DSCSA limits the distribution of prescription pharmaceutical products and imposes requirements to ensure overall accountability and security in the

drug supply chain.

The distribution of product samples continues to be regulated under the PDMA.

The commercial distribution of prescription drugs (including biological drug products) is subject to the

DSCSA, which regulates the distribution of the products at the federal level and sets certain standards for federal or state registration and compliance of entities in the supply chain (manufacturers and repackagers, wholesale distributors,

third-party logistics providers, and dispensers).

The DSCSA preempts previously enacted state pedigree laws and the pedigree requirements of the Prescription Drug Marketing Act (“PDMA”).

Trading partners within the drug supply chain must now

ensure certain product tracing requirements are met and are required to exchange certain transaction-related information in an electronic, and, as of November 2023, an interoperable form.

Further, the DSCSA limits the distribution of prescription

pharmaceutical products and imposes requirements to ensure overall accountability and security in the drug supply chain, including requirements related to the detection and investigation of suspect and illegitimate products.

The distribution of

product samples continues to be regulated under the PDMA.

FDA post-approval requirements are continually evolving.

For example, in March 2020, the U.S.

Congress passed the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, which includes various provisions

regarding FDA drug shortage and manufacturing volume 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.

As part of the CARES Act implementation, the FDA recently issued a guidance on the reporting of the volume of drugs produced, which reporting will require additional administrative efforts by drug manufacturers.

Congress passed the CARES Act, which includes various provisions regarding FDA drug shortage and manufacturing volume

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.

As part of the CARES Act implementation, the FDA

issued a guidance on the reporting of the volume of drugs produced, which reporting will require additional administrative efforts by drug manufacturers.

Executive orders have also been issued to encourage domestic manufacturing.

Advertising and Promotion

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A product cannot be promoted before it is approved.

After approval, product promotion can include only those claims relating to safety and effectiveness that are consistent

After approval, product promotion can include only those claims related to safety and effectiveness that are consistent

with the labeling approved by the FDA.

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Failure to comply with applicable FDA requirements and restrictions in this area may subject a company to adverse publicity and enforcement action by the FDA, the

Department of Justice, or the Office of the Inspector General of the Department of Health and Human Services, as well as state authorities.

Department of Justice, or the Office of Inspector General of the Department of Health and Human Services, as well as state authorities.

This could subject a company to a range of penalties that could have a significant commercial impact,

including civil and criminal fines and agreements that materially restrict the manner in which a company promotes or distributes a drug.

including civil penalties, criminal fines and agreements that materially restrict the manner in which a company promotes or distributes a drug.

From time to time, legislation is drafted, introduced and passed in Congress that could significantly change the statutory provisions governing the approval, manufacturing and marketing of products regulated by the

In addition to new legislation, FDA and other agency regulations, guidance, and policies are often revised or reinterpreted in ways that may significantly affect our business and our product candidates.

It is impossible, especially in light

of the recent change to the U.S.

administration, to predict whether further legislative or FDA regulation or other regulatory policy changes will be enacted or implemented and what the impact of such changes, if any, may be.

It is possible that

certain prior regulatory requirements may be postponed or frozen.

In addition to new legislation, FDA and other agency regulations, guidance, and policies are often revised or reinterpreted in ways that may significantly affect our business.

It is impossible to predict whether further legislative or FDA

regulation or other regulatory policy changes will be enacted or implemented and what the impact of such changes, if any, may be.

It is possible that certain prior regulatory requirements may be postponed or frozen.

Regulation of ADMA BioCenters

With some limited exceptions, all blood and blood product collection and manufacturing centers which engage in interstate commerce must be licensed by and registered with the FDA, and must be commercially distributed

blood products with the agency.

In order to achieve licensure, the organization must submit a BLA three months after the center’s first donor collection and undergo a 12-month pre-licensure inspection.

ADMA BioCenters has completed these

requirements and holds an FDA license for five of its existing plasma collection facilities.

In order to maintain an FDA license, each such facility operated by ADMA BioCenters will be inspected at least every two years and must meet certain

regulatory requirements.

With some limited exceptions, all blood and blood product collection and manufacturing centers which engage in interstate commerce must be licensed by and registered with the FDA.

In order to achieve licensure, the

organization must submit a BLA and obtain BLA approval prior to distribution of any product.

The approval of the BLA requires passage of an FDA inspection.

ADMA BioCenters has completed these requirements and holds an FDA license for eight plasma

collection facilities for source plasma.

In order to maintain an FDA license, under FDA guidance each such facility operated by ADMA BioCenters will be inspected within the first year of operations and then at least every two years and must meet

certain regulatory requirements.

ADMA BioCenters is also required to submit annual reports to the FDA, as well as reports of fatalities related to blood and blood component collection or transfusion.

Establishments must also comply with FDA’s regulatory

standards which include a variety of requirements related to, among other areas, cGMPs, deviation investigation and reporting, donor screening and product testing, as well as product labeling.

Facilities must further ensure that all tests and

equipment that are used are appropriate for their intended use, which may include FDA clearance and/or approval of the applicable test or equipment.

Establishments must also comply with FDA’s

regulatory standards which include a variety of requirements related to, among other areas, cGMPs, deviation investigation and reporting, donor screening and product testing, as well as product labeling.

Facilities must further ensure that all

tests and equipment that are used are appropriate for their intended use, which may include FDA clearance and/or approval of the applicable test or equipment.

Blood plasma collection and manufacturing centers are also subject to the Clinical Laboratory Improvement Amendments, state licensure and compliance with industry standards such as the International Quality Plasma

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in addition to the costs required to obtain regulatory approvals.

Our current products and product candidates may not be considered medically necessary or cost-effective.

If third-party payers do not consider a product to be cost-effective

compared to other available therapies, they may not cover the product after approval as a benefit under their plans or, if they do, the level of payment may not be sufficient to allow a company to sell its products at a profit.

Our current products may not be considered medically necessary or cost-effective.

If third-party payers do not consider a product to be cost-effective compared to other available

therapies, they may not cover the product after approval as a benefit under their plans or, if they do, the level of payment may not be sufficient to allow a company to sell its products at a profit.

government and state legislatures have shown significant interest in implementing cost containment programs to limit the growth of government-paid healthcare costs, including price controls, limitations on

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regulation, which became effective on April 1, 2016, to implement the changes to the Medicaid Drug Rebate Program under the ACA.

On December 21, 2020, CMS issued a final rule that modified Medicaid Drug Rebate Program regulations to permit

On December 21, 2020, CMS issued a final rule that modified the Medicaid Drug Rebate Program regulations to permit

reporting multiple best price figures with regard to value‑based purchasing arrangements (beginning in 2022);

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be available for the manufacturer’s drugs under Medicaid and Medicare Part B.

The 340B program, which is administered by the Health Resources and Services Administration, or HRSA, requires participating manufacturers to agree to charge

The 340B program, which is administered by the Health Resources and Services Administration (“HRSA”), requires participating manufacturers to agree to charge

statutorily defined covered entities no more than the 340B “ceiling price” for the manufacturer’s covered outpatient drugs.

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required to agree to provide 340B discounted pricing on drugs used in an inpatient setting.

In order to be eligible to have their products paid for with federal funds under the Medicaid and Medicare Part B programs and purchased by certain federal agencies (VA, Department of Defense (“DoD”), Coast Guard,

and Public Health Service (“PHS”)) and grantees, manufacturers must participate in the U.S.

Department of Veterans Affairs (“VA”) Federal Supply Schedule (“FSS”) pricing program.

Prices for innovator drugs purchased by the VA, DoD, Coast Guard,

and PHS are subject to a cap (known as the “Federal Ceiling Price”) equal to 76% of the annual non-federal average manufacturer price (“non-FAMP”) minus, if applicable, an additional discount.

The additional discount applies if non-FAMP increases

more than inflation (measured by reference to the Consumer Price Index – Urban (“CPIU”)).

In order to be eligible to have their products paid for with federal funds under the Medicaid and Medicare Part B programs and purchased by certain federal agencies (U.S.

Department of Veterans Affairs (“VA”),

Department of Defense (“DoD”), Coast Guard, and Public Health Service (“PHS”)) and grantees, manufacturers must participate in the VA Federal Supply Schedule (“FSS”) pricing program.

Prices for innovator drugs purchased by the VA, DoD, Coast

Guard, and PHS are subject to a cap (known as the “Federal Ceiling Price”) equal to 76% of the annual non-federal average manufacturer price (“non-FAMP”) minus, if applicable, an additional discount.

The additional discount applies if non-FAMP

increases more than inflation (measured by reference to the Consumer Price Index – Urban (“CPIU”)).

In addition, in the second and subsequent year, the price also is capped at prior year FSS contract plus CPIU.

Manufacturers must also participate in the

Tricare Retail Pharmacy Program, under which they pay quarterly rebates to DoD for prescriptions of innovator drugs dispensed to Tricare beneficiaries through Tricare Retail network pharmacies.

The governing statute provides for civil monetary

penalties for failure to provide information timely or for knowing submission of false information to the government.

Manufacturers must also participate

in the Tricare Retail Pharmacy Program, under which they pay quarterly rebates to DoD for prescriptions of innovator drugs dispensed to Tricare beneficiaries through Tricare Retail network pharmacies.

The governing statute provides for civil

monetary penalties for failure to provide information timely or for knowing submission of false information to the government.

Medicare Part D generally provides coverage to enrolled Medicare patients for self-administered drugs ( i.e.

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is administered by private prescription drug plans approved by the U.S.

government and, subject to detailed program rules and government oversight, each drug plan establishes its own Medicare Part D formulary for prescription drug coverage and

government and subject to detailed program rules and government oversight.

Each drug plan establishes its own Medicare Part D formulary for prescription drug coverage and

pricing, which the drug plan may modify from time to time.

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Congress further could enact a Medicare Part D inflation rebate, under which manufacturers would owe additional rebates if the average manufacturer price of a drug were to increase faster than the pace of inflation.

Congress also could enact a drug price negotiation program under which the prices for certain high Medicare spend single source drugs would be capped by reference to the non-federal average manufacturer price.

or any other legislative change could impact the market conditions for our products.

We further expect continued scrutiny on government price reporting from Congress, agencies, and other bodies.

Congress also could enact a drug price negotiation program under which the prices for certain high Medicare spend single source drugs would be capped by reference to the non-FAMP.

This or any other legislative change

could impact the market conditions for our products.

We further expect continued scrutiny on government price reporting from Congress, federal agencies, and other bodies.

Group health plans, health insurance issuers, health maintenance organizations, other healthcare payors, and pharmacy benefit managers in the United States are adopting more aggressive utilization management

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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 report annually to CMS information related to certain

direct or indirect payments and other transfers of value to U.S.-licensed physicians and teaching hospitals, as well as ownership and investment interests held in the company by physicians and their immediate family members.

Beginning in 2022

with respect to 2021 data, applicable manufacturers also will be required to report information regarding payments and transfers of value provided to physician assistants, nurse practitioners, clinical nurse specialists, certified nurse

anesthetists, and certified nurse-midwives.

Failure to submit required information may result in civil monetary penalties of $1,000 to $10,000 for each payment or ownership interest that is not timely, accurately, or completely reported (annual

maximum of $150,000), and $10,000 to $100,000 for each knowing failure to report (annual maximum of $1 million) (for an aggregate annual maximum of $1,150,000).

direct or indirect payments and other transfers of value to U.S.-licensed physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists and certified nurse-midwives and to U.S.

teaching hospitals,

as well as ownership and investment interests held in the company by physicians and their immediate family members.

Failure to submit required information may result in civil monetary penalties of $1,000 to $10,000 for each payment or ownership

interest that is not timely, accurately, or completely reported (annual maximum of $150,000), and $10,000 to $100,000 for each knowing failure to report (annual maximum of $1 million) (for an aggregate annual maximum of $1,150,000).

Some states have elected not to expand their Medicaid programs by raising the income limit to 133% of the federal poverty level, as is permitted under the ACA.

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our products and product candidates.

Other legislative changes relating to reimbursement have been adopted in the U.S.

Other legislative changes related to reimbursement have been adopted in the U.S.

since the ACA was enacted.

For example, on August 2, 2011, the Budget Control Act of 2011, among other things, created the Joint

Select Committee on Deficit Reduction to recommend to Congress proposals for spending reductions.

For example, on August 2, 2011, the Budget Control Act of 2011, among other things, created the Joint Select

Committee on Deficit Reduction to recommend to Congress proposals for spending reductions.

The Joint Select Committee did not achieve a targeted deficit reduction, which triggered the legislation’s automatic reductions.

In concert with

subsequent legislation, this has resulted in aggregate reductions to Medicare payments to providers of, on average, 2% per fiscal year through 2031 (with the exception of a temporary suspension from May 1, 2020 through March 31, 2022, due to the

COVID-19 pandemic).

In concert with subsequent

legislation, this has resulted in aggregate reductions to Medicare payments to providers of, on average, 2% per fiscal year through 2031 (with the exception of a temporary suspension from May 1, 2020 through March 31, 2022, due to the COVID-19

The law provides for 1% Medicare sequestration in the second quarter of 2022 and allows the full 2% sequestration thereafter until 2031.

As long as these cuts remain in effect, they could adversely impact payment for any

products we may commercialize in the future.

We expect that additional federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and

services, and in turn could significantly reduce the projected value of certain development projects and reduce our profitability.

As long as these cuts remain in effect, they could adversely impact payment for any products we

may commercialize in the future.

and in turn could significantly reduce the projected value of certain development projects and reduce our profitability.

Additional legislative changes, regulatory changes, or guidance could be adopted, which may impact the marketing approvals and reimbursement for our product candidates.

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federal healthcare program

Anti-Kickback Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving anything of value to induce (or in return for) the referral of business, including the purchase, recommendation or prescription

of a particular drug reimbursable under Medicare, Medicaid or other federally financed healthcare programs.

The statute has been interpreted to apply to arrangements between pharmaceutical companies on one hand and patients, prescribers,

purchasers and formulary managers on the other.

Although there are a number of statutory exemptions and regulatory safe harbors protecting certain common manufacturer business arrangements and activities from prosecution and administrative

sanction, the exemptions and safe harbors are drawn narrowly and are subject to regulatory revision or changes in interpretation by the U.S.

Department of Justice, or DOJ, and the Office of Inspector General of the U.S.

Department of Health and

Human Services, or OIG.

Recent regulations eliminate the discount safe harbor protection for manufacturer rebates paid directly, or indirectly through a pharmacy benefit manager (“PBM”) to Medicare Part D or Medicare Advantage plans, effective

January 1, 2026.

Practices or arrangements that involve remuneration may be subject to scrutiny if they do not qualify for an exemption or safe harbor.

Violations of the federal Anti-Kickback Statute may be established without providing

specific intent to violate the statute, and may be punishable by civil, criminal, and administrative fines and penalties, damages, imprisonment, and/or exclusion from participation in federal healthcare programs.

The federal civil False Claims Act prohibits, among other things, any person from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment of federal funds, or knowingly making, or

causing to be made, a false statement to get a false claim paid, or knowingly and improperly avoiding, decreasing or concealing an obligation to pay money to the federal government.

A claim resulting from a violation of the federal Anti-Kickback

Statute constitutes a false or fraudulent claim.

The False Claims Act also permits a private individual acting as a “whistleblower” to bring actions on behalf of themselves and the federal government alleging violations of the statute and to

share in any monetary recovery.

Violations of the False Claims Act may result in significant financial penalties (including mandatory penalties on a per claim or statement basis), treble damages and exclusion from participation in federal health

care programs.

Anti-Kickback Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving anything of value (“remuneration”) to induce (or in return for) the referral of business, including the purchase,

recommendation or prescription of a particular drug reimbursable under Medicare, Medicaid or other federally financed healthcare programs.

The statute has been interpreted to apply to arrangements between pharmaceutical companies on one hand and

patients, prescribers, purchasers and formulary managers on the other.

The Beneficiary Inducement Civil Monetary Penalties Law imposes similar restrictions on interactions between pharmaceutical manufacturers and federal healthcare program

beneficiaries.

Although there are a number of statutory exemptions and regulatory safe harbors protecting certain common manufacturer business arrangements and activities from prosecution and administrative sanction, the exceptions and safe

harbors are drawn narrowly and are subject to regulatory revision or changes in interpretation by the U.S.

Department of Justice (“DOJ”), and the Office of Inspector General of the U.S.

Department of Health and Human Services (“OIG”).

regulations eliminate the discount safe harbor protection for manufacturer rebates paid directly, or indirectly through a Pharmacy Benefit Manager (“PBM”) to Medicare Part D or Medicare Advantage plans, effective January 1, 2026.

proposed legislation, however, would permanently prohibit implementation of the rule beginning in 2026.

Practices or arrangements that involve remuneration may be subject to scrutiny if they do not qualify for an exception or safe harbor.

to meet all the requirements of a particular applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the Anti-Kickback Statute.

Instead, the legality of the arrangement will be evaluated on a

case-by-case basis based on a cumulative review of all its facts and circumstances.

Several courts have interpreted the statute’s intent requirement to mean that if any one purpose of an arrangement involving remuneration is to induce or reward referrals of federal healthcare program business,

including purchases of products paid by federal healthcare programs, the statute has been violated.

Violations of the federal Anti-Kickback Statute may be established without providing specific intent to violate the statute, and may be punishable

by civil, criminal, and administrative fines and penalties, damages, imprisonment, and/or exclusion from participation in federal healthcare programs.

The federal civil False Claims Act (“FCA”) prohibits, among other things, any person from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment of federal funds, or knowingly

making, or causing to be made, a false statement to get a false claim paid, or knowingly and improperly avoiding, decreasing or concealing an obligation to pay money to the federal government.

A claim includes “any request or demand” for money or

property presented to the U.S.

The FCA has been used to assert liability on the basis of improper referrals, improperly reported government pricing metrics such as Best Price or Average Manufacturer Price, improper use of Medicare

provider or supplier numbers when detailing a provider of services, improper promotion of off-label uses not expressly approved by the FDA in a product’s label, and allegations as to misrepresentations with respect to products, contractual

requirements, and services rendered.

In addition, private payers have been filing follow-on lawsuits alleging fraudulent misrepresentation, although establishing liability and damages in these cases is more difficult than under the FCA.

to deceive is not required to establish liability under the FCA.

Rather, a claim may be false for deliberate ignorance of the truth or falsity of the information provided or for acts in reckless disregard of the truth or falsity of that

A claim resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim.

The False Claims Act also permits a private individual acting as a “whistleblower” to bring actions on behalf of

themselves and the federal government alleging violations of the statute and to share in any monetary recovery.

Violations of the False Claims Act may result in significant financial penalties (including mandatory penalties on a per claim or

statement basis), treble damages and exclusion from participation in federal health care programs.

For these reasons, since 2004, False Claims Act lawsuits against pharmaceutical companies have increased significantly in volume and breadth,

leading to several substantial civil and criminal settlements, as much as $3.0 billion, regarding certain sales practices and promoting off label uses.

For these reasons, since 2004, False Claims Act lawsuits against pharmaceutical companies have increased significantly in volume and breadth, leading to several substantial civil and criminal settlements, as much as

$3.0 billion, regarding certain sales practices and promoting off label uses.

The government may further prosecute conduct constituting a false claim under the criminal False Claims Act.

The criminal False Claims Act prohibits the making or presenting of a claim to the government knowing such

claim to be false, fictitious, or fraudulent and, unlike the FCA, requires proof of intent to submit a false claim.

Pharmaceutical companies are subject to other federal false claim and statements laws, some of which extend to non-government health benefit programs.

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benefit program, including private third party payors, or falsifying or covering up a material fact or making any materially false or fraudulent statement in connection with the delivery of or payment for health care benefits, items or services.

Violations of HIPAA fraud provisions may result in criminal, civil and administrative penalties, fines and damages, including exclusion from participation in federal healthcare programs.

Violations of HIPAA fraud provisions may result in criminal, civil and administrative fines, penalties and damages, including exclusion from participation in federal healthcare programs.

The majority of states have adopted analogous laws and regulations, including state anti-kickback and false claims laws, that may apply to our business practices, including but not limited to, research, distribution,

sales and marketing arrangements and claims involving healthcare items or services reimbursed by any third-party payer, including private insurers.

Other states have adopted laws that, among other things, require pharmaceutical companies to

comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the U.S.

federal government, or otherwise restrict payments that may be made to healthcare providers and other potential

referral sources, and state laws and regulations that require drug manufacturers to file reports relating to pricing and marketing information, which requires tracking gifts and other remuneration and items of value provided to healthcare

professionals and entities.

In addition, some states have laws requiring pharmaceutical sales representatives to be registered or licensed, and still others impose limits on co-pay assistance that pharmaceutical companies can offer to patients.

The Physician Payment Sunshine Act requires tracking of certain payments and transfers of value to U.S.-licensed physicians and teaching hospitals and ownership interests held by physicians and their families, and

reporting to the federal government and public disclosure by the federal government of this data.

Beginning in 2022 with respect to 2021 data, reporting will also be required of information regarding payments and transfers of value provided to

physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, and certified nurse-midwives.

Other states have adopted laws and regulations that, among other things, require pharmaceutical

companies to comply with the pharmaceutical industry’s voluntary compliance guidelines with respect to interactions with healthcare professionals and the relevant compliance program guidance promulgated by the U.S.

federal government that

otherwise restrict payments that may be made to healthcare professionals and other potential referral sources, and that require drug manufacturers to file reports related to pricing and marketing information, which requires tracking price

increases and gifts and other remuneration and items of value provided to healthcare professionals and entities.

In addition, some jurisdictions have laws requiring pharmaceutical sales representatives to be registered or licensed, and still

others impose limits on co-pay assistance that pharmaceutical companies can offer to patients.

The Physician Payment Sunshine Act requires tracking of certain payments and transfers of value to U.S.-licensed physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified nurse

anesthetists and certified nurse-midwives and to U.S.

teaching hospitals, and ownership interests held by physicians and their families, and reporting to the federal government and public disclosure by the federal government of this data.

Data Protection and Privacy

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information and personal data.

The Healthcare Information Portability and Accountability Act (“HIPAA”) imposes privacy, security, breach reporting obligations, and mandatory contractual terms on covered entity health care providers, health plans,

and health care clearinghouses, as well as their “business associates” – certain persons or covered entities that create, receive, maintain, or transmit protected health information in connection with providing a specified service or performing a

function on behalf of a covered entity.

We could potentially be subject to criminal penalties if we, our affiliates, or our agents knowingly use or disclose individually identifiable health information maintained by a HIPAA-covered entity in a

manner that is not authorized or permitted by HIPAA.

The Healthcare Information Portability and Accountability Act of 1996 (“HIPAA”) imposes privacy, security, breach reporting obligations, and mandatory contractual terms on covered entity health care providers,

health plans, and health care clearinghouses, as well as their “business associates” – certain persons or covered entities that create, receive, maintain, or transmit protected health information in connection with providing a specified service

or performing a function on behalf of a covered entity.

We could potentially be subject to civil and criminal penalties if we, our affiliates, or our agents knowingly use or disclose protected health information maintained by a HIPAA-covered

entity in a manner that is not authorized or permitted by HIPAA.

Even when HIPAA does not apply, according to the Federal Trade Commission (“FTC”), failing to take appropriate steps to keep consumers’ personal information secure, or failing to provide a level of security

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The FTC’s guidance for appropriately securing consumers’ personal information is similar to,

what is required by the HIPAA Security Rule.

but less prescriptive than, what is required by the HIPAA Security Rule.

Enforcement by the FTC under the FTC Act can result in civil penalties or enforcement actions.

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health information protected by HIPAA.

Many state laws impose significant data security requirements, such as encryption or mandatory contractual terms to ensure ongoing protection of personal information.

Additionally, in California, the

California Consumer Privacy Act (“CCPA”) establishes certain requirements for data use and sharing transparency and creates new data privacy rights for California residents.

The CCPA and its implementing regulations have already been amended

multiple times since their enactment.

In November 2020, California voters approved the California Privacy Rights Act (“CPRA”) ballot initiative which introduced significant amendments to the CCPA and established and funded a dedicated California

privacy regulator, the California Privacy Protection Agency (“CPPA”).

Some state laws impose significant data security requirements, such as encryption, to ensure ongoing protection of personal information.

Additionally, in California, the California Consumer Privacy Act

(“CCPA”) establishes certain requirements for data use and sharing transparency and creates new data privacy rights for California residents.

The CCPA and its implementing regulations have already been amended multiple times since their

In November 2020, California voters approved the California Privacy Rights Act (“CPRA”) ballot initiative, which introduced significant amendments to the CCPA and established and funded a dedicated California privacy regulator, the

California Privacy Protection Agency (“CPPA”).

The amendments introduced by the CPRA go into effect on January 1, 2023, and new implementing regulations are expected to be introduced by the CPPA.

Failure to comply with the

CCPA may result in, among other things, significant civil penalties and injunctive relief, or statutory or actual damages.

In addition, California residents have the right to bring a private right of action in connection with certain types of

Failure to comply with the CCPA may result in,

among other things, significant civil penalties and injunctive relief, or statutory or actual damages.

In addition, California residents have the right to bring a private right of action in connection with certain types of security incidents.

These claims may result in significant liability and damages.

Virginia, Colorado, Connecticut and Utah have also enacted privacy laws that become effective in 2023 and are similar in many respects to the CCPA.

Activities outside of the U.S.

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Employees are responsible

to promptly report any known or suspected violations of environmental laws or any events that may result in a discharge or emissions of hazardous materials.

We manufacture, market and develop specialty plasma-derived products for the prevention

and treatment of infectious diseases in the immune compromised and other patients at risk for infection, and, as such, we consider our environmental impact to be low.

These activities do not include either industrial production or distribution,

and therefore do not use raw materials.

for promptly reporting any known or suspected violations of environmental laws or any events that may result in a discharge or emissions of hazardous materials.

We manufacture, market and develop specialty plasma-derived products for the

prevention and treatment of infectious diseases in the immune compromised and other patients at risk for infection, and, as such, we consider our environmental impact to be low.

These activities do not include either industrial production or

distribution, and therefore do not use raw materials.

Therefore, there are no significant releases into the environment or greenhouse gas emissions from our manufacturing emissions.

Further, our activities do not produce any particular noise nuisance for

staff or neighboring tenants or residents as well as wildlife surrounding our facilities and offices.

Further, our activities do not produce any particular noise

nuisance for staff or neighboring tenants or residents as well as wildlife surrounding our facilities and offices.

Annual electricity and water consumption are monitored and factored into our sustainable resource practices.

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Such filings are also available to the public on the SEC’s website at www.sec.gov.

Summary of Risk Factors

Below is a summary of the principal factors that make an investment in our common stock speculative or risky.

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.

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

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.

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

This reliance on third parties carries the risk that the services upon which we rely may not be performed in a timely

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.

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

citations or warning letters.

Business interruptions could adversely affect 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.

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.

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.

With the approval to market ASCENIV, BIVIGAM and Nabi-HB, there can be no assurance that we will be successful in further developing and expanding commercial operations or balancing our research and development activities with our

commercialization activities.

We depend on third-party researchers, developers and vendors to develop, manufacture, supply materials for or test our products and product candidates, and such parties are outside of our control.

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.

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.

Issues with product quality and compliance could have a material adverse effect upon our business, subject us to regulatory actions and cause a loss of customer confidence in us or our products.

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.

Our long-term success may depend on our ability to supplement our existing product portfolio through new product development or the in-license or acquisition of other new products, product candidates and label expansion of existing

products, and if our business development efforts are not successful, our ability to achieve profitability may be adversely impacted.

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.

Our senior credit facility with Hayfin Services LLP (“Hayfin”) is subject to acceleration in specified circumstances, which may result in Hayfin 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 damaged.

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

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

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.

We require additional funding and may be unable to raise capital in the future, which would force us to delay, curtail or eliminate one or more of our research and development programs or potentially modify our ongoing operations,

commercialization efforts and expansion plans, as well as impact the overall business plan for the organization.

The market price of our common stock may be volatile and may fluctuate in a way that is disproportionate to our operating performance.

Described below are various risks and uncertainties that may affect our business.

These risks and uncertainties are not the only ones we face.

You should recognize that other significant risks and uncertainties may

arise in the future, which we cannot foresee at this time.

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.

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 a history of losses and have historically needed to raise, and in the future may be required to raise, additional capital to operate our business.

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

control and visibility for timing of commercial product releases, continue to build out our commercial infrastructure and meet our ongoing obligations.

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 currently anticipate, based upon our projected revenue and expenditures, that our current cash, cash equivalents and accounts receivable, including the proceeds received and expected to be received from the

refinancing of our senior credit facility and the amount of remaining funds available under the distribution agreement for the sale of our common stock (see “Liquidity and Capital Resources”), will be sufficient to fund our operations, as

currently conducted, into the first quarter of 2024, at which time we believe we will begin to generate positive cash flow from operations.

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

and operational initiatives and whether or not the assumptions underlying our projected revenues and expenses are correct.

We are also continuing to evaluate a variety of strategic and financing alternatives through our ongoing engagement with

Morgan Stanley as a financial advisor.

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

If we are unable to raise additional capital if needed, we may

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 equity or debt 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.

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 if 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.

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 years ended December 31, 2021 and

2020, we incurred net losses of $71.6 million and $75.7 million, respectively.

From our inception in 2004 through December 31, 2021, we have incurred an accumulated deficit of $412.1 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 may need to continue to finance our operations through additional equity or debt financings or corporate collaboration and licensing

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;

implement additional internal systems, controls and infrastructure;

hire additional personnel;

expand and build out our plasma center network;

expand production capacity at the Boca Facility.

As a result, we will need to generate significant revenues in order to achieve and maintain profitability.

We may not be able to generate these revenues or achieve profitability in the future.

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 and Omicron variants 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.

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.

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

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

Further, in certain instances and geographic regions, we may experience decreased customer engagement (for

example, as a result of a temporary shutdown of a customer’s facilities resulting from the COVID-19 pandemic or the continuation of no in-person meetings) could impact our results of operations.

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, amongst other initiatives, we have experienced, and may experience in the future, lower than expected donor collections at our FDA-licensed plasma collection centers.

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, testing 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 than 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

and clinical product supply.

If we or any of our suppliers or manufacturers are adversely impacted by the pandemic or the restrictions resulting from the outbreak, if they or we cannot obtain the necessary supplies, or if third parties need to

prioritize other products or customers over us, including under the Defense Production Act, we may experience future delays or disruptions in our supply chain, which could have a material and adverse impact on our business.

Moreover, we, our

suppliers, and any third-party manufacturers may also need to implement measures and changes, or deviate from typical requirements, because of the pandemic that may otherwise adversely impact our supply chains or the quality of the resulting

products or supplies.

Depending on the change, we may need to obtain FDA pre-approval or otherwise provide the FDA with a notification of the change.

To the extent that we or our partners are conducting clinical trials, the pandemic could cause delays or disruptions in these or future development programs.

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.

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.

No assurances can be provided as to the timing for completion of any 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.

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, hospital admissions and delays in diagnosis of

certain health conditions 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 for or usage as well as the prescriptions of our IVIG

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

By example, in March 2020, the U.S.

Congress passed the CARES Act, which includes 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.

The CARES Act further included reporting requirements related

to the volume of products produced over the course of the year.

FDA recently issued guidance regarding this requirement.

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

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

We do not yet know the full extent of potential delays or impacts on our business, operations, or financial condition, or on

healthcare systems or the global economy as a whole.

Although the COVID-19 pandemic has not adversely affected our capital and financial resources to date, the pandemic’s effects could have a material impact on our ability to access the capital

markets as needed and on our operations and business, including those of the third parties on which we rely.

Because we are unable to determine the ultimate severity or duration of the pandemic or its effects on, among other things, the global,

national or local economies, the capital and credit markets, our workforce, our customers or our suppliers, at this time we are unable to predict whether COVID-19 will have a material adverse impact on our business, financial condition, liquidity

and results of operations.

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

This reliance on third parties carries the

risk that the services upon which we rely may not be performed in a timely 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

Third-party fill/finish providers may not perform as agreed or in accordance with FDA requirements.

Any significant problem that our fill/finish providers experience could delay or interrupt our

supply of finished drug product until the service provider cures the problem or until we locate, negotiate for, validate and receive FDA approval for an alternative provider (when necessary), if one is available.

Failure to obtain the needed

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

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:

we may be unable to identify contract fill/finishers on acceptable terms or at all because the number of potential service providers is limited and the FDA must inspect and qualify any contract manufacturers for current cGMP compliance

as part of our marketing application;

a new fill/finisher would have to be educated in, or develop substantially equivalent processes for, the production of our products and product candidates;

the COVID-19 pandemic could adversely affect our contracted fill/finishers’ operations, supply chain or workforce;

our contracted fill/finishers’ resources and level of expertise with plasma-derived biologics may be limited, and therefore they may require a significant amount of support from us in order to implement and maintain the infrastructure

and processes required to deliver our finished drug product;

our third-party fill/finishers might be unable to timely provide finished drug product in sufficient quantity to meet our commercial needs;

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;

contract manufacturers may fail to comply with applicable regulatory requirements, placing them and us at risk of regulatory enforcement actions, recalls and other adverse consequences, which may negatively impact our business and

their ability to supply products to meet our development, clinical and commercial needs;

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

our contract fill/finishers may have unacceptable or inconsistent drug product quality success rates and yields, and we have no direct control over our contract fill/finishers’ ability to maintain adequate quality control, quality

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 us or 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 supplies, 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, international conflicts, trade and sanction requirements and limits,

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

achieve the forecasted growth, our business could fail to grow at similar rates, if at all.

Market opportunity estimates and growth forecasts are subject to significant uncertainty and are based on assumptions and estimates that may not prove to be accurate, including as a result of

changing circumstances during the ongoing COVID-19 pandemic.

In particular, the size and growth of the overall U.S.

IVIG and source plasma markets are subject to significant variables that can be difficult to measure, estimate or quantify.

business depends on, among other things, successful commercialization of our existing products, market acceptance of such products and ensuring that our products are safe and effective.

Further, there can be no assurance that we will be able to

generate the revenue that we believe our products and plasma facilities are capable of generating.

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.

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 inspections,

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 may 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 FDA to not approve the use of the facility and cause us to modify certain activities identified during

the inspection.

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.

Depending on the seriousness of any findings, we or our suppliers may be subject to additional significant enforcement actions which could have a material impact

on our business.

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

We are unable to control the timing of FDA inspections, communications and

actions, and will be required to respond to the FDA and make certain submissions within certain timeframes.

We also do not know whether or not the FDA will change its requirements, guidance or expectations.

If the FDA determines that we have not

remediated the issues identified in a warning letter or any other inspection issues and deficiencies, any failure of ours to address or provide requested documentation of corrections for these issues could disrupt our business operations and the

timing of our commercialization efforts and could have a material adverse effect on our financial condition and operating results.

If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the

success of our business.

We are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal of hazardous materials and

Our commercial manufacturing and any research and development activities involve the use of biological and hazardous materials and produce hazardous waste products.

We generally contract with third parties for the disposal of these

materials and wastes.

We cannot eliminate the risk of contamination or injury from these materials, which could cause an interruption of our commercialization efforts, research and development efforts and business operations, environmental damage

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.

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.

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.

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

Business interruptions could adversely affect our business .

Our operations, including our headquarters located in Ramsey, NJ, the Boca Facility and our plasma collection facilities, are vulnerable to interruption by fire, weather related events such as hurricanes, wind and

rain, other acts of God or force majeure events, electric power loss, telecommunications failure, equipment failure, cyberattacks on our operations and information technology systems and breakdown, human error, employee issues, global health

occurrences such as the COVID-19 pandemic, and emergencies, product liability claims and events beyond our control.

While we maintain several insurance policies with reputable carriers that provide partial coverage for a variety of these risks,

including replacing or rebuilding a part of our facilities, these 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.

In addition, 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.

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.

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 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.

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

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;

determination of dosing issues;

lack of effectiveness during clinical trials;

slower than expected rates of patient recruitment;

inability to monitor patients adequately during or after treatment;

inability or unwillingness of medical investigators to follow our clinical protocols;

temporary suspension resulting from the COVID-19 pandemic.

We cannot be certain as to what type and how many clinical trials the FDA, or equivalent foreign regulatory agencies, will require us to conduct before we may successfully gain approval to market any of our product

candidates that still require FDA approval.

Prior to approving a new drug or biologic, the FDA generally requires that the effectiveness of the product candidate (which is not typically fully investigated until Phase 3) be demonstrated in two

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

prevented or delayed and our business could be adversely affected.

In addition, the FDA or an IRB may not permit us to commence a clinical trial, may require amendments to our clinical trial protocols, or may suspend our clinical trials at any time if it appears that we are exposing

participants to unacceptable health risks or if the FDA or IRB finds deficiencies in our IND submissions or the conduct of these trials.

Regulatory authorities may also not accept data from clinical trials if the trials are not conducted in

accordance with the applicable regulatory requirements.

Failure to comply with the applicable regulatory requirements may also result in enforcement actions.

Therefore, we cannot provide any assurance or predict with certainty the schedule for

future clinical trials.

In the event we do not ultimately receive regulatory approval for our product candidates, we may be required to terminate development of such product candidates.

If we fail to obtain regulatory approval to market and sell

our product candidates, or if approval is delayed, we will be unable to generate revenue from the sale of these products, our potential for generating positive cash flow will be diminished and the capital necessary to fund our operations will

If the results of our clinical trials do not support our product candidate claims, completing the development of such product candidate may be significantly delayed or we may be forced to abandon

development of such product candidate altogether.

We cannot be certain that the clinical trial results of our product candidates will support our product candidates’ claims.

Success in preclinical testing and early clinical trials does not ensure that later clinical

trials will be successful, and we cannot be sure that the results of later clinical trials will replicate the results of prior clinical trials and preclinical testing.

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.

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

Other issues that may impact our clinical trials and that could delay or prevent our ability to receive marketing approval or commercialize our product candidates, include:

Delays in reaching, or failure to reach, agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites and our CROs;

Regulators requiring us to perform additional or unanticipated clinical trials to obtain approval or becoming subject to additional post-marketing testing, surveillance, or REMS requirements to maintain regulatory approval;

Failure by our third-party contractors 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 our being required to engage in additional

clinical trial site monitoring;

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

Insufficient supply or inadequate quality of our product candidates or other materials necessary to conduct clinical trials;

Inability to achieve sufficient study enrollment, subjects dropping out or withdrawing from our studies, delays in adding new investigators or clinical trial sites or a withdrawal of clinical trial sites;

Flaws in our clinical trial design that are not discoverable until the clinical trial has progressed;

Disagreement by the FDA or comparable foreign regulatory authorities with our intended indications or study design, including endpoints, or our interpretation of data from preclinical studies and clinical trials, finding that a product

candidate’s benefits do not outweigh its safety risks or requiring that we conduct additional development or study work;

The need to make changes to our product candidates that require additional testing or that cause our product candidates to perform differently than expected;

Global trade policies that may impact our ability to obtain raw materials and/or finished product for commercialization;

FDA or comparable regulatory authorities taking longer than we anticipate to make decisions on our products or product candidates;

Potential inability to demonstrate that a product or product candidate provides an advantage over current standards of care or current or future competitive therapies in development.

In addition, our clinical trials involve a relatively small patient population.

Because of the small sample size, the results of these clinical trials may not be indicative of future results.

In addition, certain

portions of our clinical trials and product testing for our product candidates may be performed outside of the U.S., and therefore, may not be performed in accordance with standards normally required by the FDA and other regulatory agencies.

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.

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.

We cannot assure you that we will receive

the approvals necessary to commercialize any product candidate we may acquire or develop in the future.

In order to obtain FDA approval of any product candidate requiring FDA approval, our clinical development must demonstrate that the product

candidate is safe for humans and effective for its intended use, and we must successfully complete an FDA BLA review.

Obtaining FDA approval of a product candidate generally requires significant research and testing, referred to as preclinical

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.

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.

Delays in obtaining regulatory approvals may:

delay commercialization of, and our ability to derive revenues from, our product candidates;

impose costly procedures on us;

diminish any competitive advantages that we may otherwise enjoy.

Even if we comply with all FDA requests, the FDA may ultimately reject our product candidate’s BLA.

In addition, the FDA could determine that we must test additional subjects and/or require that we conduct further

studies with more subjects.

We may never obtain regulatory approval for any future potential product candidate or label expansion activity.

Failure to obtain FDA approval of any of our product candidates will severely undermine our business by

leaving us without the ability to generate additional accretive revenues.

There is no guarantee that we will ever be able to develop or acquire other product candidates.

In foreign jurisdictions, we must receive approval from the appropriate

regulatory authorities before we can commercialize any products or product candidates outside the U.S.

Foreign regulatory approval processes generally include all of the risks and uncertainties associated with the FDA review, inspection and

approval procedures described above.

We cannot assure you that we will receive the approvals necessary to commercialize any product candidate for sale outside the U.S.

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, unless

additional clinical trials are conducted successfully and the FDA approves a BLA or other required submission for review.

The FDA and other governmental authorities strictly regulate and monitor marketing, labeling and the 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 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.

While physicians in the U.S.

may choose, and are generally permitted, to prescribe drugs for uses that are not described in the product’s labeling, and for uses that differ from those tested in clinical studies and

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.

Regulatory authorities in the U.S.

generally do not regulate the behavior of physicians in their choice of treatments.

Regulatory authorities do, however, restrict communications by

pharmaceutical companies on the subject of off-label use.

If the FDA determines that our promotional activities fail to comply with the FDA’s regulations or guidelines, we may be subject to warnings from, or enforcement action by, these

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, require payment of 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.

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

with our commercialization activities.

Since receiving FDA approval for ASCENIV, we have been commercializing this product while also continuing our research and development activities.

There can be no assurance that we will be able to successfully manage

the balance of our research and development operations with our commercialization activities.

Potential investors and stockholders should be aware of the problems, delays, expenses and difficulties frequently encountered by companies balancing

development of product candidates, which can include problems such as unanticipated issues relating to clinical trials and receipt of approvals from the FDA and foreign regulatory bodies, with commercialization efforts, which can include problems

related to managing manufacturing and supply, including supply chain constraints directly or indirectly caused by the ongoing COVID-19 pandemic and government responses thereto, reimbursement, marketing challenges, development of a comprehensive

compliance program, and other related and additional costs.

For example, the raw material plasma we collect and procure to manufacture ASCENIV using our patented proprietary microneutralization assay is comprised of plasma collected from donors

which contains high titer antibodies to RSV.

This high titer plasma which meets our internal specifications for the manufacture of ASCENIV that we are able to identify with our patented testing assay amounts

to less than 10% of the total donor collection samples we test.

As a result, we may experience an insufficient supply of this plasma.

Our product candidates will require significant additional research and clinical trials, and we will need to overcome significant regulatory burdens prior to commercialization in the U.S.

and other countries.

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.

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

are, to some extent, outside of our control.

We depend on independent investigators and collaborators, such as universities and medical institutions, contract laboratories, CROs, contract manufacturers, contract fill/finishers and 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 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 ourselves.

collaborators fail to devote sufficient time and resources to our product-development programs, or if their performance is substandard, our trials may be repeated, extended, delayed, or terminated, the approval of our FDA application(s), if any,

and our introduction of new products, if any, will be delayed.

We or they may also be subject to regulatory enforcement actions and we may not be able to meet commercial demand.

These collaborators may also have relationships with other

commercial entities, some of whom may compete with us.

If our collaborators assist our competitors at our expense, our competitive position would be harmed.

Additionally, any change in the regulatory compliance status of 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 currently anticipate expanding the manufacturing capacity of our Boca Facility by approximately 50% or more.

We also anticipate expanding our production capabilities through the addition of our fill-finish machine

at our Boca Facility.

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.

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.

Our products, and any additional products for which we may obtain marketing approval in the future, could be subject to post-marketing restrictions, new FDA guidance, or other regulatory actions, such as withdrawal

from the market.

Such products, as well as the manufacturing processes, post-marketing studies and measures, labeling and advertising and promotional activities for such products, among other things, are subject to ongoing regulatory compliance

requirements, and oversight, review, and inspection by the FDA and other regulatory authorities.

These requirements include submissions of safety and other post-marketing information and reports, registration and listing requirements, adherence

with labeling and promotional requirements and restrictions, requirements relating to manufacturing, quality control, quality assurance and corresponding maintenance of records and documents, requirements regarding safeguarding the drug supply

chain as well as the distribution of samples to physicians and recordkeeping.

For example, the FDA’s approval of our PAS to allow for the commercial relaunch of BIVIGAM requires us to conduct specified post-marketing studies related to our

manufacturing controls and processes, and submit specified post-marketing reports to the FDA.

If, during the post-marketing period (after marketing approval) previously unknown adverse events, discovery that the product is less effective than

previously thought, or other potential concerns regarding our products or their manufacturing processes emerge, or we are observed in any way to fail to comply with the numerous regulatory requirements to which we are subject, those circumstances

may yield various results, including:

restrictions on such products or manufacturing processes;

restrictions on the labeling or marketing of a product;

restrictions on product distribution or use;

clinical holds or termination of clinical trials;

requirements to conduct further post-marketing studies or clinical trials, implement risk mitigation strategies, or to issue corrective information;

warning letters or untitled letters;

withdrawal of the products from the market;

refusal to approve pending applications or supplements to approved applications that we submit;

recall of products;

restrictions on coverage by third-party payers;

fines, restitution or disgorgement of profits or revenues;

suspension or withdrawal of marketing approvals;

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

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 year ended December 31, 2021, four customers, BioCare, Reliance, Curascript and AmerisourceBergen, represented an aggregate of 81% of our consolidated revenues.

For the year ended December 31, 2020, three

customers, BioCare, Reliance and Biolife Plasma Services, L.P., represented an aggregate of 82% of our consolidated revenues.

As of December 31, 2021, three customers, Curascript, BioCare and Reliance, 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.

anticipate deriving increased revenue from some of these customers over the next few years.

Factors that could influence our relationships with our customers include, among other things:

our ability to sell our products at competitive prices;

our ability to maintain features and quality standards for our products sufficient to meet the expectations of our customers;

our ability to produce and deliver a sufficient quantity of our products in a timely manner to meet our customers’ requirements;

the impact of the ongoing COVID-19 pandemic and government responses thereto on our customers and their businesses, operations and financial condition.

Additionally, an adverse change in the financial condition of any of our key customers could negatively affect revenue derived from such customer, which in turn could have a material adverse effect on our business and results of operations.

Issues with product quality and compliance could have a material adverse effect upon our business, subject us to regulatory actions and cause a loss of customer confidence in us or our products.

Our success depends upon the quality of our products.

Quality management plays an essential role in meeting customer requirements, preventing defects, improving our products and services and assuring the safety and

efficacy of our products.

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.

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.

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.

However, because our products and product candidates are

plasma-based products, not only are we subject to FDA’s drug and biologic cGMP requirements, but we are also subject to special requirements for the collection, testing, handling, storage, and use of blood products.

This adds an extra level of

compliance and complexity to our operations, which we may not be able to successfully meet.

Failure to meet any regulatory quality standards could have an adverse impact on our business.

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.

Even if the FDA approves a product made by us, physicians, payers and patients may not accept and use it.

Acceptance and use of our products depends on a number of factors including, but not limited to:

perceptions by members of the healthcare community, including physicians, about the safety and effectiveness of our products;

cost-effectiveness of our products relative to competing products;

availability of reimbursement for our products from government or other healthcare payers;

the effectiveness of marketing and distribution efforts by us and our licensees and distributors, if any.

The failure of our current or future products to find market acceptance would harm our business and could require us to seek additional financing or make such financing difficult to obtain on favorable terms, if at all.

Our long-term success may depend on our ability to supplement our existing product portfolio through new product development or the in-license or acquisition of other new products, product

candidates and label expansion of existing products, and if our business development efforts are not successful, our ability to achieve profitability may be adversely impacted.

Our current product development portfolio consists primarily of label expansion activities for Nabi-HB, BIVIGAM and ASCENIV, as well as expanding our IP estate with patents issued for S.

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

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.

Consumer privacy is highly protected by federal and state law.

The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical

Health Act of 2009 (“HITECH”), and their respective implementing regulations, impose, among other things, obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually

identifiable health information held by covered entities and business associates.

A “covered entity” is the primary type of HIPAA-regulated entity.

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 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.

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.

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.

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.

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

On March 23, 2022 (the “Hayfin Closing Date”), we entered into the Hayfin Credit Agreement with Hayfin (see “Liquidity and Capital Resources”).

Hayfin Credit Agreement provides for a senior secured term loan facility in the principal amount of up to $175.0 million (the “Hayfin Credit Facility”), composed of (i) a term loan made on the Hayfin Closing Date in the principal amount of

$150.0 million (the “Hayfin Closing Date Loan”), (ii) a delayed draw term loan in the principal amount of $25.0 million (the “Hayfin Delayed Draw Loan” and, together with the Hayfin Closing Date Loan, the “Hayfin Loans”).

The obligation of the

lenders to make the Hayfin Delayed Draw Loan expires on March 22, 2023 is subject to the satisfaction of certain conditions, including but not limited to, our meeting certain 12 - month

revenue targets as set forth in the Hayfin Credit Agreement.

The Hayfin Credit Facility has a maturity date of March 23, 2027(the “Hayfin Maturity Date”).

The Hayfin 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 control.

In addition to an increase in the rate of interest on the Hayfin Loans of 3% per annum, the occurrence of an Event of Default could result in, among other things,

the termination of commitments under the Hayfin Credit Facility, the declaration that all outstanding Loans are immediately due and payable in whole or in part, and Hayfin taking immediate possession of, and selling, any collateral securing the

Hayfin 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.

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

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.

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 damaged.

As we move forward in clinical development we are also uncovering novel aspects of our products and are drafting patents to cover our inventions.

We rely on a combination of patent rights, trade secrets and

nondisclosure and non-competition agreements to protect our proprietary intellectual property, and we will continue to do so.

There can be no assurance that our patents, trade secret policies and practices or other agreements will adequately

protect our intellectual property.

Our issued patents may be challenged, found to be over-broad or otherwise invalidated in subsequent proceedings before courts or the U.S.

Patent and Trademark Office.

Even if enforceable, we cannot provide any

assurances that they will provide significant protection from competition.

The processes, systems, and/or security measures we use to preserve the integrity and confidentiality of our data and trade secrets may be breached, and we may not have

adequate remedies as a result of any such breaches.

In addition, our trade secrets may otherwise become known or be independently discovered by competitors.

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

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

To the extent that our consultants, contractors or collaborators use intellectual property owned by others in their work for us,

disputes may arise as to the rights in related or resulting know-how and inventions.

We could lose market exclusivity of a product earlier than expected.

In the pharmaceutical and biotechnology industries, the majority of an innovative product’s commercial value is realized during its market exclusivity period.

and in some other countries, when market

exclusivity expires and generic or biosimilar versions are approved and marketed or when biosimilars are introduced (even if only for a competing product), there are usually very substantial and rapid declines in a product’s revenues.

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 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.

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 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.

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.

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.

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.

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.

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

ability to accomplish each of these factors may be negatively impacted as a consequence of the COVID-19 pandemic.

If we are unable to manage our growth effectively, our business could be harmed.

The loss of one or more key members of our management team could adversely affect our business.

Our performance is substantially dependent on the continued service and performance of our management team, who have extensive experience and specialized expertise in our business.

In particular, the loss of Adam S.

Grossman, our President and Chief Executive Officer, could adversely affect our business and operating results.

We do not have “key person” life insurance policies for any members of our management team.

We have employment agreements with each of

our executive officers;

however, the existence of an employment agreement does not guarantee retention of members of our management team and we may not be able to retain those individuals for the duration of or beyond the end of their respective

The loss of services of key personnel, or the inability to attract and retain additional qualified personnel, could result in delays in development or approval of our product candidates and diversion of management resources.

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

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 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.

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

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, including but not limited to overall increases in the cost of labor or travel restrictions related to COVID-19, prevent us

from being able to hire qualified personnel.

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.

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,

including compliance with current cGMP and blood standards and FDA and other governmental approvals, as applicable.

Failure to comply with applicable governmental regulations or to receive applicable approvals for our current or future facilities

may result in 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 material 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

FDA status for these facilities, we may be adversely affected, and may not be able to sell, manufacture or commercialize these products.

There are no assurances we will be able to maintain compliance with all FDA or other regulations.

Moreover, to the extent that we use third-party vendors to fulfill our regulatory or contractual requirements, these

third-party vendors may perform activities for themselves or other clients and we may not be privy to all regulatory findings or issues discovered by the FDA or other regulatory agencies.

Such findings, which are out of our control, may adversely

affect our ability to continue to work with these vendors, or our ability to release commercial drug product or perform necessary testing or other actions for us or our clients, which may be required in order to remain FDA compliant or to

commercialize our products.

If we are not able to maintain manufacturing compliance at our facilities or our vendors’ facilities for our products and product candidates, we may not be able to successfully develop and commercialize our products

and product candidates and we may face potential contractual or regulatory actions, which would have an adverse impact on our business.

We may incur substantial liabilities and may be required to limit commercialization of our products in response to product liability lawsuits.

The testing and marketing of medical products entail an inherent risk of product liability.

If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be

required to limit commercialization of our products.

Product liability claims may also result in recalls and/or regulatory enforcement actions.

Even successful defense, however, could impair our results of operations.

Our inability to obtain and

maintain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of pharmaceutical products we develop, either alone or with collaborators.

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.

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.

are enforceable on the federal and state levels by criminal, civil and administrative penalties.

Violations of laws such as the Federal Food, Drug, and Cosmetic Act, the

Social Security Act (including the Anti-Kickback Statute), the Public Health Service Act and the civil and criminal Federal False Claims Act, the civil monetary penalty statute, requirements regarding the reporting and repayment of overpayments,

other fraud and abuse laws and any regulations promulgated under the authority of the preceding, may result in jail sentences, fines or exclusion from federal and state programs, as may be determined by Medicare, Medicaid and HHS and other

regulatory authorities as well as by the courts.

Similarly, the violation of applicable laws, rules and regulations of states, including the State of Florida with respect to the manufacture and marketing of our products and product candidates may

result in jail sentences, fines or exclusion from applicable state programs.

There can be no assurance that our activities will not come under the scrutiny of federal and/or state regulators and other government authorities or that our practices

will not be found to violate applicable laws, rules and regulations or prompt lawsuits by private citizen “relators” under federal or state false claims laws.

For example, under the Anti-Kickback Statute and similar state laws and regulations, the offer or payment of anything of value for patient referrals, or in return for purchasing, leasing, ordering or arranging for or

recommending the purchase, lease, or ordering of any time or service reimbursable in whole or in part by a federal healthcare program is prohibited.

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.

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.

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.

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.

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

Failure to satisfy requirements under the Federal Food, Drug, and Cosmetic Act can also result in penalties, as well as requirements to enter into consent decrees or orders that prescribe allowable corporate conduct.

In addition, while regulatory authorities generally do not regulate physicians’ discretion in their choice of treatments for their patients, they do restrict communications by manufacturers on unapproved uses of approved products or on the

potential safety and efficacy of unapproved products in development.

Companies in the U.S., Canada and the European Union cannot promote approved products for other indications that are not specifically approved by the competent regulatory

authorities such as the FDA in the U.S., nor can companies promote unapproved products.

In limited circumstances, companies may disseminate to physicians information regarding unapproved uses of approved products or results of studies involving

investigational products.

If such activities fail to comply with applicable regulations and guidelines of the various regulatory authorities, we may be subject to warnings from, or enforcement action by, these authorities.

Furthermore, if such

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 sanctions.

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.

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.

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.

We will need to establish systems for collecting and reporting this data accurately to CMS and institute a compliance program to assure that the information collected is complete in all respects.

If we report pricing

information that is not accurate to the federal government, we could be subject to fines and other sanctions that could adversely affect our business.

If we choose to pursue clinical development and commercialization in the European Union or

otherwise market and sell our products outside of the U.S., we must obtain and maintain regulatory approvals and comply with regulatory requirements in such jurisdictions.

The approval procedures vary among countries in complexity and timing.

may not obtain approvals from regulatory authorities outside the U.S.

on a timely basis, if at all, which would preclude us from commercializing products in those markets.

In addition, some countries, particularly the countries of the European Union, regulate the pricing of prescription pharmaceuticals.

In these countries, pricing discussions with governmental authorities can take

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.

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

If reimbursement of our products is unavailable or limited in scope or amount, or if pricing is set at

unsatisfactory levels, in either the U.S.

or the European Union, we could be adversely affected.

Also, under the U.S.

Foreign Corrupt Practices Act, the U.S.

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.

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

Such a 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 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

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

before our products and product candidates may be lawfully marketed, and our ability to obtain regulatory approval of our products and product candidates from the FDA in a timely manner, access the public markets and obtain necessary capital in

order to properly capitalize and continue our operations may be hindered by inadequate funding for the FDA, the SEC and other state and local government agencies.

Both before and after the approval of our products, our products, operations, facilities, suppliers and CROs are subject to extensive regulation by federal, state and local governmental authorities in the U.S.

other countries, with regulations differing from country to country.

In the U.S., the FDA regulates, among other things, the pre-clinical testing, clinical trials, manufacturing, safety, efficacy, potency, labeling, storage, record keeping,

quality systems, advertising, promotion, sale and distribution of therapeutic products.

Failure to comply with applicable requirements could result in, among other things, one or more of the following actions:

notices of violation, untitled

letters, warning letters, CRLs, fines and other monetary penalties, unanticipated expenditures, delays in approval or refusal to approve a product or product candidate, product recall or seizure, interruption of manufacturing or clinical trials,

operating restrictions, injunctions and criminal prosecution.

Our products and product candidates cannot be lawfully marketed in the U.S.

without FDA and other federal, state and local business regulatory approvals.

Any failure to receive the

marketing approvals necessary to commercialize our product or product candidates could harm our business.

Additionally, the ability of the FDA and other federal, state and local business regulatory agencies to review and approve products and product candidates can be affected by a variety of factors, including government

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.

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 the

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.

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

Plasma is a raw material that is susceptible to damage and contamination and may contain human pathogens, any of which would render the plasma unsuitable as raw material for further manufacturing.

For instance,

improper storage of plasma, by us or third-party suppliers, may require us to destroy some of our raw material.

If unsuitable plasma is not identified and discarded prior to the release of the plasma to the manufacturing process, it may be

necessary to discard intermediate or finished product made from that plasma or to recall any finished product released to the market, resulting in a charge to cost of product revenue.

The manufacture of our plasma products is an extremely complex

process of fractionation, purification, testing, filling and finishing.

Our products can become non-releasable or otherwise fail to meet our stringent specifications or regulatory agencies’ specifications through a failure in one or more of these

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.

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.

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.

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.

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.

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

products cannot be entirely eliminated.

For example, since plasma-derived therapeutics involves the use and purification of human plasma, there has been concern raised about the risk of transmitting HIV, prions, West Nile virus, H1N1 virus or

“swine flu” and other blood-borne pathogens through plasma-derived products.

There are also concerns about the future transmission of H5N1 virus, or “bird flu.” In the 1980s, thousands of hemophiliacs worldwide were infected with HIV through the

use of contaminated Factor VIII.

Other producers of Factor VIII, though not us, were defendants in numerous lawsuits resulting from these infections.

New infectious diseases emerge in the human population from time to time.

If a new infectious

disease has a period during which time the causative agent is present in the bloodstream but symptoms are not present, it is possible that plasma donations could be contaminated by that infectious agent.

Typically, early in an outbreak of a new

disease, tests for the causative agent do not exist.

During this early phase, we must rely on screening of donors for behavioral risk factors or physical symptoms to reduce the risk of plasma contamination.

Screening methods are generally less

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 impaired.

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 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 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

country in which we may wish to commercialize our products.

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.

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.

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

In the event that we determine that plasma was not collected in

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.

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

administration authorities, private health maintenance organizations and health insurers and other healthcare payers, and also depends upon the approval, timing and representations by the FDA or other governmental authorities for our product

Our ability to generate product revenues will be diminished if our products sell for inadequate prices or patients are unable to obtain adequate levels of coverage.

Significant uncertainty exists as to the

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.

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.

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

The Healthcare Reform Law introduced an abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to an FDA-licensed biological product.

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.

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.

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

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.

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

manufacturer must enter into a Medicaid rebate agreement with the Secretary of HHS and pay certain rebates to the states based on utilization data provided by each state to the manufacturer and to CMS and pricing data provided by the manufacturer

to the federal government.

The states share these savings with the federal government, and sometimes implement their own additional supplemental rebate programs.

Under the Medicaid drug rebate program, the rebate amount for most branded drug

products was previously equal to a minimum of 15.1% of the Average Manufacturer Price (“AMP”) or the AMP less Best Price, whichever is greater, plus the inflation penalty if applicable.

Effective January 1, 2010, the Healthcare Reform Law

generally increased the size of the Medicaid 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, plus the

inflation penalty if applicable.

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, and the Bipartisan Budget Act of 2015 established a new inflation

penalty for these drugs.

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

These 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.

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.

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, and recent regulations have established a civil

monetary penalty for failure to refund these overcharges.

Effective in 2011, the Healthcare Reform Law imposed an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, apportioned among these entities

according to their market share in certain government healthcare programs.

These fees may adversely affect our future financial prospects and performance.

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.

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

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”).

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 others.

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 legal challenges and attempts by Congress to repeal or change the Healthcare Reform Law and the possibility of future challenges or legislative changes 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.

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.

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.

Ongoing focus on corporate responsibility matters by investors and other parties as described above may impose additional costs or

expose us to new risks.

Risks Relating to our Finances, Capital Requirements and Other Financial Matters

We require additional funding and may be unable to raise capital when needed, which would force us to delay, curtail or eliminate one or more of our research and development programs or

commercialization efforts.

Our operations have consumed substantial amounts of cash since inception.

For the years ended December 31, 2021 and 2020, we had negative cash flows from operations of approximately $112.4 million and $102.0 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 and building additional plasma collection facilities.

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

We currently anticipate, based upon our projected revenue and expenditures, that our

current cash, cash equivalents and accounts receivable, including the proceeds received and expected to be received from the refinancing of our senior credit facility, along with the remaining funds available under the distribution agreement for

the sale of our common stock (see “Liquidity and Capital Resources”), will be sufficient to fund our operations, as currently conducted, into the first quarter of 2024, at which time we believe we will begin to generate positive cash flow from

This time frame may change based upon how quickly we are able to execute on our commercialization efforts and operational initiatives and whether or not the assumptions underlying our projected revenues and expenses are correct.

are unable to raise additional capital if 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.

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.

The Hayfin Credit Facility provides for a senior secured term loan facility in an aggregate principal amount of up to $175.0 million, of which

$150.0 million has been drawn down and is currently outstanding.

Borrowings under the Hayfin Credit Facility bear interest at a rate per annum equal to 9.5% plus the greater of (i) one- or three-month SOFR as we elect and (ii) 1.25%, as more

fully described in “Liquidity and Capital Resources”;

provided, however, that upon, and during the continuance of, an Event of Default, the interest rate will automatically increase by an additional 300 basis points.

We are currently required

to make monthly payments of interest during the term of the Hayfin Credit Facility of approximately $1.1 million, with all principal and unpaid interest due at maturity.

The Hayfin Credit Facility has a maturity date of March 23, 2027, subject

to acceleration pursuant to the Hayfin Credit Agreement, including upon an Event of Default.

All of our obligations under the Hayfin 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.

If we are unable to obtain additional financing and are

otherwise unable to become profitable and generate cash from operations in the amounts necessary to repay our outstanding debt obligations when due, including as a result of the impact of the COVID-19 pandemic, our creditors would be able to

accelerate all of the amounts due and, in the case of the Hayfin Credit Facility, seek to enforce their security interests, which could lead to our creditors taking immediate possession of and selling substantially all of our assets with no

return provided to our stockholders.

Raising additional funds by issuing securities or through licensing or lending arrangements may cause dilution to our existing stockholders, restrict our operations or require us to relinquish

proprietary rights.

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.

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.

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.

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

harm our operating results, investors’ views of us and, as a result, the value of our common stock.

Pursuant to Section 404 of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”) and related rules, our management is required to report on the effectiveness of our internal control over financial reporting.

rules governing the standards that must be met for management to assess our internal control over financial reporting are complex and require significant documentation, testing and possible remediation.

To comply with the requirements of being a

reporting company under the Exchange Act, we have been required to upgrade, and may need to implement further upgrades, to our financial, information and operating systems, implement additional financial and management controls, reporting systems

and procedures and hire additional accounting and finance staff.

Consequently, we have incurred increased costs related to our compliance with Section 404 of the Sarbanes-Oxley Act and will continue to do so.

Our Audit Committee has retained the services of BDO, a Sarbanes-Oxley

advisor, to assist with our internal control over financial reporting and information technology relating to Section 404.

Moreover, if we are not able to comply with the requirements of Section 404 applicable to us in a timely manner, or if we or

our independent registered public accounting firm identifies deficiencies in our internal control over financial reporting that are deemed to be material weaknesses, the market price of our common stock could decline and we could be subject to

sanctions or investigations by the SEC or other regulatory authorities, which would require additional financial and management resources.

Our ability to use our net operating loss carryforwards (“NOLs”) may be limited.

We have incurred substantial losses during our history.

As of December 31, 2021, we had federal and state NOLs of $299.9 million and $185.0

million, respectively.

Federal and State NOLs of approximately $55.2 million and $77.8 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.

The Biotest Transaction on June 6, 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.

On October 25, 2021,

we completed a public offering of our common stock whereby we issued 57,500,000 shares of our common stock resulting in another change of ownership for ADMA under section 382 of the Code, resulting in an additional write-off of $3.0 million of

federal NOLs, $28.1 million of state NOLs and $1.0 million of research and development credits.

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

The market price of our common stock may be volatile and may fluctuate in a way that is disproportionate to our operating performance.

Our stock price may experience substantial volatility as a result of a number of factors, including:

sales or potential sales of substantial amounts of our common stock;

uncertainties in the equity markets related to the effects of the COVID-19 pandemic;

delay or failure in initiating or completing preclinical or clinical trials or unsatisfactory results of these trials;

delay in a decision by federal, state or local business regulatory authority;

the timing of acceptance, third-party reimbursement and sales of BIVIGAM and ASCENIV;

announcements about us or about our competitors, including clinical trial results, regulatory approvals or new product introductions;

developments concerning our licensors or third-party vendors;

litigation and other developments relating to our patents or other proprietary rights or those of our competitors;

conditions in the pharmaceutical or biotechnology industries;

governmental regulation and legislation;

overall market volatility;

variations in our anticipated or actual operating results;

change in securities analysts’ estimates of our performance, or our failure to meet analysts’ expectations.

Many of these factors are beyond our control.

The stock markets in general, and the market for pharmaceutical and biotechnology companies in particular, have historically experienced extreme price and volume fluctuations.

These fluctuations

often have been unrelated or disproportionate to the operating performance of these companies.

These broad market and industry factors could reduce the market price of our common stock, regardless of our actual operating performance.

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 March 18, 2022, most of our 195,920,353 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.

Sales of a substantial number of shares of our

common stock, or the perception that such sales may occur, could cause the market price of our common stock to decline or adversely affect demand for our common stock.

Our affiliates control a substantial amount of our shares of common stock.

Provisions in our Second Amended and Restated Certificate of Incorporation (the “Certificate of Incorporation”), our

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 December 31, 2021, Perceptive, Stonepine Capital Management, LLC and 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 Incorporation, our Bylaws and Delaware law may have the effect of deterring unsolicited takeovers or delaying or preventing a change in control of our Company or changes in our management, including transactions

in which our stockholders might otherwise receive a premium for their shares over then current market prices.

In addition, these provisions may limit the ability of stockholders to approve transactions that they may deem to be in their best

These provisions include:

the inability of stockholders to call special meetings;

classification of our Board and limitation on filling of vacancies could make it more difficult for a third party to acquire, or discourage a third party from seeking to acquire, control of our Company;

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.

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.

Our Board also recently adopted a short-term stockholder rights agreement with an expiration date of June 15, 2022 and an ownership trigger threshold of 10%.

This stockholder rights agreement could render more

difficult or discourage a merger, tender offer or assumption of control of the Company that is not approved by our Board.

The rights agreement, however, should not interfere with any merger, tender or exchange offer or other business combination

approved by our Board.

In addition, the rights agreement does not prevent our Board from considering any offer that it considers to be in the best interest of the Company’s stockholders.

We have never paid and do not intend to pay cash dividends in the foreseeable future.

As a result, capital appreciation, if any, will be your sole source of gain.

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.

For example, the Hayfin Credit Agreement prohibits us from paying dividends.

As a result, capital appreciation, if any, of our common stock will be your sole source of gain for the

foreseeable future.

If we fail to adhere to the strict listing requirements of the Nasdaq Global Market (“Nasdaq”), we may be subject to delisting.

As a result, our stock price may decline and our common stock may be

If our stock were no longer listed on Nasdaq, the liquidity of our securities likely would be impaired.

Our Common Stock currently trades on the Nasdaq Global Market under the symbol “ADMA.” If we fail to adhere to Nasdaq’s strict listing criteria, including with respect to stock price, market capitalization and

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.

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

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.

Penny stock regulations may affect your ability to sell our common stock.

Because the price of our common stock currently trades below $5.00 per share, our common stock is subject to Rule 15g-9 under the Exchange Act, which imposes additional sales practice requirements on broker-dealers

which sell these securities to persons other than established customers and accredited investors.

Under these rules, broker-dealers who recommend penny stocks to persons other than established customers and “accredited investors” must make a

special written suitability determination for the purchaser and receive the purchaser’s written agreement to a transaction prior to sale, which includes an acknowledgement that the purchaser’s financial situation, investment experience and

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.

The additional burdens imposed upon broker-dealers by these requirements could discourage broker-dealers from effecting transactions in our common

stock and may make it more difficult for holders of our common stock to sell shares to third parties or to otherwise dispose of them.

Our Board may, without stockholder approval, issue and fix the terms of shares of preferred stock and issue additional shares of common stock adversely affecting the rights of

holders of our common stock.

Our Certificate of Incorporation authorizes the issuance of up to 10,000,000 shares of “blank check” preferred stock, with such designation rights and preferences as may be determined from time to time by the Board.

Currently, our Certificate of Incorporation authorizes the issuance of up to 300,000,000 shares of common stock.

As of December 31, 2021, there were 87,241,078 shares remaining available for issuance, after giving effect to 16,876,015 shares of

our common stock that were subject to outstanding stock options, RSUs and warrants as of December 31, 2021 that may be issued by us without stockholder approval, as well as an additional 69,090 shares reserved for the future issuance of awards

under our equity compensation plans.

Unresolved Staff Comments

Not Applicable.

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

What changed 10-K

Item 1. Business