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Item 1. Business

2021-03-25 compared with 2020-03-13 · 453 added, 1043 removed, 95 unchanged (94% of the section changed)

Unless the context otherwise requires, references in this

Business section to “ADMA,”

“ADMA Biologics,”

the “Company,”

“we,”

“us”

and “our”

refer to ADMA Biologics, Inc., a Delaware corporation, as well as its wholly-owned and indirectly-owned subsidiaries,

ADMA Plasma Biologics, Inc., a Delaware corporation, ADMA Bio Centers Georgia Inc., a Delaware corporation (“ADMA Bio Centers”)

and ADMA BioManufacturing, LLC, a Delaware limited liability company (“ADMA BioManufacturing”).

We are an end-to-end commercial biopharmaceutical

company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient

patients at risk for infection and others at risk for certain infectious diseases.

Our targeted patient populations include immune-compromised

individuals who suffer from an underlying immune deficiency disorder or who may be immune-suppressed for medical reasons.

Unless the context otherwise requires, references in this Business section to “ADMA,” “ADMA Biologics,” the “Company,” “we,” “us” and “our” refer to ADMA Biologics, Inc., a Delaware corporation, as well as its wholly-owned and indirectly-owned subsidiaries, ADMA Plasma Biologics, Inc., a Delaware corporation, ADMA BioCenters Georgia Inc., a Delaware corporation (“ADMA BioCenters”) and ADMA BioManufacturing, LLC, a Delaware limited liability company (“ADMA BioManufacturing”).

We are an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases.

Our targeted patient populations include immune-compromised individuals who suffer from an underlying immune deficiency disorder or who may be immune-suppressed for medical reasons.

We currently have three products with U.S.

Food and Drug Administration (the “FDA”) approval, all of which are currently marketed and commercially available:

(i) BIVIGAM (Immune Globulin Intravenous, Human), an Intravenous Immune Globulin (“IVIG”) product indicated for the

treatment of Primary Humoral Immunodeficiency (“PI”), also known as Primary Immunodeficiency Disease (“PIDD”),

and for which we received FDA approval on May 9, 2019 for the commercial re-launch of the product and commenced the commercial

re-launch in August 2019;

(ii) ASCENIV (Immune Globulin Intravenous, Human –

slra 10% Liquid), previously referred to as

RI-002, 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;

and (iii) Nabi-HB (Hepatitis B Immune Globulin, Human), which is indicated for the treatment

of acute exposure to blood containing Hepatitis B surface antigen (“HBsAg”) and other listed exposures to Hepatitis

We seek to develop a pipeline of plasma-derived therapeutics, including a product based on our most recently approved patent

application under U.S.

Food and Drug Administration (the “FDA”) approval, all of which are currently marketed and commercially available:

(i) BIVIGAM (Immune Globulin Intravenous, Human), an Intravenous Immune Globulin (“IVIG”) product indicated for the treatment of Primary Humoral Immunodeficiency (“PI”), also known as Primary Immunodeficiency Disease (“PIDD”), and for which we received FDA approval on May 9, 2019 and commenced 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;

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.

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

We manufacture our products at an FDA-licensed,

400,000-liter annual capacity plasma fractionation and purification facility located in Boca Raton, Florida (the “Boca Facility”).

Based on current production yields, we believe this facility has the potential to produce quantities of our immune globulin (“IG”)

products capable of generating up to $250 million in annual revenue as we ramp-up production over the next three to five years.

Through ADMA Bio Centers, we currently operate

one FDA-approved source plasma collection facility in the U.S., which provides us with a portion of our blood plasma for the manufacture

of our products and product candidates.

We intend to open five to 10 additional plasma collection centers in the U.S.

next three to five years.

A typical plasma collection center, such as those operated by ADMA Bio Centers, 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 Bio Centers’

facilities that is not used

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

and in other locations outside

where we are approved under supply agreements or in the open “spot”

We also sell plasma-derived intermediate

fractions to certain customers, which are generated as part of our FDA-approved manufacturing process for IVIG products.

2020, we announced our entry into a five-year manufacturing and supply agreement to produce and sell these intermediate by-products,

which are used as the starting raw material to produce other plasma-derived biologics.

In addition, from time to time we provide

contract manufacturing services for certain third-party clients.

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.

We manufacture these products at our FDA-licensed, 400,000-liter annual capacity plasma fractionation and purification facility located in Boca Raton, Florida (the “Boca Facility”).

Based on current production yields and our ongoing supply chain enhancement and capacity expansion initiatives, we believe this facility has the potential to produce quantities of our immune globulin (“IG”) products of more than $250 million in annual revenue beginning in 2024 as well as achieving profitability during the first quarter of 2024, as we ramp-up production over the next three to five years.

Through our ADMA BioCenters subsidiary, we currently operate as an FDA-approved source plasma collection organization 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 opened two new plasma collection centers during 2020, and we now have seven plasma collection centers in various stages of development and approval, including three that are fully operational and collecting plasma.

With respect to our fully operational plasma collection centers, two hold FDA licenses and the third has a Biologics License Application (“BLA”) pending an FDA decision expected in the fourth quarter of 2021.

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 implement a Hepatitis B immunization program.

After giving effect to the progress we made in 2020 with our plasma collection network expansion, we believe we remain on track to achieve our goal of having 10 or more plasma collection centers in operation by 2024.

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.

and in other locations outside the U.S.

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

We sell plasma-derived intermediate fractions to certain customers, which are generated as part of our FDA-approved manufacturing process for IG and IVIG products.

In January 2020, we announced our entry into a five-year manufacturing and supply agreement to produce and sell these intermediate by-products, which are used as the starting raw material to produce other plasma-derived biologics.

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 upon FDA approval and implementation of our in-house fill-finish capabilities through our Vanrx SA25 Workcell aseptic filling machine.

Recent Developments

On February 11, 2020, we completed an underwritten

public offering of 23,500,000 shares of our common stock for gross proceeds of $82.3 million.

On February 21, 2020, we sold an

additional 3,525,000 shares pursuant to the underwriters’

exercise of their option to purchase additional shares of our common

stock for additional gross proceeds of $12.3 million.

We received net proceeds, after underwriting discounts and other expenses

associated with the offering, of approximately $88.5 million.

In January 2020, we announced our entry

into a five-year manufacturing and supply agreement with a third-party customer to produce and sell plasma-derived intermediate

fractions from our FDA-approved IG manufacturing process.

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.

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.

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.

On August 5, 2020, we entered into an Open Market Sale Agreement (the “Sale Agreement”) with Jefferies LLC (“Jefferies”), pursuant to which we could offer and sell, from time to time, at our option, through or to Jefferies, up to an aggregate of $50 million of shares of the Company’s common stock (see “Liquidity and Capital Resources”).

On November 5, 2020, we and Jefferies amended the Sale Agreement to provide for an increase in the aggregate offering amount under the Sale Agreement such that, as of November 5, 2020, the Company could sell shares having an additional aggregate offering price of up to $20 million.

On February 3, 2021, we entered into an additional amendment to the Sale Agreement to provide for an additional increase in the aggregate offering amount under the Sale Agreement to allow us to sell shares having an additional aggregate offering price of up to $35.4 million.

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.

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.

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 disorders.

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.

BPC had originally received FDA approval

for BIVIGAM on December 19, 2012, prior to our acquisition of BTBU, and product sales had commenced in the first quarter of 2013.

On May 9, 2019, the FDA approved our 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.

We resumed production of BIVIGAM during the

fourth quarter of 2017 after the closing of the Biotest Transaction and commercial production is ongoing, using our FDA-approved

IVIG manufacturing process under U.S.

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

The commercial

re-launch and first commercial sales commenced in August of 2019.

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 viruses and prevent against infection and disease.

We manufacture ASCENIV under a HHS License No.

a process known as fractionation.

As part of our proprietary manufacturing process for ASCENIV, we leverage our unique, patented

plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma and plasma from donors

tested to have high levels of neutralizing titers to RSV using our proprietary microneutralization assay.

We are able to identify

the high titer plasma that meets our internal specifications for ASCENIV with our patented testing assay.

This type of high titer

plasma is typically found in less than 10% of the total donor collection samples we test.

ASCENIV is approved for the treatment of

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.

We plan to work with the FDA and the immunology

and infectious disease community to design a clinical trial to evaluate the use of ASCENIV in this patient population in the near

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 commence commercial sales of this product in the United States.

We resumed production of BIVIGAM during the fourth quarter of 2017 and commercial production is ongoing, using our FDA-approved IVIG manufacturing process under FDA License No.

Commercial sales for this product commenced in August of 2019.

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 viruses, and prevent against infection and disease.

We manufacture ASCENIV under FDA License No.

2019 using a process known as fractionation.

The Centers for Medicare and Medicaid Services (“CMS”) has issued a permanent, product-specific J-code for ASCENIV.

Under the Healthcare Common Procedure Coding System (“HCPCS”), the J-code (J1554) will become effective April 1, 2021 and will replace the currently issued C-code for ASCENIV (C9072), which can continue to be utilized in the interim for reimbursement purposes.

As part of our proprietary manufacturing process for ASCENIV, we leverage our unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma and plasma from donors tested to have high levels of neutralizing antibody titers to respiratory syncytial virus (“RSV”) using our proprietary microneutralization testing assay.

We are able to identify the high titer or “hyperimmune” plasma that meets our internal and required specifications for ASCENIV with our patented testing methods and assay.

This type of high titer plasma is typically found in less 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.

We plan to work with the FDA and the immunology and infectious disease community to design a clinical trial to evaluate the use of ASCENIV in this patient population in the near future.

Commercial sales of ASCENIV commenced in October of 2019.

Nabi-HB is a hyperimmune globulin that is

rich in antibodies to the Hepatitis B virus.

Nabi-HB is a purified human polyclonal antibody product collected from plasma donors

who have been previously vaccinated with a Hepatitis B vaccine.

Nabi-HB is indicated for the treatment of acute exposure to blood

containing HBsAg, prenatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household

exposure to persons with acute Hepatitis B virus infection in specific, listed settings.

Hepatitis B is a potentially life-threatening

liver infection caused by the Hepatitis B virus.

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

Nabi-HB is a purified human polyclonal antibody product collected from plasma donors who have been previously vaccinated with a Hepatitis B vaccine.

Nabi-HB is indicated for the treatment of acute exposure to blood containing HBsAg, prenatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute Hepatitis B virus infection in specific, listed settings.

Hepatitis B is a potentially life-threatening liver infection caused by the Hepatitis B virus.

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.

Nabi-HB has a well-documented record of long-term safety and effectiveness

since its initial market introduction.

FDA approval for Nabi-HB was received on March 24, 1999.

Biotest acquired Nabi-HB from Nabi

Biopharmaceuticals in 2007.

Production of Nabi-HB at the Boca Facility has continued under our leadership since the third quarter

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 continue to manufacture under HHS License No.

It can cause chronic infection and puts 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.

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 FDA License No.

We are currently working on bringing fill-finish capabilities for Nabi-HB in-house and anticipate a potential FDA decision during 2021.

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 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.

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

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 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 $6.8 billion in 2018, and approximately $14 billion in 2025 based upon anticipated compounded annual growth

rate of approximately 11%.

ASCENIV contains polyclonal antibodies against

various infectious agents, such as streptococcus pneumoniae, H.

influenza type B, CMV, measles and tetanus, including standardized

antibodies against RSV.

sales of immune and hyperimmune globulin products for all its uses were reported to be approximately $8.1 billion in 2019 and are expected to reach approximately $13.9 billion in 2025 based upon an anticipated compounded annual growth rate of approximately 11%.

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

influenza type B, CMV, measles and tetanus, including standardized antibodies against RSV.

RSV is a common respiratory virus that often presents during the winter months.

Nearly all children will

have been infected with RSV by three years of age;

however, the immune systems of most healthy children prevent significant morbidity

and mortality.

Conversely, in patients who are immune-compromised, such as those with PIDD or who have undergone a hematopoietic

stem cell or solid organ transplant and may be on immunosuppressive drugs or chemotherapy, RSV infection can be associated with

significant morbidity and mortality.

Immune-compromised patients historically have a 5% to 15% rate of RSV infection, and, if left

untreated, lower respiratory tract RSV infections in immune-compromised patients can result in a mortality rate of up to 40% of

infected patients.

In hematopoietic stem cell transplant (“HSCT”) patients, a subset of the immune-compromised patient

population with approximately 25,000 transplants being performed annually in the U.S., it is estimated that about 25% of patients

treated with the current standard of care (aerosolized Ribavirin) will progress to Lower Respiratory Tract Infection (“LRTI”)

while 41% of patients untreated with the current standard of care will progress to LRTI.

The RI-002 pivotal Phase III clinical trial

was conducted as a single arm study in which patients were treated approximately once per month for a period of 12 months plus

90 days for follow up.

Nearly all children will have been infected with RSV by three years of age;

however, the immune systems of most healthy children prevent significant morbidity and mortality.

Conversely, in patients who are immune-compromised, such as those with PIDD or who have undergone a hematopoietic stem cell or solid organ transplant and may be on immunosuppressive drugs or chemotherapy, RSV infection can be associated with significant morbidity and mortality.

Immune-compromised patients historically have a 5% to 15% rate of RSV infection, and, if left untreated, lower respiratory tract RSV infections in immune-compromised patients can result in a mortality rate of up to 40% of infected patients.

In hematopoietic stem cell transplant (“HSCT”) patients, a subset of the immune-compromised patient population with approximately 25,000 transplants being performed annually in the U.S., it is estimated that about 25% of patients treated with the current standard of care (aerosolized Ribavirin) will progress to Lower Respiratory Tract Infection (“LRTI”) while 41% of patients untreated with the current standard of care will progress to LRTI.

The RI-002 pivotal Phase III clinical trial was conducted as a single arm study in which patients were treated approximately once per month for a period of 12 months plus 90 days for follow up.

Fifty-nine patients 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 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

RI-002 demonstrated positive results in

the Phase III study in patients with PIDD, meeting its primary endpoint of no SBIs reported.

RI-002 was administered in a total

of 793 infusions with zero serious adverse events to 59 patients in nine treatment centers throughout the U.S.

These results, included

in our BLA, exceed the requirement specified by FDA guidance of ≤

1 SBI 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:

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 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.

RI-002 demonstrated positive results in the Phase III study in patients with PIDD, meeting its primary endpoint of no SBIs reported.

RI-002 was administered in a total of 793 infusions with zero serious adverse events to 59 patients in nine treatment centers throughout the U.S.

These results, included in our BLA, exceed the requirement specified by FDA guidance of ≤ 1 SBI 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:

a total of 93 days, or 1.66 days per patient per year lost from work or school due to infection;

one hospitalization due to an

infection of only five days duration in the entire study and Immune Globulin (“IgG”) trough levels above those required

by the FDA for IVIG products.

Additionally, there was a marked increase in all of the measured specific anti-pathogen antibodies

in PK subjects (n=31).

The mean of maximum fold increases in specific antibody levels after infusion of RI-002 ranged from 1.9

pneumonia type 19A) to 5.3 fold (RSV), which were statistically significant fold increases from the pathogen's specific

measured baselines.

one hospitalization due to an infection of only five days duration in the entire study and Immune Globulin (“IgG”) trough levels above those required by the FDA for IVIG products.

Additionally, there was a marked increase in all of the measured specific anti-pathogen antibodies in PK subjects (n=31).

The mean of maximum fold increases in specific antibody levels after infusion of RI-002 ranged from 1.9 fold (S.

pneumonia type 19A) to 5.3 fold (RSV), which were statistically significant fold increases from the pathogen's specific measured baselines.

The safety profile of ASCENIV is comparable to that of other immunoglobulins.

Rationale for the Potential Evaluation of ASCENIV in RSV-Infected

RSV is a common virus that ordinarily leads

to mild, cold-like symptoms in healthy adults and children.

In high-risk groups, such as the PIDD population and the other immune-compromised

populations, RSV can lead to a more serious infection and may even cause death.

The polyclonal antibodies that are present in ASCENIV

are expected to prevent infections in immune-compromised patients.

In October 2019, we announced the successful

treatment of ASCENIV in two children through our compassionate use program.

The two immunocompromised children admitted to the

Mayo Clinic each were diagnosed with T-cell lymphoblastic lymphoma.

Both patients were undergoing delayed intensification chemotherapy

and each were diagnosed with RSV Lower Respiratory Tract Infection (“LRTI”).

Both children were treated with ASCENIV™

under an emergency United States Food and Drug Administration (“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.

Evaluation of ASCENIV in RSV-Infected Patients

RSV is a common virus that ordinarily leads to mild, cold-like symptoms in healthy adults and children.

In high-risk groups, such as the PIDD population and other immune-compromised populations, RSV can lead to a more serious infection and may even cause death.

The polyclonal antibodies that are present in ASCENIV are expected to prevent infections in immune-compromised patients.

In October 2019, we announced the successful treatment of ASCENIV in two children suffering with RSV through our compassionate use program.

The two immunocompromised children admitted to the Mayo Clinic each were diagnosed with T-cell lymphoblastic lymphoma.

Both patients were undergoing delayed intensification chemotherapy and each were diagnosed with RSV Lower Respiratory Tract Infection (“LRTI”).

Both children were treated with ASCENIV™ under an emergency United States Food and Drug Administration (“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.

This trial was conducted with 21 patients in the U.S., Canada, Australia, and New Zealand.

dose-ranging trial demonstrated a statistically significant improvement in the change from baseline RSV titers to day 18 in the

high dose and low dose treatment groups when compared with placebo (p=0.0043 and p=0.0268, respectively).

The mean fold increase

for high dose was 9.24 (95% CI 4.07, 21.02) and the observed mean fold increase for low dose was 4.85 (95% CI 2.22, 10.59).

mean fold change for placebo treated patients was 1.42 (95% CI 0.64, 3.17).

In addition, more patients in the high dose (85.7%)

and low dose (42.9%) groups experienced greater than a four-fold increase from baseline to day 18 in RSV titer levels compared

to placebo (0%).

The Phase II dose-ranging trial demonstrated a statistically significant improvement in the change from baseline RSV titers to day 18 in the high dose and low dose treatment groups when compared with placebo (p=0.0043 and p=0.0268, respectively).

The mean fold increase for high dose was 9.24 (95% CI 4.07, 21.02) and the observed mean fold increase for low dose was 4.85 (95% CI 2.22, 10.59).

The mean fold change for placebo treated patients was 1.42 (95% CI 0.64, 3.17).

In addition, more patients in the high dose (85.7%) and low dose (42.9%) groups experienced greater than a four-fold increase from baseline to day 18 in RSV titer levels compared to placebo (0%).

There were no serious drug-related adverse events reported during the trial.

From April 2009 through February 2011, RI-001

was also administered to 15 compassionate use patients where physicians requested access to the product for treating their patients

with documented lower respiratory tract RSV infections due to the fact that these patients had failed conventional therapeutic

interventions.

From April 2009 through February 2011, RI-001 was also administered to 15 compassionate use patients where physicians requested access to the product for treating their patients with documented lower respiratory tract RSV infections due to the fact that these patients had failed conventional therapeutic interventions.

Serum samples were obtained from 13 patients.

Samples showed that patients demonstrated a four-fold or greater rise

in RSV antibody titers from baseline.

Samples showed that patients demonstrated a four-fold or greater rise in RSV antibody titers from baseline.

Serum samples were not obtained from two patients that received Palivizumab.

All 11 surviving

patients received RI-001 within an average of 4.4 days after the onset of the diagnosis of RSV.

The drug was well-tolerated in

all 15 patients and there were no reports of serious adverse events attributable to RI-001.

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.

Based on these results, we intend to evaluate

ASCENIV for the treatment of RSV patients for treatment of PIDD.

Manufacturing and Supply of Our Products

In order to produce plasma-derived immunoglobulin

products, raw material plasma is collected from human donors and then manufactured into specialized products.

Historically, plasma

for our products and product candidates has been collected from healthy donors at FDA-licensed plasma donation centers.

under proper conditions, this plasma may have a shelf-life of up to 10 years.

Source plasma is collected at any one of over 700

FDA-licensed donation centers located throughout the U.S., using a process known as automated plasmapheresis.

This sterile, self-contained,

automated process separates red blood cells and other cellular components in the blood, which are then returned to the donor.

plasma obtained by plasmapheresis is tested and must be negative for antibodies to human immunodeficiency virus types 1 and 2 (HIV-1/2),

HBsAg and Hepatitis C virus (“HCV”), using FDA-licensed serological test procedures.

After receipt of the source plasma, the

frozen plasma is thawed and pooled and goes through the fractionation process.

This process is referred to as the Cohn method or

cold ethanol method of fractionation.

During cold ethanol fractionation, classes of proteins are precipitated and removed by centrifugation

or filtration.

The fractionation process includes the following steps;

precipitation and absorption, depth filtration, centrifugation

and chromatography.

Because of the human origin of the raw material and the thousands of donations required in the fractionation

process, a significant risk associated with plasma products is the transmission of blood-borne infectious pathogens.

These purification

processes have the potential to reduce the viral load.

The manufacturing process also utilizes a multistep viral removal/inactivation

system, which further increases the safety of the products.

The following manufacturing processes have been validated for their

capability to eliminate or inactivate viruses:

precipitation during cold ethanol fractionation, solvent/detergent treatment and

nanofiltration.

We incorporate these processes into the manufacturing process 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 nine to 12 months for a batch of FDA

released drug product.

Sales and Commercialization of Our Products

Currently, BIVIGAM, ASCENIV and Nabi-HB

are sold primarily through independent distributors, drug wholesalers acting as sales agents, specialty pharmacies and other alternate

site providers.

In the U.S., independent distributors or third-party drug wholesalers ship our products through their distribution

These centers are generally stocked with adequate inventories to facilitate prompt customer service.

Sales and distribution

methods include frequent contact by sales and customer service representatives, automated communications via various electronic

purchasing systems, circulation of catalogs and merchandising bulletins, direct-mail campaigns, trade publication presence and

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.

We also anticipate 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.

Pharmaceutical Pricing and Reimbursement of Our Products

All sales in the U.S.

of BIVIGAM, ASCENIV

and Nabi-HB depend in part upon the availability of reimbursement from third-party payers.

Third-party payers include government

health programs, managed care providers, private health insurers and other organizations.

Nabi-HB and BIVIGAM are reimbursed or

purchased under several government programs, including Medicaid, Medicare Parts B and D, the 340B/Public Health Service program,

and pursuant to an existing contract with the Department of Veterans Affairs.

Medicaid is a joint state and federal government

health plan that provides covered outpatient prescription drugs for low-income individuals.

Under Medicaid, drug manufacturers

pay rebates to the states based on utilization data provided by the states.

All 11 surviving patients received RI-001 within an average of 4.4 days after the onset of the diagnosis of RSV.

The drug was well-tolerated in all 15 patients and there were no reports of serious adverse events attributable to RI-001.

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.

Based on these results, we intend to evaluate ASCENIV for the treatment of RSV or other respiratory viral pathogens in immunocompromised patients.

Plasma Collection Operations

ADMA Bio Centers operates an FDA-licensed

source plasma collection facility located the U.S.

that provides us with a portion of our blood plasma for the manufacture of our

products and product candidates.

As part of our plans for expansion, we intend to initiate the buildout of additional plasma centers

A typical plasma collection center, such as those operated by ADMA Bio Centers, 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 Bio Centers’

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”

ADMA BioCenters has seven source plasma collection facilities in various stages of operations or development.

We are actively operating and collecting plasma at three source plasma collection facilities located in the U.S., two 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 our third facility is pending FDA approval.

In addition, 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.

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.

Acquisition Transaction with Biotest Pharmaceuticals Corporation

On June 6, 2017, we completed the acquisition

of certain assets (the “Biotest Assets”) of the Therapy Business Unit (“BTBU”) of Biotest Pharmaceuticals

Corporation (“BPC”

and, together with Biotest AG, “Biotest”), which included two FDA-licensed products,

Nabi-HB and BIVIGAM, and the Boca Facility (the “Biotest Transaction”).

Immediately following the acquisition, the

Biotest Assets were contributed into ADMA BioManufacturing.

In connection with the closing of the Biotest

Transaction, Biotest provided us with an aggregate of $40.0 million of funding.

Upon the closing of the Biotest Transaction, we

received $27.5 million from Biotest, consisting of $12.5 million in cash from BPC and a $15.0 million subordinated note at 6% interest

payable to Biotest with a maturity of five years.

Biotest also participated in our November 2017 follow-on equity offering by investing

$12.5 million of the $42.0 million of total gross proceeds from that offering.

At the closing of the Biotest Transaction,

we delivered to BPC an aggregate equity interest equal to 50%, less one share, of our then-issued and outstanding capital stock

comprised of 25%, or 4,295,580 shares, of our then-issued and outstanding voting common stock, $0.0001 par value per share (“Common

Stock”), which shares are currently held by the Biotest Divestiture Trust (the “Biotest Trust”) and registered

for resale under an effective Registration Statement on Form S-3, and 8,591,160 shares in the form of our then-authorized non-voting

common stock, $0.0001 par value per share (the “NV Biotest Shares”).

The NV Biotest Shares were convertible into our

Common Stock upon the occurrence of certain specified events.

As part of the purchase price to acquire the Biotest Assets,

we also transferred ownership of two of our plasma collection facilities to BPC on January 1, 2019.

On May 14, 2018, we entered into a Share

Transfer, Amendment and Release Agreement with BPC, Biotest AG, Biotest U.S.

Corporation and the “Biotest Trust”

“Biotest Transfer Agreement”) whereby BPC transferred to us, for no cash consideration, the NV Biotest Shares.

upon transfer of the NV Biotest Shares to us, the NV Biotest Shares were retired and are no longer available for issuance.

retired NV Biotest Shares comprised approximately 67% of the total common stock consideration provided to Biotest and approximately

19% of the total outstanding common stock of the Company as of May 14, 2018.

In exchange for the transfer and retirement of the

NV Biotest Shares, we (i) granted Biotest and its successors and assigns a release from all potential past, present and future

indemnity claims arising under the Master Purchase and Sale Agreement, dated as of January 21, 2017 (the “Master Purchase

Agreement”), which governs the Biotest Transaction, and (ii) relinquished our rights to, under certain circumstances, repurchase

the two FDA-approved plasma collection centers which were transferred to BPC on January 1, 2019.

In addition, pursuant to the Biotest

Transfer Agreement, BPC waived and terminated its rights to name a director and an observer to our Board of Directors (the “Board”).

In connection with the U.S.

Government-required divestiture of all of BPC’s U.S.

assets as a result of the sale of Biotest

AG to CREAT Group Corporation, pursuant to the Biotest Transfer Agreement BPC transferred its remaining 10,109,534 shares of our

Common Stock to the Biotest Trust on July 24, 2018, and the Biotest Trust is bound by all obligations of and has all of the remaining

rights of BPC under that certain Stockholders Agreement dated as of June 6, 2017, by and between us and BPC, as amended by the

Biotest Transfer Agreement (the “Stockholders Agreement”).

Prior to the closing of the Biotest Transaction,

the BTBU was our third-party manufacturer for ASCENIV.

In the third quarter of 2015, the FDA accepted for review our BLA for ASCENIV

(the “RI-002 BLA”) for the treatment of PIDD.

In July 2016, the FDA issued a CRL (the “RI-002 CRL”).

RI-002 CRL reaffirmed the issues set forth in a November 2014 warning letter (the “Warning Letter”) that had been issued

by the FDA to Biotest related to certain issues identified at the Boca Facility, but did not cite any concerns with the clinical

safety or efficacy data for ASCENIV submitted in our RI-002 BLA, nor did the FDA request any additional clinical studies be completed

prior to FDA approval of ASCENIV.

The FDA identified in the RI-002 CRL, among other things, certain outstanding inspection issues

and deficiencies related to chemistry, manufacturing and control (“CMC”) matters and Good Manufacturing Practices (“GMP”)

at the Boca Facility and at certain of our third-party vendors, and requested documentation of corrections for a number of these

The FDA indicated in the RI-002 CRL that it cannot grant final approval of our RI-002 BLA until, among other things, these

deficiencies are resolved.

Upon the completion of the Biotest Transaction, we gained control over the regulatory, quality, general

operations and drug substance manufacturing process at the Boca Facility.

In April 2018, we completed an FDA inspection and as

a result of the inspection, our Boca Facility’s regulatory compliance status improved from Official Action Indicated (“OAI”)

to Voluntary Action Indicated (“VAI”), allowing us to submit regulatory applications to the FDA for review.

the second quarter of 2019, we received FDA approval of the respective submissions for both ASCENIV and BIVIGAM, and the transfer

of the BIVIGAM and Nabi-HB licenses from BPC to us was completed on July 2, 2019.

Our goal is to be a leader in manufacturing,

marketing and developing specialized, targeted, plasma-derived therapeutics that are intended to extend and enhance the lives of

individuals who are naturally or medically immune-compromised.

The key elements of our strategy for achieving this goal are as

On June 6, 2017, we completed the acquisition of certain assets (the “Biotest Assets”) of the Therapy Business Unit (“BTBU”) of BPC Plasma, Inc.

(formerly Biotest Pharmaceuticals Corporation (“BPC”), together with Biotest AG, “Biotest”), which included two FDA-licensed products, Nabi-HB and BIVIGAM, and the Boca Facility (the “Biotest Transaction”).

Immediately following the acquisition, the Biotest Assets were contributed into ADMA BioManufacturing.

Upon the completion of the Biotest Transaction, we gained control over the regulatory, quality, general operations and drug substance manufacturing process at the Boca Facility.

In April 2018, we completed an FDA inspection and as a result of the inspection, our Boca Facility’s regulatory compliance status improved from Official Action Indicated (“OAI”) to Voluntary Action Indicated (“VAI”), allowing us to submit regulatory applications to the FDA for review.

During the second quarter of 2019, we received FDA approval of the respective submissions for both ASCENIV and BIVIGAM, and the transfer of the BIVIGAM and Nabi-HB licenses from BPC to us was completed on July 2, 2019.

Our goal is to be a leader in manufacturing, marketing and developing specialized, targeted, plasma-derived therapeutics that are intended to extend and enhance the lives of individuals who are naturally or medically immune-compromised.

The key elements of our strategy for achieving this goal are as follows:

Continue to expand the commercial production of our IG products, as well as the commercial presence, penetration and sales of BIVIGAM and ASCENIV for the treatment of patients with PI .

We plan to enhance our recruiting initiatives and expand our existing specialty commercial sales force to market BIVIGAM and ASCENIV to home healthcare infusion facilities, hospitals, physician offices/clinics and other specialty treatment and infusion center organizations.

Subject to the restrictions surrounding COVID-19, we plan to enhance our recruiting initiatives and expand our existing specialty commercial sales force to market BIVIGAM and ASCENIV to home healthcare infusion facilities, hospitals, physician offices/clinics and other specialty treatment and infusion center organizations.

We also anticipate staffing our Company with additional personnel for patient support, medical affairs, quality assurance, regulatory affairs, scientific affairs and third-party reimbursement.

We may also use 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.

Increase marketing efforts around Nabi-HB.

We plan to increase our marketing efforts and attend relevant medical conferences during 2020, raising awareness of the risks associated with Hepatitis B and the benefits and efficacy of Nabi-HB in its indicated populations.

Expand ASCENIV’s FDA-approved uses .

Subject to the restrictions surrounding COVID-19, we plan to increase our marketing efforts and attend relevant virtual or in-person medical conferences during 2021, raising awareness of the risks associated with Hepatitis B and the benefits and efficacy of Nabi-HB in its indicated populations.

Expand ASCENIV’s FDA-approved uses .

Having received approval by the FDA for ASCENIV as a treatment for PIDD, we plan to evaluate the clinical and regulatory paths to grow the ASCENIV franchise through expanded FDA-approved uses.

We believe that there may be patient populations beyond PIDD that would derive clinical benefit from ASCENIV, some of which may be eligible for orphan status.

We plan to leverage our previously conducted randomized, double-blind, placebo-controlled Phase II clinical trial evaluating RI-001, RI-002’s predecessor product candidate, in immune-compromised, RSV-infected patients to explore ASCENIV for the treatment of RSV.

Increase the Boca Facility’s manufacturing capacity, operating efficiency and gross margins.

During 2020, we plan to execute on our capacity optimization plan to increase the Boca Facility’s manufacturing capacity, operating efficiency and gross margins.

We believe that there may be patient populations beyond PIDD that would derive clinical benefit from ASCENIV, some of which may potentially be eligible for orphan status.

Increase the Boca Facility’s manufacturing capacity, operating efficiency and gross margins.

During 2021, we plan to execute on the capacity optimization efforts we put in place during 2020 to increase the Boca Facility’s manufacturing capacity, operating efficiency and gross margins.

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.

During 2020, we successfully implemented several manufacturing and supply chain enhancements, including the purchase and installation of a new Vanrx SA25 Workcell aseptic filling machine.

Both the capacity expansion and fill finish projects are pending FDA approval, which is anticipated to occur in the middle of 2021.

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

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Utilizing our intellectual property patents, which include our proprietary testing assay and other standardization methods and technologies, we have identified potential new product candidates that we may advance into preclinical activities.

Develop and expand ADMA Bio Centers .

Over the next three to five years, we plan on expanding our plasma collection network through opening an additional five to 10 plasma collection facilities throughout the U.S.

to potentially bolster our long-term raw material supply and prepare for production ramp-up and growth to capitalize on the global growing IVIG and source plasma markets, including obtaining FDA licenses for each new plasma collection center and regulatory approval in additional jurisdictions.

Secure new supply contracts for potential contract manufacturing organization (“CMO”) opportunities.

We are exploring new potential CMO and business development opportunities with our multi-faceted revenue generation platform, while continuing to fulfill our newly secured, long-term CMO supply agreement to produce and sell plasma-derived intermediate fractions.

Develop and expand our plasma collection center network .

We plan on expanding our plasma collection network with the goal of having 10 or more plasma collection facilities operating in the U.S.

by 2024 to potentially bolster our long-term raw material supply and prepare for production ramp-up and growth to capitalize on the global growing IVIG and source plasma markets, including obtaining FDA licenses for each new plasma collection center and regulatory approval in additional jurisdictions.

Secure new supply contracts for potential contract manufacturing organization (“CMO”) opportunities.

We are exploring new potential CMO, contract testing and business development opportunities with our multi-faceted revenue generation platform, while continuing to fulfill our newly secured, long-term CMO supply agreement to produce and sell plasma-derived intermediate fractions.

Primary Immunodeficiency Disease

PIDD is a class of hereditary disorders

characterized by defects in the immune system, due to either a lack of necessary antibodies or a failure of these antibodies to

function properly.

PIDD is a class of hereditary disorders characterized by defects in the immune system, due to either a lack of necessary antibodies or a failure of these antibodies to function properly.

According to the World Health Organization, there are over 150 different presentations of PIDD.

suffering from PIDD lack a properly functioning immune system, they typically receive monthly, outpatient infusions of IVIG therapy.

As patients suffering from PIDD lack a properly functioning immune system, they typically receive monthly, outpatient infusions of IVIG therapy.

Without this exogenous antibody immune support, these patients would be susceptible to a wide variety of infectious diseases.

has an estimated prevalence of 1:1,200 in the U.S., or approximately 250,000 people.

Of these 250,000 people diagnosed with PIDD

in the U.S., approximately 125,000 receive monthly infusions of IVIG and it is estimated that over 300,000 patients worldwide receive

monthly IVIG infusions for PIDD.

PIDD has an estimated prevalence of 1:1,200 in the U.S., or approximately 250,000 people.

Of these 250,000 people diagnosed with PIDD in the U.S., approximately 125,000 receive monthly infusions of IVIG and it is estimated that over 300,000 patients worldwide receive monthly IVIG infusions for PIDD.

Industry reports indicate the U.S.

market for IG in 2018 was $6.8 billion and is expected to grow

to $13.9 billion by 2025 based upon a compounded annual growth rate of 10.9%.

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.

market for IG in 2019 was $8.1 billion and is expected to grow to $13.9 billion by 2025 based upon a compounded annual growth rate of 11%.

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.

In subjects with PIDD, individual infections are not necessarily more severe than those that occur in a normal host.

Rather, the clinical features suggestive of an immune defect may be the recurring and/or chronic nature of infections with common

pathogens that may result in end organ damage, such as bronchiectasis.

In addition, subjects with PIDD will often respond poorly

to standard antimicrobial therapy or they may have repeated infections with the same pathogen.

The virulence of the infecting organism

should also be considered, and a subject’s immune competence should be questioned when invasive infections are caused by

low virulence or opportunistic pathogens.

For example, infection with the opportunistic pathogens Pneumocystis jiroveci (previously

Pneumocystis carinii) or atypical mycobacteria should prompt an investigation for underlying immunodeficiency.

Typical clinical

presentations for subjects with PIDD are:

Rather, the clinical features suggestive of an immune defect may be the recurring and/or chronic nature of infections with common pathogens that may result in end organ damage, such as bronchiectasis.

In addition, subjects with PIDD will often respond poorly to standard antimicrobial therapy or they may have repeated infections with the same pathogen.

The virulence of the infecting organism should also be considered, and a subject’s immune competence should be questioned when invasive infections are caused by low virulence or opportunistic pathogens.

For example, infection with the opportunistic pathogens Pneumocystis jiroveci (previously Pneumocystis carinii) or atypical mycobacteria should prompt an investigation for underlying immunodeficiency.

Typical clinical presentations for subjects with PIDD are:

antibody deficiency and recurrent bacterial infections;

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complement deficiencies.

PIDD can present at any age from birth to

adulthood, posing a considerable challenge for the practicing physician to know when and how to evaluate a subject for a possible

immune defect.

PIDD can present at any age from birth to adulthood, posing a considerable challenge for the practicing physician to know when and how to evaluate a subject for a possible immune defect.

Subjects with marked antibody deficiencies are generally dependent on IVIG therapy for survival.

Benefits of adequate

IVIG therapy in subjects not able to produce antibodies normally include a reduction of the severity and frequency of infections,

prevention of chronic lung disease and prevention of enteroviral meningoencephalitis.

Several immune globulin products have already

been approved by the FDA.

Benefits of adequate IVIG therapy in subjects not able to produce antibodies normally include a reduction of the severity and frequency of infections, prevention of chronic lung disease and prevention of enteroviral meningoencephalitis.

Several immune globulin products have already been approved by the FDA.

Plasma - Background, Composition and Manufacturing

Human blood contains a number of components

Red blood cells –

Used to carry oxygen from the lungs to the body;

White blood cells –

Used by the immune system to fight infection;

Platelets –

Used for blood clotting;

Plasma –

Used to carry the aforementioned components throughout the body and provide support in clotting and immunity.

Plasma is the most abundant blood component,

representing approximately 55% of total blood volume.

Plasma, which is 90% water, is rich in proteins used by the human body for

blood clotting and fighting infection.

These proteins account for approximately 7% of plasma’s volume.

As plasma contains

these valuable proteins, plasma collection and the manufacturing of human plasma-derived therapeutics provide therapeutic benefits

for ill patients.

In order to produce plasma-derived therapeutics

that can be administered to ill patients, raw material plasma must be collected from human donors and then manufactured into specialized

Human blood contains a number of components including:

Red blood cells – Used to carry oxygen from the lungs to the body;

White blood cells – Used by the immune system to fight infection;

Platelets – Used for blood clotting;

Plasma – Used to carry the aforementioned components throughout the body and provide support in clotting and immunity.

Plasma is the most abundant blood component, representing approximately 55% of total blood volume.

Plasma, which is 90% water, is rich in proteins used by the human body for blood clotting and fighting infection.

These proteins account for approximately 7% of plasma’s volume.

As plasma contains these valuable proteins, plasma collection and the manufacturing of human plasma-derived therapeutics provide therapeutic benefits for ill patients.

In order to produce plasma-derived therapeutics that can be administered to ill patients, raw material plasma must be collected from human donors and then manufactured into specialized products.

Plasma is collected from healthy donors at FDA-licensed plasma donation centers.

To ensure safety of the collected plasma,

all plasma donations are tested using FDA-approved methods of Nucleic Acid Testing for various infectious diseases, such as HIV

Plasma is collected using a process known

as “plasmapheresis.”

During plasmapheresis, a donor’s blood is drawn into a specialized medical device that separates

the plasma component through centrifugation, and then returns the other blood components back into the donor’s bloodstream.

To ensure safety of the collected plasma, all plasma donations are tested using FDA-approved methods of Nucleic Acid Testing for various infectious diseases, such as HIV or HCV.

Plasma is collected using a process known as “plasmapheresis.” During plasmapheresis, a donor’s blood is drawn into a specialized medical device that separates the plasma component through centrifugation, and then returns the other blood components back into the donor’s bloodstream.

Plasmapheresis is performed utilizing an FDA-approved, automated device with a sterile, self-contained collection kit.

that is collected is known as “normal source plasma.”

There are over 700 plasma donation centers in the U.S.

in a variety of plasma industry trade reports and related conferences, approximately 42 million liters of source plasma were collected

In the U.S., a donor may donate plasma a maximum of two times during any seven-day period, with at least two

days in between donations.

The plasma that is collected is known as “normal source plasma.” There are over 900 plasma donation centers in the U.S.

As noted in a variety of plasma industry trade reports and related conferences, approximately 45 million liters of source plasma were collected in the U.S.

In the U.S., a donor may donate plasma a maximum of two times during any seven-day period, with at least two days in between donations.

Plasma donation centers in the U.S.

typically pay donors $30 to $50 per donation and some donors with

rare or high antibody levels can be paid more.

In order to isolate the desired therapeutic

elements in normal source plasma, it must initially go through the fractionation process.

The process of fractionation was invented

in the 1940’s by E.J.

typically pay donors $50 to $100 per donation and some donors with rare or high antibody levels can be paid more.

In order to isolate the desired therapeutic elements in normal source plasma, it must initially go through the fractionation process.

The process of fractionation was invented in the 1940’s by E.J.

Cohn and is referred to as the Cohn method or cold ethanol fractionation.

First, the source plasma

undergoes a process called pooling, in which the individual plasma donations are combined into a pooling tank.

Second, the Cohn

fractionation method, which is a combination of time, temperature, pH, alcohol concentration and centrifugation, is used to separate

the desired plasma protein components, or “fractions.”

After fractionation, the separated proteins are then re-suspended

and are treated with a solvent detergent treatment process for viral inactivation.

Next, other forms of filtration, such as nanofiltration,

are performed as an additional viral removal and viral reduction step.

Finally, with the various components separated and purified,

the bulk product is formulated and filled into final, finished vials.

During these various steps of manufacturing, each lot is

reviewed and tested for potency and purity prior to being approved for release.

The biologics manufacturing process is time consuming

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 proteins in human plasma fall into four

albumin (60% of protein volume), immune globulins (15% of protein volume), coagulation factors (1% of protein volume),

and other proteins (24% of protein volume) such as alpha-1 proteinase inhibitor, C1 esterase inhibitor, fibrin sealants and fibrinogen.

First, the source plasma undergoes a process called pooling, in which the individual plasma donations are combined into a pooling tank.

Second, the Cohn fractionation method, which is a combination of time, temperature, pH, alcohol concentration and centrifugation, is used to separate the desired plasma protein components, or “fractions.” After fractionation, the separated proteins are then re-suspended and are treated with a solvent detergent treatment process for viral inactivation.

Next, other forms of filtration, such as nanofiltration, are performed as an additional viral removal and viral reduction step.

Finally, with the various components separated and purified, the bulk product is formulated and filled into final, finished vials.

During these various steps of manufacturing, each lot is reviewed and tested for potency and purity prior to being approved for release.

The biologics manufacturing 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 proteins in human plasma fall into four categories:

albumin (60% of protein volume), immune globulins (15% of protein volume), coagulation factors (1% of protein volume), and other proteins (24% of protein volume) such as alpha-1 proteinase inhibitor, C1 esterase inhibitor, fibrin sealants and fibrinogen.

Many of the other proteins in plasma have yet to be developed into commercial therapies.

In the U.S., not only are the plasma collection

centers subject to FDA licensure, but each plasma protein product that is derived and fractionated from plasma must undergo an

approval process with FDA’s Center for Biologics Evaluation and Research (“CBER”).

In the U.S., not only are the plasma collection centers subject to FDA licensure, but each plasma protein product that is derived and fractionated from plasma must undergo an approval process with FDA’s Center for Biologics Evaluation and Research (“CBER”).

Immune Globulins

In June 2008, the FDA published the FDA

Guidance for Industry outlining the regulatory pathway for the approval of IVIG for the treatment of PIDD (Guidance for Industry:

Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy

for Primary Humoral Immunodeficiency) .

Immune globulins can be administered in

In June 2008, the FDA published the FDA Guidance for Industry outlining the regulatory pathway for the approval of IVIG for the treatment of PIDD (Guidance for Industry:

Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency) .

Immune globulins can be administered in three ways:

intramuscularly, intravenously or subcutaneously.

IVIG principally contains antibodies and, as such, provides passive

immunization for individuals who are immune-deficient or who have been exposed to various infectious agents.

IVIG is used therapeutically

in a variety of immunological diseases/deficiencies, such as PIDD, idiopathic thrombocytopenic purpura, Guillain-Barré

Kawasaki disease, bone marrow transplant, and chronic inflammatory demyelinating polyneuropathy.

We are aware that other companies

are also evaluating IVIG in a clinical trial for the treatment of Alzheimer’s disease.

Additionally, IVIG is also used as

therapy in a variety of other diseases that do not involve primary or secondary immune deficiencies, such as multiple sclerosis,

skin disease, and asthma.

These latter uses are referred to as “off-label”

or evidence-based uses because the FDA has

not approved their use in these indications and promotion of such uses is not permitted by FDA unless a BLA or BLA supplement with

additional data is approved.

IVIG principally contains antibodies and, as such, provides passive immunization for individuals who are immune-deficient or who have been exposed to various infectious agents.

IVIG is used therapeutically in a variety of immunological diseases/deficiencies, such as PIDD, idiopathic thrombocytopenic purpura, Guillain-Barré syndrome, Kawasaki disease, bone marrow transplant, and chronic inflammatory demyelinating polyneuropathy.

We are aware that other companies are also evaluating IVIG in a clinical trial for the treatment of Alzheimer’s disease.

Additionally, IVIG is also used as therapy in a variety of other diseases that do not involve primary or secondary immune deficiencies, such as multiple sclerosis, skin disease, and asthma.

These latter uses are referred to as “off-label” or evidence-based uses because the FDA has not approved their use in these indications and promotion of such uses is not permitted by FDA unless a BLA or BLA supplement with additional data is approved.

Among the various IVIG products, there are only 14 labeled indications approved by the FDA.

medical literature identifies at least 150 evidence-based uses for IVIG, of which approximately 60 are currently included on lists

of reimbursable uses by Medicare and other healthcare plans.

This provides opportunities for new product development and submissions.

However, medical literature identifies at least 150 evidence-based uses for IVIG, of which approximately 60 are currently included on lists of reimbursable uses by Medicare and other healthcare plans.

This provides opportunities for new product development and submissions to potentially expand the label for our existing products.

There are two types of immune globulins;

standard and hyperimmune.

The difference between standard immune globulins and hyperimmune globulins is that the latter are manufactured

using plasma obtained from donors who have elevated amounts (high-titers) of specific antibodies.

These high-titer products can

be used to treat and prevent diseases that present those specific antigens that are reactive with the high-titer antibodies.

products currently available include Hepatitis B, tetanus, rabies, CMV and RhoD immune globulins.

The difference between standard immune globulins and hyperimmune globulins is that the latter are manufactured using plasma obtained from donors who have elevated amounts (high-titers) of specific antibodies.

These high-titer products can be used to treat and prevent diseases that present those specific antigens that are reactive with the high-titer antibodies.

Hyperimmune products currently available include Hepatitis B, tetanus, rabies, CMV and RhoD immune globulins.

As reported in industry journals, the U.S.

sales of immune and hyperimmune globulin products for all its uses were reported to be approximately $6.8 billion in 2018, and

approximately $14 billion in 2025 based upon anticipated compounded annual growth rate of approximately 11%.

IVIG products are

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

certain neuropathy indications.

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.

Manufacturing and Supply

In order to produce plasma-derived therapeutics

that can be administered to patients, raw material plasma is collected from healthy donors at plasma collection facilities licensed

ADMA Bio Centers operates an FDA-licensed source plasma collection facility located in the U.S.

which provides us with

a portion of our blood plasma for the manufacture of our current products and product candidates.

Over the next three to five years,

we plan to open five to 10 plasma collection centers throughout the U.S., as well as enter into additional third-party contracts

to procure normal source and high-titer plasma.

On June 6, 2017, we entered into a Termination

Agreement with BPC with respect to the Manufacturing Supply and License Agreement and Master Services Agreement, which included,

effective as of January 21, 2017, a mutual release with respect to any claims relating to or arising from any breach or default

under the existing Manufacturing Supply and License Agreement and Master Services Agreement between ADMA BioManufacturing and BPC.

Under our Manufacturing, Supply and License Agreement with BPC, we had agreed to purchase exclusively from BPC our worldwide requirements

of RSV immune globulin manufactured from human plasma containing RSV antibodies.

The term of the agreement was for a period of

ten years from January 1, 2013, renewable for two additional five-year periods at the agreement of both parties.

We were obligated

under this agreement to purchase a minimum of at least one lot of product during each calendar year after the finished product

is approved by the FDA.

This number was subject to increase at our option.

As consideration for BPC’s obligations under the

agreement, we were obligated to pay a dollar amount per lot of RSV immune globulin manufactured from human plasma containing RSV

antibodies, as well as a percentage royalty on the sales thereof and of ASCENIV, up to a specified cumulative maximum amount.

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 containing antibodies to RSV to be used in the manufacture of ASCENIV.

purchase a to-be-determined and agreed upon annual minimum volume from BPC, but may also collect high-titer RSV plasma from up

to five wholly-owned ADMA plasma collection facilities.

During 2015, we amended the 2011 Plasma Purchase Agreement with BPC to

allow us the ability to collect our raw material RSV high-titer plasma from other third-party collection organizations, thus allowing

us to expand our reach for raw material supply for ASCENIV.

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

On January 1, 2019, Grifols and ADMA entered into an additional amendment to the 2011 Plasma Purchase Agreement for the

purchase of source plasma containing antibodies to RSV from Grifols.

Pursuant to this amendment, until January 1, 2022, we may

purchase RSV plasma from Grifols from the two previously-owned ADMA plasma collection facilities which we transferred to BPC on

January 1, 2019 at a price equal to cost plus five percent (5%) (without any additional increase due to inflation).

On March 23, 2016, we entered into an Amended

and Restated Plasma Supply Agreement with BPC for the purchase by BPC of normal source plasma to be derived from automated plasmapheresis

procedures conducted at the two formerly-owned ADMA Bio Centers facilities to be used in BPC's proprietary products’

manufacturing

(the “Amended and Restated Plasma Supply Agreement”).

The initial term of the Amended and Restated Plasma Supply Agreement

expired by its terms on December 31, 2018 and was not renewed.

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 hyperimmune plasma that contain antibodies to the hepatitis B virus for the manufacture of Nabi-HB.

sales of immune and hyperimmune globulin products for all its uses were reported to be approximately $8.1 billion in 2019, and are expected to reach approximately $13.9 billion in 2025 based upon an anticipated compounded annual growth rate of approximately 11%.

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

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.

Manufacturing and Supply of Our Products

In order to produce plasma-derived therapeutics that can be administered to patients, raw material plasma is collected from healthy donors at plasma collection facilities licensed by the FDA.

When stored under proper conditions, this plasma may have a shelf-life of up to 10 years.

Source plasma is collected at any one of over 900 FDA-licensed donation centers located throughout the U.S., using a process known as automated plasmapheresis.

This sterile, self-contained, automated process separates red blood cells and other cellular components in the blood, which are then returned to the donor.

Source plasma obtained by plasmapheresis is tested and must be negative for antibodies to human immunodeficiency virus types 1 and 2 (HIV-1/2), HBsAg and Hepatitis C virus (“HCV”), using FDA-approved serological test procedures.

After receipt of the source plasma, the frozen plasma is thawed and pooled and goes through the fractionation process.

This process is referred to as the Cohn method or cold ethanol method of fractionation.

During cold ethanol fractionation, classes of proteins are precipitated and removed by centrifugation or filtration.

The fractionation process includes the following steps;

precipitation and absorption, depth filtration, centrifugation and chromatography.

Because of the human origin of the raw material and the thousands of donations required in the fractionation process, a significant risk associated with plasma products is the transmission of blood-borne infectious pathogens.

These purification processes have the potential to reduce the viral load.

The manufacturing process also utilizes a multistep viral removal/inactivation system, which further increases the safety of the products.

The following manufacturing processes have been validated for their capability to eliminate or inactivate viruses:

precipitation during cold ethanol fractionation, solvent/detergent treatment and nanofiltration.

We incorporate these processes into the manufacturing process, 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 nine 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 Vanrx SA25 Workcell 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 upon FDA approval expects to begin benefitting from these initiatives as early as mid-2021.

ADMA BioCenters operates two FDA-licensed source plasma collection facility located in the U.S.

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

We also have a third 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.

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

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 containing antibodies to RSV to be used in the manufacture of ASCENIV.

We must purchase a to-be-determined and agreed upon annual minimum volume from BPC, but may also collect high-titer RSV plasma from up to five wholly-owned ADMA plasma collection facilities.

During 2015, we amended the 2011 Plasma Purchase Agreement with BPC to allow us the ability to collect our raw material RSV high-titer plasma from other third-party collection organizations, thus allowing us to expand our reach for raw material supply for ASCENIV.

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 January 1, 2019, Grifols and ADMA entered into an additional amendment to the 2011 Plasma Purchase Agreement for the purchase of source plasma containing antibodies to RSV from Grifols.

Pursuant to this amendment, until January 1, 2022, we may purchase RSV plasma from Grifols from the two previously-owned ADMA plasma collection facilities which we transferred to BPC on January 1, 2019 at a price equal to cost plus five percent (5%) (without any additional increase due to inflation).

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 hyperimmune plasma that contain antibodies to the hepatitis B virus for the manufacture of Nabi-HB.

The Plasma Supply Agreement has a 10-year term.

On July 19, 2018, we entered into an amendment to the Plasma Supply Agreement with

BPC to provide, among other things, that in the event BPC elects not to supply in excess of ADMA BioManufacturing’s specified

amount of Hepatitis B plasma and ADMA BioManufacturing is unable to secure Hepatitis B plasma from a third party at a price which

is within a low double digit percentage of the price which ADMA BioManufacturing pays to BPC, then BPC shall reimburse ADMA BioManufacturing

for the difference in price ADMA BioManufacturing incurs.

On December 10, 2018, BPC assigned its rights and 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 additional two 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.

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.

Marketing, Sales and Market Research

We market and sell our products through

our specialty sales force, distribution relationships and other customary industry methods.

We focus our efforts specifically on

the easily identifiable treatment centers which specialize in the care and management of immune compromised individuals.

that there are approximately 500 leading specialty programs in the U.S.

which have significant patient populations for PIDD, suitable

for treatment with ASCENIV.

We are in the process of hiring our own specialty sales force which will consist 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.

On June 6, 2017, we entered into a Termination

Agreement with BPC with respect to the Manufacturing Supply and License Agreement and Master Services Agreement, which included,

effective as of January 21, 2017, a mutual release with respect to any claims related to or arising from any breach or default

under the existing Manufacturing Supply and License Agreement and Master Services Agreement between ADMA BioManufacturing and BPC.

Pursuant to our Manufacturing, Supply and License Agreement, we granted Biotest an exclusive license to market and sell RI-002

in Europe and in selected countries in North Africa and the Middle East (the “Territory”), to have access to our testing

services for testing of BPC’s plasma samples using our proprietary RSV assay, and to reference (but not access) our proprietary

information for the purpose of Biotest seeking regulatory approval for the RI-002 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

Biotest was also obligated to pay us an adjustable royalty based on a percentage of revenues from the sale of RI-002

in the Territory for 20 years from the date of first commercial sale.

On July 19, 2018, we entered into an amendment to the Plasma Supply Agreement with BPC to provide, among other things, that in the event BPC elects not to supply in excess of ADMA BioManufacturing’s specified amount of Hepatitis B plasma and ADMA BioManufacturing is unable to secure Hepatitis B plasma from a third party at a price which is within a low double digit percentage of the price which ADMA BioManufacturing pays to BPC, then BPC shall reimburse ADMA BioManufacturing for the difference in price ADMA BioManufacturing incurs.

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

Sales and Commercialization of Our Products

Currently, BIVIGAM, ASCENIV and Nabi-HB are sold primarily through independent distributors, drug wholesalers acting as sales agents, specialty pharmacies servicing both acute and ambulatory infusion centers and the home health infusion setting and other alternate site providers.

In the U.S., independent distributors or third-party drug wholesalers ship our products through their distribution centers.

These centers are generally stocked with adequate inventories to facilitate prompt customer service.

Sales and distribution methods include frequent contact by sales and customer service representatives, automated communications via various electronic purchasing systems, circulation of catalogs and merchandising bulletins, direct-mail campaigns, trade publication presence and advertising.

We market and sell our products through our specialty sales force, distribution relationships and other customary industry methods.

We focus our efforts specifically on the easily identifiable treatment centers which specialize in the care and management of immune compromised individuals.

We estimate that there are approximately 500 leading specialty programs in the U.S.

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

Pursuant to our Manufacturing, Supply and License Agreement effective as of January 21, 2017, we granted Biotest an exclusive license to market and sell RI-002 in Europe and in selected countries in North Africa and the Middle East (the “Territory”), to have access to our testing services for testing of BPC’s plasma samples using our proprietary RSV assay, and to reference (but not access) our proprietary information for the purpose of Biotest seeking regulatory approval for the RI-002 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 RI-002 in the Territory for 20 years from the date of first commercial sale.

Pharmaceutical Pricing and Reimbursement of Our Products

All sales in the U.S.

of BIVIGAM, ASCENIV and Nabi-HB depend in part upon the availability of reimbursement from third-party payers.

Third-party payers include government health programs, managed care providers, private health insurers and other organizations.

BIVIGAM and Nabi-HB are reimbursed or purchased under several government programs, including Medicaid, Medicare Parts B and D, the 340B/Public Health Service program, and pursuant to an existing contract with the Department of Veterans Affairs.

Medicaid is a joint state and federal government health plan that provides covered outpatient prescription drugs for low-income individuals.

Under Medicaid, drug manufacturers pay rebates to the states based on utilization data provided by the states.

CMS has issued a permanent, product-specific-J-code for ASCENIV.

Under the HCPCS, the J-code (J1554) will become effective April 1, 2021 and will replace the currently issued C-code for ASCENIV (C9072), which can continue to be utilized in the interim for reimbursement purposes.

Major Customers

For the year ended December 31, 2019, three

customers represented an aggregate of 70% of our consolidated revenues, with BioCARE, Inc.

(“BioCare”), Biolife Plasma

Services, L.P.

(“Biolife”) and Sanofi Pasteur S.A.

(“Sanofi”) representing approximately 26%, 24%, and

20%, respectively, of our consolidated revenues.

For the year ended December 31, 2020, three customers, BioCARE, Inc.

(“BioCare”), Reliance Life Sciences Pvt Limited (“Reliance”) and Biolife Plasma Services, L.P.

(“Biolife”), represented an aggregate of 82% of our consolidated revenues.

As of December 31, 2020, three customers, BioCare, Reliance and Priority Healthcare Distribution, Inc.

(“Curascript”), represented a total of 92% of our consolidated accounts receivable.

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, greater access to capital, greater resources for research and development, and sophisticated

marketing capabilities.

These competitors may include but are not

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.

These competitors may include but are not limited to:

CSL Behring, Grifols Biologicals, Takeda, Octapharma, Kedrion and BPL.

There are four producers of plasma-derived products

There are four producers of plasma-derived products in the U.S.

consisting of:

CSL Behring, Grifols Biologicals, 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 have 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.

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.

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.

Intellectual Property

During the second quarter of 2015, U.S.

14/592,721, entitled “Compositions and Methods for the Treatment of Immunodeficiency,”

our RI-002 product, was allowed and issued August 18, 2015 as U.S.

The ’906 patent has a term at least

through January 2035 and covers compositions comprising pooled plasma, as well as immunoglobulin prepared therefrom, that contains

a standardized, elevated titer of RSV neutralizing antibodies as well as elevated levels of antibodies specific for one or more

other respiratory pathogens, as well as methods of making and using the compositions.

Our proprietary methods allow us to effectively

identify and isolate donor plasma with high-titer RSV neutralizing antibodies and to standardize RI-002’s antibody profile,

which we believe may enable us to garner a premium price.

During the third quarter of 2017, U.S.

14/790,872, entitled “Compositions and Methods for the Treatment of Immunodeficiency,”

immunotherapeutic methods of using immune globulin compositions proprietary to us, was allowed and issued July 25, 2017 as U.S.

The ’283 patent has a term at least through January 2035.

In November 2017, U.S.

14/592,727, related to immune globulin compositions containing elevated, neutralizing antibody titers to RSV, as well as elevated

antibody titers to other respiratory pathogens, was allowed and issued as U.S.

The term of the issued patent

extends to January 2035.

In May 2018, U.S.

9,969,793 was

issued covering methods of treating respiratory infections.

The newly issued patent encompasses methods of treating upper and lower

respiratory infections, including those caused by RSV, other viruses as well as bacteria utilizing ADMA’s investigational

drug candidate RI-002, that contains elevated, neutralizing antibody titers to RSV as well as elevated antibody titers to other

respiratory pathogens, such as influenza virus, coronavirus, parainfluenza virus, and metapneumovirus.

The term of the issued patent

extends to January 2035.

On January 24, 2019, the U.S.

Trademark Office issued a Notice of Allowance for U.S.

Patent Application Serial No.

15/460,147 related to methods of treatment

and prevention of S.

pneumonia infection.

The allowed claims encompass methods of preparing immune globulin via harvesting

plasma from S.

pneumonia vaccinated, healthy adult human donors and pooling the harvested plasma as the source for manufacturing

a hyperimmune anti- S pneumococcal immune globulin containing elevated opsonic antibodies to a plurality of S.

serotypes, hyperimmune anti- S pneumococcal immune globulin so prepared and methods of treating S.

We rely on a combination of patents, patent applications, copyrights and trademarks, as well as contracts, such as confidentiality, material data transfer, license and invention assignment agreements, to protect our intellectual property rights.

We also rely upon trade secret laws to protect unpatented know-how and advancing technological innovation.

We have intellectual property (patents, know-how, etc.) related to our immunotherapeutic compositions, manufacturing processes, immunotherapeutic treatment, and related methods and formulations.

Patents related to our immune globulin product ASCENIV include U.S.

9,107,906, which covers compositions comprising pooled plasma, as well as immunoglobulin prepared therefrom, that contains a standardized, elevated titer of RSV neutralizing antibodies and elevated levels of antibodies specific for one or more other respiratory pathogens, as well as methods of making and using the compositions.

9,714,283, 9,815,886, 9,969,793 and 10,683,343, encompassing immunotherapeutic compositions and immunotherapeutic methods proprietary to us, also relate to ASCENIV.

Corresponding foreign patents and patent applications also pertain to this technology.

We also hold intellectual property, including patents and patent applications, related to immunotherapeutic compositions and immunotherapeutic methods for the treatment and prevention of S.

pneumonia infection.

and methods of providing immunotherapy using the hyperimmune anti- S pneumococcal immune globulin.

This allowed Application

is expected to issue as a patent in March 2019.

The term of the patent, once issued, is expected to extend to March 2037.

We also rely on a combination of patents,

trademarks, trade secrets and nondisclosure and non-competition agreements to protect our proprietary intellectual property and

will continue to do so.

We also seek to enhance and ensure our competitive position through a variety of means, including our unique

and proprietary plasma donor selection criteria, our proprietary formulation methodology for plasma pooling and the proprietary

reagents, controls, testing standards, standard operating procedures and methods we use in our anti-RSV microneutralization assay.

While we intend to defend against threats to our intellectual property, litigation can be costly and there can be no assurance

that our patent will be enforced or that our trade secret policies and practices or other agreements will adequately protect our

intellectual property.

We seek to preserve the integrity and confidentiality of our data and trade secrets by maintaining physical

security of our premises and physical and electronic security of our information technology systems.

These processes, systems,

and/or security measures may be breached, and we may not have adequate remedies as a result of any such breaches.

Third parties

may also own or 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.

In addition, our trade secrets may otherwise

become known or be independently discovered by competitors.

We also seek to protect our proprietary technology and processes, in

part, by confidentiality agreements with our employees, consultants, scientific advisors and contractors.

Although we rely, in

part, on 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, there

can be no assurance that these agreements or any other security measures related 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.

10,259,856, issued in April 2019, pertains to various aspects of this technology.

Additional U.S.

and numerous corresponding foreign patent applications also relate to this technology.

We continue to prepare, file, and prosecute patent applications to provide broad and strong protection of our proprietary rights, including applications focused on existing and future products.

We rely on a combination of patents, trademarks, trade secrets and nondisclosure and non-competition agreements to protect our proprietary intellectual property and will continue to do so.

We also seek to enhance and ensure our competitive position through a variety of means, including our unique and proprietary plasma donor selection criteria, our proprietary formulation methodology for plasma pooling and the proprietary reagents, controls, testing standards, standard operating procedures and methods we use in our anti-RSV microneutralization assay.

While we intend to defend against threats to our intellectual property, litigation can be costly and there can be no assurance that our patent will be enforced or that our trade secret policies and practices or other agreements will adequately protect our intellectual property.

We seek to preserve the integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises and physical and electronic security of our information technology systems.

These processes, systems, and/or security measures may be breached, and we may not have adequate remedies as a result of any such breaches.

Third parties may also own or 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.

In addition, our trade secrets may otherwise become known or be independently discovered by competitors.

We also seek to protect our proprietary technology and processes, in part, by confidentiality agreements with our employees, consultants, scientific advisors and contractors.

Although we rely, in part, on 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, there can be no assurance that these agreements or any other security measures related 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 have filed for other provisional patent applications with the U.S.

which are pending related to expanded hyperimmune

globulin products.

We currently hold multiple trademarks, including

but not limited to ASCENIV, BIVIGAM and Nabi-HB .

We have spent considerable resources registering the trademarks

and building brand awareness and equity of the ADMA Biologics trade name, which has been used in commerce since 2006.

to maintain and defend our various trademarks to the fullest extent possible.

which are pending related to expanded hyperimmune globulin products.

We currently hold multiple trademarks, including but not limited to ASCENIV, BIVIGAM and Nabi-HB.

We have spent considerable resources registering the trademarks and building brand awareness and equity of the ADMA Biologics trade name, which has been used in commerce since 2006.

We expect to maintain and defend our various trademarks to the fullest extent possible.

Government Regulation and Product Approval

The FDA and comparable regulatory agencies

in state and local jurisdictions and in foreign countries impose substantial requirements upon, among other things, the testing

(preclinical and clinical), manufacturing, labeling, storage, recordkeeping, advertising, promotion, import, export, marketing

and distribution of our products and product candidates.

If we do 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

The FDA and comparable regulatory agencies in state and local jurisdictions and in foreign countries impose substantial requirements upon, among other things, the testing (preclinical and clinical), manufacturing, labeling, storage, recordkeeping, advertising, promotion, import, export, marketing and distribution of our products and product candidates.

If we do 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.

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

Government Regulation

In the U.S., the FDA regulates products

under the Federal Food, Drug, and Cosmetic Act (the “FDCA”) and related regulations.

Our current and anticipated future

product candidates are considered “biologics”

under the FDA regulatory framework.

The FDA's regulatory authority for

the approval of biologics resides in the Public Health Service Act.

However, biologics are also subject to regulation under the

FDCA because most biological products also meet the FDCA’s definition of "drugs."

Most pharmaceuticals or “conventional

consist of pure chemical substances and their structures are known.

Most biologics, however, are complex mixtures

that are not easily identified or characterized.

Biological products differ from conventional drugs in that they tend to be heat-sensitive

and susceptible to microbial contamination.

In the U.S., the FDA regulates products under the Federal Food, Drug, and Cosmetic Act (the “FDCA”) and related regulations.

Our current and anticipated future product candidates are considered “biologics” under the FDA regulatory framework.

The FDA's regulatory authority for the approval of biologics resides in the Public Health Service Act.

However, biologics are also subject to regulation under the FDCA because most biological products also meet the FDCA’s definition of “drugs.” Most pharmaceuticals or “conventional drugs” consist of pure chemical substances and their structures are known.

Most biologics, however, are complex mixtures that are not easily identified or characterized.

Biological products differ from conventional drugs in that they tend to be heat-sensitive and susceptible to microbial contamination.

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

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 regulations and other regulations;

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

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):

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

performance of adequate and well-controlled clinical trials meeting FDA requirements to establish the safety and efficacy of the product candidate for each proposed indication;

manufacturing (through an FDA-licensed contract manufacturing organization) of product in accordance with good manufacturing practices (“cGMP”) to be used in the clinical trials and providing manufacturing information need in regulatory filings;

manufacturing (through an FDA-approved facility) of product in accordance with good manufacturing practices (“cGMP”) to be used in the clinical trials and providing manufacturing information needed in regulatory filings;

submission of a BLA to the FDA;

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the FDA review and approval of a BLA prior to any commercial marketing, sale or shipment of the product.

The testing and approval process requires

substantial time, effort and financial resources, and we cannot be certain that any approvals for our product candidates will be

granted on a timely basis, if at all.

We submit manufacturing and analytical data,

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.

Our submission of an IND, or those of our collaboration partners, may not result in the FDA

allowance to commence a clinical trial.

A separate submission to an existing IND must also be made for each successive clinical

trial conducted during product development.

The FDA must also approve certain changes to an existing IND, such as certain manufacturing

Further, an independent institutional review board (“IRB”) duly constituted to meet FDA 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 completed.

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 Good Clinical Practice requirements and regulations

for informed consent.

The testing and approval process requires substantial time, effort and financial resources, and we cannot be certain that any approvals for our product candidates will be granted on a timely basis, if at all.

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 Good Laboratory Practices (“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.

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

Our submission of an IND, or those of our collaboration partners, may not result in the FDA allowance to commence a clinical trial.

A separate submission to an existing IND must also be made for each successive clinical trial conducted during product development.

The FDA must also approve certain changes to an existing IND, such as certain manufacturing changes.

Further, an independent institutional review board (“IRB”) duly constituted to meet FDA 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 completed.

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 Good Clinical Practice requirements and regulations for informed consent, and must be conducted with product meeting cGMPs.

Clinical Trials

For purposes of BLA submission and approval,

clinical trials are typically conducted in the following three sequential phases, which may overlap (although additional or different

trials may be required by the FDA as well):

For purposes of BLA submission and approval, clinical trials are typically conducted in the following three sequential phases, which may overlap (although additional or different trials may be required by the FDA as well):

Phase I clinical trials are initially conducted in a limited population to test the product candidate for safety, dose tolerance, absorption, metabolism, distribution and excretion in healthy humans or, on occasion, in patients, such as cancer patients.

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When Phase II clinical trials demonstrate that a dose range of the product candidate is effective and has an acceptable safety profile, Phase III clinical trials are undertaken in large patient populations to provide substantial evidence of reproducibility of clinical efficacy results and to further test for safety in an expanded and diverse patient population at multiple, geographically dispersed clinical trial sites.

In addition, under the Pediatric Research

Equity Act of 2003, a BLA application or supplement for a new active ingredient, new indication, new dosage form, new dosing regimen,

or new route of administration must contain data that is adequate to assess the safety and effectiveness of the drug for the claimed

indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation

for which the product is safe and effective, unless the applicant has obtained a waiver or deferral.

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.

In addition, under the Pediatric Research Equity Act of 2003, a BLA application or supplement for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration must contain data that is adequate to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective, unless the applicant has obtained a waiver or deferral.

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.

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

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.

Such post-approval

studies are typically referred to as Phase IV studies.

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.

Such post-approval studies are typically referred to as Phase IV studies.

Biologics License Application

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.

The FDA reviews

all BLAs submitted before it accepts them for filing and may reject the filing as inadequate to merit review or may request additional

information to be submitted in a very short time frame before accepting a BLA for filing.

Once a BLA is accepted for filing, the

FDA begins an in-depth review of the application.

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.

The FDA may refuse

to approve a BLA and issue a CRL if the applicable regulatory criteria are not satisfied or the FDA has additional open questions

for which it requires clarification.

A CRL may also require additional clinical or other data, including one or more additional

pivotal Phase III clinical trials.

Even if such requested data are submitted, the FDA may ultimately decide that the BLA does not

satisfy the criteria for approval and issue a denial of the BLA.

Data from clinical trials are not always conclusive and the FDA

may interpret data differently than we do.

If the FDA’s evaluations of the BLA and the clinical and manufacturing procedures

and facilities are favorable, the FDA may issue an approval letter;

if the evaluations are not favorable the FDA will issue a CRL,

which may contain the conditions that must be met in order to secure final approval of the BLA.

If a CRL is issued, a company has

up to twelve months to resubmit or withdraw the BLA, unless the FDA allows for an extension as requested by a sponsor.

is issued, resubmissions for original applications and supplements of different types are subject to varying agency review procedures

and review timing goals.

For example, upon the resubmission of an original BLA application or efficacy supplement, CBER’s

written Standard Operating Policy and Procedure (SOPP) 8405.1 states that it will classify the resubmission as either Class 1 (triggering

a two-month review goal for the FDA) or Class 2 (triggering a six-month review goal for the FDA) depending on the circumstances,

and in this SOPP CBER stated goal for review of manufacturing and labeling supplement resubmissions for Prescription Drug User

Fee Act (“PDUFA”) BLAs is (using the timeframes referenced in 21 C.F.R.§

314.110(b)(1)(iii)) to review them within

the same timeframe as the initial review cycle for the supplement (excluding any extension due to a major amendment of the initial

supplement) (for example, under the FDA’s published PDUFA goals for fiscal years 2018 –

2022, a goal of acting on 90%

of manufacturing PASs within four months of receipt).

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.

The FDA reviews all BLAs submitted before it accepts them for filing and may reject the filing as inadequate to merit review or may request additional information to be submitted in a very short time frame before accepting a BLA for filing.

Once a BLA is accepted for filing, the FDA begins an in-depth review of the application.

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 sites.

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.

The FDA may refuse to approve a BLA and issue a Complete Response Letter (“CRL”) if the applicable regulatory criteria are not satisfied or the FDA has additional open questions for which it requires clarification.

A CRL may also require additional clinical or other data, including one or more additional pivotal Phase III clinical trials.

Even if such requested data are submitted, the FDA may ultimately decide that the BLA does not satisfy the criteria for approval and issue a denial of the BLA.

Data from clinical trials are not always conclusive and the FDA may interpret data differently than we do.

If the FDA’s evaluations of the BLA and the clinical and manufacturing procedures and facilities are favorable, the FDA may issue an approval letter;

if the evaluations are not favorable the FDA will issue a CRL, which may contain the conditions that must be met in order to secure final approval of the BLA.

If a CRL is issued, a company has up to twelve months to resubmit or withdraw the BLA, unless the FDA allows for an extension as requested by a sponsor.

If a CRL is issued, resubmissions for original applications and supplements of different types are subject to varying agency review procedures and review timing goals.

For example, upon the resubmission of an original BLA application or efficacy supplement, CBER’s written Standard Operating Policy and Procedure (SOPP) 8405.1 states that it will classify the resubmission as either Class 1 (triggering a two-month review goal for the FDA) or Class 2 (triggering a six-month review goal for the FDA) depending on the circumstances, and in this SOPP CBER stated goal for review of manufacturing and labeling supplement resubmissions for Prescription Drug User Fee Act (“PDUFA”) BLAs is (using the timeframes referenced in 21 C.F.R.§ 314.110(b)(1)(iii)) to review them within the same timeframe as the initial review cycle for the supplement (excluding any extension due to a major amendment of the initial supplement) (for example, under the FDA’s published PDUFA goals for fiscal years 2018 – 2022, a goal of acting on 90% of manufacturing PASs within four months of receipt).

In practice, FDA reviews may take longer than the stated goals.

the items identified in a CRL have been resolved to the FDA’s satisfaction, the FDA will issue an approval letter, authorizing

commercial marketing of the product for certain indications.

The FDA may withdraw product approval if ongoing regulatory requirements

are not met or if safety problems occur after the product reaches the market.

In addition, the FDA may require testing, including

Phase IV post-approval clinical trials, and 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.

If and when the items identified in a CRL have been resolved to the FDA’s satisfaction, the FDA will issue an approval letter, authorizing commercial marketing of the product for certain indications.

The FDA may withdraw product approval if ongoing regulatory requirements are not met or if safety problems occur after the product reaches the market.

In addition, the FDA may require testing, including Phase IV post-approval clinical trials, and 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 REMS which 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.

The FDA generally

does not allow drugs to be promoted for “off-label”

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 several years, and the actual time

required may vary substantially based upon the type, complexity and novelty of the product or disease.

Typically, if a product

candidate is intended to treat a chronic disease, as was the case with ASCENIV, safety and efficacy data must be gathered over

an extended period of time.

Government regulation may delay or prevent marketing of product candidates for a considerable period

of time and impose costly procedures upon our activities.

The FDA or any other regulatory agency may not grant approvals for changes

in dose form or new indications for a product candidate on a timely basis, or at all.

Even if a product candidate receives regulatory

approval, the approval may be significantly limited to specific disease states, patient populations and dosages.

Further, even

after regulatory approval is obtained, later discovery of previously unknown problems with a product may result in restrictions

on the product or even complete withdrawal of the product from the market.

Delays in obtaining, or failures to obtain, regulatory

approvals for any of our product candidates would harm our business.

In addition, we cannot predict what adverse governmental regulations

may arise from future U.S.

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 several years, and the actual time required may vary substantially based upon the type, complexity and novelty of the product or disease.

Typically, if a product candidate is intended to treat a chronic disease, as was the case with ASCENIV, safety and efficacy data must be gathered over an extended period of time.

Government regulation may delay or prevent marketing of product candidates for a considerable period of time and impose costly procedures upon our activities.

The FDA or any other regulatory agency may not grant approvals for changes in dose form or new indications for a product candidate on a timely basis, or at all.

Even if a product candidate receives regulatory approval, the approval may be significantly limited to specific disease states, patient populations and dosages.

Further, even after regulatory approval is obtained, later discovery of previously unknown problems with a product may result in restrictions on the product or even complete withdrawal of the product from the market.

Delays in obtaining, or failures to obtain, regulatory approvals for any of our product candidates would harm our business.

In addition, we cannot predict what adverse governmental regulations may arise from future U.S.

or foreign governmental action.

Other Regulatory Requirements

Biological drug products manufactured or

distributed pursuant to FDA approvals are subject to extensive and continuing regulation by the FDA, including, among other things,

requirements related to recordkeeping (including certain electronic record and signature requirements), periodic reporting, product

sampling and distribution, advertising and promotion and reporting of certain adverse experiences, deviations, and other problems

with the product.

After approval, most changes to the approved product, such as adding new indications or other labeling claims,

are subject to prior FDA review and approval.

There also are annual user fee requirements for any marketed products and the establishments

at which such products are manufactured, as well as new application fees for supplemental applications with clinical data.

Manufacturers must continue to comply with

cGMP requirements, which are extensive and require considerable time, resources and ongoing investment to ensure compliance.

addition, changes to the manufacturing process generally require prior FDA approval before being implemented and other types of

changes to the approved product, such as adding new indications and additional labeling claims, are also subject to further FDA

review and approval.

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, 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.

For biologics

products in particular, for each product lot the applicant must submit materials related to that lot to the FDA before the lot

can be released for distribution.

Changes to the manufacturing process are

strictly regulated and often require prior FDA approval before being implemented.

FDA regulations also require investigation and

correction of any deviations from cGMP and impose reporting and documentation requirements upon the sponsor and any third-party

manufacturers that the sponsor may decide to use.

Accordingly, manufacturers must continue to expend time, money, and effort in

the area of production and quality control to maintain cGMP compliance.

The FDA may impose a number of post-approval

requirements as a condition of approval of an application.

The FDA may withdraw a product approval if compliance with regulatory

requirements is not maintained or if problems occur after the product reaches the market.

Later discovery of previously unknown

problems with a product, including adverse events of unanticipated severity or frequency, problems with manufacturing processes

or failure to comply with regulatory requirements, may result in restrictions on the product or even complete withdrawal of the

product from the market.

Failure to comply with the statutory and regulatory requirements can subject a manufacturer to possible

legal or regulatory action, such as warning letters, suspension of manufacturing, sales or use, seizure of product, injunctive

action or possible fines and other penalties.

We cannot be certain that we or our present or future third-party manufacturers or

suppliers will be able to comply with the cGMP regulations and other ongoing FDA regulatory requirements.

If we or our present

or future third-party manufacturers or suppliers are not able to comply with these requirements, the FDA may halt our clinical

trials, require us to recall a product from distribution, or withdraw approval of our BLA for that product.

The FDA closely regulates the post-approval

marketing and promotion of products, including standards and regulations for direct-to-consumer advertising, off-label promotion,

industry-sponsored scientific and educational activities and promotional activities involving the Internet.

A company can make

only those claims relating to safety and efficacy that are approved by the FDA.

Failure to comply with these requirements can result

in adverse publicity, warning and/or other regulatory letters, corrective advertising and potential major fines and other penalties.

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.

Biological drug products manufactured or distributed pursuant to FDA approvals are subject to extensive and continuing regulation by the FDA, including, among other things, requirements related to recordkeeping (including certain electronic record and signature requirements), periodic reporting, product sampling and distribution, advertising and promotion and reporting of certain adverse experiences, deviations, and other problems with the product.

After approval, most changes to the approved product, such as adding new indications or other labeling claims, are subject to prior FDA review and approval.

There also are annual user fee requirements for any marketed products, as well as new application fees for supplemental applications with clinical data.

Manufacturers must continue to comply with cGMP requirements, which are extensive and require considerable time, resources and ongoing investment to ensure compliance.

In addition, changes to the manufacturing process generally require prior FDA approval before being implemented and other types of changes to the approved product, such as adding new indications and additional labeling claims, are also subject to further FDA review and approval.

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, 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.

Recently, 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 in particular, for each product lot the applicant must submit materials related to that lot to the FDA before the lot can be released for distribution.

Changes to the manufacturing process are strictly regulated and often require prior FDA approval before being implemented.

FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting and documentation requirements upon the sponsor and any third-party manufacturers that the sponsor may decide to use.

Accordingly, manufacturers must continue to expend time, money, and effort in the area of production and quality control to maintain cGMP compliance.

The FDA may impose a number of post-approval requirements as a condition of approval of an application.

The FDA may withdraw a product approval if compliance with regulatory requirements is not maintained or if problems occur after the product reaches the market.

Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, problems with manufacturing processes or failure to comply with regulatory requirements, may result in restrictions on the product or even complete withdrawal of the product from the market.

Failure to comply with the statutory and regulatory requirements can subject a manufacturer to possible legal or regulatory action, such as warning letters, suspension of manufacturing, sales or use, seizure of product, injunctive action or possible fines and other penalties.

We cannot be certain that we or our present or future third-party manufacturers or suppliers will be able to comply with the cGMP regulations and other ongoing FDA regulatory requirements.

If we or our present or future third-party manufacturers or suppliers are not able to comply with these requirements, the FDA may halt our clinical trials, require us to recall a product from distribution, or withdraw approval of our BLA for that product.

The FDA closely regulates the post-approval marketing and promotion of products, including standards and regulations for direct-to-consumer advertising, off-label promotion, industry-sponsored scientific and educational activities and promotional activities involving the Internet.

A company can make only those claims relating to safety and efficacy that are approved by the FDA.

Failure to comply with these requirements can result in adverse publicity, warning and/or other regulatory letters, corrective advertising and potential major fines and other penalties.

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.

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 FDA.

In addition to new legislation, FDA regulations, guidance, and policies are often

revised or reinterpreted by the FDA in ways that may significantly affect our business and our product candidates.

It is impossible

to predict whether further legislative or FDA regulation or policy changes will be enacted or implemented and what the impact of

such changes, if any, may be.

Regulation of ADMA Bio Centers

All blood and blood product collection and

manufacturing centers which engage in interstate commerce must be licensed by the FDA.

In order to achieve licensure, the organization

must submit a BLA and undergo pre-licensure inspection.

ADMA Bio Centers has completed these requirements and holds an FDA license

for its existing plasma collection facility.

In order to maintain an FDA license, each such facility operated by ADMA Bio Centers

will be inspected at least every two years.

ADMA Bio Centers is also required to submit annual reports to the FDA.

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 Program.

Compliance with state and industry standards is verified by means of routine

We believe that our existing ADMA Bio Centers facility is currently in compliance with state and industry standards.

Delays in obtaining, or failures to maintain, regulatory approvals for any facilities operated by ADMA Bio Centers would harm our

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 FDA.

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.

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 the FDA.

In order to achieve licensure, the organization must submit a BLA and undergo pre-licensure inspection.

ADMA BioCenters has completed these requirements and holds an FDA license for its existing plasma collection facility.

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.

ADMA BioCenters is also required to submit annual reports to the FDA.

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 Program.

Compliance with state and industry standards is verified by means of routine inspection.

We believe that our existing ADMA BioCenters facilities are currently in compliance with state and industry standards.

Delays in obtaining, or failures to maintain, regulatory approvals for any facilities operated by ADMA BioCenters would harm our business.

In addition, we cannot predict what adverse federal and state regulations and industry standards may arise in the future.

Foreign Regulation

In addition to regulations in the U.S.,

if we choose to pursue clinical development and commercialization in the European Union, we will be subject to a variety of foreign

regulations governing clinical trials and commercial sales and distribution of any future product.

Whether or not we obtain FDA

approval for a product, we must obtain approval of a product by the comparable regulatory authorities of foreign countries before

we can commence clinical trials or marketing of the product in those countries.

The approval process varies from country to country,

and the time may be longer or shorter than that required for FDA approval.

The requirements governing the conduct of clinical trials,

product licensing, pricing and reimbursement vary greatly from country to country.

Under European Union regulatory systems,

marketing authorizations may be submitted either under a centralized or mutual recognition procedure.

The centralized procedure

provides for the grant of a single marketing authorization that is valid for all European Union member states.

The mutual recognition

procedure provides for mutual recognition of national approval decisions.

Under this procedure, the holder of a national marketing

authorization may submit an application to the remaining member states.

Within 90 days of receiving the applications and assessment

report, each member state must decide whether to recognize approval, refuse it or request additional information.

In addition to regulations in the U.S., if we choose to pursue clinical development and commercialization in the European Union, we will be subject to a variety of foreign regulations governing clinical trials and commercial sales and distribution of any future product.

Whether or not we obtain FDA approval for a product, we must obtain approval of a product by the comparable regulatory authorities of foreign countries before we can commence clinical trials or marketing of the product in those countries.

The approval process varies from country to country, and the time may be longer or shorter than that required for FDA approval.

The requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from country to country.

Under European Union regulatory systems, marketing authorizations may be submitted either under a centralized or mutual recognition procedure.

The centralized procedure provides for the grant of a single marketing authorization that is valid for all European Union member states.

The mutual recognition procedure provides for mutual recognition of national approval decisions.

Under this procedure, the holder of a national marketing authorization may submit an application to the remaining member states.

Within 90 days of receiving the applications and assessment report, each member state must decide whether to recognize approval, refuse it or request additional information.

Product Coverage, Pricing and Reimbursement

Significant uncertainties exist as to the

coverage and reimbursement status of any products for which we may obtain regulatory approval.

In the U.S., sales of any products

for which we may receive regulatory approval for commercial sale will depend in part on the availability of coverage and reimbursement

from third-party payers.

Third-party payers include government authorities, managed care providers, private health insurers and

other organizations.

The process for determining whether a payer will provide coverage for a drug product may be separate from

the process for setting the reimbursement rate that the payer will pay for the drug product.

Third-party payers may limit coverage

to specific drug products on an approved list, or formulary, which might not include all of the FDA-approved drugs for a particular

Moreover, a payer’s decision to provide coverage for a drug product does not imply that an adequate reimbursement

rate will be approved.

Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient

to realize an appropriate return on our investment in product development.

Third-party payers are increasingly challenging

the price and examining the medical necessity and cost-effectiveness of medical products and services, in addition to their safety

and efficacy.

In order to obtain coverage and reimbursement for any product that might be approved for sale, we may need to conduct

expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of any products, in addition

to the costs required to obtain regulatory approvals.

Significant uncertainties exist as to the coverage and reimbursement status of any products for which we may obtain regulatory approval.

In the U.S., sales of any products for which we may receive regulatory approval for commercial sale will depend in part on the availability of coverage and reimbursement from third-party payers.

Third-party payers include government authorities, managed care providers, private health insurers and other organizations.

The process for determining whether a payer will provide coverage for a drug product may be separate from the process for setting the reimbursement rate that the payer will pay for the drug product.

Third-party payers may limit coverage to specific drug products on an approved list, or formulary, which might not include all of the FDA-approved drugs for a particular indication.

Moreover, a payer’s decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved.

Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development.

Third-party payers are increasingly challenging the price and examining the medical necessity and cost-effectiveness of medical products and services, in addition to their safety and efficacy.

In order to obtain coverage and reimbursement for any product that might be approved for sale, we may need to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of any products, in addition to the costs required to obtain regulatory approvals.

Our 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.

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, restrictions on reimbursement and requirements for substitution of generic products for branded prescription

For example, the Patient Protection and Affordable Care Act (“ACA”) and the companion Healthcare and Education

Reconciliation Act (which together are referred to as the “Healthcare Reform Law”) contains provisions that may reduce

the profitability of drug products, including, for example, increased rebates for drugs reimbursed by Medicaid programs, extension

of Medicaid rebates to Medicaid managed care plans, mandatory discounts for certain Medicare Part D beneficiaries and annual fees

based on pharmaceutical companies’

share of sales to federal healthcare programs.

Adoption of government controls and measures,

and tightening of restrictive policies in jurisdictions with existing controls and measures, could limit payments for pharmaceuticals.

The marketability of any products for which

we receive regulatory approval for commercial sale may suffer if the government and third-party payers fail to provide adequate

coverage and reimbursement.

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 coverage, restrictions on reimbursement and requirements for substitution of generic products for branded prescription drugs.

For example, the Patient Protection and Affordable Care Act (“ACA”) and the companion Healthcare and Education Reconciliation Act (which together are referred to as the “Healthcare Reform Law”) contains provisions that may reduce the profitability of drug products, including, for example, increased rebates for drugs reimbursed by Medicaid programs, extension of Medicaid rebates to Medicaid managed care plans, mandatory discounts for certain Medicare Part D beneficiaries and annual fees based on pharmaceutical companies’ share of sales to federal healthcare programs.

By further example, on November 27, 2020, CMS issued an interim final rule implementing a Most Favored Nation payment model under which reimbursement for certain Medicare Part B drugs and biologicals will be based on a price that reflects the lowest per capita Gross Domestic Product-adjusted (GDP-adjusted) price of any non-U.S.

member country of the Organisation for Economic Co-operation and Development (OECD) with a GDP per capita that is at least sixty percent of the U.S.

GDP per capita.

These and any additional healthcare reform measures could further constrain our business or limit the amounts that federal and state governments will pay for healthcare products and services, which could result in additional pricing pressures.

Adoption of government controls and measures, and tightening of restrictive policies in jurisdictions with existing controls and measures, could limit payments for pharmaceuticals.

The marketability of any products for which we receive regulatory approval for commercial sale may suffer if the government and third-party payers fail to provide adequate coverage and reimbursement.

In addition, an increasing emphasis on cost containment measures in the U.S.

has increased and we expect

will continue to increase the pressure on pharmaceutical pricing.

Coverage policies and third-party reimbursement rates may change

Even if favorable coverage and reimbursement status is attained for one or more products for which we receive regulatory

approval, less favorable coverage policies and reimbursement rates may be implemented in the future.

As of December 31, 2019, we had a total

of 314 employees, comprised of 313 full-time employees and one part-time employee.

Over the course of the next year, we anticipate

hiring additional full-time employees devoted to sales and marketing, medical and scientific affairs, general and administrative,

as well as hiring additional staff as part of the build-out of our plasma collection centers as appropriate.

We intend to use Clinical

Research Organizations (“CROs”), third parties and consultants to perform our clinical studies and manufacturing, regulatory

affairs and quality control services in addition to corporate marketing, branding and commercialization activities.

has increased and we expect will continue to increase the pressure on pharmaceutical pricing.

Coverage policies and third-party reimbursement rates may change at any time.

Even if favorable coverage and reimbursement status is attained for one or more products for which we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.

Federal price reporting laws also require manufacturers to calculate and report complex pricing metrics used to determine prescription rebates, ceiling prices charged, and provider reimbursement under the Medicaid Drug Rebate Program, Medicare Parts B and D, the Veterans Healthcare Act programs, the 340B program, and the Tricare Retail Rebate program.

Various state health care programs similarly obligate us to report drug pricing information that is used as the basis for their reimbursement of pharmacies and other health care providers and the negotiation of supplemental rebates.

Payment for a manufacturer’s drugs by these programs is conditioned on submission of this pricing information.

Recently, the Part D Medicare coverage gap rebate manufacturer percentage increased to 70%.

Rebates under these programs can also increase when commercial prices increase.

Failure to comply with the rules for calculating and submitting pricing information or otherwise overcharging the government or its beneficiaries may result in criminal, civil, or administrative sanctions or enforcement actions, and expose us to U.S.

False Claims Act, or the False Claims Act, liability.

As of December 31, 2020, we had a total of 407 employees, comprised of 406 full-time employees and one part-time employee.

Over the course of the next year, we anticipate hiring additional full-time employees devoted to sales and marketing, medical and scientific affairs, general and administrative, as well as hiring additional staff as part of the build-out of our plasma collection centers as appropriate.

We intend to use Clinical Research Organizations (“CROs”), third parties and consultants to perform our clinical studies and manufacturing, regulatory affairs and quality control services in addition to corporate marketing, branding and commercialization activities.

Corporate Information

1 unchanged sentence

was founded on June 24, 2004 as a New Jersey corporation and re-incorporated in Delaware on July 16, 2007.

We operate through our

wholly-owned subsidiaries ADMA Plasma Biologics, ADMA BioManufacturing and ADMA Bio Centers.

ADMA BioManufacturing was formed in

January 2017 to facilitate the acquisition of BTBU.

ADMA Bio Centers is the Company’s source plasma collection business which

operates in the U.S.

Each operational ADMA plasma collection center, once approved, will have a license with the FDA and may obtain

additional certifications from other regulatory agencies.

We maintain our headquarters at 465 State

Route 17, Ramsey, NJ 07446.

We operate through our wholly-owned subsidiaries ADMA Plasma Biologics, ADMA BioManufacturing and ADMA BioCenters.

ADMA BioManufacturing was formed in January 2017 to facilitate the acquisition of BTBU.

ADMA BioCenters is the Company’s source plasma collection business which operates in the U.S.

Each operational ADMA plasma collection center, once approved, will have a license with the FDA and may obtain additional certifications from other regulatory agencies.

We maintain our headquarters at 465 State Route 17, Ramsey, NJ 07446.

Our telephone number is (201) 478-5552.

Our Florida campus is located at 5800 Park of Commerce Boulevard,

Northwest, Boca Raton, FL 33487.

Our Florida campus is located at 5800 Park of Commerce Boulevard, Northwest, Boca Raton, FL 33487.

The Florida telephone number is (561) 989-5800.

1 unchanged sentence

however, the information on, or that can be accessed through, our website is not part of this Annual Report on Form 10-K.

Annual Report and all of our filings under the Exchange Act, including copies of Annual Reports on Form 10-K, Quarterly Reports

on Form 10-Q, Current Reports on Form 8-K, and any amendments to those reports, are available free of charge through our website

on the date we file those materials with, or furnish them to, the U.S.

Securities and Exchange Commission (the “SEC”).

This Annual Report and all of our filings under the Exchange Act, including copies of Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and any amendments to those reports, are available free of charge through our website on the date we file those materials with, or furnish them to, the U.S.

Securities and Exchange Commission (the “SEC”).

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

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