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Item 1. Business

2024-02-28 compared with 2023-03-23 · 1860 added, 705 removed, 518 unchanged (83% 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 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.

wholly-owned subsidiaries, ADMA BioManufacturing, LLC, a Delaware limited liability company (“ADMA BioManufacturing”), ADMA BioCenters Georgia Inc., a Delaware corporation (“ADMA BioCenters”) and ADMA Plasma Biologics, Inc., a Delaware corporation

(“ADMA Plasma Biologics”).

We are an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty 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.

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(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 in adults and adolescents, for which we received FDA approval on April 1, 2019 and commenced

first commercial sales in October 2019;

Intravenous Immune Globulin (“IVIG”) product indicated for the treatment of Primary Humoral Immunodeficiency (“PI”), also known as Primary Immunodeficiency Disease (“PIDD”) or Inborn Errors of Immunity, 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 in adults and adolescents, for which we received FDA approval on April 1,

2019 and commenced first commercial sales in October 2019;

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

We seek to develop a

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

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.

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.

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, plasma fractionation and purification facility located in Boca Raton, Florida with a peak annual processing capability of up to 600,000 liters (the “Boca Facility”).

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

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

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

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

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

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

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

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

With respect to our operational plasma

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

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

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

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

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

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

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

Plasma collected from ADMA

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

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

representing annual revenues of approximately $330 million in 2024 and potentially $380 million in 2025.

At these revenue levels, we forecast achieving consolidated gross margins in the range of 40-50% and net income margins in the range of 20-30%.

These assumptions translate to potential fiscal year 2024 and 2025 net income of $65 million and $115 million or more and adjusted EBITDA of $90 million and $140 million or more, respectively.

For the year ended December 31, 2023 we had a net loss of loss of $28.2 million and achieved adjusted net income of $0.7 million which, as further described under “Non-GAAP Financial Measures”, excludes charges related

to the refinancing of our senior debt of $26.2 million and an IT systems disruption of $2.7 million (see Management’s Discussion and Analysis of Financial Condition and Results of Operations).

We also generated positive cash flow from operations

for the year ended December 31, 2023 for the first time in the Company’s history, primarily as a result of our significant revenue growth and continued physician, patient and payer acceptance of ASCENIV and BIVIGAM that we have experienced over the

past several years.

Through our ADMA BioCenters subsidiary, we currently operate ten source plasma collection facilities in the U.S., all of which hold FDA licenses.

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

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

In addition, three

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

A typical plasma collection center, such as those

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

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

and in other locations outside the U.S.

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 services for certain third-party clients.

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

capabilities.

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

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, through a five-year manufacturing and supply agreement

we entered into in January 2020.

These intermediate by-products 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

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

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 HHS 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.

Healthcare Common Procedure Coding System (“HCPCS”), the J-code (J1554) became effective April 1, 2021.

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.

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

Our pivotal Phase 3

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

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

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

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

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

Due to the COVID-19 pandemic, our plans have

been delayed.

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

sales of ASCENIV commenced in October of 2019 and in 2023, ADMA commenced manufacturing ASCENIV at the 4,400 Liter production scale for the first time in the Company’s history.

We expect that this expansion should meaningfully improve the product’s

margin profile and increase plant production capacity as fewer batches will be needed to support our revenue goals.

ASCENIV’s prescriber and patient base continued to expand during 2023, which drove record utilization and pull-through for this

These elevated demand trends have sustained into 2024, and ADMA currently expects that this product’s rapid growth will continue throughout 2024 and beyond.

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

These antibodies are directed against bacteria and viruses, and

help to protect PI patients against serious infections.

These antibodies are directed against bacteria and viruses and help to protect PI patients

against serious infections.

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

This includes,

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

These PIs are a group of genetic

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

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

this product in the U.S.

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.

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

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

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

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

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

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

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

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

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

viruses, and prevent against infection and disease.

We manufacture ASCENIV under HHS 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

Under the Healthcare Common Procedure Coding System (“HCPCS”), the J-code (J1554) became effective April 1, 2021.

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

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

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

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

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

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

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

In the future however, we may

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

Commercial sales of ASCENIV commenced in October of 2019

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

operating results.

On December 12, 2023, we announced that the FDA approved the expansion of BIVIGAM’s label in the U.S.

to now include the pediatric setting for those two years of age and older.

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

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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 places people

at high risk of death from cirrhosis and liver cancer.

Hepatitis B is a potentially life-threatening liver infection caused by the Hepatitis B virus, which is a major global health problem.

The Hepatitis B virus can cause chronic infection

and places people at high risk of death from cirrhosis and liver cancer.

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

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

Production of Nabi-HB at the

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

Production of

Nabi-HB at the Boca Facility has continued under our leadership since the third quarter of 2017.

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

continue to manufacture Nabi-HB under HHS License No.

and we continue to manufacture Nabi-HB under HHS License No.

Evaluation of ASCENIV in PIDD Patients

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

PIDD or PI, also known as Inborn Errors of Immunity, is 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 regularly.

As reported in industry journals, the U.S.

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

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

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 by The Plasma Proteins Market In The United States , the U.S.

sales of immune and hyperimmune globulin products for all its uses were reported to be

approximately $10.5 billion in 2022 and are expected to exceed $20 billion by 2030.

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

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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

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

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.

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 SBI to less than one per year in each subject receiving IVIG.

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

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.

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

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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.

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.

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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 FDA Investigational New Drug protocol.

Both children were treated with ASCENIV under an emergency

FDA Investigational New Drug protocol.

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

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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%).

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.

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

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 over the past several years.

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 over the past several years.

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

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

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

patient population.

Plasma Collection Operations

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

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

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

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

Source plasma that is collected from our

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

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

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

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

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

Plasma collected from ADMA BioCenters’ facilities that is not used

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

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

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 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”).

BTBU had previously been our third-party contract manufacturer.

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

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 .

the continuing restrictions surrounding COVID-19, we continue to enhance our recruiting initiatives and expand our existing specialty commercial sales force and commercial-facing organization to market BIVIGAM and ASCENIV to appropriate

sites of care including 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, quality control, inventory management, regulatory affairs, scientific affairs and third-party reimbursement.

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

distributors to fulfill orders for BIVIGAM and ASCENIV.

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

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

ADMA BioCenters operates a total of ten U.S.-based plasma collection facilities, all of which hold FDA licenses and are actively collecting source and high-titer RSV plasma.

Currently, three facilities have also

received approvals from MFDS as well as FDA approval to implement a Hepatitis B immunization program.

Source plasma that is collected from our FDA-licensed facilities provides us with the blood plasma for the manufacture of our products.

plasma collection center, such as those operated by ADMA BioCenters, can collect approximately 30,000 to 50,000 liters of source plasma annually, which may be sold for different prices depending upon the type of plasma, quantity of purchase, and

market conditions at the time of sale.

Plasma collected from ADMA BioCenters’ facilities that is not used to manufacture our products or product candidates are sold to third-party customers in the U.S.

and other international locations where we are

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

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

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 ASCENIV and BIVIGAM for the treatment of patients with PI .

to enhance our recruiting initiatives and expand our existing specialty commercial sales force and commercial-facing organization to market ASCENIV and BIVIGAM to appropriate sites of care including 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, quality

control, inventory management, regulatory affairs, manufacturing, scientific affairs and third-party reimbursement.

We currently use and may continue to partner with a network of national distributors to fulfill orders for ASCENIV and

Increase marketing efforts around Nabi-HB.

Subject to the restrictions surrounding COVID-19, we plan to increase our marketing efforts

and attend relevant virtual or in-person medical conferences during 2022, raising awareness of the risks associated with Hepatitis B and the benefits and efficacy of Nabi-HB in its indicated populations.

We have published and may continue

to publish scientific data supporting the use of Nabi-HB in at-risk and appropriate patient populations.

We plan to increase our marketing efforts and attend relevant virtual or in-person medical conferences during 2024, raising awareness of the risks

associated with Hepatitis B and the benefits and efficacy of Nabi-HB in its indicated populations.

We have published and may continue to publish scientific data supporting the use of Nabi-HB in at-risk and appropriate patient populations.

Expand ASCENIV’s FDA-approved uses .

Having received approval by the FDA for ASCENIV as a treatment for PIDD, we may elect 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 could potentially derive clinical benefit from ASCENIV, some of which may potentially be eligible for orphan status.

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

Having received approval by the FDA for ASCENIV as a treatment for PIDD, we may elect to evaluate the clinical and regulatory paths to grow the ASCENIV franchise

through expanded FDA-approved uses.

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

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

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

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

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

We also plan to strengthen our supply chain capabilities to potentially

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

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

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

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

time in corporate history.

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

The Company’s successful

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

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

During 2024, we plan to advance our biologic production yield enhancement initiative to capture

additional IG production yields from our manufacturing process with the same quantities of starting raw material.

These initiatives are subject to further evaluation, validation of commercial-scale production and requisite regulatory

During 2021, we received FDA approvals for our 4,400L expanded IVIG production scale, as well as our in-house fill-finish and related operations production line using our aseptic filling machine.

In 2023, ADMA commenced

manufacturing ASCENIV at the 4,400 Liter production scale for the first time in the Company’s history.

We expect that this expansion should meaningfully improve the product’s margin profile and increase plant production capacity as fewer

batches will be needed to support revenue goals.

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

realize these benefits in the fourth quarter of 2023.

Broadly Implement Innovative AI Program, ADMAlytics, to improve efficiencies across our supply chain and production operations.

In February 2024, we announced the successful initial use of our

Artificial Intelligence (AI) program, named ADMAlytics.

ADMAlytics combines AI and machine learning to improve and predict outcomes for production and operational processes.

Recently, we successfully produced our first batch of ASCENIV

utilizing this innovative ADMAlytics software to prospectively automate and realize efficiency improvements to plasma pooling during commercial manufacturing.

We expect broad implementation of the new ADMAlytics capabilities will provide

for rapid realization of efficiencies across our supply chain and production operations.

Label expansion.

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

publications supporting product safety.

Upon regulatory approval, the ongoing post-marketing clinical study of ASCENIV, which has successfully completed enrollment, may provide a label expansion opportunity to include

pediatric-aged PI patients as well as additional publications supporting product safety.

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

Our core competency is in the development, manufacturing, testing and

commercialization of plasma-derived therapeutics.

Our core competency is in the development, manufacturing, testing and commercialization

of plasma-derived therapeutics.

We believe there are a number of under-addressed medical conditions for which plasma-derived therapeutics may be beneficial.

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 our plasma collection center network .

We plan on expanding our plasma collection network with the goal of having 10 FDA-licensed plasma collection facilities operating in the

by the end of 2023 as we seek to achieve plasma supply self-sufficiency over the next few years 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.

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.

As part of expanding our product pipeline, we are looking to develop an S.

pneumonia hyperimmune globulin.

pneumonia is the predominant cause of community-acquired pneumonia in the U.S., ranking as the ninth leading cause of overall mortality.

We believe the strategic importance and unmet need are evident in

both the prophylactic and therapeutic settings where documented anti-infective resistance is on the rise.

Annually, approximately one million U.S.

adults contract pneumococcal pneumonia, resulting in 400,000 hospitalizations and a 5-7%

mortality rate, of which approximately 7,000 deaths annually are attributable to anti-infective resistance.

Despite vaccine availabilities, vaccine-naive and immune-compromised patient populations remain at risk and could potentially

benefit from the immediately available neutralizing antibodies conferred with a hyperimmune globulin in both the in-patient and out-patient treatment settings.

We estimate that an S.

pneumonia hyperimmune globulin, if approved, has the

potential to generate peak revenue of $300-500 million.

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

We are exploring new potential CMO, contract testing and business development opportunities,

which include fill-finish capabilities, 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.

which include fill-finish capabilities, with our multi-faceted revenue generation platform, while continuing to fulfill our long-term CMO supply agreement to produce and sell plasma-derived intermediate fractions.

Primary Immunodeficiency Disease

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

Industry reports indicate the U.S.

market for IG in 2021 was

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

As reported by The Plasma

Proteins Market In The United States 2022 and Marketing Research Bureau Inc., October 2022 , the U.S.

market for IG in 2022 was $10.5 billion and is expected to exceed $20 billion by 2030.

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

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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.

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.

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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.

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

The plasma that is collected is known as “normal source

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

referred to as the Cohn method or cold ethanol fractionation.

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

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.

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 seven to 12 months, which is not unique to just ADMA as other fractionators report similar production timelines.

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.

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

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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.

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

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.

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 to potentially expand the label for our existing products.

There are two types of immune globulins;

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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 $9.6 billion in 2021 and are expected to exceed $17 billion in 2027

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

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

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

As reported by The Plasma Proteins Market In The United States 2022 and Marketing Research Bureau Inc., October 2022 , the U.S.

immune and hyperimmune globulin products for all its uses were reported to be approximately $10.5 billion in 2022 and are expected to exceed $20 billion in 2030.

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

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When stored under proper

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

conditions, this plasma may have a shelf-life of up to ten years.

Source plasma is collected at any one of over 1,000 FDA-licensed donation centers located throughout the U.S., using a process known as automated plasmapheresis.

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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.

Source plasma obtained by plasmapheresis is tested and must be negative for certain diseases, such as

antibodies to human immunodeficiency virus types 1 and 2 (HIV-1/2), HbsAg and 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.

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

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.

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 or through our own in-house fill finish process which was approved by the FDA

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

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

drug product.

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

at an increased scale.

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

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

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

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

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

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

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

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

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

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.

On December 10, 2018,

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

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

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

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

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

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

were deleted.

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

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

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

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 or through our own in-house fill-finish process, which was approved by the FDA in

the second half of 2021.

Labeling and packaging operations must further comply with regulatory requirements and products must be labeled in accordance with their regulatory approval and Drug Supply Chain Security Act (“DSCSA”) serialization

requirements.

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

Since 2020, we have successfully implemented several manufacturing and supply chain enhancements, including the

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

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

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

ADMA BioCenters has a total of ten source plasma collection facilities in its network, all of which are FDA-licensed, and should allow the Company to be essentially self-sufficient for its raw material source plasma

supply to produce its commercial IG product portfolio.

Three of our ADMA BioCenters plasma collection facilities also have approvals from the South Korean MFDS and licensure from the FDA for the collection and sale of Hepatitis B hyperimmune plasma

obtained from immunized donors.

At the present time, we do not plan to build additional plasma collection facilities beyond the existing ten, but we continue to have third-party supply contracts in place to augment our vertically integrated plasma

Pursuant to the terms of a plasma purchase agreement dated as of November 17, 2011 (the “2011 Plasma Purchase Agreement”), we agreed to purchase from our former contract manufacturer 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 the counterparty, and under the original 2011 Plasma Purchase Agreement we were permitted

to 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 to (i) allow us to collect our raw material RSV high-titer plasma from any number of

wholly-owned ADMA plasma collection facilities and (ii) allow us to purchase our raw material RSV high-titer plasma from other third-party collection organizations, in each case, provided that the annual minimum volumes from our former contract

manufacturer were met, thus allowing us to expand our reach for raw material supply as we execute our commercialization plans 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.

On December 10, 2018, our former contract manufacturer assigned its rights and obligations under the 2011 Plasma Purchase Agreement to Grifols Worldwide Operations Limited

(“Grifols”) as its successor-in-interest, effective January 1, 2019.

On June 6, 2017, we entered into a Plasma Supply Agreement with our former contract manufacturer, pursuant to which the counterparty 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 ten-year term.

On July 19, 2018, the Plasma Supply Agreement was

amended to provide, among other things, that in the event the counterparty 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 the counterparty, then the counterparty shall reimburse ADMA BioManufacturing for the difference in price ADMA BioManufacturing

On December 10, 2018, our former contract manufacturer assigned its rights and obligations under the Plasma Supply 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

Currently, ASCENIV, BIVIGAM 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.

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

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

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

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

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

sponsoring medical education symposiums.

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

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

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

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

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

ASCENIV for use by healthcare professionals and hospitals.

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

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 ASCENIV in the Territory.

Our management and Board of Directors (“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.

Efforts to generate increased market awareness for Nabi-HB include attending and presenting scientific information at medical conferences, as well as sponsoring medical education symposiums.

We have also hired a

specialty sales force consisting of account managers, medical science liaisons and other customary scientific, medical and detail representatives to market BIVIGAM and ASCENIV to hospitals, physician offices/clinics, and other specialty treatment

organizations as applicable.

In addition, we have expanded staffing efforts with additional personnel for patient support, medical affairs, quality assurance, regulatory affairs, scientific affairs, third-party reimbursement, inventory and

logistics, human resources and financial and operational management.

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

Pursuant to our Manufacturing, Supply and License Agreement effective as of December 31, 2012, we granted to Biotest AG (“Biotest”) an exclusive license to market and sell ASCENIV 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 Biotest’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 ASCENIV in the Territory.

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

Biotest is also obligated

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

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

Major Customers

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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.

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

These competitors may include but are not limited to:

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

CSL Behring, Grifols, Takeda, Octapharma and Permira.

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

consisting of:

Grifols, Takeda and ADMA Biologics.

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

In Europe, where the industry is highly regulated and healthcare

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

them to market their products more quickly.

CSL Behring, Grifols, Takeda

and ADMA Biologics.

In addition to competition from other large worldwide plasma product 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.

For example, recombinant Factor VIII products compete with plasma-derived products in the treatment of Hemophilia A.

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

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

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

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

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

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

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

One such 2021 approved FDA therapy is an anti-FcRn inhibitor (neonatal Fc

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

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

Other such FcRn

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

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

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

Intellectual Property

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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.

9,107,906, 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,

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pneumonia infection.

10,259,865 and 11,084,870 pertain to various aspects of this technology.

10,259,865 and 11,084,870, each with a term through 2037, pertain to various aspects of this technology.

Additional U.S.

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

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.

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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 patents

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.

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 patents 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.

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.

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

We have spent considerable resources registering these trademarks and building brand awareness and equity of the ADMA

Biologics trade name, which has been used in commerce since 2006.

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

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

We have spent considerable resources registering these 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.

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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), quality control,

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

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

in government healthcare programs.

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

do not comply with applicable requirements, we may be subject to civil penalties, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, fined, the government may refuse to approve our marketing applications,

supplemental applications or allow us to manufacture or market our products, we may be criminally prosecuted and we may be debarred or excluded from participation in government healthcare programs.

These requirements are continually evolving.

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

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

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

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

Government Regulation

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 (the “PHS Act”).

However, biologics are also subject to regulation under the Federal Food, Drug and Cosmetic Act (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 pharmaceuticals or “conventional drugs” consist of pure chemical substances and their structures

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.

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

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

requires sterile processes to be applied from initial manufacturing steps.

In the U.S., the FDA regulates biologic products under the Federal Food, Drug and Cosmetic Act (the “FDCA”), the Public Health Service (“PHS”) Act and related federal

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

The FDA also issues nonbinding guidance documents on a continuous basis, which provide the agency’s interpretation of its laws and regulations, as well as the FDA’s approach to

scientific issues and questions.

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

The process required by the FDA before our product

candidates may be marketed in the U.S.

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):

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Manufacturing, and Controls (“CMC”) and proposed labeling and packaging for the product candidate;

satisfactory completion of an FDA pre-approval inspection of the manufacturing facilities at which the product candidate is produced, and potentially other involved facilities as well, to assess compliance with cGMP regulations and

other applicable regulations;

satisfactory completion of potential FDA inspections of the preclinical study and clinical trial sites that generate the data in support of the BLA and;

FDA review and approval of a BLA prior to any commercial marketing, sale or shipment of the product, including agreement on post-marketing commitments.

applicable regulations;

satisfactory completion of potential FDA inspections of the preclinical study and clinical trial sites that generate the data in support of the BLA;

FDA review and approval of a BLA prior to any commercial marketing, sale or shipment of the product, including agreement on post-marketing commitments, and compliance with any post approval commitments, such as Risk Evaluation and

Mitigation Strategies (“REMS”) and post approval studies required by the FDA.

The testing, review 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 may encounter difficulties or unanticipated costs in our efforts to secure necessary governmental approvals, which could delay or preclude us from marketing our product candidates.

In addition, the FDA may limit the indications for use or

place other conditions on any approvals that could restrict the commercial application of the products.

In addition, the FDA may limit the indications for use or place

other conditions on any approvals that could restrict the commercial application of our products.

FDA may also conduct inspections, including remote regulatory assessments, of our facilities or the facilities of our contractors, both during product

development and following approval.

Any findings from those inspections could materially impact our business.

Pre-Clinical Studies

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

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

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

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

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

clinical 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.

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

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

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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

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

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

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

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

patients are being exposed to an unacceptable health risk.

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

Additionally, some clinical trials are

overseen by an independent group of qualified experts organized by the clinical trial sponsor, known as a data safety monitoring board or committee, which reviews data and makes recommendations to the sponsor regarding the trial.

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

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.

cancer patients.

Phase II clinical trials are generally conducted in a larger but limited patient population to identify possible adverse effects and safety risks, to determine the efficacy of the product candidate for specific targeted indications and

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reproducibility of clinical efficacy and safety results for approval 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 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

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 II meeting or as may be agreed between the sponsor and the FDA.

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

or partial waivers.

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

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

requirement is waived by FDA.

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

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

partial waivers.

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

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

waived by the FDA.

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

Such post-approval studies are typically referred to as Phase

IV studies, which are used to gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term safety follow-up.

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

studies, which are used to gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term safety follow-up.

During all phases of clinical development, regulatory agencies require extensive monitoring and auditing of all clinical activities, clinical data and clinical trial investigators.

Annual progress reports detailing

the results of the clinical trials must be submitted to the FDA.

Annual progress reports detailing the

results of the clinical trials must be submitted to the FDA.

Written IND safety reports must be promptly submitted to the FDA and the investigators for:

serious and unexpected adverse events;

any findings from other studies, tests in

laboratory animals or in vitro testing and other sources that suggest a significant risk for human subjects;

or any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator

any findings from other studies, tests in laboratory

animals or in vitro testing and other sources that suggest a significant risk for human subjects;

or any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator brochure.

The sponsor must submit an IND safety report within 15 calendar days after the sponsor determines that the information qualifies for reporting.

The sponsor also must notify the FDA of any unexpected fatal or life-threatening suspected

adverse reaction within seven calendar days after the sponsor’s initial receipt of the information.

The sponsor also must notify the FDA of any unexpected fatal or life-threatening suspected adverse

reaction within seven calendar days after the sponsor’s initial receipt of the information.

Phase I, Phase II and Phase III clinical trials might not be completed successfully within any specified period, if at all.

The FDA or the sponsor

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

Similarly, an IRB can suspend or terminate approval of a clinical trial at

its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the biological product has been associated with unexpected serious harm to patients.

In limited circumstances, the FDA also permits the administration of investigational biological products to patients under its expanded access regulatory authorities.

Under the FDA’s expanded access authority,

provided certain qualifying criteria are met, patients who are not able to participate in a clinical trial may be eligible for accessing investigational products, including through individual compassionate or emergency use in concert with their

requesting physician.

The FDA or the sponsor may

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

Similarly, an IRB can suspend or terminate approval of a clinical trial at its

institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the biological product has been associated with unexpected serious harm to patients.

Information about clinical trials, including results, must

be submitted within specific timeframes for listing on the ClinicalTrials.gov website.

In limited circumstances, the FDA also permits the administration of investigational biological products to patients under its expanded access program.

Under this program, provided certain qualifying criteria are met,

patients who are not able to participate in a clinical trial may be eligible for accessing investigational products, including through individual compassionate or emergency use in concert with their requesting physician.

Sponsors or distributors of

investigational products for the diagnosis, monitoring, or treatment of one or more serious diseases or conditions must also have a publicly available policy on evaluating and responding to requests for expanded access.

Concurrent with clinical trials, companies usually complete additional preclinical studies, animal studies, develop additional information about the physical characteristics of the biological product candidate and

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biological product candidate does not undergo unacceptable deterioration over its shelf life.

The manufacture of Investigational biologics for the conduct of human clinical trials is subject to cGMP requirements.

Investigational biologics and active ingredients and therapeutic substances imported into the

United States are also subject to regulation by the FDA.

Further, the export of investigational products outside the United States is subject to regulatory requirements of the receiving country as well as U.S.

export requirements under the FDCA.

Biologics License Applications

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

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

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

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

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

The FDA has agreed to specified performance goals in the review of BLAs under the PDUFA.

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

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The FDA’s PDUFA review goal is to review 90% of priority BLAs within six months of filing and

90% of standard applications within 10 months of filing, but the FDA can and frequently does extend this review timeline to consider certain later-submitted information or information intended to clarify or supplement an initial submission.

90% of standard applications within ten months of filing, but the FDA can and frequently does extend this review timeline to consider certain later-submitted information or information intended to clarify or supplement an initial submission.

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

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A CRL generally outlines the deficiencies in the submission and 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.

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 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.

CBER also includes specific goals for review of manufacturing and labeling supplements, though in

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

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 12 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 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.

CBER also includes specific goals for review of manufacturing and labeling supplements, though in practice,

FDA reviews may take longer than the stated goals.

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.

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 Risk Evaluation and

Mitigation Strategy (“REMS”).

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

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.

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.If the FDA concludes a REMS is

needed, the sponsor of the BLA must submit a proposed REMS;

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

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

Any of these limitations on approval or marketing can

materially affect the potential market and profitability of the product.

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

A REMS could include medication guides, physician communication plans or elements to assure safe use, such as restricted

distribution methods, patient registries and other risk minimization tools.

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

The FDA does not allow drugs to be promoted for “off-label” uses – that

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

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

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

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

clinical trials, and/or require additional manufacturing data.

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

type, complexity and novelty of the product or disease.

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 for 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.

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.

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 any changes on a timely basis,

The FDA or any other regulatory agency may not grant approvals for any changes on a timely basis, or

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

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Post-Approval Regulatory Requirements

After regulatory approval is obtained, biological drug products are subject to extensive and continuing regulation by the FDA, and the FDA may impose a number of post-approval requirements as a condition of approval

of an application.

After regulatory approval is obtained, biological drug products are subject to extensive and continuing regulation by the FDA, which may impose a number of post-approval requirements as a condition of approval of an

For example, as a condition of approval of a BLA, the FDA may require post-marketing testing and surveillance to monitor the product’s safety or efficacy.

In addition, holders of an approved BLA are required to keep extensive

records (including certain electronic records and signature requirements), submit annual reports, report certain adverse reactions and production problems to the FDA, provide updated safety and efficacy information, and comply with requirements

concerning advertising and promotional labeling for their products.

In addition, holders of an approved BLA are required to keep extensive records

(including certain electronic records and signature requirements), submit annual reports, report certain adverse reactions and production problems to the FDA, provide updated safety and efficacy information and comply with requirements concerning

advertising and promotional labeling for their products.

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.

BLA holders must comply with other regulatory requirements, including submitting annual reports, reporting

information about adverse drug experiences, and maintaining certain records.

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.

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 refusal to approve pending

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

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

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.

There also are annual user fee

requirements for any marketed products, as well as new application fees for supplemental applications with clinical data.

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 refusal to approve pending applications, license suspension or revocation, withdrawal of approval of a BLA, imposition of a clinical hold or termination of clinical trials, warning letters, untitled letters, suspension of manufacturing,

sales or use, product seizures or recalls, import restrictions, injunctive action or possible fines and other penalties.

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.

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.

In addition, changes to the manufacturing process

generally require prior FDA approval before being implemented.

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.

manufacturing deviations and unexpected manufacturing events must be investigated, corrected, and reported to FDA.

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

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

The cGMP requirements apply to all stages of the

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

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

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

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

volume of drugs produced during the prior year.

Certain manufacturing

deviations and unexpected manufacturing events must be investigated, corrected, and reported to the FDA.

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

The cGMP requirements apply to all stages of the manufacturing

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

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

each product batch or lot prior to its release.

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

produced during the prior year.

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

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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 towards production and quality

control to maintain cGMP compliance.

Accordingly, manufacturers must continue to expend time, money, and effort towards production and quality control

to maintain cGMP compliance.

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

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

Trading partners within the drug supply chain must now

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

Trading partners within the drug supply chain must now ensure

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

Further, the DSCSA limits the distribution of prescription

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However, FDA regulations impose restrictions on manufacturers’ communications regarding off-label uses.

Broadly speaking, a manufacturer may not promote a drug for off-label use, but under certain conditions may engage in

non-promotional, balanced, scientific communication regarding off-label use.

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

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

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

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

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

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

It is impossible to predict whether further legislative or FDA

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

Broadly speaking, a manufacturer may not promote a drug for off-label use, but under certain conditions may engage in non-promotional,

balanced, scientific communication regarding off-label use.

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

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

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

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

Companies are required to supply sufficient information that balances the risks of a product in its marketing and promotional materials.

In 2023, the FDA implemented several measures in the advertising and promotional

These included the issuance of a final rule and a guidance on the disclosure of risks and effectiveness in direct-to-consumer advertising, as well as a guidance on the dissemination of off-label scientific data about approved products.

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.

It is impossible to predict whether further legislative or FDA regulation or other regulatory policy

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

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

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

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

collection facilities for source plasma.

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

certain regulatory requirements.

ADMA BioCenters has completed these requirements and holds an FDA license for all ten of its

plasma collection facilities for source plasma.

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

meet certain regulatory requirements.

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

Establishments must also comply with FDA’s

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

Facilities must further ensure that all

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

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

Establishments must also comply with the

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

Facilities must further ensure that

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

Blood plasma collection and manufacturing centers are also subject to the Clinical Laboratory Improvement Amendments (“CLIA”), 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.

State requirements may differ significantly from federal requirements, which may complicate compliance efforts.

We believe that our existing ADMA

BioCenters facilities are currently in compliance with state and industry standards.

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.

In addition, we

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

Foreign Regulation

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commercial sales and distribution of any future product.

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

marketing of the product in those countries.

Whether or not we obtain FDA approval for a product, we must obtain approval 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.

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, decentralized or national 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 decentralized procedure provides for approval by one or more “concerned” member states based on an assessment of an application performed by one

member state, known as the “reference” member state.

The centralized procedure provides for the grant

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

The decentralized procedure provides for approval by one or more “concerned” member states based on an assessment of an application performed by one member

state, known as the “reference” member state.

Under the decentralized approval procedure, an applicant submits an application, or dossier, and related materials to the reference member state and concerned member states.

The reference

member state prepares a draft assessment report and drafts of the related materials within 120 days after receipt of a valid application.

Within 90 days of receiving the reference member state’s assessment report, each concerned member state must

decide whether to approve the assessment report and related materials.

If a member state does not recognize the marketing authorization, the disputed points are eventually referred to the European Commission, whose decision is binding on all

member states.

In addition to the centralized procedure and the decentralized procedure, it may also be possible to obtain a marketing authorization for one single member state through a national procedure.

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

The reference member state

prepares a draft assessment report and drafts of the related materials within 120 days after receipt of a valid application.

Within 90 days of receiving the reference member state’s assessment report, each concerned member state must decide whether

to approve the assessment report and related materials.

If a member state does not recognize the marketing authorization, the disputed points are eventually referred to the European Commission, whose decision is binding on all member states.

addition to the centralized procedure and the decentralized procedure, it may also be possible to obtain a marketing authorization for one single member state through a national procedure.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.

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.

Pharmaceutical Pricing and Reimbursement of Our Products

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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.

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

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for any of our products will be made on a payor-by-payor basis.

As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our

products to each payor separately, with no assurance that coverage and adequate reimbursement will be obtained.

As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our products

to each payor separately, with no assurance that coverage and adequate reimbursement will be obtained.

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

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In order to obtain

coverage and reimbursement for our current products and 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.

addition to the costs required to obtain regulatory approvals.

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

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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.

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 our current products and 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

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

Coverage policies and third-party reimbursement rates may change at

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

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.

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quarters beginning January 1, 2022, manufacturers will be required to report the average sales price for certain drugs under the Medicare program regardless of whether the manufacturer participates in the Medicaid Drug Rebate Program.

Previously, this reporting obligation extended only to manufacturers participating in the Medicaid Drug Rebate Program.

Under this Program, manufacturers are required to pay a rebate to each state Medicaid program for covered outpatient drugs

that are dispensed to Medicaid beneficiaries and paid for by a state Medicaid program as a condition of having federal funds being made available for their drugs under Medicaid and Part B of the Medicare program.

Medicaid is a joint federal and state program that is administered by the states for low-income and disabled beneficiaries.

Medicaid rebates are based on pricing data reported by manufacturers on a monthly and

quarterly basis to the CMS, the federal agency that administers the Medicaid and Medicare programs.

These data include the average manufacturer price and, in the case of innovator products, the best price for each drug, which, in general,

represents the lowest price available from the manufacturer to any entity in the U.S.

in any pricing structure, calculated to include all sales and associated rebates, discounts, and other price concessions.

The amount of the rebate is adjusted

upward if the average manufacturer price increases more than inflation (measured by reference to the Consumer Price Index - Urban).

Currently, the rebate is capped at 100 percent of the average manufacturer price, but, effective January 1, 2024,

this cap on the rebate will be removed, and our rebate liability could increase accordingly.

If a manufacturer becomes aware that its reporting for a prior quarter was incorrect or has changed as a result of recalculating the pricing data, the manufacturer is obligated to resubmit the corrected data for up

to three years after those data originally were due, which revisions could affect rebate liability for prior quarters.

The federal Patient Protection and ACA made significant changes to the Medicaid Drug Rebate Program, and CMS issued a final

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

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

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

provided definitions for “line extension,” “new formulation,” and related terms with the practical effect of expanding the scope of

drugs considered to be line extensions (beginning in 2022);

and revised best price and average manufacturer price exclusions of manufacturer-sponsored patient benefit programs, particularly regarding potential inapplicability of such exclusions

in the context of pharmacy benefit manager “accumulator” programs (beginning in 2023).

this reporting obligation extended only to manufacturers participating in the Medicaid Drug Rebate Program.

Under this Program, manufacturers are required to pay a rebate to each state Medicaid program for covered outpatient drugs that are

dispensed to Medicaid beneficiaries and paid for by a state Medicaid program as a condition of having federal funds being made available for their drugs under Medicaid and Part B of the Medicare program.

Medicaid rebates are based on pricing data reported by manufacturers on a monthly and quarterly basis to the CMS, the federal agency that administers the Medicaid and Medicare programs.

This data includes the average

manufacturer price and, in the case of innovator products, the best price for each drug, which, in general, represents the lowest price available from the manufacturer to any entity in the U.S.

in any pricing structure, calculated to include all

sales and associated rebates, discounts, and other price concessions.

The amount of the rebate is adjusted upward if the average manufacturer price increases more than inflation (measured by reference to the Consumer Price Index–- Urban).

Currently, the rebate is capped at 100% of the average manufacturer price, but, effective January 1, 2024, this cap on the rebate will be removed, and our rebate liability could increase accordingly.

three years after it was originally due, which revisions could affect rebate liability for prior quarters.

The ACA made significant changes to the Medicaid Drug Rebate Program, and CMS issued a final regulation, which became effective on April 1,

2016, to implement the changes to the Medicaid Drug Rebate Program under the ACA.

On December 21, 2020, CMS issued a final rule that modified the Medicaid Drug Rebate Program regulations to permit reporting multiple best price figures with regard

to value‑based purchasing arrangements (beginning in 2022);

provided definitions for “line extension”, “new formulation,” and related terms with the practical effect of expanding the scope of drugs considered to be line extensions (beginning in

and revised best price and average manufacturer price exclusions of manufacturer-sponsored patient benefit programs, particularly regarding potential inapplicability of such exclusions in the context of pharmacy benefit manager “accumulator”

programs (beginning in 2023).

Medicare is a federal program that is administered by the federal government that covers individuals age 65 and over or that are disabled as well as those with certain health conditions.

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Congress could enact additional changes that affect our overall rebate liability and the information manufacturers report to the government as part of price reporting calculations.

For example, Congress is

considering a Medicare Part B inflation rebate, under which manufacturers would owe additional rebates if the average sales price of a drug were to increase faster than the pace of inflation.

For example, Congress is considering

a Medicare Part B inflation rebate, under which manufacturers would owe additional rebates if the average sales price of a drug were to increase faster than the pace of inflation.

Civil monetary penalties can be applied if a manufacturer is (1) found to have knowingly submitted any false pricing or other information to the government, (2) found to have made a misrepresentation in the reporting

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Medicaid or Medicare Part B for the manufacturer’s covered outpatient drugs.

Federal law requires that any company that participates in the Medicaid Drug Rebate Program also participate in the Public Health Service’s 340B drug pricing program (the “340B program”) in order for federal funds to

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

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

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

Covered entities include hospitals that serve a disproportionate share of financially needy patients, community health

clinics, and other entities that receive certain types of grants under the Public Health Service Act.

The ACA expanded the list of covered entities to include certain free-standing cancer hospitals, critical access hospitals, rural referral

centers, and sole community hospitals, but exempts “orphan drugs” from the ceiling price requirements for these covered entities.

The 340B ceiling price is calculated using a statutory formula, which is based on the average manufacturer price and

Medicaid rebate amount for the covered outpatient drug as calculated under the Medicaid Drug Rebate Program.

In general, products subject to Medicaid price reporting and rebate liability are also subject to the 340B ceiling price calculation and

discount requirement.

HRSA issued a final regulation regarding the calculation of the 340B ceiling price and the imposition of civil monetary penalties on manufacturers that knowingly and intentionally overcharge covered entities, which

became effective on January 1, 2019.

It is currently unclear how HRSA will apply its enforcement authority under this regulation.

Any charge by HRSA that a manufacturer has violated the requirements of the regulation could result in civil

monetary penalties.

Moreover, under a final regulation effective January 13, 2021, HRSA established a new administrative dispute resolution (“ADR”) process for claims by covered entities that a manufacturer has engaged in overcharging, and by

manufacturers that a covered entity violated the prohibitions against diversion or duplicate discounts.

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

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

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

Covered entities include hospitals that serve a disproportionate share of financially needy patients, community health clinics, and other

entities that receive certain types of grants under the Public Health Service Act.

The ACA expanded the list of covered entities to include certain free-standing cancer hospitals, critical access hospitals, rural referral centers, and sole

community hospitals, but exempts “orphan drugs” from the ceiling price requirements for these covered entities.

The 340B ceiling price is calculated using a statutory formula, which is based on the average manufacturer price and Medicaid rebate

amount for the covered outpatient drug as calculated under the Medicaid Drug Rebate Program.

In general, products subject to Medicaid price reporting and rebate liability are also subject to the 340B ceiling price calculation and discount

The final regulation issued by HRSA regarding the calculation of the 340B ceiling price and the imposition of civil monetary penalties on manufacturers that knowingly and intentionally overcharge covered entities has

affected manufacturer obligations and potential liability under the 340B program.

Any charge by HRSA that a manufacturer has violated the requirements of the regulation could result in civil monetary penalties.

Moreover, under a final regulation

effective January 13, 2021, HRSA established a new Administrative Dispute Resolution “ADR”) process for claims by covered entities that a manufacturer has engaged in overcharging, and by manufacturers that a covered entity violated the prohibitions

against diversion or duplicate discounts.

Such claims are to be resolved through an ADR panel of government officials rendering a decision that can be appealed to a federal court.

ADR proceeding could subject a manufacturer to onerous procedural requirements and could result in additional liability.

HRSA also implemented a price reporting system under which manufacturers are required to report 340B ceiling prices on a

quarterly basis to HRSA, which then publishes those prices to 340B covered entities.

In addition, legislation could be passed, that would further expand the 340B program to additional covered entities, or participating manufacturers could be

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

An ADR proceeding could subject a manufacturer to onerous procedural

requirements and could result in additional liability.

HRSA also implemented a price reporting system under which manufacturers are required to report 340B ceiling prices on a quarterly basis to HRSA, which then publishes those prices to 340B

covered entities.

In addition, legislation could be passed, that would further expand the 340B program to additional covered entities, or participating manufacturers could be required to agree to provide 340B discounted pricing on drugs used in an

inpatient setting.

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

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

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

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

The additional discount applies if non-FAMP

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

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

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

The additional discount applies if non-FAMP increases

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

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

Manufacturers must also participate

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

The governing statute provides for civil

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

Manufacturers must also participate in the

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

The governing statute provides for civil monetary

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

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

, drugs that are not administered by a physician).

Medicare Part D

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

Medicare Part D is

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

government and subject to detailed program rules and government oversight.

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

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

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

which the drug plan may modify from time to time.

The prescription drug plans negotiate pricing with manufacturers and pharmacies and may condition formulary placement on the availability of manufacturer rebates.

manufacturers are required to provide to CMS a 70% discount on brand name prescription drugs utilized by Medicare Part D beneficiaries when those beneficiaries are in the coverage gap phase of the Part D benefit design.

Civil monetary penalties

can be applied if a manufacturer fails to provide these discounts in the amount of 125 percent of the discount that was due.

Congress could enact legislation that sunsets this discount program and replaces it with a new manufacturer discount

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

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

This or any other legislative change

could impact the market conditions for our products.

In addition, manufacturers are

required to provide to CMS a 70% discount on brand name prescription drugs utilized by Medicare Part D beneficiaries when those beneficiaries are in the coverage gap phase of the Part D benefit design.

If a manufacturer fails to provide these

discounts, civil monetary penalties can be applied in the amount of 125% of the discount that was due.

Congress could enact legislation that sunsets this discount program and replaces it with a new manufacturer discount program.

Congress further

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

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

This or any other legislative

change could impact the market conditions for our products.

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

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

techniques and are increasingly requiring significant discounts and rebates from manufacturers as a condition to including products on formulary with favorable coverage and cost-sharing.

These payors may not cover or adequately reimburse for use

of our products or may do so at levels that disadvantage them relative to competitive products.

and are increasingly requiring significant discounts and rebates from manufacturers as a condition to including products on formulary with favorable coverage and cost-sharing.

These payors may not cover or adequately reimburse for use of our

products or may do so at levels that disadvantage them relative to competitive products.

Outside the United States, within the EU, our products are paid for by a variety of payors, with governments being the primary source of payment.

Government health authorities in the EU determine or influence reimbursement of products and set prices or otherwise regulate pricing.

health authorities in the EU determine or influence reimbursement of products and set prices or otherwise regulate pricing.

Negotiating prices with governmental authorities can delay commercialization of our products.

Governments may

use a variety of cost-containment measures to control the cost of products, including price cuts, mandatory rebates, value-based pricing and reference pricing ( i.e.

, referencing prices in other countries

or prices of competitive products and using those reference prices to set a price).

Budgetary pressures in many EU countries are continuing to cause governments to consider or implement various cost-containment measures, such as price freezes,

increased price cuts and rebates and expanded generic substitution and patient cost-sharing.

Recently, several states also have enacted or are considering legislation intended to make drug prices more transparent and deter significant price

increases that impose reporting requirements on biopharmaceutical companies.

Governments may use a variety

of cost-containment measures to control the cost of products, including price cuts, mandatory rebates, value-based pricing and reference pricing ( i.e.

, referencing prices in other countries or prices of

competitive products and using those reference prices to set a price).

Budgetary pressures in many EU countries are continuing to cause governments to consider or implement various cost-containment measures, such as price freezes, increased price

cuts and rebates and expanded generic substitution and patient cost-sharing.

Recently, several states also have enacted or are considering legislation intended to make drug prices more transparent and deter significant price increases that impose

reporting requirements on biopharmaceutical companies.

These laws may affect our future sales, marketing, and other promotional activities by imposing administrative and compliance burdens.

Such laws also typically impose

significant civil monetary penalties for each instance of reporting noncompliance that can quickly aggregate into the millions of dollars.

Such laws also typically impose significant civil monetary

penalties for each instance of reporting noncompliance that can quickly aggregate into millions of dollars.

Healthcare Reform

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legislatures and foreign governments have shown significant interest in implementing cost-containment programs, including price controls, payment of rebates, restrictions on reimbursement and requirements for substitution of generic products.

Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could limit our net revenue and results for products, if any, we commercialize in the

The pricing and reimbursement environment for our products may change in the future and become more challenging due to state and federal healthcare reform measures.

The American Recovery and Reinvestment Act of 2009

or ARRA, for example, allocated new federal funding to compare the effectiveness of different treatments for the same condition.

(“ARRA”), for example, allocated new federal funding to compare the effectiveness of different treatments for the same condition.

The plan for the research was published in 2012 by the Department of Health and Human Services, the Agency for

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effectiveness studies for reimbursement purposes, it is not clear what effect, if any, the research will have on the sales of any products for which we receive marketing approval or on the reimbursement policies of public and private payors.

is possible that comparative effectiveness research demonstrating benefits in a competitor’s product could adversely affect the sales of any product for which we receive marketing approval.

For example, if third-party payors find our products not

to be cost-effective compared to other available therapies, they may not cover our products after approval as a benefit under their plans or, if they do, the level of payment may not be sufficient to allow us to sell our products on a profitable

possible that comparative effectiveness research demonstrating benefits in a competitor’s product could adversely affect the sales of any product for which we receive marketing approval.

For example, if third-party payors find our products not to

be cost-effective compared to other available therapies, they may not cover our products after approval as a benefit under their plans or, if they do, the level of payment may not be sufficient to allow us to sell our products on a profitable

The ACA is a sweeping measure intended to expand healthcare coverage within the U.S., primarily through the imposition of health insurance mandates on employers and individuals, the provision of subsidies to eligible

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Changes that may affect our business include those governing enrollment in Federal healthcare programs, reimbursement changes, benefits for patients within a coverage gap in the Medicare Part D prescription

drug program (commonly known as the “donut hole”), rules regarding prescription drug benefits under the health insurance exchanges, changes to the Medicaid Drug Rebate Program, expansion of the Public Health Service Act’s 340B drug pricing

program, or 340B program, and fraud and abuse enforcement.

These changes have impacted previously existing government healthcare programs and have resulted in the development of new programs, including Medicare payment for performance initiatives

and improvements to the Medicare physician quality reporting system and feedback program.

or 340B program, and fraud and abuse enforcement.

These changes have impacted previously existing government healthcare programs and have resulted in the development of new programs, including Medicare payment for performance initiatives and

improvements to the Medicare physician quality reporting system and feedback program.

One of the goals of ACA was to expand coverage for the uninsured while at the same time containing overall healthcare costs.

With regard to pharmaceutical products, among other things, the ACA increased minimum

rebates a manufacturer must pay under the Medicaid Drug Rebate Program and extended manufacturers’ Medicaid rebate liability to drugs dispensed to individuals who are enrolled in Medicaid managed care organizations.

The ACA also requires

manufacturers of drugs, devices, biologics, and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to CMS information related to certain

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

teaching hospitals,

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

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

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

With regard to pharmaceutical products, among other things, the ACA increased minimum rebates

a manufacturer must pay under the Medicaid Drug Rebate Program and extended manufacturers’ Medicaid rebate liability to drugs dispensed to individuals who are enrolled in Medicaid managed care organizations.

The ACA also requires manufacturers of

drugs, devices, biologics, and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to CMS information related to certain direct or indirect

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

teaching hospitals, as well as ownership

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

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

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

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

For each state that does not choose to expand its

Medicaid program, there may be fewer insured patients overall, which could impact sales of our products that are approved and that we successfully commercialize, and our business and financial condition.

Where Medicaid patients receive insurance

coverage under any of the new options made available through the ACA, the possibility exists that manufacturers may be required to pay Medicaid rebates on drugs used under these circumstances, a decision that could impact manufacturer revenues.

For each state that does not choose to expand its Medicaid

program, there may be fewer insured patients overall, which could impact sales of our products that are approved and that we successfully commercialize, and our business and financial condition.

Where Medicaid patients receive insurance coverage

under any of the new options made available through the ACA, the possibility exists that manufacturers may be required to pay Medicaid rebates on drugs used under these circumstances, a decision that could impact manufacturer revenues.

Certain provisions of the ACA have been subject to judicial challenges as well as efforts to modify them or to alter their interpretation or implementation.

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

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

may commercialize in the future.

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

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

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

commercialize in the future.

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

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

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manufacturers relative to certain international prices paid, and reform government healthcare program reimbursement methodologies for drug products.

If healthcare policies or reforms intended to curb healthcare costs are adopted or if we

experience negative publicity with respect to pricing of our products or the pricing of pharmaceutical drugs generally, the prices that we charge for any approved products may be limited, our commercial opportunity may be limited and/or our

revenues from sales of our products may be negatively impacted.

If healthcare policies or reforms intended to curb healthcare costs are adopted or if we experience

negative publicity with respect to pricing of our products or the pricing of pharmaceutical drugs generally, the prices that we charge for any approved products may be limited, our commercial opportunity may be limited and/or our revenues from

sales of our products may be negatively impacted.

It is possible that the ACA, as currently enacted or may be amended in the future, as well as other healthcare reform measures that may be adopted in the future, may result in additional reductions in Medicare and

other healthcare funding, more rigorous coverage criteria and new payment methodologies and in additional downward pressure on coverage and payment and the price that we receive for any approved product.

Any reduction in reimbursement from

Medicare or other government programs may result in a similar reduction in payments from private payors.

The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain

profitability or commercialize our products.

We cannot be sure whether additional legislative changes will be enacted in the United States or outside of the United States, or whether regulatory changes, guidance or interpretations will be

changed, or what the impact of such changes on the marketing approvals of our product candidates, if any, may be.

Any reduction in reimbursement from Medicare

or other government programs may result in a similar reduction in payments from private payors.

The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or

commercialize our products.

We cannot be sure whether additional legislative changes will be enacted in the U.S.

or outside the U.S., or whether regulatory changes, guidance or interpretations will be changed, or what the impact of such changes on

the marketing approvals of our product candidates, if any, may be.

Anti-Fraud and Abuse Laws

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Federal healthcare program

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

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

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

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

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

beneficiaries.

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

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

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

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

prescribers, purchasers and formulary managers on the other.

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

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

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

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

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

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

Recent regulations eliminate

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

Recent legislation and a final rule promulgated on December 29,

2023 delayed implementation of this portion of the 2020 final rule until January 1, 2032.

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

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

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

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

Failure to meet all the

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

Instead, the legality of the arrangement will be evaluated on a case-by-case basis based

on a cumulative review of all its facts and circumstances.

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

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

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

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

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

property presented to the U.S.

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

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

requirements, and services rendered.

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

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

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

presented to the U.S.

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

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

services rendered.

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

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

Intent to deceive or actual

knowledge of falsity is not required to establish liability under the FCA.

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

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

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

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

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

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

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

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

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

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

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

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

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

federal government that

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

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

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

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

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

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

Federal government that otherwise

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

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

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

co-pay assistance that pharmaceutical companies can offer to patients.

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

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

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

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information and personal data.

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

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

or performing a function on behalf of a covered entity.

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

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

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

commensurate to promises made to individual about the security of their personal information (such as in a privacy notice) may constitute unfair or deceptive acts or practices in violation of Section 5(a) of the Federal Trade Commission Act (“FTC

The FTC expects a company’s data security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexity of its business, and the cost of available tools to

improve security and reduce vulnerabilities.

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

performing a function on behalf of a covered entity.

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

that is not authorized or permitted by HIPAA.

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

to promises made to individuals about the security of their personal information (such as in a privacy notice) may constitute unfair or deceptive acts or practices in violation of Section 5(a) of the Federal Trade Commission Act (“FTC Act”).

FTC expects a company’s data security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexity of its business, and the cost of available tools to improve security

and reduce vulnerabilities.

Individually identifiable health information is considered sensitive data that merits stronger safeguards.

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

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

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

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

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

Most states have laws requiring notification of affected individuals and state regulators (breach notification laws) in the event of a breach of personal information, which is a broader class of information than the

health information protected by HIPAA.

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

Additionally, in California, the California Consumer Privacy Act

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

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

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

California Privacy Protection Agency (“CPPA”).

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

Failure to comply with the CCPA may result in,

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

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

All states have laws requiring notification of affected individuals and state regulators (breach notification laws) in the event of a breach of personal information.

Some state laws impose significant data security

requirements, such as encryption, to ensure ongoing protection of personal information.

Additionally, in California, the California Consumer Privacy Act (“CCPA”) establishes certain requirements for data use and sharing transparency and creates new

data privacy rights for California residents.

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

In November 2020, California voters approved the California Privacy Rights Act (“CPRA”) ballot

initiative, which introduced significant amendments to the CCPA and established and funded a dedicated California privacy regulator, the California Privacy Protection Agency (“CPPA”).

The amendments introduced by the CPRA became effective on

January 1, 2023.

Failure to comply with the CCPA may result in, among other things, significant civil penalties and injunctive relief, or statutory or actual damages.

In addition, California residents have the right to bring a private right of

action in connection with certain types of security incidents.

These claims may result in significant liability and damages.

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

Virginia, Colorado, Connecticut and Utah have also enacted privacy laws that became effective in 2023 and are similar in

many respects to the CCPA.

Activities outside of the U.S.

implicate local and national data protection standards, impose additional compliance requirements and generate additional risks of enforcement for non-compliance.

The European Union’s

General Data Protection Regulation (“GDPR”), which imposes fines of up to EUR 20 million or 4% of the annual global revenue of a noncompliant company, whichever is greater, and other data protection, privacy and similar national, state/provincial

and local laws may also restrict the access, use and disclosure of patient health information abroad.

We may be required to expend significant capital and other resources to ensure ongoing compliance with applicable privacy and data security

laws, to protect against security breaches and hackers, or to alleviate problems caused by such breaches.

Compliance with these laws is difficult, constantly evolving, time consuming, and requires a flexible privacy framework and substantial

For example, the

European Union’s General Data Protection Regulation (“GDPR”), which imposes fines of up to EUR 20 million or 4% of the annual global revenue of a noncompliant company, whichever is greater, and other data protection, privacy and similar national,

state/provincial and local laws may also restrict the access, use and disclosure of patient health information abroad.

We may be required to expend significant capital and other resources to ensure ongoing compliance with applicable privacy and

data security laws, to protect against security breaches and hackers, or to alleviate problems caused by such breaches.

Compliance with these laws is difficult, constantly evolving, time consuming, and requires a flexible privacy framework and

substantial resources.

Compliance efforts will likely be an increasing and substantial cost in the future.

Environmental, Social and Governance (“ESG”)

Our Corporate Code of Ethics ensures employee adherence to strive to conserve resources and reduce water consumption and emissions through recycling and other energy conservation measures.

Employees are responsible

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

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

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

These activities do not include either industrial production or

distribution, and therefore do not use raw materials.

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

Further, our activities do not produce any particular noise

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

Our Code of Ethics and Business Conduct states that employees should strive to conserve resources and reduce water consumption and emissions through recycling and other energy conservation measures.

Employees are

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

We manufacture, market and develop specialty biologics for the prevention

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

These activities do not include either industrial production or distribution, and

therefore do not use raw materials that would result in significant releases into the environment or greenhouse gas emissions from our manufacturing emissions.

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

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

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

Waste Management Policy

Our waste management’s mission is to identify and mitigate risks and hazards with the aim of achieving zero incidents, zero injuries, and zero spills or environmental harm.

We are dedicated to the safe handling and

management of all non-hazardous and hazardous materials, and all employees are responsible for appropriate waste management.

The objective of our waste management policy is to identify and mitigate risks and hazards with the aim of achieving zero incidents, zero injuries, and zero spills or environmental harm.

We are dedicated to the safe

handling and management of all non-hazardous and hazardous materials, and all employees are responsible for appropriate waste management.

We are dedicated to high environmental standards and expect all employees to be familiar with and comply with the contents of this policy.

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with all applicable laws, regulations, and requirements associated with our environmental obligations and impact.

We are committed to the continual improvement of all environmental impacts associated with our operations.

We strive for the continual improvement of all environmental impacts associated with our operations.

We are committed to the

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We actively sponsor and participate in industry-related charitable events on a local and national level and encourage our employees to actively participate and volunteer their time and participation.

support and fund initiatives designed to improve the communities in which we operate and our employees and stakeholders reside.

support and fund initiatives designed to improve the communities in which we operate and where our employees and stakeholders reside.

We pursue fair employment practices in every aspect of our business.

We strive to ensure and are extremely proud that our board of directors and employee base is diverse and consists of individuals of varying gender,

origin, sexual orientation and backgrounds with various and relevant career experience, relevant technical skills, education, industry knowledge and experience and possess local or community ties.

We strive to ensure and are extremely proud that our Board and our employee base is diverse and consists of individuals of varying gender, origin,

sexual orientation and backgrounds with various and relevant career experience, relevant technical skills, education, industry knowledge and experience and possess local or community ties.

As of December 31, 2023, we had a total of 624 employees, all of whom are full-time.

Over the course of the next year, we anticipate hiring additional full-time employees devoted to compliance, production, quality

assurance, quality control, plasma collection and processing, 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

We use Clinical Research Organizations (“CROs”), third parties and consultants to perform our post-marketing commitment clinical studies and other process and/or analytical development projects to augment our in-house capabilities

assurance, quality control, plasma collection and processing, sales and marketing, medical and scientific affairs and administration, as well as hiring additional staff for our plasma collection centers as appropriate.

We use Clinical Research

Organizations (“CROs”), third parties and consultants to perform our post-marketing commitment clinical studies and other process and/or analytical development projects to augment our in-house capabilities and staff.

Corporate Information

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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 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.

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

We operate through our wholly-owned subsidiaries ADMA

BioManufacturing, ADMA BioCenters and ADMA Plasma Biologics.

ADMA BioManufacturing was formed in January 2017 to facilitate the acquisition of certain assets held by the Company’s then-third-party contract manufacturer.

ADMA BioCenters is the

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

Each of ADMA’s ten operational plasma collection centers 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.

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

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.

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.

Summary of Risk Factors

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

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

Additional discussion of the risks summarized

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

an investment decision regarding our common stock.

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

Although we achieved net income on a non-GAAP basis and generated positive cash flows for the year ended December 31, 2023 for the first time, we may not be able to achieve profitability and generate positive cashflows in the future.

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

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

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

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

at similar rates, if at all.

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

citations, warning letters or other enforcement actions.

Business interruptions could adversely affect our business.

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

we may deem to be reasonable.

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

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

commercialization activities.

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

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

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

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

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

financial condition.

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

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

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

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

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

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

Our senior secured credit facility with Ares Capital Corporation and certain of its affiliates (“Ares”) is subject to acceleration in specified circumstances, which may result in Ares taking possession and disposing of any collateral.

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

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

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

counter transmittable diseases.

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

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

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

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

You should recognize that other significant risks and uncertainties may

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

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

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

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

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

and adversely affected.

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

Risks Relating to our Business

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

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

build out our commercial infrastructure and meet our ongoing obligations.

In addition, our end-to-end production cycle from procurement of raw materials to commercial release of finished product can take between seven and 12 months or potentially

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

We currently anticipate, based upon our projected revenue and expenditures, that our current cash, cash equivalents and accounts receivable, along with our projected future operating cash flow, will be sufficient to

fund our operations, as currently conducted, through the end of the first quarter of fiscal 2025.

However, our current outlook on cash flows and profitability may change based upon how quickly we are able to execute on our commercialization efforts

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

Although we achieved net income on a non-GAAP basis (see “Non-GAAP Financial Measures” within Management’s Discussion and

Analysis of Financial Condition and Results of Operations) and positive cash flow from operations for the first time in our history for the year ended December 31, 2023, at present we cannot be certain that we will be able to generate a sufficient

amount of product revenue to maintain profitability through 2024 and beyond.

If we are unable to generate sufficient positive cash flow throughout 2024 and cannot raise additional capital if needed, we may have to delay, curtail or eliminate our

commercialization efforts and product development activities.

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

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

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

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

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

The actual amount of additional cash that we may need, if any, is subject to

many factors.

There can be no assurances that additional financing will be available if needed or that management will be able to obtain financing on terms acceptable to us or that we will continue to be profitable and generate positive operating

We may not be able to achieve profitability in 2024 and beyond.

We have a history of losses through December 31, 2023, and we may not be able to achieve profitability.

For the years ended December 31, 2023, 2022 and 2021, we incurred net losses of $28.2 million, $65.9 million and

$71.6 million, respectively.

From our inception in 2004 through December 31, 2023, we have incurred an accumulated deficit of $506.3 million.

We may not be able to generate a sufficient amount of product revenue to achieve profitability throughout

2024, and if we are unable to continue to generate positive cash flow we may need to continue to finance our operations through additional equity or debt financings or corporate collaboration and licensing agreements.

We also expect to continue to

incur significant operating and capital expenditures and anticipate that as our business continues to grow our operating expenses will increase accordingly as we:

expand commercialization and marketing efforts;

implement additional internal systems, controls and infrastructure;

hire additional personnel;

expand production capacity at the Boca Facility.

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

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

Pandemics, or a resurgence of a pandemic, may adversely affect our business, financial condition, liquidity or results of operations.

The COVID-19 pandemic negatively impacted certain aspects of our business and operations.

The resurgence of the COVID-19 pandemic, or a future pandemic or health epidemic, could adversely affect our business,

financial condition, liquidity or results of operations.

These adverse effects include, but are not limited to, the potential adverse effects on the global economy, our manufacturing processes, including our supply chain, our submissions or

applications to the FDA and our employees.

The ultimate impact will depend on the severity and duration of the pandemic and actions taken by governmental authorities and other third parties in response, each of which is uncertain and difficult to

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

This reliance on

third parties carries the risk that the services upon which we rely may not be performed in a timely manner, in sufficient quantities or according to our specifications, which could delay the availability of our finished drug product and could

adversely affect our commercialization efforts and our revenues.

Third parties may not perform as agreed or in accordance with FDA requirements.

Any significant problem that our third-party providers experience could delay or interrupt our supply of finished drug product until the

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

Failure to obtain the needed services and products meeting the necessary

quality standards or at all could have a material and adverse effect on our products, business, financial condition and results from operations.

Although we are utilizing our FDA-approved fill/finish suite that we built at the Boca Facility for a portion of our finished drug product and although we receive our raw material plasma from our ADMA BioCenters plasma

collection facilities, we also intend to continue to utilize third parties to supplement our fill/finish process for final drug product and to supply raw material source and high-titer RSV plasma.

Any failure by us, our contract fill/finishers, or

other third parties involved in the process for producing our products or product candidates to comply with the applicable manufacturing and regulatory requirements, including quality requirements, could place us and them at risk of regulatory

enforcement actions, recalls and other adverse consequences, could adversely impact our products, and could adversely impact patients receiving our products, which may negatively impact our business and our ability to produce and supply products to

meet commercial and clinical needs.

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

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

our marketing application;

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

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

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

processes required to deliver our finished drug product;

our third-party contractors might be unable to timely provide finished drug product or raw material plasma in sufficient quantity to meet our commercial needs;

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

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

compliance with these regulations;

contractors may fail to comply with applicable regulatory requirements, placing them and us at risk of regulatory enforcement actions, recalls and other adverse consequences, and which place our patients at risk, which may negatively

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

our third parties could breach or terminate their agreements with us;

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

assurance and qualified personnel.

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

These risks could also result

in the delay in obtaining clinical supplies, which would delay our development programs.

In addition, our contract fill/finishers and our other third-party vendors may source their materials and supplies globally and are therefore subject to supply

disruptions in the event of fire, weather related events such as hurricanes, wind and rain, international conflicts, trade and sanction requirements and limits, other acts of God or force majeure events or global health occurrences and emergencies.

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

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

Market opportunity estimates and growth forecasts are subject to significant uncertainty and are based on assumptions and estimates that may not prove to be accurate.

In particular, the size and growth of the overall

IVIG and source plasma markets and the potential market opportunity for an S.

pneumonia hyperimmune globulin are subject to significant variables that can be difficult to measure, estimate or quantify.

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

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

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

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

For these reasons, the estimates and forecasts in our filings

relating to revenue generation and growth may prove to be inaccurate.

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

Geopolitical conditions, war, terrorism or other military actions may have a material adverse effect on our business.

Geopolitical conflicts, war or other military action or international acts of terrorism may cause significant disruption to commerce throughout the world.

To the extent that such disruptions result in disruptions to

our supply chain, delays or cancellations of customer orders, a general decrease in consumer spending, our inability to effectively market and distribute our products and/or our inability to access the capital markets, our business and results of

operations could be materially and adversely affected.

For example, in response to the ongoing conflict between Russia and Ukraine, the United States has imposed and may further impose, and other countries may additionally impose, broad sanctions

or other restrictive actions against governmental and other entities in Russia.

Additionally, further escalation of geopolitical tensions, such as ongoing conflicts in the Middle East and the surrounding areas could have a broader impact that

extends into other markets where we do business.

We are unable to predict geopolitical conditions, whether acts of international terrorism or the involvement in a war or other military actions will result in any long-term commercial disruptions or

if such involvement or responses will have any long-term material adverse effect on our business, results of operations, or financial condition.

Both of our business segments and our facilities, as well as our suppliers and contractors, are subject to periodic inspections by the FDA and other regulatory authorities, which, depending on the

outcome of such inspections, could result in certain regulatory actions, including the issuance of observations, notices, citations or warning letters.

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

other regulatory authorities are authorized to perform inspections and remote regulatory assessments of our and our suppliers’ facilities, including the Boca Facility.

The FDA and other regulatory authorities also may inspect and approve our and

our third-parties’ facilities before they may be used for commercial production.

If we or our suppliers are not able to comply with the applicable regulatory requirements, we or they may be subject to regulatory enforcement actions, which can

materially impact our business.

For instance, at the end of such an inspection, the FDA could issue a Form 483 Notice of Inspectional Observations, which could cause the FDA to not approve the use of the facility and cause us to modify certain

activities identified during the inspection.

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

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

FDA also may issue

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

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

could have a material impact on our business.

In the event of any enforcement actions, we and our third-party contractors would need to implement remedial actions which may be time-intensive or costly.

We may not be able to timely resolve concerns raised by the

applicable regulator as a result of an inspection or without expending significant resources.

We are unable to control the timing of inspections, communications and actions, and will be required to respond to the regulator and make certain

submissions within certain timeframes.

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

If the regulator determines that we have not remediated the issues identified in a warning letter or any

other inspection issues and deficiencies, any failure of ours to address or provide requested documentation of corrections for these issues could disrupt our business operations and the timing of our commercialization efforts and could have a

material adverse effect on our financial condition and operating results.

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

success of our business.

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

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

We generally contract with third parties for the disposal of these

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

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

Although we believe that the safety procedures utilized internally and by our

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

accidental contamination or injury from these materials.

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

certain materials and/or interrupt our business operations.

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

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

of our future compliance.

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

These current or future laws and regulations may impair our commercial

manufacturing, research and development, or production efforts.

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

Business interruptions could adversely affect our business .

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

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

occurrences such as the COVID-19 pandemic, global and economic uncertainty, war, geopolitical conditions and emergencies, product liability claims and events beyond our control.

While we maintain several insurance policies with reputable carriers

that provide partial coverage for a variety of these risks, including replacing or rebuilding a part of our facilities, these policies are subject to the insurance carriers’ final determination of compensation to us and we may not have adequate

coverage if we need to rebuild or replace our inventory, infrastructure, business income or our entire facility.

In addition, our disaster recovery plans for our facilities may not be adequate and we do not have an alternative manufacturing

facility or contractual arrangements with other manufacturers in the event of a casualty to or destruction of any of our facilities.

If we are required to rebuild or relocate any of our facilities, a substantial investment in improvements and

equipment would be necessary.

We carry only a limited amount of business interruption insurance, which may not sufficiently compensate us for losses that may occur.

As a result, any significant business interruption could adversely affect our

business and results of operations.

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

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

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

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

The conduct of preclinical studies and clinical trials is subject to numerous risks and results of the studies and trials are highly uncertain.Human clinical trials are very expensive and difficult to design and implement, in part

because they are subject to rigorous regulatory requirements.

The clinical trial process is also time-consuming.

Furthermore, delays or setbacks can occur at any stage of the process, and we could encounter problems that cause us to abandon our

product development programs and related INDs or BLAs, or to repeat clinical trials.

The commencement and completion of clinical trials or ultimate product approval for any current or future development product candidate may be delayed by several

factors, including:

unforeseen safety issues;

determination of dosing issues;

lack of safety or effectiveness, or other adverse study results during clinical trials;

slower than expected rates of patient recruitment or noncompliance with clinical trial requirements;

inability to monitor patients adequately during or after treatment;

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

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

candidates that still require FDA approval.

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

adequate and well-controlled clinical trials.

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

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

prevented or delayed and our business could be adversely affected.

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

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

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

accordance with the applicable regulatory requirements.

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

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

future clinical trials.

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

If we fail to obtain regulatory approval to market and sell

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

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

development of such product candidate altogether.

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

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

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

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

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

of other product candidates.

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

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

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

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

Failure by our third-party contractors to comply with regulatory requirements or the clinical trial protocol, or meet their contractual obligations to us in a timely manner, or at all, or our being required to engage in additional

clinical trial site monitoring;

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

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

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

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

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

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

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

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

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

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

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

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

In addition, certain

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

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

or international regulatory approvals to commercialize a product candidate, we will not be able to sell that product candidate, which would make

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

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

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

We cannot assure you that we will receive

the approvals necessary to commercialize any product candidate we may acquire or develop in the future or that we will be able to maintain our current approvals.

In order to obtain FDA approval of any product candidate requiring FDA approval, our

clinical development must demonstrate that the product candidate is safe for humans and effective for its intended use, and we must successfully complete an FDA BLA review.

Obtaining FDA approval of a product candidate generally requires

significant research and testing, referred to as preclinical studies, as well as human tests, referred to as clinical trials.

Satisfaction of the FDA’s regulatory requirements typically takes many years, depends upon the type, complexity and

novelty of the product candidate and requires substantial resources for research, development and testing.

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

for indicated uses.

The FDA has substantial discretion in the product approval process and may require us to conduct additional preclinical and clinical testing or to perform post-marketing studies or may require additional CMC or other data and

information, and the development and provision of this data and information may be time-consuming and expensive.

The approval process may also be delayed by changes in government regulation, future legislation or administrative action or changes in

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

Delays in obtaining regulatory approvals may:

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

impose costly procedures on us;

diminish any competitive advantages that we may otherwise enjoy.

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

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

studies with more subjects.

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

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

leaving us without the ability to generate additional accretive revenues.

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

In foreign jurisdictions, we must receive approval from the appropriate

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

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

approval procedures described above.

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

Although we have received approval from the FDA to market ASCENIV as a treatment for PIDD, our ability to market or seek approval for ASCENIV for alternative indications could be limited, unless

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

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

These regulations include standards and restrictions for

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

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

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

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

In addition to the FDA approval required for new formulations,

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

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

future indications for ASCENIV.

While physicians in the U.S.

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

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

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

treatment for some patients in varied circumstances.

Regulatory authorities in the U.S.

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

Regulatory authorities do, however, restrict communications by

pharmaceutical companies on the subject of off-label use.

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

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

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

our business.

With the approval of ASCENIV, there can be no assurance that we will be successful in further developing and expanding commercial operations, collecting and procuring an adequate supply of

high-titer antibody RSV plasma or balancing our research and development activities with our commercialization activities.

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

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

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

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

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

related to managing manufacturing and supply, including supply chain constraints, reimbursement, marketing challenges, development of a comprehensive compliance program, and other related and additional costs.

For example, the raw material plasma

we collect and procure to manufacture ASCENIV using our patented proprietary microneutralization assay is comprised of plasma collected from donors which contains high-titer antibodies to RSV.

This high titer-plasma which meets our internal

specifications for the manufacture of ASCENIV that we are able to identify with our patented testing assay amounts to less than 10% of the total donor collection samples we test.

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

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

and other countries.

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

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

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

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

performance is, to some extent, outside of our control.

We depend on independent investigators and collaborators, such as universities and medical institutions, contract laboratories, CROs, contract manufacturers, contract fill/finishers, third-party plasma centers and

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

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

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

If outside collaborators fail to devote sufficient time and resources to our

products and/or development programs, or if their performance is substandard or does not comply with the applicable regulatory standards, our trials may be repeated, extended, delayed, or terminated, the approval of our FDA application(s), if any,

and our introduction of new products, if any, will be delayed, and we may not be able to maintain existing approvals or meet our regulatory requirements.

We or they may also be subject to regulatory enforcement actions, may need to take corrective

actions, including initiating recalls, and we may not be able to meet commercial demand.

These collaborators may also have relationships with other commercial entities, some of whom may compete with us.

If our collaborators assist our competitors

at our expense, our competitive position would be harmed.

Additionally, any change in the regulatory compliance status of any of our vendors may impede our ability to receive and maintain approval for our product candidates.

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

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

We currently anticipate expanding the manufacturing capacity and product output capability of our Boca Facility.

Following the expansion of any of our manufacturing processes or the addition of new equipment, such as

our fill-finish machine, we will need to validate the expanded facility and equipment, make the necessary submissions to FDA, obtain any FDA-required approvals and have it inspected by the FDA.

Given the significant delays that may result during

the validation process, we may experience a supply shortage of our products or our production capabilities may be limited until completion of and validation of our facility expansion and new manufacturing equipment.

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

and we could be subject to substantial penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products following approval.

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

from the market.

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

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

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

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

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

For example, the FDA’s approval of our application supplement to allow for the commercial relaunch of BIVIGAM, as well as the FDA’s approval of our BLA for ASCENIV, require us

to conduct specified post-marketing studies, including pediatric and safety studies.

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

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

circumstances may yield various results, including:

restrictions on such products or manufacturing processes;

restrictions on the labeling or marketing of a product;

restrictions on product distribution or use;

clinical holds or termination of clinical trials;

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

warning letters or untitled letters;

withdrawal of the products from the market;

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

recall of products;

restrictions on coverage by third-party payers;

fines, restitution or disgorgement of profits or revenues;

suspension or withdrawal of marketing approvals;

refusal to permit the import or export of products;

FDA debarment, suspension and debarment from government programs, refusal of orders under existing government contracts, exclusion from participation in federal healthcare programs, consent decrees, deferred or non-prosecution agreements

or corporate integrity agreements;

product seizure or detention;

injunctions or the imposition of civil penalties or criminal fines.

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

business, results of operations and financial condition.

For the year ended December 31, 2023, two customers, BioCARE, Inc.

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

d/b/a CuraScript SD Specialty Distribution (“Curascript”), represented an aggregate of 72% of

our consolidated revenues.

For the year ended December 31, 2022, BioCare and Curascript represented an aggregate of 74% of our consolidated revenues.

As of December 31, 2023, five customers, BioCare, Healix Infusion Therapy, LLC (“Healix”), Curascript, AmerisourceBergen Corporation and Reliance Life Sciences Pvt.

Ltd., represented an aggregate of approximately 98%

of our consolidated accounts receivable.

As of December 31, 2022, BioCare and Healix represented an aggregate of 92% of our consolidated accounts receivable.

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

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

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

our ability to sell our products at competitive prices;

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

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

the impact of a pandemic, or the resurgence of a pandemic, and government responses thereto on our customers and their businesses, operations and financial condition;

widespread economic conditions or geopolitical conditions, including the exacerbated conflicts in Europe, the Middle East and the surrounding areas.

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

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

Our success depends upon the quality of our products.

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

efficacy of our products.

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

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

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

restrictions on operations or withdrawal of existing approvals and licenses.

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

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

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

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

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

However, because our products and product candidates are plasma-based

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

This adds an extra level of compliance

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

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

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

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

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

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

cost-effectiveness of our products relative to competing products;

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

the effectiveness of marketing and distribution efforts by us and our licensees and distributors, if any.

The failure of our current or future products to find market acceptance would harm our business and could require us to seek additional financing or make such financing difficult to obtain on favorable terms, if at all.

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

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

Our current product development portfolio consists primarily of label expansion activities for ASCENIV, as well as expanding our IP estate with patents issued for S.

hyperimmune IG.

We have initiated small- scale preclinical activities to potentially expand our current portfolio through new product development efforts.

If we are not successful in developing or acquiring additional products and product

candidates, we will have to depend on our ability to continue to generate revenues from ASCENIV, BIVIGAM, Nabi-HB, contract manufacturing, intermediate fractions and plasma attributable to the operations of ADMA BioCenters to support our

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

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

meet their requirements.

Consumer privacy is highly protected by federal and state law.

The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health

Act of 2009 (“HITECH”), and their respective implementing regulations, impose requirements with respect to safeguarding the privacy, security and transmission of protected health information (“PHI”) held by covered entities and business associates.

HIPPAA “covered entities” include health plans/insurers, healthcare providers engaging in HIPPA standard electronic transactions and healthcare clearinghouses.

A “business associate” provides services to covered entities (directly or as

subcontractors to other business associates) involving arranging, creating, receiving, maintaining, or transmitting PHI on a covered entity’s behalf.

In order to legally provide access to PHI to service providers, covered entities and business

associates must enter into a “business associate agreement” (“BAA”) with the service provider that receives PHI on behalf of the entity.

While we are not a covered entity or business associate subject to HIPAA, personal information that we obtain pursuant to a clinical trial may be subject to U.S.

Federal Trade Commission (the “FTC”) privacy regulation.

Failing to take appropriate steps to keep consumers’ personal information secure may constitute an unfair act or practice violating Section 5(a) of the Federal Trade Commission Act, 15 U.S.C § 45(a).

The FTC expects a company’s data security

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

is considered sensitive data that merits stronger safeguards.

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

In addition, states

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

In addition, federal and state privacy, data security, and breach

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

For example, the CCPA was amended by the CPRA, effective January 1, 2023.

The CCPA, among other things, imposes data privacy obligations for covered companies and provides new privacy rights to California residents, including the right to

opt out of certain disclosures of their information.

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

We could be subject to

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

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

Several other states have also enacted privacy laws similar to the CCPA that will become effective in the coming years, adding to potential privacy compliance obligations.

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

On December 18, 2023 (the “Ares Closing Date”), we entered into a new senior secured credit facility with Ares (the “Ares Credit Agreement”) (see “Liquidity and Capital Resources”).

The Ares Credit Agreement provides

for a total of $135 million in senior secured credit facilities (the “Ares Credit Facility”) consisting of (i) a term loan in the aggregate principal amount of $62.5 million and (ii) a revolving credit facility in the aggregate principal amount of

$72.5 million (collectively, the “Ares Loans”), both of which were fully drawn on the Ares Closing Date.

The Ares Credit Facility has a maturity date of December 20, 2027 (the “Ares Maturity Date”).

The Ares Loans are secured by substantially all

of our assets, including our intellectual property.

Events of default include, among others, non-payment of principal, interest or fees, violation of covenants, inaccuracy of representations and warranties, bankruptcy and insolvency events,

material judgments, cross-defaults to material contracts and events constituting a change of control.

If there is an event of default, we would incur an increase in the rate of interest on the Ares Loans of 2% per annum.

The occurrence of an event

of default could result in, among other things, the termination of commitments under the Ares Credit Facility, the declaration that all outstanding loans are immediately due and payable in whole or in part, and Ares taking immediate possession of,

and selling, any collateral securing the Ares Loans.

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

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

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

other marketed therapies.

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

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

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

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

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

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

joint ventures or other collaborations.

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

and business prospects may be materially damaged.

As we move forward in clinical development, we continue to discover novel technologies related to our products and we may draft patent applications directed to these technologies.

We rely on a combination of patent

rights, trade secrets and nondisclosure and non-competition agreements to protect our proprietary intellectual property, and we will continue to do so.

There can be no assurance that our patents, trade secret policies and practices or other

agreements will adequately protect our intellectual property.

Our issued patents may be challenged, found to be over-broad or otherwise invalidated in subsequent proceedings before courts, the U.S.

Patent and Trademark Office or foreign patent

Even if enforceable, we cannot provide any assurances that they will provide significant protection from competition.

The processes, systems, and/or security measures we use to preserve the integrity and confidentiality of our data and

trade secrets may be breached, and we may not have adequate remedies as a result of any such breaches.

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

There can be no assurance that the

confidentiality, nondisclosure and non-competition agreements with employees, consultants and other parties with access to our proprietary information to protect our trade secrets, proprietary technology, processes and other proprietary rights, or

any other security measures relating to such trade secrets, proprietary technology, processes and proprietary rights, will be adequate, will not be breached, that we will have adequate remedies for any breach, that others will not independently

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

To the extent that our consultants, contractors or collaborators use intellectual property

owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions.

We could lose market exclusivity of a product earlier than expected.

In the pharmaceutical and biotechnology industries, the majority of an innovative product’s commercial value is realized during its market exclusivity period.

and in some other countries, when market

exclusivity expires and generic or biosimilar versions are approved and marketed or when biosimilars are introduced (even if only for a competing product), there are usually very substantial and rapid declines in a product’s revenues.

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

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

of meaningful legal remedies in a country.

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

In some countries, basic patent protections for our products may

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

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

enforceability of patents cannot be predicted with certainty.

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

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

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

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

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

given that we will prevail.

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

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

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

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

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

Numerous U.S.

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

and commercialization of IG.

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

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

market increases.

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

We cannot be certain that the conduct of

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

and in foreign jurisdictions.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

If we are unable to

manage our growth effectively, our business could be harmed.

The loss of one or more key members of our management team could adversely affect our business.

Our performance is substantially dependent on the continued service and performance of our management team, who have extensive experience and specialized expertise in our business.

In particular, the loss of Adam S.

Grossman, our President and Chief Executive Officer, could adversely affect our business and operating results.

We do not have “key person” life insurance policies for any members of our management team.

We have employment agreements with each of

our executive officers;

however, the existence of an employment agreement does not guarantee retention of members of our management team and we may not be able to retain those individuals for the duration of or beyond the end of their respective

The loss of services of key personnel, or the inability to attract and retain additional qualified personnel, could result in delays in development or approval of our product candidates and diversion of management resources.

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

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

The secure storage, maintenance, and transmission of and access

to this information is important to our operations and reputation.

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

communications.

Further, while many of our employees and certain suppliers with whom we do business operate in a remote working environment, the risk of cybersecurity attacks and data breaches, particularly through phishing attempts, may be

increased as we and third parties with whom we interact leverage our IT infrastructure in unanticipated ways.

In addition, an employee, contractor, or other third party with whom we do business may attempt to obtain such information and may

purposefully or inadvertently cause a breach involving such information.

While we have certain safeguards in place to reduce the risk of and detect cyberattacks, including a Company-wide cybersecurity policy, our information technology networks and

infrastructure may be vulnerable to unpermitted access by hackers or other breaches, such as the IT disruption described elsewhere in this report, or employee error or malfeasance.

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

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

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

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

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

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

government regulation, formulation, quality control, manufacturing, finance, general and operational management and plasma collections.

In particular, over the next 12-24 months, we expect to hire several new employees devoted to our plasma

collection centers, commercialization, sales, marketing, medical and scientific affairs, regulatory affairs, quality control, information technology, finance and general and operational management.

Qualified individuals of the requisite caliber and

number needed to fill these positions may be in short supply in some areas.

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

Competition for such individuals is intense,

and we cannot assure you that our search for such personnel will be successful.

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

Additionally, any material increases in existing employee turnover rates or increases in labor costs could have a material adverse effect on our business, financial condition or operating results.

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

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

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

Collection facilities are subject to FDA and potentially other governmental and regulatory inspections and extensive regulation, including compliance with current cGMP and blood standards and FDA licensure and other governmental

approvals, as applicable.

Failure to comply with applicable governmental regulations or to receive applicable approvals for our current or future facilities may result in enforcement actions, such as adverse inspection reports, warning or untitled

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

operations or withdrawal of existing approvals and licenses, any of which may significantly delay or suspend our operations for these locations, potentially having a material adverse effect on our ability to manufacture our products or offer for

sale plasma collected at the affected sites.

Failure to comply with applicable governmental regulations may also impact the ultimate quality and compliance of our finished biologic products, which may have a material adverse effect on our business.

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

status for these facilities, we may be adversely affected, and may not be able to sell, manufacture or commercialize these products.

There are no assurances we will be able to maintain compliance with all FDA or other regulations.

There is also no guarantee that we will be able to fulfill our contractual requirements to our customers.

the extent that we use third-party vendors to fulfill our regulatory or contractual requirements, these third-party vendors may perform activities for themselves or other clients and we may not be privy to all regulatory findings or issues

discovered by the FDA or other regulatory agencies.

Such findings, which are out of our control, may adversely affect our ability to continue to work with these vendors, or our ability to release commercial drug product or perform necessary testing

or other actions for us or our clients, which may be required in order to remain FDA compliant or to commercialize our products.

If we are not able to maintain manufacturing compliance at our facilities or our vendors’ facilities for our products

and product candidates, we may not be able to successfully develop and commercialize our products and product candidates and we may face potential contractual or regulatory actions, which would have an adverse impact on our business.

We may incur substantial liabilities and may be required to limit commercialization of our products in response to product liability lawsuits.

The testing and marketing of medical products entail an inherent risk of product liability.

If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be

required to limit commercialization of our products.

Product liability claims may also result in recalls and/or regulatory enforcement actions.

Even successful defense, however, could impair our results of operations.

Our inability to obtain and

maintain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of pharmaceutical products we develop, either alone or with collaborators.

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

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

The laws governing our conduct in the U.S.

are enforceable on the federal, state and local levels by criminal, civil and administrative sanctions.

Violations of laws such as the Federal Food, Drug, and Cosmetic Act,

the Social Security Act (including the Anti-Kickback Statute), the Public Health Service Act, the civil and criminal federal False Claims Act, the civil monetary penalty statute, requirements regarding the reporting and repayment of overpayments,

other fraud and abuse laws and any regulations promulgated under the authority of the preceding, may result in significant criminal and/or civil sanctions, including jail sentences, fines or exclusion from participation in or debarment from federal

and state healthcare or government procurement programs, pursuant to enforcement actions by DOJ, Medicare, Medicaid, OIG and other regulatory authorities.

Similarly, the violation of applicable laws, rules and regulations of states, including the

State of Florida, with respect to the manufacture and marketing of our products and product candidates may result in significant criminal and/or civil sanctions, including jail sentences, fines or exclusion from participation in applicable state

healthcare programs.

There can be no assurance that our activities will not come under the scrutiny of federal and/or state regulators and other government authorities or that our practices will not be found to violate applicable laws, rules and

regulations or prompt lawsuits by private citizen “relators” under federal or state false claims laws.

For example, under the Anti-Kickback Statute and similar state laws and regulations, the offer or payment of anything of value to induce or reward patient referrals, or in return for purchasing, leasing, ordering or

arranging for or recommending the purchase, lease, or ordering of any item or service reimbursable in whole or in part by a federal healthcare program is prohibited.

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

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

including, among others, exclusion from participation in the Medicare and Medicaid programs.

Arrangements with referral sources such as purchasers, group purchasing organizations, healthcare organizations, physicians and pharmacists must be

structured with care to comply with applicable requirements.

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

For example, HHS recently promulgated a regulation that is

effective in two phases.

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

reflected in point-of-sale reductions in price and (b) PBM service fees paid by a manufacturer to a PBM.

Second, effective January 1, 2023, the regulation expressly provides that rebates to plan sponsors under Medicare Part D either directly to the

plan sponsor under Medicare Part D, or indirectly through a pharmacy benefit manager, will not be protected under the Anti-Kickback Statute discounts safe harbor.

Recent legislation and a final rule promulgated on December 29, 2023 delayed

implementation of this portion of the rule until January 1, 2032.

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

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

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

Under the Healthcare Reform Law, payments and transfers of value by pharmaceutical manufacturers of drugs, devices, biologics and medical supplies for

which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to or at the request of covered recipients, such as, but limited to, U.S.-licensed physicians, physician assistants, nurse

practitioners, clinical nurse specialists and certified registered nurse anesthetists and U.S.

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

Such “applicable manufacturers” are also required to report certain

ownership interests held by physicians and their immediate family members.

A number of states have similar laws in place.

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

Where such practices have been

found to be improper incentives to use such products, government investigations and sanctions against manufacturers have resulted in substantial fines, penalties and damages.

Many manufacturers have been required to enter into consent decrees or

orders that prescribe allowable corporate conduct and/or Corporate Integrity Agreements that impose ongoing compliance requirements on a manufacturer.

Failure to satisfy requirements under the Federal Food, Drug, and Cosmetic Act can also result in penalties, as well as requirements to enter into consent decrees or orders that prescribe allowable corporate conduct.

In addition, while regulatory authorities generally do not regulate physicians’ discretion in their choice of treatments for their patients, they do restrict communications by manufacturers on unapproved uses of approved products or on the

potential safety and efficacy of unapproved products in development.

Companies in the U.S., Canada and the European Union cannot promote approved products for other indications that are not specifically approved by the competent regulatory

authorities such as the FDA in the U.S., nor can companies promote unapproved products.

In limited circumstances, companies may disseminate to physicians information regarding unapproved uses of approved products or results of studies involving

investigational products.

If such activities fail to comply with applicable regulations and guidelines of the various regulatory authorities, we may be subject to warnings from, or enforcement action by, these authorities.

Furthermore, if such

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

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

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

Medicare and other federal programs.

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

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

Anti-Kickback Statute that applies to government healthcare programs, and other healthcare fraud provisions, leading to the possibility of greatly increased lawsuits by whistleblowers for perceived violations.

Violations or allegations of

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

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

federal and state rebate obligations.

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

We have established systems for collecting and reporting this data accurately to CMS and have instituted a compliance program to assure that the information collected is complete in all respects.

If we report pricing

information that is not accurate to the federal government, we could be subject to fines and other sanctions that could adversely affect our business.

If we choose to pursue clinical development and commercialization in the European Union or

otherwise market and sell our products outside of the U.S., we must obtain and maintain regulatory approvals and comply with regulatory requirements in such jurisdictions.

The approval procedures vary among countries in complexity and timing.

may not obtain approvals from regulatory authorities outside the U.S.

on a timely basis, if at all, which would preclude us from commercializing products in those markets.

In addition, some countries, particularly the countries of the European Union, regulate the pricing of prescription pharmaceuticals.

In these countries, pricing discussions with governmental authorities can take

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

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

other available therapies.

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

If reimbursement of our products is unavailable or limited in scope or amount, or if pricing is set at

unsatisfactory levels, in either the U.S.

or the European Union, we could be adversely affected.

Also, under the U.S.

Foreign Corrupt Practices Act, the U.S.

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

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

for the purpose of obtaining or retaining business.

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

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

Sentencing Commission

Guidelines Manual.

Most U.S.-based pharmaceutical companies have such programs.

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

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

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

manufacturing facility is located.

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

Although compliant with applicable federal requirements, we may be

required to comply with additional state and local laws, rules, regulations and permits.

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

well as fines and other sanctions.

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

We are subject to extensive and rigorous governmental regulation, including the requirement of FDA and other federal, state and local business regulatoryapprovals before our products and product

candidates may be lawfully marketed, and our ability to obtain regulatory approval of our products and product candidates from the FDA in a timely manner, access the public markets and obtain necessary capital in order to properly capitalize and

continue our operations may be hindered by inadequate funding for the FDA, the SEC and other state and local government agencies.

Both before and after the approval of our products, our products, operations, facilities, suppliers and CROs are subject to extensive regulation by Federal, state and local governmental authorities in the U.S.

other countries, with regulations differing from country to country.

In the U.S., the FDA regulates, among other things, the pre-clinical and nonclinical testing, clinical trials, manufacturing, safety, efficacy, potency, labeling, storage, record

keeping, quality systems, advertising, promotion, sale and distribution of therapeutic products.

Failure to comply with applicable requirements could result in, among other things, one or more of the following actions:

notices of violation,

untitled letters, warning letters, CRLs, fines and other monetary penalties, unanticipated expenditures, delays in approval or refusal to approve a product or product candidate, product recall or seizure, interruption of manufacturing or clinical

trials, operating restrictions, injunctions and criminal prosecution.

Our products and product candidates cannot be lawfully marketed in the U.S.

without FDA and other Federal, state and local business regulatory approvals.

Any failure to receive

the marketing approvals necessary to commercialize our products or product candidates could harm our business.

Additionally, the ability of the FDA and other federal, state and local business regulatory agencies to review and approve products and product candidates can be affected by a variety of factors, including government

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

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

agencies have fluctuated in recent years as a result.

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

political process, which is inherently fluid and unpredictable.

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

agencies, which would adversely affect our business.

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

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

have had to furlough critical employees and stop critical activities.

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

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

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

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

Plasma is a raw material that is susceptible to damage and contamination and may contain human pathogens, any of which would render the plasma unsuitable as raw material for further manufacturing.

For instance,

improper storage of plasma, by us or third-party suppliers, may require us to destroy some of our raw material.

If unsuitable plasma is not identified and discarded prior to the release of the plasma to the manufacturing process, it may be

necessary to discard intermediate or finished product made from that plasma or to recall any finished product released to the market, resulting in a charge to cost of product revenue.

The manufacture of our plasma products is an extremely complex

process of fractionation, purification, testing, filling and finishing.

Our products can become non-releasable or otherwise fail to meet our stringent specifications or regulatory agencies’ specifications through a failure in one or more of these

process steps.

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

or other regulations.

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

Once manufactured,

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

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

require that those products be destroyed.

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

While we expect to write off

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

of our expectations and the reserves we have established for these purposes.

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

Product or component quality issues may also result in regulatory

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

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

adversely affect our revenues.

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

for whom we do contract manufacturing.

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

processes against transmittable diseases.

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

products cannot be entirely eliminated.

For example, since plasma-derived therapeutics involves the use and purification of human plasma, there has been concern raised about the risk of transmitting HIV, prions, West Nile virus, H1N1 virus or

“swine flu” and other blood-borne pathogens through plasma-derived products.

There are also concerns about the future transmission of H5N1 virus, or “bird flu.” In the 1980s, thousands of hemophiliacs worldwide were infected with HIV through the

use of contaminated Factor VIII.

Other producers of Factor VIII, though not us, were defendants in numerous lawsuits resulting from these infections.

New infectious diseases emerge in the human population from time to time.

If a new infectious

disease has a period during which time the causative agent is present in the bloodstream but symptoms are not present, it is possible that plasma donations could be contaminated by that infectious agent.

Typically, early in an outbreak of a new

disease, tests for the causative agent do not exist.

During this early phase, we must rely on screening of donors for behavioral risk factors or physical symptoms to reduce the risk of plasma contamination.

Screening methods are generally less

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

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

process’ capacity to inactivate or remove the infectious agent.

To the extent our manufacturing processes are inadequate to inactivate or remove an infectious agent, our ability to manufacture and distribute our products would be impaired.

infectious disease were to emerge in the human population or if there were a reemergence of an infectious disease, the regulatory and public health authorities could impose precautions to limit the transmission of the disease that would impair our

ability to procure plasma, manufacture our products or both.

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

In recent years, new testing

and viral inactivation methods have been developed that more effectively detect and inactivate infectious viruses in collected plasma.

There can be no assurance, however, that such new testing and inactivation methods will adequately screen for,

and inactivate, infectious agents in the plasma used in the production of our products.

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

necessary raw materials.

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

country in which we may wish to commercialize our products.

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

Therefore, even if we

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

among other enforcement actions.

Additionally, although we achieved plasma supply self-sufficiency with the approval of our tenth plasma collection center in November 2023, we remain reliant on the purchase of plasma from third parties and the

collection of plasma from our FDA-licensed plasma collection centers to manufacture our products.

We can give no assurances that appropriate plasma will be available to us through our own plasma collection facilities or on commercially reasonable

terms, or at all, to manufacture our products.

Further, the COVID-19 pandemic resulted in significant constraints in raw material supply across various different industries, including the supply of plasma.

It is possible that in the future,

pandemics and government responses thereto will have an adverse effect on our ability to source plasma from donors in quantity and quality sufficient for our manufacturing processes.

In order to maintain a plasma center’s license, its operations

must continue to conform to cGMP and other regulatory requirements.

In the event that we determine that plasma was not collected in compliance with cGMP and other applicable regulatory requirements, we may be unable to use and may ultimately

destroy plasma collected from that center, which would be recorded as a charge to cost of product revenue.

Additionally, if non-compliance in the plasma collection process is identified after the impacted plasma has been pooled with compliant

plasma from other sources, entire plasma pools, in-process intermediate materials and final products could be impacted.

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

business and financial results.

We plan to increase our supplies of plasma for use in the manufacturing processes through increased purchases of plasma from third-party suppliers as well as collections from our existing ADMA BioCenters plasma

collection facilities.

This strategy is dependent upon our ability to maintain a cGMP compliant environment at our plasma collection facilities and to expand production and attract donors to our facilities.

There is no assurance that the FDA will

inspect and license any of our current or future unlicensed plasma collection facilities in a timely manner consistent with our production plans.

If we misjudge the readiness of a center for an FDA inspection, we may lose credibility with the FDA

and cause the FDA to more closely examine all of our operations.

Such additional scrutiny could materially hamper our operations and our ability to increase plasma collections.

Our ability to expand production and increase our plasma collection

facilities to more efficient production levels may be affected by changes in the economic environment and population in selected regions where ADMA BioCenters operates its current or future plasma facilities, by the entry of competitive plasma

centers into regions where ADMA BioCenters operates such centers, by misjudging the demographic potential of individual regions where ADMA BioCenters expects to expand production and attract new donors, by unexpected facility related challenges, or

by unexpected management challenges at selected plasma facilities held by us from time to time.

Additionally, our supply contract with Grifols for the purchase of normal source plasma (“NSP”) expired on December 31, 2022 and was not renewed.

Although we have executed additional agreements with other third-party

suppliers of NSP, we anticipate that the NSP used in IG production in 2024 and beyond will be sourced from our ADMA BioCenters plasma collection facilities.

There can be no assurances that we will be able to obtain an adequate supply of NSP from

other third-party suppliers or be able to collect NSP in the same quantities, or at all, through our ADMA BioCenters plasma collection facilities at a cost that is not higher than the price we paid to Grifols for NSP.

If our costs to obtain NSP

through collections at our ADMA BioCenters plasma collection facilities or from other third-party suppliers are higher than what we paid to Grifols under our supply contract, our liquidity and results of operations could be adversely impacted.

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

authorities, private health maintenance organizations and health insurers and other healthcare payers, and also depends upon the approval, timing and representations by the FDA or other governmental authorities for our product candidates.

Our ability to generate product revenues will be diminished if our products sell for inadequate prices or patients are unable to obtain adequate levels of insurance coverage.

Significant uncertainty exists as to the

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

Healthcare payers, including Medicare, are challenging the prices charged

for medical products and services.

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

Even if one of our product candidates is approved by

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

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

approved, market acceptance of such product could be reduced.

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

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

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

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

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

The existence of direct

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

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

The Healthcare Reform Law introduced an abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to an FDA-licensed biological product.

A biological product may be demonstrated to be

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

reference product.

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

reference product was first licensed.

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

Moreover, in an effort to increase competition

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

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

The 2020 Further

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

on commercially reasonable market-based terms.

The FDA approved the first biosimilar product in 2015 and has since approved a number of biosimilars.

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

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

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

may adversely affect our business.

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

millions of individuals who currently lack insurance coverage.

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

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

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

manufacturer must enter into a Medicaid rebate agreement with the Secretary of HHS and pay certain rebates to the states based on utilization data provided by each state to the manufacturer and to CMS and pricing data provided by the manufacturer

to the federal government.

The states share these savings with the federal government, and sometimes implement their own additional supplemental rebate programs.

Under the Medicaid drug rebate program, the rebate amount for most branded drug

products was previously equal to a minimum of 15.1% of the Average Manufacturer Price (“AMP”) or the AMP less Best Price, whichever is greater, plus the inflation penalty if applicable.

Effective January 1, 2010, the Healthcare Reform Law generally

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

penalty if applicable.

For non-innovator multiple source (generic) products, the rebate percentage was increased from a minimum of 11.0% to a minimum of 13.0% of AMP, and the Bipartisan Budget Act of 2015 established a new inflation penalty for

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

These increases in required rebates may adversely affect our future

financial prospects and performance.

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

government agencies, the manufacturer must extend discounts

to entities eligible to participate in the 340B drug pricing program.

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

As the 340B drug pricing is determined

based on AMP and Medicaid rebate data, the revisions to the Medicaid rebate formula and AMP definition described above could cause the required 340B discount to increase, and recent regulations have established a civil monetary penalty for failure

to refund these overcharges.

Effective in 2011, the Healthcare Reform Law imposed an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, apportioned among these entities

according to their market share in certain government healthcare programs.

These fees may adversely affect our future financial prospects and performance.

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

federal government primarily for persons 65 years

old and over.

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

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

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

biologics which the Part D plan sponsor has provided to its Medicare Part D beneficiaries who are in the “donut hole” (or a gap in Medicare Part D coverage for beneficiaries who have expended certain amounts for drugs).

The Part D plan sponsor is

responsible for calculating and providing the discount directly to its beneficiaries and for reporting these amounts paid to CMS’s contractor, which notifies drug manufacturers of the rebate amounts it must pay to each Part D plan sponsor.

rebate requirement could adversely affect our future financial performance, particularly if contracts with Part D plans cannot be favorably renegotiated or the Part D plan sponsors fail to accurately calculate payments due in a manner that

overstates our rebate obligation.

Regarding access to our products, the Healthcare Reform Law established and provided significant funding for a Patient-Centered Outcomes Research Institute to coordinate and fund Comparative Effectiveness Research

While the stated intent of CER is to develop information to guide providers to the most efficacious therapies, outcomes of CER could influence the reimbursement or coverage for therapies that are determined to be less cost-effective than

Should any of our products be determined to be less cost effective than alternative therapies, the levels of reimbursement for these products, or the willingness to reimburse at all, could be impacted, which could materially impact our

future financial prospects and results.

There have been repeated legal challenges and attempts by Congress to repeal or change the Healthcare Reform Law and the possibility of future challenges or legislative changes contribute to the uncertainty of the

ongoing implementation and impact of the law and also underscores the potential for additional reform going forward.

We cannot assure that the law, as currently enacted or as amended in the future, will not adversely affect our business and

financial results and we cannot predict how future Federal or state legislative or administrative changes relating to healthcare reform will affect our business.

Certain provisions of enacted or proposed legislative changes may negatively impact

coverage and reimbursement of, or rebates paid by manufacturers for, healthcare items and services.

We will continue to evaluate the effect that the Healthcare Reform Law and any potential changes may have on our business.

Corporate responsibility, specifically related to Environmental, Social and Governance (“ESG”) matters, may impose additional costs and expose us to new risks.

Public ESG and sustainability reporting is becoming more broadly expected by investors, stockholders and other third parties.

Certain organizations that provide corporate governance and other corporate risk information

to investors and stockholders have developed, and others may in the future develop, scores and ratings to evaluate companies and investment funds based upon ESG or “sustainability” metrics.

Many investment funds focus on positive ESG business

practices and sustainability scores when making investments and may consider a company’s ESG or sustainability scores as a reputational or other factor in making an investment decision.

In addition, investors, particularly institutional investors,

use these scores to benchmark companies against their peers and if a company is perceived as lagging, these investors may engage with such company to improve ESG disclosure or performance and may also make voting decisions, or take other actions,

to hold these companies and their boards of directors accountable.

Board diversity is an ESG topic that is, in particular, receiving heightened attention by investors, stockholders, lawmakers and listing exchanges.

Certain states have passed laws

requiring companies to meet certain gender and ethnic diversity requirements on their boards of directors.

We may face reputational damage in the event our corporate responsibility initiatives or objectives, including with respect to board

diversity, do not meet the standards set by our investors, stockholders, lawmakers, listing exchanges or other constituencies, or if we are unable to achieve an acceptable ESG or sustainability rating from third-party ratingservices.

sustainability rating by a third-party rating service could also result in the exclusion of our common stock from consideration by certain investors who may elect to invest with our competition instead.

Ongoing focus on corporate responsibility

matters by investors and other parties as described above may impose additional costs or expose us to new risks.

Risks Relating to our Finances, Capital Requirements and Other Financial Matters

If we are unable to continue to generate positive cashflows and net income, we may require additional funding and may be unable to raise capital when needed, which would adversely affect our

operations and could force us to delay, curtail or eliminate some of our commercialization efforts or one or more of our research and development programs.

Although we generated positive cash flow from operations for the year ended December 31, 2023, our operations have consumed substantial amounts of cash since inception.

While we generated positive cash flow of $8.8

million for the year ended December 31, 2023, for the years ended December 31, 2022 and 2021, we had negative cash flows from operations of $59.5 million and $112.4 million, respectively.

We expect to continue to spend substantial amounts for

collecting plasma at our plasma collection centers, maintaining our plasma collection centers, procurement of raw material plasma and other raw materials necessary to scale up our manufacturing operations, commercial product launches and capacity

expansion at the Boca Facility.

In addition, our end-to-end production cycle from collecting and procuring raw material source plasma to commercial release of finished product can take between seven and 12 months or potentially longer, requiring

substantial investments in raw material plasma and other manufacturing materials.

We had a net loss of $28.2 million for the year ended December 31, 2023 and although we achieved adjusted net income of $0.7 million which, as further described under

“Non-GAAP Financial Measures”, excludes charges related to the refinancing of our senior debt of $26.2 million and an IT systems disruption of $2.7 million (see Management’s Discussion and Analysis of Financial Condition and Results of Operations),

at present we cannot be certain that we will be able to generate a sufficient amount of product revenue to achieve profitability on an ongoing basis.

If we are unable to continue to generate positive cash flow throughout fiscal 2024, we may need to

continue to finance our operations through additional equity or debt financings or corporate collaboration and licensing agreements.

We currently anticipate, based upon our projected revenue and expenditures, that our current cash, cash equivalents

and accounts receivable, along with our projected future operating cash flow, will be sufficient to fund our operations, as currently conducted, through the first quarter of fiscal 2025.

Our current outlook with respect to cash flows and

profitability may change based upon how effective we are in continuing to execute on our commercialization efforts and operational initiatives and whether or not the assumptions underlying our projected revenues and expenses are correct.

required to raise additional capital and if such capital is not available due to widespread liquidity constraints or significant market instability that could result from widespread economic or geopolitical conditions, we may have to delay, curtail

or eliminate our commercialization efforts or our product development activities.

We may not have cash available to us in amounts sufficient to enable us to make interest or principal payments on our indebtedness when due.

The Ares Credit Facility provides for total senior secured loans in an aggregate principal amount of up to $135.0 million, all of which has been drawn down and is currently outstanding.

Borrowings under the Ares Credit

Facility currently bear interest at a weighted-average rate of approximately 10.4% per annum, which reflects the three-month term SOFR rate;

provided, however, that upon, and during the continuance of, an event of default, the interest rate will

automatically increase by an additional 200 basis points.

We are currently required to make quarterly payments of interest during the term of the Ares Credit Facility of approximately $3.7 million, with all principal and unpaid interest due at

In addition, our monthly interest rate obligation is subject to rising interest rates.

The Ares Credit Facility has a maturity date of December 20, 2027, subject to acceleration pursuant to the Ares Credit Agreement, including upon an

event of default.

All of our obligations under the Ares Credit Facility are secured by a first-priority lien and security interest in substantially all of our and our subsidiaries’ tangible and intangible assets, including intellectual property,

and all of the equity interests in our subsidiaries.

Our current and projected cash, cash equivalents and accounts receivable may not be sufficient to repay all of our current outstanding debt obligations as they mature.

If we are unable to achieve sufficient positive

cash flow to repay our outstanding debt obligations as they mature, we will need to obtain additional financing in the amounts necessary to repay our outstanding debt obligations when due.

If we are unable to repay our outstanding debt obligations

when they mature, our creditors would be able to accelerate all of the amounts due and, in the case of the Ares Credit Facility, seek to enforce their security interests, which could lead to our creditors taking immediate possession of and selling

substantially all of our assets with no return provided to our stockholders.

Raising additional funds by issuing securities or through licensing or lending arrangements may cause dilution to our existing stockholders, restrict our operations or require us to relinquish

proprietary rights.

To the extent that we raise additional capital by issuing equity securities, the share ownership of existing stockholders will be diluted.

Any future debt financing may involve covenants that, among other restrictions,

limit our ability to incur liens or additional debt, pay dividends, redeem or repurchase our common stock, make certain investments or engage in certain merger, consolidation or asset sale transactions.

In addition, if we raise additional funds

through licensing arrangements or the disposition of any of our assets, it may be necessary to relinquish potentially valuable rights to our product candidates or grant licenses on terms that are not favorable to us.

Our cash and cash equivalents could be adversely affected if the financial institutions in which we hold our cash and cash equivalents fail.

We regularly maintain cash balances at third-party financial institutions in excess of the Federal Deposit Insurance Corporation insurance limit.

While we monitor the cash balances in our operating accounts on a daily

basis and adjust the balances as appropriate, these balances could be impacted, and there could be a material adverse effect on our business, if one or more of the financial institutions with which we deposit cash fails or is subject to other

adverse conditions in the financial or credit markets.

To date, we have experienced no loss or lack of access to our invested cash or cash equivalents;

however, we can provide no assurance that access to our invested cash and cash equivalents will

not be impacted by adverse conditions in the financial and credit markets.

If we fail to maintain proper and effective internal control over financial reporting in the future, our ability to produce accurate and timely financial statements could be impaired, which could

result in investors losing confidence in the accuracy and completeness of our financial statements, harm our operating results and negatively affect the market price of our common stock.

Pursuant to Section 404 of the Sarbanes-Oxley Act of 2002 and related rules (the “Sarbanes-Oxley Act”), we are required to maintain internal control over financial reporting and our management is required to report on

the effectiveness of our internal control over financial reporting, including any material weaknesses in such internal controls.

The rules governing the standards that must be met for management to assess our internal control over financial

reporting are complex and require significant documentation, testing and possible remediation.

To comply with the requirements of being a reporting company under the Exchange Act, we have been required to upgrade, and may need to implement further

upgrades, to our financial, information and operating systems, implement additional financial and management controls, reporting systems and procedures and hire additional accounting and finance staff.

Because we became a large accelerated filer effective December 31, 2023, the Sarbanes-Oxley Act requires our independent registered public accounting firm to attest to the effectiveness of our internal control over

financial reporting.

Our transition to large accelerated filer status and becoming subject to additional requirements of the Sarbanes-Oxley Act will be time-consuming, and there is a risk of noncompliance.

Further, the costs associated with the

compliance with and implementation of procedures under these and future laws and related rules could have a material impact on our results of operations.

Consequently, we have incurred increased costs related to our compliance with Section 404 of the Sarbanes-Oxley Act and will continue to do so.

Our Audit Committee has retained the services of BDO, a Sarbanes-Oxley

advisor, to assist with our internal control over financial reporting and information technology related to the Sarbanes-Oxley Act.

Moreover, if we have a material weakness in our internal control over financial reporting, we may not detect errors

on a timely basis and our financial statements may be materially misstated.

If we identify material weaknesses in our internal control over financial reporting, if we are unable to comply with the requirements of Section 404 of the Sarbanes-Oxley

Act in a timely manner, if we are unable to assert that our internal controls over financial reporting is effective or if our independent registered public accounting firm is unable to express an opinion as to the effectiveness of our internal

control over financial reporting, investors may lose confidence in the accuracy and completeness of our financial reports, and the market price of our common stock could be negatively affected.

In addition, we could become subject to investigations

by any stock exchange on which our securities are listed, the SEC or other regulatory authorities, which could require additional financial and management resources, which could have an adverse impact on our business.

Our ability to use our net operating loss carryforwards (“NOLs”) may be limited.

We have incurred substantial losses during our history.

As of December 31, 2023, we had federal and state NOLs of $315.6 million and $216.4 million, respectively.

Federal and state NOLs of approximately $35.6 million

and $95.1 million, respectively, will begin to expire at various dates beginning in 2028, if not limited by triggering events prior to such time.

Under the provisions of the Internal Revenue Code of 1986, as amended (the “Code”), changes in our

ownership, in certain circumstances, will limit the amount of federal NOLs that can be utilized annually in the future to offset taxable income.

In particular, Section 382 of the Code ("Section 382") imposes limitations on a company’s ability to

use NOLs upon certain changes in such ownership.

If we are limited in our ability to use our NOLs in future years in which we have taxable income, we will pay more taxes than if we were able to fully utilize our NOLs.

The acquisition transaction

that we completed on June 6, 2017 resulted in a change in ownership of ADMA under Section 382 and, as a result, we were required to write off $57.6 million of Federal NOLs.

On October 25, 2021, we completed a public offering of our common stock

whereby we issued 57,500,000 shares of our common stock resulting in another change of ownership for ADMA under section 382 of the Code, resulting in an additional write-off of $3.0 million of Federal NOLs, $28.1 million of state NOLs and $1.0

million of research and development credits.

Although we did not experience any ownership changes for the years ended December 31, 2023 and 2022, we may experience ownership changes in the future as a result of subsequent changes in our stock

ownership that we cannot predict or control that could result in further limitations being placed on our ability to utilize our Federal NOLs.

Risks Associated with our Common Stock

The market price of our common stock may be volatile and may fluctuate in a way that is disproportionate to our operating performance.

Our stock price may experience substantial volatility as a result of a number of factors, including:

sales or potential sales of substantial amounts of our common stock;

delay or failure in initiating or completing preclinical or clinical trials or unsatisfactory results of these trials;

delay in a decision by Federal, state or local business regulatory authority;

the timing of acceptance, third-party reimbursement and sales of BIVIGAM and ASCENIV;

announcements about us or about our competitors, including clinical trial results, regulatory approvals or new product introductions;

developments concerning our licensors or third-party vendors;

litigation and other developments relating to our patents or other proprietary rights or those of our competitors;

conditions in the pharmaceutical or biotechnology industries;

governmental regulation and legislation;

overall market volatility;

global and economic uncertainty;

variations in our anticipated or actual operating results;

change in securities analysts’ estimates of our performance, or our failure to meet analysts’ expectations.

Many of these factors are beyond our control.

The stock markets in general, and the market for pharmaceutical and biotechnology companies in particular, have historically experienced extreme price and volume fluctuations.

These fluctuations

often have been unrelated or disproportionate to the operating performance of these companies.

These broad market and industry factors could reduce the market price of our common stock, regardless of our actual operating performance.

Sales of a substantial number of shares of our common stock, or the perception that such sales may occur, may adversely affect the market price of our common stock.

As of February 23, 2024, most of our 228,220,236 outstanding shares of common stock, as well as a substantial number of shares of our common stock underlying outstanding warrants, were available for sale in the public

market, subject to certain restrictions with respect to sales of our common stock by our affiliates, either pursuant to Rule 144 under the Securities Act, or under effective registration statements.

Sales of a substantial number of shares of our

common stock, or the perception that such sales may occur, could cause the market price of our common stock to decline or adversely affect demand for our common stock.

Our affiliates control a substantial amount of our shares of common stock.

Provisions in our Second Amended and Restated Certificate of Incorporation, as amended (the “Certificate of

Incorporation”), our Amended and Restated Bylaws (the “Bylaws”) and Delaware law might discourage, delay or prevent a change in control of our Company or changes in our management and, therefore, depress the trading price of our common stock.

As of December 31, 2023, BlackRock Inc., Vanguard Group and our directors and executive officers and their affiliates owned approximately 16% of the outstanding shares of our common stock.

Provisions of our Certificate

of Incorporation, our Bylaws and Delaware law may have the effect of deterring unsolicited takeovers or delaying or preventing a change in control of our Company or changes in our management, including transactions in which our stockholders might

otherwise receive a premium for their shares over then current market prices.

In addition, these provisions may limit the ability of stockholders to approve transactions that they may deem to be in their best interests.

These provisions include:

the inability of stockholders to call special meetings;

classification of our Board and limitation on filling of vacancies could make it more difficult for a third party to acquire, or discourage a third party from seeking to acquire, control of our Company;

authorization of the issuance of “blank check” preferred stock, with such designation rights and preferences as may be determined from time to time by the Board, without any need for action by stockholders.

In addition, Section 203 of the Delaware General Corporation Law prohibits a publicly-held Delaware corporation from engaging in a business combination with an interested stockholder, generally a person which together

with its affiliates owns, or within the last three years, has owned 15% of our voting stock, for a period of three years after the date of the transaction in which the person became an interested stockholder, unless the business combination is

approved in a prescribed manner.

The existence of the foregoing provisions and anti-takeover measures could limit the price that investors might be willing to pay in the future for shares of our common stock.

They could also deter potential

acquirers of our Company, thereby reducing the likelihood that you could receive a premium for your common stock in an acquisition.

In addition, as a result of the concentration of ownership of our shares of common stock, our stockholders may, from

time to time, observe instances where there may be less liquidity in the public markets for our securities.

We have never paid and do not intend to pay cash dividends in the foreseeable future.

As a result, capital appreciation, if any, will be your sole source of gain.

We have never paid cash dividends on any of our capital stock, and we currently intend to retain future earnings, if any, to fund the development and growth of our business.

In addition, the terms of existing and

future debt agreements may preclude us from paying dividends.

For example, the Ares Credit Agreement prohibits us from paying dividends.

As a result, capital appreciation, if any, of our common stock will be your sole source of gain for the

foreseeable future.

If we fail to adhere to the strict listing requirements of the Nasdaq Global Market (“Nasdaq”), we may be subject to delisting.

As a result, our stock price may decline and our common stock may be

If our stock were no longer listed on Nasdaq, the liquidity of our securities likely would be impaired.

Our Common Stock currently trades on the Nasdaq Global Market under the symbol “ADMA.” If we fail to adhere to Nasdaq’s strict listing criteria, including with respect to stock price, market capitalization and

stockholders’ equity, our stock may be delisted.

This could potentially impair the liquidity of our securities not only in the number of shares that could be bought and sold at a given price, which may be depressed by the relative illiquidity, but

also through delays in the timing of transactions and the potential reduction in media coverage.

As a result, an investor might find it more difficult to dispose of our common stock.

We believe that current and prospective investors would view an

investment in our common stock more favorably if it continues to be listed on Nasdaq.

Any failure at any time to meet the Nasdaq continued listing requirements could have an adverse impact on the value and trading activity of our common stock.

Although we currently satisfy the listing criteria for Nasdaq, if our stock price declines dramatically, we could be at risk of failing to meet the Nasdaq continued listing criteria.

Our Board may, without stockholder approval, issue and fix the terms of shares of preferred stock and issue additional shares of common stock adversely affecting the rights of

holders of our common stock.

Our Certificate of Incorporation authorizes the issuance of up to 10,000,000 shares of “blank check” preferred stock, with such designation rights and preferences as may be determined from time to time by the Board.

Currently, our Certificate of Incorporation authorizes the issuance of up to 300,000,000 shares of common stock.

As of December 31, 2023, there were 31,033,333 shares remaining available for issuance, after giving effect to 23,066,387 shares of our

common stock that were subject to outstanding stock options, RSUs and warrants as of December 31, 2023 that may be issued by us without stockholder approval, as well as an additional 19,837,248 shares reserved for the future issuance of awards

under our equity compensation plans.

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