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What changed in ADMA BIOLOGICS, INC.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of ADMA BIOLOGICS, INC.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+581 added−562 removedSource: 10-K (2026-02-25) vs 10-K (2025-03-18)

Top changes in ADMA BIOLOGICS, INC.'s 2025 10-K

581 paragraphs added · 562 removed · 428 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

190 edited+56 added−27 removed240 unchanged
Biggest changeThe process required by the FDA before our product candidates may be marketed in the U.S. generally involves the following (although the FDA is given wide discretion to impose different or more stringent requirements on a case-by-case basis): • completion of extensive preclinical laboratory tests, preclinical, nonclinical and formulation studies performed in accordance with the FDA’s Good Laboratory Practice (“GLP”) regulations and other applicable laws and regulations; • submission to the FDA of an IND application which must become effective before clinical trials may begin; • obtaining approval by an Institutional Review Board (“IRB”) at each clinical site before a clinical trial may be initiated at that site; • performance of adequate and well-controlled clinical trials meeting FDA requirements, commonly referred to as Good Clinical Practices (“GCP”), and other additional requirements for the protection of human research subjects and to establish the safety and efficacy of the product candidate for each proposed indication; • manufacturing (through an FDA-approved facility) of product in accordance with the FDA’s current Good Manufacturing Practices (“cGMP”) to be used in the clinical trials and providing manufacturing information needed in regulatory filings; • submission of a BLA to the FDA for marketing approval that includes substantial evidence of safety, purity and potency from results of clinical trials; the results of preclinical testing; detailed information about the Chemistry, 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, and compliance with any post approval commitments, such as Risk Evaluation and Mitigation Strategies (“REMS”) and post approval studies required by the FDA. 16 Table of Contents 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.
Biggest changeThe 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): 16 Table of Contents ● completion of extensive preclinical laboratory tests, preclinical, nonclinical and formulation studies performed in accordance with the FDA’s Good Laboratory Practice (“GLP”) regulations and other applicable laws and regulations; ● submission to the FDA of an IND application which must become effective before clinical trials may begin; ● obtaining approval by an Institutional Review Board (“IRB”) at each clinical site before a clinical trial may be initiated at that site; ● performance of adequate and well-controlled clinical trials meeting FDA requirements, commonly referred to as Good Clinical Practices (“GCP”), and other additional requirements for the protection of human research subjects and to establish the safety and efficacy of the product candidate for each proposed indication; ● manufacturing of product in accordance with the FDA’s current Good Manufacturing Practices (“cGMP”) to be used in the clinical trials and providing manufacturing information needed in regulatory filings (this facility must be approved by FDA prior to commercial distribution of a product); ● submission of a BLA to the FDA for marketing approval that includes substantial evidence of safety, purity and potency from results of clinical trials; the results of preclinical testing; detailed information about the Chemistry, 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, and compliance with any post approval commitments, such as Risk Evaluation and Mitigation Strategies (“REMS”) and post approval studies required by the FDA.
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.
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.
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 of average sales price, or (3) fails to submit the required data on a timely basis.
Civil monetary penalties can be applied if a manufacturer (1) is found to have knowingly submitted any false pricing or other information to the government, (2) is found to have made a misrepresentation in the reporting of average sales price, or (3) fails to submit the required data on a timely basis.
On February 22, 2015, at the 2015 American Academy of Allergy, Asthma & Immunology Annual Meeting, scientific investigators reported on the secondary outcomes that included: a total of 93 days, or 1.66 days per patient per year lost from work or school due to infection; one hospitalization due to an infection of only five days duration in the entire study and Immune Globulin (“IgG”) trough levels above those required by the FDA for IVIG products.
In February 2015, at the 2015 American Academy of Allergy, Asthma & Immunology Annual Meeting, scientific investigators reported on the secondary outcomes that included: a total of 93 days, or 1.66 days per patient per year lost from work or school due to infection; one hospitalization due to an infection of only five days duration in the entire study and Immune Globulin (“IgG”) trough levels above those required by the FDA for IVIG products.
We plan to leverage our previously conducted randomized, double-blind, placebo-controlled Phase II clinical trial evaluating RI-001, ASCENIV’s predecessor product candidate, as well as the drug’s real-world impact on patient outcomes, to drive further penetration into ASCENIV’s targeted market principally comprised of patients suffering from complex and comorbid primary immunodeficiencies. • Improve the Boca Facility’s and ADMA BioCenters’ operating efficiencies, yields and gross margins.
We plan to leverage our previously conducted randomized, double-blind, placebo-controlled Phase II clinical trial evaluating RI-001, ASCENIV’s predecessor product candidate, as well as the drug’s real-world impact on patient outcomes, to drive further penetration into ASCENIV’s targeted market principally comprised of patients suffering from complex and comorbid primary immunodeficiencies. ● Improve the Boca Facility’s and ADMA BioCenters’ supply, operating efficiencies, yields and gross margins.
For example, the ACA and the companion Healthcare and Education Reconciliation Act (which together are referred to as the “Healthcare Reform Law”) contains provisions that may reduce the profitability of drug products, including, for example, increased rebates for drugs reimbursed by Medicaid programs, extension of Medicaid rebates to Medicaid managed care plans, mandatory discounts for certain Medicare Part D beneficiaries and annual fees based on pharmaceutical companies’ share of sales to federal healthcare programs.
For example, the ACA and the companion Healthcare and Education Reconciliation Act of 2010 (which together are referred to as the “Healthcare Reform Law”) contains provisions that may reduce the profitability of drug products, including, for example, increased rebates for drugs reimbursed by Medicaid programs, extension of Medicaid rebates to Medicaid managed care plans, mandatory discounts for certain Medicare Part D beneficiaries and annual fees based on pharmaceutical companies’ share of sales to federal healthcare programs.
There have been several Congressional inquiries and proposed and enacted federal and state legislation and regulatory initiatives designed to, among other things, bring more transparency to product pricing, evaluate the relationship between pricing and manufacturer patient assistance and support programs, potentially permit government negotiation of Medicare pricing with manufacturers relative to certain international prices paid, and reform government healthcare program reimbursement methodologies for drug products.
There have been several Congressional inquiries and proposed and enacted federal and state legislation and regulatory initiatives designed to, among other things, bring more transparency to product pricing, evaluate the relationship between pricing and manufacturer patient assistance and support programs, permit government negotiation of Medicare pricing with manufacturers relative to certain international prices paid, and reform government healthcare program reimbursement methodologies for drug products.
Several states have enacted legislation requiring pharmaceutical companies to, among other things, establish marketing compliance programs, file periodic reports with the state, make periodic public disclosures on sales, marketing, pricing, clinical trials and other activities, and/or register their sales representatives, as well as to prohibit pharmacies and other healthcare entities from providing specified physician prescribing data to pharmaceutical companies for use in sales and marketing, and to prohibit other specified sales and marketing practices.
Several states and localities have enacted legislation requiring pharmaceutical companies to, among other things, establish marketing compliance programs, file periodic reports with the state, make periodic public disclosures on sales, marketing, pricing, clinical trials and other activities, and/or register their sales representatives, as well as to prohibit pharmacies and other healthcare entities from providing specified physician prescribing data to pharmaceutical companies for use in sales and marketing, and to prohibit other specified sales and marketing practices.
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. Our telephone number is (201) 478-5552. Our Florida campus is located at 5800 Park of Commerce Boulevard, Northwest, Boca Raton, FL 33487.
Each of ADMA’s 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. Our telephone number is (201) 478-5552. Our Florida campus is located at 5800 Park of Commerce Boulevard, Northwest, Boca Raton, FL 33487.
If a drug product is reimbursed by Medicare or Medicaid, pricing and rebate programs must comply with, as applicable, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 as well as the Medicaid rebate requirements of the Omnibus Budget Reconciliation Act of 1990 (the “OBRA”), the Veterans Health Care Act of 1992, Deficit Reduction Act of 2005, Patient Protection and Affordable Care Act (the “ACA”), and the Inflation Reduction Act of 2022, each as amended.
If a drug product is reimbursed by Medicare or Medicaid, pricing and rebate programs must comply with, as applicable, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 as well as the Medicaid rebate requirements of the Omnibus Budget Reconciliation Act of 1990 (the “OBRA”), the Veterans Health Care Act of 1992 (the “VHCA”), Deficit Reduction Act of 2005, Patient Protection and Affordable Care Act (the “ACA”), and the Inflation Reduction Act of 2022, each as amended.
Our Products ASCENIV 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.
Our Products ASCENIV ASCENIV is a plasma-derived IVIG product 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.
Serum samples were obtained from 13 patients. Samples showed that patients demonstrated a four-fold or greater rise in RSV antibody titers from baseline. Serum samples were not obtained from two patients that received Palivizumab. All 11 surviving patients received RI-001 within an average of 4.4 days after the onset of the diagnosis of RSV.
Samples showed that patients demonstrated a four-fold or greater rise in RSV antibody titers from baseline. Serum samples were not obtained from two patients that received Palivizumab. All 11 surviving patients received RI-001 within an average of 4.4 days after the onset of the diagnosis of RSV.
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.
In order to obtain coverage and reimbursement for our current products and any product that might be approved for sale in the future, 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.
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.
Pursuant to the terms of a Plasma Purchase Agreement dated as of November 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.
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.
While we intend to vigorously 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.
For example, the healthcare fraud provisions under the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations, or HIPAA, impose criminal liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any health care benefit program, including private third party payors, or falsifying or covering up a material fact or making any materially false or fraudulent statement in connection with the delivery of or payment for health care benefits, items or services.
For example, the healthcare fraud provisions under the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations, or HIPAA, impose criminal liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any health care benefit program, including private third party payers, or falsifying or covering up a material fact or making any materially false or fraudulent statement in connection with the delivery of or payment for health care benefits, items or services.
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 incurs.
In July 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 incurs.
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.
Subsequent 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.
In the future, 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 in 2023, we commenced manufacturing ASCENIV at the 4,400 Liter production scale.
In the future, 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 2019 and in fiscal year 2023, we commenced manufacturing ASCENIV at the 4,400 Liter production scale.
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 basis.
For example, if third-party payers 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 basis.
Similarly, the Inflation Reduction Act of 2022 requires manufacturers of selected drugs to negotiate discounted prices with the Secretary of the Department of Health and Human Services. Failure to reach an agreement can subject manufacturers to an excise tax or withdraw of all drug products from coverage under Medicare and Medicaid.
Similarly, t he Inflation Reduction Act of 2022 requires manufacturers of selected drugs to negotiate discounted prices with the Secretary of the Department of Health and Human Services. Failure to reach an agreement can subject manufacturers to an excise tax or withdraw of all drug products from coverage under Medicare and Medicaid.
Coverage policies and third-party reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more products, less favorable coverage policies and reimbursement rates may be implemented in the future. Any reduction in reimbursement from Medicare and/or other government programs may result in a similar reduction in payments from private payors.
Coverage policies and third-party reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more products, less favorable coverage policies and reimbursement rates may be implemented in the future. Any reduction in reimbursement from Medicare and/or other government programs may result in a similar reduction in payments from private payers.
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.
These payers 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 payers, with governments being the primary source of payment.
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 Nabi-HB is a hyperimmune globulin that is rich in antibodies to the Hepatitis B virus.
In December 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 Nabi-HB is a hyperimmune globulin that is rich in antibodies to the Hepatitis B virus.
Effective for calendar quarters beginning January 1, 2022, manufacturers are 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.
Effective for calendar quarters beginning January 1, 2022, manufacturers are required to report the average sales price for certain drugs under the Medicare Part B 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.
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 payer separately, with no assurance that coverage and adequate reimbursement will be obtained.
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.
Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payers. 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.
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.
The Healthcare Information Portability and Accountability Act of 1996 (“HIPAA”) imposes privacy, security, breach reporting obligations, and mandatory contractual terms on “covered entities,” including 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.
Foreign Regulation In addition to regulations in the U.S., if we choose to pursue clinical development and commercialization in the European Union, we will be subject to a variety of foreign regulations governing clinical trials and commercial sales and distribution of any future product.
Foreign Regulation In addition to regulations in the U.S., if we choose to pursue clinical development and commercialization in the European Union, we will be subject to a variety of foreign regulations governing clinical trials, manufacture, authorization and commercial sales and distribution of any future product.
These requirements are continually evolving. We and our manufacturers may also be subject to regulations under other federal, state and local laws. 15 Table of Contents U.S. Government Regulation Our current and anticipated future product candidates are considered “biologics” under the FDA regulatory framework. Most pharmaceuticals or “conventional drugs” consist of pure chemical substances and their structures are known.
These requirements are continually evolving. We and our manufacturers may also be subject to regulations under other federal, state and local laws. U.S. Government Regulation Our current and anticipated future product candidates are considered “biologics” under the FDA regulatory framework. Most pharmaceuticals or “conventional drugs” consist of pure chemical substances and their structures are known.
If we do not comply with applicable requirements, we may be subject to civil penalties, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, fines, refusal by the government to approve our marketing applications and supplemental applications or to allow us to manufacture or market our products, and criminal prosecution, and we may be debarred or excluded from participation in government healthcare programs.
If we do not comply with applicable requirements, we may be subject to enforcement actions, including civil penalties, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, fines, refusal by the government to approve our marketing applications and supplemental applications or to allow us to manufacture or market our products, and criminal prosecution, and we may be debarred or excluded from participation in government healthcare programs.
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.
All states have laws requiring notification of affected individuals and state regulators (i.e., 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.
Survey results are shared across the organization to provide greater transparency into employee responses and to reinforce how employee feedback directly informs leadership decisions. By consistently tracking and acting on engagement data, we strengthen our commitment to a collaborative, communicative, and employee-focused culture. 32 Table of Contents Governance We pursue fair employment practices in every aspect of our business.
Survey results are shared across the organization to provide greater transparency into employee responses and to reinforce how employee feedback directly informs leadership decisions. By consistently tracking and acting on engagement data, we strengthen our commitment to a collaborative, communicative, and employee-focused culture. Governance We pursue fair employment practices in every aspect of our business.
In addition, we cannot predict what adverse governmental regulations may arise from future U.S. or foreign governmental action. Post-Approval Regulatory Requirements 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 application.
In addition, we cannot predict what adverse governmental regulations may arise from future U.S. or foreign governmental action. 20 Table of Contents Post-Approval Regulatory Requirements 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 application.
Nabi-HB is indicated for the treatment of acute exposure to blood containing HbsAg, prenatal exposure of infants born to HbsAg-positive mothers, sexual exposure to HbsAg-positive persons and household exposure to persons with acute Hepatitis B virus infection in specific, listed settings.
Nabi-HB is indicated for the treatment of acute exposure to blood containing HbsAg, perinatal exposure of infants born to HbsAg-positive mothers, sexual exposure to HbsAg-positive persons and household exposure to persons with acute Hepatitis B virus infection in specific, listed settings.
Such laws also typically impose significant civil monetary penalties for each instance of reporting noncompliance that can quickly aggregate into millions of dollars. U.S. Healthcare Reform The containment of healthcare costs has become a priority of Federal and state governments, and the prices of drugs have been a focus in this effort.
Such laws also typically impose significant civil monetary penalties for each instance of reporting noncompliance that can quickly aggregate into millions of dollars. 27 Table of Contents U.S. Healthcare Reform The containment of healthcare costs has become a priority of Federal and state governments, and the prices of drugs have been a focus in this effort.
Changes in government legislation or regulation and changes in private third-party payors’ policies toward reimbursement for our products, if successfully developed and approved, may reduce reimbursement of our products’ costs to physicians, pharmacies, patients and distributors.
Changes in government legislation or regulation and changes in private third-party payers’ policies toward reimbursement for our products, if successfully developed and approved, may reduce reimbursement of our products’ costs to physicians, pharmacies, patients and distributors.
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. 27 Table of Contents One of the goals of ACA was to expand coverage for the uninsured while at the same time containing overall healthcare costs.
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.
The Centers for Medicare and Medicaid Services (“CMS”) has issued a permanent, product-specific-J-code for ASCENIV. Under the Healthcare Common Procedure Coding System (“HCPCS”), the J-code (J1554) became effective April 1, 2021.
The Centers for Medicare and Medicaid Services (“CMS”) has issued a permanent, product-specific-J-code for ASCENIV. Under the Healthcare Common Procedure Coding System (“HCPCS”), the J-code (J1554) became effective in April 2021.
The polyclonal antibodies that are present in ASCENIV are expected to prevent infections in immune-compromised patients. In October 2019, we announced the successful treatment of ASCENIV in two children suffering with RSV through our compassionate use program. The two immunocompromised children admitted to the Mayo Clinic each were diagnosed with T-cell lymphoblastic lymphoma.
The polyclonal antibodies that are present in ASCENIV are expected to prevent infections in immune-compromised patients. 7 Table of Contents In October 2019, we announced the successful treatment of ASCENIV in two children suffering with RSV through our compassionate use program. The two immunocompromised children admitted to the Mayo Clinic each were diagnosed with T-cell lymphoblastic lymphoma.
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. 21 Table of Contents Companies are required to supply sufficient information that balances the risks of a product in its marketing and promotional materials.
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.
No uniform policy of coverage and reimbursement for drug products exists. Accordingly, decisions regarding the extent of coverage and amount of reimbursement to be provided for any of our products will be made on a payor-by-payor basis.
No uniform policy of coverage and reimbursement for drug products exists. Accordingly, decisions regarding the extent of coverage and amount of reimbursement to be provided for any of our products will be made on a payer-by-payer basis.
Data Protection and Privacy Throughout the clinical trial process, we may obtain the private health information of our trial subjects. There are a number of state, federal and international laws protecting the privacy and security of health information and personal data.
Data Protection and Privacy Throughout the clinical trial process, we may obtain the protected health information of our trial subjects. There are a number of state, federal and international laws protecting the privacy and security of health information and personal data.
The FDA may not complete its review or approve a BLA within these established goal review times. Before approving a marketing application, the FDA typically will inspect the facility or facilities where the product is manufactured, referred to as a Pre-Approval Inspection, as well as one or more clinical trial sites.
The FDA may not complete its review or approve a BLA within these established goal review times. Before approving a marketing application, the FDA typically will inspect (remotely or in-person) the facility or facilities where the product is manufactured, referred to as a Pre-Approval Inspection, as well as one or more clinical trial sites.
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.
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 an interoperable form.
Further, the DSCSA limits the distribution of prescription pharmaceutical products and imposes requirements to ensure overall accountability and security in the drug supply chain, including requirements related to the detection and investigation of suspect and illegitimate products. The distribution of product samples continues to be regulated under the PDMA. FDA post-approval requirements are continually evolving.
Further, the DSCSA limits the distribution of prescription pharmaceutical products and imposes requirements to ensure overall accountability and security in the drug supply chain, including requirements related to the detection and investigation of suspect and illegitimate products. The distribution of product samples continues to be regulated under the PDMA. 21 Table of Contents FDA post-approval requirements are continually evolving.
We actively support and fund initiatives designed to improve the communities in which we operate and where our employees and stakeholders reside. Employee Development The ongoing development of our employees continues to be a catalyst for our growth and success as a company. Many of our employees have obtained advanced degrees in their professions.
We actively support and fund initiatives designed to improve the communities in which we operate and where our employees and stakeholders reside. 32 Table of Contents Employee Development The ongoing development of our employees continues to be a catalyst for our growth and success as a company. Many of our employees have obtained advanced degrees in their professions.
Patent Nos. 9,714,283, 9,815,886, 9,969,793, 10,683,343, 11,339,206 and 11,780,906, encompassing immunotherapeutic compositions and immunotherapeutic methods proprietary to us, also relate to ASCENIV. Additional U.S. and numerous foreign patents and patent applications also pertain to this technology.
Patent Nos. 9,714,283; 9,815,886; 9,969,793; 10,683,343; 11,339,206; 11,780,906 and 12,473,351, encompassing immunotherapeutic compositions and immunotherapeutic methods proprietary to us, also relate to ASCENIV. Additional U.S. and numerous foreign patents and patent applications also pertain to this technology.
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 ADMA Biologics, Inc. was founded on June 24, 2004 as a New Jersey corporation and re-incorporated in Delaware on July 16, 2007.
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. 33 Table of Contents Corporate Information ADMA Biologics, Inc. was founded on June 24, 2004 as a New Jersey corporation and re-incorporated in Delaware on July 16, 2007.
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.
Information about clinical trials, including results, must be submitted within specific timeframes for listing on the ClinicalTrials.gov website. 18 Table of Contents In limited circumstances, the FDA also permits the administration of investigational biological products to patients under its expanded access program.
The FDA will not approve a product candidate unless cGMP compliance is satisfactory. After the FDA conducts its in-depth review of the application and after the inspection of the manufacturing facilities and clinical trial sites, the FDA issues either an approval letter or a Complete Response Letter (“CRL”).
The FDA will not approve a product candidate unless cGMP compliance is satisfactory. 19 Table of Contents After the FDA conducts its in-depth review of the application and after the inspection of the manufacturing facilities and clinical trial sites, the FDA issues either an approval letter or a Complete Response Letter (“CRL”).
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.
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 (or more frequently) and must meet certain regulatory requirements.
Overview 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.
Overview We are a U.S. based 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.
The key elements of our strategy for achieving this goal are as follows: • Continue to expand the commercial production of our IG products and notably drive a revenue mix shift favoring sales of ASCENIV for the treatment of patients with PI .
The key elements of our strategy for achieving this goal are as follows: ● Continue to expand the commercial production and distribution network of, and access for, our IG products and notably drive a revenue mix shift favoring sales of ASCENIV for the treatment of patients with PI .
On May 9, 2019, the FDA approved the PAS for the use of our IVIG manufacturing process (known as fractionation), thereby enabling us to re-launch and commercialize this product in the U.S. We resumed production of BIVIGAM during the fourth quarter of 2017 and commercial production is ongoing, using our FDA-approved IVIG manufacturing process under U.S.
In May 2019, the FDA approved the PAS for the use of our IVIG manufacturing process (known as fractionation), thereby enabling us to re-launch and commercialize this product in the U.S. We resumed production of BIVIGAM during the fourth quarter of 2017 and commercial production is ongoing, using our FDA-approved IVIG manufacturing process under U.S. License No. 2019.
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.
Pursuant to our Manufacturing, Supply and License Agreement effective as of December 2012, we granted to Biotest AG (“Biotest”) an exclusive license to market and sell ASCENIV in Europe and in certain countries in Northern 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.
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.
In December 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 2019.
As patients suffering from PIDD lack a properly functioning immune system, they typically receive monthly, outpatient infusions of IVIG therapy. Without this exogenous antibody immune support, these patients would be susceptible to a wide variety of infectious diseases. PIDD has an estimated prevalence of 1:1,200 in the U.S., or approximately 250,000 people.
As patients suffering from PIDD lack a properly functioning immune system, they typically receive monthly, outpatient infusions of IVIG therapy. Without this exogenous antibody immune support, these patients would be susceptible to a wide variety of infectious diseases. PIDD has an estimated prevalence of 1:2,000 in the U.S., or approximately 150,000 to 250,000 people. As reported in the 2024 U.S.
Food and Drug Administration (the “FDA”) approval, all of which are currently marketed and commercially available: (i) ASCENIV (Immune Globulin Intravenous, Human – slra 10% Liquid), an 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, in adults and adolescents, for which we received FDA approval on April 1, 2019 and commenced first commercial sales in October 2019; (ii) BIVIGAM , an IVIG product indicated for the treatment of PI, and for which we received FDA approval on May 9, 2019 and commenced commercial sales in August 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.
Food and Drug Administration (the “FDA”) approval, all of which are currently marketed and commercially available: (i) ASCENIV (Immune Globulin Intravenous, Human – slra 10% Liquid), an 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, in adults and adolescents, for which we received FDA approval in April 2019 and commenced first commercial sales in October 2019; (ii) BIVIGAM, an IVIG product indicated for the treatment of PI in adults and pediatric patients two years of age and older , and for which we received FDA approval in May 2019 and commenced commercial sales in August 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.
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 (“IND”) 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.
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 use FDA IND 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.
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.
RI-002 was administered in a total of 793 infusions with zero serious adverse events to 59 patients in nine treatment centers throughout the U.S. These results, included in our BLA, exceed the requirement specified by FDA guidance of ≤ 1 serious infection per patient-year.
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. 13 Table of Contents 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.
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 our products 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.
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 our products to hospitals, physician offices/clinics, and other specialty treatment organizations as applicable.
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.
Based on recent estimates, these disorders are no longer considered to be very rare, with as many as one in every 2,000 people in the United States having some form of PI.
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 projected annual revenues greater than $490 million in 2025 and $605 million in 2026.
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 projected annual revenues greater than $635 million in 2026 and $775 million in 2027.
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.
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. Under the HCPCS, the J-code (J1554) became effective in April 2021.
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. Individually identifiable health information is considered sensitive data that merits stronger safeguards.
The Federal Trade Commission (“FTC”) expects a company’s data security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information the company 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.
On December 10, 2018, our former contract manufacturer assigned its rights and obligations under the Plasma Supply Agreement to Grifols, effective January 1, 2019.
In December 2018, our former contract manufacturer assigned its rights and obligations under the Plasma Supply Agreement to Grifols, effective January 2019.
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.
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.
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.
Under the decentralized approval procedure, an applicant submits materially the same application, or dossier, and related materials to the reference member state and concerned member states in parallel. The reference member state coordinates the preparation of a draft assessment report and drafts of the related materials within 120 days after receipt of a valid application.
We anticipate filing our sBLA in mid-2025, with potential FDA approval in the first half of 2026, for the expansion of ASCENIV’s label in the U.S. to include the pediatric setting for patients who are two years and older. • Expand and develop our pipeline with additional specialty plasma and/or hyperimmune immunoglobulin products .
In June 2025, we filed our sBLA for the expansion of ASCENIV’s label to include the pediatric setting for patients who are two years and older and we anticipate potential FDA approval in the first half of 2026. 9 Table of Contents ● Expand and develop our pipeline with additional specialty plasma and/or hyperimmune immunoglobulin products .
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.
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 CPIU).
Department of Health and Human Services (“HHS”) License No. 2019. The commercial re-launch and first commercial sales for this product commenced in August of 2019. On April 28, 2021, we announced that the FDA granted approval for our expanded plasma pool production scale process, allowing for a 4,400-liter plasma pool for the manufacture of our BIVIGAM IVIG product.
The commercial re-launch and first commercial sales for this product commenced in August 2019. In April 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.
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.
One of our ADMA BioCenters plasma collection facilities also has approval from the South Korean MFDS and ADMA BioCenters has licensure from the FDA for the collection and sale of Hepatitis B hyperimmune plasma obtained from immunized donors.
Major Customers For the year ended December 31, 2024, two customers, BioCARE, Inc. (“BioCare”) and Priority Healthcare Distribution, Inc. (“Curascript”), represented an aggregate of 72% of our consolidated revenues. Competition The plasma products industry is highly competitive.
Major Customers For the year ended December 31, 2025, two customers, BioCare, Inc. (“BioCare”) and Priority Healthcare Distribution, Inc. (“CuraScript”), represented an aggregate of approximately 73% of our consolidated revenues. 14 Table of Contents Competition The plasma products industry is highly competitive.
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.
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. Certain manufacturing deviations and unexpected manufacturing events must be investigated, corrected, and reported to the FDA.
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. 31 Table of Contents We are dedicated to high environmental standards and expect all employees to be familiar with and comply with the contents of this policy.
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. We are committed to providing a safe and healthy work environment.
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.
FDA may also conduct inspections, both remotely or in person, 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.
Plasma – Background, Composition and Manufacturing Human blood contains a number of components including: • Red blood cells – Used to carry oxygen from the lungs to the body; • White blood cells – Used by the immune system to fight infection; • Platelets – Used for blood clotting; and • Plasma – Used to carry the aforementioned components throughout the body and provide support in clotting and immunity.
Several immune globulin products have already been approved by the FDA. 10 Table of Contents Plasma – Background, Composition and Manufacturing Human blood contains a number of components including: ● Red blood cells – Used to carry oxygen from the lungs to the body; ● White blood cells – Used by the immune system to fight infection; ● Platelets – Used for blood clotting; and ● Plasma – Used to carry the aforementioned components throughout the body and provide support in clotting and immunity.
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. 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.
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. The mutual recognition procedure provides for mutual recognition of national approval decisions in other member states through a shortened procedure.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeWe are unable to predict whether geopolitical or economic conditions, 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.
Biggest changeWe are unable to predict whether geopolitical or economic conditions, 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. 38 Table of Contents 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, warning letters or other enforcement actions.
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.
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 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.
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.
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 current or future sales and difficulty in successfully commercializing our current products and launching new products.
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.
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 data breach.
Our anticipated reliance on a limited number of third-party contractors 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, or a cyberattack or data breach, could adversely affect our contractors’ 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 or in accordance with our specifications to meet our commercial needs; • contractors may not be able to execute our inspection procedures and required tests appropriately; 36 Table of Contents • 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; and • 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.
Our anticipated reliance on a limited number of third-party contractors 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, or a cyberattack or data breach, could adversely affect our contractors’ 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 or in accordance with our specifications 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; 37 Table of Contents • our third parties could breach or terminate their agreements with us; and • 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.
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.
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 not 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.
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. 55 Table of Contents 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 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. 57 Table of Contents 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.
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: 43 Table of Contents • 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; or • injunctions or the imposition of civil penalties or criminal fines.
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, if before or after approval, 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: 44 Table of Contents ● 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; or ● injunctions or the imposition of civil penalties or criminal fines.
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.
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 impairment provisions and write-offs which could adversely affect our business and financial results.
Although we did not experience any ownership changes for the years ended December 31, 2024 and 2023, 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.
Although we did not experience any ownership changes for the years ended December 31, 2025, 2024 and 2023, 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.
Medicaid rebates because of the extensive time delay between the recording of the accrual and its ultimate settlement, an interval that can generally take up to several years or more. These estimates may change from time to time based on changes in utilization, payer and channel mixes or the ultimate settlement or resolution of payor claims.
Medicaid rebates because of the extensive time delay between the recording of the accrual and its ultimate settlement, an interval that can generally take up to several years or more. These estimates may change from time to time based on changes in utilization, payer and channel mixes or the ultimate settlement or resolution of payer claims.
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.
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 and ransomware attacks, may be increased as we and third parties with whom we interact leverage our IT infrastructure in unanticipated ways.
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 and revenues generated from new contract manufacturing arrangements with third parties.
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, sales of intermediates and revenues generated from new contract manufacturing arrangements with third parties.
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.
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 regulations have established a civil monetary penalty for failure to refund these overcharges.
Significant estimates include, among other things, accruals for U.S. Medicaid rebates related to the sale of our immunoglobulin products. We accrue these rebates at the time of sale based on our estimates of the sales mix of our products and the portion of the products we sell that will be prescribed to Medicaid beneficiaries.
Estimates include, among other things, accruals for U.S. Medicaid rebates related to the sale of our immunoglobulin products. We accrue these rebates at the time of sale based on our estimates of the sales mix of our products and the portion of the products we sell that will be prescribed to Medicaid beneficiaries.
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. 42 Table of Contents We depend on third-party researchers, developers and vendors to develop, manufacture, supply materials for or test our 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.
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. 43 Table of Contents We depend on third-party researchers, developers and vendors to develop, manufacture, supply materials for or test our 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.
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; and • change in securities analysts’ estimates of our performance, or our failure to meet analysts’ expectations.
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; 62 Table of Contents ● 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; and ● change in securities analysts’ estimates of our performance, or our failure to meet analysts’ expectations.
This reliance on third parties carries the risk that the services and raw materials 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. • 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. 33 Table of Contents • 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, 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 unless additional clinical trials are conducted successfully and the FDA approves a Biologics License Application (“BLA”) or other required submission for review. • 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. • We depend on third-party researchers, developers and vendors to develop, manufacture, supply materials for or test our 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 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. • 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 accruals for U.S.
This reliance on third parties carries the risk that the services and raw materials 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. ● 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, 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, warning letters or other enforcement actions. ● Business interruptions could adversely affect our business. ● Issues in the development and use of AI may result in reputational harm and increased liability exposure. ● 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 Biologics License Application (“BLA”) or other required submission for review. ● 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. 34 Table of Contents ● We depend on third-party researchers, developers and vendors to develop, manufacture, supply materials for or test our 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 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. ● 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 accruals for U.S.
We considered several qualitative factors when evaluating our rebate accrual, such as the absence of a statutory limitation on the rebate amounts drug manufacturers pay to state Medicaid programs and general uncertainty that pharmaceutical manufacturers have historically seen with government payors often submitting lagged claims many periods after the initial dispensing of a product to an end patient.
We considered several qualitative factors when evaluating our rebate accrual, such as the absence of a statutory limitation on the rebate amounts drug manufacturers pay to state Medicaid programs and general uncertainty that pharmaceutical manufacturers have historically seen with government payers often submitting lagged claims many periods after the initial dispensing of a product to an end patient.
There was additional new information that arose during June 2024 that suggested our liabilities for certain payor claims were successfully resolved, which resulted in the $12.6 million adjustment to the accrual for U.S. Medicaid rebates in June 2024. In addition, the Patient Protection and Affordable Care Act (“ACA”) included a significant expansion of state Medicaid programs.
There was additional new information that arose during June 2024 that suggested our liabilities for certain payer claims were successfully resolved, which resulted in the $12.6 million adjustment to the accrual for U.S. Medicaid rebates in June 2024. In addition, the Patient Protection and Affordable Care Act (“ACA”) included a significant expansion of state 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.
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 promulgated a regulation in 2020 that is effective in two phases.
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. 59 Table of Contents Our ability to use our net operating loss carryforwards (“NOLs”) may be limited.
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. 61 Table of Contents Our ability to use our net operating loss carryforwards (“NOLs”) may be limited.
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.
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 Infection status subject to heightened standards.
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. 49 Table of Contents Cyberattacks and other security breaches could compromise our proprietary and confidential information or otherwise penetrate our network, which could harm our business and reputation.
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. 50 Table of Contents Cyberattacks and other security breaches could compromise our proprietary and confidential information or otherwise penetrate our network, which could harm our business and reputation.
Failure to meet any regulatory quality standards could have an adverse impact on our business. 45 Table of Contents 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.
Failure to meet any regulatory quality standards could have an adverse impact on our business. 46 Table of Contents 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.
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 years ended December 31, 2024 and 2023, two customers, BioCARE, Inc.
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 years ended December 31, 2025 and 2024, two customers, BioCare, Inc.
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.
In addition, the terms of existing and future debt agreements may preclude us from paying dividends. For example, the JPM 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.
These provisions include: 61 Table of Contents • 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; and • 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.
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; and ● 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.
As a result of the biosimilar pathway in the United States, we expect in the future to face greater competition from biosimilar products, including a possible increase in patent challenges. 56 Table of Contents The implementation of the Healthcare Reform Law in the United States may adversely affect our business.
As a result of the biosimilar pathway in the United States, we expect in the future to face greater competition from biosimilar products, including a possible increase in patent challenges. 58 Table of Contents The implementation of the Healthcare Reform Law in the United States may adversely affect our business.
Any such compromise of our data security and access to, or public disclosure or loss of, confidential business or proprietary information could disrupt our operations, damage our reputation, provide our competitors with valuable information and subject us to additional costs which could adversely affect our business.
Any such compromise of our data security and access to, integrity, availability of, or public disclosure or loss of, confidential business or proprietary information could disrupt our operations, damage our reputation, provide our competitors with valuable information and subject us to additional costs which could adversely affect our business and reputation.
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.
In particular, over the next 12-24 months, we may hire additional 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.
Cybersecurity vulnerabilities can also arise from human error, fraud or malice on the part of our employees, other insiders or third parties, or from technology or product enhancements or the migration of information and data to new technology platforms, systems or applications.
Cybersecurity vulnerabilities can also arise from human error, fraud or malice on the part of our employees, other insiders, vendors, suppliers, other third parties, or from technology or product enhancements or the migration of information and data to new technology platforms, systems or applications.
Absent relevant patent protection for a product, once the data exclusivity period expires, generic versions can be approved and marketed. 48 Table of Contents Patent rights covering our products may become subject to patent litigation.
Absent relevant patent protection for a product, once the data exclusivity period expires, generic versions can be approved and marketed. 49 Table of Contents Patent rights covering our products may become subject to patent litigation.
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.
A quality or safety issue may result in failure to obtain product approval, adverse inspection reports, warning letters, product recalls or seizures, voluntary or involuntary withdrawals, 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.
Delays in obtaining regulatory approvals may: • delay commercialization of, and our ability to derive revenues from, our product candidates; • impose costly procedures on us; and • diminish any competitive advantages that we may otherwise enjoy. 41 Table of Contents Even if we comply with all FDA requests, the FDA may ultimately reject our product candidate’s BLA.
Delays in obtaining regulatory approvals may: • delay commercialization of, and our ability to derive revenues from, our product candidates; • impose costly procedures on us; and • 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, 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 numbers, driver’s license numbers, government identifiers, credit card and financial account numbers. For example, the CCPA was amended by the CPRA, effective January 1, 2023.
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, such as Social Security Numbers, driver’s license numbers, government identifiers, credit card and financial account numbers. For example, the CCPA was amended by the CPRA, effective January 1, 2023.
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. • Although we achieved net income on a GAAP basis for the year ended December 31, 2024 for the first time, we may not be able to maintain profitability and continue to generate positive cashflows in the future. • We contract with third parties for the filling, packaging, testing and labeling of the drug substance we manufacture, and we also obtain source plasma from certain third parties.
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. ● Although we achieved net income on a GAAP basis for the fiscal years ended December 31, 2025 and 2024, we may not be able to maintain profitability and continue to generate positive cashflows in the future. ● We contract with third parties for the filling, packaging, testing and labeling of the drug substance we manufacture, and we also obtain source plasma from certain third parties.
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.
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. 63 Table of Contents We have never paid cash dividends and do not intend to pay cash dividends in the foreseeable future.
Failure to comply with these laws and regulations also may result in substantial fines, penalties, or other sanctions. 38 Table of Contents Business interruptions could adversely affect our business .
Failure to comply with these laws and regulations also may result in substantial fines, penalties, or other sanctions. 39 Table of Contents Business interruptions could adversely affect our business .
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.
We may be unable to successfully expand our manufacturing processes to fulfill demand for our products or increase our production capabilities through the addition of new equipment, including if we do not obtain requisite approval from the FDA. We may expand our manufacturing capacity and product output capability of the Boca Facility.
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 contract research organizations (“CROs”); • Regulators requiring us to perform additional or unanticipated clinical trials to obtain approval or becoming subject to additional post-marketing testing, surveillance, or Risk Evaluation and Mitigation Strategies 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; • 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; 40 Table of Contents • 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; and • 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.
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 contract research organizations (“CROs”); • Regulators requiring us to perform additional or unanticipated clinical trials to obtain approval or becoming subject to additional post-marketing testing, surveillance, or Risk Evaluation and Mitigation Strategies 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 and user fees being greater than we anticipate; • 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; • Regulatory authorities may not accept data from foreign clinical studies or sites or may find that such data is not sufficiently representative of the population of the approving jurisdiction; • The need to make changes to our product candidates that require additional testing or that cause our product candidates to perform differently than expected; 41 Table of Contents • 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; and • 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, 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.
In addition, an employee, contractor, or other third parties with whom we do business may attempt to obtain such information and may purposefully or inadvertently cause a breach involving such information.
Outcomes from these audits could have a material effect on our financial condition or financial results. 60 Table of Contents 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.
Outcomes from these audits could have a material effect on our financial condition or financial results. 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.
Any such change could have a material effect on our business, financial position and operating results. • 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 maintain profitability may be adversely impacted. • Our ADMA BioCenters operations collect information from donors in the United States 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 damaged. • Cyberattacks and other security breaches could compromise our proprietary and confidential information or otherwise penetrate our network, which could harm our business and reputation. 34 Table of Contents • 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 and high-titer plasma with proper specifications or other necessary raw materials. • Our ability to use our net operating loss carryforwards (“NOLs”) may be limited. • Fluctuations in our tax obligations and effective tax rate and realization of our net deferred tax assets may result in volatility of our operating results and materially impact our financial condition or financial results. • The market price of our common stock may be volatile and may fluctuate in a way that is disproportionate to our operating performance.
Any such change could have a material effect on our business, financial position and operating results. ● 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 maintain profitability may be adversely impacted. ● Our ADMA BioCenters operations collect information from donors in the United States 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 JPMorgan Chase Bank, N.A. and certain other lenders party thereto (collectively “JPMorgan”) is subject to acceleration in specified circumstances, which may result in JPMorgan taking possession and disposing of any collateral. ● If we are unable to protect our patents, trade secrets or other proprietary rights, if our patents are challenged or if our provisional patent applications do not get approved, our competitiveness and business prospects may be materially damaged. ● Cyberattacks and other security breaches could compromise our proprietary and confidential information or otherwise penetrate our network, 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 and high-titer plasma with proper specifications or other necessary raw materials. 35 Table of Contents ● Our ability to use our net operating loss carryforwards (“NOLs”) may be limited. ● Fluctuations in our tax obligations and effective tax rate and realization of our net deferred tax assets may result in volatility of our operating results and materially impact our financial condition or financial results. ● The market price of our common stock may be volatile and may fluctuate in a way that is disproportionate to our operating performance.
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.
Computer hackers may attempt to penetrate our computer systems and, if successful, misappropriate personal data and our proprietary and confidential information including e-mails and other electronic communications.
Failure to obtain the needed services, raw materials 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.
Failure to obtain the needed services, raw materials and products meeting the necessary quality standards, in sufficient quantities or at all could have a material and adverse effect on our products, business, financial condition and results from operations.
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. 37 Table of Contents Geopolitical and economic conditions, war, terrorism or other military actions may have a material adverse effect on our business.
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 and economic conditions, war, terrorism or other military actions may have a material adverse effect on our business.
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.
If there is an event of default, we would incur an increase in the rate of interest on the JPM Loans of 2% per annum.
Recent legislation and a final rule promulgated on December 29, 2023 delayed implementation of this portion of the rule until January 1, 2032.
Subsequent legislation and a final rule promulgated on December 29, 2023 delayed implementation of this portion of the rule until January 1, 2032.
We may not be able to maintain profitability in 2025 or beyond, and if we are unable to continue to consistently achieve positive cash flows we may need to finance our operations through additional equity or debt financings or corporate collaboration and licensing agreements.
We may not be able to maintain profitability in the future, and if we are unable to continue to consistently achieve positive cash flows we may need to finance our operations through additional equity or debt financings or corporate collaboration and licensing agreements.
We may face reputational damage in the event our corporate responsibility initiatives or objectives, including with respect to board diversity, do not meet the standards set by our investors, stockholders, lawmakers, listing exchanges or other constituencies, or if we are unable to achieve an acceptable ESG or sustainability rating from third-party rating services.
We may face reputational damage in the event our corporate responsibility initiatives or objectives do not meet the standards set by our investors, stockholders, lawmakers, listing exchanges or other constituencies, or if we are unable to achieve an acceptable ESG or sustainability rating from third-party rating services.
Through the March 2010 adoption of the Healthcare Reform Law in the United States, substantial changes are being made to the current system for paying for healthcare in the United States, including programs to extend medical benefits to millions of individuals who currently lack insurance coverage.
Through the March 2010 adoption of the Healthcare Reform Law in the United States, substantial changes have been made to the current system for paying for healthcare in the United States, including programs to extend medical benefits to millions of individuals who currently lack insurance coverage.
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.
All of our obligations under the JPM Credit Facilities 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.
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.
For example, over the last several years, including in December 2018, January 2019 and most recently October 2025, 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.
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. 47 Table of Contents Developments by competitors may render our products or technologies obsolete or non-competitive.
The occurrence of an event of default could result in, among other things, the termination of commitments under the JPM Credit Facilities, the declaration that all outstanding loans are immediately due and payable in whole or in part, and JPMorgan taking immediate possession of, and selling, any collateral securing the JPM Loans. 48 Table of Contents Developments by competitors may render our products or technologies obsolete or non-competitive.
Hackers may impersonate our vendors, suppliers or other third parties with whom we do business, which may result in financial harm to our business.
Hackers and other threat actors may impersonate our vendors, suppliers or other third parties with whom we do business, which may result in financial harm to our business.
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.
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 JPMorgan Credit Facilities are subject to acceleration in specified circumstances, which may result in JPMorgan taking possession and disposing of any collateral.
Therefore, even if we are able to construct new plasma collection centers to complement our current plasma collection facilities, an unsatisfactory inspection could prevent a new center from being licensed or risk the suspension or revocation of an existing license, among other enforcement actions.
Therefore, even if we or our third-party suppliers are able to construct or acquire new plasma collection centers to complement our current plasma collection network, 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.
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 and breakdown, cyberattacks on our operations and information technology systems as well as the systems of our customers, suppliers and related entities, human error, employee issues, global health occurrences such as a pandemic, global and economic uncertainty, war, terrorism, geopolitical conditions and emergencies, product liability claims and events beyond our control.
Our operations, including our headquarters located in Ramsey, NJ, the Boca Facility, our new real estate in Boca Raton, FL and our plasma collection facilities, are vulnerable to natural disasters (including as a result of climate change), such as interruption by fires, weather related events such as hurricanes, wind and rain, other acts of God or force majeure events, electric power loss, telecommunications failure, equipment failure and breakdown, cyberattacks on our operations and information technology systems as well as the systems of our customers, suppliers and related entities, human error, employee issues, global health occurrences such as a pandemic, global and economic uncertainty, war, terrorism, geopolitical conditions and emergencies, product liability claims and events beyond our control.
Additionally, certain of our third-party suppliers may be single-sourced or may not be able to supply sufficient materials for our operations, and it may be time-consuming, expensive or otherwise not feasible to locate an alternative supplier.
Certain of our third-party suppliers may be single-sourced, or may not be able to supply sufficient materials for our operations at a reasonable price, and it may be time-consuming, expensive or otherwise not feasible to locate an alternative supplier.
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. We also depend on third-party suppliers for materials used in our operations.
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.
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.
Additionally, further escalation of geopolitical tensions, such as ongoing conflicts in certain countries in South America, Northern Africa and in the Middle East and the surrounding areas could have a broader impact that extends into other markets where we do business.
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; • the impact of a cyberattack or data breach on our customers or related entities; and • widespread economic conditions or geopolitical conditions, including the exacerbated conflicts in Europe, the Middle East and the surrounding areas.
Factors that could influence our relationships with our customers include, among other things: 45 Table of Contents ● 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; ● the impact of a cyberattack or data breach on our customers or related entities; ● our customers’ inability to comply with the terms of our distribution agreements; and ● widespread economic conditions or geopolitical conditions, including the exacerbated conflicts in Europe, certain countries in South America, Northern Africa and in the Middle East and the surrounding areas.
Violations of laws such as the FDCA, 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.
Violations of laws such as the FDCA, 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 criminal fines, imprisonment, civil monetary penalties and damages, exclusion from participation in federal healthcare programs (including Medicare and Medicaid), suspension and debarment from government contracts, and refusal of orders under existing government contracts, pursuant to enforcement actions by DOJ, CMS, OIG and other regulatory authorities.
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.
While we have certain safeguards in place to reduce the risk of and detect cyberattacks, including a Company-wide cybersecurity policy, our information technology networks and infrastructure may be vulnerable to unpermitted access by hackers or other breaches, or employee error or malfeasance.
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.
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. States also may have their own licensing and regulatory requirements.
We are subject to extensive and rigorous governmental regulation, including the requirement of FDA and other federal, state and local business regulatory approvals 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.
Any such penalties may have a material adverse effect on our business and results of operations. 54 Table of Contents We are subject to extensive and rigorous governmental regulation, including the requirement of FDA and other federal, state and local business regulatory approvals 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.
Risks Relating to our Business Although we achieved net income on a GAAP basis for the year ended December 31, 2024 for the first time, we may not be able to maintain profitability andcontinue to generate positive cash flows in the future.
Risks Relating to our Business Although we achieved net income on a GAAP basis for the years ended December 31, 2024 and 2025, we may not be able to maintain profitability and continue to generate positive cash flows in the future.
Each of these risks could delay or prevent production, 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.
Each of these risks could delay or prevent production, 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.
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.
When we or our third-party suppliers open a new plasma center, and on an ongoing basis after licensure, it must be inspected by the FDA and the applicable regulatory authorities for compliance with cGMP and other regulatory requirements.
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.
Given the significant delays that may result during the validation and approval process, we may not receive the necessary manufacturing or product approvals, 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 and until the necessary approvals are obtained.
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.
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. This exclusivity period, however, is subject to certain limitations.
We have incurred substantial losses during our history. As of December 31, 2024, we had federal and state NOLs of $265.6 million and $203.4 million, respectively. Federal and state NOLs of approximately $33.4 million and $62.0 million, respectively, will begin to expire at various dates beginning in 2028, if not limited by triggering events prior to such time.
We have incurred substantial losses during our history. As of December 31, 2025, we had federal and state NOLs of $265.6 million and $176.9 million, respectively. Federal and state NOLs of approximately $33.4 million and $46.8 million, respectively, will begin to expire at various dates beginning in 2029, if not limited by triggering events prior to such time.
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 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.
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, strikes, embargoes, trade and sanction requirements and limits, other acts of God or force majeure events or global health occurrences and emergencies.
In addition, our contract fill/finishers and our other third-party vendors may source their materials and supplies globally and are therefore subject to potential tariffs, which could be passed along to us in whole or in part and adversely impact our results of operations, and supply disruptions in the event of fire, weather related events such as hurricanes, wind and rain, international conflicts, strikes, embargoes, trade and sanction requirements and limits, other acts of God or force majeure events or global health occurrences and emergencies.
The volatility of our future effective tax rate could be materially impacted by a number of factors, including: • changes in the valuation of our deferred tax assets and liabilities; • expected timing and amount of the release of any valuation allowance on our deferred tax assets; or • changes in U.S. federal, state and local tax rates, tax laws, regulations, or interpretations thereof.
The volatility of our future effective tax rate could be materially impacted by a number of factors, including: ● changes in our assessment of the lack of a need for a valuation allowance on our deferred tax assets; or ● changes in U.S. federal, state and local tax rates, tax laws, regulations, or interpretations thereof.
As of December 31, 2024, BlackRock Inc., The Vanguard Group, Inc., State Street Corporation, Invesco Ltd. and our directors and executive officers and their affiliates owned approximately 37% of the outstanding shares of our common stock.
As of December 31, 2025, BlackRock, Inc., The Vanguard Group, Inc., State Street Corporation and our directors and executive officers and their affiliates collectively owned approximately 30% of the outstanding shares of our common stock.
As more individuals become eligible for coverage under these programs, Medicaid utilization of our products could increase, resulting in a corresponding increase in our rebate payments. Such rebate payments may exceed what we have accrued for during the applicable period.
If more states decide to take advantage of these programs such that more individuals become eligible for coverage, Medicaid utilization of our products could increase, resulting in a corresponding increase in our rebate payments. Such rebate payments may exceed what we have accrued for during the applicable period.
If a prolonged government shutdown or regulatory agency disruption 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.
If a prolonged government shutdown or regulatory agency disruption reoccurs, or in the event the FDA has an insufficient amount of staff, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, conduct evaluations and inspections and other reporting requirements which could have a material adverse effect on our business.
Separately, in response to the COVID-19 pandemic, the FDA postponed most inspections at domestic and foreign manufacturing facilities from March 2020 until July 2021.
Separately, in response to the COVID-19 pandemic, the FDA postponed most inspections at domestic and foreign manufacturing facilities from March 2020 until July 2021. Also, in 2025, there was an FDA reduction in force.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

4 edited+4 added−3 removed4 unchanged
Biggest changeADMA also has strict processes in place for the review of third-party service providers engaged, including thorough security assessments before engagement and annual monitoring of their IT environments and controls.
Biggest changeADMA also has strict processes in place for the review of third-party service providers engaged, including thorough security assessments before engagement and annual monitoring of their IT environments and controls. 64 Table of Contents Governance Our President and Chief Executive Officer and Chief Operating Officer are primarily responsible for timely updating the Board and Audit Committee about any material cybersecurity incidents or threats or any cybersecurity related issues worthy of their attention.
Our Board has designated the Audit Committee as the primary committee responsible for reviewing and managing cybersecurity risks and threats at ADMA. The Audit Committee is comprised of Board members with diverse experience in healthcare, finance and information technology, enabling them to effectively oversee cybersecurity risks and threats.
Our Board has designated the Audit Committee as the primary committee responsible for overseeing, reviewing and managing cybersecurity risks and threats at ADMA. The Audit Committee is comprised of Board members with diverse experience in healthcare, finance and information technology, enabling them to effectively oversee cybersecurity risks and threats.
Our management team, with assistance from third-party consultants or advisors as appropriate, provides quarterly updates regarding cybersecurity risks and threats to the Audit Committee and ad hoc updates or communications are provided to the entire Board as needed. The Data Integrity and IT Operations team are primarily responsible for the timely identification, review, severity assessment and management of cybersecurity incidents.
Our management team, with assistance from third-party consultants or advisors as appropriate, provides quarterly updates regarding cybersecurity risks and threats to the Audit Committee and ad hoc updates or communications are provided to the entire Board as needed. The IT Operations team is primarily responsible for the timely identification, review, severity assessment and management of cybersecurity incidents.
In accordance with this policy, senior management will also communicate the occurrence of any significant cybersecurity incidents to our Board, Audit Committee and auditors on a timely basis and will keep them informed of the remediation plans and progress. 64
In accordance with this policy, senior management will also communicate the occurrence of any significant cybersecurity incidents to our Board, Audit Committee and auditors on a timely basis and will keep them informed of the remediation plans and progress. We maintain cybersecurity insurance coverage in an amount appropriate for our risk profile.
Removed
During the year ended December 31, 2023, as initially disclosed in our Quarterly Report on Form 10-Q for the period ending June 30, 2023 and updated elsewhere in our subsequent filings with the SEC, we experienced an IT systems disruption, which did result in a non-recurring charge to our results of operations.
Added
We also conduct mandatory cybersecurity training for employees annually, and all new hires are required to complete cybersecurity training within 90 days of receiving their Company computer. Periodically, management conducts simulated phishing exercises to evaluate the effectiveness of its training programs. Employees who fall victim to these simulations may be required to participate in additional remedial cybersecurity training.
Removed
There was no original financial systems data loss or any evidence of data exfiltrated due to this disruption.
Added
Employees within our IT Department receive ongoing cybersecurity awareness communications, including monthly newsletters highlighting emerging cybersecurity threats and developments, as well as targeted communications as appropriate. Separately, the IT Department periodically conducts cybersecurity tabletop exercises with assistance from third-party experts. Lessons learned from these exercises are incorporated into management’s ongoing assessment of cybersecurity risks and mitigation strategies.
Removed
Normal course operations quickly resumed across the Company’s business units. 63 Table of Contents Governance Our President and Chief Executive Officer and Chief Operating Officer are primarily responsible for timely updating the Board and Audit Committee about any material cybersecurity incidents or threats or any cybersecurity related issues worthy of their attention.
Added
In addition, members of the IT Department maintain industry recognized certifications related to cybersecurity, threat detection, and incident management. The Company also supports ongoing development by enabling IT personnel to participate in industry-led conferences and forums to stay informed of evolving cybersecurity trends, threats, and best practices.
Added
Insights gained through these activities are considered as part of ADMA’s broader cybersecurity risk management program.

Item 2. Properties

Properties — owned and leased real estate

3 edited+0 added−0 removed1 unchanged
Biggest changeWe also have ten plasma collection centers in leased facilities mainly in the southeastern part of the U.S., which require lease payments through the respective lease terms that expire at various dates through 2033 (see Note 12 to the consolidated financial statements appearing elsewhere in this report).
Biggest changeGrossman, our President and Chief Executive Officer. 65 Table of Contents As of December 31, 2025, we maintained ten plasma collection centers in leased facilities mainly in the southeastern part of the U.S., which require lease payments through the respective lease terms that expire at various dates through 2033 (see Notes 5 and 12 to the consolidated financial statements appearing elsewhere in this report).
Properties The table below describes our principal facilities as of December 31, 2024: Location Principal Business Activity Approximate Square Feet Owned or expiration date of lease Ramsey, NJ Corporate Headquarters 4,200 December 31, 2026 * Boca Raton, FL Manufacturing and Administration 84,462 Owned Boca Raton, FL Laboratory and Administration 44,495 Owned * Pursuant to a shared services agreement, as amended, with Areth, LLC ("Areth") for office, warehouse space and related services pursuant to which the Company pays Areth monthly lease payments of $10,000.
Properties The table below describes our principal facilities as of December 31, 2025: Location Principal Business Activity Approximate Square Feet Owned or expiration date of lease Ramsey, NJ Corporate Headquarters 4,200 December 31, 2026* Boca Raton, FL Manufacturing and Administration 84,462 Owned Boca Raton, FL Laboratory and Administration 44,495 Owned Boca Raton, FL Warehousing and Administration 38,195 Owned *Pursuant to a shared services agreement, as amended, with Areth, LLC ("Areth") for office, warehouse space and related services pursuant to which the Company pays Areth monthly lease payments of $10,000.
Areth is a company controlled by Dr. Jerrold B. Grossman, our Vice Chairman of the Board of Directors, and Adam S. Grossman, our President and Chief Executive Officer.
Areth is a company controlled by Dr. Jerrold B. Grossman, our Vice Chairman of the Board of Directors, and Adam S.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

4 edited+2 added−2 removed0 unchanged
Biggest changeStock Performance Graph The following graph assumes a $100 investment on December 31, 2019 in each of the Company’s Common Stock, the XBI Biotech Index of biotechnology companies and the Russell 2000 Index. 2019 2020 2021 2022 2023 2024 ADMA $ 100.00 $ 48.75 $ 35.25 $ 97.00 $ 113.00 428.75 XBI $ 100.00 $ 148.02 $ 117.72 $ 87.27 $ 93.88 94.69 Russell 2000 $ 100.00 $ 118.34 $ 134.27 $ 105.25 $ 121.15 133.37 66 Table of Contents Sale of Unregistered Securities During the year ended December 31, 2024, we had no sales of unregistered securities that have not been previously disclosed in a Current Report on Form 8-K or Quarterly Report on Form 10-Q.
Biggest changeStock Performance Graph The following graph assumes a $100 investment on December 31, 2020 in each of (i) the Company’s Common Stock, (ii) the XBI Biotech Index of biotechnology companies and (iii) the Russell 2000 Index. 2020 2021 2022 2023 2024 2025 ADMA $ 100.00 $ 72.31 $ 198.97 $ 231.79 $ 879.49 $ 935.38 XBI $ 100.00 $ 79.53 $ 58.96 $ 63.43 $ 63.97 $ 86.61 Russell 2000 $ 100.00 $ 113.46 $ 88.93 $ 102.37 $ 112.70 $ 125.43 Sale of Unregistered Securities None.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Market Information Our Common Stock had been listed on the Nasdaq Capital Market (“Nasdaq”) under the symbol “ADMA” since November 10, 2014. Since October 22, 2019, our Common Stock has been listed on the Nasdaq Global Market.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Market Information Since October 22, 2019, our common stock has been listed on the Nasdaq Global Market under the symbol “ADMA”. Holders As of February 20, 2026, there were seven record holders of our common stock, based upon information received from our transfer agent.
As of February 1, 2025, we estimate that there are more than 30,000 beneficial owners of our Common Stock. Dividend Policy We have never paid any cash dividends on our capital stock. We anticipate that we will retain earnings, if any, to support operations and to finance the growth and development of our business.
Dividend Policy We have never paid any cash dividends on our capital stock. We anticipate that we will retain earnings, if any, to support operations and to finance the growth and development of our business. In addition, the terms of our JPM Credit Agreement preclude us from paying cash dividends without their consent.
In addition, the terms of our Credit Agreement with Ares preclude us from paying cash dividends without their consent. Therefore, we do not expect to pay any cash dividends for the foreseeable future.
Therefore, we do not expect to pay any cash dividends for the foreseeable future.
Removed
Holders As of December 31, 2024, there were five record holders of our Common Stock, based upon information received from our transfer agent. However, this number does not include beneficial owners whose shares were held of record by nominees or broker dealers.
Added
Purchases of Equity Securities by the Issuer and Affiliated Purchasers The table below reflects shares of common stock we repurchased during the three months ended December 31, 2025: For the Month Ended Total Number of Shares Purchased Average Price Paid Per Share (1) Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs Approximate Dollar Value of Shares that May Yet Be Purchased Under the Plans or Programs (2) October 31, 2025 361,262 $ 14.95 361,262 $ 471,559,993 November 30, 2025 229,160 $ 15.27 229,160 $ 468,059,744 December 31, 2025 - $ - - $ 468,059,744 Total 590,422 $ 15.09 590,422 (1) Includes broker commissions.
Removed
Purchases of Equity Securities by the Issuer and Affiliated Purchasers We did not repurchase any of our securities during the three months ended December 31, 2024.
Added
(2) Shares were repurchased pursuant to our share repurchase program publicly announced on May 5, 2025. There is no expiration date for this share repurchase program. The authorization to repurchase shares will end when we have repurchased the maximum number of shares authorized, or if we have determined to terminate such program. 67 Table of Contents Item 6. Reserved

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

78 edited+51 added−78 removed42 unchanged
Biggest changeYear Ended December 31, 2024 Compared to Year Ended December 31, 2023 The following table presents a summary of the changes in our results of operations for the year ended December 31, 2024 compared to the year ended December 31, 2023: Year Ended December 31, (in thousands) 2024 2023 Increase (Decrease) Revenues $ 426,454 $ 258,215 $ 168,239 Cost of product revenue 206,901 169,273 37,628 Gross profit 219,553 88,942 130,611 Research and development expenses 1,813 3,300 (1,487 ) Plasma center operating expenses 4,245 4,266 (21 ) Amortization of intangibles 388 724 (336 ) Selling, general and administrative expenses 74,124 59,020 15,104 Income from operations 138,983 21,632 117,351 Interest expense (13,930 ) (25,027 ) 11,097 Loss on extinguishment of debt (1,243 ) (26,174 ) 24,931 Other income, net 1,904 1,330 574 Income (loss) from before taxes 125,714 (28,239 ) 153,953 Income tax benefit (71,959 ) - (71,959 ) Net income (loss) $ 197,673 $ (28,239 ) $ 225,912 Adjusted EBITDA * $ 164,612 $ 40,251 $ 124,361 Adjusted net income* $ 119,218 $ 705 $ 118,513 * - See Non-GAAP Financial Measures appearing at the end of this discussion 72 Table of Contents Revenues We recorded total revenues of $426.5 million for the year ended December 31, 2024, as compared to $258.2 million for the year ended December 31, 2023, an increase of $168.2 million, or 65%.
Biggest changeThe provision for income taxes for fiscal 2024 includes a deferred tax benefit of ($84.3) million related to the release of the valuation allowance against our net deferred tax assets, partially offset by current income tax expense of $12.3 million, which reflects federal and state income tax liabilities that are not fully sheltered by NOLs due to limitations from prior ownership changes and other limitations on net operating loss carryforwards under the Internal Revenue Code of 1986, as amended (see “Risk Factors - Our ability to use our net operating loss carryforwards (“NOLs”) may be limited.” appearing elsewhere in this report and Note 11 to the Consolidated Financial Statements). 74 Table of Contents Year Ended December 31, 2024 Compared to Year Ended December 31, 2023 The following table presents a summary of the changes in our results of operations for the year ended December 31, 2024, compared to the year ended December 31, 2023: Year Ended December 31, 2024 2023 Increase (Decrease) (in thousands) Revenues $ 426,454 $ 258,215 $ 168,239 Cost of product revenue 206,901 169,273 37,628 Gross profit 219,553 88,942 130,611 Research and development expenses 1,813 3,300 (1,487 ) Plasma center operating expenses 4,245 4,266 (21 ) Amortization of intangibles 388 724 (336 ) Selling, general and administrative expenses 74,124 59,020 15,104 Income from operations 138,983 21,632 117,351 Interest expense (13,930 ) (25,027 ) 11,097 Loss on extinguishment of debt (1,243 ) (26,174 ) 24,931 Other income, net 1,904 1,330 574 Income before taxes 125,714 (28,239 ) 153,953 Income tax benefit (71,959 ) - (71,959 ) Net income (loss) $ 197,673 $ (28,239 ) $ 225,912 Adjusted EBITDA* $ 164,612 $ 40,251 $ 124,361 Adjusted net income* $ 119,218 $ 705 $ 118,513 * - See Non-GAAP Financial Measures appearing at the end of this discussion Revenues We recorded total revenues of $426.5 million for the year ended December 31, 2024, as compared to $258.2 million for the year ended December 31, 2023, an increase of $168.2 million, or 65%.
Following FDA approval in April 2019, commercial sales of ASCENIV commenced in October of 2019 and in 2023 we commenced manufacturing ASCENIV at the 4,400 Liter production scale. This expansion has improved the product’s margin profile and increased plant production capacity as fewer batches are needed to support our revenue goals .
Following FDA approval in April 2019, commercial sales of ASCENIV commenced in October 2019 and in 2023 we commenced manufacturing ASCENIV at the 4,400 Liter production scale. This expansion has improved the product’s margin profile and increased plant production capacity as fewer batches are needed to support our revenue goals.
On the Ares Closing Date, we used the proceeds from the Ares Loans, along with a portion of our existing cash on hand, to terminate and pay in full all of the outstanding obligations under our previous senior credit facility (the “Hayfin Credit Facility”) with Hayfin Services LLP (“Hayfin”) including the outstanding principal in the amount of $158.6 million, a prepayment penalty in the amount $11.1 million, an exit fee of $1.6 million, all accrued and unpaid interest outstanding on the Hayfin Credit Facility as of the Ares Closing date, as well as certain fees and expenses related thereto.
On the Ares Closing Date, we used the proceeds from the Ares Loans, along with a portion of its existing cash on hand, to terminate and pay in full all of the outstanding obligations under our previous senior credit facility (the “Hayfin Credit Facility”) with Hayfin Services LLP (“Hayfin”) including the outstanding principal in the amount of $158.6 million, a prepayment penalty in the amount $11.1 million, an exit fee of $1.6 million, all accrued and unpaid interest outstanding on the Hayfin Credit Facility as of the Ares Closing date, as well as certain fees and expenses related thereto.
The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses. On an ongoing basis, we evaluate these estimates and assumptions, including those described below.
GAAP”). The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses. On an ongoing basis, we evaluate these estimates and assumptions, including those described below.
In the future however, we may elect to 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.
In the future, we may elect to 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.
Food and Drug Administration (the “FDA”) approval, all of which are currently marketed and commercially available: (i) ASCENIV (Immune Globulin Intravenous, Human – slra 10% Liquid), an 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 in adults and adolescents, for which we received FDA approval on April 1, 2019 and commenced first commercial sales in October 2019; (ii) BIVIGAM (Immune Globulin Intravenous, Human), an IVIG product indicated for the treatment of PI, and for which we received FDA approval on May 9, 2019 and commenced commercial sales in August 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.
Food and Drug Administration (the “FDA”) approval, all of which are currently marketed and commercially available: (i) ASCENIV (Immune Globulin Intravenous, Human – slra 10% Liquid), an 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 in adults and adolescents, for which we received FDA approval in April 2019 and commenced first commercial sales in October 2019; (ii) BIVIGAM (Immune Globulin Intravenous, Human), an IVIG product indicated for the treatment of PI, and for which we received FDA approval in May 2019 and commenced commercial sales in August 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.
Department of Health and Human Services (“HHS”) License No. 2019. The commercial re-launch and first commercial sales for this product commenced in August of 2019. On April 28, 2021, we announced that the FDA granted approval for our expanded plasma pool production scale process, allowing for a 4,400-liter plasma pool for the manufacture of our BIVIGAM IVIG product.
Department of Health and Human Services (“HHS”) License No. 2019. The commercial re-launch and first commercial sales for this product commenced in August 2019. In April 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.
Selling, General and Administrative Expenses Selling, general and administrative (“SG&A”) expenses were $74.1 million for the year ended December 31, 2024, an increase of $15.1 million from the year ended December 31, 2023, and reflects an increase in stock-based compensation expense of $6.4 million in 2024, largely due to the higher valuation of grants awarded in 2024 and to additional compensation expense recognized for the modification of certain outstanding equity awards.
Selling, General and Administrative Expenses Selling, general and administrative expenses were $74.1 million for the year ended December 31, 2024, an increase of $15.1 million from the year ended December 31, 2023, and reflects an increase in stock-based compensation expense of $6.4 million in 2024, largely due to the higher valuation of grants awarded in 2024 and to additional compensation expense recognized for the modification of certain outstanding equity awards.
Plasma Center Operating Expenses Plasma center operating expenses, which primarily consists of compensation, benefits and travel for plasma center management and administrative staff, along with certain initial opening, marketing and start-up costs, were essentially unchanged at $4.2 million for the year ended December 31, 2024 as compared to approximately $4.3 million for the year ended December 31, 2023.
Plasma Center Operating Expenses Plasma center operating expenses, which primarily consist of compensation, benefits and travel for plasma center management and administrative staff, along with certain initial opening, marketing and start-up costs, were essentially unchanged at $4.2 million for the year ended December 31, 2024 as compared to approximately $4.3 million for the year ended December 31, 2023.
In addition, some of our third-party inventory purchase agreements provide for scheduled price increases that are tied to various consumer price indices, which have resulted in higher than historical percentage price increases and could result in higher source plasma and other raw material and supplies costs in 2025 and beyond.
In addition, some of our third-party inventory purchase agreements provide for scheduled price increases that are tied to various consumer price indices, which have resulted in higher than historical percentage price increases and could result in higher source plasma and other raw material and supplies costs in 2026 and beyond.
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”).
We manufacture these products at our FDA-licensed, plasma fractionation and purification facility located in Boca Raton, FL with a peak annual processing capability of up to 600,000 liters (the “Boca Facility”).
The Centers for Medicare and Medicaid Services (“CMS”) has issued a permanent, product-specific-J-code for ASCENIV. Under the Healthcare Common Procedure Coding System (“HCPCS”), the J-code (J1554) became effective April 1, 2021.
The Centers for Medicare and Medicaid Services (“CMS”) has issued a permanent, product-specific-J-code for ASCENIV. Under the Healthcare Common Procedure Coding System (“HCPCS”), the J-code (J1554) became effective in April 2021.
Based upon the macroeconomic environment, publicly available information and reports from the U.S. government, we expect this trend to subside somewhat in 2025, however we cannot predict the extent to which future domestic and global economic conditions including, but not limited to, supply chain constraints or geopolitical conditions, including the continuing conflicts in Europe and in the Middle East and surrounding areas, could have a significant impact on our future results of operations.
Based upon the macroeconomic environment, publicly available information and reports from the U.S. government, we expect this trend to subside somewhat in 2026, however we cannot predict the extent to which future domestic and global economic conditions including, but not limited to, supply chain constraints or geopolitical conditions, including the continuing conflicts in South America, Europe and in the Middle East and surrounding areas, could have a significant impact on our future results of operations.
Borrowings under the revolving facility bear interest at the adjusted Term SOFR for a three‑month tenor in effect on the day that is two business days prior to the first day of the applicable calendar quarter plus 3.75% (the “SOFR Revolving Facility Applicable Margin”).
Borrowings under the Ares revolving facility bore interest at the adjusted Term SOFR for a three‑month tenor in effect on the day that is two business days prior to the first day of the applicable calendar quarter plus 3.75% (the “SOFR Revolving Facility Applicable Margin”).
Borrowings under the term loan bear interest at the adjusted Term SOFR for a three‑month tenor in effect on the day that is two business days prior to the first day of the applicable calendar quarter plus 6.50% (the “Initial SOFR Term Loan Applicable Margin”).
Borrowings under the Ares term loan bore interest at the adjusted Term SOFR for a three‑month tenor in effect on the day that is two business days prior to the first day of the applicable calendar quarter plus 6.50% (the “Initial SOFR Term Loan Applicable Margin”).
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. From time to time we may provide contract manufacturing services for certain third-party clients.
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. 68 Table of Contents From time to time, we may provide contract manufacturing services for certain third-party clients.
Also, in a higher inflationary environment, we may not be able to raise the prices of our products to keep up with the rate of inflation.
Also, in a higher inflationary environment, we may not be able to raise the prices of our products to keep up with the rate of inflation. 82 Table of Contents
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.
The FDA approved Nabi-HB in March 1999. Production of Nabi-HB at the Boca Facility has continued under our leadership since the third quarter of 2017.
Loss on Extinguishment of Debt In connection with the foregoing refinancing of our senior debt in December of 2023, we incurred a loss on extinguishment of debt in the amount of $26.2 million, which is comprised of a prepayment penalty paid to our previous lender in the amount of $11.1 million, and the write-off of unamortized discount related to the retired indebtedness in the approximate amount of $15.1 million (see “Liquidity and Capital Resources”).
In connection with the foregoing refinancing of our senior debt in December of 2023, we incurred a loss on extinguishment of debt in the amount of $26.2 million, which was comprised of a prepayment penalty paid to our previous lender in the amount of $11.1 million, and the write-off of unamortized discount related to the retired indebtedness in the approximate amount of $15.1 million.
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 2026.
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 2027 and beyond.
(the “Company,” “ADMA,” “we,” “us” or “our”) is 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.
(the “Company,” “ADMA,” “we,” “us” or “our”) is a U.S. based, 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.
The Ares Credit Facility has a maturity date of December 20, 2027 (the “Ares Maturity Date”).
The Ares Credit Facility had a maturity date of December 20, 2027 (the “Ares Maturity Date”).
We base our estimates on our historical experience and on various other assumptions that we believe to be reasonable under the circumstances. These estimates and assumptions form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.
We base our estimates on our historical experience and on various other assumptions that we believe to be reasonable under the circumstances. These estimates and assumptions form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results and experiences may differ materially from these estimates.
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 Nabi-HB is a hyperimmune globulin that is rich in antibodies to the Hepatitis B virus.
In December 2023, we announced that the FDA approved the expansion of BIVIGAM’s label in the United States to now include the pediatric setting for those two years of age and older. Nabi-HB Nabi-HB is a hyperimmune globulin that is rich in antibodies to the Hepatitis B virus.
For the year ended December 31, 2024 we achieved net income of $197.7 million, the first time in our history that we achieved net income on a GAAP basis, and generated positive cash flow from operations of $118.7 million.
Trends and Developments For the year ended December 31, 2024, we achieved net income of $197.7 million, the first time in our history that we achieved net income on a GAAP basis and generated positive cash flow from operations of $118.7 million. Positive cash flow from operations continued throughout fiscal year 2025.
Our material cash requirements are primarily comprised of: • The collection and procurement of raw material source plasma, which includes plasma donor fees and plasma center supplies, and other raw materials necessary to maintain and scale up our manufacturing operations; • Employee compensation and benefits; • Capital expenditures for equipment upgrades and capacity expansion at the Boca Facility and to maintain our plasma collection facilities; • Interest on our debt; • Marketing programs, medical education and continued commercialization efforts; • Boca Facility maintenance, improvements, repairs and supplies; • Conducting required post-marketing clinical trials for ASCENIV; and • Continuous improvements and updates to our IT infrastructure, laboratory equipment and assays, and facilities and engineering equipment.
Our material cash requirements are primarily comprised of: 78 Table of Contents ● The collection and procurement of raw material source plasma, which includes plasma donor fees and plasma center supplies, and other raw materials necessary to maintain and scale up our manufacturing operations; ● Employee compensation and benefits; ● Capital expenditures for equipment upgrades and maintenance of our plasma collection facilities; ● Interest on our debt; ● Marketing programs, medical education and continued commercialization efforts; ● Boca Facility maintenance, improvements, repairs and supplies; ● Research and development, including studies and development activities relating to SG-001; ● Conducting required post-marketing clinical trials for ASCENIV; and ● Continuous improvements and updates to our IT infrastructure, laboratory equipment and assays, and facilities and engineering equipment.
We believe this clinical data together with the FDA approval for the treatment of 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.
We believe this clinical data together with the FDA approval for the treatment of 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.
On May 9, 2019, the FDA approved the Prior Approval Supplement (the “PAS”) for the use of our IVIG manufacturing process, thereby enabling us to re-launch and commercialize this product in the U.S. We resumed production of BIVIGAM during the fourth quarter of 2017 and commercial production is ongoing, using our FDA-approved IVIG manufacturing process under U.S.
In May 2019, the FDA approved the PAS for the use of our IVIG manufacturing process, thereby enabling us to re-launch and commercialize this product in the United States. We resumed production of BIVIGAM during the fourth quarter of 2017 and commercial production is ongoing, using our FDA-approved IVIG manufacturing process under U.S.
Excluding the $12.6 million adjustment we recorded in the second quarter of 2024 to decrease our accrual for estimated U.S. Medicaid rebates (which had the effect of increasing net revenues by $12.6 million), revenue increased by approximately $155.6 million, or 60%.
The $12.6 million U.S. Medicaid rebate adjustment recorded in 2024 is also included under intermediates and other products. Excluding the $12.6 million adjustment we recorded in the second quarter of 2024 to decrease our accrual for estimated U.S. Medicaid rebates (which had the effect of increasing net revenues by $12.6 million), revenue increased by approximately $155.6 million, or 60%.
We may prepay the outstanding principal under the revolving facility, together with any accrued but unpaid interest on the prepaid principal amount, at any time and from time to time upon three business days’ prior written notice with no prepayment premium.
The Ares Credit Agreement permitted prepayment of the outstanding principal under the revolving facility, together with any accrued but unpaid interest on the prepaid principal amount, at any time and from time to time upon three business days’ prior written notice with no prepayment premium.
Loss on Extinguishment of Debt As a result of the prepayment we made on our senior debt on December 19, 2024, we incurred a prepayment penalty in the amount of $0.45 million and recorded a partial write-down of unamortized debt discount of approximately $0.8 million, for a loss on this partial extinguishment of debt in the amount of $1.2 million.
We also incurred lower expense related to the amortization of debt discount in 2024 in the amount of $1.6 million. 76 Table of Contents Loss on Extinguishment of Debt As a result of the prepayment we made on our senior debt on December 19, 2024, we incurred a prepayment penalty in the amount of $0.45 million and recorded a partial write-down of unamortized debt discount of approximately $0.8 million, for a loss on this partial extinguishment of debt in the amount of $1.2 million.
In connection with the repayment against the term loan, we recognized a loss on extinguishment of debt in the approximate amount of $1.2 million, which is comprised of a prepayment penalty in the amount of $0.45 million and a partial write-off of unamortized discount attributable to the term loan in the amount of $0.8 million.
In connection with the repayment against the term loan, during the year ended December 31, 2024, we recognized a loss on extinguishment of debt in the approximate amount of $1.2 million, which was comprised of a prepayment penalty in the amount of $0.5 million and a partial write-off of unamortized discount attributable to the term loan in the amount of $0.8 million.
We anticipate filing our supplemental Biologics License Application (“sBLA”) in mid-2025, with potential FDA approval in the first half of 2026 for the expansion of ASCENIV’s label to include the pediatric setting for patients who are two years and older. 69 Table of Contents BIVIGAM BIVIGAM is a plasma-derived IVIG that contains a broad range of antibodies similar to those found in normal human plasma.
In June 2025, we filed our sBLA for the expansion of ASCENIV’s label to include the pediatric setting for patients who are two years and older and we anticipate potential FDA approval in the first half of 2026. BIVIGAM BIVIGAM is a plasma-derived IVIG that contains a broad range of antibodies similar to those found in normal human plasma.
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.
In addition, one of our FDA-approved plasma collection centers also has approval from the Korean Ministry of Food and Drug Safety (“MFDS”), and ADMA BioCenters has FDA approval to operate a Hepatitis B immunization program.
We may prepay the outstanding principal on the term loan, together with any accrued but unpaid interest on the prepaid principal amount, at any time and from time to time upon three business days’ prior written notice, subject to the payment to Ares of a prepayment premium equal to (i) the present value as of such date of all remaining required interest payments on the principal amount being repaid plus 1.5% of the prepaid principal amount, if prepaid on or prior to the first anniversary of the Ares Closing Date, (ii) 1.5% of the prepaid principal amount, if prepaid after the first anniversary of the Ares Closing Date and on or prior to the second anniversary of the Ares Closing Date, or (iii) 1.0% of the prepaid principal amount, if prepaid on or prior to the third anniversary of the Ares Closing Date.
The Ares Credit Agreement permitted prepayment of the outstanding principal on the term loan, together with any accrued but unpaid interest on the prepaid principal amount, at any time and from time to time upon three business days’ prior written notice, subject to the payment to Ares of a prepayment premium equal to (i) 1.5% of the prepaid principal amount, if prepaid after the first anniversary of the Ares Closing Date and on or prior to the second anniversary of the Ares Closing Date or (ii) 1.0% of the prepaid principal amount, if prepaid on or prior to the third anniversary of the Ares Closing Date.
SG&A expenses as a percentage of net revenues decreased from 22.9% in fiscal 2023 to 17.4% in fiscal 2024. Income from Operations Our operating income was $139.0 million for the year ended December 31, 2024, as compared to $21.6 million for the year ended December 31, 2023.
SG&A expenses as a percentage of net revenues decreased from 22.9% in fiscal 2023 to 17.4% in fiscal 2024. Interest Expense Interest expense for the year ended December 31, 2024 was $13.9 million, as compared to $25.0 million for the year ended December 31, 2023.
ASCENIV’s prescriber and patient base continued to expand during 2024, which drove record utilization and pull-through for this product. These elevated demand trends have sustained into 2025, and ADMA currently expects that this product’s rapid growth will continue throughout 2025 and beyond.
ASCENIV’s prescriber and patient base continued to expand during 2024, which drove record utilization and pull-through for this product. These elevated demand trends continued throughout fiscal year 2025, and we expect the product’s rapid growth to continue through 2026 and beyond.
Net cash used in financing activities for the year ended December 31, 2023 was $39.0 million, as we reduced our outstanding debt principal by $23.6 million with the refinancing of our senior debt on December 18, 2023 and paid approximately $12.7 million to exit the Hayfin Credit Facility.
During the year ended December 31, 2023, we reduced our outstanding debt principal by $23.6 million with the refinancing of our senior debt and paid approximately $12.7 million to exit the Hayfin Credit Facility.
The revenue increase also includes an increase in sales of normal source plasma (“NSP”) and hyperimmune Hepatitis B plasma by our Plasma Collection Centers business segment in the amount of $2.2 million.
The revenue increase also includes an increase in sales of normal source plasma (“NSP”) and hyperimmune Hepatitis B plasma in the amount of $6.5 million.
As of December 31, 2024, we were in compliance with all of the covenants contained in the Ares Credit Agreement.
As of December 31, 2025, we were in compliance with all of its debt covenants in the JPM Credit Agreement.
Cost of Product Revenue and Gross Profit Cost of product revenue was $206.9 million for the year ended December 31, 2024, as compared to $169.3 million for the year ended December 31, 2023.
Cost of Product Revenue and Gross Profit Cost of product revenue was $217.4 million for the year ended December 31, 2025, as compared to $206.9 million for the year ended December 31, 2024, an increase of $10.5 million, or 5%.
Research and Development Expenses R&D expenses totaled $3.3 million for the year ended December 31, 2023, as compared to $3.6 million for the year ended December 31, 2022.
Research and Development Expenses Research and development (“R&D”) expenses totaled $1.8 million for the year ended December 31, 2024, as compared to $3.3 million for the year ended December 31, 2023.
Although we have incurred an accumulated deficit of $308.6 million since inception, we had positive cash flow from operations for the years ended December 31, 2024 and 2023 of $118.7 million and $8.8 million for the years ended December 31, 2024 and 2023, respectively.
Although we have incurred an accumulated deficit of $161.8 million since inception, we had positive cash flow from operations for the years ended December 31, 2025, 2024 and 2023 of $50.4 million, $118.7 million and $8.8 million, respectively. Prior to fiscal 2024, we funded our operations from the sale of our equity securities and debt financings.
The negative covenants restricted or limited our ability and the ability of our subsidiaries to, among other things and subject to certain exceptions contained in the Hayfin Credit Agreement, incur new indebtedness; create liens on assets; engage in certain fundamental corporate changes, such as mergers or acquisitions, or changes to our or our subsidiaries’ business activities; make certain Investments or Restricted Payments (each as defined in the Hayfin Credit Agreement); change our fiscal year; pay dividends; repay other certain indebtedness; engage in certain affiliate transactions; or enter into, amend or terminate any other agreements that have the impact of restricting our ability to make loan repayments under the Hayfin Credit Agreement.
The negative covenants also restrict or limit our ability to, among other things and subject to certain exceptions contained in the JPM Credit Agreement, incur new indebtedness; create liens on assets; engage in certain fundamental corporate changes; make certain investments; dispose of certain assets; engage in sale and leaseback transactions or swap agreements; make certain Restricted Payments (as defined in the JPM Credit Agreement); engage in certain affiliate transactions; enter into any other agreements that have the impact of restricting our ability to make loan repayments under the JPM Credit Agreement; or amend certain material documents.
While we do not have any firm commitments for material capital expenditures in 2025, we expect our total capital expenditures will be between $12.0 million and $18.0 million for fiscal 2025.
While we do not have any firm commitments for material capital expenditures, we estimate that our total 2026 capital expenditures will be between $22.0 million and $27.0 million.
In addition, the stated interest rate on our debt during 2024 was approximately 10.1%, as compared to approximately 13.9% during 2023. We also incurred lower expense related to the amortization of debt discount in 2024 in the amount of $1.6 million.
In addition, the stated interest rate on our debt during 2024 was approximately 10.1%, as compared to approximately 13.9% during 2023.
With our patented testing methods and assay, we are able to identify the high-titer or “hyperimmune” plasma that meets our internal and required specifications for ASCENIV. This type of high-titer plasma is typically found in less than 10% of the total donor collection samples we test.
With our patented testing methods and assay, we are able to identify the high-titer or “hyperimmune” plasma that meets our internal and required specifications for ASCENIV.
The following table illustrates the primary components of our cash flows from operations: Year Ended December 31, (in thousands) 2024 2023 2022 Net income (loss) $ 197,673 $ (28,239 ) $ (65,904 ) Non-cash expenses, gains and losses (60,462 ) 47,162 24,682 Changes in accounts receivable (22,578 ) (11,916 ) 13,072 Changes in inventories 2,671 (9,626 ) (38,556 ) Changes in accounts payable and accrued expenses 5,192 11,369 8,334 Other (3,824 ) 50 (1,136 ) Cash provided by (used in) operations $ 118,672 $ 8,800 $ (59,508 ) Net Cash Used in Investing Activities Cash used in investing activities for the year ended December 31, 2024 was $8.6 million and is mainly comprised of equipment purchases and other capital expenditures at the Boca Facility.
The following table illustrates the primary components of our cash flows from operations: 81 Table of Contents Year Ended December 31, 2025 2024 2023 (in thousands) Net income (loss) $ 146,930 $ 197,673 $ (28,239 ) Non-cash expenses, gains and losses 43,061 (60,462 ) 47,162 Changes in accounts receivable (108,430 ) (22,578 ) (11,916 ) Changes in inventories (36,230 ) 2,671 (9,626 ) Changes in accounts payable and accrued expenses 7,542 5,192 11,369 Other (2,477 ) (3,824 ) 50 Cash provided by operations $ 50,396 $ 118,672 $ 8,800 Net Cash Used in Investing Activities Cash used in investing activities for the year ended December 31, 2025, was $21.9 million as compared to cash used in investing activities for the year ended December 31, 2024 of $8.6 million.
However, in the event that we pay down an aggregate amount under the revolving facility that is greater than 50% of revolving facility commitment of $72.5 million, we will still be required to pay interest on 50% of this amount, or $36.3 million, through the term of Ares Credit Facility.
However, in the event we paid down an aggregate amount under the revolving facility that was greater than 50% of the $72.5 million commitment amount, or $36,250,000, we were still required to pay an amount of interest on the revolving facility that would have been payable had $36,250,000 been outstanding, through the Ares Maturity Date.
In addition, our end-to-end production cycle time from procurement of raw materials to commercial release of finished product can take between seven and 12 months or potentially longer, requiring substantial inventories of raw material plasma and other manufacturing and laboratory testing materials and single use disposables. 78 Table of Contents For the year ended December 31, 2024, we had pre-tax income and GAAP net income of $125.7 million and $197.7 million, respectively.
Our end-to-end production cycle time from procurement of raw materials to commercial release of finished product can take between seven and 12 months or potentially longer, requiring substantial inventories of raw material plasma and other manufacturing and laboratory testing materials and single use disposables.
On December 18, 2023 (the “Ares Closing Date”), we and all of our subsidiaries entered into a senior secured credit facility (the “Ares Credit Agreement”) with Ares Capital Corporation and certain credit funds affiliated with Ares Capital Corporation (collectively, “Ares”).
ADMA continues to evaluate a variety of strategic alternatives, and the exploration of value-creating opportunities remains a top corporate priority. Ares Credit Agreement On December 18, 2023 (the “Ares Closing Date”), we entered into a senior secured credit facility (the “Ares Credit Agreement”) with Ares Capital Corporation and certain credit funds affiliated with Ares Capital Corporation (collectively, “Ares”).
All of our obligations under the Ares Credit Agreement are secured by a first-priority lien and security interest in substantially all of our tangible and intangible assets, including intellectual property and all of the equity interests in our subsidiaries.
All of our obligations under the JPM Credit Agreement 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 equity interests. The JPM Credit Agreement contains certain representations and warranties, affirmative covenants, negative covenants and conditions that are customarily required for similar debt financings.
RESULTS OF OPERATIONS Critical Accounting Policies and Estimates This Management’s Discussion and Analysis of Financial Condition and Results of Operations is based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”).
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 United States and we continue to manufacture Nabi-HB under HHS License No. 2019. 70 Table of Contents RESULTS OF OPERATIONS Critical Accounting Policies and Estimates This Management’s Discussion and Analysis of Financial Condition and Results of Operations is based on our condensed consolidated financial statements, which have been prepared in accordance with Accounting Principles Generally Accepted in the United States of America (“U.S.
Secondary efficacy endpoints further demonstrated the benefits of ASCENIV in the low incidence of infection, therapeutic antibiotic use, days missed from work, school and daycare and unscheduled medical visits and hospitalizations.
Our pivotal Phase III 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 and daycare and unscheduled medical visits and hospitalizations.
Net Cash (Used in) Provided by Financing Activities Net cash used in financing activities for the year ended December 31, 2024 was $58.3 million and was primarily composed of an aggregate of $60.0 million of debt principal payments during the year.
Net Cash Used in Financing Activities Net cash used in financing activities for the year ended December 31, 2025 was $44.0 million, as compared to cash used in financing activities for the year ended December 31, 2024 of $58.3 million.
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 projected annual revenues greater than $490 million in 2025 and $605 million in 2026.
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. Through our ADMA BioCenters subsidiary, we currently operate eight source plasma collection facilities in the U.S., all of which hold FDA licenses.
On August 14, 2024, we repaid $30.0 million against the revolving credit facility and the outstanding balance on the revolving credit facility as of December 31, 2024 was $42.5 million. On December 19, 2024 we repaid $30.0 million against the term loan and the outstanding balance on the term loan as of December 31, 2024 was $32.5 million.
We were required to pay an unused commitment fee of 0.5% per annum for this availability. On December 19, 2024 we repaid $30.0 million against the Ares term loan and the outstanding balance on the Ares term loan as of December 31, 2024 was $32.5 million.
Net proceeds after underwriting discounts and expenses associated with the offering were approximately $64.6 million and were used to accelerate commercialization and production activities, complete plasma center buildouts and obtain FDA approvals, to conclude post‑FDA marketing approval research and development projects, and for working capital, capital expenditures and general corporate purposes. 81 Table of Contents Cash Flows The following table sets forth a summary of our cash flows for the periods indicated: Year Ended December 31, (in thousands) 2024 2023 2022 Net cash provided by (used in) operating activities $ 118,672 $ 8,800 $ (59,508 ) Net cash used in investing activities (8,575 ) (4,981 ) (13,911 ) Net cash (used in) provided by financing activities (58,302 ) (38,989 ) 108,852 Net change in cash and cash equivalents 51,795 (35,170 ) 35,433 Cash and cash equivalents - beginning of year 51,352 86,522 51,089 Cash and cash equivalents - end of year $ 103,147 $ 51,352 $ 86,522 Net Cash Provided by (Used in) Operating Activities Cash provided by operations for the year ended December 31, 2024 was $118.7 million, as compared to $8.8 million for the year ended December 31, 2023.
Cash Flows The following table sets forth a summary of our cash flows for the periods indicated: Year Ended December 31, 2025 2024 2023 (in thousands) Net cash provided by operating activities $ 50,396 $ 118,672 $ 8,800 Net cash used in investing activities (21,891 ) (8,575 ) (4,981 ) Net cash used in financing activities (44,022 ) (58,302 ) (38,989 ) Net change in cash and cash equivalents (15,517 ) 51,795 (35,170 ) Cash and cash equivalents - beginning of year 103,147 51,352 86,522 Cash and cash equivalents - end of year $ 87,630 $ 103,147 $ 51,352 Net Cash Provided by Operating Activities Cash provided by operations for the year ended December 31, 2025 was $50.4 million, as compared to $118.7 million for the year ended December 31, 2024.
The following table presents the reconciliation of net loss to EBITDA and Adjusted EBITDA for the years ended December 31, 2024, 2023 and 2022: Year Ended December 31, 2024 2023 2022 (In thousands) Net income (loss) $ 197,673 $ (28,239 ) $ (65,904 ) Depreciation 7,657 7,608 6,398 Amortization 388 724 715 Income tax benefit (71,959 ) - - Interest expense 13,930 25,027 19,279 EBITDA 147,689 5,120 (39,512 ) Stock-based compensation 13,616 6,187 5,215 Loss on extinguishment of debt 1,243 26,174 6,670 Yield enhancement 2,064 - - IT systems disruption - 2,770 - Adjusted EBITDA $ 164,612 $ 40,251 $ (27,627 ) 77 Table of Contents Adjusted EBITDA improved by $122.3 million for the year ended December 31, 2024 as compared to the year ended December 31, 2023, mainly due to the substantial increase in operating income in 2024 of $117.4 million.
The following table presents the reconciliation of net income/(loss) to EBITDA and Adjusted EBITDA for the years ended December 31, 2025, 2024 and 2023: 77 Table of Contents Year Ended December 31, 2025 2024 2023 (In thousands) Net income (loss) $ 146,930 $ 197,673 $ (28,239 ) Depreciation 7,952 7,657 7,608 Amortization 144 388 724 Income tax expense (benefit) 35,726 (71,959 ) - Interest expense 7,110 13,930 25,027 EBITDA 197,862 147,689 5,120 Stock-based compensation expense 20,026 13,616 6,187 Voluntary Withdrawal and product replacements 6,215 - - Loss on extinguishment of debt 3,336 1,243 26,174 Yield enhancement expense 1,810 2,064 - Non-recurring professional fees (a) 1,781 - 2,770 Adjusted EBITDA $ 231,030 $ 164,612 $ 40,251 (a) Non-recurring professional fees represent incremental costs associated with a vendor change that we do not expect to incur in future periods and other one-time professional fees.
As a result of this transaction, we recorded a loss on the extinguishment of the Hayfin Credit Facility in the amount of $26.2 million in the year ended December 31, 2023, which is mainly comprised of the write-off of unamortized debt discount and the prepayment penalty.
As a result of the debt prepayment we made in 2024, we incurred a prepayment penalty in the amount of $0.5 million and recorded a partial write-down of unamortized debt discount of approximately $0.8 million, for a total loss on this partial extinguishment of debt in the amount of $1.2 million recognized during the year ended December 31, 2024.
As of December 31, 2024, the interest rate on the term loan was approximately 10.9% and the interest rate on the revolving facility was approximately 8.3%, representing a weighted-average interest rate of approximately 9.4%. 79 Table of Contents On the Ares Maturity Date, we are required to pay Ares the entire outstanding principal amount underlying the Ares Loans and any accrued and unpaid interest thereon.
We were required to pay Ares the entire outstanding principal amount underlying the Ares term loan and revolving loan (together, the “Ares Loans”) and any accrued and unpaid interest thereon as of the Ares Maturity Date. Prior to the Ares Maturity Date, there were no scheduled principal payments on the Ares Loans.
On the Ares Closing Date, the interest rate on the term loan was approximately 11.9% and the interest rate on the revolving facility was approximately 9.1%, representing a weighted-average interest rate of approximately 10.4%.
As of December 31, 2024, the interest rate on the Ares term loan was approximately 10.85%, and the interest rate on the Ares revolving facility was approximately 8.34%.
Our improved operating results are primarily the result of the substantial revenue growth and continued physician, patient and payer acceptance of ASCENIV.
Our improved operating results were primarily the result of the substantial revenue growth and continued physician, patient and payer acceptance of ASCENIV. In April 2025, the FDA approved our Prior Approval Supplement (the “PAS”) for our innovative yield enhancement production process (the “Yield Enhancement”) benefiting both ASCENIV and BIVIGAM.
We expect to see further shifts in our revenue mix toward higher margin IVIG products in fiscal 2025. Research and Development Expenses Research and development (“R&D”) expenses totaled $1.8 million for the year ended December 31, 2024, as compared to $3.3 million for the year ended December 31, 2023.
Research and Development Expenses Research and development (“R&D”) expenses totaled $4.8 million for the year ended December 31, 2025, as compared to $1.8 million for the year ended December 31, 2024. The increase is driven by the investments made in connection with SG-001.
Interest Expense Interest expense for the year ended December 31, 2023 was $25.0 million, as compared to $19.3 million for the year ended December 31, 2022.
Amortization of Intangibles Amortization expense decreased to $0.1 million for the year ended December 31, 2025, as compared to $0.4 million for the year ended December 31, 2024.
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.
This type of high-titer plasma is typically found in less than 10% of the total donor collection samples we test. 69 Table of Contents 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).
Net cash used in investing activities for the year ended December 31, 2022 was $13.9 million, which consisted of $8.7 million for the construction and buildout of several new plasma collection facilities and $5.2 million for equipment purchases and upgrades to the Boca Facility.
Cash used in investing activities for the year ended December 31, 2024 was $8.6 million and is mainly comprised of equipment purchases and other capital expenditures at the Boca Facility.
We have successfully completed production of a pilot-scale batch and are conducting animal studies for our S. pneumoniae hyperimmune globulin program, SG-001. 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.
In September 2025, a Commissioner’s National Priority Voucher (CNPV) application was submitted and, if accepted, could accelerate FDA review by two fiscal quarters or more. 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.
Selling, General and Administrative Expenses Selling, general and administrative (“SG&A”) expenses were $59.0 million for the year ended December 31, 2023, an increase of $6.6 million from the year ended December 31, 2022.
Selling, General and Administrative Expenses Selling, general and administrative (“SG&A”) expenses were $91.6 million for the year ended December 31, 2025, an increase of $17.5 million from the year ended December 31, 2024, or approximately 24%. The increase is primarily driven by higher compensation costs due to increased headcount to support the growth of our business and manufacturing operations.
Cost of Product Revenue and Gross Profit Cost of product revenue was $169.3 million for the year ended December 31, 2023, as compared to $118.8 million for the year ended December 31, 2022. This increase is primarily attributable to volume-driven increases in product revenue costs related to the increased sales of our immunoglobulin products of $54.9 million.
The revenue increase also includes an increase in sales of normal source plasma (“NSP”) and hyperimmune Hepatitis B plasma by our Plasma Collection Centers business segment in the amount of $2.2 million. 75 Table of Contents Cost of Product Revenue and Gross Profit Cost of product revenue was $206.9 million for the year ended December 31, 2024, as compared to $169.3 million for the year ended December 31, 2023.
Net Income/Loss Our net income was $197.7 million for the year ended December 31, 2024, as compared to a net loss of $28.2 million for the year ended December 31, 2023, an improvement of $225.9 million.
Other Income, Net Other income, net, for the year ended December 31, 2025 was $1.7 million, as compared to $1.9 million for the year ended December 31, 2024, driven by the decrease in 2025 of the prevailing short-term interest rates which resulted in lower interest income.
The increase is primarily related to increased sales of our immunoglobulin products, mainly ASCENIV and BIVIGAM, generated by our Boca Facility manufacturing operations in 2023 of $105.8 million, as we continue to experience increased physician, payer and patient acceptance and utilization of ASCENIV and expand our customer base for BIVIGAM, partially offset by a decrease in sales of plasma in our Plasma Collection Centers business segment of $1.5 million.
Medicaid rebate adjustment recorded in 2024 is also included under intermediates and other products. 72 Table of Contents The increase in total revenue is primarily related to increased sales of ASCENIV, as we continue to experience increased physician, payer and patient acceptance and utilization of this product, partially offset by the decrease in sales of BIVIGAM, intermediates and other.
The increase is mainly due to substantially higher net income. The improvement in cash flow from operations in 2023 as compared to the year ended December 31, 2022 was mainly due to the improvement in our operating results, driven by higher revenues and gross margins, and a lower increase in inventories.
The decrease is primarily due to the unfavorable impact of the timing of sales and due to inventory investments made in 2025 to support our manufacturing and distribution objectives. The improvement in cash flow from operations during the year ended December 2024, compared to that for the year ended December 31, 2023, is primarily due to substantially higher net income.
The following table presents the reconciliation of Net income (loss) to Adjusted net income (loss) for the years ended December 31, 2024, 2023 and 2022: Years Ended December 31, (in thousands) 2024 2023 2022 Net income (loss) $ 197,673 $ (28,239 ) $ (65,904 ) Loss on extinguishment of debt 1,243 26,174 6,670 Deferred tax benefit (84,280 ) - - Yield enhancement 2,064 - - Stock-based compenstion modifications 2,518 - - IT systems disruption - 2,770 - Adjusted net income (loss) $ 119,218 $ 705 $ (59,234 ) LIQUIDITY AND CAPITAL RESOURCES At December 31, 2024, we had working capital of $275.9 million, primarily consisting of $170.2 million of inventory, cash and cash equivalents of $103.1 million and $50.0 million of accounts receivable, partially offset by current liabilities of $55.5 million, as compared to working capital at December 31, 2023 of $207.2 million, primarily consisting of $172.9 million of inventory, cash and cash equivalents of $51.4 million and accounts receivable of $27.4 million, partially offset by current liabilities of $49.8 million.
LIQUIDITY AND CAPITAL RESOURCES At December 31, 2025, we had working capital of $397.0 million primarily consisting of $206.5 million of inventory, cash and cash equivalents of $87.6 million and $158.4 million of accounts receivable, partially offset by current liabilities of $69.5 million, as compared to working capital at December 31, 2024 of $275.9 million, primarily consisting of $170.2 million of inventory, cash and cash equivalents of $103.1 million and $50.0 million of accounts receivable, partially offset by current liabilities of $55.5 million.
Income/Loss from Operations For the year ended December 31, 2023, we had operating income of $21.6 million, as compared to an operating loss of $39.4 million for the year ended December 31, 2022.
Adjusted EBITDA improved by $66.4 million for the year ended December 31, 2025, as compared to the year ended December 31, 2024, mainly due to the increase of $52.5 million in our 2025 income from operations, as compared to that in 2024.
GAAP require very difficult, subjective and/or complex judgments about matters that are inherently uncertain and, as a result, we have identified those as critical accounting estimates, which are considered critical to an understanding of our historical financial condition and results of operations and are reasonably likely to have a material impact on our future results of operations and financial condition.
Significant estimates include estimates related to the Company’s effective tax rate. Some of the estimates and assumptions we are required to make under U.S. GAAP require difficult, subjective and/or complex judgments about matters that are inherently uncertain and, as a result, actual results could differ from those estimates.
Medicaid rebates which increased our revenues for the year ended December 31, 2024 by $12.6 million. 73 Table of Contents Interest Expense Interest expense for the year ended December 31, 2024 was $13.9 million, as compared to $25.0 million for the year ended December 31, 2023.
Medicaid rebates (which had the effect of increasing net revenues by $12.6 million during the year ended December 31, 2024), total revenue increased by approximately $96.3 million, or 23%.
Net cash provided by financing activities for the year ended December 31, 2022 was $108.9 million, as we received approximately $47.0 in net proceeds from the refinancing of our senior credit facility in March of 2022 and $64.6 million in net proceeds from the December 9, 2022 public offering of our common stock. 82 Table of Contents Effect of Inflation Inflation impacted a number of facets of our business during the years ended December 31, 2024, 2023 and 2022 at each of our business segments.
Effect of Inflation Inflation impacted a number of facets of our business during the years ended December 31, 2025, 2024 and 2023 at each of our business segments.
Removed
These revenue targets translate to potential fiscal year 2025 and 2026 Adjusted Net Income exceeding $175 million and $235 million, respectively, and Adjusted EBITDA exceeding $225 million and $305 million, respectively. The foregoing financial targets do not account for the potential FDA approval of our innovative yield enhancement production process described below.
Added
We have successfully completed production of a pilot-scale batch and are conducting animal studies for our S. pneumoniae hyperimmune globulin program, SG-001. We anticipate submitting a pre-Investigational New Drug (“IND”) package to the FDA in fiscal year 2026, which could enable us to progress development of SG-001 directly into a registrational clinical trial.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

3 edited+1 added−0 removed0 unchanged
Biggest changeAs a result, the effect of a hypothetical, instantaneous and unfavorable change of 100 basis points in the interest rate would have an approximate $0.8 million annualized negative impact on our earnings and cash flows.
Biggest changeAs a result, the effect of a hypothetical, instantaneous and unfavorable change of 100 basis points in the interest rate would have an approximate $0.7 million annualized negative impact on our earnings and cash flows. Effects of Inflation Inflation generally affects us by increasing our research and development, labor, clinical trials and/or manufacturing costs.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk We are exposed to market risk as the result of changes in interest rates. Our senior credit facility with Ares requires quarterly payments of interest based on the adjusted Term SOFR plus the Applicable Margin.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk Interest Rate Risk We are exposed to market risk as the result of changes in interest rates. The JPM Credit Agreement requires monthly payments of interest based on the adjusted Term SOFR plus the applicable margin.
We currently do not utilize any derivative financial instruments, such as interest rate swaps or caps, to mitigate this risk. As of December 31, 2024, we had $75.0 million outstanding under our senior credit facility that is subject to a variable interest rate.
We currently do not utilize any derivative financial instruments, such as interest rate swaps or caps, to mitigate this risk. As of December 31, 2025, we had $72.1 million outstanding under our JPM Credit Agreement that was subject to a variable interest rate.
Added
We do not believe that inflation had a material effect on our business, financial condition or results of operations as of December 31, 2025.

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