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What changed in ADMA BIOLOGICS, INC.'s 10-K — 2023 vs 2024

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Paragraph-level year-over-year comparison of ADMA BIOLOGICS, INC.'s 2023 and 2024 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 2024 report.

+507 added−488 removedSource: 10-K (2025-03-18) vs 10-K (2024-02-28)

Top changes in ADMA BIOLOGICS, INC.'s 2024 10-K

507 paragraphs added · 488 removed · 364 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

133 edited+55 added−24 removed269 unchanged
Biggest changeIn addition, the FDA may require testing, including Phase IV post-approval clinical trials, and surveillance programs to monitor the effect of approved products that have been commercialized, and the FDA has the power to prevent or limit further marketing of a product based on the results of these post-marketing programs.
Biggest changeIn addition, the FDA may require testing, including Phase IV post-approval clinical trials, and surveillance programs to monitor the effect of approved products that have been commercialized, and the FDA has the power to prevent or limit further marketing of a product based on the results of these post-marketing programs. 19 Table of Contents Even if the FDA approves a product, it may limit the approved indications or populations for use of the product, require that contraindications, warnings, or precautions be included in the product labeling, including a boxed warning, require testing and surveillance programs to monitor the product after commercialization, or impose other conditions, including distribution restrictions or other risk management mechanisms under a REMS.
Food and Drug Administration (the “FDA”) approval, all of which are currently marketed and commercially available: (i) BIVIGAM (Immune Globulin Intravenous, Human), an Intravenous Immune Globulin (“IVIG”) product indicated for the treatment of Primary Humoral Immunodeficiency (“PI”), also known as Primary Immunodeficiency Disease (“PIDD”) or Inborn Errors of Immunity, and for which we received FDA approval on May 9, 2019 and commenced commercial sales in August 2019; (ii) ASCENIV (Immune Globulin Intravenous, Human – slra 10% Liquid), an IVIG product indicated for the treatment of PI in adults and adolescents, for which we received FDA approval on April 1, 2019 and commenced first commercial sales in October 2019; and (iii) Nabi-HB (Hepatitis B Immune Globulin, Human), which is indicated for the treatment of acute exposure to blood containing HBsAg and other listed exposures to Hepatitis B.
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.
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.
Data from clinical trials are not always conclusive and the FDA may interpret data differently than we do. If the FDA’s evaluations of the BLA and the clinical and manufacturing procedures and facilities are favorable, the FDA may issue an approval letter.
Data from clinical trials are not always conclusive and the FDA may interpret data differently than we do. If the FDA’s evaluations of the BLA, the clinical and manufacturing procedures and facilities are favorable, the FDA may issue an approval letter.
The additional discount applies if non-FAMP increases more than inflation (measured by reference to the Consumer Price Index – Urban (“CPIU”)). In addition, in the second and subsequent year, the price also is capped at prior year FSS contract plus CPIU.
The additional discount applies if non-FAMP increases more than inflation (measured by reference to the Consumer Price Index – Urban (“CPIU”)). In addition, in the second and subsequent year, the price also is capped at the prior year FSS contract plus CPIU.
During 2015, we amended the 2011 Plasma Purchase Agreement to (i) allow us to collect our raw material RSV high-titer plasma from any number of wholly-owned ADMA plasma collection facilities and (ii) allow us to purchase our raw material RSV high-titer plasma from other third-party collection organizations, in each case, provided that the annual minimum volumes from our former contract manufacturer were met, thus allowing us to expand our reach for raw material supply as we execute our commercialization plans for ASCENIV.
During 2015, we amended the 2011 Plasma Purchase Agreement to (i) allow us to collect our raw material high-titer plasma from any number of wholly-owned ADMA plasma collection facilities and (ii) allow us to purchase our raw material high-titer plasma from other third-party collection organizations, in each case, provided that the annual minimum volumes from our former contract manufacturer were met, thus allowing us to expand our reach for raw material supply as we execute our commercialization plans for ASCENIV.
Both patients were undergoing delayed intensification chemotherapy and each were diagnosed with RSV Lower Respiratory Tract Infection (“LRTI”). Both children were treated with ASCENIV under an emergency FDA Investigational New Drug protocol. 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 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.
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 our average sales price, or (3) fails to submit the required data on a timely basis.
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.
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.
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.
One such 2021 approved FDA therapy is an anti-FcRn inhibitor (neonatal Fc receptor, IgG receptor) which is a protein in humans responsible for maintaining IgG levels. This FDA approved anti-FcRn is for the treatment of generalized Myasthenia Gravis that may impact a subset of overall general IVIG usage.
One such therapy approved by the FDA in 2021 is an anti-FcRn inhibitor (neonatal Fc receptor, IgG receptor) which is a protein in humans responsible for maintaining IgG levels. This FDA approved anti-FcRn is for the treatment of generalized Myasthenia Gravis that may impact a subset of overall general IVIG usage.
ADMA BioCenters has a total of ten source plasma collection facilities in its network, all of which are FDA-licensed, and should allow the Company to be essentially self-sufficient for its raw material source plasma supply to produce its commercial IG product portfolio.
ADMA BioCenters has a total of ten source plasma collection facilities in its network, all of which are FDA-licensed, and should allow the Company to be essentially self-sufficient for its raw material normal source plasma supply to produce its commercial IG product portfolio.
We must purchase a to-be-determined and agreed upon annual minimum volume from the counterparty, and under the original 2011 Plasma Purchase Agreement we were permitted to also collect high-titer RSV plasma from up to five wholly-owned ADMA plasma collection facilities.
We must purchase a to-be-determined and agreed upon annual minimum volume from the counterparty, and under the original 2011 Plasma Purchase Agreement we were permitted to also collect high-titer plasma from up to five wholly-owned ADMA plasma collection facilities.
Although we rely, in part, on confidentiality, nondisclosure and non-competition agreements with employees, consultants and other parties with access to our proprietary information to protect our trade secrets, proprietary technology, processes and other proprietary rights, there can be no assurance that these agreements or any other security measures related to such trade secrets, proprietary technology, processes and proprietary rights will be adequate, will not be breached, that we will have adequate remedies for any breach, that others will not independently develop substantially equivalent proprietary information or that third parties will not otherwise gain access to our trade secrets or proprietary knowledge.
Although we rely, in part, on confidentiality, nondisclosure, non-competition and invention assignment agreements with employees, consultants and other parties with access to our proprietary information to protect our trade secrets, proprietary technology, processes and other proprietary rights, there can be no assurance that these agreements or any other security measures related to such trade secrets, proprietary technology, processes and proprietary rights will be adequate, will not be breached, that we will have adequate remedies for any breach, that others will not independently develop substantially equivalent proprietary information or that third parties will not otherwise gain access to our trade secrets or proprietary knowledge.
Under the HCPCS, the J-code (J1554) became effective April 1, 2021. 22 Table of Contents Significant uncertainties exist as to the coverage and reimbursement status of our current products as well as any products for which we may obtain regulatory approval.
Under the HCPCS, the J-code (J1554) became effective April 1, 2021. 23 Table of Contents Significant uncertainties exist as to the coverage and reimbursement status of our current products as well as any products for which we may obtain regulatory approval.
As is customary in the plasma products industry, we may also use a network of national distribution organizations that have specialty divisions that focus on plasma products to fulfill orders for ASCENIV. Efforts to generate increased market awareness for Nabi-HB include attending and presenting scientific information at medical conferences, as well as sponsoring medical education symposiums.
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.
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.
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.
Such post-approval studies are typically referred to as Phase IV studies, which are used to gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term safety follow-up. 17 Table of Contents During all phases of clinical development, regulatory agencies require extensive monitoring and auditing of all clinical activities, clinical data and clinical trial investigators.
Such post-approval studies are typically referred to as Phase IV studies, which are used to gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term safety follow-up. During all phases of clinical development, regulatory agencies require extensive monitoring and auditing of all clinical activities, clinical data and clinical trial investigators.
For biologics products subject to lot release, for each product lot the applicant must submit materials related to that lot to the FDA prior to that lot being released for distribution. Changes to the manufacturing process are strictly regulated and often require prior FDA approval before being implemented.
For biologics products subject to lot release, for each product lot the applicant must submit materials related to that lot to the FDA prior to that lot being released for distribution. Changes to the manufacturing process are strictly regulated and often require prior FDA approval before implementation.
We believe this clinical data together with the FDA approval for the treatment of patients diagnosed with PIDD better positions ADMA to potentially further evaluate ASCENIV in immune-compromised patients infected with or at-risk for RSV infection or potentially other respiratory viral pathogens at an appropriate time. Due to the COVID-19 pandemic, our plans have been delayed.
We believe this clinical data together with the FDA approval for the treatment of patients diagnosed with PIDD better positions ADMA to potentially further evaluate ASCENIV in immune-compromised patients infected with or at-risk for RSV infection or potentially other respiratory viral pathogens at an appropriate time. Due to the COVID-19 pandemic, our plans were delayed.
The 340B program, which is administered by the Health Resources and Services Administration (“HRSA”), requires participating manufacturers to agree to charge statutorily defined covered entities no more than the 340B“ceiling price” for the manufacturer’s covered outpatient drugs.
The 340B program, which is administered by the Health Resources and Services Administration (“HRSA”), requires participating manufacturers to agree to charge statutorily defined covered entities no more than the 340B “ceiling price” for the manufacturer’s covered outpatient drugs.
Such laws also typically impose significant civil monetary penalties for each instance of reporting noncompliance that can quickly aggregate into millions of dollars. 25 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.
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.
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.
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.
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.
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.
For these reasons, since 2004, False Claims Act lawsuits against pharmaceutical companies have increased significantly in volume and breadth, leading to several substantial civil and criminal settlements, as much as $3.0 billion, regarding certain sales practices and promoting off label uses. 28 Table of Contents The government may further prosecute conduct constituting a false claim under the criminal False Claims Act.
For these reasons, since 2004, False Claims Act lawsuits against pharmaceutical companies have increased significantly in volume and breadth, leading to several substantial civil and criminal settlements, as much as $3.0 billion, regarding certain sales practices and promoting off label uses. The government may further prosecute conduct constituting a false claim under the criminal False Claims Act.
For example, the Patient Protection and Affordable Care Act (“ACA”) and the companion Healthcare and Education Reconciliation Act (which together are referred to as the “Healthcare Reform Law”) contains provisions that may reduce the profitability of drug products, including, for example, increased rebates for drugs reimbursed by Medicaid programs, extension of Medicaid rebates to Medicaid managed care plans, mandatory discounts for certain Medicare Part D beneficiaries and annual fees based on pharmaceutical companies’ share of sales to federal healthcare programs.
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.
Although there are a number of statutory exemptions and regulatory safe harbors protecting certain common manufacturer business arrangements and activities from prosecution and administrative sanction, the exceptions and safe harbors are drawn narrowly and are subject to regulatory revision or changes in interpretation by the U.S. Department of Justice (“DOJ”), and the Office of Inspector General of the U.S.
Although there are a number of statutory exemptions and regulatory safe harbors protecting certain common manufacturer business arrangements and activities from prosecution and administrative sanction, the exceptions and safe harbors are drawn narrowly and are subject to regulatory revision or changes in interpretation by the DOJ, and the Office of Inspector General of the U.S.
Further, an independent Institutional Review Board (“IRB”) duly constituted to meet FDA requirements for each medical center proposing to conduct the clinical trial must review and approve the plan for any clinical trial before it commences at that center and it must monitor the safety of the study and study subjects until completed.
Further, an independent IRB duly constituted to meet FDA requirements for each medical center proposing to conduct the clinical trial must review and approve the plan for any clinical trial before it commences at that center and it must monitor the safety of the study and study subjects until completed.
For calendar quarters beginning January 1, 2022, manufacturers will be required to report the average sales price for certain drugs under the Medicare program regardless of whether the manufacturer participates in the Medicaid Drug Rebate Program. Previously, this reporting obligation extended only to manufacturers participating in the Medicaid Drug Rebate Program.
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.
We seek to develop a pipeline of plasma-derived therapeutics, including a product based on our most recently approved patent application under U.S. Patent No. 10,259,865 related to methods of treatment and prevention of S. pneumonia infection for an immunoglobulin manufactured to contain standardized antibodies to numerous serotypes of S. pneumoniae .
We seek to develop a pipeline of plasma-derived therapeutics, including a product based on our most recently approved patent application under U.S. Patent Nos. 10,259,865 and 11,084,870 related to methods of treatment and prevention of S. pneumonia infection for an immunoglobulin manufactured to contain standardized antibodies to numerous serotypes of S. pneumoniae .
As reported by The Plasma Proteins Market In The United States 2022 and Marketing Research Bureau Inc., October 2022 , the U.S. market for IG in 2022 was $10.5 billion and is expected to exceed $20 billion by 2030. 9 Table of Contents As most patients with PIDD present with infections, the differential diagnosis and initial investigations for an underlying immune defect are typically guided by the clinical presentation.
As reported by The Plasma Proteins Market In The United States 2023 and Marketing Research Bureau Inc., October 2023 , the U.S. market for IG in 2023 was approximately $12 billion and is expected to exceed $20 billion by 2030. 9 Table of Contents As most patients with PIDD present with infections, the differential diagnosis and initial investigations for an underlying immune defect are typically guided by the clinical presentation.
The amount of the rebate is adjusted upward if the average manufacturer price increases more than inflation (measured by reference to the Consumer Price Index–- Urban). Currently, the rebate is capped at 100% of the average manufacturer price, but, effective January 1, 2024, this cap on the rebate will be removed, and our rebate liability could increase accordingly.
The amount of the rebate is adjusted upward if the average manufacturer price increases more than inflation (measured by reference to the Consumer Price Index–- Urban). Previously, the rebate was capped at 100% of the average manufacturer price, but, effective January 1, 2024, this cap on the rebate was removed, and our rebate liability could increase accordingly.
The process required by the FDA before our product candidates may be marketed in the U.S. generally involves the following (although the FDA is given wide discretion to impose different or more stringent requirements on a case-by-case basis): 15 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 Investigational New Drug (“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.
The process required by the FDA before our product candidates may be marketed in the U.S. generally involves the following (although the FDA is given wide discretion to impose different or more stringent requirements on a case-by-case basis): • completion of extensive preclinical laboratory tests, preclinical, nonclinical and formulation studies performed in accordance with the FDA’s Good Laboratory Practice (“GLP”) regulations and other applicable laws and regulations; • submission to the FDA of an 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.
ADMAlytics combines AI and machine learning to improve and predict outcomes for production and operational processes. Recently, we successfully produced our first batch of ASCENIV utilizing this innovative ADMAlytics software to prospectively automate and realize efficiency improvements to plasma pooling during commercial manufacturing.
ADMAlytics combines AI and machine learning to improve and predict outcomes for production and operational processes. In early 2024, we successfully produced our first batch of ASCENIV utilizing our innovative ADMAlytics software to prospectively automate and realize efficiency improvements to plasma pooling during commercial manufacturing.
Since 2020, we have successfully implemented several manufacturing and supply chain enhancements, including the purchase and installation of a new aseptic filling machine and the manufacturing of four conformance batches of BIVIGAM at an increased scale.
Since 2020, we have successfully implemented several manufacturing and supply chain enhancements, including the purchase and installation of a new aseptic filling machine and the manufacturing of ASCENIV and BIVIGAM at an increased scale.
Third-party payers include government health programs, managed care providers, private health insurers and other organizations. BIVIGAM and Nabi-HB are reimbursed or purchased under several government programs, including Medicaid, Medicare Parts B and D, the 340B/Public Health Service program, and pursuant to an existing contract with the Department of Veterans Affairs.
Third-party payers include government health programs, managed care providers, private health insurers and other organizations. Our products are reimbursed or purchased under several government programs, including Medicaid, Medicare Parts B and D, the 340B Drug Pricing Program/Public Health Service program, and pursuant to an existing contract with the Department of Veterans Affairs.
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.
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.
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, fined, the government may refuse to approve our marketing applications, supplemental applications or allow us to manufacture or market our products, we may be criminally prosecuted and we may be debarred or excluded from participation in government healthcare programs.
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.
Plasma donation centers in the U.S. typically pay donors $50 to $100 per donation and some donors with rare or high antibody levels can be paid more. In order to isolate the desired therapeutic elements in normal source plasma, it must initially go through the fractionation process. The process of fractionation was invented in the 1940’s by E.J.
Plasma donation centers in the U.S. typically pay donors $50 to $100 per donation and some donors with rare or high antibody levels can be paid more. 10 Table of Contents In order to isolate the desired therapeutic elements in normal source plasma, it must initially go through the fractionation process.
We also seek to enhance and ensure our competitive position through a variety of means, including our unique and proprietary plasma donor selection criteria, our proprietary formulation methodology for plasma pooling and the proprietary reagents, controls, testing standards, standard operating procedures and methods we use in our anti-RSV microneutralization assay.
We seek to enhance and ensure our competitive position through a variety of means, including our unique and proprietary plasma donor selection criteria, our proprietary formulation methodologies and proprietary reagents, controls, testing standards, standard operating procedures and methods used in our anti-RSV microneutralization assay.
Cohn and is referred to as the Cohn method or cold ethanol fractionation. First, the source plasma undergoes a process called pooling, in which the individual plasma donations are combined into a pooling tank.
The process of fractionation was invented in the 1940’s by E.J. Cohn and is referred to as the Cohn method or cold ethanol fractionation. First, the source plasma undergoes a process called pooling, in which the individual plasma donations are combined into a pooling tank.
These competitors may include but are not limited to: CSL Behring, Grifols, Takeda, Octapharma and Permira. There are four producers of plasma-derived products in the U.S. consisting of: CSL Behring, Grifols, Takeda and ADMA Biologics. In addition to competition from other large worldwide plasma product providers, we face competition in local areas from smaller entities.
There are four producers of plasma-derived products in the U.S. consisting of: CSL Behring, Grifols, Takeda and ADMA Biologics. In addition to competition from other large worldwide plasma product providers, we face competition in local areas from smaller entities.
In 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.
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.
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.
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 also anticipate staffing our Company with additional personnel for patient support, medical affairs, quality assurance, quality control, inventory management, regulatory affairs, manufacturing, scientific affairs and third-party reimbursement. We currently use and may continue to partner with a network of national distributors to fulfill orders for ASCENIV and BIVIGAM. • Increase marketing efforts around Nabi-HB.
We also anticipate staffing our Company with additional personnel for patient support, medical affairs, quality assurance, quality control, inventory management, regulatory affairs, manufacturing, scientific affairs and third-party reimbursement. We currently use and may continue to partner with a network of national distributors to fulfill orders for ASCENIV and BIVIGAM. • Expand ASCENIV’s FDA-approved uses .
Manufacturers and certain other entities involved in the manufacturing and distribution of approved products are required to register their establishments with the FDA and certain state agencies, list the manufactured products to the FDA, and are subject to periodic unannounced inspections or remote regulatory assessments by the FDA and certain state agencies for compliance with cGMP and other laws.
Certain manufacturing deviations and unexpected manufacturing events must be investigated, corrected, and reported to the FDA. 20 Table of Contents Manufacturers and certain other entities involved in the manufacturing and distribution of approved products are required to register their establishments with the FDA and certain state agencies, list the manufactured products to the FDA, and are subject to periodic unannounced inspections or remote regulatory assessments by the FDA and certain state agencies for compliance with cGMP and other laws.
Based on current production yields, our completed and ongoing supply chain enhancements and capacity expansion initiatives, we believe this facility has the potential to produce sufficient quantities of our immune globulin (“IG”) products representing annual revenues of approximately $330 million in 2024 and potentially $380 million in 2025.
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.
Fifty-nine patients were enrolled in nine treatment centers in the U.S. The pivotal Phase III primary endpoint followed published FDA industry guidance, which provides for a reduction in the incidence of SBI to less than one per year in each subject receiving IVIG.
The pivotal Phase III primary endpoint followed published FDA industry guidance, which provides for a reduction in the incidence of SBI to less than one per year in each subject receiving IVIG.
As reported by The Plasma Proteins Market In The United States , the U.S. sales of immune and hyperimmune globulin products for all its uses were reported to be approximately $10.5 billion in 2022 and are expected to exceed $20 billion by 2030.
As reported by The Plasma Proteins Market In The United States 2023 and Marketing Research Bureau Inc., October 2023 , the U.S. sales of immune and hyperimmune globulin products for all its uses were reported to be approximately $12 billion in 2023 and are expected to exceed $20 billion in 2030.
Congress also could enact a drug price negotiation program under which the prices for certain high Medicare spend single source drugs would be capped by reference to the non-FAMP price. This or any other legislative change could impact the market conditions for our products. We further expect continued scrutiny on government price reporting from Congress, federal agencies, and other bodies.
Congress also could enact a drug price negotiation program under which the prices for certain high Medicare spend single source drugs would be capped by reference to the non-FAMP price. This or any other legislative change could impact the market conditions for our products.
In addition, more patients in the high dose (85.7%) and low dose (42.9%) groups experienced greater than a four-fold increase from baseline to day 18 in RSV titer levels compared to placebo (0%). There were no serious drug-related adverse events reported during the trial.
In addition, more patients in the high dose (85.7%) and low dose (42.9%) groups experienced greater than a four-fold increase from baseline to day 18 in RSV titer levels compared to placebo (0%).
Group health plans, health insurance issuers, health maintenance organizations, other healthcare payors, and pharmacy benefit managers in the United States are adopting more aggressive utilization management techniques and are increasingly requiring significant discounts and rebates from manufacturers as a condition to including products on formulary with favorable coverage and cost-sharing.
We expect further continued scrutiny on government price reporting from Congress, federal agencies, and other bodies. 26 Table of Contents Group health plans, health insurance issuers, health maintenance organizations, other healthcare payors, and pharmacy benefit managers in the United States are adopting more aggressive utilization management techniques and are increasingly requiring significant discounts and rebates from manufacturers as a condition to including products on formulary with favorable coverage and cost-sharing.
During 2024, we plan to advance our biologic production yield enhancement initiative to capture additional IG production yields from our manufacturing process with the same quantities of starting raw material. These initiatives are subject to further evaluation, validation of commercial-scale production and requisite regulatory review.
During 2025, we plan to advance our biologic production yield enhancement initiative to capture additional IG production yields from our manufacturing process with the same quantities of starting raw material. These initiatives are subject to further evaluation and requisite regulatory review. In December 2024, we successfully submitted a PAS for potential approval of our innovative yield enhancement production process.
Accordingly, manufacturers must continue to expend time, money, and effort towards production and quality control to maintain cGMP compliance. 20 Table of Contents The commercial distribution of prescription drugs (including biological drug products) is subject to the DSCSA, which regulates the distribution of the products at the federal level and sets certain standards for federal or state registration and compliance of entities in the supply chain (manufacturers and repackagers, wholesale distributors, third-party logistics providers, and dispensers).
The commercial distribution of prescription drugs (including biological drug products) is subject to the DSCSA, which regulates the distribution of the products at the federal level and sets certain standards for federal or state registration and compliance of entities in the supply chain (manufacturers and repackagers, wholesale distributors, third-party logistics providers, and dispensers).
We expect that additional federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, and in turn could significantly reduce the projected value of certain development projects and reduce our profitability.
We expect that additional federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, and in turn could significantly reduce the projected value of certain development projects and reduce our profitability. 28 Table of Contents Additional legislative changes, regulatory changes, or guidance could be adopted, which may impact the marketing approvals and reimbursement for our product candidates.
The key elements of our strategy for achieving this goal are as follows: • Continue to expand the commercial production of our IG products, as well as the commercial presence, penetration and sales of ASCENIV and BIVIGAM 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 of our IG products and notably drive a revenue mix shift favoring sales of ASCENIV for the treatment of patients with PI .
We comply with all applicable laws, regulations, and requirements associated with our environmental obligations and impact. We strive for the continual improvement of all environmental impacts associated with our operations.
We are committed to providing a safe and healthy work environment. We comply with all applicable laws, regulations, and requirements associated with our environmental obligations and impact. We strive for the continual improvement of all environmental impacts associated with our operations.
During cold ethanol fractionation, classes of proteins are precipitated and removed by centrifugation or filtration. The fractionation process includes the following steps; precipitation and absorption, depth filtration, centrifugation and chromatography.
After receipt of the source plasma, the frozen plasma is thawed and pooled and goes through the fractionation process. During cold ethanol fractionation, classes of proteins are precipitated and removed by centrifugation or filtration. The fractionation process includes the following steps; precipitation and absorption, depth filtration, centrifugation and chromatography.
From April 2009 through February 2011, RI-001 was also administered to 15 compassionate use patients where physicians requested access to the product for treating their patients with documented lower respiratory tract RSV infections due to the fact that these patients had failed conventional therapeutic interventions. Serum samples were obtained from 13 patients.
There were no serious drug-related adverse events reported during the trial. 7 Table of Contents From April 2009 through February 2011, RI-001 was also administered to 15 compassionate use patients where physicians requested access to the product for treating their patients with documented lower respiratory tract RSV infections due to the fact that these patients had failed conventional therapeutic interventions.
Under this Program, manufacturers are required to pay a rebate to each state Medicaid program for covered outpatient drugs that are dispensed to Medicaid beneficiaries and paid for by a state Medicaid program as a condition of having federal funds being made available for their drugs under Medicaid and Part B of the Medicare program. 23 Table of Contents Medicaid rebates are based on pricing data reported by manufacturers on a monthly and quarterly basis to the CMS, the federal agency that administers the Medicaid and Medicare programs.
Under this Program, manufacturers are required to pay a rebate to each state Medicaid program for covered outpatient drugs that are dispensed to Medicaid beneficiaries and paid for by a state Medicaid program as a condition of having federal funds being made available for their drugs under Medicaid and Part B of the Medicare program.
In order to be eligible to have their products paid for with federal funds under the Medicaid and Medicare Part B programs and purchased by certain federal agencies (U.S. Department of Veterans Affairs “VA”), Department of Defense (“DoD”), Coast Guard, and Public Health Service (“PHS”)) and grantees, manufacturers must participate in the VA Federal Supply Schedule “FSS”) pricing program.
In order to be eligible to have their products paid for with federal funds under the Medicaid and Medicare Part B programs and purchased by certain federal agencies, including the VA, DoD, Coast Guard, and PHS and grantees, manufacturers must participate in the VA Federal Supply Schedule (“FSS”) pricing program.
Nearly all children will have been infected with RSV by three years of age; however, the immune systems of most healthy children prevent significant morbidity and mortality.
RSV is a common respiratory virus that often presents during the winter months. Nearly all children will have been infected with RSV by three years of age; however, the immune systems of most healthy children prevent significant morbidity and mortality.
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. Corresponding foreign patents and patent applications also pertain to this technology. We also hold intellectual property, including patents and patent applications, related to immunotherapeutic compositions and immunotherapeutic methods for the treatment and prevention of S. pneumonia infection. U.S.
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.
In general, products subject to Medicaid price reporting and rebate liability are also subject to the 340B ceiling price calculation and discount requirement. 24 Table of Contents The final regulation issued by HRSA regarding the calculation of the 340B ceiling price and the imposition of civil monetary penalties on manufacturers that knowingly and intentionally overcharge covered entities has affected manufacturer obligations and potential liability under the 340B program.
The final regulation issued by HRSA regarding the calculation of the 340B ceiling price and the imposition of civil monetary penalties on manufacturers that knowingly and intentionally overcharge covered entities has affected manufacturer obligations and potential liability under the 340B program.
We cannot be sure whether additional legislative changes will be enacted in the U.S. or outside the U.S., or whether regulatory changes, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals of our product candidates, if any, may be. 27 Table of Contents Anti-Fraud and Abuse Laws We are also subject to numerous fraud and abuse laws and regulations globally.
We cannot be sure whether additional legislative changes will be enacted in the U.S. or outside the U.S., or whether regulatory changes, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals of our product candidates, if any, may be.
The 340B ceiling price is calculated using a statutory formula, which is based on the average manufacturer price and Medicaid rebate amount for the covered outpatient drug as calculated under the Medicaid Drug Rebate Program.
The 340B ceiling price is calculated using a statutory formula, which is based on the average manufacturer price and Medicaid rebate amount for the covered outpatient drug as calculated under the Medicaid Drug Rebate Program. In general, products subject to Medicaid price reporting and rebate liability are also subject to the 340B ceiling price calculation and discount requirement.
During 2021, we received FDA approvals for our 4,400L expanded IVIG production scale, as well as our in-house fill-finish and related operations production line using our aseptic filling machine. In 2023, ADMA commenced manufacturing ASCENIV at the 4,400 Liter production scale for the first time in the Company’s history.
During 2021, we received FDA approvals for our 4,400L expanded IVIG production scale, as well as our in-house fill-finish and related operations production line using our aseptic filling machine.
A separate submission to an existing IND must also be made for each successive clinical trial conducted during product development. The FDA must also approve certain changes to an existing IND, such as certain manufacturing changes.
Our submission of an IND, or those of our collaboration partners, may not result in the FDA allowing us to commence a clinical trial. A separate submission to an existing IND must also be made for each successive clinical trial conducted during product development. The FDA must also approve certain changes to an existing IND, such as certain manufacturing changes.
Intellectual Property We rely on a combination of patents, patent applications, copyrights and trademarks, as well as contracts, such as confidentiality, material data transfer, license and invention assignment agreements, to protect our intellectual property rights. We also rely upon trade secret laws to protect unpatented know-how and advancing technological innovation.
Intellectual Property We rely on a combination of patents, patent applications, copyrights and trademarks, as well as contracts, such as confidentiality, material data transfer, nondisclosure, non-competition, license and invention assignment agreements, to protect our intellectual property rights.
Some state laws impose significant data security requirements, such as encryption, to ensure ongoing protection of personal information. Additionally, in California, the California Consumer Privacy Act (“CCPA”) establishes certain requirements for data use and sharing transparency and creates new data privacy rights for California residents. The CCPA and its implementing regulations have already been amended multiple times since their enactment.
Additionally, in California, the California Consumer Privacy Act (“CCPA”) establishes certain requirements for data use and sharing transparency and creates new data privacy rights for California residents. The CCPA and its implementing regulations have already been amended multiple times since their enactment.
FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting and documentation requirements upon the sponsor and any third-party manufacturers that the sponsor may decide to use.
FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting and documentation requirements upon the sponsor and any third-party manufacturers that the sponsor may decide to use. Accordingly, manufacturers must continue to expend time, money, and effort towards production and quality control to maintain cGMP compliance.
In the future, however, we may elect to work with the FDA and the immunology and infectious disease community to potentially design an appropriate clinical trial to evaluate the use of ASCENIV in this patient population.
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.
Utilizing our intellectual property patents, which include our proprietary testing assay and other standardization methods and technologies, we have identified potential new product candidates that we may advance into preclinical activities. As part of expanding our product pipeline, we are looking to develop an S. pneumonia hyperimmune globulin.
Utilizing our intellectual property patents, which include our proprietary testing assay and other standardization methods and technologies, we have identified potential new product candidates that we may advance into preclinical activities.
The FTC’s guidance for appropriately securing consumers’ personal information is similar to, but less prescriptive than, what is required by the HIPAA Security Rule.
The FTC’s guidance for appropriately securing consumers’ personal information is similar to, but less prescriptive than, what is required by the HIPAA Security Rule. Enforcement by the FTC under the FTC Act can result in civil penalties or enforcement actions.
In addition, under the Pediatric Research Equity Act of 2003, a BLA or supplement for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration must contain data that is adequate to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective, unless the applicant has obtained a waiver or deferral.
Phase III clinical trials aim to provide substantial evidence of reproducibility of clinical efficacy and safety results for approval and to further test for safety in an expanded and diverse patient population at multiple, geographically dispersed clinical trial sites. 17 Table of Contents In addition, under the Pediatric Research Equity Act of 2003, a BLA or supplement for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration must contain data that is adequate to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective, unless the applicant has obtained a waiver or deferral.
In the U.S., there are a variety of Federal and state laws restricting certain marketing practices in the pharmaceutical industry pertaining to healthcare fraud and abuse, including anti-kickback laws and false claims laws. Our sales, marketing, patient support and medical activities may be subject to scrutiny under these laws. The U.S.
Anti-Fraud and Abuse Laws We are also subject to numerous fraud and abuse laws and regulations globally. In the U.S., there are a variety of Federal and state laws restricting certain marketing practices in the pharmaceutical industry pertaining to healthcare fraud and abuse, including anti-kickback laws and false claims laws.
If there are any modifications to the product, including changes in indications, other labeling changes, or manufacturing processes or facilities, we may be required to submit for and obtain FDA approval of a new BLA or BLA supplement, which may require us to develop additional data or conduct additional preclinical studies and clinical trials, and/or require additional manufacturing data. 19 Table of Contents Satisfaction of the FDA regulations and approval requirements or similar requirements of foreign regulatory agencies typically takes many years, and the actual time required may vary substantially based upon the type, complexity and novelty of the product or disease.
If there are any modifications to the product, including changes in indications, other labeling changes, or manufacturing processes or facilities, we may be required to submit for and obtain FDA approval of a new BLA or BLA supplement, which may require us to develop additional data or conduct additional preclinical studies and clinical trials, and/or require additional manufacturing data.
Biologics License Applications The results of product candidate development, preclinical and nonclinical testing and clinical trials, together with, among other things, detailed information on the manufacture and composition of the product and proposed labeling, and the payment of a user fee, are submitted to the FDA as part of a BLA.
Further, the export of investigational products outside the United States is subject to regulatory requirements of the receiving country as well as U.S. export requirements under the FDCA. 18 Table of Contents Biologics License Applications The results of product candidate development, preclinical and nonclinical testing and clinical trials, together with, among other things, detailed information on the manufacture and composition of the product and proposed labeling, and the payment of a user fee, are submitted to the FDA as part of a BLA.
Additional U.S. and numerous corresponding foreign patent applications also relate to this technology. 14 Table of Contents We continue to prepare, file, and prosecute patent applications to provide broad and strong protection of our proprietary rights, including applications focused on existing and future products.
We continue to prepare, file, and prosecute patent applications to provide broad and strong protection of our proprietary rights, including applications focused on existing and future products.
Annually, approximately one million U.S. adults contract pneumococcal pneumonia, resulting in 400,000 hospitalizations and a 5-7% mortality rate, of which approximately 7,000 deaths annually are attributable to anti-infective resistance.
We believe the strategic importance and unmet need are evident in both the prophylactic and therapeutic settings where documented anti-infective resistance is on the rise. Approximately one million U.S. adults contract pneumococcal pneumonia annually, resulting in 400,000 hospitalizations and a 5-7% mortality rate, of which approximately 7,000 deaths annually are attributable to anti-infective resistance.
Even when HIPAA does not apply, according to the Federal Trade Commission (“FTC”) failing to take appropriate steps to keep consumers’ personal information secure, or failing to provide a level of security commensurate to promises made to individuals about the security of their personal information (such as in a privacy notice) may constitute unfair or deceptive acts or practices in violation of Section 5(a) of the Federal Trade Commission Act (“FTC Act”).
We could potentially be subject to civil and criminal penalties if we, our affiliates, or our agents use or disclose protected health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA. 30 Table of Contents Even when HIPAA does not apply, according to the Federal Trade Commission (“FTC”) failing to take appropriate steps to keep consumers’ personal information secure, or failing to provide a level of security commensurate to promises made to individuals about the security of their personal information (such as in a privacy notice) may constitute unfair or deceptive acts or practices in violation of Section 5(a) of the Federal Trade Commission Act (“FTC Act”).

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeUnless additional clinical trials are successfully conducted and the FDA approves a BLA or other required submission for review, we may not be authorized to market ASCENIV for any other indication. • With the approval to market ASCENIV, BIVIGAM and Nabi-HB, there can be no assurance that we will be successful in further developing and expanding commercial operations or balancing our research and development activities with our commercialization activities. • We depend on third-party researchers, developers and vendors to develop, manufacture, supply materials for or test our products and product candidates, and such parties are outside of our control. • We may be unable to successfully expand our manufacturing processes to fulfill demand for our products or increase our production capabilities through the addition of new equipment, including if we do not obtain requisite approval from 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 long-term success may depend on our ability to supplement our existing product portfolio through new product development or the in-license or acquisition of other new products, product candidates and label expansion of existing products, and if our business development efforts are not successful, our ability to achieve profitability may be adversely impacted. • Our ADMA BioCenters operations collect information from donors in the U.S. that subjects us to consumer and health privacy laws, which could create enforcement and litigation exposure if we fail to meet their requirements. • Our senior secured credit facility with Ares Capital Corporation and certain of its affiliates (“Ares”) is subject to acceleration in specified circumstances, which may result in Ares taking possession and disposing of any collateral. • If we are unable to protect our patents, trade secrets or other proprietary rights, if our patents are challenged or if our provisional patent applications do not get approved, our competitiveness and business prospects may be materially damaged. • Cyberattacks and other security breaches could compromise our proprietary and confidential information, which could harm our business and reputation. 32 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 plasma with proper specifications or other necessary raw materials. • The market price of our common stock may be volatile and may fluctuate in a way that is disproportionate to our operating performance.
Biggest changeAny 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.
The clinical trial process may fail to demonstrate that our product candidates are safe for humans and effective for indicated uses. This failure would cause us to abandon a product candidate and may delay development of other product candidates.
The clinical trial process may fail to demonstrate that our product candidates are safe for humans and effective for indicated uses. This failure would cause us to abandon a product candidate and may delay the development of other product candidates.
As our biologics production levels increase, there may be normal course inventory losses or write-downs as we ensure product quality and compliance with cGMP, FDA, state and local regulations, or due to testing results not meeting specifications.
As our biologics production levels increase, there may be normal course inventory losses or write-downs as we ensure product quality and compliance with cGMP, FDA and state and local regulations, or due to testing results not meeting specifications.
Furthermore, sanctions under the federal False Claims Act have been brought against companies accused of promoting off-label uses of drugs, because such promotion induces unapproved the use and subsequent claims for reimbursement under Medicare and other federal programs. Similar actions for off-label promotion have been initiated by several states for Medicaid fraud.
Furthermore, sanctions under the federal False Claims Act have been brought against companies accused of promoting off-label uses of drugs, because such promotion induces unapproved use and subsequent claims for reimbursement under Medicare and other federal programs. Similar actions for off-label promotion have been initiated by several states for Medicaid fraud.
We may detect instances in which an unreleased product was produced without adherence to our manufacturing procedures or plasma used in our production process was not collected or stored in a compliant manner consistent with our cGMP or other regulations.
We may detect instances in which an unreleased product was produced without adherence to our manufacturing procedures or plasma used in our production process was not collected or stored in a compliant manner consistent with cGMP or other regulations.
If we identify material weaknesses in our internal control over financial reporting, if we are unable to comply with the requirements of Section 404 of the Sarbanes-Oxley Act in a timely manner, if we are unable to assert that our internal controls over financial reporting is effective or if our independent registered public accounting firm is unable to express an opinion as to the effectiveness of our internal control over financial reporting, investors may lose confidence in the accuracy and completeness of our financial reports, and the market price of our common stock could be negatively affected.
If we identify material weaknesses in our internal control over financial reporting, if we are unable to comply with the requirements of Section 404 of the Sarbanes-Oxley Act in a timely manner, if we are unable to assert that our internal control over financial reporting is effective or if our independent registered public accounting firm is unable to express an opinion as to the effectiveness of our internal control over financial reporting, investors may lose confidence in the accuracy and completeness of our financial reports, and the market price of our common stock could be negatively affected.
If, during the post-marketing period (after marketing approval) previously unknown adverse events emerge, there is the discovery that the product is less effective than previously thought, or other potential concerns regarding our products or their manufacturing processes emerge, or we are observed in any way to fail to comply with the numerous regulatory requirements to which we are subject, those circumstances may yield various results, including: • restrictions on such products or manufacturing processes; • restrictions on the labeling or marketing of a product; • restrictions on product distribution or use; • clinical holds or termination of clinical trials; • requirements to conduct further post-marketing studies or clinical trials, implement risk mitigation strategies, or to issue corrective information; • warning letters or untitled letters; • withdrawal of the products from the market; • refusal to approve pending applications or supplements to approved applications that we submit; • recall of products; • restrictions on coverage by third-party payers; • fines, restitution or disgorgement of profits or revenues; • suspension or withdrawal of marketing approvals; • refusal to permit the import or export of products; • FDA debarment, suspension and debarment from government programs, refusal of orders under existing government contracts, exclusion from participation in federal healthcare programs, consent decrees, deferred or non-prosecution agreements or corporate integrity agreements; • product seizure or detention; 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 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.
In addition, federal and state privacy, data security, and breach notification laws, rules and regulations, and other laws apply to the collection, use and security of personal information, including social security number, driver’s license numbers, government identifiers, credit card and financial account numbers. 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, 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.
We are unable to predict geopolitical conditions, whether acts of international terrorism or the involvement in a war or other military actions will result in any long-term commercial disruptions or if such involvement or responses will have any long-term material adverse effect on our business, results of operations, or financial condition.
We 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.
As we move forward in clinical development, we continue to discover novel technologies related to our products and we may draft patent applications directed to these technologies. We rely on a combination of patent rights, trade secrets and nondisclosure and non-competition agreements to protect our proprietary intellectual property, and we will continue to do so.
As we move forward in clinical development, we continue to discover novel technologies related to our products and we may draft patent applications directed to these technologies. We rely on a combination of patent rights, trade secrets, intellectual property assignment agreements and nondisclosure and non-competition agreements to protect our proprietary intellectual property, and we will continue to do so.
Both of our business segments and our facilities, as well as our suppliers and contractors, are subject to periodic inspections by the FDA and other regulatory authorities, which, depending on the outcome of such inspections, could result in certain regulatory actions, including the issuance of observations, notices, citations or warning letters.
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.
Failure to obtain FDA approval of any of our product candidates will severely undermine our business by leaving us without the ability to generate additional accretive revenues. There is no guarantee that we will ever be able to develop or acquire other product candidates.
Failure to obtain FDA approval for any of our product candidates will severely undermine our business by leaving us without the ability to generate additional accretive revenues. There is no guarantee that we will ever be able to develop or acquire other product candidates.
If we are unable to repay our outstanding debt obligations when they mature, our creditors would be able to accelerate all of the amounts due and, in the case of the Ares Credit Facility, seek to enforce their security interests, which could lead to our creditors taking immediate possession of and selling substantially all of our assets with no return provided to our stockholders. 56 Table of Contents Raising additional funds by issuing securities or through licensing or lending arrangements may cause dilution to our existing stockholders, restrict our operations or require us to relinquish proprietary rights.
If we are unable to repay our outstanding debt obligations when they mature, our creditors would be able to accelerate all of the amounts due and, in the case of the Ares Credit Facility, seek to enforce their security interests, which could lead to our creditors taking immediate possession of and selling substantially all of our assets with no return provided to our stockholders. 58 Table of Contents Raising additional funds by issuing securities or through licensing or lending arrangements may cause dilution to our existing stockholders, restrict our operations or require us to relinquish proprietary rights.
Each of these risks could delay or prevent the completion of our finished drug product and the release of finished drug product by us or the FDA, which could result in higher costs or adversely impact our revenues. These risks could also result in the delay in obtaining clinical supplies, which would delay our development programs.
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.
In order to legally provide access to PHI to service providers, covered entities and business associates must enter into a “business associate agreement” (“BAA”) with the service provider that receives PHI on behalf of the entity.
In order to legally provide access to PHI to service providers, covered entities and business associates must enter into a “business associate agreement” with the service provider that receives PHI on behalf of the entity.
There can be no assurance that the confidentiality, nondisclosure and non-competition agreements with employees, consultants and other parties with access to our proprietary information to protect our trade secrets, proprietary technology, processes and other proprietary rights, or any other security measures relating to such trade secrets, proprietary technology, processes and proprietary rights, will be adequate, will not be breached, that we will have adequate remedies for any breach, that others will not independently develop substantially equivalent proprietary information or that third parties will not otherwise gain access to our trade secrets or proprietary knowledge.
There can be no assurance that the confidentiality, invention assignment, nondisclosure and non-competition agreements with employees, consultants and other parties with access to our proprietary information to protect our trade secrets, proprietary technology, processes and other proprietary rights, or any other security measures relating to such trade secrets, proprietary technology, processes and proprietary rights, will be adequate, will not be breached, that we will have adequate remedies for any breach, that others will not independently develop substantially equivalent proprietary information or that third parties will not otherwise gain access to our trade secrets or proprietary knowledge.
In addition, our contract fill/finishers and our other third-party vendors may source their materials and supplies globally and are therefore subject to supply disruptions in the event of fire, weather related events such as hurricanes, wind and rain, international conflicts, trade and sanction requirements and limits, other acts of God or force majeure events or global health occurrences and emergencies.
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, 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. 57 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. 59 Table of Contents Our ability to use our net operating loss carryforwards (“NOLs”) may be limited.
Delays in obtaining regulatory approvals may: 39 Table of Contents • 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.
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.
We may face reputational damage in the event our corporate responsibility initiatives or objectives, including with respect to board diversity, do not meet the standards set by our investors, stockholders, lawmakers, listing exchanges or other constituencies, or if we are unable to achieve an acceptable ESG or sustainability rating from third-party ratingservices.
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.
Borrowings under the Ares Credit Facility currently bear interest at a weighted-average rate of approximately 10.4% per annum, which reflects the three-month term SOFR rate; provided, however, that upon, and during the continuance of, an event of default, the interest rate will automatically increase by an additional 200 basis points.
Borrowings under the Ares Credit Facility currently bear interest at a weighted-average rate of approximately 9.4% per annum, which reflects the three-month term SOFR rate; provided, however, that upon, and during the continuance of, an event of default, the interest rate will automatically increase by an additional 200 basis points.
This reliance on third parties carries the risk that the services upon which we rely may not be performed in a timely manner, in sufficient quantities or according to our specifications, which could delay the availability of our finished drug product and could adversely affect our commercialization efforts and our revenues.
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.
Although we did not experience any ownership changes for the years ended December 31, 2023 and 2022, we may experience ownership changes in the future as a result of subsequent changes in our stock ownership that we cannot predict or control that could result in further limitations being placed on our ability to utilize our Federal NOLs.
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.
The Ares Credit Agreement provides for a total of $135 million in senior secured credit facilities (the “Ares Credit Facility”) consisting of (i) a term loan in the aggregate principal amount of $62.5 million and (ii) a revolving credit facility in the aggregate principal amount of $72.5 million (collectively, the “Ares Loans”), both of which were fully drawn on the Ares Closing Date.
The Ares Credit Agreement provided for a total of $135 million in senior secured credit facilities (the “Ares Credit Facility”) consisting of (i) a term loan in the aggregate principal amount of $62.5 million and (ii) a revolving credit facility in the aggregate principal amount of $72.5 million (collectively, the “Ares Loans”), both of which were fully drawn on the Ares Closing Date.
If we are not able to generate revenue from our products and product candidates, our sources of revenue may continue to be from a product mix consisting only of plasma collection and sales revenues, revenues generated from sales of our FDA-approved commercial products, revenues generated from new contract manufacturing arrangements with third parties and revenues generated from the sales of manufacturing intermediates.
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.
Our long-term success may depend on our ability to supplement our existing product portfolio through new product development or the in-license or acquisition of other new products, product candidates and label expansion of existing products, and if our business development efforts are not successful, our ability to achieve profitability may be adversely impacted.
Our 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.
Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations. The manufacturing processes for plasma-based biologics are complex and involve biological intermediates that are susceptible to contamination and impurities.
Further, future government shutdowns could impact our ability to access the public markets and obtain capital that may be necessary in order to properly capitalize and continue our operations. The manufacturing processes for plasma-based biologics are complex and involve biological intermediates that are susceptible to contamination and impurities.
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.
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.
To comply with the requirements of being a reporting company under the Exchange Act, we have been required to upgrade, and may need to implement further upgrades, to our financial, information and operating systems, implement additional financial and management controls, reporting systems and procedures and hire additional accounting and finance staff.
To comply with the requirements of being a reporting company under the Exchange Act, we have been required to upgrade, and will need to implement further upgrades, to our financial, information and operating systems, implement additional financial and management controls, reporting systems and procedures and hire additional accounting and finance staff.
Violations of laws such as the Federal Food, Drug, and Cosmetic Act, the Social Security Act (including the Anti-Kickback Statute), the Public Health Service Act, the civil and criminal federal False Claims Act, the civil monetary penalty statute, requirements regarding the reporting and repayment of overpayments, other fraud and abuse laws and any regulations promulgated under the authority of the preceding, may result in significant criminal and/or civil sanctions, including jail sentences, fines or exclusion from participation in or debarment from federal and state healthcare or government procurement programs, pursuant to enforcement actions by DOJ, Medicare, Medicaid, OIG and other regulatory authorities.
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.
However, because our products and product candidates are plasma-based products, not only are we subject to the FDA’s drug and biologic cGMP requirements, but we are also subject to special requirements for the collection, testing, handling, storage, and use of blood products.
Additionally, because our products and product candidates are plasma-based products, not only are we subject to the FDA’s drug and biologic cGMP requirements, but we are also subject to special requirements for the collection, testing, handling, storage, and use of blood products.
Failure to obtain the needed services and products meeting the necessary quality standards or at all could have a material and adverse effect on our products, business, financial condition and results from operations.
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.
Foreign Corrupt Practices Act, the U.S. has increasingly focused on regulating the conduct by U.S. businesses occurring outside of the U.S., generally prohibiting remuneration to foreign officials for the purpose of obtaining or retaining business.
Foreign Corrupt Practices Act, the United States has increasingly focused on regulating the conduct by U.S. businesses occurring outside of the United States, generally prohibiting remuneration to foreign officials for the purpose of obtaining or retaining 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. 35 Table of Contents Geopolitical 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. 37 Table of Contents Geopolitical and economic conditions, war, terrorism or other military actions may have a material adverse effect on our business.
For example, the FDA’s approval of our application supplement to allow for the commercial relaunch of BIVIGAM, as well as the FDA’s approval of our BLA for ASCENIV, require us to conduct specified post-marketing studies, including pediatric and safety studies.
For example, the FDA’s approval of our application supplement to allow for the commercial relaunch of BIVIGAM, as well as the FDA’s approval of our BLA for ASCENIV, required us to conduct specified post-marketing studies, including pediatric and safety studies.
To the extent that our consultants, contractors or collaborators use intellectual property owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions. 45 Table of Contents We could lose market exclusivity of a product earlier than expected.
To the extent that our consultants, contractors or collaborators use intellectual property owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions. We could lose market exclusivity of a product earlier than expected.
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. 44 Table of Contents 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 Ares Credit Facility is subject to acceleration in specified circumstances, which may result in Ares taking possession and disposing of any collateral.
The ultimate impact will depend on the severity and duration of the pandemic and actions taken by governmental authorities and other third parties in response, each of which is uncertain and difficult to predict.
The ultimate impact will depend on the severity and duration of the pandemic and actions taken by governmental authorities and other third parties in response, each of which is unforeseeable and difficult to predict.
We also expect to continue to incur significant operating and capital expenditures and anticipate that as our business continues to grow our operating expenses will increase accordingly as we: • expand commercialization and marketing efforts; • implement additional internal systems, controls and infrastructure; • hire additional personnel; and • expand production capacity at the Boca Facility.
We also expect to continue to incur significant operating and capital expenditures and anticipate that as our business continues to grow our operating expenses will increase accordingly as we: • expand commercialization and marketing efforts; • expand our research and development programs; • implement additional internal systems, controls and infrastructure; • hire additional personnel; and • expand production capacity at the Boca Facility.
HIPPAA “covered entities” include health plans/insurers, healthcare providers engaging in HIPPA standard electronic transactions and healthcare clearinghouses. A “business associate” provides services to covered entities (directly or as subcontractors to other business associates) involving arranging, creating, receiving, maintaining, or transmitting PHI on a covered entity’s behalf.
HIPAA “covered entities” include health plans/insurers, healthcare providers engaging in HIPAA standard electronic transactions and healthcare clearinghouses. A “business associate” provides services to covered entities (directly or as subcontractors to other business associates) involving arranging, creating, receiving, maintaining, or transmitting PHI on a covered entity’s behalf.
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. 58 Table of Contents Many of these factors are beyond 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.
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; 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: • 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.
If outside collaborators fail to devote sufficient time and resources to our products and/or development programs, or if their performance is substandard or does not comply with the applicable regulatory standards, our trials may be repeated, extended, delayed, or terminated, the approval of our FDA application(s), if any, and our introduction of new products, if any, will be delayed, and we may not be able to maintain existing approvals or meet our regulatory requirements.
If outside collaborators fail to devote sufficient time and resources to our products and/or development programs, or if their performance is substandard or does not comply with the applicable regulatory standards, our trials may be repeated, extended, delayed, or terminated, the approval of our FDA application(s), if any, and our introduction of new products, if any, will be delayed, and we may not be able to maintain existing approvals or meet our regulatory requirements or we may not be able to produce forecasted amounts of product.
Historically, a few customers have accounted for a significant amount of our total revenue and accounts receivable and the loss of any of these customers could have a material adverse effect on our business, results of operations and financial condition. For the year ended December 31, 2023, two customers, BioCARE, Inc.
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.
Any failure by us, our contract fill/finishers, or other third parties involved in the process for producing our products or product candidates to comply with the applicable manufacturing and regulatory requirements, including quality requirements, could place us and them at risk of regulatory enforcement actions, recalls and other adverse consequences, could adversely impact our products, and could adversely impact patients receiving our products, which may negatively impact our business and our ability to produce and supply products to meet commercial and clinical needs. 34 Table of Contents Our anticipated reliance on a limited number of third-party manufacturers exposes us to the following risks: • we may be unable to identify contractors on acceptable terms or at all because the number of potential service providers is limited and the FDA must inspect and qualify any contract manufacturers for current cGMP compliance as part of our marketing application; • a new fill/finisher would have to be educated in, or develop substantially equivalent processes for, the production of our products and product candidates; • a pandemic, or the resurgence of a pandemic such as the COVID-19 pandemic, could adversely affect our contracted fill/finishers’ operations, supply chain or workforce; • our contracted fill/finishers’ resources and level of expertise with plasma-derived biologics may be limited, therefore they may require a significant amount of support from us in order to implement and maintain the infrastructure and processes required to deliver our finished drug product; • our third-party contractors might be unable to timely provide finished drug product or raw material plasma in sufficient quantity to meet our commercial needs; • contractors may not be able to execute our inspection procedures and required tests appropriately; • contractors are subject to ongoing periodic unannounced inspection by the FDA and corresponding state agencies to ensure strict compliance with cGMP and other government regulations, and we do not have control over third-party providers’ compliance with these regulations; • contractors may fail to comply with applicable regulatory requirements, placing them and us at risk of regulatory enforcement actions, recalls and other adverse consequences, and which place our patients at risk, which may negatively impact our business and their ability to supply products to meet our development, clinical and commercial needs; • our third parties could breach or terminate their agreements with us; 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; 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.
“Off-label” uses are common across medical specialties and may constitute an appropriate treatment for some patients in varied circumstances. Regulatory authorities in the U.S. generally do not regulate the behavior of physicians in their choice of treatments. Regulatory authorities do, however, restrict communications by pharmaceutical companies on the subject of off-label use.
“Off-label” uses are common across medical specialties and may constitute an appropriate treatment for some patients in varied circumstances. Regulatory authorities in the United States generally do not regulate the behavior of physicians in their choice of treatments. Regulatory authorities do, however, restrict communications by pharmaceutical companies on the subject of off-label use.
Additionally, although we achieved plasma supply self-sufficiency with the approval of our tenth plasma collection center in November 2023, we remain reliant on the purchase of plasma from third parties and the collection of plasma from our FDA-licensed plasma collection centers to manufacture our products.
Additionally, although we achieved normal source plasma supply self-sufficiency with the approval of our tenth plasma collection center in November 2023, we remain reliant on the purchase of RSV plasma from third parties and the collection of RSV and normal source plasma from our FDA-licensed plasma collection centers to manufacture our products.
In the U.S., where pricing levels for our products are substantially established by third-party payers, including Medicare, if payers reduce the amount of reimbursement for a product, it may cause groups or individuals dispensing the product to discontinue administration of the product, to administer lower doses, to substitute lower cost products or to seek additional price-related concessions.
In the United States, where pricing levels for our products are substantially established by third-party payers, including Medicare, if payers reduce the amount of reimbursement for a product, it may cause groups or individuals dispensing the product to discontinue administration of the product, to administer lower doses, to substitute lower cost products or to seek additional price-related concessions.
If a prolonged government shutdown reoccurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions and other reporting requirements which could have a material adverse effect on our business.
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.
Furthermore, delays or setbacks can occur at any stage of the process, and we could encounter problems that cause us to abandon our product development programs and related INDs or BLAs, or to repeat clinical trials.
Furthermore, delays or setbacks can occur at any stage of the process, and we could encounter problems that cause us to abandon our product development programs and related IND applications or BLAs, or to repeat clinical trials.
While physicians in the U.S. may choose, and are generally permitted, to prescribe drugs for uses that are not described in the product’s labeling, and for uses that differ from those tested in clinical studies and approved by the regulatory authorities, our ability to promote our products is narrowly limited to those indications that are specifically approved by the FDA.
While physicians in the United States may choose, and are generally permitted, to prescribe drugs for uses that are not described in the product’s labeling, and for uses that differ from those tested in clinical studies and approved by the regulatory authorities, our ability to promote our products is narrowly limited to those indications that are specifically approved by the FDA.
If we choose to pursue clinical development and commercialization in the European Union or otherwise market and sell our products outside of the U.S., we must obtain and maintain regulatory approvals and comply with regulatory requirements in such jurisdictions. The approval procedures vary among countries in complexity and timing.
If we choose to pursue clinical development and commercialization in the European Union or otherwise market and sell our products outside of the United States, we must obtain and maintain regulatory approvals and comply with regulatory requirements in such jurisdictions. The approval procedures vary among countries in complexity and timing.
We may not obtain approvals from regulatory authorities outside the U.S. on a timely basis, if at all, which would preclude us from commercializing products in those markets. In addition, some countries, particularly the countries of the European Union, regulate the pricing of prescription pharmaceuticals.
We may not obtain approvals from regulatory authorities outside the United States on a timely basis, if at all, which would preclude us from commercializing products in those markets. In addition, some countries, particularly the countries of the European Union, regulate the pricing of prescription pharmaceuticals.
As a result, we will need to generate significant revenues in order to maintain profitability. We may not be able to generate these revenues or maintain profitability in the future. Pandemics, or a resurgence of a pandemic, may adversely affect our business, financial condition, liquidity or results of operations.
As a result, we will need to continue to generate significant revenues in order to maintain profitability. We may not be able to generate these revenues or maintain profitability in the future. 35 Table of Contents Pandemics, or a resurgence of a pandemic, may adversely affect our business, financial condition, liquidity or results of operations.
In the U.S. and in some other countries, when market exclusivity expires and generic or biosimilar versions are approved and marketed or when biosimilars are introduced (even if only for a competing product), there are usually very substantial and rapid declines in a product’s revenues.
In the United States and in some other countries, when market exclusivity expires and generic or biosimilar versions are approved and marketed or when biosimilars are introduced (even if only for a competing product), there are usually very substantial and rapid declines in a product’s revenues.
Our operations, including our headquarters located in Ramsey, NJ, the Boca Facility and our plasma collection facilities, are vulnerable to interruption by fire, weather related events such as hurricanes, wind and rain, other acts of God or force majeure events, electric power loss, telecommunications failure, equipment failure, cyberattacks on our operations and information technology systems and breakdown, human error, employee issues, global health occurrences such as the COVID-19 pandemic, global and economic uncertainty, war, geopolitical conditions and emergencies, product liability claims and events beyond our control.
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.
Any of these events could seriously harm our business, operating results and financial condition. 46 Table of Contents If we are unable to successfully manage our growth, our business may be harmed.
Any of these events could seriously harm our business, operating results and financial condition. If we are unable to successfully manage our growth, our business may be harmed.
The failure of our current or future products to find market acceptance would harm our business and could require us to seek additional financing or make such financing difficult to obtain on favorable terms, if at all.
The failure of our current or future products to find market acceptance would harm our business and could require us to seek additional financing or make such financing difficult to obtain on favorable terms, if at all. Our accruals for U.S.
Both before and after the approval of our products, our products, operations, facilities, suppliers and CROs are subject to extensive regulation by Federal, state and local governmental authorities in the U.S. and other countries, with regulations differing from country to country.
Both before and after the approval of our products, our products, operations, facilities, suppliers and CROs are subject to extensive regulation by federal, state and local governmental authorities in the United States and other countries, with regulations differing from country to country.
Other issues that may impact our clinical trials and that could delay or prevent our ability to receive marketing approval or commercialize our product candidates, include: • Delays in reaching, or failure to reach, agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites and our CROs; • Regulators requiring us to perform additional or unanticipated clinical trials to obtain approval or becoming subject to additional post-marketing testing, surveillance, or REMS requirements to maintain regulatory approval; • Failure by our third-party contractors to comply with regulatory requirements or the clinical trial protocol, or meet their contractual obligations to us in a timely manner, or at all, or our being required to engage in additional clinical trial site monitoring; 38 Table of Contents • The cost of clinical trials of our product candidates being greater than we anticipate or our having insufficient funds for a clinical trial or to pay the substantial user fees required by FDA upon the filing of a marketing application; • Insufficient supply or inadequate quality of our product candidates or other materials necessary to conduct clinical trials; • Inability to achieve sufficient study enrollment, subjects dropping out or withdrawing from our studies, delays in adding new investigators or clinical trial sites or a withdrawal of clinical trial sites; • Flaws in our clinical trial design that are not discoverable until the clinical trial has progressed; • Disagreement by the FDA or comparable foreign regulatory authorities with our intended indications or study design, including endpoints, or our interpretation of data from preclinical studies and clinical trials, finding that a product candidate’s benefits do not outweigh its safety risks or requiring that we conduct additional development or study work; • The need to make changes to our product candidates that require additional testing or that cause our product candidates to perform differently than expected; • Global trade policies that may impact our ability to obtain raw materials and/or finished product for commercialization; • FDA or comparable regulatory authorities taking longer than we anticipate to make decisions on our products or product candidates; 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 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.
In addition, certain portions of our clinical trials and product testing for our product candidates may be performed outside of the U.S., and therefore, may not be performed in accordance with standards normally required by the FDA and other regulatory agencies.
In addition, certain portions of our clinical trials and product testing for our product candidates may be performed outside of the United States, and therefore, may not be performed in accordance with standards normally required by the FDA and other regulatory agencies.
In the U.S., the FDA regulates, among other things, the pre-clinical and nonclinical testing, clinical trials, manufacturing, safety, efficacy, potency, labeling, storage, record keeping, quality systems, advertising, promotion, sale and distribution of therapeutic products.
In the United States, the FDA regulates, among other things, the pre-clinical and nonclinical testing, clinical trials, manufacturing, safety, efficacy, potency, labeling, storage, record keeping, quality systems, advertising, promotion, sale and distribution of therapeutic products.
Absent relevant patent protection for a product, once the data exclusivity period expires, generic versions can be approved and marketed. Patent rights covering our products may become subject to patent litigation.
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.
We are currently required to make quarterly payments of interest during the term of the Ares Credit Facility of approximately $3.7 million, with all principal and unpaid interest due at maturity. In addition, our monthly interest rate obligation is subject to rising interest rates.
We are currently required to make quarterly payments of interest during the remaining term of the Ares Credit Facility of approximately $1.8 million, with all principal and unpaid interest due at maturity. In addition, our monthly interest rate obligation is subject to rising interest rates.
Companies in the U.S., Canada and the European Union cannot promote approved products for other indications that are not specifically approved by the competent regulatory authorities such as the FDA in the U.S., nor can companies promote unapproved products.
Companies in the United States, Canada and the European Union cannot promote approved products for other indications that are not specifically approved by the competent regulatory authorities such as the FDA in the United States, nor can companies promote unapproved products.
If we are unable to achieve sufficient positive cash flow to repay our outstanding debt obligations as they mature, we will need to obtain additional financing in the amounts necessary to repay our outstanding debt obligations when due.
If we are unable to maintain sufficient positive cash flow to repay our outstanding debt obligations as they mature, we would need to obtain additional financing in the amounts necessary to repay our outstanding debt obligations when due.
Furthermore, if such activities are prohibited, it may harm demand for our products. Promotion of unapproved drugs or devices or unapproved indications for a drug or device is a violation of the Federal Food, Drug, and Cosmetic Act and subjects us to civil and criminal sanctions.
Furthermore, if such activities are prohibited, it may harm demand for our products. Promotion of unapproved drugs or devices or unapproved indications for a drug or device is a violation of the FDCA and subjects us to civil and criminal sanctions.
The loss of services of key personnel, or the inability to attract and retain additional qualified personnel, could result in delays in development or approval of our product candidates and diversion of management resources. Cyberattacks and other security breaches could compromise our proprietary and confidential information, which could harm our business and reputation.
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.
We cannot be certain that the conduct of our business does not and will not infringe intellectual property or other proprietary rights of others in the U.S. and in foreign jurisdictions.
We cannot be certain that the conduct of our business does not and will not infringe intellectual property or other proprietary rights of others in the United States and in foreign jurisdictions.
Failure to comply with these laws and regulations also may result in substantial fines, penalties, or other sanctions. Business interruptions could adversely affect our business .
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 .
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 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.
As a result, our operating results are subject to potentially significant variability from one reporting period to the next should such normal course losses occur in any given period.
As a result, our operating results are subject to potentially significant variability from one reporting period to the next should such losses or write-downs occur in any given period.
We cannot assure you that we will receive the approvals necessary to commercialize any product candidate for sale outside the U.S.
We cannot assure you that we will receive the approvals necessary to commercialize any product candidate for sale outside the United States.
On December 18, 2023 (the “Ares Closing Date”), we entered into a new senior secured credit facility with Ares (the “Ares Credit Agreement”) (see “Liquidity and Capital Resources”).
On December 18, 2023 (the “Ares Closing Date”), we entered into a credit agreement with Ares (the “Ares Credit Agreement”) (see “Liquidity and Capital Resources”).
This high titer-plasma which meets our internal specifications for the manufacture of ASCENIV that we are able to identify with our patented testing assay amounts to less than 10% of the total donor collection samples we test.
This high-titer plasma which meets our internal specifications for the manufacture of ASCENIV that we are able to identify with our patented testing assay amounts to less than 10% of the total donor collection samples we test. As a result, we may experience an insufficient supply of this plasma.
Any such penalties may have a material adverse effect on our business and results of operations. 50 Table of Contents We are subject to extensive and rigorous governmental regulation, including the requirement of FDA and other federal, state and local business regulatoryapprovals before our products and product candidates may be lawfully marketed, and our ability to obtain regulatory approval of our products and product candidates from the FDA in a timely manner, access the public markets and obtain necessary capital in order to properly capitalize and continue our operations may be hindered by inadequate funding for the FDA, the SEC and other state and local government agencies.
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.
As of February 23, 2024, most of our 228,220,236 outstanding shares of common stock, as well as a substantial number of shares of our common stock underlying outstanding warrants, were available for sale in the public market, subject to certain restrictions with respect to sales of our common stock by our affiliates, either pursuant to Rule 144 under the Securities Act, or under effective registration statements.
As of March 10, 2025, most of our 237,615,100 outstanding shares of common stock, as well as a substantial number of shares of our common stock underlying outstanding warrants, were available for sale in the public market, subject to certain restrictions with respect to sales of our common stock by our affiliates, either pursuant to Rule 144 under the Securities Act, or under effective registration statements.
We have incurred substantial losses during our history. As of December 31, 2023, we had federal and state NOLs of $315.6 million and $216.4 million, respectively. Federal and state NOLs of approximately $35.6 million and $95.1 million, respectively, will begin to expire at various dates beginning in 2028, if not limited by triggering events prior to such time.
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.
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. 41 Table of Contents Our products, and any additional products for which we may obtain marketing approval in the future, could be subject to post-marketing restrictions, new FDA guidance, or other regulatory actions, such as withdrawal from the market.
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.
The implementation of the Healthcare Reform Law in the U.S. may adversely affect our business. Through the March 2010 adoption of the Healthcare Reform Law in the U.S., substantial changes are being made to the current system for paying for healthcare in the U.S., including programs to extend medical benefits to millions of individuals who currently lack insurance coverage.
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.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

3 edited+0 added−0 removed8 unchanged
Biggest changeDuring 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, including this Annual Report on Form 10-K, we experienced an IT Systems Disruption, which did result in a non-recurring charge to our results of operations.
Biggest changeDuring 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.
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.
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
Normal course operations have resumed across the Company’s business units. 60 Table of Contents Governance Our Chief Executive Officer and Chief Financial 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.
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.

Item 2. Properties

Properties — owned and leased real estate

1 edited+0 added−0 removed3 unchanged
Biggest changeProperties The table below describes our principal facilities as of December 31, 2023: 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.
Biggest changeProperties 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.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

4 edited+0 added−2 removed2 unchanged
Biggest changeStock Performance Graph The following graph assumes a $100 investment on December 31, 2018 in each of the Company’s Common Stock, the XBI Biotech Index of biotechnology companies and the Russell 2000 Index. 62 Table of Contents Sale of Unregistered Securities During the year ended December 31, 2023, 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, 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.
As of February 1, 2024, 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.
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.
Holders As of December 31, 2023, 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.
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.
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, 2023.
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.
Removed
Our directors and executive officers may from time to time enter into plans or other arrangements for the purchase or sale of our common stock that are intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) or may represent a non-Rule 10b5-1 trading arrangement under the Exchange Act.
Removed
During the quarter ended December 31, 2023, none of our directors or executive officers adopted or terminated any such contract, instruction or written plans.

Item 7. Management's Discussion & Analysis

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

83 edited+43 added−61 removed72 unchanged
Biggest changeYear Ended December 31, 2022 Compared to December 31, 2021 The following table presents a summary of the changes in our results of operations for the year ended December 31, 2022 compared to the year ended December 31, 2021: Year Ended December 31, (in thousands) 2022 2021 Increase (Decrease) Revenues $ 154,080 $ 80,943 $ 73,137 Cost of product revenue 118,815 79,770 39,045 Gross profit 35,265 1,173 34,092 Research and development expenses 3,614 3,646 (32 ) Plasma center operating expenses 17,843 12,289 5,554 Amortization of intangibles 715 715 - Selling, general and administrative expenses 52,458 42,897 9,561 Loss from operations (39,365 ) (58,374 ) 19,009 Interest expense (19,279 ) (13,057 ) (6,222 ) Loss on extinguishment of debt (6,670 ) - (6,670 ) Other expense, net (590 ) (217 ) (373 ) Net loss $ (65,904 ) $ (71,648 ) $ 5,744 Adjusted EBITDA * $ (27,627 ) $ (49,608 ) $ 21,981 Adjusted net loss * $ (59,234 ) $ (71,648 ) $ 12,414 * - See Non-GAAP Financial Measures appearing at the end of this discussion 71 Table of Contents Revenues We recorded total revenues of $154.1 million during the year ended December 31, 2022, as compared to $80.9 million during the year ended December 31, 2021, an increase of $73.1 million, or approximately 90%.
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%.
The increase is mainly due to approximately $51.8 million of additional debt principal resulting from the refinancing of our senior credit facility on March 23, 2022, additional debt principal resulting from interest payments made “in kind” in the form of additional indebtedness of approximately $6.8 million, as well as an increase in the stated interest rate on our senior debt from 10.75% in 2022 to as high as 14.4% at certain points in fiscal 2023 as a result increases in the Secured Overnight Financing Rate (“SOFR”).
The increase is mainly due to approximately $51.8 million of additional debt principal resulting from the refinancing of our senior credit facility on March 23, 2022, additional debt principal resulting from interest payments made “in kind” in the form of additional indebtedness of approximately $6.8 million, as well as an increase in the stated interest rate on our senior debt from 10.75% in 2022 to as high as 14.4% at certain points in fiscal 2023 as a result of increases in the Secured Overnight Financing Rate (“SOFR”).
However, our current outlook with respect to cash flows and profitability may change based upon several factors, including the success of our commercial efforts with respect to the sale of our products and the continued acceptability of our immune globulin products by physicians, patients or payers, and whether or not the assumptions underlying our projected revenues and expenses are correct.
However, our current outlook with respect to cash flows and profitability may change based upon several factors, including the continued success of our commercial efforts with respect to the sale of our products and the continued acceptability of our immune globulin products by physicians, patients or payers, and whether or not the assumptions underlying our projected revenues and expenses are correct.
Net Cash (Used in) Provided by Financing Activities 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.
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.
The Hayfin Credit Agreement, as amended, provided for a senior secured term loan facility in a principal amount of up to $175.0 million (the “Hayfin Credit Facility”), composed of (i) a term loan made on the Hayfin Closing Date in the principal amount of $150.0 million (the “Hayfin Closing Date Loan”), and (ii) a delayed draw term loan in the principal amount of $25.0 million (the “Hayfin Delayed Draw Loan” and, together with the Hayfin Closing Date Loan, the “Hayfin Loans”).
The Hayfin Credit Agreement, as amended, provided for a senior secured term loan facility in a principal amount of up to $175.0 million, composed of (i) a term loan made on the Hayfin Closing Date in the principal amount of $150.0 million (the “Hayfin Closing Date Loan”), and (ii) a delayed draw term loan in the principal amount of $25.0 million (the “Hayfin Delayed Draw Loan” and, together with the Hayfin Closing Date Loan, the “Hayfin Loans”).
Borrowings under the term loan initially 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 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”).
The Ares Credit Agreement provides for a total of $135.0 million in senior secured credit facilities (the “Ares Credit Facility”) consisting of (i) a term loan in the aggregate principal amount of $62.5 million and (ii) a revolving credit facility in the aggregate principal amount of $72.5 million (collectively, the “Ares Loans”), both of which were fully drawn on the Ares Closing Date.
The Ares Credit Agreement provided for a total of $135.0 million in senior secured credit facilities (the “Ares Credit Facility”) consisting of (i) a term loan in the aggregate principal amount of $62.5 million and (ii) a revolving credit facility in the aggregate principal amount of $72.5 million (collectively, the “Ares Loans”), both of which were fully drawn on the Ares Closing Date.
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, payor and channel mixes.
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.
We currently anticipate, based upon our projected revenue and expenditures, that our current cash, cash equivalents and accounts receivable, along with our projected future operating cash flow, will be sufficient to fund our operations, as currently conducted, through the end of the first quarter of fiscal 2025.
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.
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, repairs and supplies; • Conducting required post-marketing clinical trials for our FDA-approved products; 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: • 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.
GAAP”). The preparation of these 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.
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.
As of the Ares Closing Date and December 31, 2022, we were in compliance with all of the financial covenants contained in the Hayfin Credit Agreement. 77 Table of Contents On December 9, 2022, we completed an underwritten public offering whereby we issued 24,125,873 shares of our common stock.
As of the Ares Closing Date and December 31, 2022, we were in compliance with all of the financial covenants contained in the Hayfin Credit Agreement. On December 9, 2022, we completed an underwritten public offering whereby we issued 24,125,873 shares of our common stock.
The Hayfin Delayed Draw Loan was not drawn prior to the Hayfin Closing Date. The Hayfin Credit Facility had a maturity date of March 23, 2027 (the “Hayfin Maturity Date”), subject to acceleration pursuant to the Hayfin Credit Agreement, including upon an Event of Default (as defined in the Hayfin Credit Agreement).
The Hayfin Delayed Draw Loan was not drawn prior to our termination of the Hayfin Credit Agreement. The Hayfin Credit Facility had a maturity date of March 23, 2027 (the “Hayfin Maturity Date”), subject to acceleration pursuant to the Hayfin Credit Agreement, including upon an Event of Default (as defined in the Hayfin Credit Agreement).
This valuation allowance reflects our assessment of whether it is more likely than not that we will generate sufficient taxable income in the future to be able to utilize our deferred tax assets. In determining whether a valuation allowance is warranted, we evaluate factors such as prior earnings history, expected future earnings, carryback and carryforward periods and tax strategies.
This valuation allowance reflected our assessment of whether it is more likely than not that we would generate sufficient taxable income in the future to be able to utilize our deferred tax assets. In determining whether a valuation allowance is warranted, we evaluate factors such as prior earnings history, expected future earnings, carryback and carryforward periods and tax strategies.
In addition, we are also required to pay Ares an exit fee of $1.7 million upon the earlier of any prepayment date or the Ares Maturity Date, and this amount has been accrued as a separate liability in our consolidated balance sheet as of December 31, 2023.
In addition, we are also required to pay Ares an exit fee of $1.7 million upon the earlier of any prepayment date or the Ares Maturity Date, and this obligation has been accrued as a separate liability in our consolidated balance sheet as of December 31, 2024 and 2023 in the amount of $1.3 million and $1.7 million, respectively.
Historically, adjustments to these estimates to reflect actual results or updated expectations have not been material to our overall business. While we have some historical sales and rebate experience from our two primary immunoglobulin products, ASCENIV and BIVIGAM, since their FDA approvals in 2019, it is not extensive.
Prior to 2024, adjustments to these estimates to reflect actual results or updated expectations have not been material to our overall business. While we have some historical sales and rebate experience from our two primary immunoglobulin products, ASCENIV and BIVIGAM, since their FDA approvals in 2019, our historical experience is not extensive.
Year Ended December 31, 2023 Compared to Year Ended December 31, 2022 The following table presents a summary of the changes in our results of operations for the year ended December 31, 2023, compared to the year ended December 31, 2022: Year Ended December 31, (in thousands) 2023 2022 Increase (Decrease) Revenues $ 258,215 $ 154,080 $ 104,135 Cost of product revenue 169,273 118,815 50,458 Gross profit 88,942 35,265 53,677 Research and development expenses 3,300 3,614 (314 ) Plasma center operating expenses 4,266 17,843 (13,577 ) Amortization of intangibles 724 715 9 Selling, general and administrative expenses 59,020 52,458 6,562 Income (loss) from operations 21,632 (39,365 ) 60,997 Interest expense (25,027 ) (19,279 ) (5,748 ) Loss on extinguishment of debt (26,174 ) (6,670 ) (19,504 ) Other income (expense), net 1,330 (590 ) 1,920 Net loss $ (28,239 ) $ (65,904 ) $ 37,665 Adjusted EBITDA * $ 40,251 $ (27,627 ) $ 67,878 Adjusted net income (loss) * $ 705 $ (59,234 ) $ 59,939 * - See Non-GAAP Financial Measures appearing at the end of this discussion Revenues We recorded total revenues of $258.2 million for the year ended December 31, 2023, as compared to $154.1 million for the year ended December 31, 2022, an increase of $104.1 million, or approximately 68%.
The foregoing change in estimate in our accrual for Medicaid rebates favorably impacted our net after-tax income for the year ended December 31, 2024 by approximately $11.4 million. 74 Table of Contents Year Ended December 31, 2023 Compared to Year Ended December 31, 2022 The following table presents a summary of the changes in our results of operations for the year ended December 31, 2023, compared to the year ended December 31, 2022: Year Ended December 31, (in thousands) 2023 2022 Increase (Decrease) Revenues $ 258,215 $ 154,080 $ 104,135 Cost of product revenue 169,273 118,815 50,458 Gross profit 88,942 35,265 53,677 Research and development expenses 3,300 3,614 (314 ) Plasma center operating expenses 4,266 17,843 (13,577 ) Amortization of intangibles 724 715 9 Selling, general and administrative expenses 59,020 52,458 6,562 Income (loss) from operations 21,632 (39,365 ) 60,997 Interest expense (25,027 ) (19,279 ) (5,748 ) Loss on extinguishment of debt (26,174 ) (6,670 ) (19,504 ) Other income (expense), net 1,330 (590 ) 1,920 Net loss $ (28,239 ) $ (65,904 ) $ 37,665 Adjusted EBITDA * $ 40,251 $ (27,627 ) $ 67,878 Adjusted net income (loss) * $ 705 $ (59,234 ) $ 59,939 * - See Non-GAAP Financial Measures appearing at the end of this discussion Revenues We recorded total revenues of $258.2 million for the year ended December 31, 2023, as compared to $154.1 million for the year ended December 31, 2022, an increase of $104.1 million, or approximately 68%.
If we are unable to generate sufficient revenue to maintain positive cash flow throughout fiscal 2024 and need to raise additional capital, we may decide to do so through public or private equity offerings or debt financings, or we may enter into a corporate collaboration or licensing arrangement.
If we are unable to generate sufficient revenue to maintain positive cash flow throughout fiscal 2025 and elect to raise additional capital, we may decide to do so through public or private equity offerings or debt financings, or we may enter into a corporate collaboration or licensing arrangement.
We seek to develop a pipeline of plasma-derived therapeutics, including a product based on our most recently approved patent application under U.S. Patent No. 10,259,865 related to methods of treatment and prevention of S. pneumonia infection for an immunoglobulin manufactured to contain standardized antibodies to numerous serotypes of S. pneumoniae .
We seek to develop a pipeline of plasma-derived therapeutics, including a product based on our most recently approved patent application under U.S. Patent Nos. 10,259,865 and 11,084,870 related to methods of treatment and prevention of S. pneumonia infection for an immunoglobulin manufactured to contain standardized antibodies to numerous serotypes of S. pneumoniae .
The expected stock price volatility for our stock options was calculated by examining the historical volatility of our Common Stock since our Common Stock became publicly traded in the fourth quarter of 2013. We will continue to analyze the expected stock price volatility and expected term assumptions and will adjust our Black-Scholes option pricing assumptions as appropriate.
The expected stock price volatility for our stock options was calculated by examining the historical volatility of our common stock since our common stock became publicly traded. We will continue to analyze the expected stock price volatility and expected term assumptions and will adjust our Black-Scholes option pricing assumptions as appropriate.
As a result, we recognized an aggregate debt discount of $4.4 million as of the Ares Closing Date, and the weighted-average effective interest rate on the Ares Loans as of December 31, 2023 was 11.39%.
As a result, we recognized an aggregate debt discount of $4.4 million as of the Ares Closing Date, and the weighted-average effective interest rate on the Ares Loans as of December 31, 2024 and 2023 was 10.81% and 11.39%, respectively.
Borrowings under the revolving facility initially 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 quarterplus3.75% (the “SOFR Revolving Facility Applicable Margin”).
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”).
Prior to the Ares Maturity Date, there are no scheduled principal payments on the Ares Credit Facility, and we are required to make quarterly interest payments during the term of Ares Credit Facility of approximately $3.7 million.
Prior to the Ares Maturity Date, there are no scheduled principal payments on the Ares Credit Facility, and we are required to make quarterly interest payments during the term of Ares Credit Facility of approximately $1.8 million.
We experienced price increases for, among other items, certain raw materials, consumable supplies, services for repairs and maintenance of our facilities, utilities, shipping and freight charges, fuel surcharges and labor costs, among other expenses.
We also experienced price increases for, among other items, consumable supplies, services for repairs and maintenance of our facilities, utilities, shipping and freight charges, fuel surcharges and labor costs, among other expenses.
In addition, some of our third-party inventory purchase agreements provide for annual price increases that are tied to various consumer price indices, which have resulted in higher than historical percentage price increases and has resulted in and could continue to result in higher source plasma and other raw material and supplies costs in 2024 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 2025 and beyond.
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, which is mainly comprised of the write-off of unamortized debt discount and the prepayment penalty.
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.
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.
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.
While we do not have any firm commitments for material capital expenditures in 2024, we expect our total capital expenditures will be between $8.0 million and $12.0 million for fiscal 2024.
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.
However, in the event that we prepay an amount under the revolving facility that is greater than 50% of the current $72.5 million outstanding balance, we will still be required to pay interest on 50% of this balance, or $36.3 million, through the term of Ares Credit Facility.
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.
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%. Prior to the Ares Closing Date, the interest rate on the Hayfin Credit Facility was approximately 13.9%.
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%.
Based on current production yields, our completed and ongoing supply chain enhancements and capacity expansion initiatives, we believe this facility has the potential to produce sufficient quantities of our immune globulin (“IG”) products representing annual revenues of approximately $330 million in 2024 and potentially $380 million in 2025.
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.
In connection with the refinancing of our senior credit facility on March 23, 2022, we incurred a loss on the extinguishment of debt in the amount of $6.7 million as a result of the redemption premium we paid to retire our previously existing credit facility in the amount of $2.0 million, and the write-off of unamortized debt discount of $4.7 million related to that facility (see Note 7 to the Consolidated Financial Statements).
In connection with the refinancing of our senior credit facility on March 23, 2022, we incurred a loss on the extinguishment of debt in the amount of $6.7 million as a result of the redemption premium we paid to retire our previously existing credit facility in the amount of $2.0 million, and the write-off of unamortized debt discount of $4.7 million related to that facility (see Note 7 to the Consolidated Financial Statements). 76 Table of Contents Other Income (Expense), Net Other income, net, for the year ended December 31, 2023 was $1.3 million, as compared to other expense, net, of $0.6 million for the year ended December 31, 2022.
Borrowings under the Hayfin Credit Agreement bore interest at the adjusted Term SOFR for either a one-month or three-month tenor, as elected by us, and subject to a floor of 1.25%, plus an applicable margin of 9.5% (the “Applicable Margin”); provided, however, that upon, and during the continuance of, an Event of Default, the Applicable Margin would increase by an additional 3% per annum.
In addition, a $1.8 million upfront fee payable to Hayfin was paid “in kind” and was added to the outstanding principal balance in accordance with the terms of the Hayfin Credit Agreement. 80 Table of Contents Borrowings under the Hayfin Credit Agreement bore interest at the adjusted Term SOFR for either a one-month or three-month tenor, as elected by us, and subject to a floor of 1.25%, plus an applicable margin of 9.5% (the “Applicable Margin”); provided, however, that upon, and during the continuance of, an Event of Default, the Applicable Margin would increase by an additional 3% per annum.
We have funded our operations over the past few years primarily from the sale of our equity securities and debt financings.
Prior to fiscal 2024, we funded our operations over the previous few years primarily from the sale of our equity securities and debt financings.
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.
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.
Changes in either of these estimates could potentially materially impact our cost of product revenue and results of operations. 67 Table of Contents Stock-Based Compensation and Valuation of Warrants All equity-based payments, including grants of stock options and Restricted Stock Units (“RSUs”), are recognized at their estimated fair value at the date of grant, and compensation expense is recognized on a straight-line basis over the grantee’s requisite vesting period.
Medicaid and other rebate obligations could materially impact our revenues and our results of operations in the future. Stock-Based Compensation All equity-based payments, including grants of stock options and restricted stock units (“RSUs”), are recognized at their estimated fair value at the date of grant, and compensation expense is recognized on a straight-line basis over the grantee’s requisite vesting period.
The expected term of the options granted is in accordance with SEC Staff Accounting Bulletins 107 and 110 and is based on the average between vesting terms and contractual terms. The expected dividend yield reflects our current and expected future policy for dividends on our Common Stock.
Securities and Exchange Commission (“SEC”) Staff Accounting Bulletins 107 and 110 and is based on the average between vesting terms and contractual terms. The expected dividend yield reflects our current and expected future policy for dividends on our common stock.
We consider all positive and negative evidence to estimate if sufficient future taxable income will be generated to realize our deferred tax assets.
We consider all positive and negative evidence to estimate if sufficient future taxable income will be generated to realize our deferred tax assets, and we considered cumulative losses in recent years to be a significant type of negative evidence.
The sale of additional equity securities or debt financings, if convertible, could result in dilution to our stockholders and, in such event, the value and potential future market price of our common stock may decline.
The sale of additional equity securities or debt financings, if convertible, could result in dilution to our stockholders and, in such event, the value and potential future market price of our common stock may decline. ADMA continues to evaluate a variety of strategic alternatives, and the exploration of value-creating opportunities remains a top corporate priority.
As of December 31, 2023, we were in compliance with all of the covenants contained in the Ares Credit Agreement. 76 Table of Contents Events of default on the Ares Loans include, among others, non-payment of principal, interest or fees, violation of covenants, inaccuracy of representations and warranties, bankruptcy and insolvency events, material judgments, cross-defaults to material contracts and events constituting a change of control.
Events of default on the Ares Loans include, among others, non-payment of principal, interest or fees, violation of covenants, inaccuracy of representations and warranties, bankruptcy and insolvency events, material judgments, cross-defaults to material contracts and events constituting a change of control.
Cost of product revenue was also impacted by the inventory losses of $2.1 million related to the June 2023 IT disruption, partially offset by a decrease in other manufacturing expenses of approximately $6.2 million in 2023, mainly due to a shorter planned shutdown of the Boca Facility in 2023 as compared to 2022. 69 Table of Contents For the year ended December 31, 2023, we had gross profit of $88.9 million, as compared to $35.3 million for the same period of a year ago.
Cost of product revenue was also impacted by the inventory losses of $2.1 million related to the June 2023 IT disruption, partially offset by a decrease in other manufacturing expenses of approximately $6.2 million in 2023, mainly due to a shorter planned shutdown of the Boca Facility in 2023 as compared to 2022.
The following table presents the reconciliation of Net loss to Adjusted net income (loss) for the years ended December 31, 2023, 2022 and 2021: Years Ended December 31, (in thousands) 2023 2022 2021 Net loss $ (28,239 ) $ (65,904 ) $ (71,648 ) Loss on extinguishment of debt 26,174 6,670 - IT systems disruption 2,770 - - Adjusted net income (loss) $ 705 $ (59,234 ) $ (71,648 ) 74 Table of Contents LIQUIDITY AND CAPITAL RESOURCES At December 31, 2023, we had working capital of $207.2 million, primarily consisting of $172.9 million of inventory, cash and cash equivalents of $51.4 million and $27.4 million of accounts receivable, partially offset by current liabilities of $49.8 million, as compared to working capital at December 31, 2022 of $231.1 million, primarily consisting of $163.3 million of inventory, cash and cash equivalents of $86.5 million and accounts receivable of $15.5 million, partially offset by current liabilities of $39.3 million.
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.
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. We are unable to predict when these external drivers of inflation will subside. 79 Table of Contents
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.
Estimates and assumptions used in projecting future liquidity and capital requirements are described in Note 1 to the Consolidated Financial Statements. Revenues Our gross product revenues are subject to a variety of deductions, which are estimated and recorded in the same period that the revenues are recognized. These deductions primarily consist of rebates, distribution fees, chargebacks and sales allowances.
Revenue Deductions for Rebates and Chargebacks Our gross product revenues are subject to a variety of deductions which are estimated and recorded in the same period that the revenues are recognized. These deductions primarily consist of rebates, distribution fees, chargebacks and sales allowances.
Other Income (Expense), Net Other income, net, for the year ended December 31, 2023 was $1.3 million, as compared to other expense, net, of $0.6 million for the year ended December 31, 2022.
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.
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.
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.
We have incurred an accumulated deficit of $506.3 million since inception and although we had positive cash flow from operations of $8.8 million for the year ended December 31, 2023, we had negative cash flows from operations of $59.5 million and $112.4 million for the years ended December 31, 2022 and 2021, respectively.
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.
Cost of Product Revenue and Gross Profit Cost of product revenue was $118.8 million for the year ended December 31, 2022, as compared to $79.8 million for the year ended December 31, 2021.
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.
ADMA continues to evaluate a variety of strategic alternatives, and the exploration of value-creating opportunities remains a top corporate priority. 75 Table of Contents On December 18, 2023 (the “Ares Closing Date”), we and all of our subsidiaries entered into a new senior secured credit facility (the “Ares Credit Agreement”) with Ares Capital Corporation and certain credit funds affiliated with Ares Capital Corporation (collectively, “Ares”).
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”).
The improvement is driven primarily by an increase in operating income in 2023 of $61.0 million. Adjusted EBITDA improved by $22.0 million for the year ended December 31, 2022 as compared to the year ended December 31, 2021, mainly due to the decreasing in operating loss in 2022 of $19.0 million.
Adjusted EBITDA increased by $67.9 million for the year ended December 31, 2023 as compared to the same period of a year ago. The improvement is driven primarily by an increase in operating income in 2023 of $61.0 million.
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 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 following table presents the reconciliation of net loss to EBITDA and Adjusted EBITDA for the years ended December 31, 2023, 2022 and 2021: Years Ended December 31, (in thousands) 2023 2022 2021 Net loss $ (28,239 ) $ (65,904 ) $ (71,648 ) Depreciation 7,608 6,398 4,780 Amortization 724 715 715 Interest expense 25,027 19,279 13,057 EBITDA 5,120 (39,512 ) (53,096 ) Stock-based compensation 6,187 5,215 3,488 IT systems disruption 2,770 - - Loss on extinguishment of debt 26,174 6,670 - Adjusted EBITDA $ 40,251 $ (27,627 ) $ (49,608 ) Adjusted EBITDA increased by $67.9 million for the year ended December 31, 2023 as compared to the same period of a year ago.
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.
Our products and product candidates are intended to be used by physician specialists focused on caring for immune-compromised patients with or at risk for certain infectious diseases. We manufacture these products at our FDA-licensed, plasma fractionation and purification facility located in Boca Raton, Florida with a peak annual processing capability of up to 600,000 liters (the “Boca Facility”).
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”).
Research and Development Expenses Research and development (“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. The decrease is primarily due to lower expenditures attributable to a third-party service provider in connection with an R&D project that was completed in early 2023.
The decrease is primarily due to lower expenditures attributable to a third-party service provider in connection with an R&D project that was completed in early 2023. 75 Table of Contents Plasma Center Operating Expenses Plasma Center Operating Expenses decreased from $17.8 million in the year ended December 31, 2022 to $4.3 million in the year ended December 31, 2023.
The decrease in net loss of $5.7 million was mainly due to the decrease in operating loss, largely offset by the higher interest expense and loss on extinguishment of debt in 2022. 73 Table of Contents Non-GAAP Financial Measures Earnings Before Interest, Taxes, Depreciation and Amortization (“EBITDA”), Adjusted EBITDA and Adjusted Net Income (Loss) EBITDA, Adjusted EBITDA and Adjusted net income (loss) are important non-GAAP financial measures used by our management and Board of Directors to assess our operating performance.
Non-GAAP Financial Measures Earnings Before Interest, Taxes, Depreciation and Amortization (“EBITDA”), Adjusted EBITDA and Adjusted Net Income (Loss) EBITDA, Adjusted EBITDA and Adjusted net income (loss) are important non-GAAP financial measures used by our management and Board of Directors to assess our operating performance.
The following table illustrates the primary components of our cash flows from operations: 78 Table of Contents Years Ended December 31, (in thousands) 2023 2022 2021 Net loss $ (28,239 ) $ (65,904 ) $ (71,648 ) Non-cash expenses, gains and losses 47,162 24,682 10,959 Changes in accounts receivable (11,917 ) 13,072 (15,340 ) Changes in inventories (9,625 ) (38,556 ) (43,188 ) Changes in prepaid expenses and other current assets (239 ) (756 ) (1,293 ) Changes in accounts payable and accrued expenses 11,369 8,334 9,697 Other 289 (380 ) (1,556 ) Cash provided by (used) in operations $ 8,800 $ (59,508 ) $ (112,369 ) Net Cash Used in Investing Activities Cash used in investing activities for the year ended December 31, 2023 was $5.0 million, which was primarily comprised of capital expenditures of $3.0 million for equipment purchases and facilities upgrades at the Boca Facility, and $1.8 million to complete the buildout of our plasma collection facilities.
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.
We resumed production of BIVIGAM during the fourth quarter of 2017 and commercial production is ongoing, using our FDA-approved IVIG manufacturing process under U.S. Department of Health and Human Services (“HHS”) License No. 2019. The commercial re-launch and first commercial sales for this product commenced in August of 2019.
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.
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. 64 Table of Contents We sell plasma-derived intermediate fractions to certain customers, which are generated as part of our FDA-approved manufacturing process for IG and IVIG products, through a five-year manufacturing and supply agreement we entered into in January 2020.
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.
This improvement was mainly due to the improvement in our operating results, driven by higher revenues and gross margins, and a lower increase in inventories.
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.
For the purpose of valuing stock options granted to our employees, directors and officers, we use the Black-Scholes option pricing model. The Black-Scholes option pricing model was developed for use in estimating the fair value of publicly traded options, which have no vesting restrictions and are fully transferable.
The Black-Scholes option pricing model was developed for use in estimating the fair value of publicly traded options, which have no vesting restrictions and are fully transferable. The Company’s employee stock options have characteristics significantly different from those of traded options, and changes in the underlying Black-Scholes assumptions can materially affect the fair value estimate.
Net cash used in investing activities for the year ended December 31, 2021 was $13.5 million, which consisted of $8.6 million for the construction and buildout of new plasma collection facilities and $4.9 million of capital expenditures at the Boca Facility, which included equipment purchases and continued implementation of our in-house fill/finish capabilities.
Cash used in investing activities for the year ended December 31, 2023 was $5.0 million, which was primarily comprised of capital expenditures of $3.0 million for equipment purchases and facilities upgrades at the Boca Facility, and $1.8 million to complete the buildout of our plasma collection facilities.
We carry appropriate insurance for these types of instances, and while there can be no assurances ADMA will be reimbursed for the insurance claims made pertaining to these charges, we are actively working with our insurance broker and carriers. 66 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 consolidated financial statements, which have been prepared in accordance with Accounting Principles Generally Accepted in the United States of America (“U.S.
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”).
The Company’s employee stock options have characteristics significantly different from those of traded options, and changes in the underlying Black-Scholes assumptions can materially affect the fair value estimate. To determine the risk-free interest rate, we utilize the U.S. Treasury yield curve in effect at the time of the grant with a term consistent with the expected term of our awards.
To determine the risk-free interest rate, we utilize the U.S. Treasury yield curve in effect at the time of the grant with a term consistent with the term of our awards. The expected term of the options granted is in accordance with U.S.
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. 65 Table of Contents 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.
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.
Significant estimates include rebates and certain other deductions from gross revenues, impairment of long-lived assets, valuation of inventory, assumptions used in projecting future liquidity and capital requirements, assumptions used in the fair value of awards granted under our equity incentive plans and warrants issued in connection with the issuance of notes payable and the valuation allowance for our deferred tax assets.
Critical accounting estimates include rebates and potentially certain other deductions from gross revenues, assumptions used in the fair value of awards granted under our equity incentive plans and estimates related to the valuation allowance for our deferred tax assets. For a description of our significant accounting policies, see Note 2 to the Consolidated Financial Statements.
Cash Flows The following table sets forth a summary of our cash flows for the periods indicated: Years Ended December 31, (in thousands) 2023 2022 2021 Net cash provided by (used in) operating activities $ 8,800 $ (59,508 ) $ (112,369 ) Net cash used in investing activities (4,981 ) (13,911 ) (13,511 ) Net cash (used in) provided by financing activities (38,989 ) 108,852 121,048 Net change in cash and cash equivalents (35,170 ) 35,433 (4,832 ) Cash and cash equivalents - beginning of year 86,522 51,089 55,921 Cash and cash equivalents - end of year $ 51,352 $ 86,522 $ 51,089 Net Cash Provided by (Used in) Operating Activities Cash provided by operations for the year ended December 31, 2023 was $8.8 million, as compared to cash used in operations of $59.5 million for the same period of a year ago.
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.
Loss on Extinguishment of Debt In connection with the refinancing of our senior credit facility on March 23, 2022, we incurred a loss on the extinguishment of debt in the amount of $6.7 million as a result of the redemption premium we paid to retire our previously existing credit facility in the amount of $2.0 million, and the write-off of unamortized debt discount of $4.7 million related to that facility (see Note 7 to the Consolidated Financial Statements).
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 Note 7 to the Consolidated Financial Statements).
Based upon the macroeconomic environment, publicly available information and reports form the U.S. government, we expect this trend to continue in 2024 and potentially longer, which could potentially 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 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.
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.
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.
Net Loss Our net loss was $65.9 million for the year ended December 31, 2022, as compared to $71.6 million for the year ended December 31, 2021.
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.
Any changes in the foregoing Black-Scholes assumptions, or an election by us to utilize an alternative method for valuing stock options granted to employees, directors and officers, could potentially impact our stock-based compensation expense and our results of operations.
Any changes in the foregoing Black-Scholes assumptions, or our election to utilize an alternative method for valuing stock options granted to employees, directors and executive officers, could potentially impact our stock-based compensation expense and our results of operations. 71 Table of Contents Deferred Tax Assets Prior to December 31, 2024, we maintained a full valuation allowance against all of our net deferred tax assets, and as a result we have historically not recorded an income tax benefit in the accompanying consolidated financial statements despite continued losses through December 31, 2023.
The $61.0 million improvement in operating results was mainly due to the improved gross profit of $53.7 million and the lower total operating expenses of $7.3 million. 70 Table of Contents 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.
The $61.0 million improvement in operating results was mainly due to the improved gross profit of $53.7 million, largely driven by the year-over-year revenue growth and shift in revenue mix toward higher margin IVIG products, and the lower total operating expenses of $7.3 million.
These intermediate by-products are used as the starting raw material to produce other plasma-derived biologics. In addition, from time to time we provide contract manufacturing services for certain third-party clients. We also provide laboratory contracting services to certain customers and anticipate providing contract filling, labeling and packing services utilizing our FDA-approved in-house fill-finish capabilities.
We also provide laboratory contracting services to certain customers and may provide contract filling, labeling and packing services utilizing our FDA-approved in-house fill-finish capabilities.
Plasma Center Operating Expenses Plasma center operating expenses increased by $5.6 million to $17.8 million for the year ended December 31, 2022, as compared to $12.3 million for the year ended December 31, 2021.
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.
Following FDA approval in April 2019, commercial sales of ASCENIV commenced in October of 2019 and in 2023 ADMA commenced manufacturing ASCENIV at the 4,400 Liter production scale for the first time in the Company’s history.
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 .
Some of the estimates and assumptions we have to make under U.S. GAAP require difficult, subjective or complex judgments about matters that are inherently uncertain and, as a result, actual results could differ from those estimates.
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.
Through our ADMA BioCenters subsidiary, we currently operate ten source plasma collection facilities in the U.S., all of which hold FDA licenses.
This innovative process has demonstrated an ability to increase production yields by approximately 20% from the same starting plasma volume, potentially driving significant increases to financial targets, if approved. 68 Table of Contents Through our ADMA BioCenters subsidiary, we currently operate ten source plasma collection facilities in the U.S., all of which hold FDA licenses.
As a result, we achieved a gross margin of 22.9% for the year ended December 31, 2022, as compared to a gross margin of 1.4% for the year ended December 31, 2021.
For the year ended December 31, 2023, we had gross profit of $88.9 million, as compared to $35.3 million for the same period of a year ago.
This increase of $39.0 million is primarily attributable to volume-related increases in product revenue costs related to the sale of our immunoglobulin products of $30.4 million and increased product revenue costs related to our ADMA BioCenters business segment in the amount of $4.3 million.
This increase is primarily attributable to volume-driven increases in product revenue costs related to our increased sales of IG products and plasma of $39.5 million and $3.1 million, respectively, partially offset by a reduction in other manufacturing costs, mainly unabsorbed manufacturing expenses, of $5.1 million.
For the year ended December 31, 2023 we had a net loss of loss of $28.2 million and achieved adjusted net income of $0.7 million which, as further described under “Non-GAAP Financial Measures”, excludes charges related to the refinancing of our senior debt of $26.2 million and an IT systems disruption of $2.7 million, as well as positive cash flow from operations, both for the first time in our history.
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.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeWe currently do not utilize any derivative financial instruments, such as interest rate swaps or caps, to mitigate this risk. As of December 31, 2023, we had $135.0 million outstanding under our senior credit facility that is subject to a variable interest rate.
Biggest changeWe 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.
As a result, the effect of a hypothetical, instantaneous and unfavorable change of 100 basis points in the interest rate would have an approximate $1.4 million annualized negative impact on our earnings and cash flows.
As 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.

Other ADMA 10-K year-over-year comparisons