ADMA 10-K & 10-Q changes, risk factors and insider trading

Although we achieved net income on a GAAP basis for the yearyears ended December 31, 2024 forand the first time,2025, we may not be able to maintain profitability andcontinueand continue to generate positive cash flows in the future.

We have a history of losses through December 31, 2023, and we may not be able to maintain profitability. Although we achieved net income of $197.7 million and $146.9 million for the years ended December 31, 2024 and 2025, respectively, for the year ended December 31, 2024, for the years ended December 31, 2023 and 2022, we incurred a net lossesloss of $28.2 million and $65.9 million, respectively.million. From our inception in 2004 through December 31, 2024,2025, we have incurred an accumulated deficit of $308.6$161.7 million. We may not be able to maintain profitability in 2025the or beyond,future, and if we are unable to continue to consistently achieve positive cash flows we may need to finance our operations through additional equity or debt financings or corporate collaboration and licensing agreements. If, in the future, our operating or financial results for a particular period do not meet our guidance, analyst estimates or the expectations of investors, or if we reduce our guidance for future periods, our stock price may decline. Any sustained or increased profitability or financial performance may contribute to increased scrutiny from the investment community and applicable federal, state and foreign regulatory authorities and government bodies. 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:

TheOur COVID-19business pandemiccould negativelybe impactedadversely certainaffected aspectsby health epidemics in regions where we have concentrations of ourbusiness businessactivities and operations.such epidemics could cause significant disruption in the operations of third-party service providers upon whom we rely. The resurgenceoccurrence of the COVID-19 pandemic, or a futureglobal pandemic or health epidemic,epidemic could adversely affect our business, financial condition, liquidity or results of operations. These adverse effects include, but are not limited to, the potential adverse effects on the global economy, our manufacturing processes, including our supply chain, our submissions or applications to the FDA and our employees. The ultimate impact will depend on the severity and duration of the pandemic and actions taken by governmental authorities and other third parties in response, each of which is unforeseeable and difficult to predict.

Third parties may not perform as agreed or in accordance with FDA requirements. Any significant problem that our third-party providers experience could delay or interrupt our supply of finished drug product until the service provider cures the problem or until we locate, negotiate for, validate and receive FDA approval for an alternative provider (when necessary), if one is available.available, which may be time consuming and costly. Failure to obtain the needed services, raw materials and products meeting the necessary quality standardsstandards, in sufficient quantities or at all could have a material and adverse effect on our products, business, financial condition and results from operations.

Although we are utilizing our FDA-approved fill/finish suite that we built at the Boca Facility for a portion of our finished drug product and although we receive our raw material plasma from our ADMA BioCenters plasma collection facilities, we also intend to continue to utilize third parties to supplement our fill/finish process for final drug product and to supply raw material source and high-titer RSV plasma. Any failure by us, our contract fill/finishers, or other third parties involved in the process for producing our products or product candidates to comply with the applicable manufacturing and regulatory requirements, including quality requirements, could place us and them at risk of regulatory enforcement actions, recalls and other adverse consequences, could adversely impact our products, and could adversely impact patients receiving our products, which may negatively impact our business and our ability to produce and supply products to meet commercial and clinical needs.

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.programs, or could result in the need to repeat clinical or preclinical studies. Any failure of any third parties to meet the applicable regulatory requirements could also result in the need for time-consuming and costly corrective actions. In addition, our contract fill/finishers and our other third-party vendors may source their materials and supplies globally and are therefore subject to potential tariffs, which could be passed along to us in whole or in part and adversely impact our results of operations, and supply disruptions in the event of fire, weather related events such as hurricanes, wind and rain, international conflicts, strikes, embargoes, trade and sanction requirements and limits, other acts of God or force majeure events or global health occurrences and emergencies.

Market opportunity estimates and growth forecasts are subject to significant uncertainty and are based on assumptions and estimates that may not prove to be accurate. In particular, the size and growth of the overall U.S. IVIG and source plasma markets and the potential market opportunity for an S. pneumoniae hyperimmune globulin are subject to significant variables that can be difficult to measure, estimate or quantify. Additionally, we anticipate receiving FDA approval by mid-2025 for the PAS for our innovative yield enhancement production process, which has demonstrated an ability to increase production yields by approximately 20% from the same starting plasma volume, potentially driving significant increases to financial targets beginning in the second half of 2025, if approved. Although our financial targets for 2025 and 2026 described in Part 1, Item 1. Business- Overview do not account for the potential FDA approval of our innovative yield enhancement production process, in the event that the FDA does not approve the PAS, or in the event that such approval occurs after mid-2025, our growth rate may be materially impacted.

Our business depends on, among other things, successful manufacturing and commercialization of our existing products, strong payer access to our products, successful medical education initiatives, market acceptance of such products and ensuring that our products are safe and effective. Further, there can be no assurance that we will be able to generate the revenue that we believe our products and plasma collection facilities are capable of generating.generating, including but not limited to our current expectations with respect to our yield enhancement production process, which received FDA approval in April 2025. As a result, we may not be able to accurately forecast or predict revenue. For these reasons, the estimates and forecasts in our filings relating to revenue generation and growth may prove to be inaccurate. Even if the markets in which we compete meet our size estimates and forecasted growth, our business could fail to grow at similar rates, if at all.

Geopolitical conflicts, war or other military action or international acts of terrorism may cause significant disruption to commerce throughout the world. To the extent that such disruptions result in disruptions to our supply chain, delays or cancellations of customer orders, a general decrease in consumer spending, our inability to effectively market and distribute our products and/or our inability to access the capital markets, our business and results of operations could be materially and adversely affected. For example, in response to the ongoing conflict between Russia and Ukraine, the United States has imposed and may further impose, and other countries may additionally impose, broad sanctions or other restrictive actions against governmental and other entities in Russia. Additionally, further escalation of geopolitical tensions, such as ongoing conflicts in certain countries in South America, Northern Africa and in the Middle East and the surrounding areas could have a broader impact that extends into other markets where we do business. Additionally, rapid changes in U.S. trade policy, such as the imposition of additional tariffs and trade barriers, as well as potential retaliatory measures taken by other governments, could increase the price of and/or affect the availability of imported raw materials used in the production of our products. 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.

We and our suppliers and contractors may be unable to comply with our specifications, cGMP requirements and with other FDA, state, and foreign regulatory requirements for commercial and clinical supply. They and us may need to maintain certain licenses that we or they may not be able to maintain. The FDA and other regulatory authorities are authorized to perform inspections (remotely and remotein regulatory assessmentsperson) of our and our suppliers’ facilities, including the Boca Facility. The FDA and other regulatory authorities also may inspect and approve our and our third-parties’ facilities before they may be used for commercial production. If we or our suppliers are not able to comply with the applicable regulatory requirements, we or they may be subject to regulatory enforcement actions, which can materially impact our business. For instance, at the end of such an inspection, the FDA could issue a Form 483 Notice of Inspectional Observations, which could cause the FDA to not approve the use of the facility and cause us to modify certain activities identified during the inspection. Following such inspections, the FDA may issue an untitled letter as an initial correspondence that cites violations that do not meet the threshold of regulatory significance of a warning letter. FDA guidelines also provide for the issuance of warning letters for violations of “regulatory significance” for which the failure to adequately and promptly achieve correction may be expected to result in an enforcement action. FDA also may issue warning letters and untitled letters in connection with events or circumstances unrelated to an FDA inspection. Depending on the seriousness of any findings, we or our suppliers may be subject to additional significant enforcement or other actions and events, may need to undertake product recalls, may have a disruption in the supply of commercial or clinical product, or may need to modify or repeat studies, which could have a material impact on our business.

Our operations, including our headquarters located in Ramsey, NJ, the Boca FacilityFacility, our new real estate in Boca Raton, FL and our plasma collection facilities, are vulnerable to natural disasters (including as a result of climate change), such as interruption by fire,fires, weather related events such as hurricanes, wind and rain, other acts of God or force majeure events, electric power loss, telecommunications failure, equipment failure and breakdown, cyberattacks on our operations and information technology systems as well as the systems of our customers, suppliers and related entities, human error, employee issues, global health occurrences such as a pandemic, global and economic uncertainty, war, terrorism, geopolitical conditions and emergencies, product liability claims and events beyond our control. While we maintain several insurance policies with reputable carriers that provide partial coverage for a variety of these risks, including replacing or rebuilding a part of our facilities, these policies are subject to the insurance carriers’ final determination of compensation to us and we may not have adequate coverage if we need to rebuild or replace our inventory, infrastructure, business income or our entire facility. In addition, our disaster recovery plans for our facilities may not be adequate and we do not have an alternative manufacturing facility or contractual arrangements with other manufacturers in the event of a casualty to or destruction of any of our facilities. If we are required to rebuild or relocate any of our facilities, a substantial investment in improvements and equipment would be necessary. We carry only a limited amount of business interruption insurance, which may not sufficiently compensate us for losses that may occur. As a result, any significant business interruption could adversely affect our business and results of operations.

We cannot be certain as to what type and how many clinical trials the FDA, or equivalent foreign regulatory agencies, will require us to conduct before we may successfully gain approval to market any of our product candidates that still require FDA approval. Prior to approving a new drug or biologic, the FDA generally requires that the effectiveness of the product candidate (which is not typically fully investigated until Phase III) be demonstrated in two adequate and well-controlled clinical trials. However, if the FDA or an equivalent foreign regulatory authority determines that our Phase III clinical trial results do not demonstrate a statistically significant, clinically meaningful benefit with an acceptable safety profile, or if a relevant regulator requires us to conduct additional Phase III clinical trials in order to gain approval, we will incur significant additional development costs and commercialization of these products would be prevented or delayed and our business could be adversely affected. Regulators may also disagree with our interpretation of data from our studies, with our study design, or with the statistical analyses that we use. They may also find issues within our study data, including confounding factors, which make data difficult to interpret.

ADMA Biologics, Inc. (the “Company,” “ADMA,” “we,” “us” or “our”) is ana U.S. based, end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. Our targeted patient populations include immune-compromised individuals who suffer from an underlying immune deficiency disorder or who may be immune-suppressed for medical reasons.

Through our ADMA BioManufacturing business segment, we currently have three products with U.S. Food and Drug Administration (the “FDA”) approval, all of which are currently marketed and commercially available: (i) 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 onin April 1, 2019 and commenced first commercial sales in October 2019; (ii) BIVIGAM (Immune Globulin Intravenous, Human), an IVIG product indicated for the treatment of PI, and for which we received FDA approval onin 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. 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. We have successfully completed production of a pilot-scale batch and are conducting animal studies for our S. pneumoniae hyperimmune globulin program, SG-001. We anticipate submitting a pre-Investigational New Drug (“IND”) package to the FDA in fiscal year 2026, which could enable us to progress development of SG-001 directly into a registrational clinical trial. In September 2025, a Commissioner’s National Priority Voucher (CNPV) application was submitted and, if accepted, could accelerate FDA review by two fiscal quarters or more. Our products and product candidates are intended to be used by physician specialists focused on caring for immune-compromised patients with or at risk for certain infectious diseases.

We manufacture these products at our FDA-licensed, plasma fractionation and purification facility located in Boca Raton, FloridaFL with a peak annual processing capability of up to 600,000 liters (the “Boca Facility”). 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. These revenue targets translate to potential fiscal year 2025 and 2026 Adjusted Net Income exceeding $175 million and $235 million, respectively, and Adjusted EBITDA exceeding $225 million and $305 million, respectively. The foregoing financial targets do not account for the potential FDA approval of our innovative yield enhancement production process described below.products.

Through our ADMA BioCenters subsidiary, we currently operate teneight source plasma collection facilities in the U.S., all of which hold FDA licenses. This business unit, which we refer to as our Plasma Collection Centers business segment, provides us with the blood plasma required for the manufacture of our products, and also allows us to sell certain quantities of source and hyperimmune plasma to third-party customers for further manufacturing. In addition, three one of our FDA-approved plasma collection centers also havehas approvalsapproval from the Korean Ministry of Food and Drug Safety (“MFDS”), asand wellADMA asBioCenters has FDA approval to operate a Hepatitis B immunization program. A typical plasma collection center, such as those operated by ADMA BioCenters, can collect approximately 30,000 to 50,000 liters of source plasma annually, which may be sold for different prices depending upon the type of plasma, quantity of purchase and market conditions at the time of sale. Plasma collected from ADMA BioCenters’ facilities that is not used to manufacture our products is sold to third-party customers in the U.S. and in other locations outside the U.S. where we are approved under supply agreements or in the open “spot” market.

From time to timetime, we may provide contract manufacturing services for certain third-party clients. 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.

For the year ended December 31, 20242024, we achieved net income of $197.7 million, the first time in our history that we achieved net income on a GAAP basis,basis and generated positive cash flow from operations of $118.7 million. Positive cash flow from operations continued throughout fiscal year 2025. Our improved operating results arewere primarily the result of the substantial revenue growth and continued physician, patient and payer acceptance of ASCENIV.

ASCENIV is a plasma-derived IVIG that contains naturally occurring polyclonal antibodies, which are proteins that are used by the body’s immune system to neutralize microbes, such as bacteria and viruses, and prevent against infection and disease. We manufacture ASCENIV under HHS License No. 2019 using a process known as fractionation. The Centers for Medicare and Medicaid Services (“CMS”) has issued a permanent, product-specific-J-code for ASCENIV. Under the Healthcare Common Procedure Coding System (“HCPCS”), the J-code (J1554) became effective in April 1, 2021. As part of our proprietary manufacturing process for ASCENIV, we leverage our unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma and plasma from donors tested to have high levels of neutralizing antibody titers to Respiratory Syncytial Virus (“RSV”) using our proprietary microneutralization testing assay. With our patented testing methods and assay, we are able to identify the high-titer or “hyperimmune” plasma that meets our internal and required specifications for ASCENIV. This type of high-titer plasma is typically found in less than 10% of the total donor collection samples we test.

ASCENIV is approved for the treatment of PIDD or PI, a class of inherited genetic disorders that causes a deficient or absent immune system in adults and adolescents (12 to 17 years of age). Our pivotal Phase 3III clinical trial in 59 PIDD patients met the primary endpoint of no Serious Bacterial Infections (“SBI”) reported during 12 months of treatment. Secondary efficacy endpoints further demonstrated the benefits of ASCENIV in the low incidence of infection, therapeutic antibiotic use, days missed from work, school and daycare and unscheduled medical visits and hospitalizations. We believe this clinical data together with the FDA approval for the treatment of PIDD better positions ADMA to potentially further evaluate ASCENIV in immune-compromised patients infected with or at-risk for RSV infection or potentially other respiratory viral pathogens at an appropriate time. Due to the COVID-19 pandemic, our plans have been delayed. In the future however,future, we may elect to work with the FDA and the immunology and infectious disease community to design an appropriate clinical trial to evaluate the use of ASCENIV in this patient population. 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. ASCENIV’s prescriber and patient base continued to expand during 2024, which drove record utilization and pull-through for this product. These elevated demand trends havecontinued sustainedthroughout intofiscal year 2025, and ADMAwe currentlyexpect expects that thisthe product’s rapid growth willto continue throughoutthrough 20252026 and beyond.

WeIn anticipateJune filing2025, we filed our supplemental Biologics License Application (“sBLA”) in mid-2025, with potential FDA approval in the first half of 2026 for the expansion of ASCENIV’s label to include the pediatric setting for patients who are two years and older.older and we anticipate potential FDA approval in the first half of 2026.

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

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

OnIn December 12, 2023, we announced that the FDA approved the expansion of BIVIGAM’s label in the U.S.United States to now include the pediatric setting for those two years of age and older.

Nabi-HB is a hyperimmune globulin that is rich in antibodies to the Hepatitis B virus. Nabi-HB is a purified human polyclonal antibody product collected from plasma donors who have been previously vaccinated with a Hepatitis B vaccine. Nabi-HB is indicated for the treatment of acute exposure to blood containing HBsAg, prenatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute Hepatitis B virus infection in specific, listed settings. Hepatitis B is a potentially life-threatening liver infection caused by the Hepatitis B virus, which is a major global health problem. The Hepatitis B virus can cause chronic infection and places people at high risk of death from cirrhosis and liver cancer. Nabi-HB has a well-documented record of long-term safety and effectiveness since its initial market introduction. The FDA approved Nabi-HB onin March 24, 1999. Production of Nabi-HB at the Boca Facility has continued under our leadership since the third quarter of 2017. In early 2018, we received authorization from the FDA for the release of our first commercial batch of Nabi-HB for commercial distribution in the U.S. United States and we continue to manufacture Nabi-HB under HHS License No. 2019.

This Management’s Discussion and Analysis of Financial Condition and Results of Operations is based on our condensed consolidated financial statements, which have been prepared in accordance with accountingAccounting principlesPrinciples generally acceptedGenerally Accepted in the United States of America (“U.S. GAAP”). The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses. On an ongoing basis, we evaluate these estimates and assumptions, including those described below. 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. Significant estimates include estimates related to the Company’s effective tax rate.

Some of the estimates and assumptions we haveare required to make under U.S. GAAP require very difficult, subjective and/or complex judgments about matters that are inherently uncertain and, as a result, weactual haveresults identifiedcould differ from those as criticalestimates. Due to the estimation processes involved, the following summary of accounting estimates,estimates whichand their application are considered to be critical to an understanding of our historicalbusiness operations, financial condition and results of operations and are reasonably likely to have a material impact on our future results of operations and financial condition. 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.operations. For a description of our significant accounting policies, see Note 2 to the Consolidated Financial Statements.Statements included in this Annual Report on Form 10-K.

DeferredEffective Tax AssetsRate

* - See Non-GAAP Financial Measures appearing at the end of this discussion 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%. Excluding the $12.6 million adjustment we recorded in the second quarter of 2024 to decrease our accrual for estimated U.S. Medicaid rebates (which had the effect of increasing net revenues by $12.6 million), revenue increased by approximately $155.6 million, or 60%. This increase is primarily related to increased sales of ASCENIV, as we continue to experience increased physician, payer and patient acceptance and utilization of this product, as well as sales increases for some of our other IG products. The revenue increase also includes an increase in sales of normal source plasma (“NSP”) and hyperimmune Hepatitis B plasma by our Plasma Collection Centers business segment in the amount of $2.2 million.

For the year ended December 31, 2024, we had gross profit of $219.6 million, as compared to $88.9 million for the prior year, which represents a gross margin for fiscal 2024 of 51.5%, as compared to 34.4% for fiscal 2023. Excluding the $12.6 million adjustment we recorded in the second quarter of 2024 to reduce our accrual for estimated U.S. Medicaid rebates, our gross profit for the year ended December 31, 2024 was approximately $207.0 million, representing a gross margin of approximately 50.0%. The improvement in gross margin is mainly driven by a significantly more favorable mix of higher margin IG sales in 2024 as compared to 2023, along with the reduction in other manufacturing costs. We expect to see further shifts in our revenue mix toward higher margin IVIG products in fiscal 2025.

Plasma center operating expenses, which primarily consistsconsist of compensation, benefits and travel for plasma center management and administrative staff, along with certain initial opening, marketing and start-up costs, were essentially unchanged at $4.2 million for the year ended December 31, 2024 as compared to approximately $4.3 million for the year ended December 31, 2023.

Selling, general and administrative (“SG&A”) expenses were $74.1 million for the year ended December 31, 2024, an increase of $15.1 million from the year ended December 31, 2023, and reflects an increase in stock-based compensation expense of $6.4 million in 2024, largely due to the higher valuation of grants awarded in 2024 and to additional compensation expense recognized for the modification of certain outstanding equity awards. The increase in SG&A also reflects increases in employee-related costs, including salaries and wages, benefits, relocation and recruiting, in the aggregate amount of $4.8 million, software maintenance expense of $1.2 million, consulting and professional fees of $0.9 million, audit and tax fees of $0.6 million, insurance expense of $0.6 million and temporary labor expense of $0.7 million. SG&A expenses as a percentage of net revenues decreased from 22.9% in fiscal 2023 to 17.4% in fiscal 2024.

Interest expense for the year ended December 31, 2024 was $13.9 million, as compared to $25.0 million for the year ended December 31, 2023. Prior to the refinancing of our senior debt on December 18, 2023 (see “Liquidity and Capital Resources”), our outstanding debt principal balance throughout 2023 ranged between $155.1 million and $158.6 million. The refinancing transaction reduced our debt principal to $135.0 million as of December 31, 2023, and we made additional principal payments on this indebtedness of $30.0 million on each of August 14, 2024 and December 19, 2024, reducing our debt principal balance to $75.0 million as of December 31, 2024. In addition, the stated interest rate on our debt during 2024 was approximately 10.1%, as compared to approximately 13.9% during 2023. We also incurred lower expense related to the amortization of debt discount in 2024 in the amount of $1.6 million. We expect our interest expense to continue to decline in 2025 due to the reduced debt principal balance and potential further repayments on our outstanding debt.

As a result of the prepayment we made on our senior debt on December 19, 2024, we incurred a prepayment penalty in the amount of $0.45 million and recorded a partial write-down of unamortized debt discount of approximately $0.8 million, for a loss on this partial extinguishment of debt in the amount of $1.2 million. In connection with the 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 iswas 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).million.

We recorded a total income tax benefit of $72.0 million for the year ended December 31, 2024, with no comparable amount for the year ended December 31, 2023. The provision for income taxes for fiscal 2024 includes a deferred tax benefit of $84.3 million related to the release of the valuation allowance against our net deferred tax assets, partially offset by current income tax expense of $12.3 million, which reflects federal and state income tax liabilities that are not fully sheltered by NOLs due to limitations from prior ownership changes and other limitations on net operating loss carryforwards under the Internal Revenue Code of 1986, as amended (see “Risk Factors - Our ability to use our net operating loss carryforwards (“NOLs”) may be limited.” appearing elsewhere in this report and Note 11 to the Consolidated Financial Statements). We expect that we will record income tax expense in 2025 and beyond as we expect to continue to generate additional taxable income for the foreseeable future.

Although we have received approval from the FDA to market ASCENIV as a treatment for PIDD, our ability to market or seek approval for ASCENIV for alternative indications could be limited unless additional clinical trials are conducted successfully and the FDA approves a Biologics License Application (“BLA”) or other required submission for review.

Described below are various risks and uncertainties that may affect our business. These risks and uncertainties are not the only ones we face. You should recognize that other significant risks and uncertainties may arise in the future, which we cannot foresee at this time. Also, the risks that we now foresee might affect us to a greater or different degree than expected. Certain risks and uncertainties, including ones that we currently deem immaterial or that are similar to those faced by other companies in our industry or business in general, may also affect our business. If any of the risks described below actually occur, our business, financial condition orcondition, results of operations operationsor cash flows could be materially and adversely affected. You should carefully consider the following risk factors and the section entitled “Special Note Regarding Forward-Looking Statements” before you decide to invest in our securities.

Although we achieved net income of $197.7 million and $146.9 million for the years ended December 31, 2024 and 2025, respectively, for the year ended December 31, 2023 we incurred a net loss of $28.2 million. From our inception in 2004 through December 31, 2025, we have incurred an accumulated deficit of $161.7 million. We may not be able to maintain profitability in the future, and if we are unable to continue to consistently achieve positive cash flowsflows, we may need to finance our operations through additional equity or debt financings or corporate collaboration and licensing agreements. If, in the future, our operating or financial results for a particular period do not meet our guidance, analyst estimates or the expectations of investors, or if we reduce our guidance for future periods, our stock price may decline. Any sustained or increased profitability or financial performance may contribute to increased scrutiny from the investment community and applicable federal, state and foreign regulatory authorities and government bodies. 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:

Although we are utilizing our FDA-approved fill/finish suite that we built at the Boca Facility for a portion of our finished drug product and although we receive raw material plasma from our ADMA BioCenters plasma collection facilities, we also intend to continue to utilize third parties to supplement our fill/finish process for final drug product and to supply raw material source and high-titer RSV plasma. 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,products or product candidates, and could adversely impact patients receiving our products,products or product candidates, which may negatively impact our business and our ability to produce and supply products to meet commercial and clinical needs.

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 or clinical needs;

contractors may not be able to execute our inspection procedures and required tests appropriately or timely, and we may be reliant on a single or limited number of contract laboratories;

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, or could result in the need to repeat clinical or preclinical studies. Any failure of any third parties to meet the applicable regulatory requirements could also result in the need for time-consuming and costly corrective actions. In addition, our contract fill/finishers and our other third-party vendors may source their materials and supplies globally and are therefore subject to potential tariffs, which could be passed along to us in whole or in part and adversely impact our results of operations, and supply disruptions in the event of fire, weather related events such as hurricanes, earthquakes, 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.emergencies which could materially impact our ability to manufacture our products and product candidates and therefore adversely impact our business and results of operations.

Our market opportunity estimates and growth forecasts are subject to significant uncertainty and are based on assumptions and estimates that may not prove to be accurate. In particular, the size and growth of the overall U.S. IVIG and source plasma markets and the potential market opportunity for our products and product candidates, including an S. pneumoniae hyperimmune globulinglobulin, are subject to significant variables that can be difficult to measure, estimate or quantify.

Geopolitical conflicts, war or other military action or international acts of terrorism may cause significant disruption to commerce throughout the world. To the extent that such disruptions result in disruptions to our supply chain, delays or cancellations of customer orders, a general decrease in consumer spending, our inability to effectively market and distribute our products and/or our inability to access the capital markets, our business and results of operations could be materially and adversely affected. For example, in response to the ongoing conflictconflicts between Russia and Ukraine, Ukraine,and between the United States and Iran, the United States has imposed and may further impose, and other countries may additionally impose, broad sanctions or other restrictive actions against governmental and other entities in Russia. Additionally, further escalation of geopolitical tensions, such as ongoing conflicts in certain countries in South America, Northern Africa and in the Middle East and the surrounding areas could have a broader impact that extends into other markets where we do business. 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.

Our operations, including our headquarters located in Ramsey, New Jersey, the Boca Facility, our new real estate in Boca Raton, Florida and our plasma collection facilities, are vulnerable to natural disasters (including as a result of climate change), such as interruption by fires, weather related events such as hurricanes, earthquakes, wind and rain, other acts of God or force majeure events, electric power loss, telecommunications failure, equipment failure and breakdown,breakdown including the disruption or misalignment of specialized laboratory machinery, 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. While we maintain several insurance policies with reputable carriers that provide partial coverage for a variety of these risks, including replacing or rebuilding a part of our facilities, these policies are subject to the insurance carriers’ final determination of compensation to us and we may not have adequate coverage if we need to rebuild or replace our inventory, infrastructure, business income or our entire facility. facilities. In addition, our disaster recovery plans for our facilities may not be adequate and we do not have an alternative manufacturing facility or contractual arrangements with other manufacturers in the event of a casualty to or destruction of any of our facilities. If we are required to rebuild or relocate any of our facilities, a substantial investment in improvements and equipment would be necessary. We carry only a limited amount of business interruption insurance, which may not sufficiently compensate us for losses that may occur. As a result, any significant business interruption could adversely affect our business, businessfinancial condition and results of operations.

If we are unsuccessful in obtaining regulatory approval for any of our product candidates or if any of our product candidates do not provide positive results, we may be required to delay or abandon development of such product,product candidate, which would have a material adverse impact on our business.

We cannot be certain as to what type and how many clinical trials the FDA, or equivalent foreign regulatory agencies, will require us to conduct before we may successfully gain approval to market any of our product candidates that still require FDAregulatory approval. Prior to approving a new drug or biologic, the FDA generally requires that the effectiveness of the product candidate (which is not typically fully investigated until Phase III) be demonstrated in two adequate and well-controlled clinical trials. However, if the FDA or an equivalent foreign regulatory authority determines that our Phase III clinical trial results do not demonstrate a statistically significant, clinically meaningful benefit with an acceptable safety profile, or if a relevant regulator requires us to conduct additional Phase III clinical trials in order to gain approval, we will incur significant additional development costs and commercialization of these productsproduct candidates would be prevented or delayed and our business could be adversely affected. Regulators may also disagree with our interpretation of data from our studies, with our study design, or with the statistical analyses that we use. They may also find issues within our study data, including confounding factors, which make data difficult to interpret.

In addition, the FDA or an institutional review board (“IRB”) may not permit us to commence a clinical trial, may require amendments to our clinical trial protocols, or may suspend our clinical trials at any time if it appears that we are exposing participants to unacceptable health risks or if the FDA or an IRB finds deficiencies in our IND submissions or the conduct of these trials. Regulatory authorities may also not accept data from clinical trials if the trials are not conducted in accordance with the applicable regulatory requirements. Failure to comply with the applicable regulatory requirements may also result in enforcement actions. Therefore, we cannot provide any assurance or predict with certainty the schedule for future clinical trials. In the event we do not ultimately receive regulatory approval for our product candidates, we may be required to terminate development of such product candidates. If we fail to obtain regulatory approval to market and sell our product candidates, or if approval is delayed, we will be unable to generate revenue from the sale of these products,product our potential for generating positive cash flows will be diminishedcandidates and the capital necessary to fund our operations will increase.

FDA or comparable foreign regulatory authorities taking longer than we anticipate to make decisions on our products or product candidates; and Potential inability to demonstrate that aour product orcandidates product candidate providesprovide an advantage over current standards of care or current or future competitive therapies in development.

If we are not able to generate revenue from our products and product candidates, our sources of revenue may continue to be from a product mix consisting only of plasma collection and sales revenues, revenues generated from sales of our FDA-approved commercial products, sales of intermediates and revenues generated from new contract manufacturing arrangements with third parties. We cannot assure you that we will receive the approvals necessary to commercialize any product candidate we may acquire or develop in the future or that we will be able to maintain our currentsuch approvals. In order to obtain FDA approval of any product candidate requiring FDA approval, our clinical development must demonstrate that the product candidate is safe for humans and effective for its intended use, and we must successfully complete an FDA BLA review. Obtaining FDA approval of a product candidate generally requires significant research and testing, referred to as preclinical studies, as well as human tests, referred to as clinical trials. Satisfaction of the FDA’s regulatory requirements typically takes many years, depends upon the type, complexity and novelty of the product candidate and requires substantial resources for research, development and testing. We cannot predict whether our research and clinical approaches will result in products that the FDA considers safe for humans and effective for indicated uses. The FDA has substantial discretion in the product approval process and may require us to conduct additional preclinical and clinical testing or to perform post-marketing studies or may require additional Chemistry, Manufacturing, and Controls (“CMC”) or other data and information, and the development and provision of this data and information may be time-consuming and expensive. The approval process may also be delayed by changes in government regulation, future legislation or administrative action or changes in FDA policy that occur prior to or during our regulatory review. Delays in obtaining regulatory approvals may:

Even if we comply with all FDA requests, the FDA may ultimately reject our product candidate’s BLA. In addition, the FDA could determine that we must test additional subjects and/or require that we conduct further studies with more subjects. We may never obtain regulatory approval for any future potential product candidate or label expansion activity. Failure to obtain FDA approval 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. In foreign jurisdictions, we must receive approval from the appropriate regulatory authorities before we can commercialize any products orin such product candidates outside the U.S.jurisdictions. Foreign regulatory approval processes generally include all of the risks and uncertainties associated with the FDA review, inspection and approval procedures described above. We cannot assure you that we will receive the approvals necessary to commercialize any product candidate for sale outside the United States.

We depend on independent investigators and collaborators, such as universities and medical institutions, contract laboratories, CROs, contract manufacturers, contract fill/finishers, third-party plasma centers and consultants to conduct our preclinical activities, clinical trials, CMC testing and other activities under agreements with us. These collaborators are not our employees and we cannot control the amount or timing of resources that they devote to our programs. These third parties may not assign as great a priority to our programs or pursue them as diligently as we would if we were undertaking such programs ourselves. If outside collaborators fail to devote sufficient time and resources to our products and/or development programs, or if their performance is substandard or does not comply with the applicable regulatory standards, our trials may be repeated, extended, delayed, or terminated, the approval of our FDA application(s), if any, and our introduction of new products, if any, will be delayed, and we may not be able to maintain existing approvals or meet our regulatory requirements or we may not be able to produce forecasted amounts of product. We or they may also be subject to regulatory enforcement actions, may need to take corrective actions, including initiating recalls, and we may not be able to meet commercial demand. These collaborators may also have relationships with other commercial entities, some of whom may compete with us. If our collaborators assist our competitors at our expense, our competitive position would be harmed. We also depend on third-party suppliers for materials used in our operations. Certain of our third-party suppliers may be single-sourced, or may not be able to supply sufficient materials for our operations at a reasonable price,price or on a timely basis, and it may be time-consuming, expensive or otherwise not feasible to locate an alternative supplier. In the event a single-source supplier is unable to provide us with a sufficient amount of materials,materials on a timely basis, such shortage and/or delay could have a material adverse effect on our business, results of operations and financial condition. Additionally, any change in the regulatory compliance status of any of our vendors may impede our ability to receive and maintain approval for our product candidates.

● clinical holds or termination of clinical trials;

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

For the threesix months ended MarchJune 31,30, 2026 and 2025, two customers, BioCare, Inc. (“BioCare”) and Priority Healthcare Distribution, Inc. d/b/a CuraScript SD Specialty Distribution (“Curascript”), represented an aggregate of approximately 71%67% and 64%,72%, respectively, of our consolidated revenues.

As of MarchJune 31,30, 2026, two customers, BioCare and Curascript,Curascript represented an aggregate of approximately 82%81% of our consolidated accounts receivable. As of December 31, 2025, two customers, BioCare and CuraScript, CuraScript represented an aggregate of approximately 87% of our consolidated accounts receivable.

Personal information that we obtain pursuant to a clinical trial may be subject to U.S. Federal Trade Commission (the “FTC”) privacy regulation. Failing to take appropriate steps to keep consumers’ personal information secure may constitute an unfair act or practice violating Section 5(a) of the Federal Trade Commission Act, 15 U.S.C § 45(a). The FTC expects a company’s data security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexity of its business, and the cost of available tools to improve security and reduce vulnerabilities. Medical data is considered sensitive data that merits stronger safeguards. The FTC’s guidance for appropriately securing consumers’ personal information is similar to, but less prescriptive than, what is required by the HIPAA Security Rule. In addition, states impose a variety of laws protecting consumer information, with certain sensitive information such as HIV/Sexually Transmitted Infection status subject to heightened standards. In addition, federal and state privacy, data security, and breach notification laws, rules and regulations, and other laws apply to the collection, use and security of personal information, such as Social Security Numbers, driver’s license numbers, government identifiers, credit card and financial account numbers. For example, the California Consumer Privacy Act (“CCPA”) was amended by the CPRA,California Privacy Rights Act, effective January 1, 2023. The CCPA, among other things, imposes data privacy obligations for covered companies and provides new privacy rights to California residents, including the right to opt out of certain disclosures of their information. The CCPA also creates a private right of action with statutory damages for certain data breaches, thereby potentially increasing risks associated with data breach. We could be subject to enforcement action and litigation exposure if we fail to adhere to these data privacy and security laws. Virginia, Colorado, Connecticut and Utah have also enacted privacy laws that became effective in 2023 and are similar in many respects to the CCPA. 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.

On August 5, 2025 ( the “JPM Closing Date”),Date, we entered into a credit agreement with JPMorgan and certain other lenders party thereto (the “JPM Credit Agreement”) (see “Liquidity and Capital Resources”). The JPM Credit Agreement provides for a total of $300 million in senior secured credit facilities (the “JPM Credit Facilities”) consistingof which $198.1 million is outstanding as of (i)June a30, term loan in the aggregate principal amount of $75 million, which was drawn in full on the JPM Closing Date, and (ii) a revolving credit facility in the aggregate principal amount of up to $225 million (collectively, the “JPM Loans”), none of which was drawn on the JPM Closing Date.2026. The JPM Credit Facilities Facility hashave a maturity date of August 5, 2028.

As we move forward in clinical development, we continue to discover novel technologies related to our products and product candidates 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. There can be no assurance that our patents, trade secret policies and practices or other agreements will adequately protect our intellectual property. Our issued patents may be challenged, found to be over-broad or otherwise invalidated in subsequent proceedings before courts, the U.S. Patent and Trademark Office or foreign patent offices. Even if enforceable, we cannot provide any assurances that they will provide significant protection from competition. The processes, systems, and/or security measures we use to preserve the integrity and confidentiality of our data and trade secrets may be breached, and we may not have adequate remedies as a result of any such breaches. In addition, our trade secrets may otherwise become known or be independently discovered by competitors. There can be no assurance that the confidentiality, 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. 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.

In the ordinary course of our business, we generate, collect and store proprietary information, including intellectual property and business information. The secure storage, maintenance, and transmission of and access to this information is important to our operations and reputation. Computer hackers may attempt to penetrate our computer systems and, if successful, misappropriate personal data and our proprietary and confidential information including e-mails and other electronic communications. Cybersecurity vulnerabilities can also arise from human error, fraud or malice on the part of our employees, other insiders, vendors, suppliers, other third parties, or from technology or product enhancements or the migration of information and data to new technology platforms, systems or applications. Hackers and other threat actors may impersonate our vendors, suppliers or other third parties with whom we do business, which may result in financial harm to our business. Further, while many of our employees and certain suppliers with whom we do business operate in a remote working environment, the risk of cybersecurity attacks and data breaches, particularly through phishing attempts and ransomware attacks, may be increased as we and third parties with whom we interact leverage our IT infrastructure in unanticipated ways. In addition, an employee, contractor, or other third parties with whom we do business may attempt to obtain such information and may purposefully or inadvertently cause a breach involving such information. While we have certain safeguards in place to reduce the risk of and detect cyberattacks, including a Company-wide cybersecurity policy,policy and annual training, our information technology networks and infrastructure may be vulnerable to unpermitted access by hackers or other breaches, or employee error or malfeasance. Any such compromise of our data security and access to, integrity, availability of, or public disclosure or loss of, confidential business or proprietary information could disrupt our operations, damage our reputation, provide our competitors with valuable information and subject us to additional costs which could adversely affect our business and reputation. We have set out in our 2025 10-K our obligations relating to cybersecurity under certain laws and potential liabilities and risks arising from any infringements under these laws. We may also be subject to additional industry-specific privacy, cybersecurity, data protection, operational and information systems resilience, and artificial intelligence-related laws in the applicable jurisdictions which may subject us to additional similar risks and impacts.

We have engaged a third-party firm to assist the Company with the development and deployment of an AI tool, ADMAlytics, to improve efficiencies across our supply chain, production, and commercial operations. This tool has been used to assist with activities including plasma pool composition and identifying other manufacturing efficiencies to streamline certain operational processes. While we have successfully implemented ADMAlytics in certain aspects of our commercial manufacturing and expanded its use throughout fiscal year 2025,2025 and into 2026, the development, implementation, and ongoing use of AI technologies involve inherent risks. While ADMA has not experienced any issues to date, these risks include potential data inaccuracies, flawed assumptions, system errors, cybersecurity vulnerabilities, unintended outcomes, and difficulties in integrating AI-driven insights into complex and highly regulated manufacturing and operational environments. If ADMAlytics fails to perform as intended or produces unreliable or biased outputs, our reputation could be harmed and we could be subject to legal exposure, which could adversely affect our business, results of operations, and financial condition.

The laws governing our conduct in the United States are enforceable on the federal, state and local levels by criminal, civil and administrative sanctions. Violations of laws such as the FDCA,Federal Food, Drug and Cosmetic Act (the “FDCA”), the Social Security Act (including the Anti-Kickback Statute), the Public Health Service Act, the civil and criminal federal False Claims Act, the civil monetary penalty statute, requirements regarding the reporting and repayment of overpayments, other fraud and abuse laws and any regulations promulgated under the authority of the preceding, may result in significant criminal and/or civil sanctions, including criminal fines, imprisonment, civil monetary penalties and damages, exclusion from participation in federal healthcare programs (including Medicare and Medicaid), suspension and debarment from government contracts, and refusal of orders under existing government contracts, pursuant to enforcement actions by DOJ, CMS, OIG and other regulatory authorities. Similarly, the violation of applicable laws, rules and regulations of states, including the State of Florida, with respect to the manufacture and marketing of our products and product candidates may result in significant criminal and/or civil sanctions, including jail sentences, fines or exclusion from participation in applicable state healthcare programs. There can be no assurance that our activities will not come under the scrutiny of federal and/or state regulators and other government authorities or that our practices will not be found to violate applicable laws, rules and regulations or prompt lawsuits by private citizen “relators” under federal or state false claims laws.

Also, certain business practices, such as payments of consulting fees to healthcare professionals, sponsorship of educational or research grants, charitable donations, interactions with healthcare professionals who prescribe products for uses not approved by the FDA and financial support for continuing medical education programs, must be conducted within narrowly prescribed and controlled limits to avoid any possibility of wrongfully influencing healthcare professionals to prescribe or purchase particular products or as a reward for past prescribing. Under the ACA and the companion Healthcare and Education Reconciliation Act of 2010 (which together are referred to as the “Healthcare Reform Law,Law”), payments and transfers of value by pharmaceutical manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to or at the request of covered recipients, such as, but not limited to, U.S.-licensed physicians, physician assistants, nurse practitioners, clinical nurse specialists and certified registered nurse anesthetists and U.S. teaching hospitals, must be tracked and reported to CMS, and are publicly disclosed. Such “applicable manufacturers” are also required to report certain ownership interests held by physicians and their immediate family members. A number of states have similar laws in place. Additional and stricter prohibitions could be implemented by federal and state authorities. Where such practices have been found to be improper incentives to use such products, government investigations and sanctions against manufacturers have resulted in substantial fines, penalties and damages. Many manufacturers have been required to enter into consent decrees or orders that prescribe allowable corporate conduct and/or Corporate Integrity Agreements that impose ongoing compliance requirements on a manufacturer.

The ACA and the companion Healthcare and Education Reconciliation Act (which together are referred to as the “ Healthcare Reform Law”) introduced an abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to an FDA-licensed biological product. A biological product may be demonstrated to be “biosimilar” if data shows that, among other things, the product is “highly similar” to an already-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. The law provides that a biosimilar application may be submitted as soon as four years after the reference product is first licensed, and that the FDA may not make approval of an application effective until 12 years after the reference product was first licensed. This exclusivity period, however, is subject to certain limitations. For example, the exclusivity only applies to the first licensure of a product, as defined in statute and FDA guidance, and, thus, not all BLAs will have exclusivity protection. There may also be future legislative efforts to decrease this period of exclusivity. The FDA also may not consider a particular biologic to be a reference product or competitors may pursue full traditional BLAs, rather than the biosimilar pathway, which full BLAs would not be blocked by the regulatory exclusivity. Moreover, following the submission of a biosimilar application, we may need to institute patent infringement actions or may be subject to actions for declaratory judgment, which may be time consuming and costly.

The JPM Credit Facilities provide for total senior secured loans in an aggregate principal amount of $300.0 million, of which $74.0$198.1 million is currently outstanding.outstanding as of June 30, 2026. The borrowing under the JPM Credit Facilities currently bears interest at a rate equal to approximately 6.4%6.12% per annum, which reflects the one-month term SOFR rate; provided, however, that upon, and during the continuance of, an event of default, the interest rate will automatically increase by an additional 200 basis points. We are currently required to make (i) payments of interest for our revolving facility, at quarterly, one-month or three-month intervals, depending upon the type of borrowing, during the remaining term of the JPM Credit Facilities, with all principal and unpaid interest due at maturity, and (ii) principal under our term loan facility, in accordance with and on the dates specified in the amortization schedule set forth in the JPM Credit Agreement, through the JPM Term Maturity Date. In addition, our monthly interest rate obligation under our revolving facility is subject to rising interest rates. The JPM Credit Facilities are subject to acceleration pursuant to the JPM Credit Agreement, including upon an event of default. All of our obligations under the JPM Credit Facilities are secured by a first-priority lien and security interest in substantially all of our and our subsidiaries’ tangible and intangible assets, including intellectual property, and all of the equity interests in our subsidiaries.

Our ability to use our net operating loss carryforwards (“NOLs”) may be limited.

We have incurred substantial losses during our history. As of December 31, 2025, we had federal and state NOLs of $265.6 million and $176.9 million, respectively. Federal and state NOLs of approximately $33.4 million and $62.0 million, respectively, will begin to expire at various dates beginning in 2029, if not limited by triggering events prior to such time. Under the provisions of the Internal Revenue Code of 1986, as amended (the “Code”), changes in our ownership, in certain circumstances, will limit the amount of federal NOLs that can be utilized annually in the future to offset taxable income. In particular, Section 382 of the Code ("Section 382") imposes limitations on a company’s ability to use NOLs upon certain changes in such ownership. If we are limited in our ability to use our NOLs in future years in which we have taxable income, we will pay more taxes than if we were able to fully utilize our NOLs. The acquisition transaction that we completed onin June 6, 2017,2017 resulted in a change in ownership of ADMAthe Company under Section 382 and, as a result, we were required to write off $57.6 million of federal NOLs. OnIn October 25, 2021, we completed a public offering of our common stock whereby we issued 57,500,000 shares of our common stock resulting in another change of ownership for ADMA under section 382 of the Code, resulting in an additional write-off of $3.0 million of federal NOLs, $28.1 million of state NOLs and $1.0 million of research and development credits. Although we did not experience any ownership changes for the years ended December 31, 2025, 2024 and 2023, we may experience ownership changes in the future as a result of subsequent changes in our stock ownership that we cannot predict or control that could result in further limitations being placed on our ability to utilize our federal NOLs.

We are subject to taxes by the U.S. federal, state, and local tax authorities. We record income tax expense based on our estimates of future payments, which may include the recording of, or adjustments to, liabilities for uncertain tax positions, and the determination of a need for a valuation allowance related to our net deferred tax assets. In addition, at any one timetime, multiple tax years may be subject to audit by various tax authorities. The results of these audits and negotiations with taxing authorities may affect the ultimate settlement of these issues and impact our results of operations. For fiscal year 2026 and beyondbeyond, there could be ongoing variability in our effective tax rate as events occur and exposures are evaluated. The volatility of our future effective tax rate could be materially impacted by a number of factors, including:

variations in our anticipated or actual operating results; and change in securities analysts’ estimates of our performance, or our failure to meet analysts’ expectations.

As of MayJuly 1,31, 2026, most of our 231,772,715223,984,680 outstanding shares of common stock, were available for sale in the public market, subject to certain restrictions with respect to sales of our common stock by our affiliates, either pursuant to Rule 144 under the Securities Act, or under effective registration statements. Sales of a substantial number of shares of our common stock, or the perception that such sales may occur, could cause the market price of our common stock to decline or adversely affect demand for our common stock.

As of MarchJune 31,30, 2026, BlackRock, Inc., State Street Corporation, Invesco Ltd., Vanguard Capital Management LLC and our directors and executive officers and their affiliates owned approximately 30% of the outstanding shares of our common stock. Provisions of our Certificate of Incorporation, our Bylaws and Delaware law may have the effect of deterring unsolicited takeovers or delaying or preventing a change in control of our Company or changes in our management, including transactions in which our stockholders might otherwise receive a premium for their shares over then current market prices. In addition, these provisions may limit the ability of stockholders to approve transactions that they may deem to be in their best interests. These provisions include:

Through our ADMA BioManufacturing business segment, we currently have three products with U.S. Food and Drug Administration (the “FDA”) approval, all of which are currently marketed and commercially available: (i) ASCENIV (Immune Globulin Intravenous, Human – slra 10% Liquid), an Intravenousintravenous Immuneimmune Globulinglobulin (“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 children ages two and above, for which we received FDA approval in April 2019 and commenced first commercial sales in October 2019; (ii) BIVIGAM (Immune Globulin Intravenous, Human), an IVIG product indicated for the treatment of PI,PI in adults and children ages two and above, and for which we received FDA approval in May 2019 and commenced commercial sales in August 2019; and (iii) Nabi-HB (Hepatitis B Immune Globulin, Human), which is indicated for the treatment of acute exposure to blood containing Hepatitis B surface antigen (“HBsAg”) and other listed exposures to Hepatitis B. WeIn seekaddition to developour commercially aavailable pipelineimmunoglobulin products, we generate revenues from the sale of plasma-derivedintermediate therapeutics,by-products includingthat aresult productfrom basedthe onimmunoglobulin our most recently approved patent application under U.S. Patent Nos. 10,259,865production process and 11,084,870from relatedtime to methodstime ofprovide treatmentcontract manufacturing and prevention of S. pneumonia infection for an immunoglobulin manufactured to contain standardized antibodies to numerous serotypes of S. pneumoniae. We have successfully completed production of a pilot-scale batch and are conducting animal studies for our S. pneumoniae hyperimmune globulin program, SG-001. We anticipate submitting a pre-Investigational New Drug (“IND”) package to the FDA in fiscal year 2026, which could enable us to progress development of SG-001 directly into a registrational clinical trial. Our products and product candidates are intended to be used by physician specialists focused on caring for immune-compromised patients with or at risklaboratory services for certain infectious diseases.clients.

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

Through our ADMA BioCenters subsidiary, we currently operate seven source plasma collection facilities in the U.S., all of which hold FDA licenses. This business unit, which we refer to as our Plasma Collection Centers business segment, provides us with a significant portion of the blood plasma required for the manufacture of our products, and also allows us to sell certain quantities of source and hyperimmune plasma to third-party customers for further manufacturing. In addition, oneeach of our FDA-approved plasma collection centers also has approval from the Korean Ministry of Food and Drug Safety (“MFDS”),Safety, and ADMA BioCenters has FDA approval to operate a Hepatitis B immunization program. A typical plasma collection center, such as those operated by ADMA BioCenters, can collect approximately 30,000 to 50,000 liters of source plasma annually, which may be sold for different prices depending upon the type of plasma, quantity of purchase and market conditions at the time of sale. Plasma collected from ADMA BioCenters’ facilities that is not used to manufacture our products is sold to third-party customers in the U.S. and in other locations outside the U.S. where we are approved under supply agreements or in the open “spot” market.

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 onin aaccordance with accounting principles generally accepted in the United States of America (“U.S. GAAP basis”), and generated positive cash flows from operations of $118.7 million. Positive cash flows from operations continued throughout fiscal year 2025. Our improved operating results were primarily the result of the substantial revenue growth and continued physician, patient and payer acceptance of ASCENIV.

In April 2025, the FDA approved our Prior Approval Supplement (thea “PAS”) for our innovative yield enhancement production process (the “Yield Enhancement”) benefiting both ASCENIV and BIVIGAM. This PAS approval amends the Biologics License Application (“BLA”) approvals for ASCENIV and BIVIGAM and will continue to be the process by which we will manufacture these products on a go-forward basis. The production methods approved in this PAS have started to resultresulted in additional bulk drug yield from the same starting raw material source plasma volumes and thewe Companybelieve believes itwe should experience meaningful revenue and earnings accretion accelerating further into 2026 and beyond. This innovative process has demonstrated an ability to increase ASCENIV and BIVIGAM production yields by 20% or more from the same starting source plasma volume. Fiscal year 2026 will beis our first full year of yield-enhanced production, supporting anticipated sustained margin expansion.

In December 2025, we entered into an agreement for the divestiture of three of our plasma collection centers for an aggregate purchase price of $12.0 million. The sale of these plasma centers was completed during the first quarter of 2026. We continue to own and operate seven plasma collection centers. In conjunction with the divestiture agreement, we entered into a long-term respiratory syncytial virus (“RSV”) plasma supply agreementsagreement with the purchaser of the three plasma collection centers, further diversifying our third-party high-titer plasma supply base. Collectively, these actions reflect a deliberate focus on a more flexible, capital-efficient supply model and are expected to deliver accretive cost savings in fiscal year 2026, improve capital efficiency, support increased ASCENIV production capacity, and provide durable plasma supply confidence through the late 2030s.

Beginning in the second half of 2025 and continuing into the first quarter of 2026, new FDA-approved IVIG products, and other pharmaceutical products which compete with certain IVIG product uses, entered the market with aggressive pricing tactics, including extended payment terms, rebates and discounts. This has led to increases in raw material plasma supply and finished goods inventory across the distribution network. This created competitive competitive intensity and distribution recalibration across the industry which has impacted impactedour ourresults for the first quarterhalf of 2026 results,2026, mainly as it relates to BIVIGAM, but but broadly across the IVIG complex. If this trend of competitive pricing tactics tactics continues, future results and penetrationmarket adoption for our products may be adversely adversely impacted.

ASCENIV is a plasma-derived IVIG product that contains naturally occurring polyclonal antibodies, which are proteins that are used by the body’s immune system to neutralize microbes, such as bacteria and viruses, and prevent against infection and disease. We manufacture ASCENIV under U.S. Department of Health and Human Services (“HHS”) License No. 2019 using a process known as fractionation. The Centers for Medicare and Medicaid Services (“CMS”) has issued a permanent, product-specific-J-code for ASCENIV. Under the Healthcare Common Procedure Coding System (“HCPCS”),System, the J-code (J1554) became effective in April 2021. As part of our proprietary manufacturing process for ASCENIV, we leverage our unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma and plasma from donors tested to have high levels of neutralizing antibody titers to respiratory syncytial virus (“RSV”) using our proprietary microneutralization testing assay. With our patented testing methods and assay, we are able to identify the high-titer or “hyperimmune” plasma that meets our internal and required specifications for ASCENIV. This type of high-titer plasma is typically found in less than 10% of the total donor collection samples we test.

ASCENIV is approved for the treatment of PIDD or PI, a class of inherited genetic disorders that causes a deficient or absent immune system in adults and children ages two and above. Our pivotal Phase III clinical trial in 59 PIDD patients met the primary endpoint of no Serious Bacterial Infections (“SBI”) reported during 12 months of treatment. Secondary efficacy endpoints further demonstrated the benefits of ASCENIV in the low incidence of infection, therapeutic antibiotic use, reduced days missed from work, school and daycare and reduced unscheduled medical visits and hospitalizations. We believe this clinical data together with the FDA approval of ASCENIV for the treatment of PIDD better positions ADMA to potentially further evaluate ASCENIV in immune-compromised patients infected with or at-risk for RSV infection or potentially other respiratory viral pathogens at an appropriate time. In the future, we may elect to work with the FDA and the immunology and infectious disease community to design an appropriate clinical trial to evaluate the use of ASCENIV in this patient population. Following FDA approval in April 2019, commercial sales of ASCENIV commenced in October 2019 and in 2023 we commenced manufacturing ASCENIV at the 4,400 Liter 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. ASCENIV’s prescriber and patient base continued to expand during 2024 and 2025, which drove record end-user utilization and pull-through for this product. These elevated demand trends have sustained into 2026, and we currently expect that this product’s rapid growth will continue throughout 2026 and beyond.

BIVIGAM is a plasma-derived IVIG product that contains a broad range of antibodies similar to those found in normal human plasma. These antibodies are directed against bacteria and viruses and help to protect PI patients against serious infections. BIVIGAM is a purified, sterile, ready-to-use preparation of concentrated human Immunoglobulin G antibodies indicated for the treatment of PI, a group of genetic disorders. This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome and severe combined immunodeficiency. These PIs are a group of genetic disorders. Based on recent estimates, these disorders are no longer considered to be very rare, with as many as one in every 2,000 people in the United States having some form of PI.

In May 2019, the FDA approved theour PAS for the use of our IVIG manufacturing process (known as fractionation), thereby enabling us to re-launch and commercialize this product in the United States. WeFollowing our acquisition of the Boca Facility, which included BIVIGAM and Nabi-HB, in June 2017, 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 under our leadership commenced in August 2019.

This Management’s Discussion and Analysis of Financial Condition and Results of Operations is based on our condensed consolidated financial statements, which have been prepared in accordance with Accounting Principles Generally Accepted in the United States of America (“U.S. GAAP”).GAAP. The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses. On an ongoing basis, we evaluate these estimates and assumptions, including those described below. 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. Significant estimates include estimates related to the Company’s effective tax rate.

Three Months Ended MarchJune 31,30, 2026 Compared to Three Months Ended MarchJune 31, 30, 2025

The following table presents a summary of the changes in our results of operations for the three months ended MarchJune 31,30, 2026, ourcompared first fiscal quarter, compared to the three months ended MarchJune 31,30, 2025:

We recorded total revenues of $114.5$124.4 million for the three months ended MarchJune 31,30, 2026, as compared to $114.8$122.0 million for the three months ended MarchJune 31,30, 2025, aan decrease increase of $0.3$2.4 million, or approximately 0.3%. 2.0%. Revenues by product for the three months ended MarchJune 31,30, 2026 and 2025 were as follows:

Cost of product revenue was $33.7$38.1 million for the three months ended March 31,June 30, 2026, as compared to $53.7$54.8 million for the three months ended MarchJune 31,30, 2025. 2025. This decrease is primarily attributable to lower volume of BIVIGAM,BIVIGAM and lower product losses, partially offset by the increase in ASCENIV volume.

For the three months ended MarchJune 31,30, 2026, we had gross profit of $80.8 $86.3 million, as compared to $61.1 $67.2 million for the same period of a year ago, which represents gross margin in the firstsecond quarter of 20252026 of 70.5%,69.4%, as compared to 53.2% 55.1% in the firstsecond quarter of 2025. The improvement in gross margin is primarily driven by the favorable product mix in 2026, mix, along with the margin benefits of the yield enhancement manufacturing process.

Research and development expenses totaled $2.6$6.0 million for the firstsecond quarter of 2026, as compared to $0.8$1.0 million for the firstsecond quarter of 2025. The increase of $5.0 million is primarily mainly due to the ramp-up investmentsof in the SG-001clinical development and trial activities related to our SG-001 development project.

Plasma center operating expenses, which primarily consist of compensation and benefits for plasma center management and administrative staff, decreased from $1.3$1.2 million for the three months ended June 30, 2025 to $1.0 million for the three months ended MarchJune 31, 2025 to $1.1 million for the three months ended March 31,30, 2026, primarily due to the sale of three plasma centers in the first quarter of 2026.

Amortization expense mainly pertains to internally developed software and was $0.1 million and less than $0.1 $0.1 million for the three months ended MarchJune 31,30, 2026 and 2025, respectively.

Selling, general and administrative (“SG&A”) expenses were $26.7 million for the three months ended March 31, 2026, an increase of $2.7 million as compared to the three months ended MarchJune 31,30, 2025.2026. TheThis increase isof $4.5 million, or 20.4%, was primarily driven by the higher employee-related costs, increased software maintenance costs ofand $2.4higher million,professional whichand includedlegal thefees impactassociated with of share-basedongoing compensationlitigation modificationand related to the departure of our former Chief Financial Officermatters and Treasurerstrategic ininitiatives supporting thecorporate amount of $0.8 million and increased headcount to support our business.growth.

Interest and other income for the three months ended MarchJune 31,30, 2026 was $1.1$1.2 million, as compared to $0.6$0.4 million for the three months ended MarchJune 31,30, 2025, driven by the higher average cash balances in 2026 and refinement of our cash investment strategy.

Interest expense for the three months ended MarchJune 31,30, 2026 was $2.1$3.4 million, as compared compared to $2.0$1.8 million for the three months ended MarchJune 31,30, 2025,2025. This increase of $1.6 million was driven by the higherMarch 2026 borrowing averageunder debtour balancescredit infacility 2026,to partiallysupport offsetthe byaccelerated lowershare interestrepurchase rates.agreement (the "ASR Agreement").

Other expense was less than $0.1 million for the three months ended MarchJune 31,30, 20252026 and 2026.$0.1 million for the three months ended June 30, 2025.

The provision for income taxes of $11.8$12.4 million for the three months ended MarchJune 31,30, 2026 represented an effective tax rate of 20.7%,24.7%, as compared to the provision of $6.5$5.9 million for the three months ended MarchJune 31,30, 2025, with an effective tax rate of 19.6%.14.7%. The increase was primarily driven by lower year-over-year excess tax benefits on stock-based compensation.