ADMA BIOLOGICS, INC.

ADMA Biologics, Inc. is a U.S.-based, end-to-end commercial biopharmaceutical company focused on manufacturing, marketing, and developing specialty biologics for immunodeficient patients at risk for infection and others susceptible to certain infectious diseases. The company targets immune-compromised individuals with underlying immune deficiency disorders or those who are immune-suppressed for medical reasons. The U.S. market for immune and hyperimmune globulin products was approximately $13 billion ¹ in 2024 and is projected to exceed $30 billion ² by 2033, indicating a significant and growing market opportunity for ADMA's products.

The company's core business model revolves around two segments: ADMA BioManufacturing and Plasma Collection Centers. The ADMA BioManufacturing segment is responsible for the manufacturing, marketing, and development of FDA-approved specialty biologics. The Plasma Collection Centers segment, operated through ADMA BioCenters, collects source plasma for internal manufacturing and sells excess plasma to third-party customers. Revenue is generated through the sale of immunoglobulin products, intermediate by-products, and contract manufacturing and laboratory services. The company's revenue streams are a mix of product sales and services, with a focus on expanding its commercialized biologics.

ADMA BioManufacturing currently markets three FDA-approved products: ASCENIV (Immune Globulin Intravenous, Human – slra 10% Liquid), BIVIGAM (Immune Globulin Intravenous, Human), and Nabi-HB (Hepatitis B Immune Globulin, Human). ASCENIV, approved in April 2019, is indicated for Primary Humoral Immunodeficiency (PI) in adults and adolescents (12 to 17 years of age). Its proprietary manufacturing process utilizes a patented plasma donor screening methodology and tailored plasma pooling, blending normal source plasma with high-titer RSV neutralizing antibody plasma, which is found in less than 10% ³ of tested donor samples. BIVIGAM, approved in May 2019, is also an IVIG product for PI in adults and pediatric patients two years of age and older. Nabi-HB, approved in March 1999, is a hyperimmune globulin rich in Hepatitis B virus antibodies, indicated for acute and perinatal exposures to Hepatitis B.

The company's Boca Raton, Florida facility has a peak annual processing capability of up to 600,000 liters ⁴ and is believed to have the potential to produce sufficient quantities of IG products representing projected annual revenues greater than $635 million ⁵ in 2026 and $775 million ⁶ in 2027. In April 2025, the FDA approved a Prior Approval Supplement for an innovative yield enhancement production process for ASCENIV and BIVIGAM, which has demonstrated an ability to increase production yields by 20% or more ⁷ from the same starting source plasma volume.

As of December 31, 2025, the ADMA BioCenters subsidiary operated ten FDA-licensed source plasma collection facilities in the U.S. ⁸. A typical center can collect approximately 30,000 to 50,000 liters ⁹ of source plasma annually. In December 2025, ADMA entered an agreement to divest three plasma collection centers for an aggregate purchase price of $12.0 million ¹⁰, with two centers already sold and the third expected to close in Q1 2026. Post-divestiture, the company will operate seven FDA-approved plasma collection centers ¹¹. This divestiture is part of a strategic shift towards a more flexible, capital-efficient supply model, expected to deliver accretive cost savings starting in fiscal year 2026 ¹² and provide durable plasma supply confidence through the late 2030s ¹³.

For the fiscal year ended December 31, 2025, ADMA Biologics reported total revenues of $510.173 million ¹⁴, an increase of $83.719 million ¹⁵ or 20% ¹⁶ from $426.454 million ¹⁷ in 2024. Gross profit for 2025 was $292.765 million ¹⁸, resulting in a gross margin of 57.4% ¹⁹, up from 51.5% ²⁰ in 2024. Operating income for 2025 was $191.443 million ²¹, compared to $138.983 million ²² in 2024. Net income for 2025 was $146.930 million ²³, a decrease from $197.673 million ²⁴ in 2024, primarily due to a significant income tax benefit recognized in 2024. Basic EPS was $0.62 ²⁵ and diluted EPS was $0.60 ²⁶ for 2025, compared to $0.85 ²⁷ and $0.81 ²⁸ respectively for 2024. Cash and cash equivalents stood at $87.630 million ²⁹ as of December 31, 2025, with total debt of $72.143 million ³⁰ (current portion of $2.813 million ³¹ and long-term debt of $69.330 million ³²). Net cash provided by operating activities was $50.396 million ³³ in 2025.

Year-over-year, ASCENIV sales increased by $122.937 million ³⁴, or 51% ³⁵, reaching $362.531 million ³⁶ in 2025 from $239.594 million ³⁷ in 2024. Conversely, BIVIGAM sales decreased by $20.324 million ³⁸, or 14% ³⁹, to $122.033 million ⁴⁰ in 2025 from $142.357 million ⁴¹ in 2024. Sales of intermediates and other products decreased by $25.419 million ⁴², or 75% ⁴³, to $8.579 million ⁴⁴ in 2025 from $33.998 million ⁴⁵ in 2024. Plasma Collection Centers revenue increased by $6.525 million ⁴⁶, or 62% ⁴⁷, to $17.030 million ⁴⁸ in 2025 from $10.505 million ⁴⁹ in 2024. The overall gross margin expansion from 51.5% ⁵⁰ in 2024 to 57.4% ⁵¹ in 2025 was mainly driven by a more favorable mix of higher-margin IG sales and a reduction in other manufacturing costs.

Significant operational developments in 2025 included the FDA approval of the yield enhancement production process for ASCENIV and BIVIGAM in April 2025 ⁵², expected to increase production yields by 20% or more ⁵³. The company also filed a supplemental Biologics License Application (sBLA) in June 2025 for ASCENIV's label expansion to include pediatric patients two years and older ⁵⁴. In July 2025, ADMA acquired real estate in Boca Raton, FL for $12.6 million ⁵⁵ to expand production operations and provide storage redundancies. The divestiture of three plasma collection centers for $12.0 million ⁵⁶ in December 2025, coupled with new long-term plasma supply agreements, aims to enhance capital efficiency and ensure durable plasma supply. The company also continued to implement its AI program, ADMAlytics, to improve supply chain, production, and commercial operations efficiencies, having successfully produced its first batch of ASCENIV using this software in early 2024 ⁵⁷ and expanded its implementation to the commercial division in Q3 2024 ⁵⁸.

ADMA Biologics anticipates continued rapid growth for ASCENIV throughout fiscal year 2026 and beyond, driven by expanding prescriber and patient bases, and record utilization and pull-through observed in 2025. The company projects its Boca Facility, leveraging current production yields and ongoing supply chain enhancements, to produce sufficient quantities of immune globulin products representing annual revenues greater than $635 million ⁵⁹ in 2026 and $775 million ⁶⁰ in 2027. These revenue targets are expected to translate to potential fiscal year 2026 and 2027 Adjusted Net Income exceeding $255 million ⁶¹ and $315 million ⁶², respectively, and Adjusted EBITDA exceeding $360 million ⁶³ and $455 million ⁶⁴, respectively.

A major growth area for ADMA is the expansion of ASCENIV's FDA-approved uses. In June 2025, the company filed its sBLA for the expansion of ASCENIV's label to include the pediatric setting for patients who are two years and older, with anticipated FDA approval in the first half of fiscal year 2026 ⁶⁵. This label expansion is expected to drive further penetration into ASCENIV's targeted market of patients with complex and comorbid primary immunodeficiencies. The company plans to leverage previously conducted Phase II clinical trial data for RI-001 (ASCENIV's predecessor) and real-world outcomes data to support this expansion.

Another significant growth vector is the development of new specialty plasma and/or hyperimmune immunoglobulin products. ADMA is developing an S. pneumonia hyperimmune globulin, SG-001, for which a pilot-scale batch was successfully produced in 2024 ⁶⁶ and animal studies are currently underway. The company anticipates submitting a pre-Investigational New Drug (IND) package to the FDA in fiscal year 2026 ⁶⁷, which could allow for direct progression into a registrational clinical trial. A Commissioner's National Priority Voucher (CNPV) application was submitted in September 2025, which, if accepted and approved, could accelerate FDA review by two fiscal quarters or more ⁶⁸. ADMA estimates that an S. pneumonia hyperimmune globulin, if approved, has the potential to generate peak annual revenue of $300-500 million ⁶⁹.

Operationally, the company expects sustained gross margin expansion in fiscal year 2026, its first full year of yield-enhanced production, supported by a continued shift in revenue mix toward higher-margin IVIG products and reduced manufacturing costs. The FDA-approved yield enhancement production process, which increases ASCENIV and BIVIGAM production yields by 20% or more ⁷⁰, is a key driver for this margin improvement. The divestiture of three plasma collection centers and the establishment of long-term plasma supply agreements are expected to deliver accretive cost savings starting in fiscal year 2026 ⁷¹ and improve capital efficiency. The ongoing implementation and optimization of the ADMAlytics AI program are also expected to enhance production efficiency, supply chain visibility, commercial planning, and reduce variability and personnel hours, further benefiting future earnings growth.

Planned capital allocation includes estimated total capital expenditures between $22.0 million and $27.0 million ⁷² for 2026, focusing on equipment upgrades and maintenance of plasma collection facilities, Boca Facility maintenance, improvements, repairs and supplies, and continuous improvements to IT infrastructure, laboratory equipment, assays, and facilities and engineering equipment. The company's current cash, cash equivalents, and accounts receivable, combined with projected future operating cash flow, are anticipated to be sufficient to fund operations through the first quarter of 2027 and beyond ⁷³. The JPM Credit Agreement, entered into in August 2025, provides $300 million ⁷⁴ in senior secured credit facilities, including a $75 million ⁷⁵ term loan and a $225 million ⁷⁶ revolving credit facility, with a maturity date of August 5, 2028 ⁷⁷. The company does not anticipate the need to raise additional capital at this time, assuming continued market acceptance and utilization of its finished drug products.

Management has explicitly flagged several structural headwinds and execution risks. The company's ability to maintain profitability and positive cash flows is not assured, as evidenced by a net loss of $28.2 million ⁷⁸ in 2023. Reliance on third-party contractors for fill/finish, packaging, testing, labeling, and plasma supply poses risks of delays, insufficient quantities, or non-compliance with specifications. The estimates of market opportunity and revenue growth may prove inaccurate, and the business may not grow at forecasted rates. Geopolitical and economic conditions, including ongoing conflicts in Europe, South America, Northern Africa, and the Middle East, could disrupt supply chains and adversely affect business. Regulatory inspections by the FDA and other authorities could result in enforcement actions, and failure to comply with environmental, health, and safety laws could lead to fines or penalties. The complex manufacturing processes for plasma-based biologics are susceptible to contamination and impurities, potentially leading to product write-offs or recalls. The ability to obtain adequate quantities of FDA-approved source and high-titer plasma with proper specifications is crucial and could become supply-constrained. Furthermore, the ability to use net operating loss carryforwards (NOLs) may be limited by ownership changes, and fluctuations in tax obligations and effective tax rates could impact financial results.

The company faces material risks including the potential inability to maintain profitability and positive cash flows, as demonstrated by a net loss of $28.2 million ⁷⁹ in 2023 and an accumulated deficit of $161.7 million ⁸⁰ as of December 31, 2025. Significant reliance on third-party contractors for manufacturing, testing, and plasma supply introduces risks of delays, insufficient quantities, or non-compliance with FDA requirements. Market opportunity estimates and revenue growth forecasts, such as the U.S. immune and hyperimmune globulin market expected to exceed $30 billion ⁸¹ by 2033, may prove inaccurate. Both business segments and facilities are subject to periodic FDA inspections, which could lead to regulatory actions. Geopolitical conflicts, such as those in Europe, South America, Northern Africa, and the Middle East, could disrupt supply chains and adversely affect operations. The complex manufacturing processes for plasma-based biologics are susceptible to contamination and impurities, potentially leading to product write-offs. The ability to obtain adequate quantities of FDA-approved source and high-titer plasma, particularly RSV plasma which is found in less than 10% ⁸² of donor samples, is critical and could lead to supply constraints. Cybersecurity threats, including potential data inaccuracies or system errors from the ADMAlytics AI program, could result in reputational harm and increased liability. The company's ability to use its federal and state net operating loss carryforwards of $265.6 million ⁸³ and $176.9 million ⁸⁴ respectively, may be limited by ownership changes under Section 382 of the Code, as seen with prior write-offs of $57.6 million ⁸⁵ and $3.0 million ⁸⁶ in federal NOLs. The JPM Credit Facilities, with $72.1 million ⁸⁷ outstanding at a variable interest rate of approximately 6.4% ⁸⁸ as of December 31, 2025, are subject to acceleration upon default, and a hypothetical 100 basis point increase in interest rates would have an approximate $0.7 million ⁸⁹ annualized negative impact on earnings and cash flows.

Management's message to shareholders emphasizes a strategic shift towards a more flexible, capital-efficient supply model and a focus on expanding the commercial footprint of its key products. The company anticipates continued rapid growth for ASCENIV throughout fiscal year 2026 and beyond, with projected annual revenues greater than $635 million ⁹⁰ in 2026 and $775 million ⁹¹ in 2027 from its immune globulin products. These revenue targets are expected to result in Adjusted Net Income exceeding $255 million ⁹² and $315 million ⁹³ for fiscal years 2026 and 2027, respectively, and Adjusted EBITDA exceeding $360 million ⁹⁴ and $455 million ⁹⁵ for the same periods. The three strategic priorities highlighted for the period ahead are: first, expanding ASCENIV's FDA-approved uses, specifically through the sBLA for pediatric patients two years and older with anticipated FDA approval in the first half of 2026 ⁹⁶; second, improving supply, operating efficiencies, and gross margins at the Boca Facility and ADMA BioCenters, driven by the FDA-approved yield enhancement process expected to increase production yields by 20% or more ⁹⁷ and the divestiture of three plasma collection centers to secure long-term plasma supply; and third, expanding and developing the product pipeline with additional specialty plasma and/or hyperimmune immunoglobulin products, including advancing SG-001 with a pre-IND package submission anticipated in fiscal year 2026 ⁹⁸ and an estimated peak annual revenue potential of $300-500 million ⁹⁹.