Company Description
ADMA Biologics, Inc. (NASDAQ: ADMA) is a U.S.-based, end-to-end commercial biopharmaceutical company focused on specialty plasma-derived biologics and other specialty biologics. According to the company, its mission is to manufacture, market and develop products for immunodeficient patients at risk for infection and for others at risk for certain infectious diseases. ADMA operates in the biological product manufacturing space within the broader manufacturing sector and emphasizes a fully U.S.-based operating footprint.
Core business and product portfolio
ADMA states that it currently manufactures and markets three U.S. Food and Drug Administration (FDA)-approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases:
- ASCENIV™ (immune globulin intravenous, human – slra 10% liquid), a plasma-derived, polyclonal intravenous immune globulin (IVIG) indicated for the treatment of primary humoral immunodeficiency (PI), also known as primary immune deficiency disease (PIDD), in adults and adolescents 12 to 17 years of age.
- BIVIGAM® (immune globulin intravenous, human), indicated for the treatment of primary humoral immunodeficiency.
- NABI-HB® (hepatitis B immune globulin, human), which is described as providing enhanced immunity against the hepatitis B virus.
These products are plasma-derived immune globulin therapies that address immune deficiencies and specific infectious disease risks. ADMA notes that ASCENIV is manufactured using a patented plasma donor screening methodology and a tailored plasma pooling design that blends normal source plasma with respiratory syncytial virus (RSV) plasma obtained from donors tested using the company’s proprietary microneutralization assay. ASCENIV contains naturally occurring polyclonal antibodies used by the immune system to help neutralize microbes such as bacteria and viruses.
Manufacturing footprint and vertical integration
ADMA describes itself as an end-to-end commercial biopharmaceutical company. It manufactures its immune globulin products and product candidates at an FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA BioCenters subsidiary, the company also operates as an FDA-approved source plasma collector in the United States, supplying plasma for the manufacture of its products.
The company has repeatedly highlighted that it is U.S.-based, with all manufacturing operations, end-market sales, and customer engagements conducted exclusively within the United States, and that its vertically integrated supply chain is fully domiciled in the U.S. This structure is described as providing end-to-end domestic control over sourcing, manufacturing and distribution.
Business segments and activities
According to prior descriptions, ADMA operates through at least two main business areas: an ADMA BioManufacturing segment and a Plasma Collection Centers segment, along with a corporate segment. The BioManufacturing activities include the manufacture and commercialization of plasma-derived biologics such as ASCENIV and BIVIGAM. The Plasma Collection Centers business, operated through ADMA BioCenters, focuses on collecting source plasma as input material for these therapies.
The company has also disclosed that it sells plasma-derived intermediate fractions generated as part of its FDA-approved manufacturing process for immune globulin products to certain customers. In addition, ADMA has indicated that it provides laboratory contracting services to some customers and has anticipated providing contract filling, labeling and packing services.
Research and development pipeline
Beyond its commercial portfolio, ADMA is developing SG-001, described as a pre-clinical, investigative hyperimmune globulin targeting Streptococcus pneumoniae (S. pneumoniae). The company has characterized SG-001 as a hyperimmune IVIG (hIVIG 10%) program designed to provide passive immunity against S. pneumoniae in immunocompromised patients. ADMA has reported preclinical data in animal models and has discussed plans for regulatory interactions, including anticipated submission of a pre-IND package to the FDA.
ADMA also emphasizes a broader internal R&D platform that spans both product development and process innovation. A notable example is its FDA-approved yield enhancement production process, which the company states is designed to increase finished immune globulin output by approximately 20% from the same starting plasma volume. This yield enhancement is described as benefitting both ASCENIV and BIVIGAM.
Plasma supply and collection network
The company reports that it operates internal plasma collection centers in the U.S. and also works with third-party plasma suppliers. ADMA has discussed record high-titer plasma collections, access to a large network of external plasma collection centers, and long-term plasma supply agreements intended to support its growth and production needs.
In its updates, ADMA has described actions such as strategic plasma network repositioning, including divestiture of certain plasma centers while maintaining ownership of others and entering into long-term supply agreements with the purchaser. The company presents these steps as part of a shift toward a more flexible and capital-efficient supply model, with the goal of enhancing margins, improving high-titer plasma supply visibility and supporting increased ASCENIV production capacity.
U.S.-focused commercial strategy
ADMA states that its end-market sales and customer engagements are conducted exclusively within the United States. It has highlighted relationships with payers across commercial, Medicare and Medicaid segments, and has referenced strong payer coverage for ASCENIV and BIVIGAM supported by strategic agreements. The company has also reported efforts to expand its distribution network, including entering into an authorized distribution agreement for ASCENIV and BIVIGAM with McKesson Specialty, with the goal of broadening sites of care and patient access.
Intellectual property
ADMA reports that it holds numerous U.S. and foreign patents related to various aspects of its products and product candidates. For ASCENIV, the company notes that the product is protected by issued patents in the United States and internationally, along with a wide range of patent applications worldwide. It also references intellectual property covering proprietary plasma screening assays, unique plasma pooling methods and methods of immune globulin use.
Regulatory and safety information for ASCENIV
ASCENIV is an FDA-approved IVIG product. The company provides detailed safety information, including a boxed warning regarding thrombosis, renal dysfunction and acute renal failure associated with immune globulin intravenous products. The safety information notes risk factors for thrombosis, the possibility of renal dysfunction and acute renal failure, and the need for careful dosing, infusion rate management, hydration and monitoring in at-risk patients.
Additional warnings and precautions include risks related to hypersensitivity in IgA-deficient patients with antibodies to IgA, thrombotic events, renal function changes, hyperproteinemia, increased serum viscosity, hyponatremia or pseudohyponatremia, aseptic meningitis syndrome, hemolytic anemia and transfusion-related acute lung injury (TRALI). The most common adverse reactions (≥5% of study subjects) reported for ASCENIV include headache, sinusitis, diarrhea, viral gastroenteritis, nasopharyngitis, upper respiratory tract infection, bronchitis and nausea.
Corporate updates and financial communications
ADMA is listed on the Nasdaq under the ticker symbol ADMA. The company regularly issues press releases and files reports, such as Form 8-K, to announce financial results and provide business updates. For example, an 8-K dated November 5, 2025, references a press release announcing financial results for the quarter ended September 30, 2025 and a business update.
In its public communications, ADMA has discussed topics such as total revenue trends, adjusted EBITDA, adjusted net income, operating cash flow, debt refinancing, share repurchase authorizations and guidance for future periods. These disclosures are framed as part of the company’s approach to communicating its financial performance and outlook to investors.
Position within the biopharmaceutical and plasma-derived products space
Within the biological product manufacturing industry, ADMA focuses on plasma-derived immune globulin therapies and hyperimmune globulins targeted to niche patient populations, particularly individuals with primary or secondary immune deficiencies and those at risk for specific infectious diseases such as hepatitis B or S. pneumoniae. The company emphasizes its vertically integrated, U.S.-based model, its portfolio of FDA-approved immune globulin products, and its ongoing development of additional plasma-derived therapies.
FAQs about ADMA Biologics (ADMA)
The following frequently asked questions summarize key aspects of ADMA’s business based on the company’s own descriptions.