ADMA Biologics, Inc. (‘ADMA’) operates as an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases.
The company’s 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 the company...
ADMA Biologics, Inc. (‘ADMA’) operates as an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases.
The company’s 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 the company’s ADMA BioManufacturing business segment, it has three products with U.S. Food and Drug Administration (the ‘FDA’) approval, all of which are currently marketed and commercially available: 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 the company received FDA approval on April 1, 2019, and commenced first commercial sales in October 2019; BIVIGAM, an IVIG product indicated for the treatment of PI, for which the company received FDA approval on May 9, 2019, and commenced commercial sales in August 2019; and 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. The company seeks to develop a pipeline of plasma-derived therapeutics, including a product based on its most recently approved patent application under the U.S. Patent Nos. 10,259,865 and 11,084,870, related to methods of treatment and prevention of S. pneumonia infection for an immunoglobulin manufactured to contain standardized antibodies to numerous serotypes of S. pneumoniae. The company has successfully completed production of a pilot-scale batch, and is conducting animal studies for its S. pneumoniae hyperimmune globulin program, SG-001. The company’s 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. The company manufactures these products at its 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’).
Through the company’s ADMA BioCenters subsidiary, it currently operates ten source plasma collection facilities in the U.S., all of which hold FDA licenses. This business unit, which the company refers to as its Plasma Collection Centers business segment, provides the company with the blood plasma required for the manufacture of its products, and also allows the company to sell certain quantities of source and hyperimmune plasma to third-party customers for further manufacturing. In addition, three of the company’s FDA-approved plasma collection centers also have approvals from the Korean Ministry of Food and Drug Safety (‘MFDS’), as well as FDA approval to operate a Hepatitis B immunization program. 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 its products is sold to third-party customers in the U.S., and in other locations outside the U.S. where the company is approved under supply agreements, or in the open ‘spot’ market.
From time to time, the company may provide contract manufacturing services for certain third-party clients. It also provides laboratory contracting services to certain customers, and may provide contract filling, labeling, and packing services utilizing the company’s FDA-approved in-house fill-finish capabilities.
Products
ASCENIV
ASCENIV is a plasma-derived IVIG that contains naturally occurring polyclonal antibodies, which are proteins that are used by the body’s immune system to neutralize microbes, such as bacteria and viruses, and prevent against infection and disease. The company manufactures 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 April 1, 2021. As part of the company’s proprietary manufacturing process for ASCENIV, it leverages its 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 its proprietary microneutralization testing assay. The company is able to identify the high titer or ‘hyperimmune’ plasma that meets its internal and required specifications for ASCENIV with its patented testing methods and assay. This type of high titer plasma is typically found in less than 10% of the total donor collection samples tested.
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). The company’s pivotal Phase 3 clinical trial in 59 PIDD patients met the primary endpoint of no Serious Bacterial Infections (‘SBI’) reported during 12 months of treatment. Secondary efficacy endpoints further demonstrated the benefits of ASCENIV in the low incidence of infection, therapeutic antibiotic use, days missed from work/school/daycare, and unscheduled medical visits and hospitalizations.
The company anticipates filing its 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.
BIVIGAM
BIVIGAM is a plasma-derived IVIG 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.
On May 9, 2019, the FDA approved the Prior Approval Supplement (the ‘PAS’) for the use of the company’s IVIG manufacturing process (known as fractionation), thereby enabling the company to re-launch and commercialize this product in the U.S. The company resumed production of BIVIGAM during the fourth quarter of 2017, and commercial production is ongoing, using its FDA-approved IVIG manufacturing process under the U.S. Department of Health and Human Services (‘HHS’) License No. 2019. The commercial re-launch and first commercial sales for this product commenced in August of 2019.
On April 28, 2021, the company announced that the FDA granted approval for its expanded plasma pool production scale process, allowing for a 4,400-liter plasma pool for the manufacture of its BIVIGAM IVIG product.
On December 12, 2023, the company announced that the FDA approved the expansion of BIVIGAM’s label in the U.S. to now include the pediatric setting for those two years of age and older.
Nabi-HB
Nabi-HB is a hyperimmune globulin that is rich in antibodies to the Hepatitis B virus. 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 on March 24, 1999. Production of Nabi-HB at the Boca Facility has continued under the company’s leadership since the third quarter of 2017. In early 2018, the company received authorization from the FDA for the release of its first commercial batch of Nabi-HB for commercial distribution in the U.S., and it continues to manufacture Nabi-HB under HHS License No. 2019.
Plasma Collection Operations
ADMA BioCenters operates a total of ten U.S.-based plasma collection facilities, all of which hold FDA licenses and are actively collecting source and high-titer RSV plasma. Currently, three facilities have also received approvals from MFDS, as well as FDA approval to implement a Hepatitis B immunization program. Source plasma that is collected from its FDA-licensed facilities provides the company with the blood plasma for the manufacture of its products. Plasma collected from ADMA BioCenters’ facilities that is not used to manufacture its products or product candidates is sold to third-party customers in the U.S., and other international locations where the company is approved under supply agreements, or in the open ‘spot’ market.
Strategy
The company’s strategies are to continue to expand the commercial production of its IG products, and notably drive a revenue mix shift favoring sales of ASCENIV for the treatment of patients with PI; expand ASCENIV’s FDA-approved uses; improve the Boca Facility’s and ADMA BioCenters’ yields; broadly implement its innovative AI program, ADMAlytics, to improve efficiencies across the company’s supply chain and production; label expansion; and expand and develop its pipeline with additional specialty plasma and/or hyperimmune immunoglobulin products.
Manufacturing and Supply
On June 6, 2017, the company entered into a Plasma Supply Agreement with its former contract manufacturer, pursuant to which the counterparty supplies, on an exclusive basis subject to certain exceptions, to ADMA BioManufacturing an annual minimum volume of hyperimmune plasma that contains antibodies to the Hepatitis B virus for the manufacture of Nabi-HB. The Plasma Supply Agreement has a ten-year term. On July 19, 2018, the Plasma Supply Agreement was amended to provide, among other things, that in the event the counterparty elects not to supply in excess of ADMA BioManufacturing’s specified amount of Hepatitis B plasma, and ADMA BioManufacturing is unable to secure Hepatitis B plasma from a third party at a price which is within a low double-digit percentage of the price which ADMA BioManufacturing pays to the counterparty, then the counterparty shall reimburse ADMA BioManufacturing for the difference in price ADMA BioManufacturing incurs. On December 10, 2018, the company’s former contract manufacturer assigned its rights and obligations under the Plasma Supply Agreement to Grifols, effective January 1, 2019.
Sales and Commercialization
ASCENIV, BIVIGAM, and Nabi-HB are sold primarily through independent distributors, drug wholesalers acting as sales agents, specialty pharmacies servicing both acute and ambulatory infusion centers, and the home health infusion setting, and other alternate site providers. In the U.S., independent distributors, or third-party drug wholesalers, ship the company’s products through their distribution centers.
The company markets and sells its products through its specialty sales force, distribution relationships, and other customary industry methods. It focuses its efforts specifically on the easily identifiable treatment centers which specialize in the care and management of immune-compromised individuals. The company estimates that there are approximately 500 leading specialty programs in the U.S. which have significant patient populations for PIDD, suitable for the treatment with ASCENIV.
Efforts to generate increased market awareness for Nabi-HB include attending and presenting scientific information at medical conferences, as well as sponsoring medical education symposiums. The company has also hired a specialty sales force consisting of account managers, medical science liaisons, and other customary scientific, medical, and detail representatives to market BIVIGAM and ASCENIV to hospitals, physician offices/clinics, and other specialty treatment organizations, as applicable.
Pursuant to the company’s Manufacturing, Supply, and Licensed Agreement effective as of December 31, 2012, it granted to Biotest AG (‘Biotest’) an exclusive license to market and sell ASCENIV in Europe, and in selected countries in North Africa and the Middle East (the ‘Territory’), to have access to the company’s testing services for testing of Biotest’s plasma samples using its proprietary RSV assay, and to reference (but not access) its proprietary information for the purpose of Biotest seeking regulatory approval for ASCENIV in the Territory.
Major Customers
For the year ended December 31, 2024, two customers, BioCARE, Inc. (‘BioCare’) and Priority Healthcare Distribution, Inc. (‘Curascript’), represented an aggregate of 72% of the company’s consolidated revenues.
As of December 31, 2024, three customers, BioCare, Healix Infusion Therapy, LLC (‘Healix’), and Cencora, Inc., represented an aggregate of approximately 91% of the company’s consolidated accounts receivable.
Intellectual Property
Patents related to the company’s immune globulin product ASCENIV include the U.S. Patent No. 9,107,906, which covers compositions comprising pooled plasma, as well as immunoglobulin prepared therefrom, that contains a standardized, elevated titer of RSV neutralizing antibodies, and elevated levels of antibodies specific for one or more other respiratory pathogens, as well as methods of making and using the compositions. The U.S. Patent Nos. 9,714,283, 9,815,886, 9,969,793, 10,683,343, 11,339,206, and 11,780,906, encompassing immunotherapeutic compositions and immunotherapeutic methods proprietary to the company, also relate to ASCENIV. Additional U.S. and numerous foreign patents and patent applications also pertain to this technology.
The company also holds intellectual property, including patents and patent applications, related to immunotherapeutic compositions and immunotherapeutic methods for the treatment and prevention of S. pneumonia infection. The U.S. Patent Nos. 10,259,865, 11,084,870, and 11,897,943, each with a term through 2037, pertain to various aspects of this technology.
The company holds multiple trademarks, including, but not limited to, ADMA, ADMA Biologics (including logo), ASCENIV, BIVIGAM, CIVACIR, Nabi-HB, Designed to Deliver, Partner in Protection, and Advantage Ig.
Government Regulation and Product Approval
The FDA and comparable regulatory agencies in state and local jurisdictions, and in foreign countries impose substantial requirements upon, among other things, the testing (preclinical and clinical), quality control, research and development, approval and post-approval monitoring and reporting, manufacturing, labeling, storage, recordkeeping, advertising, promotion, import, export, marketing, sales, and distribution of the company’s products and product candidates.
The company’s current and anticipated future product candidates are considered ‘biologics’ under the FDA regulatory framework. Prior to commencing the first clinical trial at a United States investigational site, the company must submit manufacturing and analytical data, pre-clinical or nonclinical data from studies conducted in accordance with GLP, and clinical trial plans, among other information, to the FDA as part of an IND application.
The company’s submission of an IND, or those of its collaboration partners, may not result in the FDA allowing the company to commence a clinical trial.
The company’s products are reimbursed or purchased under several government programs, including Medicaid, Medicare Parts B and D, the 340B Drug Pricing Program/Public Health Service program, and pursuant to an existing contract with the Department of Veterans Affairs.
Research and Development
The company’s research and development (‘R&D’) expenses totaled $1.8 million for the year ended December 31, 2024.
History
ADMA Biologics, Inc. was founded in 2004. The company was incorporated in New Jersey in 2004 and re-incorporated in Delaware in 2007.
