ADMA Biologics, Inc.

ADMA Biologics is a U.S.-based commercial biopharmaceutical company that manufactures, markets, and develops specialty biologics. The company focuses on treating immunodeficient patients susceptible to infection and individuals at risk for specific infectious diseases, including immune-compromised individuals with underlying immune deficiency disorders or those who are medically immune-suppressed. Through its ADMA BioManufacturing business segment, ADMA Biologics has three FDA-approved products that are currently marketed and commercially available. These include ASCENIV (Immune Globulin Intravenous, Human - slra 10% Liquid), an Intravenous Immune Globulin (IVIG) product approved in April 2019, with first commercial sales in October 2019, for treating Primary Humoral Immunodeficiency in adults and adolescents. Another product is BIVIGAM, an IVIG product approved in May 2019, with commercial sales starting in August 2019, for treating Primary Immunodeficiency in adults and pediatric patients aged two years and older. The third product is Nabi-HB (Hepatitis B Immune Globulin, Human), indicated for treating acute exposure to blood containing HBsAg and other listed Hepatitis B exposures. The company is also developing plasma-derived therapeutics, including a product based on U.S. Patent Nos. 10,259,865 and 11,084,870, related to methods for treating and preventing S. pneumoniae infection using an immunoglobulin with standardized antibodies. A pilot-scale batch of this product has been produced, and animal studies are underway.