ADMA

ASCENIV™

Primary humoral immunodeficiency (PI)

Stage (next event)

Next Event

Expected Date

Approved

Quarterly Sales

March 05, 2021 (Est)

Achieved Fourth Quarter 2020 Preliminary Unaudited Total Revenues of $13.9 Million, the Highest Revenue Quarter for the Company Since Inception

Catalyst Info & Data Links

MORE INFORMATION:

FDA Label
Centers for Medicare and Medicaid Services (CMS) has approved transitional pass-through payment status and established a new reimbursement C-code, C9072, for ASCENIV which is effective January 1, 2021.
Achieved Fourth Quarter 2020 Preliminary Unaudited Total Revenues of $13.9 Million, the Highest Revenue Quarter for the Company Since Inception

DRUG HISTORY:

Q3 2020 sales $28.3 Million
2020 Revenue Guidance: N/A
01-19-2021 Preliminary Fourth Quarter and Full Year 2020 Revenues and Provides 2021 Strategic Outlook
01-04-2021 Receives Unique Temporary C-Code and Pass-Through Payment Status for ASCENIV™
02-11-2020 ADMA Biologics Receives BioNJ 2020 Innovator Award for ASCENIV™
10-21-2019 Announces First Commercial Sales of ASCENIV™
04-01-2019 FDA Approves ASCENIV™, a Novel Intravenous Immune Globulin

Mechanism of Action

ASCENIV is a replacement therapy for patients with primary humoral immunodeficiency (PI) (e.g. agammaglobulinemia, hypogammaglobulinemia, CVID, SCID). The broad spectrum of neutralizing IgG antibodies against bacterial and viral pathogens and their toxins helps to avoid recurrent serious opportunistic infections. IgG antibodies are opsonins that increase phagocytosis and elimination of pathogens from the circulation. The mechanism of action has not been fully elucidated in PI.

MARKET

PI is a class of inherited genetic disorders that causes an individual to have a deficient or absent immune system. According to the World Health Organization, there are approximately 350 different genetic mutations encompassing PI. Some disorders present at birth or in early childhood, the disorders can affect anyone regardless of age or gender. Some affect a single part of the immune system, others may affect one or more components of the system. PI patients are vulnerable to infections and more likely to suffer complications from these infections as compared to individuals with a normal functioning immune system. The infections may occur in any part of the body. Because patients suffering from PI lack a properly functioning immune system, they typically receive monthly treatment with polyclonal immune globulin products. Without this exogenous antibody replacement, these patients would remain vulnerable to persistent and chronic infections. PI has an estimated prevalence of 1:1,200 in the United States, or approximately 250,000 people in the U.S.

ADMA, ASCENIV, replacement therapy, primary humoral immunodeficiency (PI) (e.g. agammaglobulinemia, hypogammaglobulinemia, CVID, SCID), IgG antibodies

Prior Data (click to view full image)