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ADMA Looks to Expand Asceniv's Label: Will This Boost Sales?
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Key Takeaways
ADMA saw record demand for Asceniv and plans a 2025 filing to expand into pediatric use.
Label expansion and new patient starts are expected to drive growth in Asceniv sales.
ADMA trades at 8.75X forward sales, above its historical average and industry valuation levels.
ADMA Biologics (ADMA - Free Report) markets plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases.
ADMA’s lead product, Asceniv, is a plasma-derived Intravenous Immune Globulin that contains naturally occurring polyclonal antibodies. These antibodies are proteins used by the body’s immune system to neutralize microbes, such as bacteria and viruses, and prevent infection and disease.
Asceniv is indicated for the treatment of primary immunodeficiency disease or inborn errors of immunity in adults and adolescents. It is manufactured using ADMA’s unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma with respiratory syncytial virus plasma obtained from donors tested using the company’s proprietary microneutralization assay.
Demand was record high in the first quarter. ADMA plans to file a supplemental Biologics License Application in mid-2025 for the expansion of Asceniv’s label to include the pediatric setting for patients who are two years and older.
A potential label expansion will increase the target patient population. An acceleration in new patient starts, a potential label expansion and further penetration in existing markets should significantly expand Asceniv's sales.
GRFS is a leading plasma derivatives producer globally, ranking among the three largest producers in the industry in terms of total sales, along with Takeda and CSL Group. The main plasma products GRFS manufactures are IG, Factor VIII, Alpha 1 (A1PI) and albumin. Grifols also manufactures intramuscular (hyperimmune) immunoglobulins (IGs), ATIII, Factor IX and plasma thromboplastin component.
GRFS boasts a market in various segments of the plasma derivatives industry, including A1PI, IG and albumin, as well as in terms of plasma collection centers and fractionation capacity.
Takeda’s broad immunoglobulin portfolio includes Hyqvia, Cuvitru, Gammagard Liquid and Gammagard S/D.
ADMA’s Price Performance, Valuation & Estimates
Shares of ADMA have rallied 21.4% year to date compared with the industry’s breakeven performance.
Image Source: Zacks Investment Research
From a valuation perspective, ADMA is expensive at this moment. Going by the price/sales ratio, ADMA shares currently trade at 8.44X forward sales, higher than its mean of 3.33X and the industry’s 1.69X.
Image Source: Zacks Investment Research
The Zacks Consensus Estimate for ADMA’s 2025 earnings per share has moved south in the past 60 days. However, the metric for 2026 has moved north during the same time frame.
Image: Bigstock
ADMA Looks to Expand Asceniv's Label: Will This Boost Sales?
Key Takeaways
ADMA Biologics (ADMA - Free Report) markets plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases.
ADMA’s lead product, Asceniv, is a plasma-derived Intravenous Immune Globulin that contains naturally occurring polyclonal antibodies. These antibodies are proteins used by the body’s immune system to neutralize microbes, such as bacteria and viruses, and prevent infection and disease.
Asceniv is indicated for the treatment of primary immunodeficiency disease or inborn errors of immunity in adults and adolescents. It is manufactured using ADMA’s unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma with respiratory syncytial virus plasma obtained from donors tested using the company’s proprietary microneutralization assay.
Demand was record high in the first quarter. ADMA plans to file a supplemental Biologics License Application in mid-2025 for the expansion of Asceniv’s label to include the pediatric setting for patients who are two years and older.
A potential label expansion will increase the target patient population. An acceleration in new patient starts, a potential label expansion and further penetration in existing markets should significantly expand Asceniv's sales.
Competition in the Plasma Therapy Market
ADMA competes with Grifols (GRFS - Free Report) and Takeda (TAK - Free Report) for plasma-derived products.
GRFS is a leading plasma derivatives producer globally, ranking among the three largest producers in the industry in terms of total sales, along with Takeda and CSL Group. The main plasma products GRFS manufactures are IG, Factor VIII, Alpha 1 (A1PI) and albumin. Grifols also manufactures intramuscular (hyperimmune) immunoglobulins (IGs), ATIII, Factor IX and plasma thromboplastin component.
GRFS boasts a market in various segments of the plasma derivatives industry, including A1PI, IG and albumin, as well as in terms of plasma collection centers and fractionation capacity.
Takeda’s broad immunoglobulin portfolio includes Hyqvia, Cuvitru, Gammagard Liquid and Gammagard S/D.
ADMA’s Price Performance, Valuation & Estimates
Shares of ADMA have rallied 21.4% year to date compared with the industry’s breakeven performance.
Image Source: Zacks Investment Research
From a valuation perspective, ADMA is expensive at this moment. Going by the price/sales ratio, ADMA shares currently trade at 8.44X forward sales, higher than its mean of 3.33X and the industry’s 1.69X.
Image Source: Zacks Investment Research
The Zacks Consensus Estimate for ADMA’s 2025 earnings per share has moved south in the past 60 days. However, the metric for 2026 has moved north during the same time frame.
Image Source: Zacks Investment Research
ADMA currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.