ADMA Looks to Expand Asceniv's Label: Will This Boost Sales?

ADMA Biologics ADMA 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 and Takeda TAK 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.

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.

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.

ADMA currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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This article originally published on Zacks Investment Research (zacks.com).

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