ADMA Biologics’ ADMA shares have lost 8.9% in a month against the industry’s growth of 6.6%.

The company has put up a phenomenal performance in 2024 and hit a 52-week high of $23.64 on Nov. 11.

Last month, ADMA reported preliminary revenues for 2024 and provided a business update. On a preliminary basis, total revenues in 2024 are estimated to be in the $417-$425 million range (exceeding previous guidance of $415 Million). Total cash holdings at the end of 2024 grew to more than $100 million.

ADMA Underperforms Industry, Sector & S&P 500

Image Source: Zacks Investment Research

Asceniv’s Performance Fuels ADMA’ Growth

ADMA Biologics markets plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases.

The company’s top line currently comprises sales of three FDA-approved products — Bivigam (an Intravenous Immune Globulin [“IVIG”] product to treat primary humoral immunodeficiency), Asceniv (to treat primary immunodeficiency disease or PIDD) and Nabi-HB (to treat and provide enhanced immunity against the hepatitis B virus).

Asceniv, its lead product, is a plasma-derived IVIG 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 PIDD 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 2024 with further growth expected in 2025 with further penetration. ADMA Biologics executed multiple, long-term third-party plasma supply contracts, which should contribute to a continuous and growing supply of high-titer plasma expected to meet Asceniv’s growth targets through the late 2030s. Management anticipated these supply agreements to position ADMA to potentially achieve $1 billion in total annual revenues before 2030, with significant growth potential in the 2030s.

ADMA’s Efforts to Expand Asceniv’s Label

In connection with the FDA’s approval of Asceniv in April 2019, ADMA is required to conduct a pediatric study to evaluate the safety and efficacy of Asceniv in children and adolescents. The ongoing post-marketing study for Asceniv may provide an opportunity for label expansion to include pediatric-aged PI patients.

All pediatric patients in Asceniv’s post-marketing pediatric study have now completed their treatment schedule.  ADMA expects to file its supplemental biologics license application over the coming quarters, with a potential approval for label expansion in the first half of 2026. A potential label expansion should strengthen ADMA’s product portfolio.

ADMA’s Financial Targets

Along with providing preliminary results, ADMA provided its outlook for 2025 and 2026. ADMA now expects to generate revenues of more than $485 million in 2025 and $600 million in 2026 (previous guidance: more than $465 million in 2025). Net income is projected to exceed $170 million in 2025 and $230 million in 2026 (up from the prior guidance of $165 million for 2025).

Margin Improvement

ADMA’s higher-margin product portfolio now accounts for more than 50% of its total revenues. The company is working to increase Asceniv's supply. Asceniv will account for a significant portion of ADMA's total revenues over time, further advancing its potential margin expansion and earnings growth.

Valuation & Estimates

Going by the price/sales ratio, ADMA’s shares currently trade at 8.21x forward sales, higher than its mean of 3.31x and the industry’s 1.71x.

Image Source: Zacks Investment Research

Estimate Movement

The estimate for 2024 and 2025 EPS has moved down 1 cent and 3 cents, respectively, to 51 cents and 60 cents over the past 30 days.

Image Source: Zacks Investment Research

Stay Invested in ADMA Stock

ADMA Biologics, which competes with Takeda TAK and Grifols GRFS in the U.S. market for plasma-derived products, should maintain momentum in the upcoming quarters. Incremental additional penetration of Asceniv should accelerate near-term revenue growth.

The targeted market has significant growth potential. Management expects additional opportunities for ADMA to continue to grow substantially in the underserved, immune-compromised and co-morbid patient population despite the availability of standard-of-care therapy.

However, the exceptional rally witnessed by the stock might limit any further gain. We advise investors to wait for now. For investors already owning the stock, staying invested would be a prudent move.

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

 

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

Grifols, S.A. (GRFS) : Free Stock Analysis Report

ADMA Biologics Inc (ADMA) : Free Stock Analysis Report

Takeda Pharmaceutical Co. (TAK) : Free Stock Analysis Report

To read this article on Zacks.com click here.

Zacks Investment Research