ADMA Biologics, Inc. (ADMA) a biopharmaceutical company focused on commercializing specialty plasma-derived biologics, confirmed that the U.S. Food and Drug Administration (FDA) has approved the Company’s enlarged production process, which allows fractionation and purification of plasma pool with a 4400 liter volume, to produce Intravenous Immune Globulin (“IVIG”). ADMA stock surged adjacent to the news.

At last check in premarket trading, shares of ADMA Biologics Inc. (ADMA) were up 17.89% at $2.06. The price range of the company’s shares was between $1.82 and $1.95. The stock recorded a trading volume of 1.69 million shares, which is below the average daily trading volume published for the last 50 days of 3.16 million shares.

About ADMA Biologics, Inc

ADMA has presently developed three FDA-approved plasma-derived biologics for the treatment of immune deficiencies and to prevent several infectious diseases and provide enhanced immunity. ADMA produces its immune globulin-related products in Boca Raton, Florida, at its FDA-licensed plasma fractionation and purification facility. ADMA also focuses on plasma collecting in the U.S., which provides a portion of its blood plasma to produce its products.

The 4,400-liter IVIG plasma pool scale for BIVIGAM® lets ADMA increases the production plant’s total processing volume from 400,000 liters to an expected 600,000 liters. Allowing ADMA to manufacture BIVIGAM® at an increased capacity, maintaining the same quality as the previous manufacturing scale, while using the same machinery and labor force.

ADMA expects this will improve gross margins due to increased production combined with economies of scale. With this approval for FDA, ADMA additionally will now be able to offer BIVIGAM® in two unique sizes, consisting of 50ml and 100ml variations.

“The FDA approval of the 4,400-liter IVIG plasma pool production scale process is a transformative milestone for the ADMA organization and will allow the Company to produce significantly more IVIG for the U.S. market and for patients living with immune deficiencies,” said Adam Grossman, President and Chief Executive Officer of ADMA.

ADMA Biologics is expecting its quarter-over-quarter revenue to grow throughout 2021 due to a substantial increase in production capacity. Expansion of plasma pool manufacturing has allowed the company to forecast generating more than $300M in revenue. Enhanced Gross Margins and Cost Efficiencies are expected to accelerate in 2022 and provide profitability.

Conclusion.

FDA approval for the Company’s enlarged manufacturing process has peaked investor interest. Total Capacity increase from 400,000 Liters up to 600,000 Liters has forecasted revenue to surge substantially, with ADMA stock rising immensely.