Shares of microcap biopharmaceutical company ADMA Biologics (ADMA) - Get Report jumped Wednesday after the U.S. Food and Drug Administration approved the company increasing the manufacturing capacity of its plant.
ADMA can now produce up to 600,000 liters of its Intravenous Immune Globulin (IVIG) to treat primary humoral immunodeficiency, up from its previous 400,000 liter cap, after the FDA granted approval to the company to expand its manufacturing process.
ADMA shares soared 24.3% to $2.36 per share Wednesday morning on the news.
"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 CEO Adam Grossman.
The expanded plasma pool production scale has the company confident that it will generate peak revenues greater than $300 million annually and the company says the approval solidifies its path to "meaningful gross margin expansion."
That expansion is expected to potentially begin in the second half of 2021 and accelerate throughout 2022.
With the IVIG change, ADMA now has FDA approval to produce its BIVIGAM intravenous drug at an expanded capacity using the same equipment and labor force.
The company expects the expanded capacity to translate into "meaningful gross margin improvement" as production of the treatment for humoral immunodeficiency goes through the standard 7 to 12-month manufacturing cycle.
The company now says it will be able to offer BIVIGAM in two vial sizes, 50 mL and 100 mL.