Commercial-stage biopharmaceutical company ADMA Biologics Inc. (ADMA:NASDAQ), which is focused on manufacturing, marketing and developing specialty plasma-derived biologics, today announced that "the U.S. Food and Drug Administration (FDA) has granted approval for the company's expanded manufacturing process, enabling fractionation and purification of a 4,400-liter plasma pool for the manufacture of Intravenous Immune Globulin (IVIG)."
ADMA Biologics' President and CEO Adam Grossman commented, "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...The expanded plasma pool production scale allows us to confidently commit to generating peak revenues in excess of $300 million and this approval solidifies the pathway to meaningful gross margin expansion beginning potentially in the second half of 2021 and accelerating throughout 2022."
"In addition to the increase in ADMA's multi-year financial guidance, the company is reiterating its expectation for quarter-over-quarter revenue growth throughout 2021 and beyond," Grossman added.
The company pointed out that the newly authorized 4,400-liter IVIG plasma pool scale for BIVIGAM® will facilitate the expansion of its processing capacity by 50% from 400,000 to 600,000 liters. ADMA believes that it will be able to produce BIVIGAM® utilizing it same equipment, release testing assays, disposables and labor force.
The firm stated that it expects that the higher product output volumes will provide meaningful improvement to its gross margin throughout its 7 to 12 month manufacturing cycle for plasma-derived therapies. The company indicated that after receiving approval to boost production levels from the FDA its now able to distribute BIVIGAM® in both 50 mL and 100 mL vial sizes.
ADMA Biologics develops, manufactures and markets specialty plasma-derived biologics used in the treatment of immunodeficient patients who are at risk for infection and various infectious diseases. The company presently manufactures and sells three FDA-approved plasma-derived biologics, "BIVIGAM® (immune globulin intravenous, human) for the treatment of primary humoral immunodeficiency (PI), ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of PI and NABI-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus."
The company makes its IVIG products at its FDA-licensed facility in Boca Raton, Fla., and additionally operates a FDA-approved source plasma collector through a subsidiary company that provides a portion of its blood plasma for the manufacture of ADMA's products.
ADMA Biologics started the day with a market cap around $233.8 million with approximately 123.0 million shares outstanding and a short interest of about 8.4%. ADMA shares opened 24% higher today at $2.36 (+$0.46, +24.21%) over yesterday's $1.90 closing price. The stock has traded today between $2.06 and $2.63 per share and closed for trading at $2.07 (+$0.17, +8.95%).
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