ADMA stock rose in early trading on April 28, 2021, after the company announced that it has received FDA approval for increased IVIG production.
ADMA Biologics, Inc., an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing, and developing specialty plasma-derived biologics, announced that the U.S. Food and Drug Administration (“FDA”) had approved 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”).
“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. “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. We commend our employees’ dedication in achieving this important manufacturing milestone and look forward to increasing our production capacity rapidly over the forward-looking quarters.”
The 4,400-liter IVIG plasma pool scale for BIVIGAM® will allow ADMA to expand its manufacturing plant’s total processing capacity from 400,000 liters to an anticipated peak throughput of up to 600,000 liters. ADMA now has FDA approval to produce BIVIGAM® at an expanded capacity with the same high quality as the previous manufacturing scale, while using the same equipment, release testing assays, disposables and labor force. The Company anticipates this will translate into meaningful gross margin improvement as production throughput flows through the standard 7 to 12-month manufacturing cycle for plasma-derived therapies. With this approval, ADMA additionally will now be able to offer BIVIGAM® in two vial sizes, both the 50 mL and 100 mL configurations.
ADMA Biologics is an end-to-end American commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. ADMA currently manufactures and markets three FDA-approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases: 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. ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA BioCenters subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides a portion of its blood plasma for the manufacture of its products. ADMA’s mission is to manufacture, market and develop specialty plasma-derived, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases and management of immune compromised patient populations who suffer from an underlying immune deficiency, or who may be immune compromised for other medical reasons.
On April 26, 2021, ADMA Biologics, Inc. announced commencement of operations and initiation of donor plasma collections at its newest ADMA BioCenters plasma collection facility located in Goose Creek, South Carolina.
“We are honored to have commemorated the opening of our Goose Creek, South Carolina plasma collection facility with South Carolina Governor, Henry McMaster, to whom we are sincerely grateful for his and his administration’s support. The state’s impressive infrastructure and skilled workforce create a terrific foundation for ADMA to safely collect and process plasma, and we look forward to continuing to grow our operations in the state now and in the coming years. The Governor’s ribbon cutting at our newest plasma collection facility marks the latest achievement in what has been an excellent start to 2021 for ADMA across all of its business units,” said Adam Grossman, President and Chief Executive Officer of ADMA. “ADMA currently has seven plasma collection facilities under its corporate umbrella at various stages of approval and development and remains on track to achieve its stated goal of having 10 or more plasma collection centers in operation by 2024.”
“Securing raw material plasma supply has never been more important than it is today, and we believe the series of recent acquisitions of plasma collection facilities validates this scarcity value. We anticipate that our BioCenters’ expansion strategy will support our goal of generating quarter-over-quarter revenue growth throughout 2021 and beyond, solidify our objective to establish a fully integrated and self-sufficient plasma supply chain, enable ADMA to ensure continuity of product supply to customers and patients and ultimately create significant asset value for our shareholders,” concluded Mr. Grossman.