ADMA Biologics Inc (NASDAQ:ADMA) announced the US FDA approval for its expanded manufacturing process. It allows the company to manufacture IVIG (Intravenous Immune Globulin) using a purified 4,400-liter plasma pool.
FDA approval satisfy IVIG requirement in the US
CEO of ADMA, Adam Grossman, said the receipt of FDA nod for 4,400-liter plasma pool purification for the manufacture of IVIG is a significant milestone. It enables the company to scale up the production of IVIG and satisfy the demand for patients with immune deficiency and in the U.S.
Expected revenues of $300 million
ADMA expects to realize revenues of more than $300 million from the expanded plasma pool. It strengthens gross margins in H2 2021 and expedites in 2022.
With FDA nod, ADMA expands its total processing capacity to 600,000 liters from the current 400,000 liters. It will use the same equipment, labor, disposables, and release testing assays and maintains high quality. ADMA can now provide BIVIGAM in 100 ml and 50 ml configurations.
Live conference call
ADMA will report its Q1 2021 financial results on May 12, 2021, after the close of the hours in the US. The management team of ADMA will host a live conference call on May 12, 2021, at 4:30 PM ET to discuss company updates and financial results.
Inaugurates plasma collection facility in S.C.
ADMA inaugurated its BioCenters donor plasma collection center in Goose Creek, S.C.
Grossman said the company is pleased to inaugurate its plasma collection center in South Carolina. It is also grateful for the support extended by Henry McMaster, the South Carolina Governor, and his staff.
It can safely collect plasma using a skilled workforce and impressive infrastructure in the state. The company will also expand its operations in South Carolina in the future.
ADMA operates seven plasma collection centers under the corporate brand, and they are at various stages of development and approval. It targets to maintain ten plasma collection centers in 2024.
Grossman further said securing raw materials is essential. The expansion of BioCenters expects to improve revenues QoQ in 2021 and beyond. He said product supply to the customers is unabated and generates significant value for the investors. The company needs to secure sponsors for collecting plasma donations three months before applying for BLA.