ADMA Biologics Opens Newest ADMA BioCenters Plasma Collection Facility in Maryville, TN

Rhea-AI Summary

ADMA Biologics has announced the opening of a new plasma collection facility in Maryville, Tennessee, which is part of its strategy to enhance plasma supply chain control. The facility is designed to support increased plasma collection throughput as the company aims to establish a self-sufficient supply chain. ADMA has submitted a Biologics License Application (BLA) for this center to the FDA, expecting a decision by Q4 2021. The facility will be equipped with advanced technology to improve donor experience and will employ 50 trained staff members.

Positive

• Opening of new plasma collection center in Maryville, TN, enhancing supply chain control.
• Submission of BLA to FDA for additional center, indicating growth strategy.
• Facility designed to increase plasma collection efficiency with state-of-the-art technology.

Negative

• FDA approval for the new facility is subject to a lengthy review process, potentially delaying operations.
• Execution of future expansion plans depends on regulatory approval and market conditions.

RAMSEY, N.J. and BOCA RATON, Fla. and MARYVILLE, Tenn., Dec. 01, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced commencement of operations and initiation of collections at its newest ADMA BioCenters plasma collection facility located in Maryville, Tennessee. ADMA also announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval for this third plasma collection center.

“We believe the rapid expansion of our ADMA BioCenters plasma collections facilities demonstrates the Company’s focus on ensuring essential raw material supply chain continuity and control into the future,” said Adam Grossman, President and Chief Executive Officer of ADMA. “The opening of the Maryville, TN facility will allow us to continue to increase plasma collection throughput into 2021 and beyond, thereby ensuring the Company’s ability to self-supply a portion of its needs in order to continue to execute on top-line revenue growth. In the face of COVID-19 headwinds, we currently remain on track to achieve the Company’s stated goal of opening five to ten new plasma collection centers over the next three to five years, and ultimately progressing towards our goal of solidifying a fully vertically integrated and essentially self-sufficient supply chain.”

This new, state-of-the-art plasma collection center features automated registration, high-tech collection equipment designed to shorten the donation process, free Wi-Fi wireless network in the donor collection area, individual flat-screen TVs with cable at each donor station, and highly trained and certified staff who put donor comfort and safety first. At full capacity, the plasma center expects to maintain a staff of 50 highly trained healthcare workers.

The FDA regulatory process for obtaining approval for this plasma collection center includes a site inspection and an approximately 12-month BLA review period. As such, ADMA expects to receive an approval decision for this third plasma facility in the fourth quarter of 2021. In the meantime, ADMA is permitted to collect plasma donations at this site, and once FDA approved, it can use the plasma collected for production of its FDA approved immunoglobulin products.

About ADMA BioCenters

ADMA BioCenters is an FDA licensed facility specializing in the collection of human plasma used to make special medications for the treatment and prevention of diseases. Managed by a team of experts who have decades of experience in the specialized field of plasma collection, ADMA BioCenters provides a safe, professional and pleasant donation environment. ADMA BioCenters strictly follows FDA regulations and guidance and enforces cGMP (current good manufacturing practices) in all of its facilities. For more information about ADMA BioCenters, please visit www.admabiocenters.com.

About ADMA Biologics, Inc. (ADMA)

ADMA Biologics is an end-to-end 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 United States Food and Drug Administration (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. ADMA has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain aspects of its products and product candidates. For more information, please visit www.admabiologics.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains “forward-looking statements” pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about ADMA Biologics, Inc. (“we,” “our” or the “Company”). Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain such words as “intend,” “target,” “plan,” “expect,” “believe,” “will,” “is likely,” “will likely,” “should,” “could,” “would,” “may,” or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements also include, but are not limited to, statements about ADMA’s future results of operations; expansion plans and the goal of opening five to ten new plasma collection centers over the next three to five years; our expectation to receive an FDA approval decision to our filed BLA and the timing thereof; and the use of plasma collected at the Maryville facility for production of immunoglobulin products. Actual events or results may differ materially from those described in this document due to a number of important factors. Current and prospective security holders are cautioned that there also can be no assurance that the forward-looking statements included in this press release will prove to be accurate. Except to the extent required by applicable laws or rules, ADMA does not undertake any obligation to update any forward-looking statements or to announce revisions to any of the forward-looking statements. Forward-looking statements are subject to many risks, uncertainties and other factors that could cause our actual results, and the timing of certain events, to differ materially from any future results expressed or implied by the forward-looking statements, including, but not limited to, the risks and uncertainties described in our filings with the U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

COMPANY CONTACT:
Skyler Bloom
Director, Investor Relations and Corporate Strategy | 201-478-5552 | sbloom@admabio.com 

INVESTOR RELATIONS CONTACT:
Sam Martin
Managing Director, Argot Partners | 212-600-1902 | sam@argotpartners.com

FAQ

What is the significance of ADMA's new plasma collection facility in Maryville, TN?

The facility aims to enhance plasma supply chain control and increase collection throughput.

When did ADMA submit the Biologics License Application for its new center?

ADMA submitted the BLA to the FDA on December 1, 2020.

What are ADMA's future plans for plasma collection centers?

ADMA plans to open five to ten new plasma collection centers in the next three to five years.

When does ADMA expect to receive FDA approval for the Maryville facility?

ADMA anticipates a decision from the FDA in the fourth quarter of 2021.

How many employees will work at the new ADMA facility?

The facility is expected to employ 50 trained healthcare workers at full capacity.