RAMSEY, N.J. and BOCA RATON, Fla. and GOOSE CREEK, S.C., April 26, 2021 (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, 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.
Pursuant to updated United States Food and Drug Administration (“FDA”) guidance to obtain approval for plasma collection centers, sponsors are now required to collect plasma donations for 3 months prior to submitting a Biologics License Application (“BLA”) filing. Accordingly, ADMA expects to file its BLA for the Goose Creek, S.C. plasma collection facility in approximately 3 months from center opening and anticipates a standard 12-month BLA review period by the FDA. In the meantime, ADMA is permitted to collect plasma donations at this site, and once FDA approved, it can utilize the plasma collected for further use in the manufacturing of life saving therapies.
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 up to 50 highly trained healthcare workers.
Eligible plasma donors can receive $70 on the first donation and up to $650/month. To learn more about the ADMA BioCenters donation process, and to schedule an appointment, please visit
www.admabiocenters.com
, or visit in person at: 214 Saint James Avenue, Goose Creek, S.C. 29445.
About ADMA BioCenters
ADMA BioCenters operates FDA licensed facilities 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 new regulations and guidance and enforces current good manufacturing practices “cGMP” 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-licensed 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 ten or more new plasma collection centers by 2024; and the use of plasma collected at the Goose Creek 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 |
[email protected]
INVESTOR RELATIONS CONTACT:
Sam Martin
Managing Director, Argot Partners | 212-600-1902 |
[email protected]