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 that it has received U.S. Food and Drug Administration
(“FDA”) approval for its fifth ADMA BioCenters plasma collection
facility located in Conyers, Georgia. This plasma collection
facility commenced operations and initiated source plasma
collection in the third quarter of 2021. With the approval
announced today, this facility is now FDA-approved to collect and
introduce into interstate commerce, human source plasma for further
manufacturing in the U.S.
“The successful expansion of ADMA’s plasma collection network
supports the Company’s goal of plasma supply self-sufficiency and
ongoing revenue growth objectives, and importantly, further
solidifies the pathway towards profitability. The approval is a
testament to the BioCenters team’s tireless commitment, and we
thank the FDA for its efforts and expeditious review of the
Conyers, GA Biologics License Application (“BLA”), which came well
in advance of the agency’s targeted approval date,” said Adam
Grossman, President and Chief Executive Officer of ADMA.
“ADMA now has ten plasma collection centers under its corporate
umbrella at various stages, five of which are now FDA-approved to
collect normal source and RSV hyperimmune plasma. The Company
remains on track to have ten or more of its BioCenters locations
FDA-approved by year-end 2023. ADMA’s growing internal plasma
collections are currently being supplemented by third-party supply
contracts as well as the yield enhancements resulting from the
implementation of the Haemonetics’ NexSys Persona® system. We
anticipate our encouraging plasma supply position will enable ADMA
to continue to expand its customer base and grow revenues in the
U.S. immunoglobulin market,” said Brian Lenz, Executive Vice
President, Chief Financial Officer, and General Manager, ADMA
BioCenters.
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. This center is approved to use the state-of-the-art
Haemonetics NexSys Persona® plasma collection system.
To learn more about the ADMA BioCenters donation process, and to
schedule an appointment, please visit: www.admabiocenters.com,
or visit in person at: 1820 Highway 20 Southeast, Suite 112,
Conyers, Georgia 30013.
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 and European Patent No. 3375789 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. and its subsidiaries (collectively, “ADMA”, “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
“anticipate,” “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 (including, but not limited to, revenue growth);
expansion plans and the goal of operating ten or more FDA-approved
plasma collection centers by year-end 2023; our pathway to
profitability; the Company’s plasma supply and ability to become
plasma self-sufficient; our expectation to file additional BLAs and
the timing thereof; the yield enhancements anticipated to result
from the implementation of Haemonetics’ NexSys Persona® technology;
the Company’s growing customer base and revenue as a result of its
strong plasma supply position; and the expected staff count at the
Conyers, GA facility. Actual events or results may differ
materially from those described in this press release 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 BloomSenior Director,
Corporate Strategy and Business Development | 201-478-5552 |
sbloom@admabio.com
INVESTOR RELATIONS CONTACT:Michelle
PappanastosSenior Managing Director, Argot Partners | 212-600-1902
| michelle@argotpartners.com
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