ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), an
end-to-end commercial biopharmaceutical company dedicated to
manufacturing, marketing and developing specialty plasma-derived
biologics, announced the commencement of operations and initiation
of donor plasma collections at its newest ADMA BioCenters location
in Myrtle Beach, South Carolina.
“ADMA continues to successfully advance its ADMA BioCenters
expansion strategy, and in doing so, we believe is well-positioned
to ensure continuity of plasma supply to support the significant
revenue growth targets for the Company’s commercial Immune Globulin
(IG) portfolio,” said Adam Grossman, President and Chief Executive
Officer of ADMA. “With the opening of this Myrtle Beach plasma
collection center, ADMA currently collects plasma from six centers
and three additional centers are under construction. The Company
remains on track to have 10 or more plasma collection centers
licensed by the United States Food and Drug Administration (“FDA”)
by year-end 2023, which we believe will support source plasma
supply self-sufficiency as well as sustained quarter-over-quarter
revenue growth,” concluded Mr. Grossman.
ADMA BioCenters’ newest, state-of-the-art plasma collection
center located in Myrtle Beach, South Carolina features automated
registration, Haemonetics’ Persona® plasma collection solution for
the NexSys PCS® system designed to shorten the donation process and
increase collection yields, 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 center
expects to maintain a staff of up to 50 highly trained healthcare
workers. Pursuant to updated FDA direction to obtain approval for
plasma collection centers, sponsors are now required to collect
plasma donations for three months prior to submitting a Biologics
License Application (“BLA”) filing. Accordingly, ADMA expects to
file its BLA for the Myrtle Beach, South Carolina plasma collection
facility in approximately three months 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 the
site is FDA approved, ADMA can utilize the plasma collected for
further use in the manufacturing of life saving therapies.
To learn more about the ADMA BioCenters donation process, and to
schedule an appointment, please visit: www.admabiocenters.com, or
visit in person at: 1100 A Legends Rd, Myrtle Beach, SC 29579.
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 certain infectious
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 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.
About Haemonetics
Haemonetics (NYSE: “HAE”) is a global healthcare
company dedicated to providing a suite of innovative medical
products and solutions for customers, to help them improve patient
care and reduce the cost of healthcare. Its technology addresses
important medical markets: blood and plasma component collection,
the surgical suite and hospital transfusion services. To learn more
about Haemonetics, visit www.haemonetics.com. Persona®, a
proprietary, patented solution built upon Haemonetics’ NexSys PCS®
platform, tailors plasma collections to each donor’s individual
characteristics and is clinically shown to yield +9% to 12% (based
on baseline device, software configuration and donor population)
more plasma per donation on average to maximize both cost-efficient
output and patient impact from plasma collection centers. To learn
more about Haemonetics, visit www.haemonetics.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 (“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; plasma supply self-sufficiency; the strategic value of
our ADMA Biocenters; yield enhancement resulting from the Persona®
technology implementation; expansion plans and the goal of opening
ten or more plasma collection centers approved by year-end 2023;
timing relating to the filing, and review period, of a Biologics
License Application for the Myrtle Beach, South Carolina facility
and the number of employees at such location; and the use of plasma
collected at the Myrtle Beach, South Carolina facility for
production of immunoglobulin products. 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 BloomDirector,
Investor Relations and Corporate Strategy | 201-478-5552 |
sbloom@admabio.com
INVESTOR RELATIONS CONTACT:Michelle Pappanastos
Senior Managing Director, Argot Partners | 212-600-1902 |
michelle@argotpartners.com
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