ADMA Biologics Receives FDA Approval for VanRx Aseptic Fill-Finish Machine and Related Operations
September 08 2021 - 07:00AM
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 that the U.S. Food and Drug Administration
(“FDA”) has granted approval for the Company’s in-house aseptic
fill-finish machine, the VanRx SA25 (“VanRx”).
“The FDA approval of the VanRx marks the
successful completion of ADMA’s multi-year supply chain enhancement
initiative, firmly establishing ADMA as the only American domiciled
end-to-end producer of specialty plasma-derived biologic drugs.
Today’s announcement is expected to have transformative financial
and strategic implications for ADMA as the Company now joins an
elite group of U.S.-based drug manufacturers with comprehensive
in-house control of its critical manufacturing functions,” said
Adam Grossman, President and Chief Executive Officer of ADMA. “The
VanRx approval provides ADMA with internal fill-finish operations,
capable of sufficiently addressing all forecasted production
requirements for our commercial products. With the VanRx
operational, we are anticipating meaningfully improved gross
margins, enhanced patient supply consistency, accelerated inventory
production cycle times, and increased control and visibility of
commercial product lot releases, creating more predictable
near-term revenue results.
“The approval of the VanRx will also provide
ADMA with the opportunity to onboard new fill-finish contract
manufacturing opportunities with third parties. This additional
revenue stream can provide the Company with the ability to
potentially exceed previous financial targets, which we will update
as progress unfolds. With extensive vertical integration
successfully established and the Company’s more meaningful capital
investment initiatives having now concluded, ADMA is entering the
next phase of its profit-focused growth strategy. We look forward
to sustaining quarter-over-quarter revenue growth for the
foreseeable future as well as meaningfully improving profitability
metrics in the periods ahead,” concluded Mr. Grossman.
The VanRx fill-finish machine utilizes a
state-of-the-art closed isolator design, allowing for the removal
of human interventions and providing safe drug products for
patients. The VanRx machine has the capability of rapidly switching
between different container and closure formats, enabling aseptic
filling in a variety of different fill volumes and presentation
sizes. The combination of the FDA-approved increased BIVIGAM®
manufacturing production scale earlier this year as well as the
enhanced vertical integration resulting from this approval of the
VanRx machine is expected to allow ADMA to bring its products to
market faster, improve gross margins and substantially increase
ADMA’s end-to-end control over its critical manufacturing process.
ADMA will continue to work with its third-party contract
manufacturing organization (CMO) fill-finish partner who will
continue to fill a portion of ADMA’s production at their site. The
CMO’s site will remain in ADMA’s FDA-approved product Biologics
License Applications to provide the Company with alternatives on a
go-forward basis to ensure continued supply-chain robustness.
About ADMA Biologics, Inc.
(ADMA)
ADMA Biologics is an end-to-end American
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-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.
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 “estimate,” “project,”
“intend,” “forecast,” “target,” “anticipate,” “plan,” “planning,”
“expect,” “believe,” “will,” “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 our production capacity; and the expected financial,
strategic and commercial benefits of the VanRx approval. 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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