Full Press Release Details
ADMA Biologics Receives FDA Approval for Increased
IVIG Production Scale
ADMA Increases Total Forecasted Plant Manufacturing
Capacity from 400,000 Liters up to 600,000 Liters and Increases Total Forecasted Peak Revenues in Excess of $300 Million
Enhanced Gross Margins and Cost Efficiencies
Expected to be Realized Beginning Late 2021 and Accelerate Throughout 2022 on Path to Profitability
RAMSEY, N.J. and BOCA RATON, Fla., April 28, 2021 - 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 expanded manufacturing process, enabling fractionation and purification of a 4,400-liter
plasma pool for the manufacture of Intravenous Immune Globulin ("IVIG").
"The FDA approval of the 4,400-liter IVIG plasma pool production
scale process is a transformative milestone for the ADMA organization and will allow the Company to produce significantly more IVIG for
the U.S. market and for patients living with immune deficiencies," said Adam Grossman, President and Chief Executive Officer of
ADMA. "The expanded plasma pool production scale allows us to confidently commit to generating peak revenues in excess of
$300 million and this approval solidifies the pathway to meaningful gross margin expansion beginning potentially in the second half of
2021 and accelerating throughout 2022. In addition to the increase in ADMA's multi-year financial guidance, the Company is reiterating
its expectation for quarter-over-quarter revenue growth throughout 2021 and beyond. We commend our employees' dedication in achieving
this important manufacturing milestone and look forward to increasing our production capacity rapidly over the forward-looking quarters."
The 4,400-liter IVIG plasma pool scale for BIVIGAM will allow
ADMA to expand its manufacturing plant's total processing capacity from 400,000 liters to an anticipated peak throughput of up to
600,000 liters. ADMA now has FDA approval to produce BIVIGAM at an expanded capacity with the same high quality as the previous manufacturing
scale, while using the same equipment, release testing assays, disposables and labor force. The Company anticipates this will translate
into meaningful gross margin improvement as production throughput flows through the standard 7 to 12-month manufacturing cycle for plasma-derived
therapies. With this approval, ADMA additionally will now be able to offer BIVIGAM in two vial sizes, both the 50 mL and 100 mL configurations.
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; anticipated
timing for reaching profitability and meaningful gross margin expansion and cost efficiencies; our anticipated revenue growth; and the
amount of potential peak revenues to be generated by the Company and the related timing associated therewith. 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.
Director, Investor Relations and Corporate Strategy | 201-478-5552
INVESTOR RELATIONS CONTACT:
Managing Director, Argot Partners | 212-600-1902 | sam@argotpartners.com