Full Press Release Details
ADMA Biologics Reports Full Year 2018
RAMSEY, N.J. and BOCA RATON, FL., - March 13, 2019 -
ADMA Biologics, Inc. (NASDAQ: ADMA) ("ADMA" or the "Company"), a vertically integrated commercial biopharmaceutical
and specialty immunoglobulin company that manufactures, markets and develops specialty plasma-derived biologics for the treatment
of immune deficiencies and the prevention and treatment of certain infectious diseases, today announced its financial results for
the year ended December 31, 2018, and provided an update on its operations and upcoming milestones.
"During 2018, we achieved several key objectives, most
notably the improvement of our Boca Raton, FL manufacturing facility's FDA compliance status to Voluntary Action Indicated
("VAI"). This improved VAI classification has afforded us the opportunity to submit regulatory applications to the
U.S. Food and Drug Administration (the "FDA") for potential approval of new drug product candidates," stated
Adam Grossman, President and Chief Executive Officer of ADMA.
"As part of our compliance enhancement upgrades to our
Boca Raton, FL facility, we optimized the intravenous immunoglobulin ("IVIG") manufacturing process for BIVIGAM .
We continue to work with the FDA to finalize our BIVIGAM Prior Approval Supplement ("PAS") for drug substance, with
the goal of reintroducing BIVIGAM to the market this year. We are also working closely with the FDA on the pending application
for RI-002's initial approval, and the FDA action date is scheduled for April 2, 2019," continued Mr. Grossman.
"Other notable accomplishments include: retiring
approximately 8.6 million shares of our non-voting common stock from Biotest Pharmaceuticals Corporation, receiving FDA
approval of our plasma collection center in Kennesaw, GA, obtaining FDA approval for the BIVIGAM drug product PAS and
completing a debt refinancing of up to $72.5 million with Perceptive Advisors."
Mr. Grossman concluded, "We look forward to continuing
to work with the FDA during 2019 as we seek FDA approval for the pending applications for both RI-002 and BIVIGAM . FDA approval
for RI-002 and BIVIGAM , if received, along with Nabi-HB , our presently commercially available hyperimmune globulin, would
give us three commercial immune globulin products and would make ADMA one of the few globally recognized plasma manufacturers offering
a portfolio of novel immune globulin products."
Recent Achievements and Upcoming Milestones
Financial Results for the Year Ended December 31, 2018
ADMA reported total revenues of $17.0 million for the year
ended December 31, 2018, as compared to $22.8 million for the year ended December 31, 2017, representing a decrease of $5.8 million.
The decrease in revenues is primarily due to $7.0 million of non-recurring revenue generated in 2017 that was related to an amendment
to our contract manufacturing agreement and a decrease in the sale of normal source plasma of $1.6 million in 2018 due to increased
competition from other plasma donation centers which have opened in close proximity to the plasma collection centers we transferred
to Biotest on January 1, 2019, partially offset by an increase in Nabi-HB revenues of $2.8 million.
The consolidated net loss for the year ended December 31, 2018
was $65.7 million, or $(1.45) per basic and diluted share, as compared to a consolidated net loss of $43.8 million, or $(1.91)
per basic and diluted share for the year ended December 31, 2017. The increase in net loss of $22.0 million was primarily attributable
to an increase in cost of product revenue from the manufacture of conformance lots production of RI-002 and BIVIGAM , which
can be used for commercial sales upon FDA approval, higher operational expenses reflecting a full year of operations at the Boca
Raton, FL facility for 2018, as compared to just seven months of operating activity at the Boca Raton, FL facility in 2017, as
well as the initiation of marketing and commercial activities and the decrease in revenues. Included in the net loss for the year
ended December 31, 2018 were non-cash expenses of $6.8 million for stock-based compensation, depreciation and amortization, and
non-cash interest expense.
At December 31, 2018, ADMA had cash and cash equivalents of
$22.8 million, as compared to $43.1 million at December 31, 2017. ADMA's net working capital was $34.9 million as of December
31, 2018, as compared to $52.9 million as of December 31, 2017.
ADMA Biologics, Inc. (ADMA)
ADMA Biologics is a vertically integrated commercial biopharmaceutical and specialty immunoglobulin company that manufactures,
markets and develops specialty plasma-based biologics for the treatment of immune deficiencies and the prevention of and treatment
of certain infectious diseases. The target patient populations include immune-compromised individuals who suffer from an underlying
immune deficiency disease or who may be immune-suppressed for medical reasons. ADMA has received U.S. Patents 9,107,906, 9,714,283,
9,815,886 and 9,969,793 related to certain aspects of its lead product candidate, RI-002. For more information, please visit www.admabiologics.com.
BIVIGAM is an intravenous immune globulin indicated for
the treatment of primary humoral immunodeficiency. This includes, but is not limited to, agammaglobulinemia, common variable immunodeficiency,
Wiskott-Aldrich syndrome and severe combined immunodeficiency. These primary immunodeficiencies ("PI") are a group
of genetic disorders. Initially thought to be very rare, it is now believed that as many as 250,000 people in the U.S. have some
form of PI. BIVIGAM contains a broad range of antibodies similar to those found in normal human plasma. These antibodies are
directed against bacteria and viruses, and help to protect Primary Immune Deficiency Disease ("PIDD") patients against
serious infections. BIVIGAM is a purified, sterile, ready-to-use preparation of concentrated polyclonal Immunoglobulin ("IgG")
antibodies. Antibodies are proteins in the human immune system that work to defend against infections and disease. FDA's
initial approval for BIVIGAM was received by Biotest Pharmaceuticals Corporation on December 19, 2012, and production of BIVIGAM
was halted by Biotest in December 2016. ADMA obtained ownership and all rights, title and interest in BIVIGAM on June 6, 2017
as part of the Biotest Therapy Business Unit asset acquisition and resumed the production of BIVIGAM during the fourth quarter
ADMA's lead portfolio product candidate, RI-002, which has demonstrated
positive Phase III pivotal clinical trial data, is a specialty plasma-derived, polyclonal, intravenous immune globulin ("IVIG")
derived from human plasma containing naturally occurring polyclonal antibodies (e.g., Streptococcus pneumoniae, H. influenza type
B, cytomegalovirus ("CMV"), measles, tetanus, etc.) as well as plasma from donors tested to have high levels of neutralizing
antibodies to respiratory syncytial virus ("RSV"). ADMA is pursuing an indication for the use of this specialty polyclonal
IVIG product for treatment of patients diagnosed with PIDD. Polyclonal antibodies are the primary active component of IVIG products.
Polyclonal antibodies are proteins that are used by the body's immune system to neutralize microbes, such as bacteria and viruses
and prevent against infection and disease. Data review which has been published in peer reviewed journals indicates that the polyclonal
antibodies present in RI-002 support its ability to prevent infections in immune-compromised patients. This data and other information
about RI-002 or ADMA Biologics products can be found on the Company website at: www.admabiologics.com. RI-002 is manufactured with
novel technology protected by U.S. Patents: 9,107,906, 9,714,283, 9,815,886 and 9,969,793, the latter of which affords ADMA patent
exclusivity for the use of an immune globulin as a prevention and/or treatment for any type of respiratory infection.
About Primary Immune Deficiency Disease (PIDD)
PIDD is a class of inherited genetic disorders that causes an
individual to have a deficient or absent immune system. According to the World Health Organization, there are approximately 350
different genetic mutations encompassing PIDD. Some disorders present at birth or in early childhood, the disorders can affect
anyone regardless of age or gender. Some affect a single part of the immune system, others may affect one or more components of
the system. PIDD patients are vulnerable to infections and more likely to suffer complications from these infections as compared
to individuals with a normal functioning immune system. The infections may occur in any part of the body. As patients suffering
from PIDD lack a properly functioning immune system, they typically receive monthly treatment with polyclonal immune globulin products.
Without this exogenous antibody replacement, these patients would remain vulnerable to persistent and chronic infections. PIDD
has an estimated prevalence of 1:1,200 in the United States, or approximately 250,000 people in the U.S.
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 the words "estimate,"
"project," "intend," "forecast," "target," "anticipate," "plan,"
"planning," "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 concerning our plans to develop,
manufacture, market, launch and expand our own commercial infrastructure and commercialize our current products and future products,
the safety, efficacy and expected timing of, and our ability to, obtain and maintain regulatory approvals of our current products
and product candidates, and the labeling or nature of any such approvals, the success of our work with our third party vendors
and the U.S. Food and Drug Administration (the "FDA") in furtherance of and progress towards an approval of our Biologics
License Application for specialty plasma-based biologics and the ability of such third parties to respond adequately or in a timely
manner to the issues raised by the FDA, our ability to successfully pursue commercialization and prelaunch activities, the timeframe
within which we may receive approval from the FDA for specialty plasma-based biologics, if at all, the potential of our specialty