Full Press Release Details
ADMA Biologics Announces Preliminary
Fourth Quarter and Full Year 2019 Revenues and Provides 2020 Strategic Outlook
Achieved Fourth Quarter 2019 Preliminary
Unaudited Total Revenues of $11.9 Million, a 193% Increase Over Fourth Quarter 2018
Full Year 2019 Preliminary Unaudited
Total Revenues of $29.2 Million, a 72% Increase Over Full Year 2018
ADMA to Host Conference Call and Webcast
in the First Quarter of 2020 to Report Fourth Quarter and Full Year 2019 Financial Results
RAMSEY, NJ and BOCA RATON, FL, January 9, 2020 -- ADMA
Biologics, Inc. (NASDAQ: ADMA), 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 for the prevention
of certain infectious diseases, today announced its preliminary unaudited fourth quarter and full year 2019 revenues. The Company
also provided updates on the commercial launches of its marketed intravenous immunoglobulin (IVIG) products, BIVIGAM
and ASCENIV , as well as introduced its 2020 strategic outlook.
Fourth Quarter and Full Year 2019 Highlights
"We are extremely pleased with our preliminary fourth
quarter and full year 2019 revenue results, which are primarily attributable to the commercial rollouts of BIVIGAM and ASCENIV,
as well as our first sale of intermediate fractions related to our IVIG production process, and we look forward to continuing the
upward production ramp throughout the coming year," said Adam Grossman, ADMA's President and Chief Executive Officer.
"ADMA made significant progress and achieved a number of milestones over the past year and we believe we are entering 2020
well positioned to execute on several strategic priorities aimed at growing our overall revenues. These strategic priorities include
expanding throughput capacity at our manufacturing facility, enhancing our control over the supply-chain for our commercial products,
securing new contract manufacturing (CMO) supply agreements, and building and opening new plasma collection centers. We are actively
pursuing potential new pipeline assets targeting specialty plasma products and/or hyperimmune immunoglobulin indications and compositions
and we will provide further details when available."
ADMA executed on its 2019 strategic objectives, including:
ADMA is focused on the following key strategic priorities
ADMA plans to discuss these results with investors while attending
the 38th Annual J.P. Morgan Healthcare Conference taking place January 13-16, 2020 in San Francisco, CA.
Fourth Quarter and Full Year 2019 Financial Results Conference
ADMA plans to host a conference call and webcast to discuss
its fourth quarter and full year 2019 financial results during the first quarter of 2020 in conjunction with filing its annual
report on Form 10-K, which is expected to be filed with the U.S. Securities and Exchange Commission no later than March 16, 2020.
The financial information included in this press release is
preliminary, unaudited and subject to adjustment. It does not present all information necessary for an understanding of the Company's
fourth quarter and full year financial results for 2019.
About Primary Humoral Immunodeficiency
Primary humoral immunodeficiency (PI), also known as primary
immune deficiency disease (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
PI. Some disorders are present at birth or in early childhood and 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. PI patients are vulnerable
to infections and are more likely to suffer complications from these infections compared to individuals with a normal functioning
immune system. Because patients suffering from PI 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. Initially thought to be very rare, it is now estimated that the prevalence of PI in the U.S.
is 1 in 1,200, which translates to approximately 250,000 people.
BIVIGAM (immune globulin intravenous, human - 10% liquid)
is a plasma-derived, polyclonal, intravenous immune globulin (IVIG). BIVIGAM was approved by the FDA in May 2019 and is indicated
for the treatment of primary humoral immunodeficiency (PI), including, but not limited to the following group of genetic disorders:
X-linked and congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome and severe combined immunodeficiency.
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 PI patients against serious infections. BIVIGAM is a purified, sterile, ready-to-use preparation
of concentrated human Immunoglobulin (IgG) antibodies.
About ASCENIV (Formerly RI-002)
ASCENIV (immune globulin intravenous, human - slra 10%
liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG). ASCENIV was approved by the FDA on April 1, 2019 and
is indicated for the treatment of primary humoral immunodeficiency (PI), also known as primary immune deficiency disease (PIDD),
in adults and adolescents (12 to 17 years of age). ASCENIV is manufactured using ADMA's unique, patented plasma donor screening
methodology and tailored plasma pooling design, which blends normal source plasma and plasma from donors tested using the Company's
proprietary microneutralization assay. ASCENIV contains naturally occurring polyclonal antibodies, which 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.
ASCENIV is protected by U.S. Patents: 9,107,906, 9,714,283 and 9,815,886.
ASCENIV (immune globulin intravenous,
human - slra) is a 10% immune globulin liquid for intravenous injection, indicated for the treatment of primary humoral immunodeficiency
(PI) in adults and adolescents (12 to 17 years of age). PI includes, but is not limited to, the humoral immune defect in congenital
agammaglobulinemia, common variable immunodeficiency (CVID), X linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe
combined immunodeficiencies (SCID).
WARNING: THROMBOSIS, RENAL DYSFUNCTION
AND ACUTE RENAL FAILURE
Thrombosis may occur with immune
globulin (IGIV) products, including ASCENIV. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable
conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity,
and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.
Renal dysfunction, acute renal failure,
osmotic nephrosis, and death may occur with the administration of Immune Globulin Intravenous (Human) (IGIV) products in predisposed
Renal dysfunction and acute renal
failure occur more commonly in patients receiving IGIV products containing sucrose. ASCENIV does not contain sucrose.
For patients at risk of thrombosis,
renal dysfunction or renal failure, administer ASCENIV at the minimum dose and infusion rate practicable. Ensure adequate hydration
in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk
For additional safety information
about ASCENIV, please see full Prescribing Information.
ASCENIV is contraindicated in:
-Patients who have had an anaphylactic
or severe systemic reaction to the administration of human immune globulin.
-IgA-deficiency patients with
antibodies to IgA and a history of hypersensitivity.
Warnings and Precautions
Severe hypersensitivity reactions may
occur with IGIV products, including ASCENIV. In case of hypersensitivity, discontinue ASCENIV infusion immediately and institute
appropriate treatment. Patients with known antibodies to IgA may have a greater risk of developing potentially severe hypersensitivity
and anaphylactic reactions.
Thrombosis may occur following treatment
with immunoglobulin products and in the absence of known risk factors. Consider baseline assessment of blood viscosity in patients
at risk for hyperviscosity and ensure adequate hydration before administration. For patients at risk of thrombosis, administer
ASCENIV at the minimum dose and infusion rate practicable. Monitor for signs and symptoms of thrombosis and assess blood viscosity
in patients at risk for hyperviscosity.
Acute renal dysfunction/failure, osmotic
nephrosis, and death may occur upon use of human IGIV products. Ensure that patients are not volume depleted before administering