Full Press Release Details
ADMA Biologics Reports Third Quarter
2018 Financial Results
RAMSEY, N.J. and BOCA RATON, FL., - November 8, 2018 -
ADMA Biologics, Inc. (NASDAQ: ADMA) ("ADMA" or the "Company"), a vertically integrated commercial biopharmaceutical
company that develops, manufactures and markets specialty plasma-based biologics for the treatment of Primary Immune Deficiency
Disease ("PIDD") and the prevention and treatment of certain infectious diseases, today announced its financial results
for the quarter and nine months ended September 30, 2018 and provided an update on its operations and upcoming milestones.
"We have made substantial progress executing on our key
initiatives throughout 2018. Most importantly, we improved the U.S. Food and Drug Administration ("FDA") compliance
status for our manufacturing facility in Boca Raton, Florida, which allowed us to submit applications for approval for the relaunch
of BIVIGAM and the approval and launch of RI-002," stated Adam Grossman, President and Chief Executive Officer of ADMA.
"We have two upcoming Prescription Drug User Fee Act ("PDUFA") dates for these products: BIVIGAM on December
18, 2018 and RI-002 on April 2, 2019."
"We were also pleased to obtain FDA approval for our third plasma collection
center, which was announced during the third quarter and occurred ahead of expectations. We look forward to the coming months
as we continue working with the FDA and commercialize our intravenous immune globulin products, which are expected to grow our
top line in 2019," concluded Mr. Grossman.
Recent Achievements and Upcoming Milestones
Financial Results for the Three Months Ended September 30,
ADMA reported total revenues of $4.2 million for the quarter
ended September 30, 2018, as compared to $4.7 million for the quarter ended September 30, 2017, representing a decrease of $0.5
million. The decrease in revenues was primarily due to the timing of shipments of normal source plasma to certain customers in
accordance with their agreements from our ADMA Bio Centers plasma collection business segment, partially offset by an increase
in revenues from commercial product produced at our plasma manufacturing facility (the "Boca Facility").
The consolidated net loss for the quarter ended September 30,
2018 was $15.1 million, or $(0.33) per basic and diluted share, as compared to a consolidated net loss of $15.2 million, or $(0.59)
per basic and diluted share, for the quarter ended September 30, 2017. The net loss in 2018 includes approximately $7.0 million
in unabsorbed manufacturing costs at the Boca Facility and non-cash expenses of $1.7 million for stock-based compensation, depreciation
and amortization, and non-cash interest expense.
Financial Results for the Nine Months Ended September 30,
ADMA reported total revenues of $12.9 million for the nine months
ended September 30, 2018, as compared to $10.8 million for the nine months ended September 30, 2017, representing an increase of
$2.1 million, or approximately 20%. The increase in revenues was attributable to the sales of our FDA licensed product Nabi-HB ,
which was acquired in June 2017, partially offset by lower revenues from our ADMA Bio Centers business segment due to the timing
of shipments of normal source plasma to certain customers in accordance with their agreements along with increased competition
from other local plasma donation centers which have opened in close proximity to our more established centers.
The consolidated net loss for the nine months ended September
30, 2018 was $47.7 million, or $(1.06) per basic and diluted share, as compared to a consolidated net loss of $30.8 million, or
$(1.67) per basic and diluted share, for the nine months ended September 30, 2017. The increase in net loss of $16.9 million was
primarily attributable to increased product revenue costs of $13.8 million, which reflects a full nine months of operations at
the Boca Facility as compared to four months of operating activity at the Boca Facility in 2017, as well as conformance lot production
of RI-002 and BIVIGAM , which can be used for commercial sales upon FDA approval, as well as higher selling, general and administrative
expenses attributed to increased headcount along with initiating marketing and commercial activities, partially offset by higher
revenues. Included in the net loss for the nine months ended September 30, 2018 were non-cash expenses of $5.0 million for stock-based
compensation, depreciation and amortization, and non-cash interest expense.
At September 30, 2018, ADMA had cash and cash equivalents of
$42.4 million, as compared to $43.1 million at December 31, 2017. ADMA's net working capital as of September 30, 2018 was
$52.6 million, as compared to $53.7 million as of December 31, 2017. In the second quarter of 2018, the Company completed an underwritten
public offering of its common stock and received net proceeds of $42.9 million.
ADMA Biologics, Inc. (ADMA)
ADMA is a vertically integrated commercial biopharmaceutical company that manufactures, markets and develops specialty plasma-based
biologics for the treatment of Primary Immune Deficiency Disease ("PIDD") and the prevention and treatment of certain
infectious diseases. ADMA's mission is to develop and commercialize plasma-derived, human immune globulins targeted to niche patient
populations, including immune-compromised individuals who suffer from an underlying immune deficiency disease 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 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 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 approval for BIVIGAM was received by Biotest
Pharmaceuticals Corporation ("BPC" or "Biotest") on December 19, 2012, and production of BIVIGAM was
halted by Biotest in December 2016. ADMA Biologics obtained ownership and all rights, title and interest in BIVIGAM on June
6, 2017 as part of the Biotest Therapy Business Unit ("BTBU") asset acquisition. ADMA optimized the production process
for BIVIGAM and submitted a Prior Approval Supplement ("PAS") to the United States Food and Drug Administration
("FDA") to amend the Biologics License Application ("BLA") for BIVIGAM in June of 2018, with a target
action date of December 18, 2018 under the Prescription Drug User Fee Act ("PDUFA"). If the PAS is approved by the
FDA, ADMA expects to be able to relaunch the product for commercial sale during the first half of 2019.
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. In September 2018, ADMA
resubmitted its BLA for RI-002 and in October 2018 the FDA provided a target action date under PDUFA of April 2, 2019. If the BLA
is approved by the FDA, ADMA anticipates the commercial launch of RI-002 to occur during the second half of 2019. 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 protected by U.S. Patents: 9,107,906, 9,714,283, 9,815,886 and 9,969,793, the latter of which affords the Company 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,"