Full Press Release Details
ADMA Biologics Reports First Quarter
2019 Financial Results
RAMSEY, N.J. and BOCA RATON, FL., - May 8, 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 of certain infectious diseases, today announced its financial results for the first quarter
ended March 31, 2019, and provided an update on its recent achievements, operations and upcoming milestones.
"We had a strong and productive start to 2019, most notably
due to the United States Food and Drug Administration ("FDA") approval of ASCENIV , the announcement of our fifth
patent, which expands our proprietary hyperimmune immunotechnology product and product candidate portfolio, along with entering
into a favorable credit facility with Perceptive Advisors ("Perceptive"). As a result of ASCENIV's FDA
approval, we recently accessed the available second tranche of funding from the credit facility in the principal amount of $27.5
million and also announced Perceptive's additional financial commitment to ADMA by upsizing the original amount of the credit
facility by $12.5 million, which is predicated on BIVIGAM's FDA approval. This second tranche of funding received from
Perceptive will be used to support our commercial launch of ASCENIV , procurement of additional raw material plasma inventory
and to initiate the project planning and buildout of another plasma center," stated Adam Grossman, President and Chief Executive
Officer of ADMA Biologics.
Recent Achievements and Upcoming Milestones
Financial Results for the First Quarter Ended March 31, 2019
ADMA reported total revenues of $3.5 million for the first quarter
ended March 31, 2019, as compared to $4.0 million for the first quarter ended March 31, 2018, representing a decrease of $0.5 million.
The decrease in revenues is primarily attributable to the Company generating revenues from one plasma collection center during
the first quarter of 2019, as compared to generating revenues from two plasma collection centers during the first quarter of 2018.
In accordance with the June 2017 purchase agreement for the Biotest Therapy Business Unit ("BTBU"), on January 1, 2019,
the Company transferred ownership of two of its FDA approved plasma collection centers to Biotest Pharmaceuticals Corporation ("BPC").
The decrease in quarterly revenues is also attributable to the timing of certain customers' shipment requests for Nabi-HB .
The consolidated net loss for the first quarter of 2019 was
$13.1 million, or $(0.28) per basic and diluted share, as compared to a consolidated net loss of $17.8 million, or $(0.39) per
basic and diluted share, for the first quarter of 2018. The decrease in net loss of $4.7 million was mainly due to the Company
recording a non-cash gain of $11.5 million pertaining to the value of its two plasma centers transferred to BPC on January 1, 2019
and a decrease in total operating expenses of $3.8 million in the first quarter of 2019 as compared to the first quarter of 2018,
partially offset by a $10.0 million loss on the extinguishment of debt pertaining to the refinancing of the Company's senior
credit facility during the first quarter of 2019. Included in the net loss for the quarter ended March 31, 2019 were non-cash expenses
of $1.7 million for stock-based compensation, depreciation and amortization, and amortization of debt discount.
At March 31, 2019, ADMA had cash and cash equivalents of $16.5
million, as compared to $22.8 million at December 31, 2018. ADMA's net working capital was $30.0 million as of March 31,
2019, as compared to $34.9 million as of December 31, 2018. Subsequent to March 31, 2019, ADMA accessed $27.5 million of additional
funding from Perceptive Advisors, with another $12.5 million of funding from Perceptive available upon FDA approval of BIVIGAM .
ADMA Biologics, Inc. (ADMA)
ADMA Biologics is a vertically integrated commercial biopharmaceutical company that manufactures, markets and develops specialty
plasma-based biologics for the treatment of Primary Immune Deficiency Disease ("PI") 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 for the treatment and prevention 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-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.
About ASCENIV (Formerly referred to as RI-002)
ASCENIV , Immune Globulin Intravenous, Human - slra 10% Liquid, is a plasma-derived, polyclonal, intravenous immune
globulin ("IVIG"). ASCENIV is protected by U.S. Patents: 9,107,906, 9,714,283 and 9,815,886. ASCENIV
is manufactured using our unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends
normal source plasma and plasma from donors tested using our proprietary microneutralization assay. ASCENIV contains
naturally occurring polyclonal antibodies. ASCENIV is indicated for the treatment of Primary Humoral Immunodeficiency
("PI") in adults and adolescents (12 to 17 years of age). ADMA received FDA approval for ASCENIV on April
1, 2019. 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. ASCENIV prevented serious bacterial infection among fifty-nine
patients treated for twelve months during the pivotal investigation. The most common adverse reactions to ASCENIV
( 5% of study subjects) were headache, sinusitis, diarrhea,
gastroenteritis viral, nasopharyngitis, upper respiratory tract infection, bronchitis, and nausea. ADMA anticipates the commercial
launch of ASCENIV during the second half of 2019. Certain data and other information about ASCENIV or ADMA
Biologics and its products can be found on the Company's website at: 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 PIs 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 PI 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. The FDA's initial approval for BIVIGAM was received by BPC in December 2012, and production
of BIVIGAM was halted by BPC in December 2016. ADMA obtained ownership and all rights, title and interest in BIVIGAM
in June 6, 2017 as part of the Biotest Therapy Business Unit asset acquisition (the "Biotest Transaction") and resumed
the production of BIVIGAM during the fourth quarter of 2017.
Nabi-HB is a hyperimmune globulin that is rich in
antibodies to the Hepatitis B virus. Nabi-HB is a purified human polyclonal antibody product collected from plasma donors
who have been previously vaccinated with a Hepatitis B vaccine. Nabi-HB is indicated for the treatment of acute exposure to
blood containing Hepatitis B surface antigen ("HBsAg"), prenatal exposure to infants born to HBsAg-positive mothers,
sexual exposure to HBsAg-positive persons and household exposure to persons with acute Hepatitis B virus infection. Hepatitis B
is a potentially life-threatening liver infection caused by the Hepatitis B virus. It is a major global health problem and can
cause chronic infection and put people at high risk of death from cirrhosis and liver cancer. Nabi-HB has a well-documented
record of long-term safety and effectiveness since its initial market introduction. FDA approval for Nabi-HB was received
on March 24, 1999. Biotest acquired Nabi-HB from Nabi Biopharmaceuticals in 2007. ADMA resumed production of Nabi-HB
in the third quarter of 2017, as substantially all of the Nabi-HB inventory received as part of the Biotest Transaction has
been sold in the normal course of business.
About Primary Immune Deficiency Disease ("PI")
PI 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 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.
PI 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. 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. PI 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