Full Press Release Details
ADMA Biologics Reports Second Quarter
and First Half 2019 Financial Results
RAMSEY, N.J. and BOCA RATON, FL., - August 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 second
quarter and six months ended June 30, 2019, and provided an update on its recent achievements, operations and upcoming milestones.
"We are pleased with our significant accomplishments reported
during the second quarter of 2019, which include two United States Food and Drug Administration ("FDA") approvals,
BIVIGAM and ASCENIV , as well as the FDA authorizations of product license transfers for BIVGAM and Nabi-HB ,"
stated Adam Grossman, ADMA's President and Chief Executive Officer. "During the second quarter, we completed an equity
financing of approximately $52 million in gross proceeds, which we expect to use to support the commercial inventory build and
product launches for BIVIGAM and ASCENIV , expand the manufacturing capacity of our Boca Raton, FL facility, the procurement
of raw materials, plasma center expansion, other capital expenditures and for general corporate purposes."
Anticipated Milestones
Financial Results for the Three Months Ended June 30, 2019
ADMA reported total revenues of $6.6 million for the quarter
ended June 30, 2019, as compared to $4.7 million for the quarter ended June 30, 2018, representing an increase of $1.9 million,
or approximately 41%. The increase in revenues was primarily due to $2.4 million of contract manufacturing revenue in the second
quarter of 2019, with no corresponding amount in the second quarter of 2018, partially offset by a $0.5 million decrease in Nabi-HB
revenues related to the timing of shipment requests from a key customer. The contract manufacturing revenue is related to an agreement
we assumed from Biotest Pharmaceuticals Corporation ("BPC"). While we expect to generate additional revenue under this
contract during the second half of 2019, this contract is set to expire at the end of 2019.
The consolidated net loss for the quarter ended June 30, 2019
was $13.2 million, or $(0.25) per basic and diluted share, as compared to a consolidated net loss of $14.7 million, or $(0.35)
per basic and diluted share, for the quarter ended June 30, 2018. The decrease in net loss of $1.5 million was primarily attributable
to higher revenues and lower plasma center operating costs as a result of having one plasma collection center in operation in 2019
as compared to three during the same period last year, partially offset by higher selling, general and administrative costs, comprised
of commercialization, marketing and prelaunch expenses for BIVIGAM and ASCENIV , as well as increased employee related
expenses, including stock-based compensation, and to increased interest expense. Included in the net loss for the quarter ended
June 30, 2019 were non-cash expenses of approximately $1.6 million for stock-based compensation, depreciation and amortization,
and non-cash interest expense.
Financial Results for the Six Months Ended June 30, 2019
ADMA reported total revenues of $10.1 million for the six months
ended June 30, 2019, as compared to $8.7 million for the six months ended June 30, 2018, representing an increase of $1.4 million,
or approximately 16%. The increase in revenues was primarily attributable to the $2.4 million of contract manufacturing revenue
generated during the second quarter of 2019, partially offset by a $0.9 million decrease in Nabi-HB revenues related to the timing
of shipment requests from a key customer.
The consolidated net loss for the six months ended June 30,
2019 was $26.3 million, or $(0.53) per basic and diluted share, as compared to a consolidated net loss of $32.6 million, or $(0.74)
per basic and diluted share, for the six months ended June 30, 2018. The decrease in net loss of $6.3 million was primarily attributable
to higher revenues and lower manufacturing and plasma center operating costs, partially offset by higher selling, general and administrative
costs, comprised of commercialization, marketing and prelaunch expenses for BIVIGAM and ASCENIV as well as increased
employee related expenses, including stock-based compensation, in addition to a non-cash gain of $11.5 million from the transfer
of two of ADMA's plasma centers on January 1, 2019 as part of the consideration of the Biotest Therapy Business Unit ("BTBU")
acquisition in June of 2017, largely offset by a loss on extinguishment of debt of $10.0 million related to the refinancing of
ADMA's senior secured notes and higher interest expense. Included in the net loss for the six months ended June 30, 2019
were non-cash expenses of approximately $3.3 million for stock-based compensation, depreciation and amortization, and non-cash
At June 30, 2019, ADMA had cash and cash equivalents of $73.6
million and accounts receivable of $5.1 million, as compared to $22.8 million and $1.4 million, respectively, at December 31, 2018.
ADMA's net working capital as of June 30, 2019 was $93.8 million, as compared to $34.9 million as of December 31, 2018. In
the second quarter of 2019, the Company completed an underwritten public offering of its common stock and received net proceeds
ADMA Biologics, Inc. (ADMA)
ADMA Biologics is a vertically integrated biopharmaceutical manufacturer with three FDA approved commercial specialty plasma-based
biologics. 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 and management of immune compromised patient populations. 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 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.
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
or Primary Immune Deficiency Disease ("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 immune globulin intravenous (human), 10%
liquid, indicated for the treatment of primary humoral immunodeficiency. This includes, but is not limited to, X-linked and congenital
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 Primary Humoral Immunodeficiency ("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 human 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 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 2017 as part of the Biotest
Therapy Business Unit ("BTBU") acquisition in June 2017 and resumed the production of BIVIGAM during the fourth
quarter of 2017. The FDA approved BIVIGAM's prior approval supplement to amend the biologics license application for the
product on May 9, 2019 allowing the Company to resume supplying BIVIGAM to the U.S. market. ADMA anticipates the commercial
launch of BIVIGAM during the second half of 2019. The FDA completed the license transfer for BIVIGAM to ADMA on
July 2, 2019. Certain data and other information about BIVIGAM or ADMA Biologics and its products can be found on the Company's
website at: www.admabiologics.com.
Nabi-HB is a hyperimmune globulin that is rich in