Full Press Release Details
ADMA Biologics Reports Third Quarter
2019 Financial Results and Highlights Recent Company Progress
Third Quarter Total Revenues of $7.2
Million, a 71% Increase Year Over Year
Commercial Rollouts for Immunoglobulins
(IVIG) Off to an Encouraging Start
RAMSEY, N.J. and BOCA RATON, FL., - November 6, 2019
- ADMA Biologics, Inc. (NASDAQ: ADMA) (ADMA or the Company), a commercial biopharmaceutical company dedicated to manufacturing,
marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection
and the prevention of certain infectious diseases, today announced financial results for the third quarter and nine months ended
September 30, 2019, and provided an overview of its recent corporate achievements.
"To date, 2019 has been a transformational year for ADMA,
marked most importantly by the recent re-launch and launch, respectively, and first commercial sales of our lead assets BIVIGAM
and ASCENIV, both indicated for the treatment of patients with primary humoral immunodeficiency (PI)," said Adam Grossman,
ADMA's President and Chief Executive Officer. "Our commercial rollouts are off to an encouraging early start for our
IVIG brands. As we look ahead to the remainder of 2019 and into 2020, we remain focused on maximizing these initial product launches
and executing on several strategic corporate initiatives aimed at growing our overall revenues, including potentially expanding
the capacity at our manufacturing facility, opening new plasma collection centers, as well as growing our commercial team and hiring
additional staff to support the anticipated production ramp up for 2020 and beyond."
Third Quarter 2019 and Recent Highlights
Third Quarter 2019 Financial Results
Total revenues for the quarter ended September 30, 2019 were
$7.2 million, compared to $4.2 million for the quarter ended September 30, 2018, representing an increase of $3.0 million, or approximately
71%. The increase in revenues was primarily due to increased production and sales of IVIG and related products manufactured at
Consolidated net loss for the quarter ended September 30, 2019
was $11.4 million, or $(0.19) per basic and diluted share, compared to a consolidated net loss of $15.1 million, or $(0.33) per
basic and diluted share, for the quarter ended September 30, 2018. The decrease in net loss of $3.7 million was primarily due to
the $3.0 million of higher revenues and a $1.7 million reduction in total operating expenses, partially offset by higher interest
expense of $1.2 million. The reduction in operating expenses was comprised of (i) lower product revenue costs of $1.2 million attributable
to a reduction in underabsorbed manufacturing expenses, (ii) lower research and development expenses of $0.5 million related to
the FDA approval of ASCENIV earlier in 2019, (iii) lower plasma center expenses of $1.5 million resulting from the transfer of
two of our plasma centers on January 1, 2019 in connection with the acquisition of the Boca Facility; partially offset by (iv)
higher selling, general and administrative expenses of $1.5 million attributable to expenses associated with the BIVIGAM and ASCENIV
product launches and enhancements to our information technology and customer support infrastructure necessary to support our commercialization
activities. Included in the net loss for the third quarter 2019 were non-cash expenses of approximately $1.8 million for stock-based
compensation, depreciation and amortization, and non-cash interest expense.
Financial Results for the Nine Months Ended September 30,
Total revenues for the nine months ended September 30,
2019 were $17.3 million, compared to $12.9 million for the nine months ended September 30, 2018, representing an increase of
$4.4 million, or approximately 34%. The increase in revenues was primarily due to increased production and sales of IVIG and
related products manufactured at the Boca Facility.
Consolidated net loss for the nine months ended September 30,
2019 was $37.7 million, or $(0.72) per basic and diluted share, compared to a consolidated net loss of $47.7 million, or $(1.06)
per basic and diluted share, for the nine months ended September 30, 2018. The decrease in net loss of $10.0 million was primarily
due to the $4.4 million of higher revenues and lower total operating expenses of $5.8 million, which reflects reductions in product
revenue costs of $3.2 million, research and development costs of $1.1 million and plasma center operating expenses of $3.8 million,
partially offset by higher selling, general and administrative expenses of $2.4 million. Included in the net loss for the nine
months ended September 30, 2019 were non-cash expenses of approximately $5.2 million for stock-based compensation, depreciation
and amortization, and non-cash interest expense.
At September 30, 2019, ADMA had cash and cash equivalents of
$48.0 million and accounts receivable of $7.3 million, as compared to cash and cash equivalents and accounts receivable of $22.8
million and $1.4 million, respectively, at December 31, 2018. ADMA's net working capital as of September 30, 2019 was $82.2
million, as compared to $34.9 million as of December 31, 2018.
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 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.
About ADMA Biologics, Inc.
ADMA Biologics is a commercial biopharmaceutical company dedicated
to manufacturing, marketing and developing specialty plasma-derived biologics for the treatments of immunodeficient patients at
risk for infection. ADMA currently manufactures and markets three United States Food and Drug Administration approved plasma-derived
biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases: ASCENIV (immune globulin
intravenous, human - slra 10% liquid) for the treatment of primary humoral immunodeficiency (PI); BIVIGAM
(immune globulin intravenous, human) for the treatment of PI; and NABI-HB (hepatitis B immune globulin, human)
to provide enhanced immunity against hepatitis B. ADMA's mission is to manufacture, market and develop specialty 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 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.
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 such words as "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