Full Press Release Details
ADMA Biologics Reports Third Quarter
2020 Financial Results and Business Highlights
Generated Total Revenues of $28.3 Million
for the First Nine Months of 2020, Reflecting a 63% Increase Over the Same Prior Year Period
Successfully Opened Newest ADMA BioCenters
Plasma Collection Facility; On Track to Achieve Stated Goal of Opening Five to 10 New Collection Centers Over the Next Three to
Management to Host Conference Call and
Webcast Today at 4:30 p.m. ET
RAMSEY, NJ and BOCA RATON, FL - November 5, 2020
- ADMA Biologics, Inc. (Nasdaq: ADMA) ("ADMA" or the "Company"), an end-to-end commercial biopharmaceutical
company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today reported financial results
for its fiscal third quarter and nine months ended September 30, 2020, and provided an overview of recent progress and accomplishments.
"On the commercial front, demand for immune globulins
and our marketed products remained robust with our product portfolio generating sales of $28.3 million year-to-date ( YTD')
in 2020, an increase of 63% compared to the same period in 2019. The third quarter was our strongest quarter of the year, even
in the face of continued COVID-19 operating headwinds, as we generated $10.3 million in revenue, representing quarterly year-over-year
growth of 42%," said Adam Grossman, President and Chief Executive Officer of ADMA. "We continue to build our inventory
balance in support of anticipated revenue growth in the fourth quarter and into 2021. Our supply chain robustness initiatives continue
as planned and the expansion of our Company-owned plasma collection center network is ahead of schedule. We now have six centers
under our corporate umbrella at various stages of approval and development, including two that are fully operational and collecting
plasma. We are confident in our continued ability to successfully navigate the Company against the backdrop of COVID-19, and anticipate
a strong fourth quarter and ultimately achieving considerable growth in the second half of 2020 versus the first half."
Third Quarter 2020 and Recent Highlights
Financial Results for the Three Months Ended September 30,
Total revenues for the quarter ended September 30, 2020 were
$10.3 million, compared to $7.2 million for the quarter ended September 30, 2019, representing an increase of approximately $3.1
million, or 42%. The revenue growth for the third quarter of 2020, compared to the third quarter of 2019, was favorably impacted
by the continued commercial ramp up of BIVIGAM and ASCENIV, and by the manufacturing and supply agreement ADMA entered into in
January 2020 to produce and sell intermediate fractions.
Consolidated net loss for the quarter ended September 30, 2020
was $16.9 million, or $(0.19) per basic and diluted share, compared to a consolidated net loss of $11.4 million, or $(0.19) per
basic and diluted share, for the quarter ended September 30, 2019. The $5.5 million increase in net loss compared to the prior
year period was primarily attributable to a $3.9 million increase in cost of product revenue resulting from the higher product
revenues generated from our immunoglobulin products portfolio, and to increases in selling, general and administrative expenses
of $1.9 million related to employee compensation, new hires and other costs to support the commercialization efforts of BIVIGAM
and ASCENIV, as well as a $1.2 million increase in research and development expenses related to the validation of a new filling
line at one of our contracted third party fill-finishers. Research and development expenses were also impacted by costs associated
with developing our neutralization MICRO-ELISA proprietary assay to detect SARS-CoV-2 neutralizing antibodies in plasma in collaboration
with a third-party. The increase in net loss also includes a $0.8 million increase in plasma center operating expenses due to the
opening of additional plasma centers during 2020. Included in the net loss for the third quarter of 2020 were non-cash expenses
of approximately $2.3 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, 2020
were $28.3 million, compared to $17.3 million for the nine months ended September 30, 2019, representing an increase of $11.0 million,
or approximately 63%. The increase in revenues was primarily attributable to increased sales of our immunoglobulin products portfolio:
BIVIGAM , ASCENIV , Nabi-HB and intermediate fractions.
Consolidated net loss for the nine months ended September 30,
2020 was $56.3 million, or $(0.68) per basic and diluted share, compared to a consolidated net loss of $37.7 million, or $(0.72)
per basic and diluted share, for the nine months ended September 30, 2019. The increase in net loss of $18.6 million was primarily
attributable to a $14.4 million increase in cost of product revenue related to production costs incurred for the manufacture of
BIVIGAM conformance lots at an increased plasma pool production scale that pertains to our planned capacity expansion at our Boca
Raton, FL plasma fractionation facility, as well as higher product revenues generated from our immunoglobulin products portfolio.
The increase in net loss during the first nine months of 2020 was also attributable to increased selling, general administrative
expenses of $6.9 million in connection with the overall growth in the size and scope of the Company's operations, including
the commercialization efforts of BIVIGAM and ASCENIV , and a $3.0 million increase in research and development expenses
associated with the validation of a new line at one of our third party fill-finishers, and increases in various clinical research
activities, some of which are required by the FDA. Included in the net loss for the first nine months of 2020 were non-cash expenses
of approximately $6.2 million for stock-based compensation, depreciation and amortization and non-cash interest expense.
At September 30, 2020, ADMA had cash and cash equivalents of
$59.7 million and accounts receivable of $6.3 million, compared to cash and cash equivalents of $26.8 million and accounts receivable
of $3.5 million at December 31, 2019. ADMA's net working capital as of September 30, 2020 was $123.1 million, compared to
$71.8 million as of December 31, 2019.
Conference Call Information
ADMA will host a conference call today, Thursday, November 5,
2020, at 4:30 p.m. Eastern Time, to discuss the third quarter 2020 financial results and recent corporate updates. To access the
conference call, please dial (855) 884-8773 (local) or (615) 622-8043 (international) at least 10 minutes prior to the start time
and refer to conference ID 8185674. A live audio webcast of the call will be available under "Events & Webcasts"
in the Investor section of the Company's website, https://ir.admabiologics.com/events-webcasts. An archived webcast will be available
on the Company's website approximately two hours after the event.
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.
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.
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. Certain data and other information about Nabi-HB or ADMA Biologics
and its products can be found on the Company's website at www.admabiologics.com.
About ADMA BioCenters
ADMA BioCenters is an FDA licensed facility specializing in
the collection of human plasma used to make special medications for the treatment and prevention of diseases. Managed by a team
of experts who have decades of experience in the specialized field of plasma collection, ADMA BioCenters provides a safe, professional
and pleasant donation environment. ADMA BioCenters strictly follows FDA regulations and guidance and enforces cGMP (current good
manufacturing practices) in all of its facilities. For more information about ADMA BioCenters, please visit www.atlantaplasma.com.
About ADMA Biologics, Inc. (ADMA)