Full Press Release Details
ADMA Biologics Reports Business Highlights
and Second Quarter 2020 Financial Results
Generated Total Revenues of $18.0 Million
for the First Half of 2020, Reflecting a 78% Increase Over First Half of 2019
Joined CoVIg-19 Plasma Alliance and Successfully
Opened New ADMA BioCenters Plasma Collection Center
Company Anticipates Generating $250 Million
or More in Annual Revenues Within Next Three to Five Calendar Years
Management to Host Conference Call and
Webcast Today at 4:30 p.m. ET
RAMSEY, NJ and BOCA RATON, FL - August 5, 2020
- ADMA Biologics, Inc. (Nasdaq: ADMA) ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated
to manufacturing, marketing and developing specialty plasma-derived biologics, today reported business highlights and financial
results for its fiscal second quarter and six months ended June 30, 2020, and provided an overview of recent progress and accomplishments.
"The first half of 2020 was marked by several achievements
and challenges as we navigate through these unprecedented macro-market conditions," said Adam Grossman, President and Chief
Executive Officer of ADMA. "Total revenues for the first half of 2020 increased approximately 78% compared to the same prior
year period. While the second quarter 2020 revenues were approximately 19% higher than second quarter 2019 revenues, ADMA, and
certain of its third-party vendors, experienced impacts from the global COVID-19 pandemic which resulted in unforeseen supply chain
disruptions. These COVID-19 disruptions were primarily related to delays with final product Current Good Manufacturing Practice
("cGMP") release testing by third-party vendors. This means that a few of our production batches were finished on schedule
but we were unable to submit for U.S. Food and Drug Administration ("FDA") lot release authorization due to delayed
These delays were mainly experienced during the latter part
of the second quarter and have since been resolved during July. In response to these delays, and in partnership with the FDA, we
added additional release testing laboratories to our approved consortium and believe we have completely resolved the issue and
do not anticipate additional testing or batch release delays going forward.
Market demand for our immunoglobulin product portfolio remains
strong and we anticipate considerable revenue growth for the second half of the year and are excited for the anticipated production
volume increases from our capacity expansion efforts in 2021 and beyond. We also believe we remain on track to achieve
our stated goal of generating $250 million or more in annual revenues within the next three to five calendar years."
"In accordance with our stated corporate objectives, during
the quarter we completed construction of a new plasma collection center, initiated donor collections and submitted a Biologics
License Application ("BLA") to the FDA, with an approval decision expected in mid-2021. We also installed
and qualified a new aseptic fill-finish machine at our Boca Raton facility, and manufactured conformance batches of BIVIGAM
at an increased scale that will ultimately allow us to manufacture at twice the volume as the process that is in place today. And
finally, we joined the CoVIg-19 Plasma Alliance and began collection of plasma from COVID-19 convalesced patients. We are proud
of these important achievements and milestones and believe we have set the stage to now be in a position to ensure the U.S. market
has a continuous supply of BIVIGAM , ASCENIV and NABI-HB . We are on target for positioning our operations to capitalize
on the continued forecasted growth of the plasma products industry. Our production throughput and finished product supply remains
on track to begin realizing the benefits from these initiatives as early as mid-2021," concluded Mr. Grossman.
Second Quarter 2020 Highlights and Recent Events
Financial Results for the Three Months Ended June 30, 2020
Total revenues for the quarter ended June 30, 2020 were $7.8
million, compared to $6.6 million for the quarter ended June 30, 2019, representing an increase of approximately $1.2 million,
or approximately 19%. The increase is primarily due to sales of BIVIGAM, ASCENIV and intermediates, compared to no sales from these
products during the same prior year period. ADMA's revenues for the second quarter of 2020, compared to the second quarter
of 2019, were favorably impacted by the FDA approvals of BIVIGAM and ASCENIV on May 9, 2019 and April 1, 2019, respectively, and
by the manufacturing and supply agreement ADMA entered into in January 2020 to produce and sell intermediate fractions to a certain
Consolidated net loss for the quarter ended June 30, 2020 was
$20.2 million, or $(0.23) per basic and diluted share, compared to a consolidated net loss of $13.2 million, or $(0.25) per basic
and diluted share, for the quarter ended June 30, 2019. The increase in net loss of $7.0 million was primarily due to increased
cost of product revenue of $3.0 million related to sales of FDA-approved immunoglobulin products not present in the same prior
year period, along with the remaining costs associated with the manufacturing of BIVIGAM's increased plasma pool conformance
lots as part of our planned capacity expansion, partially offset by a decrease in unabsorbed manufacturing expense at the Boca
Raton, FL production facility. The increase in net loss during the second quarter of 2020 is also attributable to higher research
and development expenses of $1.1 million, largely due to costs associated with the testing and development of a new filling line
at one of our third-party fill finishers, and to increased selling, general and administrative expenses of $2.6 million,
mainly due to increases in employee compensation expenses and other costs in support of our commercialization efforts for BIVIGAM
and ASCENIV. In addition, interest expense for the quarter increased by $1.0 million due to our accessing additional debt during
the second quarter of 2019 and first quarter of 2020. Included in the net loss for the second quarter of 2020 were non-cash expenses
of approximately $2.0 million for stock-based compensation, depreciation and amortization, and non-cash interest expense.
Financial Results for the Six Months Ended June 30, 2020
Total revenues for the six months ended June 30, 2020 were $18.0
million, compared to $10.1 million for the six months ended June 30, 2019, representing an increase of $7.9 million, or approximately
78%. The increase in revenues was primarily attributable to sales of BIVIGAM, ASCENIV and intermediates, compared to no sales from
these products during the same prior year period.
Consolidated net loss for the six months ended June 30, 2020
was $39.4 million, or $(0.49) per basic and diluted share, compared to a consolidated net loss of $26.3 million, or $(0.53) per
basic and diluted share, for the six months ended June 30, 2019. The increase in net loss of $13.1 million was primarily attributable
to increased cost of product revenue of $10.4 million related to sales of BIVIGAM, ASCENIV and intermediates not present during
the first half of 2019, along with the costs associated with the manufacturing of BIVIGAM's increased plasma pool
conformance lots as part of our planned capacity expansion, along with other production initiatives and investments at the Boca
Raton facility. Other factors contributing to the increase in net loss include: higher research and development expenses attributed
to costs associated with testing and development of a new fill line at our third-party fill finisher and costs incurred for a study
we commenced to potentially extend ASCENIV's approved and labeled expiration dating, higher selling, general administrative
expenses in support of our commercialization efforts of BIVIGAM's relaunch and ASCENIV's launch and the overall growth
in the size and scope of the Company's operations along with higher interest expense due to accessing additional debt during
the second quarter of 2019 and first quarter of 2020. Included in the net loss for the first half of 2020 were non-cash expenses
of approximately $3.9 million for stock-based compensation, depreciation and amortization, and non-cash interest expense.
At June 30, 2020, ADMA had cash and cash equivalents of $75.8
million and accounts receivable of $6.5 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 June 30, 2020 was $130.1 million, compared to $71.8
million as of December 31, 2019.
Conference Call Information
ADMA will host a conference call today, Wednesday, August 5,
2020, at 4:30 p.m. Eastern Time, to discuss the second 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 8992308. 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),