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 announced its preliminary unaudited fourth quarter
and full year 2020 revenues. The Company also provided commercial
updates for its immune globulin product portfolio, as well as
introduced its 2021 strategic and operational outlook.
Fourth Quarter and Full Year 2020
Highlights
- Achieved
record fourth quarter 2020 preliminary unaudited revenues of $13.9
million, compared to $12.0 million during the fourth quarter of
2019, reflecting a 16% increase. The preliminary results for the
fourth quarter of 2020 represent the Company’s highest revenue
generating quarter since its inception.
- Full year 2020
preliminary unaudited total revenues of $42.2 million, compared to
$29.3 million for the full year 2019, reflecting a substantial 44%
increase over full year 2019.
“We are extremely pleased with our preliminary record fourth
quarter and full year 2020 revenue results. ADMA’s continued
execution through COVID-19 headwinds is a testament to our
organization’s unwavering commitment to provide patients with
products to ensure the continuity of care. Our 2020 full year
operating results, we believe, will ultimately unlock significant
value for ADMA shareholders,” said Adam Grossman, ADMA’s President
and Chief Executive Officer. “2021 is poised to be a transformative
year for ADMA as we continue to execute on our mission of providing
specialty immune globulin products to patients and building a
highly profitable, end-to-end biologics manufacturing company.”
Mr. Grossman continued, “Throughout 2021 and beyond, we
anticipate delivering ongoing quarter-over-quarter revenue growth.
We also anticipate realizing robust operating efficiencies as early
as mid-2021, pending United States Food and Drug Administration
(FDA) decisions regarding ADMA’s submissions for its supply chain
enhancement initiatives, most notably consisting of our Intravenous
Immune Globulin (IVIG) production scale increase and for our
in-house aseptic fill-finish production line. Additionally, we
expect to potentially obtain FDA approvals in 2021 for two new
plasma collection centers located in Knoxville and Maryville, TN as
well as file Biologics License Applications (BLAs) for an
additional two plasma collection centers. COVID-19 notwithstanding,
ADMA remained on track in 2020 and achieved all its stated 2020
strategic and operating objectives. We anticipate 2021 will be
another year of achieving value-creating milestones, including
executing on the ongoing production ramp up and inventory build to
support annual revenue generation in excess of $250 million by 2024
which will provide for substantial profitability.”
ADMA executed on all of its 2020 strategic objectives,
including:
- Navigated
COVID-19 operating headwinds evidenced by preliminary total
revenues of approximately $42.2 million generated for the first
full calendar year of commercialization, in addition to
significantly building inventory balances throughout the year,
establishing a solid basis for continued quarter-over-quarter
revenue growth.
- Expanded ADMA
BioCenters’ plasma collection center network on schedule with the
construction of two new collection centers which are currently
operational and collecting plasma, as well as initiated the
establishment of three additional collection centers. The Company
currently has six plasma collection centers under its corporate
umbrella at various stages of approval and development.
- Refinanced
ADMA’s senior secured term loan with Perceptive Advisors, which
among other things, consolidated ADMA’s long term debt and provided
for a two year extension of the interest-only period through March
2024, which we believe will allow ADMA to reach profitability prior
to maturity. As part of the refinancing transaction, the Company
negotiated a $1 million principal reduction to the payoff of ADMA’s
subordinated debt facility prior to maturity without any prepayment
penalty.
- Advanced
supply chain enhancements and capacity expansion initiatives
in-line with Company provided timelines and maintained anticipated
regulatory decisions and FDA interactions.
- Expanded the
Company’s IP portfolio with new patents and developed the
ImmunoRank™ Neutralization MICRO-ELISA to detect the presence and
levels of COVID-19 neutralizing antibodies.
- Entered into a
manufacturing and supply agreement to produce and sell
plasma-derived intermediate fractions which is expected to
contribute $10-20 million in revenues at full scale.
- Hosted an
exclusive educational event at IDWeek 2020 on respiratory viral
infections and novel treatment modalities, as well as presented new
data on the preparation of a hyperimmune globulin for the
prevention and treatment of Streptococcus pneumonia in an on-demand
poster session.
ADMA is focused on the following key strategic
priorities in 2021:
- Generate ongoing
quarter-over-quarter and year-over-year revenue growth throughout
2021 and beyond as the Company progresses towards achieving
profitability with peak revenues of $250 million or greater by
2024.
- Continue building ADMA’s inventory
balance to support anticipated ongoing revenue growth and solidify
ADMA’s position as a reliable supplier for the growing U.S. immune
globulin marketplace ultimately ensuring the continuity of immune
globulin supply for our patients and customers.
- Complete certain
supply chain enhancements and capacity expansion programs as early
as mid-2021. Once FDA approved, the Company’s newly installed
fill-finish machine as well as the IVIG manufacturing scale
increase should allow ADMA to realize significant operating
efficiencies and improved gross margins beginning potentially as
early as mid-2021. These projects will ultimately position the
Company to be fully vertically integrated with in-house control
over the Company’s most critical manufacturing functions.
- Expand ADMA’s
plasma collection center network to achieve the goal of building up
to 10 plasma collection centers in the U.S. by 2024. During 2021,
ADMA expects two regulatory approval decisions for the Company’s
Knoxville and Maryville, TN plasma collection centers. ADMA also
anticipates filing BLAs for two additional plasma collection
centers during 2021.
Fourth Quarter and Full Year 2020 Financial Results
Conference Call
ADMA plans to host a conference call and webcast to discuss its
fourth quarter and full year 2020 financial results during the
first quarter of 2021 in conjunction with filing its Annual Report
on Form 10-K, which is expected to be filed with the U.S.
Securities and Exchange Commission in the first quarter of
2021.
The financial information included in this press release is
preliminary, unaudited and subject to adjustment. It does not
present all information necessary for an understanding of the
Company’s fourth quarter and full year financial results for
2020.
About ADMA Biologics, Inc. (ADMA)
ADMA Biologics is an end-to-end American commercial
biopharmaceutical company dedicated to manufacturing, marketing and
developing specialty plasma-derived biologics for the treatment of
immunodeficient patients at risk for infection and others at risk
for certain infectious diseases. ADMA currently manufactures and
markets three United States Food and Drug Administration (FDA)
approved plasma-derived biologics for the treatment of immune
deficiencies and the prevention of certain infectious diseases:
BIVIGAM® (immune globulin intravenous, human) for the treatment of
primary humoral immunodeficiency (PI); ASCENIV™ (immune globulin
intravenous, human – slra 10% liquid) for the treatment of PI; and
Nabi-HB® (hepatitis B immune globulin, human) to provide enhanced
immunity against the hepatitis B virus. ADMA manufactures its
immune globulin products at its FDA-licensed plasma fractionation
and purification facility located in Boca Raton, Florida. Through
its ADMA BioCenters subsidiary, ADMA also operates as an
FDA-approved source plasma collector in the U.S., which provides a
portion of its blood plasma for the manufacture of its products.
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, 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
StatementsThis 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,” “should,” “could,” “would,” “may,” or,
in each case, their negative, or words or expressions of similar
meaning. These forward-looking statements also include, but are not
limited to, statements about ADMA’s future results of operations;
timing of revenue and profitability; execution of corporate
objectives and achievement of goals, including but not limited to,
the Company’s key strategic priorities for 2021; receipt of future
regulatory approvals; realization of shareholder value; and future
appreciation of the asset value of manufactured plasma and plasma
collection centers. Actual events or results may differ materially
from those described in this document due to a number of important
factors. Current and prospective security holders are cautioned
that there also can be no assurance that the forward-looking
statements included in this press release will prove to be
accurate. Except to the extent required by applicable laws or
rules, ADMA does not undertake any obligation to update any
forward-looking statements or to announce revisions to any of the
forward-looking statements. Forward-looking statements are subject
to many risks, uncertainties and other factors that could cause our
actual results, and the timing of certain events, to differ
materially from any future results expressed or implied by the
forward-looking statements, including, but not limited to, the
risks and uncertainties described in our filings with the U.S.
Securities and Exchange Commission, including our most recent
reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.
COMPANY
CONTACT:Skyler BloomDirector,
Investor Relations and Corporate Strategy | 201-478-5552 |
sbloom@admabio.com
INVESTOR RELATIONS CONTACT:Sam
MartinManaging Director, Argot Partners | 212-600-1902 |
sam@argotpartners.com
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