ADMA Biologics Announces Record Preliminary Fourth Quarter and Full Year 2021 Revenues and Provides 2022 Business Update
January 19 2022 - 7:00AM
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 2021 revenues. The Company also provided commercial
updates for its immune globulin product portfolio as well as 2022
business updates.
Based on preliminary unaudited financial information, ADMA
expects record fourth quarter 2021 revenues of approximately $26
million, compared to $14 million during the fourth quarter of 2020,
reflecting an approximately 86% increase. The preliminary results
for the fourth quarter of 2021 represent the Company’s highest
quarterly revenue since its inception. For full year 2021,
preliminary unaudited total revenues of approximately $81 million,
compared to $42 million for the full year 2020, reflect a
substantial increase of approximately 92% over full year 2020.
“Following the successful establishment of end-to-end control of
its most critical manufacturing and supply chain functions, coupled
with a substantial expansion of its production capacity, 2021 was a
foundational year for ADMA, culminating in a year-exiting
annualized revenue run rate in excess of $100 million,” said Adam
Grossman, President and Chief Executive Officer of ADMA. “The
Company’s commitment to building an industry-leading commercial
organization is yielding results. Two years into the launch of its
Immunoglobulin (IG) product portfolio, ADMA has established itself
as a differentiated competitor capable of successfully penetrating
and competing in, the US IG market. The aggressive expansion of its
vertically integrated BioCenters plasma collection center network
has allowed ADMA to grow its inventories, solidify uninterrupted
plasma supply and expand its customer base. With broader industry
plasma collection headwinds anticipated to persist in early 2022
due to COVID-19 and other factors, ADMA believes its strong plasma
supply position will support the continued acquisition of new
customers, as larger competitors are expected to allocate supply
primarily to existing customer accounts.”
“We believe ADMA enters 2022 from a position of strength, and
the Company looks forward to continued execution as it enters the
next phase of its profit-oriented business cycle. This positioning
would not have been possible without the dedication and focus of
ADMA’s staff, leadership and advisors. We commend the entire team
for their extraordinary efforts focused on improving healthcare for
U.S. patients,” concluded Mr. Grossman.
2021 Achievements and 2022 Business Update:
-
Completed Multi-Year Supply Chain Robustness and
Remediation Processes. With multiple US Food and Drug
Administration (FDA) inspections conducted at ADMA’s Boca Raton, FL
facility and certain of its BioCenters throughout 2021, the agency
has published on its website that ADMA remains in Current Good
Manufacturing Practice (cGMP) compliance across its manufacturing
and plasma collection operations. The Company’s current compliant
standing is a direct result of the tireless efforts of its
dedicated and focused leadership team with ongoing commercial
operations as well as the multi-year remediation and expansion
efforts by the organization since taking over the product assets
and manufacturing facility in 2017. During 2021, ADMA received FDA
approvals for its 4,400L expanded intravenous immune globulin
(IVIG) production scale as well as its in-house fill-finish and
related operations production line using the VanRx SA25 Workcell
aseptic filling machine (VanRx). In addition to the significant
operating and cost efficiencies anticipated as a result of these
approvals, ADMA’s in-house fill-finish capabilities position the
Company as the only U.S.-domiciled fractionator of plasma-derived
products with complete end-to-end control of its critical
manufacturing functions. This milestone FDA approval will also
enable ADMA to explore potential accretive revenue opportunities
through providing contract manufacturing to third parties not
currently contemplated in ADMA’s current financial guidance. The
collective achievements in 2021 largely de-risk the asset’s
regulatory profile and support the achievement of all financial
targets over the near and longer term.
-
Continued ADMA BioCenters Expansion. ADMA
currently has nine plasma collection facilities under its corporate
umbrella at various stages of FDA approval and development,
including six facilities that are currently operational and
collecting plasma. The Company remains on track to have 10 or more
plasma collection centers FDA-licensed by year-end 2023. The
anticipated yield enhancement resulting from the recent Haemonetics
Persona® implementation, in combination with the Company’s growing
BioCenters network, has ADMA well-positioned to achieve source
plasma self-sufficiency by year end 2023 and contribute to
quarter-over-quarter revenue and plasma collections growth
throughout 2022 and beyond. We believe these activities will help
ensure continuity of commercial product supply to customers and
patients in the growing U.S. IG market.
-
Strengthened Cash Position. On October 25,
2021, ADMA completed an underwritten public offering, raising
approximately $53.9 million, net of all underwriting discounts and
expenses associated with the offering. ADMA continues to actively
engage prospective debt lenders to potentially refinance and expand
ADMA’s current debt facility.
-
Limited Impact Anticipated from COVID-19. ADMA
continues to successfully navigate headwinds presented by the
COVID-19 pandemic, including limited impacts from the recent surge
of the Omicron variant. This is evidenced by preliminary total
revenues of approximately $81 million generated for 2021, the
second full calendar year of commercialization, and a significant
build of inventory balances throughout the year, establishing what
we believe to be a solid basis for continued quarter-over-quarter
revenue growth. Based upon current market conditions, ADMA does not
anticipate any material impact on its BioManufacturing or
BioCenters business segments, nor does the Company anticipate any
material regulatory delays resulting from the FDA’s recent
suspension of US manufacturing inspections. As per the Code of
Federal Regulations (CFR) guidelines, ADMA’s August 2021 FDA
inspection of its Boca Raton, FL facility, during which the
Company’s regulatory status was deemed to be Voluntary Action
Indicated (VAI) on the FDA’s website, supports ADMA’s continued
cGMP compliance without any routine FDA inspection requirements
prior to the second half of 2023.
- Commercial Opportunities
Remain Strong for ADMA’s Product Portfolio. ADMA is
particularly encouraged with the recent physician adoption and
utilization of its hyperimmune product portfolio, notably ASCENIV™.
The Company’s medical education initiatives and commercial
detailing are illuminating the product’s novel manufacturing
methods and resulting differentiated profile, which the Company
believes will continue to resonate with physicians, providers and
patients.
-
Ongoing Strategic Review & Debt Refinancing
Activities. As previously disclosed, ADMA has engaged
Morgan Stanley as an advisor to evaluate a variety of strategic and
financing alternatives. The evaluation of these alternatives as
well as the formal engagement with Morgan Stanley demonstrate
ADMA’s management and Board of Directors’ unwavering commitment to
creating value for its stockholders. Further, ADMA continues to
actively engage prospective debt lenders to potentially refinance
and expand ADMA’s current debt facility. These concurrent processes
are ongoing, and the Company will communicate developments as they
unfold and as required by the Securities and Exchange
Commission.
Fourth Quarter and Full Year 2021 Financial Results
Conference Call
ADMA plans to host a conference call and webcast to discuss its
fourth quarter and full year 2021 financial results during the
first quarter of 2022 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
2022.
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
2021.
About ADMA Biologics,
Inc.
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 and European Patent No. 3375789 related to certain
aspects of its products and product candidates. For more
information, please visit www.admabiologics.com.
Forward-Looking Statements
Any statements contained in this press release
that do not describe historical facts may constitute
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended, including statements
regarding the anticipated benefits and expected consequences of the
rights plan that ADMA has adopted. Such statements are identified
by use of the words “anticipates,” “believes,” “estimates,”
“expects,” “intends,” “plans,” “predicts,” “projects,” “should,”
and similar expressions. These forward-looking statements also
include, but are not limited to, statements about ADMA’s fourth
quarter 2021 revenues or future results of operations; any impact
on its business as a result of the FDA’s recent suspension of U.S.
manufacturing inspections; the Company’s growing customer base as a
result of its strong plasma supply position; the success of
ASCENIV™, particularly with physicians, providers and patients;
operating and cost efficiencies as a result of recent FDA
approvals; accretive revenue opportunities following the FDA’s
approval of the VanRx aseptic filling machine; the ability to
obtain FDA approval of its plasma collection centers and the
associated timing in connection therewith; the ability to achieve
source plasma self-sufficiency and the associated timing in
connection therewith, as well as related underlying contributing
factors and benefits thereof; plasma collection as an industry; the
Company’s ongoing discussions with prospective debt lenders to
refinance and expand the Company’s debt facility; and the filing
timing of the Company’s Annual Report on Form 10-K. 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 BloomSenior Director,
Corporate Strategy and Business Development | 201-478-5552 |
sbloom@admabio.com
INVESTOR RELATIONS CONTACT:Michelle
PappanastosSenior Managing Director, Argot Partners | 212-600-1902
| michelle@argotpartners.com
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