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 second quarter 2022 financial
results and provided a business update.
“The second quarter of 2022 was another banner period of
execution for ADMA Biologics, with total revenue growth of 90%
year-over-year, significantly improved gross margins
quarter-over-quarter, and meaningfully narrowed net losses compared
to prior periods. We believe this significant revenue growth
coupled with disciplined expense management establish a strong
foundation for the Company to accelerate towards profitability,”
said Adam Grossman, President and Chief Executive Officer of
ADMA.
“We are particularly pleased with the utilization and growth of
our higher margin immune globulin product, ASCENIV™. Drawing from
the robust underlying product demand trends, we expect that the
product and margin mix will continue to favorably evolve over the
coming periods. In this context, we anticipate the Company’s
pathway to profitability will become increasingly visible as the
year progresses and our anticipated margin expansion continues to
unfold. We believe we are well-positioned to deliver 2022 total
revenues exceeding $130 million, driven by both Intravenous
Immunoglobulin (“IVIG”) end-market growth as well as anticipated
share gains for our product portfolio. Additionally, our strategic
alternatives process remains a top corporate priority and is
ongoing. We will update the market as developments
materialize.”
“The investments made in the Boca Raton production facility, as
well as our end-to-end supply chain, have enabled ADMA to
successfully navigate historically challenging macroeconomic
conditions,” said Brian Lenz, ADMA’s Chief Financial Officer, and
General Manager, ADMA BioCenters. “We are encouraged by the
continued operational efficiencies being unlocked and look forward
to expanding on these trends as we accelerate towards
profitability. The Company remains well-capitalized, holding
approximately $52 million in cash and cash equivalents at the end
of the second quarter, while having access to an additional $25
million in non-dilutive funds from the Hayfin credit facility.”
Second Quarter 2022 and Recent
Achievements:
- Significant Revenue Growth: Achieved second
quarter 2022 total revenues of $33.9 million, as compared to $17.8
million during the second quarter of 2021, an increase of $16.1
million, or approximately 90%. Due to a favorable product mix, as
the Company continues to expand its customer base for both BIVIGAM®
and ASCENIV, ADMA realized a gross margin of approximately 23%
during the second quarter of 2022, resulting from sales of higher
margin products and continued supply chain operating
efficiencies.
- Durable Mix Shift Toward Higher Margin
Products: ADMA is particularly encouraged with the
continued physician adoption and utilization of its proprietary
IVIG product, ASCENIV. We believe that leading product demand
indicators continue to support durable and sustained upside for
this product, with possible upside to peak potential.
- Advancing Toward
Profitability: The Company maintains and reiterates its
previously provided profitability timeline, which is expected no
later than the first quarter of 2024, while taking into account
current macroeconomic uncertainties. However, should current demand
trends and margin dynamics sustain, accelerated profitability
timelines may be achievable.
- On-Track BioCenters Expansion: At present, the
Company’s BioCenters segment has ten plasma collection centers
under its corporate umbrella: six centers are United States Food
and Drug Administration (“FDA”)-licensed, two additional centers
are operational and collecting plasma, and two centers are in
various stages of construction. The Company remains on track to
have ten BioCenter locations FDA-licensed by year-end 2023 and, in
the same period, forecasts raw material plasma supply
self-sufficiency. ADMA anticipates its strong plasma supply
position will support its upwardly revised production and revenue
forecasts.
- Expanded Patent Estate: In May 2022, the
United States Patent and Trademark Office issued U.S. Pat. No.
11,339,206 (the “‘206 Patent”). The ‘206 Patent relates to methods
of treating respiratory infections and expands ADMA’s estate of
patents encompassing its proprietary immunotherapeutic
compositions. In particular, the ‘206 Patent encompasses use of
standardized, hyperimmune globulin for treating respiratory
infections including those caused by respiratory syncytial virus
(“RSV”), coronavirus, influenza virus, parainfluenza virus, and
metapneumovirus.
- Ongoing Strategic Review: ADMA continues to
evaluate a variety of strategic alternatives through its ongoing
engagement with Morgan Stanley. The Company will communicate
material developments as required by the U.S. Securities and
Exchange Commission (“SEC”). The exploration of strategic
opportunities remains a top corporate priority for ADMA.
2022 & Long-Term Financial Guidance:
- 2022 Financial
Guidance: Enabled by the strong start to the year, ADMA
anticipates total 2022 revenues will exceed $130 million. ADMA
reiterates expectations for continued gross profit expansion and
narrowing net losses as 2022 progresses.
- 2024-2025 Financial
Guidance: The Company continues to anticipate generating
approximately $250 million or more in topline revenue in 2024, and
approximately $300 million or more thereafter. At these revenue
levels, and based upon current assumptions, ADMA continues to
forecast achieving corporate gross margins in the range of 40-50%
and net income margins in the range of 20-30%. These assumptions
translate to potential annual gross profit and net income in the
range of $100-150 million and $50-100 million, respectively, during
the 2024-2025 time period and beyond.
Second Quarter 2022 Financial Results:
Total revenues for the second quarter ended June 30, 2022 were
$33.9 million, as compared to $17.8 million during the second
quarter of 2021, an increase of $16.1 million, or approximately
90%. The revenue growth for the second quarter of 2022, compared to
the second quarter of 2021, was favorably impacted by the continued
commercial ramp-up of the Company’s IVIG product portfolio and
expanding the customer base for BIVIGAM and ASCENIV.
Gross profit for the second quarter of 2022 was $7.8 million,
compared to a gross loss of $1.0 million for the second quarter of
2021. Gross profit growth during the second quarter was driven by a
favorable contribution from higher margin products, notably
ASCENIV.
Consolidated net loss for the quarter ended June 30, 2022 was
$13.8 million, or $(0.07) per basic and diluted share, compared to
a consolidated net loss of $18.9 million, or $(0.15) per basic and
diluted share, for the quarter ended June 30, 2021. Net loss
decreased by approximately $5.1 million, primarily attributed to
higher gross margins of $8.8 million offset by a $1.3 million
increase in interest expense as a result of additional debt
principal as well as rising interest rates. Additional offsets
during the quarter included increased plasma center operating
expenses of $1.1 million attributed to having eight plasma centers
in operation compared to four operating centers during the period
last year, as well as increased general and administrative expenses
of $1.5 million resulting in increased headcount,
commercialization, and marketing expenditures.
As of June 30, 2022, ADMA had working capital of $194.7 million,
primarily consisting of $146.1 million of inventory, cash, and cash
equivalents of $52.4 million and net accounts receivable of $18.9
million, partially offset by an aggregate of $27.3 million of
accounts payable and accrued expenses, as compared to working
capital of $153.2 million as of June 30, 2021.
Conference Call InformationTo access the
conference call on August 10, 2022 at 4:30 PM ET, participants may
register for the call here to receive the dial-in numbers and
unique PIN to access the call seamlessly. It is recommended that
you join 10 minutes prior to the event starting (although you may
register and dial in at any time during the call). 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.
About ASCENIV™
ASCENIV (immune globulin intravenous, human – slra 10% liquid)
is a plasma-derived, polyclonal, intravenous immune globulin
(IVIG). ASCENIV was approved by the FDA in April 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 respiratory syncytial virus (RSV) plasma obtained
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.
Certain data and other information about ASCENIV™ or ADMA Biologics
and its products can be found on the Company’s website at
www.admabiologics.com.
About BIVIGAM®
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 antibodies. Certain data and other information about
BIVIGAM® or ADMA Biologics and its products can be found on the
Company’s website at www.admabiologics.com.
About ADMA BioCenters
ADMA BioCenters operates FDA-licensed facilities 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.admabiocenters.com.
About ADMA Biologics, Inc.
(ADMA)
ADMA Biologics is an end-to-end 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, among others, related
to certain aspects of its products and product candidates. For more
information, please visit www.admabiologics.com.
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., and its
subsidiaries (collectively, “our”, “ADMA” 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
“anticipates,” “believes,” “could,” “estimates,” “expects,”
“forecasts,” “intends,” “may,” “plans,” “predicts,” “projects,”
“should,” “targets,” “will,” “would,” 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 and pro forma
results; the success of ASCENIV™ in future periods, and market
share of the Company’s product portfolio; the timeline associated
with profitability; 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
benefits thereof; and the Company’s ongoing discussions with Morgan
Stanley regarding the evaluation of strategic alternatives. Actual
events or results may differ materially from those described in
this press release 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 SEC, including our most recent reports on Form
10-K, 10-Q and 8-K, and any amendments thereto.
COMPANY CONTACT:Skyler BloomSenior Director,
Business Development and Corporate Strategy | 201-478-5552 |
sbloom@admabio.com
INVESTOR RELATIONS CONTACT:Michelle
PappanastosSenior Managing Director, Argot Partners | 212-600-1902
| michelle@argotpartners.com
ADMA BIOLOGICS, INC. AND
SUBSIDIARIESCONSOLIDATED STATEMENTS OF
OPERATIONS (Unaudited)
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
|
|
|
|
|
|
|
REVENUES: |
|
|
|
|
|
|
|
|
Product revenue |
|
$ |
33,869,298 |
|
|
$ |
17,794,881 |
|
|
$ |
62,936,683 |
|
|
$ |
33,807,791 |
|
License revenue |
|
|
35,709 |
|
|
|
35,709 |
|
|
|
71,417 |
|
|
|
71,417 |
|
Total revenues |
|
|
33,905,007 |
|
|
|
17,830,590 |
|
|
|
63,008,100 |
|
|
|
33,879,208 |
|
Cost of
product revenue |
|
|
26,135,614 |
|
|
|
18,832,624 |
|
|
|
51,576,660 |
|
|
|
36,602,746 |
|
Gross profit (loss) |
|
|
7,769,393 |
|
|
|
(1,002,034 |
) |
|
|
11,431,440 |
|
|
|
(2,723,538 |
) |
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES: |
|
|
|
|
|
|
|
|
Research and development |
|
|
873,386 |
|
|
|
1,158,866 |
|
|
|
1,497,497 |
|
|
|
2,146,515 |
|
Plasma center operating expenses |
|
|
3,921,486 |
|
|
|
2,803,326 |
|
|
|
7,896,075 |
|
|
|
5,045,669 |
|
Amortization of intangible assets |
|
|
178,838 |
|
|
|
178,838 |
|
|
|
357,676 |
|
|
|
357,676 |
|
Selling, general and administrative |
|
|
11,970,422 |
|
|
|
10,438,168 |
|
|
|
25,669,997 |
|
|
|
20,472,083 |
|
Total operating expenses |
|
|
16,944,132 |
|
|
|
14,579,198 |
|
|
|
35,421,245 |
|
|
|
28,021,943 |
|
|
|
|
|
|
|
|
|
|
LOSS
FROM OPERATIONS |
|
|
(9,174,739 |
) |
|
|
(15,581,232 |
) |
|
|
(23,989,805 |
) |
|
|
(30,745,481 |
) |
|
|
|
|
|
|
|
|
|
OTHER INCOME (EXPENSE): |
|
|
|
|
|
|
|
|
Interest income |
|
|
2,269 |
|
|
|
5,926 |
|
|
|
35,337 |
|
|
|
27,985 |
|
Interest expense |
|
|
(4,573,015 |
) |
|
|
(3,246,680 |
) |
|
|
(7,962,053 |
) |
|
|
(6,442,430 |
) |
Loss on extinguishment of debt |
|
|
- |
|
|
|
- |
|
|
|
(6,669,941 |
) |
|
|
- |
|
Other expense |
|
|
(19,421 |
) |
|
|
(83,317 |
) |
|
|
(186,301 |
) |
|
|
(125,318 |
) |
Other expense, net |
|
|
(4,590,167 |
) |
|
|
(3,324,071 |
) |
|
|
(14,782,958 |
) |
|
|
(6,539,763 |
) |
|
|
|
|
|
|
|
|
|
NET
LOSS |
|
$ |
(13,764,906 |
) |
|
$ |
(18,905,303 |
) |
|
$ |
(38,772,763 |
) |
|
$ |
(37,285,244 |
) |
|
|
|
|
|
|
|
|
|
BASIC AND DILUTED LOSS PER COMMON SHARE |
|
$ |
(0.07 |
) |
|
$ |
(0.15 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.31 |
) |
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING: |
|
|
|
|
|
|
|
|
Basic and Diluted |
|
|
196,353,185 |
|
|
|
127,416,126 |
|
|
|
196,113,888 |
|
|
|
121,571,501 |
|
|
|
|
|
|
|
|
|
|
ADMA BIOLOGICS, INC. AND
SUBSIDIARIESCONDENSED CONSOLIDATED BALANCE
SHEETS
|
June
30, |
|
December
31, |
|
|
2022 |
|
|
|
2021 |
|
ASSETS |
(Unaudited) |
|
|
Current
assets: |
|
|
|
Cash and cash equivalents |
$ |
52,415,053 |
|
|
$ |
51,089,118 |
|
Accounts receivable, net |
|
18,883,847 |
|
|
|
28,576,857 |
|
Inventories |
|
146,075,459 |
|
|
|
124,724,091 |
|
Prepaid expenses and other current assets |
|
5,399,928 |
|
|
|
4,339,245 |
|
Total current assets |
|
222,774,287 |
|
|
|
208,729,311 |
|
Property and
equipment, net |
|
54,951,267 |
|
|
|
50,935,074 |
|
Intangible
assets, net |
|
1,371,092 |
|
|
|
1,728,768 |
|
Goodwill |
|
3,529,509 |
|
|
|
3,529,509 |
|
Right to use
assets |
|
10,550,236 |
|
|
|
7,262,658 |
|
Deposits and
other assets |
|
3,755,938 |
|
|
|
4,067,404 |
|
TOTAL ASSETS |
$ |
296,932,329 |
|
|
$ |
276,252,724 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable |
$ |
11,388,048 |
|
|
$ |
12,429,409 |
|
Accrued expenses and other current liabilities |
|
15,961,070 |
|
|
|
17,214,988 |
|
Current portion of deferred revenue |
|
142,834 |
|
|
|
142,834 |
|
Current portion of lease obligations |
|
579,661 |
|
|
|
591,084 |
|
Total current liabilities |
|
28,071,613 |
|
|
|
30,378,315 |
|
Senior notes
payable, net of discount |
|
139,810,931 |
|
|
|
94,866,239 |
|
Deferred
revenue, net of current portion |
|
1,904,448 |
|
|
|
1,975,865 |
|
End of term
fee |
|
1,500,000 |
|
|
|
- |
|
Lease
obligations, net of current portion |
|
10,870,907 |
|
|
|
7,462,388 |
|
Other
non-current liabilities |
|
373,903 |
|
|
|
397,351 |
|
TOTAL LIABILITIES |
|
182,531,802 |
|
|
|
135,080,158 |
|
|
|
|
|
COMMITMENTS AND CONTINGENCIES |
|
|
|
|
|
|
|
STOCKHOLDERS' EQUITY |
|
|
|
Preferred
Stock, $0.0001 par value, 10,000,000 shares authorized, |
|
|
|
no shares issued and outstanding |
|
- |
|
|
|
- |
|
Common Stock
- voting, $0.0001 par value, 300,000,000 shares authorized, |
|
|
|
196,356,232 and 195,813,817 shares issued and outstanding |
|
19,636 |
|
|
|
19,581 |
|
Additional
paid-in capital |
|
565,266,375 |
|
|
|
553,265,706 |
|
Accumulated
deficit |
|
(450,885,484 |
) |
|
|
(412,112,721 |
) |
TOTAL STOCKHOLDERS' EQUITY |
|
114,400,527 |
|
|
|
141,172,566 |
|
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY |
$ |
296,932,329 |
|
|
$ |
276,252,724 |
|
|
|
|
|
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