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 third quarter 2022 financial results
and provided a business update.
“We are pleased to again be raising revenue guidance for
full-year 2022; the Company now expects to generate total revenue
of approximately $145 million, increased from $130 million as
previously provided. We believe that the third quarter revenue
growth of 99% year-over-year establishes a strong foundation from
which ADMA will continue to generate substantial revenue growth and
improve margins as we accelerate towards corporate profitability,”
said Adam Grossman, President and Chief Executive Officer of
ADMA.
Mr. Grossman continued, “Enabled by this continued revenue
growth, we opportunistically undertook several investments during
the quarter which we believe will strengthen commercial
initiatives, advance growth opportunities and enhance margins
moving forward. Research and development expenditures increased due
to accelerated enrollment of the post-marketing clinical study for
BIVIGAM. We believe the rapid pace of enrollment and investigator
excitement speaks to the reputation ADMA and its products have
established in the market. Additionally, during the quarter, we
mobilized a robust medical education and conference symposia
strategy which is anticipated to solidify ASCENIV’s growth outlook
and further expand the product’s growing customer base to areas not
yet penetrated.”
"While we are pleased with our reported gross profit expansion,
it is important to note that a substantial portion of BIVIGAM
revenues during the third quarter consisted of legacy 2,200-liter
scale product, which yields a significantly lower margin compared
to the current 4,400-liter batch production scale,” said Brian
Lenz, ADMA’s Chief Financial Officer, and General Manager, ADMA
BioCenters. “BIVIGAM inventory at the 2,200-liter scale sold during
this quarter was produced during 2021, prior to the Company
receiving FDA approval of the 4,400L-liter scale production.
Encouragingly, ADMA has been exclusively producing BIVIGAM at the
4,400-liter scale since the second half of 2021. The residual,
lower margin inventory produced at the 2,200-liter scale is
anticipated to be fully exhausted over the coming quarters and once
sold, we believe our profit margins will substantially
improve.”
Mr. Grossman concluded, “As we look to 2023, we believe ADMA is
well-positioned in its advancement towards profitability. The
immunoglobulin (“IG”) end market remains one of the fastest growing
segments in the pharmaceutical sector, and we are proud to have
clearly demonstrated ADMA’s staying power within this landscape.
The pieces are in place for ADMA to sustain its best-in-class
revenue growth profile and deliver on our longstanding commitment
of reaching profitability as rapidly as possible.”
Third Quarter 2022 and Recent Achievements:
- Significant Revenue Growth: Achieved third
quarter 2022 total revenues of $41.1 million, as compared to $20.7
million during the third quarter of 2021, an increase of $20.4
million, or approximately 99%.
- Operating Leverage Materializing.
Excluding the impact associated with the sale of lower margin,
2,200-liter scale BIVIGAM, the Company estimates corporate gross
margins for the third quarter would have been approximately 2-4%
higher compared to reported results, translating to an approximate
26-28% corporate gross margin in a normalized quarter. As the
Company has been exclusively producing BIVIGAM at the expanded
4,400-liter scale since the second half of 2021 and considering the
record high BIVIGAM product pull-through realized during the third
quarter of 2022, ADMA anticipates this lower margin inventory will
be fully monetized over the coming periods. ADMA anticipates
further margin enhancements as product throughput transitions
throughout the first half of 2023 to exclusively the higher margin
4,400-liter scale product.
- Accounting for the transient gross margin dynamics amounting to
approximately $1.3 million at the midpoint, in addition to
approximately $1 million in non-recurring operating expenditures
incurred during the quarter, the Company estimates third quarter
operating loss would have been approximately $7 million, the
equivalent of approximately 50% less than the prior year’s third
quarter.
- Product Mix Continues to Favorably Evolve:
ASCENIV’s prescriber and patient base continued to expand during
the third quarter, which drove record utilization and pull-through
for the product. These elevated demand trends have sustained into
the fourth quarter, and we expect that the product’s rapid growth
will continue into 2023 and beyond.
- Newly Identified Growth Opportunities: Strong
reception to ADMA’s medical education and scientific symposia
strategy is anticipated to catalyze penetration into additional
targeted growth opportunities. During the third quarter, ADMA
expanded educational initiatives on identifying clinical needs in
managing respiratory infections in the immunocompromised host,
specifically:
- Case study presentations by nationally recognized clinical
experts in areas of transplantation, infectious disease, and
immunology at national and regional medical meetings (i.e., Immune
Globulin National Society, Infectious Disease Week, and Florida
Allergy Asthma & Immunology Society).
- Full-capacity attendance of symposia discussions of real-world
experience of ASCENIV in patients with primary immunodeficiency
(“PI”).
- The ongoing post-marketing clinical studies may provide for
label expansion opportunities for both BIVIGAM and ASCENIV to
include pediatric-aged PI patients as well as additional
publications supporting product safety.
- 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: The Company’s
BioCenters segment has ten plasma collection centers under its
corporate umbrella: seven centers are United States Food and Drug
Administration (“FDA”)-licensed, two additional centers are
operational and collecting plasma presently under FDA licensing
preparation and review and one center is in the construction phase.
The Company remains on track to have ten BioCenters 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.
- 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 value-creating
opportunities remains a top corporate priority for ADMA.
2022 & Long-Term Financial Guidance:
- 2022 Financial Guidance: Enabled by the strong
year-to-date execution, ADMA anticipates total 2022 revenues will
reach approximately $145 million. ADMA reiterates expectations for
continued gross profit expansion and narrowing net losses into
2023.
- 2024-2025 Financial
Guidance: The Company continues to anticipate generating
approximately $250 million or more in 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.
Third Quarter 2022 Financial Results:
Total revenues for the third quarter ended September 30, 2022
were $41.1 million, as compared to $20.7 million during the third
quarter of 2021, an increase of $20.4 million, or approximately
99%. The revenue growth for the third quarter of 2022, compared to
the third quarter of 2021, was favorably impacted by the continued
commercial ramp-up of the Company’s intravenous immune globulin
(IVIG) product portfolio and expanding the customer base for
BIVIGAM and ASCENIV.
Gross profit for the third quarter of 2022 was $9.7 million,
compared to gross profit of $0.4 million for the third quarter of
2021. Gross profit growth during the third quarter was driven by a
favorable contribution from ASCENIV. Partially offsetting the
favorably evolving product mix, ADMA sold a material amount of the
remaining 2,200-liter scale, lower margin BIVIGAM product during
the third quarter of 2022. Moving forward, this lower margin
inventory is anticipated to be exhausted over the coming quarters,
after which production throughput and sales recognition is
anticipated to be confined exclusively to the higher margin
4,400-liter BIVIGAM product.
Consolidated net loss for the quarter ended September 30, 2022
was $14.9 million, or $(0.08) per basic and diluted share, compared
to a consolidated net loss of $17.7 million, or $(0.13) per basic
and diluted share, for the quarter ended September 30, 2021.
Net loss decreased by approximately $2.8 million compared to the
third quarter of 2021, primarily attributed to higher gross profit
of $9.3 million, partially offset by a $2.3 million increase in
interest expense as a result of additional debt principal as well
as rising interest rates. Additional offsets during the third
quarter of 2022 included increased plasma center operating expenses
of $1.7 million attributed to having nine plasma centers in
operation compared to five operating centers during the same period
last year, as well as increased general and administrative expenses
of $2.2 million resulting from increased headcount,
commercialization, and marketing expenditures.
As of September 30, 2022, ADMA had working capital of
approximately $179.7 million, primarily consisting of $162.9
million of inventory, $34.9 million of cash and cash equivalents
and net accounts receivable of $20.9 million, partially offset by
an aggregate of $43.6 million of accounts payable and accrued
expenses.
Conference Call InformationTo access the
conference call on November 9, 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 BIVIGAM® and ASCENIV™ in future periods,
including certain opportunities for such products; the production
scale of BIVIGAM; future growth opportunities; the timeline
associated with profitability; the ability to obtain FDA approval
of its plasma collection centers and the associated timing in
connection therewith; expectations regarding the Company’s future
gross margins; and the ability to achieve source plasma
self-sufficiency and the associated timing in connection therewith,
as well as benefits thereof. 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 September 30, |
|
Nine Months Ended September 30, |
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
|
|
|
|
|
|
|
|
|
REVENUES: |
|
|
|
|
|
|
|
|
Product revenue |
|
$ |
41,054,429 |
|
|
$ |
20,644,842 |
|
|
$ |
103,991,112 |
|
|
$ |
54,452,633 |
|
License revenue |
|
|
35,708 |
|
|
|
35,708 |
|
|
|
107,125 |
|
|
|
107,125 |
|
Total revenues |
|
|
41,090,137 |
|
|
|
20,680,550 |
|
|
|
104,098,237 |
|
|
|
54,559,758 |
|
Cost of
product revenue |
|
|
31,433,496 |
|
|
|
20,295,213 |
|
|
|
83,010,156 |
|
|
|
56,897,959 |
|
Gross profit (loss) |
|
|
9,656,641 |
|
|
|
385,337 |
|
|
|
21,088,081 |
|
|
|
(2,338,201 |
) |
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES: |
|
|
|
|
|
|
|
|
Research and development |
|
|
1,041,947 |
|
|
|
770,557 |
|
|
|
2,539,444 |
|
|
|
2,917,072 |
|
Plasma center operating expenses |
|
|
4,859,450 |
|
|
|
3,146,221 |
|
|
|
12,755,525 |
|
|
|
8,191,890 |
|
Amortization of intangible assets |
|
|
178,838 |
|
|
|
178,838 |
|
|
|
536,514 |
|
|
|
536,514 |
|
Selling, general and administrative |
|
|
12,893,139 |
|
|
|
10,726,797 |
|
|
|
38,563,136 |
|
|
|
31,198,880 |
|
Total operating expenses |
|
|
18,973,374 |
|
|
|
14,822,413 |
|
|
|
54,394,619 |
|
|
|
42,844,356 |
|
|
|
|
|
|
|
|
|
|
LOSS
FROM OPERATIONS |
|
|
(9,316,733 |
) |
|
|
(14,437,076 |
) |
|
|
(33,306,538 |
) |
|
|
(45,182,557 |
) |
|
|
|
|
|
|
|
|
|
OTHER INCOME (EXPENSE): |
|
|
|
|
|
|
|
|
Interest income |
|
|
7,236 |
|
|
|
4,256 |
|
|
|
42,573 |
|
|
|
32,241 |
|
Interest expense |
|
|
(5,580,366 |
) |
|
|
(3,298,680 |
) |
|
|
(13,542,419 |
) |
|
|
(9,741,110 |
) |
Loss on extinguishment of debt |
|
|
- |
|
|
|
- |
|
|
|
(6,669,941 |
) |
|
|
- |
|
Other expense |
|
|
(9,641 |
) |
|
|
18,546 |
|
|
|
(195,942 |
) |
|
|
(106,772 |
) |
Other expense, net |
|
|
(5,582,771 |
) |
|
|
(3,275,878 |
) |
|
|
(20,365,729 |
) |
|
|
(9,815,641 |
) |
|
|
|
|
|
|
|
|
|
NET
LOSS |
|
$ |
(14,899,504 |
) |
|
$ |
(17,712,954 |
) |
|
$ |
(53,672,267 |
) |
|
$ |
(54,998,198 |
) |
|
|
|
|
|
|
|
|
|
BASIC AND DILUTED LOSS PER COMMON SHARE |
|
$ |
(0.08 |
) |
|
$ |
(0.13 |
) |
|
$ |
(0.27 |
) |
|
$ |
(0.44 |
) |
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING: |
|
|
|
|
|
|
|
|
Basic and Diluted |
|
|
196,383,935 |
|
|
|
133,770,147 |
|
|
|
196,204,893 |
|
|
|
125,682,400 |
|
|
|
|
|
|
|
|
|
|
|
ADMA
BIOLOGICS, INC. AND SUBSIDIARIESCONDENSED
CONSOLIDATED BALANCE SHEETS |
|
|
|
|
|
September 30, |
|
December 31, |
|
2022 |
|
2021 |
ASSETS |
(Unaudited) |
|
|
Current
assets: |
|
|
|
Cash and cash equivalents |
$ |
34,906,020 |
|
|
$ |
51,089,118 |
|
Accounts receivable, net |
|
20,902,385 |
|
|
|
28,576,857 |
|
Inventories |
|
162,913,633 |
|
|
|
124,724,091 |
|
Prepaid expenses and other current assets |
|
5,372,484 |
|
|
|
4,339,245 |
|
Total current assets |
|
224,094,522 |
|
|
|
208,729,311 |
|
Property and
equipment, net |
|
56,946,090 |
|
|
|
50,935,074 |
|
Intangible
assets, net |
|
1,192,254 |
|
|
|
1,728,768 |
|
Goodwill |
|
3,529,509 |
|
|
|
3,529,509 |
|
Right to use
assets |
|
10,335,873 |
|
|
|
7,262,658 |
|
Deposits and
other assets |
|
4,459,322 |
|
|
|
4,067,404 |
|
TOTAL ASSETS |
$ |
300,557,570 |
|
|
$ |
276,252,724 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable |
$ |
25,197,806 |
|
|
$ |
12,429,409 |
|
Accrued expenses and other current liabilities |
|
18,378,932 |
|
|
|
17,214,988 |
|
Current portion of deferred revenue |
|
142,834 |
|
|
|
142,834 |
|
Current portion of lease obligations |
|
720,755 |
|
|
|
591,084 |
|
Total current liabilities |
|
44,440,327 |
|
|
|
30,378,315 |
|
Senior notes
payable, net of discount |
|
141,365,706 |
|
|
|
94,866,239 |
|
Deferred
revenue, net of current portion |
|
1,868,739 |
|
|
|
1,975,865 |
|
End of term
fee |
|
1,500,000 |
|
|
|
- |
|
Lease
obligations, net of current portion |
|
10,636,083 |
|
|
|
7,462,388 |
|
Other
non-current liabilities |
|
362,179 |
|
|
|
397,351 |
|
TOTAL LIABILITIES |
|
200,173,034 |
|
|
|
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, 196,776,871 and 195,813,817 shares issued and
outstanding |
|
19,678 |
|
|
|
19,581 |
|
Additional
paid-in capital |
|
566,149,846 |
|
|
|
553,265,706 |
|
Accumulated
deficit |
|
(465,784,988 |
) |
|
|
(412,112,721 |
) |
TOTAL STOCKHOLDERS' EQUITY |
|
100,384,536 |
|
|
|
141,172,566 |
|
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY |
$ |
300,557,570 |
|
|
$ |
276,252,724 |
|
|
|
|
|
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