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 first quarter 2023 financial results
and provided a business update.
“ADMA generated first-time Adjusted EBITDA
profitability, totaling $2.5 million, during the first quarter of
2023. In addition to continued gross profit growth and realization
of operating efficiencies, this breakthrough achievement was
propelled by an impressive 96% year-over-year increase in total
revenues, which reached $57 million in the quarter,” said Adam
Grossman, President and Chief Executive Officer of ADMA. “Based on
these results, we have increased our 2023 total revenue guidance,
now expected to exceed $220 million, and we anticipate continuing
to grow EBITDA from the newly established baseline throughout the
remainder of 2023.”
Mr. Grossman continued, “With the recent
reduction in interest expense resulting from the Hayfin credit
amendment announced last week, as well as overall increased
operating efficiencies, we believe an opportunity to accelerate net
income profitability earlier than previously anticipated is now
likely. Lastly, during the first quarter, we made progress in
advancing new growth initiatives that could allow ADMA to
potentially exceed 2024 and 2025 financial targets, setting the
foundation for a highly profitable growth cycle over the near and
longer term. We look forward to building on the momentum of early
2023 to drive further success.”
2023 Milestones & Objectives:
-
Accelerated Adjusted EBITDA Profitability. Driven
by 96% year-over-year revenue growth, which reached $57 million
during the first quarter, and the resulting operating efficiencies,
ADMA achieved first-time Adjusted EBITDA profitability, totaling
$2.5 million and ahead of the forecasted timeline. The Company
anticipates maintaining this momentum throughout the remainder of
2023 by focusing on increasing gross profits, managing expenses,
and building on the newly established Adjusted EBITDA
baseline.
- Lowered Cost of
Capital. The Company's financial position has been
strengthened by its recent credit amendment with Hayfin Capital
Management (“Hayfin”), which reduced its interest rate and
increased prepayment flexibility. The amendment includes several
favorable changes that are expected to benefit the Company and its
stockholders. In addition to the 1% reduction in the nominal
interest rate, the amendment allows for a newly structured 50%
waiver of the prepayment fee upon an acquisition of the Company,
among other scenarios further detailed in our Current Report on
Form 8-K filed with the Securities and Exchange Commission (“SEC”)
on May 2, 2023. These changes are expected to provide the Company
with greater financial flexibility and support as it explores
value-creating opportunities for its stockholders.
- Advanced Growth
Initiatives. During the first quarter, the Company made
progress advancing its recently identified growth opportunities.
These initiatives may provide an opportunity to accelerate net
income profitability earlier than previously provided without
requiring significant additional resources.
- Expanded ASCENIV Production Scale: ADMA
successfully commenced manufacturing of ASCENIV at the 4,400 Liter
production scale for the first time in corporate history. We expect
that this expansion will meaningfully improve the product’s margin
profile and increase plant production capacity as fewer batches
will be needed to support revenue goals. We believe these benefits
could be realized as early as the second half of 2023.
- Yield Enhancement
Opportunities: The Company progressed development scale
and laboratory analyses to advance its initiative aiming to capture
additional Immunoglobulin production yields, which could
significantly increase both peak revenues as well as margin
potential, if successful.
- Label Expansion: The post-marketing clinical
studies have progressed as planned, and if successful, may provide
for label expansion opportunities for both BIVIGAM and ASCENIV to
include pediatric-aged primary humoral immunodeficiency (PI)
patients as well as additional publications supporting product
safety.
- Legacy
Lower Margin BIVIGAM Inventory Depleted. As previously
communicated, an appreciable portion of the BIVIGAM product
revenues during the first quarter of 2023 were attributable to the
lower margin, legacy product. The accelerated monetization of the
product was enabled by record product demand and channel
pull-through. As a result, ADMA anticipates material BIVIGAM gross
margin expansion over the coming quarters.
- On-Track
BioCenters Expansion. The Company’s BioCenters segment now
has eight U.S. Food and Drug Administration (FDA)-licensed
collection centers with two additional centers operational and
collecting plasma pending FDA licensure. The Company remains on
track to have all 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.
- Product Mix Continues to
Favorably Evolve. ASCENIV’s prescriber and patient base
continued to expand during the first quarter of 2023, which drove
record utilization and pull-through for the product. ADMA currently
expects the product’s rapid growth will continue throughout 2023
and beyond.
- Ongoing Strategic
Review. ADMA continues to evaluate a variety of strategic
alternatives through its ongoing engagement with Morgan Stanley.
The exploration of value-creating opportunities remains a top
corporate priority for ADMA.
2023 & Long-Term Financial Guidance:
- 2023
Financial Guidance: ADMA now anticipates full year 2023
total revenues to exceed $220 million. From the newly established
$2.5 million Adjusted EBITDA base, ADMA anticipates continued
growth in Adjusted EBITDA profitability over the course of 2023.
While the guidance framework considers several macroeconomic
uncertainties, should ADMA’s current demand trends and margin
dynamics sustain, accelerated net income profitability timelines
may be achievable.
- 2024-2025 Financial
Guidance: The Company anticipates generating approximately
$250 million or more in topline revenue in 2024, and approximately
$300 million or more thereafter. At these revenue levels, ADMA
forecasts 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.
First Quarter 2023 Financial Results:
Total revenues for the three months ended March
31, 2023 were $56.9 million, as compared to $29.1 million during
the three months ended March 31, 2022, an increase of $27.8
million, or approximately 96%. The increase is due to increased
sales of our immunoglobulin products, primarily ASCENIV and
BIVIGAM, as we continue to experience increased physician, payer
and patient acceptance and utilization of ASCENIV and expand our
customer base for BIVIGAM. We also benefitted from an increase in
sales of normal source plasma through ADMA BioCenters of $4.0
million as we fulfilled our long-term plasma commitment for 2023
with our third-party customer.
Gross profit for the first quarter of 2023 was
$16.5 million, translating to a 29.0% gross margin, as compared to
$3.7 million, or a 12.6% gross margin, for the same period of a
year ago. This gross profit improvement of approximately $13.0
million was primarily driven by the revenue increases and the
reduction in other manufacturing costs related to an extended,
otherwise-routine plant shutdown in the first quarter of 2022.
Additionally, during the first quarter of 2023, ADMA sold a
significant amount of the remaining 2,200-liter scale, lower margin
BIVIGAM product. Moving forward, production throughput and sales
recognition is anticipated to be substantially confined to the
higher margin 4,400-liter BIVIGAM product, along with ASCENIV.
Consolidated net loss for the quarter ended
March 31, 2023 was $6.8 million, as compared to $25.0 million for
the first quarter of 2022. The $18.2 million decrease in net loss
was mainly due to the narrowed operating loss of $14.0 million and
the loss on extinguishment of debt of $6.7 million we recorded in
the first quarter of 2022 in connection with the refinancing of our
senior credit facility, partially offset by the increase in
interest expense.
Adjusted EBITDA increased by $14.2 million for
the three months ended March 31, 2023 to $2.5 million, as compared
to an Adjusted EBITDA loss of $11.7 million the same period of a
year ago. The improvement is driven primarily by increased sales
and gross profit and, to a lesser extent, lower total operating
expenses in 2023.
At March 31, 2023, ADMA had working capital of
$227.4 million, primarily consisting of $164.0 million of
inventory, cash and cash equivalents of $69.2 million and $26.5
million of accounts receivable, partially offset by current
liabilities of $36.7 million.
Conference Call Information
To attend the conference call on May 10, 2023 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://www.admabiologics.com/investors/events-and-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.
Use of Non-GAAP Financial
Measures
This press release includes certain non-GAAP
financial measures that are not prepared in accordance with
accounting principles generally accepted in the United States
(“GAAP”). The Company believes EBITDA and Adjusted EBITDA are
useful to investors in evaluating the Company’s financial
performance. The Company uses EBITDA and Adjusted EBITDA as key
performance measures because we believe that they facilitate
operating performance comparisons from period to period that
exclude potential differences driven by the impact of variations of
non-cash items such as depreciation and amortization, as well as,
in the case of Adjusted EBITDA, stock-based compensation or certain
non-recurring items. The Company believes that investors should
have access to the same set of tools used by our management and
board of directors to assess our operating performance. EBITDA and
Adjusted EBITDA should not be considered as measures of financial
performance under U.S. GAAP, and the items excluded from EBITDA and
Adjusted EBITDA are significant components in understanding and
assessing the Company’s financial performance. Accordingly, these
key business metrics have limitations as an analytical tool. They
should not be considered as an alternative to net income/loss or
any other performance measures derived in accordance with U.S. GAAP
and may be different from similarly titled non-GAAP measures used
by other companies. Please refer to the tables below for the
reconciliation of GAAP measures to these non-GAAP measures for
applicable periods.
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,” “can,” “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, financial
condition and pro forma results, as well as certain underlying
assumptions in connection therewith; expected benefits from the
recent Hayfin credit agreement amendment; the success of BIVIGAM®
and ASCENIV™ in future periods, including certain yield enhancement
and label expansion opportunities for such products; the higher
production scale of ASCENIV and the timing for realizing related
benefits; future growth opportunities; the timeline associated with
net income profitability; the ability to obtain FDA approval of our
ninth and tenth plasma collection centers and the associated timing
in connection therewith; 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:Jason Finkelstein,
MBAManaging Director, Argot Partners | 212-600-1902 |
jason@argotpartners.com
|
ADMA
BIOLOGICS, INC. AND SUBSIDIARIES |
CONSOLIDATED
STATEMENTS OF OPERATIONS |
|
|
Three Months Ended March 31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
REVENUES |
$ |
56,913,534 |
|
|
$ |
29,103,093 |
|
Cost of
product revenue |
|
40,400,544 |
|
|
|
25,441,046 |
|
Gross profit |
|
16,512,990 |
|
|
|
3,662,047 |
|
|
|
|
|
OPERATING EXPENSES: |
|
|
|
Research and development |
|
855,351 |
|
|
|
624,111 |
|
Plasma center operating expenses |
|
1,780,463 |
|
|
|
3,974,589 |
|
Amortization of intangible assets |
|
178,838 |
|
|
|
178,838 |
|
Selling, general and administrative |
|
14,511,656 |
|
|
|
13,699,575 |
|
Total operating expenses |
|
17,326,308 |
|
|
|
18,477,113 |
|
|
|
|
|
LOSS
FROM OPERATIONS |
|
(813,318 |
) |
|
|
(14,815,066 |
) |
|
|
|
|
OTHER INCOME (EXPENSE): |
|
|
|
Interest income |
|
166,971 |
|
|
|
33,068 |
|
Interest expense |
|
(6,115,484 |
) |
|
|
(3,389,038 |
) |
Loss on extinguishment of debt |
|
- |
|
|
|
(6,669,941 |
) |
Other expense |
|
(26,984 |
) |
|
|
(166,880 |
) |
Other expense, net |
|
(5,975,497 |
) |
|
|
(10,192,791 |
) |
|
|
|
|
NET
LOSS |
$ |
(6,788,815 |
) |
|
$ |
(25,007,857 |
) |
|
|
|
|
BASIC AND DILUTED LOSS PER COMMON SHARE |
$ |
(0.03 |
) |
|
$ |
(0.13 |
) |
|
|
|
|
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING: |
|
|
|
Basic and Diluted |
|
221,921,750 |
|
|
|
195,871,932 |
|
|
|
|
|
ADMA
BIOLOGICS, INC. AND SUBSIDIARIES |
CONDENSED
CONSOLIDATED BALANCE SHEETS |
|
|
March
31, |
|
December
31, |
|
|
2023 |
|
|
|
2022 |
|
ASSETS |
(Unaudited) |
|
|
Current
assets: |
|
|
|
Cash and cash equivalents |
$ |
69,204,163 |
|
|
$ |
86,521,542 |
|
Accounts receivable, net |
|
26,518,495 |
|
|
|
15,505,048 |
|
Inventories |
|
163,984,873 |
|
|
|
163,280,047 |
|
Prepaid expenses and other current assets |
|
4,378,681 |
|
|
|
5,095,146 |
|
Total current assets |
|
264,086,212 |
|
|
|
270,401,783 |
|
Property and
equipment, net |
|
57,370,783 |
|
|
|
58,261,481 |
|
Intangible
assets, net |
|
834,577 |
|
|
|
1,013,415 |
|
Goodwill |
|
3,529,509 |
|
|
|
3,529,509 |
|
Right to use
assets |
|
10,247,700 |
|
|
|
10,485,447 |
|
Deposits and
other assets |
|
4,718,761 |
|
|
|
4,770,246 |
|
TOTAL ASSETS |
$ |
340,787,542 |
|
|
$ |
348,461,881 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable |
$ |
12,956,486 |
|
|
$ |
13,229,390 |
|
Accrued expenses and other current liabilities |
|
22,672,464 |
|
|
|
24,989,349 |
|
Current portion of deferred revenue |
|
142,834 |
|
|
|
142,834 |
|
Current portion of lease obligations |
|
956,045 |
|
|
|
905,369 |
|
Total current liabilities |
|
36,727,829 |
|
|
|
39,266,942 |
|
Senior notes
payable, net of discount |
|
144,300,930 |
|
|
|
142,833,063 |
|
Deferred
revenue, net of current portion |
|
1,797,323 |
|
|
|
1,833,031 |
|
End of term
fee |
|
1,500,000 |
|
|
|
1,500,000 |
|
Lease
obligations, net of current portion |
|
10,468,109 |
|
|
|
10,704,176 |
|
Other
non-current liabilities |
|
338,731 |
|
|
|
350,454 |
|
TOTAL LIABILITIES |
|
195,132,922 |
|
|
|
196,487,666 |
|
|
|
|
|
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, |
|
|
|
222,262,588 and 221,816,930 shares issued and outstanding |
|
22,226 |
|
|
|
22,182 |
|
Additional
paid-in capital |
|
630,437,880 |
|
|
|
629,968,704 |
|
Accumulated
deficit |
|
(484,805,486 |
) |
|
|
(478,016,671 |
) |
TOTAL STOCKHOLDERS' EQUITY |
|
145,654,620 |
|
|
|
151,974,215 |
|
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY |
$ |
340,787,542 |
|
|
$ |
348,461,881 |
|
|
|
|
|
NON-GAAP
RECONCILIATION |
RECONCILIATION OF GAAP NET LOSS TO EBITDA AND ADJUSTED
EBITDA |
|
|
Three Months Ended March 31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
Net
loss |
$ |
(6,788,815 |
) |
|
$ |
(25,007,857 |
) |
Depreciation |
|
1,854,127 |
|
|
|
1,411,378 |
|
Amortization |
|
178,838 |
|
|
|
178,839 |
|
Interest expense |
|
6,115,484 |
|
|
|
3,389,038 |
|
EBITDA |
|
1,359,634 |
|
|
|
(20,028,602 |
) |
Stock-based compensation |
|
1,110,166 |
|
|
|
1,641,388 |
|
Loss on extinguishment of debt |
|
- |
|
|
|
6,669,941 |
|
Adjusted EBITDA |
$ |
2,469,800 |
|
|
$ |
(11,717,273 |
) |
|
|
|
|
(1) Adjusted EBITDA is a non-GAAP financial measure. For a
reconciliation of Adjusted EBITDA to the most comparable GAAP
measure, please see the reconciliation included in the financial
tables.
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