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 2022 financial results
and provided a business update.
“Year-to-date execution for ADMA’s intravenous immunoglobulin
product portfolio has exceeded internal expectations and serves as
the basis for the increased 2022 total revenue financial guidance
to $130 million or more,” said Adam Grossman, President and Chief
Executive Officer of ADMA. “We continue to gain confidence that
above-expectation trends for our higher margin products, notably
ASCENIV™, will prove durable, which is improving visibility on the
Company’s pathway to profitability. Over the remainder of 2022, we
expect to deliver significant revenue growth and market share gains
for our product portfolio, improve margins as operating leverage is
realized, and continue to prioritize the exploration of strategic
alternatives, to maximize stockholder value.”
“We are very encouraged with our first quarter financial
results, particularly when considering some of the non-recurring
dynamics that occurred during the quarter,” said Brian Lenz, ADMA’s
Chief Financial Officer, and General Manager, ADMA BioCenters. “The
reported first quarter net loss includes a $6.7 million one-time
charge related to the Hayfin debt refinancing, which, among other
things, extended the Company’s interest-only period at a lowered
cost of capital and provided significant non-dilutive capital.
Further, we elected to extend the previously scheduled, and
otherwise routine shutdown at the Boca Raton manufacturing facility
to enable the completion of certain projects forecasted for later
in the year. The facility’s production schedule is anticipated to
progress on a normal course moving forward, and as such, this cost
headwind is anticipated to normalize over the coming quarters.
Finally, we incurred additional, non-operational expenses related
to the ongoing strategic review process. Accounting for these
non-operational quarterly occurrences, we are encouraged by the
continued operational efficiencies being unlocked and look forward
to expanding on these trends as we accelerate towards
profitability.”
Mr. Lenz continued, “The Company is well-capitalized, holding
approximately $70 million in cash and cash equivalents at the end
of the first quarter. Further, as a result of our continued revenue
growth in the first quarter of 2022, we have achieved the revenue
milestone under the Hayfin loan agreement to draw down an
additional $25 million in non-dilutive funds at the Company’s
option.”
First Quarter 2022 and Recent Achievements:
- Executed Financially: Achieved first
quarter 2022 total revenues of $29.1 million, as compared to $16.0
million during the first quarter of 2021, an increase of $13.1
million, or approximately 81%. Due to a favorable product mix, as
we continue to expand our customer base for both BIVIGAM® and
ASCENIV, ADMA realized a gross margin of approximately 13% during
the first quarter of 2022, resulting from continued supply chain
operating efficiencies. This improved gross margin compared to the
first quarter of 2021 was achieved despite our election to extend
the previously scheduled and otherwise routine plant shutdown that
occurred during the quarter, which resulted in additional costs to
complete certain projects that had been forecasted later in the
year. Excluding the costs associated with the extended facility
shutdown, the Company estimates first quarter 2022 gross margins
would have been closer to 20% in a normalized production
quarter.
- Driving Greater Adoption of Higher Margin
Product: ADMA is particularly encouraged with the
continued physician adoption and utilization of its proprietary
immune globulin product ASCENIV. Elevated product demand trends
have sustained throughout April and into May, lending incremental
confidence that ASCENIV’s upside will prove durable and margin mix
will continue to favorably evolve throughout 2022 and beyond.
- Expiration Dating
Extension: Announced the United States Food and Drug
Administration’s (“FDA”) approval to extend the expiration dating
from 24 to 36 months for both its ASCENIV and BIVIGAM drug product
stored at 2-8°C. The extension of ASCENIV’s and BIVIGAM’s shelf
life to 36 months dating is a meaningful enhancement of each
product’s go-to market offering as it should provide for a more
efficient net working capital cycle for the Company, as well as
allow for more versatile utilization and inventory management by
providers. As a result of this approval, in the second quarter of
2022, ADMA anticipates realizing certain, previously reserved for
product at an outsized margin contribution.
- On-Track BioCenters Expansion: At present, our
BioCenters segment has ten plasma collection centers under its
corporate umbrella: five centers are FDA-licensed, two additional
collection centers are operational and collecting plasma, and three
centers in various stages of construction. The Company remains on
track to have ten BioCenters locations FDA-licensed by year-end
2023 and in the same period forecasts raw material plasma supply
self-sufficiency. We anticipate our strong plasma supply position
will support our upwardly revised production and revenue
forecasts.
- Refinanced Senior Secured Term Loan:
Refinanced the Company’s senior secured term loan with Hayfin
Capital Management (“Hayfin”), which among other things, lowered
the effective cost of capital, extended the interest-only period by
three years to March 2027 and, importantly, enabled the Company to
raise significant non-dilutive capital. We have achieved the
revenue milestone under the Hayfin loan agreement to draw down an
additional $25 million in non-dilutive funds at the Company’s
discretion.
- 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. The exploration of strategic opportunities
remains a corporate priority for ADMA.
2022 & Long-Term Financial Guidance:
- 2022 Financial
Guidance: Enabled by the strong start to the year, ADMA
increases 2022 total revenue guidance to $130 million or more,
upwardly revised from $125 million. ADMA reiterates expectations to
grow revenues and gross profits and narrow net losses as 2022
progresses.
- 2024-2025 Financial
Guidance: We believe that ADMA is on track to potentially
generate $250 million in topline revenue in 2024, and $300 million
thereafter. At this revenue level, and based upon current
assumptions, we anticipate potentially achieving 40-50% corporate
gross margins and 20-30% net income margins. These assumptions
translate to potential annual gross profit and net income of
$100-150 million and $50-100 million respectively during the
2024-2025 time-period and beyond.
First Quarter 2022 Financial Results:
Total revenues for the first quarter ended March 31, 2022 were
$29.1 million, as compared to $16.0 million during the first
quarter of 2021, an increase of $13.1 million, or approximately
81%. The revenue growth for the first quarter of 2022, compared to
the first quarter of 2021, was favorably impacted by the continued
commercial ramp up of our intravenous immunoglobulin (IVIG) product
portfolio and expanding our customer base for BIVIGAM and
ASCENIV.
Gross profit for the first quarter of 2022 was $3.7 million,
compared to a gross loss of $1.7 million for the first quarter of
2021. Gross profit growth during the first quarter was driven by a
favorable contribution from higher margin products, notably
ASCENIV, which was partially offset by a meaningful
quarter-over-quarter and year-over-year increase in overhead costs
attributable to an extended, routine plant shutdown in the first
quarter of 2022. The Company anticipates the facility’s production
schedule will proceed on a standard course moving forward, with
overhead costs normalizing in the coming quarters.
Consolidated net loss for the quarter ended March 31, 2022 was
$25.0 million, or $(0.13) per basic and diluted share, compared to
a consolidated net loss of $18.4 million, or $(0.16) per basic and
diluted share, for the quarter ended March 31, 2021. The reported
net loss for the quarter ended March 31, 2022 includes
non-recurring charges from the extinguishment of debt related to
the Hayfin debt transaction of $6.7 million and professional
services fees of $1.3 million related to the strategic review
process.
As of March 31, 2022, ADMA had working capital of $208.2
million, primarily consisting of $139.1 million of inventory, cash
and cash equivalents of $69.5 million and net accounts receivable
of $25.6 million, partially offset by an aggregate of $31.6 million
of accounts payable and accrued expenses and other current
liabilities, as compared to working capital of $178.4 million as of
December 31, 2021.
Conference Call InformationTo access the
conference call on May 11, 2022 at 4:30PM ET, please dial (855)
884-8773 (local) or (615) 622-8043 (international) at least 10
minutes prior to the start time and refer to conference ID 1783606.
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 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 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 ADMA BioCenters
ADMA BioCenters is an FDA-licensed facility 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 (including,
but not limited to, total 2022 revenues) and pro forma results; the
success of ASCENIV™, particularly with physicians, providers and
patients, and market share of the Company’s product portfolio; the
benefits of extending the routine shutdown at the Boca Raton
manufacturing facility; our production schedule and its impact on
financial performance; the operational and financial benefits of
expiration dating extension for ASCENIV and BIVIGAM®; 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 March 31, |
|
|
2022 |
|
|
|
2021 |
|
|
|
|
|
REVENUES: |
|
|
|
Product revenue |
$ |
29,067,385 |
|
|
$ |
16,012,910 |
|
License revenue |
|
35,708 |
|
|
|
35,708 |
|
Total revenues |
|
29,103,093 |
|
|
|
16,048,618 |
|
Cost of
product revenue |
|
25,441,046 |
|
|
|
17,770,122 |
|
Gross profit (loss) |
|
3,662,047 |
|
|
|
(1,721,504 |
) |
|
|
|
|
OPERATING EXPENSES: |
|
|
|
Research and development |
|
624,111 |
|
|
|
987,649 |
|
Plasma center operating expenses |
|
3,974,589 |
|
|
|
2,242,343 |
|
Amortization of intangible assets |
|
178,838 |
|
|
|
178,838 |
|
Selling, general and administrative |
|
13,699,575 |
|
|
|
10,033,915 |
|
Total operating expenses |
|
18,477,113 |
|
|
|
13,442,745 |
|
|
|
|
|
LOSS
FROM OPERATIONS |
|
(14,815,066 |
) |
|
|
(15,164,249 |
) |
|
|
|
|
OTHER INCOME (EXPENSE): |
|
|
|
Interest income |
|
33,068 |
|
|
|
22,059 |
|
Interest expense |
|
(3,389,038 |
) |
|
|
(3,195,750 |
) |
Loss on extinguishment of debt |
|
(6,669,941 |
) |
|
|
- |
|
Other expense |
|
(166,880 |
) |
|
|
(42,001 |
) |
Other expense, net |
|
(10,192,791 |
) |
|
|
(3,215,692 |
) |
|
|
|
|
NET
LOSS |
$ |
(25,007,857 |
) |
|
$ |
(18,379,941 |
) |
|
|
|
|
BASIC AND DILUTED LOSS PER COMMON SHARE |
$ |
(0.13 |
) |
|
$ |
(0.16 |
) |
|
|
|
|
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING: |
|
|
|
Basic and Diluted |
|
195,871,932 |
|
|
|
115,661,937 |
|
|
|
|
|
ADMA BIOLOGICS, INC. AND
SUBSIDIARIESCONDENSED CONSOLIDATED BALANCE
SHEETS
|
|
March 31, |
|
|
|
December 31, |
|
|
|
2022 |
|
|
|
2021 |
|
ASSETS |
(Unaudited) |
|
|
Current
assets: |
|
|
|
Cash and cash equivalents |
$ |
69,504,946 |
|
|
$ |
51,089,118 |
|
Accounts receivable, net |
|
25,629,625 |
|
|
|
28,576,857 |
|
Inventories |
|
139,146,311 |
|
|
|
124,724,091 |
|
Prepaid expenses and other current assets |
|
5,519,301 |
|
|
|
4,339,245 |
|
Total current assets |
|
239,800,183 |
|
|
|
208,729,311 |
|
Property and
equipment, net |
|
53,220,480 |
|
|
|
50,935,074 |
|
Intangible
assets, net |
|
1,549,930 |
|
|
|
1,728,768 |
|
Goodwill |
|
3,529,509 |
|
|
|
3,529,509 |
|
Right to use
assets |
|
7,106,642 |
|
|
|
7,262,658 |
|
Deposits and
other assets |
|
2,825,748 |
|
|
|
4,067,404 |
|
TOTAL ASSETS |
$ |
308,032,492 |
|
|
$ |
276,252,724 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable |
$ |
14,115,135 |
|
|
$ |
12,429,409 |
|
Accrued expenses and other current liabilities |
|
16,654,540 |
|
|
|
17,214,988 |
|
Current portion of deferred revenue |
|
142,834 |
|
|
|
142,834 |
|
Current portion of lease obligations |
|
654,003 |
|
|
|
591,084 |
|
Total current liabilities |
|
31,566,512 |
|
|
|
30,378,315 |
|
Senior notes
payable, net of discount |
|
138,423,052 |
|
|
|
94,866,239 |
|
Deferred
revenue, net of current portion |
|
1,940,156 |
|
|
|
1,975,865 |
|
End of term
fee |
|
1,500,000 |
|
|
|
- |
|
Lease
obligations, net of current portion |
|
7,284,079 |
|
|
|
7,462,388 |
|
Other
non-current liabilities |
|
385,628 |
|
|
|
397,351 |
|
TOTAL LIABILITIES |
|
181,099,427 |
|
|
|
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, |
|
|
|
196,347,529 and 195,813,817 shares issued and outstanding |
|
19,635 |
|
|
|
19,581 |
|
Additional
paid-in capital |
|
564,034,008 |
|
|
|
553,265,706 |
|
Accumulated
deficit |
|
(437,120,578 |
) |
|
|
(412,112,721 |
) |
TOTAL STOCKHOLDERS' EQUITY |
|
126,933,065 |
|
|
|
141,172,566 |
|
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY |
$ |
308,032,492 |
|
|
$ |
276,252,724 |
|
|
|
|
|
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