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 fourth quarter and full year 2021
financial results. Additionally, ADMA today announced the closing
of a debt refinancing with Hayfin Capital Management (“Hayfin”) of
$150 million, and up to an additional $25 million tied to the
achievement of certain revenue targets during 2022. The
first tranche of the newly issued loan from Hayfin was fully drawn
and used to completely repay the obligations under the Perceptive
Advisors (“Perceptive”) senior secured notes, including all
associated prepayment fees.
“The 2021 financial results of 92% revenue growth and positive
gross margin signify that our investments are yielding returns for
the Company. As evidenced by the improving gross profits and
narrowing net losses, we are particularly encouraged by the recent
uptick in ASCENIV™ utilization by prescribers. We believe
ASCENIV™’s product composition and unique antibody profile are
beginning to resonate as our marketing, sales and medical education
initiatives are being well-received. We are encouraged by the early
2022 growth trends, and accordingly, anticipate revenues to exceed
$125 million for the full year 2022. From a margin perspective, we
anticipate the improved uptake of ASCENIV™ in our overall product
mix will be further bolstered by tailwinds resulting from the
4,400-liter expanded production scale and in-house fill finishing
capabilities. All told, our foundation is well established for the
Company to advance towards profitability no later than the first
quarter of 2024 and be highly cash generative thereafter,” said
Adam Grossman, President and Chief Executive Officer of ADMA.
Mr. Grossman continued, “We believe the Company’s improved
funding position resulting from today’s announced debt refinancing
with Hayfin will enable ADMA to execute on its operating strategy,
while continuing to explore strategic business opportunities with
Morgan Stanley. Financially, the new debt meaningfully reduces
ADMA’s cost of capital, extends the interest-only period to March
2027 and provides significant non-dilutive capital to fund the
Company’s continued growth. This new loan from Hayfin completely
repays all outstanding indebtedness to Perceptive and we thank
Perceptive for their multi-year partnership and support.”
“Despite persisting pandemic-related and supply-chain headwinds,
2021 was another foundational year for ADMA operationally,
financially, and strategically. We are extremely grateful to our
dedicated staff and leadership team for all their efforts in
ensuring the continuity of treatment with ADMA’s product portfolio
for patients across the U.S.,” concluded Mr. Grossman.
“We are pleased to support ADMA through this $175 million debt
refinancing. The extensive relationships and expertise of our
specialist healthcare team allow us to originate, structure and
finance loans that enable best-in-class companies like ADMA to meet
their growth objectives and potential,” said Howard Rowe, Managing
Director at Hayfin.
The new loan agreement provides for, among other things, a
three-year extension from the previous Perceptive note of the
interest-only period through the duration of the credit facility
now maturing in March 2027. Borrowings under the Hayfin credit
agreement bear interest at a rate per annum equal to 8.25% plus an
accumulating 2.50% paid-in-kind (“PIK”) component. The first
tranche of $150 million from Hayfin was fully drawn and used to
discharge the remaining obligations under the previously held
Perceptive senior secured notes, including all associated
prepayment fees. The net proceeds remaining under the first tranche
in addition to the $25 million second tranche levered to revenue
milestones, if drawn, will be used to support continuing operations
and to fund the Company’s ongoing growth. The debt
financing terms disclosed in this press release are not all
inclusive and, as such, the statements in this press release are
qualified in their entirety by reference to the description of the
debt financing transaction and corresponding exhibits, including
the Credit Agreement, which are included in a Current Report on
Form 8-K filed concurrently with this press release by ADMA with
the Securities and Exchange Commission (“SEC”).
2021 Achievements:
- Executed Financially. Achieved
full year 2021 total revenues of $80.9 million, as compared to
$42.2 million during the year ended December 31, 2020, an increase
of $38.7 million, or approximately 92%. Due to a favorable product
mix as well as the beginnings of supply chain related operating
efficiencies, ADMA realized first-time corporate gross
profitability during the full year 2021. Enabled by encouraging
early 2022 growth trends, ADMA anticipates exceeding $125 million
in 2022 revenues, translating to a more than 50% growth rate
compared to 2021 results.
- Driving Greater Adoption of Higher Margin
Products. ADMA is particularly encouraged with the recent
physician adoption and utilization of its unique immune globulin
product ASCENIV™. The Company’s marketing, sales and medical
education initiatives are illuminating the product’s patented
plasma pooling antibody composition and manufacturing methods,
which the Company believes will continue to resonate with
physicians, providers and patients.
- On-Track BioCenters Expansion. ADMA now has
ten plasma collection centers under its corporate umbrella at
various stages, five of which are now FDA-approved to collect
normal source and Respiratory Syncytial Virus (“RSV”) hyperimmune
plasma. The Company remains on track to have ten of its BioCenters
locations FDA-approved by year-end 2023 and in the same period
forecasts raw material plasma supply self-sufficiency. ADMA’s
growing internal plasma collections are currently being
supplemented by third-party supply contracts as well as the yield
enhancements resulting from the implementation of the Haemonetics’
NexSys Persona® system. We anticipate our encouraging plasma supply
position will enable ADMA to execute on its increasing production
plan without any significant impact from the global plasma supply
constraints being reported by other fractionators.
- Refinanced Senior Secured Term Loan.
Refinanced senior secured term loan with 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 net
of servicing all remaining obligations associated with the
previously held senior secured notes with Perceptive.
- Ongoing Strategic Review. As previously
disclosed, ADMA has engaged Morgan Stanley as an advisor to
evaluate a variety of strategic and financing alternatives. The
evaluation of these alternative business opportunities is ongoing.
ADMA will communicate material developments as required by the
SEC.
Fourth Quarter 2021 Financial ResultsTotal
revenues for the quarter ended December 31, 2021 were $26.4
million, compared to $14.0 million for the quarter ended December
31, 2020, representing an increase of approximately $12.4 million,
or 89%. The revenue growth for the fourth quarter of 2021, compared
to the fourth quarter of 2020, was favorably impacted by the
continued commercial ramp up of our Intravenous Immunoglobulin
(“IVIG”) product portfolio.
Consolidated net loss for the quarter ended December 31, 2021,
was $16.6 million, or $(0.09) per basic and diluted share, compared
to a consolidated net loss of $19.4 million, or $(0.20) per basic
and diluted share, for the quarter ended December 31, 2020. The
$2.8 million improved net loss compared to the prior year period
was primarily attributable to a gross profit contribution of $3.5
million for the fourth quarter of 2021 compared to a gross loss of
$5.2 million during the fourth quarter of 2020, partially offset by
an increase in selling, general and administrative (“SG&A”)
expenses of $2.4 million related to employee compensation, new
hires along with other costs to support the commercialization
efforts for BIVIGAM® and ASCENIV™ and a $2.5 million increase in
plasma center operating expenses related to the Company’s plasma
center buildout and expansion activities.
Full Year 2021 Financial Results
Total revenues of $80.9 million were recorded during the year
ended December 31, 2021, as compared to $42.2 million during the
year ended December 31, 2020, an increase of $38.7 million, or
approximately 92%. The increase is mainly due to increased sales of
our immunoglobulin products and intermediate fractions generated by
our Boca Raton manufacturing segment operations in 2021, totaling
$38.1 million, as we concluded our second full year of commercial
sales of BIVIGAM® and ASCENIV™. We attribute this increase in
revenue, which reflects sales volume increases across our entire
portfolio of IVIG products, to an expansion of our customer base in
2021 and to increased physician, payer and patient acceptance of
both BIVIGAM® and ASCENIV™. We also experienced a $0.5 million
increase in plasma revenues generated by our plasma collection
centers business segment.
Net loss was $71.6 million for the year ended December 31, 2021,
as compared to $75.7 million for the year ended December 31, 2020.
The improved net loss was mainly due to the improved gross profit
for the year ended December 31, 2021 of $20.2 million compared with
the year ended December 31, 2020, further aided by $2.3 million of
lower research and development expenses. These amounts were largely
offset by increases in plasma center operating expenses of $8.1
million, increases in SG&A of $7.8 million and higher interest
expense compared to the full year 2020.
As of December 31, 2021, ADMA had working capital of $178.4
million, primarily consisting of $124.7 million of inventory, cash
and cash equivalents of $51.1 million and net accounts receivable
of $28.6 million, partially offset by $29.6 million of accounts
payable and accrued expenses and other current liabilities, as
compared to working capital of $133.8 million, mainly comprised of
$81.5 million of inventory, cash and cash equivalents of $55.9
million and net accounts receivable of $13.2 million, partially
offset by accounts payable and accrued expenses and other current
liabilities of $19.4 million, as of December 31, 2020.
Conference Call InformationTo access the
conference call, 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 7180004. 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 on April 1, 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 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 related to certain
aspects of its products and product candidates. For more
information, please visit www.admabiologics.com.
About Hayfin Capital Management
LLP
Founded in 2009, Hayfin Capital Management
(“Hayfin”) is a leading alternative asset management firm with over
€23 billion of assets under management. Hayfin focuses on
delivering best-in-class risk-adjusted returns for its investors
across its private credit, liquid credit and private equity
solutions businesses.
Hayfin has a diverse international team of over
165 experienced industry professionals with offices globally,
including headquarters in London and offices in Frankfurt, Madrid,
Milan, New York, Paris, Luxembourg, San Diego, Singapore and Tel
Aviv.
Further information can be found at
hayfin.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, “we”, “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), including anticipated
timing for reaching profitability; the success of ASCENIV™,
particularly with physicians, providers and patients; 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; 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,
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
ADMA BIOLOGICS, INC. AND
SUBSIDIARIESCONSOLIDATED STATEMENTS OF
OPERATIONS
|
|
Three Months Ended December 31, |
|
Years Ended December 31, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
REVENUES: |
|
|
|
|
|
|
|
|
Product revenue |
|
$ |
26,347,158 |
|
|
$ |
13,920,378 |
|
|
$ |
80,799,791 |
|
|
$ |
42,076,949 |
|
License revenue |
|
|
35,709 |
|
|
|
35,709 |
|
|
|
142,834 |
|
|
|
142,834 |
|
Total revenues |
|
|
26,382,867 |
|
|
|
13,956,087 |
|
|
|
80,942,625 |
|
|
|
42,219,783 |
|
Cost of product revenue |
|
|
22,871,382 |
|
|
|
19,111,107 |
|
|
|
79,769,341 |
|
|
|
61,291,426 |
|
Gross profit (loss) |
|
|
3,511,485 |
|
|
|
(5,155,020 |
) |
|
|
1,173,284 |
|
|
|
(19,071,643 |
) |
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES: |
|
|
|
|
|
|
|
|
Research and development |
|
|
728,988 |
|
|
|
1,013,464 |
|
|
|
3,646,060 |
|
|
|
5,907,013 |
|
Plasma center operating expenses |
|
|
4,096,833 |
|
|
|
1,572,607 |
|
|
|
12,288,723 |
|
|
|
4,170,051 |
|
Amortization of intangible assets |
|
|
178,839 |
|
|
|
178,839 |
|
|
|
715,353 |
|
|
|
715,353 |
|
Selling, general and administrative |
|
|
11,698,009 |
|
|
|
9,300,359 |
|
|
|
42,896,889 |
|
|
|
35,050,817 |
|
Total operating expenses |
|
|
16,702,669 |
|
|
|
12,065,269 |
|
|
|
59,547,025 |
|
|
|
45,843,234 |
|
|
|
|
|
|
|
|
|
|
LOSS FROM OPERATIONS |
|
|
(13,191,184 |
) |
|
|
(17,220,289 |
) |
|
|
(58,373,741 |
) |
|
|
(64,914,877 |
) |
|
|
|
|
|
|
|
|
|
OTHER INCOME (EXPENSE): |
|
|
|
|
|
|
|
|
Interest income |
|
|
2,291 |
|
|
|
19,483 |
|
|
|
34,532 |
|
|
|
288,126 |
|
Interest expense |
|
|
(3,315,724 |
) |
|
|
(3,109,469 |
) |
|
|
(13,056,834 |
) |
|
|
(11,985,066 |
) |
Gain on extinguishment of debt |
|
|
- |
|
|
|
991,797 |
|
|
|
- |
|
|
|
991,797 |
|
Other expense |
|
|
(144,803 |
) |
|
|
(89,296 |
) |
|
|
(251,575 |
) |
|
|
(128,528 |
) |
Other expense, net |
|
|
(3,458,236 |
) |
|
|
(2,187,485 |
) |
|
|
(13,273,877 |
) |
|
|
(10,833,671 |
) |
|
|
|
|
|
|
|
|
|
NET LOSS |
|
$ |
(16,649,420 |
) |
|
$ |
(19,407,774 |
) |
|
$ |
(71,647,618 |
) |
|
$ |
(75,748,548 |
) |
|
|
|
|
|
|
|
|
|
BASIC AND DILUTED LOSS PER COMMON SHARE |
|
$ |
(0.09 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.51 |
) |
|
$ |
(0.88 |
) |
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING: |
|
|
|
|
|
|
|
|
Basic and Diluted |
|
|
180,813,817 |
|
|
|
96,620,486 |
|
|
|
139,578,538 |
|
|
|
86,145,052 |
|
|
|
|
|
|
|
|
|
|
ADMA BIOLOGICS, INC. AND
SUBSIDIARIESCONDENSED CONSOLIDATED BALANCE
SHEETS
|
December 31, |
|
December 31, |
|
|
|
2021 |
|
|
|
2020 |
|
|
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
$ |
51,089,118 |
|
|
$ |
55,921,152 |
|
|
Accounts receivable, net |
|
28,576,857 |
|
|
|
13,237,290 |
|
|
Inventories |
|
124,724,091 |
|
|
|
81,535,599 |
|
|
Prepaid expenses and other current assets |
|
4,339,245 |
|
|
|
3,046,466 |
|
|
Total current assets |
|
208,729,311 |
|
|
|
153,740,507 |
|
|
Property and equipment, net |
|
50,935,074 |
|
|
|
41,593,090 |
|
|
Intangible assets, net |
|
1,728,768 |
|
|
|
2,444,121 |
|
|
Goodwill |
|
3,529,509 |
|
|
|
3,529,509 |
|
|
Right to use assets |
|
7,262,658 |
|
|
|
4,259,191 |
|
|
Deposits and other assets |
|
4,067,404 |
|
|
|
2,106,976 |
|
|
TOTAL ASSETS |
$ |
276,252,724 |
|
|
$ |
207,673,394 |
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
$ |
12,429,409 |
|
|
$ |
11,073,708 |
|
|
Accrued expenses and other current liabilities |
|
17,214,988 |
|
|
|
8,365,143 |
|
|
Current portion of deferred revenue |
|
142,834 |
|
|
|
142,834 |
|
|
Current portion of lease obligations |
|
591,084 |
|
|
|
365,682 |
|
|
Total current liabilities |
|
30,378,315 |
|
|
|
19,947,367 |
|
|
Senior notes payable, net of discount |
|
94,866,239 |
|
|
|
92,968,866 |
|
|
Deferred revenue, net of current portion |
|
1,975,865 |
|
|
|
2,118,698 |
|
|
Lease obligations, net of current portion |
|
7,462,388 |
|
|
|
4,334,151 |
|
|
Other non-current liabilities |
|
397,351 |
|
|
|
54,886 |
|
|
TOTAL LIABILITIES |
|
135,080,158 |
|
|
|
119,423,968 |
|
|
|
|
|
|
|
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 and
150,000,000 shares authorized, |
|
|
|
|
195,813,817 and 104,902,888 shares issued and outstanding |
|
19,581 |
|
|
|
10,490 |
|
|
Additional paid-in capital |
|
553,265,706 |
|
|
|
428,704,039 |
|
|
Accumulated deficit |
|
(412,112,721 |
) |
|
|
(340,465,103 |
) |
|
TOTAL STOCKHOLDERS' EQUITY |
|
141,172,566 |
|
|
|
88,249,426 |
|
|
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY |
$ |
276,252,724 |
|
|
$ |
207,673,394 |
|
|
|
|
|
|
|
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