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 reported financial results for its fiscal fourth
quarter and year ended December 31, 2020 and provided an overview
of recent progress and accomplishments.
“In a year full of unprecedented health and economic challenges
due to the pandemic, the ADMA team’s unwavering commitment produced
remarkable achievements across all our business segments,”
said Adam Grossman, President and Chief Executive Officer of
ADMA Biologics. “Operationally, while enacting all the medically
recommended COVID-19 safeguards to protect our patients, employees
and customers, we successfully expanded our plasma collection
center network ahead of schedule and delivered on all of our
manufacturing and regulatory objectives as a part of our supply
chain enhancement initiatives. We generated record revenues of
$42.2 million despite COVID-19 headwinds, and because of our strong
commercial execution, we confidently provided first-time peak
annual revenue guidance of $250 million or greater expected to be
achieved in 2024 and additionally committed to reaching
profitability no later than the first quarter of 2024.”
“On the financial front, we substantially strengthened our
balance sheet with year-end 2020 assets totaling $207.7 million,
significantly growing inventories to a year-end balance of $81.5
million as well as increasing accounts receivable and investments
in property, plant and equipment. We look forward to continuing to
deliver quarter-over-quarter revenue growth and execute on our
strategy during 2021, building on the momentum created by 2020’s
achievements across all of our business segments,” concluded Mr.
Grossman.
Select 2020 Achievements & Recent Corporate
Developments:
- Executed Commercially with Significant Year-Over-Year
Revenue Growth. Achieved full year 2020 total revenues of
$42.2 million, compared to $29.3 million for the full year 2019,
reflecting a substantial 44% increase. Achieved fourth quarter 2020
total revenues of $14.0 million, compared to $12.0 million for the
fourth quarter of 2019, representing an approximately 16%
increase.
- Substantially Increased Inventory Levels. Grew
inventories to a year-end 2020 balance of $81.5 million compared to
$53.1 million at year-end 2019, which we regard as a solid basis to
support our anticipated quarter-over-quarter revenue growth in 2021
and beyond. This inventory consists of raw materials, including
source plasma, work-in-process and finished goods.
- Refinanced Senior Secured Term Loan.
Refinanced senior secured term loan with Perceptive Advisors, which
among other things, lowered the effective cost of capital,
consolidated ADMA’s long-term debt and provided for a two-year
extension of the interest-only period through March 2024, which we
believe will allow ADMA to reach profitability prior to
maturity.
- Expanded Plasma Collection Center Network.
With the approval of another plasma collection facility in early
February, ADMA now has seven plasma collection facilities under its
corporate umbrella at various stages of development and approval,
including one facility pending Biologics License Application
(“BLA”) approval in the second half of this year, and two
additional plasma collection centers which we intend to open and
file BLAs during 2021. Accordingly, we have revised our previous
guidance from building 5-10 plasma collection facilities by 2024 to
our current expectation of having 10 or more plasma collection
facilities in operation by 2024.
- Advanced Supply Chain Enhancement Initiatives.
We remain on track to receive potential United States Food and Drug
Administration (“FDA”) approval decisions mid-year for our
Intravenous Immune Globulin (“IVIG”) increased production capacity
scale, as well as our in-house Vanrx aseptic fill-finish machine.
Upon FDA approval, ADMA expects to realize significant operating
efficiencies and improved gross margins beginning potentially as
early as mid-2021, which will ultimately support durable
profitability and a fully vertically integrated value chain.
- Strengthened ASCENIV’s Coverage and Patient
Access. Secured a permanent J-code, to be effective April
1, 2021, which will provide for a streamlined and permanent
reimbursement process in outpatient treatment settings.
- Continued Medical Community Engagement. At the
recent American Academy of Allergy, Asthma & Immunology
Conference (“AAAAI”), ADMA presented a late-breaking abstract
detailing data that underscore the exciting prospect of bridging
vaccination and protective seroconversion with a targeted,
plasma-derived hyperimmune anti S. pneumonia globulin to ensure
protection against infection for at-risk patients in the hospital
and outpatient settings. Our existing intellectual property
portfolio includes issued patents on the composition of matter and
methods of use for producing a standardized hyperimmune globulin
targeted to the most common 23 serotypes of S. pneumoniae bacteria.
We will continue to evaluate opportunities to expand our pipeline
and future product offerings to maximize value for our
shareholders.
- Received Several Industry Awards.
Our organization’s 2020 achievements were recognized in the form of
several third-party accolades, including receiving the BioNJ
Innovator of the Year Award, being included on the Deloitte Fast
500 List as well as in 2021 our CEO being voted a Top 10 Biotech
Executive by Healthcare Technology Report.
Fourth Quarter 2020 Financial Results
Total revenues for the quarter ended December 31, 2020 were
$14.0 million, compared to $12.0 million for the quarter ended
December 31, 2019, representing an increase of approximately $2.0
million, or approximately 16%. The revenue growth for the fourth
quarter of 2020, compared to the fourth quarter of 2019, was
favorably impacted by the continued commercial ramp up of our IVIG
product portfolio.
Consolidated net loss for the quarter ended December 31, 2020
was $19.4 million, or $(0.20) per basic and diluted share, compared
to a consolidated net loss of $10.6 million, or $(0.18) per basic
and diluted share, for the quarter ended December 31, 2019. The
$8.8 million increase in net loss compared to the prior year period
was primarily attributable to increased cost of product revenue of
$7.4 million; increases in selling, general and administrative
expenses of $2.3 million related to employee compensation, new
hires along with other costs to support the commercialization
efforts for BIVIGAM® and ASCENIV™ and a $0.5 million increase in
research and development expenses mainly related to increased costs
associated with clinical studies. The increased net loss
additionally includes $1.1 million in higher plasma center
operating expenses due to the opening of additional plasma centers
during 2020. Included in the net loss for the fourth quarter of
2020 were non-cash expenses of approximately $2.4 million for
stock-based compensation, depreciation and amortization, and
non-cash interest expense.
Full Year 2020 Financial Results
Total revenues for the year ended December 31, 2020 were $42.2
million, compared to $29.3 million for the year ended December 31,
2019, representing an increase of $12.9 million, or 44%. The
increase in revenues was primarily attributable to increased sales
of our IVIG products portfolio offset by lower plasma collection
revenues.
Consolidated net loss for the year ended December 31, 2020 was
approximately $75.7 million, or $(0.88) per basic and diluted
share, compared to a consolidated net loss of $48.3 million, or
$(0.89) per basic and diluted share, for the year ended December
31, 2019. The increase in net loss of approximately $27.4 million
was primarily attributable to a $21.8 million increase in cost of
product revenue, which reflects the increase in sales volume as
well as $7.5 million of non-recurring production charges incurred
for the manufacturing of BIVIGAM conformance lots at an increased
plasma pool production scale in connection with our planned
capacity expansion. The increase in net loss in 2020 was also
attributable to increased selling, general administrative expenses
of approximately $9.1 million related to the overall growth in the
size and scope of the Company’s operations, including the
commercialization efforts of BIVIGAM® and ASCENIV™; a $3.6 million
increase in research and development expenses associated with the
validation for a capacity expansion of a new filling line and
increases in various clinical research activities, some of which
are required by the FDA. Included in the net loss for the year
ended 2020 were non-cash expenses of $8.6 million for stock-based
compensation, depreciation and amortization and non-cash interest
expense.
At December 31, 2020, ADMA had cash and cash equivalents of
$55.9 million and accounts receivable of $13.2 million, compared to
cash and cash equivalents of $26.8 million and accounts receivable
of $3.5 million at December 31, 2019. ADMA’s net working capital as
of December 31, 2020 was $133.8 million, compared to $71.8 million
as of December 31, 2019.
Conference Call Information
ADMA will host a conference call today, March 25, 2021, at 4:30
p.m. Eastern Time, to discuss the fiscal fourth quarter and full
year 2020 financial results and recent corporate updates. To access
the conference call, please dial (855) 884-8773 or (615) 622-8043
(international) at least 10 minutes prior to the start time and
refer to conference ID 5109699. 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 Nabi-HB®
Nabi-HB® is a hyperimmune globulin that is rich in antibodies to
the Hepatitis B virus. Nabi-HB® is a purified human polyclonal
antibody product collected from plasma donors who have been
previously vaccinated with a Hepatitis B vaccine. Nabi-HB® is
indicated for the treatment of acute exposure to blood containing
Hepatitis B surface antigen (HBsAg), prenatal exposure to infants
born to HBsAg-positive mothers, sexual exposure to HBsAg-positive
persons and household exposure to persons with acute Hepatitis B
virus infection. Hepatitis B is a potentially life-threatening
liver infection caused by the Hepatitis B virus. It is a major
global health problem and can cause chronic infection and put
people at high risk of death from cirrhosis and liver cancer.
Nabi-HB® has a well-documented record of long-term safety and
effectiveness since its initial market introduction. Certain data
and other information about Nabi-HB® 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 American
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 related to certain aspects of its products and
product candidates. For more information, please visit
www.admabiologics.com.
Cautionary Note Regarding 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. (“we,”
“our” 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 “estimate,” “project,” “intend,”
“forecast,” “target,” “anticipate,” “plan,” “planning,” “expect,”
“believe,” “will,” “should,” “could,” “would,” “may,” 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
our anticipated timing for reaching profitability; the goal of
building and opening new plasma collection centers by 2024; the
outcome and timing of our BLA application for our new plasma
centers; and our continued evaluation of opportunities to expand
our pipeline and future product offerings. Actual events or results
may differ materially from those described in this document 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 U.S.
Securities and Exchange Commission, including our most recent
reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.
COMPANY CONTACT:Skyler BloomDirector, Investor
Relations and Corporate Strategy | 201-478-5552
| sbloom@admabio.com
INVESTOR RELATIONS CONTACT:Sam MartinManaging
Director, Argot Partners | 212-600-1902 | sam@argotpartners.com
ADMA BIOLOGICS, INC. AND
SUBSIDIARIESCONSOLIDATED STATEMENTS OF
OPERATIONS
|
|
Three Months EndedDecember 31, |
|
Year EndedDecember 31, |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
|
|
|
|
REVENUES: |
|
|
|
|
|
|
|
|
Product revenue |
|
$ |
13,920,378 |
|
|
$ |
12,001,340 |
|
|
$ |
42,076,949 |
|
|
$ |
29,206,249 |
|
License revenue |
|
|
35,709 |
|
|
|
35,709 |
|
|
|
142,834 |
|
|
|
142,834 |
|
Total Revenues |
|
|
13,956,087 |
|
|
|
12,037,049 |
|
|
|
42,219,783 |
|
|
|
29,349,083 |
|
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES: |
|
|
|
|
|
|
|
|
Cost of product revenue |
|
|
19,111,107 |
|
|
|
11,691,603 |
|
|
|
61,291,426 |
|
|
|
39,504,238 |
|
Research and development |
|
|
1,013,464 |
|
|
|
464,823 |
|
|
|
5,907,013 |
|
|
|
2,343,848 |
|
Plasma center operating expenses |
|
|
1,572,607 |
|
|
|
464,131 |
|
|
|
4,170,051 |
|
|
|
2,169,629 |
|
Amortization of intangible assets |
|
|
178,839 |
|
|
|
211,234 |
|
|
|
715,353 |
|
|
|
844,938 |
|
Selling, general and administrative |
|
|
9,300,359 |
|
|
|
7,032,067 |
|
|
|
35,050,817 |
|
|
|
25,910,757 |
|
Total operating expenses |
|
|
31,176,376 |
|
|
|
19,863,858 |
|
|
|
107,134,660 |
|
|
|
70,773,410 |
|
|
|
|
|
|
|
|
|
|
LOSS FROM
OPERATIONS |
|
|
(17,220,289 |
) |
|
|
(7,826,809 |
) |
|
|
(64,914,877 |
) |
|
|
(41,424,327 |
) |
|
|
|
|
|
|
|
|
|
OTHER INCOME
(EXPENSE): |
|
|
|
|
|
|
|
|
Interest and other income |
|
|
19,483 |
|
|
|
181,682 |
|
|
|
288,126 |
|
|
|
800,785 |
|
Interest expense |
|
|
(3,109,469 |
) |
|
|
(2,730,890 |
) |
|
|
(11,985,066 |
) |
|
|
(8,993,379 |
) |
Gain (loss) on extinguishment of debt |
|
|
991,797 |
|
|
|
- |
|
|
|
991,797 |
|
|
|
(9,962,495 |
) |
Gain on transfer of plasma center assets |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
11,527,421 |
|
Other expense |
|
|
(89,296 |
) |
|
|
(185,014 |
) |
|
|
(128,528 |
) |
|
|
(227,322 |
) |
Other expense, net |
|
|
(2,187,485 |
) |
|
|
(2,734,222 |
) |
|
|
(10,833,671 |
) |
|
|
(6,854,990 |
) |
|
|
|
|
|
|
|
|
|
NET LOSS |
|
$ |
(19,407,774 |
) |
|
$ |
(10,561,031 |
) |
|
$ |
(75,748,548 |
) |
|
$ |
(48,279,317 |
) |
|
|
|
|
|
|
|
|
|
BASIC AND DILUTED LOSS
PER COMMON SHARE |
|
$ |
(0.20 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.88 |
) |
|
$ |
(0.89 |
) |
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE
COMMON SHARES OUTSTANDING: |
|
|
|
|
|
|
|
|
Basic and Diluted |
|
|
96,620,486 |
|
|
|
59,318,355 |
|
|
|
86,145,052 |
|
|
|
54,348,136 |
|
ADMA BIOLOGICS, INC. AND
SUBSIDIARIESCONDENSED CONSOLIDATED BALANCE
SHEETS
|
December 31, |
|
December 31, |
|
|
2020 |
|
|
|
2019 |
|
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
55,921,152 |
|
|
$ |
26,752,135 |
|
Accounts receivable, net |
|
13,237,290 |
|
|
|
3,469,919 |
|
Inventories |
|
81,535,599 |
|
|
|
53,064,734 |
|
Prepaid expenses and other current assets |
|
3,046,466 |
|
|
|
2,533,593 |
|
Total current assets |
|
153,740,507 |
|
|
|
85,820,381 |
|
Property and equipment,
net |
|
41,593,090 |
|
|
|
31,741,317 |
|
Intangible assets, net |
|
2,444,121 |
|
|
|
3,159,474 |
|
Goodwill |
|
3,529,509 |
|
|
|
3,529,509 |
|
Right-to-use assets |
|
4,259,191 |
|
|
|
1,245,029 |
|
Deposits and other assets |
|
2,106,976 |
|
|
|
1,595,015 |
|
TOTAL
ASSETS |
$ |
207,673,394 |
|
|
$ |
127,090,725 |
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
11,073,708 |
|
|
$ |
9,174,591 |
|
Accrued expenses and other current liabilities |
|
8,365,143 |
|
|
|
4,481,395 |
|
Current portion of deferred revenue |
|
142,834 |
|
|
|
142,834 |
|
Current portion of lease obligations |
|
365,682 |
|
|
|
229,073 |
|
Total current liabilities |
|
19,947,367 |
|
|
|
14,027,893 |
|
Senior notes payable, net of
discount |
|
92,968,866 |
|
|
|
68,291,163 |
|
Deferred revenue, net of
current portion |
|
2,118,698 |
|
|
|
2,261,532 |
|
Subordinated note payable, net
of discount |
|
- |
|
|
|
14,908,053 |
|
Lease obligations, net of
current portion |
|
4,334,151 |
|
|
|
1,302,361 |
|
Other non-current
liabilities |
|
54,886 |
|
|
|
106,574 |
|
TOTAL
LIABILITIES |
|
119,423,968 |
|
|
|
100,897,576 |
|
|
|
|
|
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, 150,000,000 shares authorized, |
|
|
|
104,902,888 and 59,318,355 shares issued and outstanding |
|
10,490 |
|
|
|
5,932 |
|
Additional paid-in
capital |
|
428,704,039 |
|
|
|
290,903,772 |
|
Accumulated deficit |
|
(340,465,103 |
) |
|
|
(264,716,555 |
) |
TOTAL STOCKHOLDERS'
EQUITY |
|
88,249,426 |
|
|
|
26,193,149 |
|
TOTAL LIABILITIES AND
STOCKHOLDERS' EQUITY |
$ |
207,673,394 |
|
|
$ |
127,090,725 |
|
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