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 third
quarter and nine months ended September 30, 2020, and provided an
overview of recent progress and accomplishments.
“On the commercial front, demand for immune globulins and our
marketed products remained robust with our product portfolio
generating sales of $28.3 million year-to-date (‘YTD’) in 2020, an
increase of 63% compared to the same period in 2019. The third
quarter was our strongest quarter of the year, even in the face of
continued COVID-19 operating headwinds, as we generated $10.3
million in revenue, representing quarterly year-over-year growth of
42%,” said Adam Grossman, President and Chief Executive Officer of
ADMA. “We continue to build our inventory balance in support of
anticipated revenue growth in the fourth quarter and into 2021. Our
supply chain robustness initiatives continue as planned and the
expansion of our Company-owned plasma collection center network is
ahead of schedule. We now have six centers under our corporate
umbrella at various stages of approval and development, including
two that are fully operational and collecting plasma. We are
confident in our continued ability to successfully navigate the
Company against the backdrop of COVID-19, and anticipate a strong
fourth quarter and ultimately achieving considerable growth in the
second half of 2020 versus the first half.”
Third Quarter 2020 and
Recent Highlights
- Expansion of
ADMA BioCenters Plasma Collection
Center Network Ahead of Schedule – ADMA
BioCenters, a wholly-owned subsidiary of ADMA Biologics,
successfully opened, began donor collections and submitted a
Biologics License Application to the U.S. Food and Drug
Administration (“FDA”) seeking FDA approval for this second plasma
collection center, which we anticipate receiving in mid-2021. The
Company currently has six plasma collection centers at various
stages of approval and development, including two that are fully
operational and collecting plasma, three that are under
construction with favorable long-term leases, and one in the
planning stage. ADMA remains on track to achieve its stated goal of
opening five to 10 new, FDA-approved plasma collection centers over
the next three to five years.
- Manufacturing Capacity
Expansion Initiatives – ADMA continues to invest in
and make progress with supply chain robustness enhancements,
including the successful onboarding of aseptic fill-finish
capabilities with our newly installed Vanrx SA25 Workcell, in
addition to advancing regulatory efforts for the planned capacity
expansion to the 4,400 liter BIVIGAM® plasma pool. These
important initiatives are designed to reduce operating costs,
improve margins, increase scale and provide for faster production
cycle turnaround time, ultimately providing increased control and
independence from third-party vendors and contractors. ADMA
remains on track to submit the appropriate applications to the FDA
during the second half of 2020 and into 2021, and expects to begin
benefitting from these initiatives as early as mid-2021.
- Developed
COVID-19 ImmunoRank™
Neutralization MICRO-ELISA – The COVID-19
ImmunoRank Neutralization MICRO-ELISA is a proprietary,
fully-validated ELISA assay for the detection of SARS-CoV-2
neutralizing antibodies in plasma. ImmunoRank, which was developed
in collaboration with Leinco Technologies, Inc., is intended for
use as an aid to identify individuals who produce an adaptive
immune response to SARS-CoV-2, indicating recent or prior
infection, and specifically for the detection of circulating
SARS-CoV-2 neutralizing antibodies in human plasma of all immune
globulin classes. ImmunoRank is important because it offers a
potentially faster, simpler, more cost effective way to identify
high titer convalescent plasma for use in both treating COVID-19
patients and for creating COVID-19 hyperimmune globulins.
Financial Results for the Three Months Ended
September 30, 2020
Total revenues for the quarter ended September 30, 2020 were
$10.3 million, compared to $7.2 million for the quarter ended
September 30, 2019, representing an increase of approximately $3.1
million, or 42%. The revenue growth for the third quarter of 2020,
compared to the third quarter of 2019, was favorably impacted by
the continued commercial ramp up of BIVIGAM and ASCENIV, and by the
manufacturing and supply agreement ADMA entered into in January
2020 to produce and sell intermediate fractions.
Consolidated net loss for the quarter ended September 30, 2020
was $16.9 million, or $(0.19) per basic and diluted share, compared
to a consolidated net loss of $11.4 million, or $(0.19) per basic
and diluted share, for the quarter ended September 30, 2019. The
$5.5 million increase in net loss compared to the prior year period
was primarily attributable to a $3.9 million increase in cost of
product revenue resulting from the higher product revenues
generated from our immunoglobulin products portfolio, and to
increases in selling, general and administrative expenses of $1.9
million related to employee compensation, new hires and other costs
to support the commercialization efforts of BIVIGAM and ASCENIV, as
well as a $1.2 million increase in research and development
expenses related to the validation of a new filling line at one of
our contracted third party fill-finishers. Research and development
expenses were also impacted by costs associated with developing our
neutralization MICRO-ELISA proprietary assay to detect SARS-CoV-2
neutralizing antibodies in plasma in collaboration with a
third-party. The increase in net loss also includes a $0.8 million
increase in plasma center operating expenses due to the opening of
additional plasma centers during 2020. Included in the net loss for
the third quarter of 2020 were non-cash expenses of approximately
$2.3 million for stock-based compensation, depreciation and
amortization, and non-cash interest expense.
Financial Results for the Nine
Months Ended September
30, 2020
Total revenues for the nine months ended September 30, 2020 were
$28.3 million, compared to $17.3 million for the nine months ended
September 30, 2019, representing an increase of $11.0 million, or
approximately 63%. The increase in revenues was primarily
attributable to increased sales of our immunoglobulin products
portfolio: BIVIGAM®, ASCENIV™, Nabi-HB® and intermediate
fractions.
Consolidated net loss for the nine months ended September 30,
2020 was $56.3 million, or $(0.68) per basic and diluted share,
compared to a consolidated net loss of $37.7 million, or $(0.72)
per basic and diluted share, for the nine months ended September
30, 2019. The increase in net loss of $18.6 million was primarily
attributable to a $14.4 million increase in cost of product revenue
related to production costs incurred for the manufacture of BIVIGAM
conformance lots at an increased plasma pool production scale that
pertains to our planned capacity expansion at our Boca Raton, FL
plasma fractionation facility, as well as higher product revenues
generated from our immunoglobulin products portfolio. The increase
in net loss during the first nine months of 2020 was also
attributable to increased selling, general administrative expenses
of $6.9 million in connection with the overall growth in the size
and scope of the Company’s operations, including the
commercialization efforts of BIVIGAM® and ASCENIV™, and a $3.0
million increase in research and development expenses associated
with the validation of a new filling line at one of our third party
fill-finishers, and increases in various clinical research
activities, some of which are required by the FDA. Included in the
net loss for the first nine months of 2020 were non-cash expenses
of approximately $6.2 million for stock-based compensation,
depreciation and amortization and non-cash interest expense.
At September 30, 2020, ADMA had cash and cash equivalents of
$59.7 million and accounts receivable of $6.3 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 September 30, 2020 was $123.1 million, compared to $71.8 million
as of December 31, 2019.
Conference Call
Information
ADMA will host a conference call today, Thursday, November 5,
2020, at 4:30 p.m. Eastern Time, to discuss the third quarter 2020
financial results and recent corporate updates. To 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 8185674. 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 (IgG) antibodies.
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 plasma 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.
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.atlantaplasma.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 Bio Centers 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; the goal
of opening new collection centers over the next three to five
years; our supply chain robustness initiatives and their intended
outcome, expected benefits, and timing thereof; the outcome and
timing of our BLA application for our new plasma center; the
expected benefits from the new aseptic fill-finish machine
installed at our Boca Raton facility; the intended outcome and
expected benefits from our several manufacturing and supply chain
enhancement initiatives, and the expected timing for realizing
those benefits, and our plan to submit appropriate applications to
the FDA related thereto; and the expected benefits relating to the
development of the COVID-19 ImmunoRank Neutralization MICRO-ELISA.
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(Unaudited)
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
|
|
|
REVENUES: |
|
|
|
|
|
|
|
Product revenue |
$ |
10,240,650 |
|
|
$ |
7,186,795 |
|
|
$ |
28,156,571 |
|
|
$ |
17,204,909 |
|
License revenue |
|
35,708 |
|
|
|
35,708 |
|
|
|
107,125 |
|
|
|
107,125 |
|
Total Revenues |
|
10,276,358 |
|
|
|
7,222,503 |
|
|
|
28,263,696 |
|
|
|
17,312,034 |
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES: |
|
|
|
|
|
|
|
Cost of product revenue (exclusive of amortization expense shown
below) |
|
11,855,464 |
|
|
|
7,916,220 |
|
|
|
42,180,319 |
|
|
|
27,812,635 |
|
Research and development |
|
1,708,391 |
|
|
|
491,404 |
|
|
|
4,893,549 |
|
|
|
1,879,025 |
|
Plasma center operating expenses |
|
1,218,898 |
|
|
|
456,899 |
|
|
|
2,597,444 |
|
|
|
1,705,498 |
|
Amortization of intangible assets |
|
178,838 |
|
|
|
211,235 |
|
|
|
536,514 |
|
|
|
633,704 |
|
Selling, general and administrative |
|
9,115,744 |
|
|
|
7,197,173 |
|
|
|
25,750,458 |
|
|
|
18,878,690 |
|
Total operating expenses |
|
24,077,335 |
|
|
|
16,272,931 |
|
|
|
75,958,284 |
|
|
|
50,909,552 |
|
|
|
|
|
|
|
|
|
LOSS FROM
OPERATIONS |
|
(13,800,977 |
) |
|
|
(9,050,428 |
) |
|
|
(47,694,588 |
) |
|
|
(33,597,518 |
) |
|
|
|
|
|
|
|
|
OTHER INCOME
(EXPENSE): |
|
|
|
|
|
|
|
Interest and other income |
|
1,164 |
|
|
|
281,896 |
|
|
|
268,643 |
|
|
|
619,103 |
|
Interest expense |
|
(3,091,200 |
) |
|
|
(2,649,404 |
) |
|
|
(8,875,597 |
) |
|
|
(6,262,489 |
) |
Loss on extinguishment of debt |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(9,962,495 |
) |
Gain on transfer of plasma center assets |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
11,527,421 |
|
Other expense, net |
|
(26,440 |
) |
|
|
(20,523 |
) |
|
|
(39,232 |
) |
|
|
(42,308 |
) |
Other expense, net |
|
(3,116,476 |
) |
|
|
(2,388,031 |
) |
|
|
(8,646,186 |
) |
|
|
(4,120,768 |
) |
|
|
|
|
|
|
|
|
NET LOSS |
$ |
(16,917,453 |
) |
|
$ |
(11,438,459 |
) |
|
$ |
(56,340,774 |
) |
|
$ |
(37,718,286 |
) |
|
|
|
|
|
|
|
|
BASIC AND DILUTED LOSS
PER COMMON SHARE |
$ |
(0.19 |
) |
|
$ |
(0.19 |
) |
|
$ |
(0.68 |
) |
|
$ |
(0.72 |
) |
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE
COMMON SHARES OUTSTANDING: |
|
|
|
|
|
|
|
Basic and Diluted |
|
87,698,258 |
|
|
|
59,317,830 |
|
|
|
82,627,753 |
|
|
|
52,673,190 |
|
|
|
ADMA BIOLOGICS, INC. AND
SUBSIDIARIESCONDENSED CONSOLIDATED BALANCE
SHEETS
|
|
September 30, |
|
December 31, |
|
|
|
2020 |
|
|
|
2019 |
|
ASSETS |
|
(Unaudited) |
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
59,675,045 |
|
|
$ |
26,752,135 |
|
Accounts receivable, net |
|
|
6,334,536 |
|
|
|
3,469,919 |
|
Inventories |
|
|
69,752,528 |
|
|
|
53,064,734 |
|
Prepaid expenses and other current assets |
|
|
3,786,421 |
|
|
|
2,533,593 |
|
Total current assets |
|
|
139,548,530 |
|
|
|
85,820,381 |
|
Property and equipment,
net |
|
|
39,622,510 |
|
|
|
31,741,317 |
|
Intangible assets, net |
|
|
2,622,959 |
|
|
|
3,159,474 |
|
Right to use assets |
|
|
2,782,987 |
|
|
|
1,245,029 |
|
Goodwill |
|
|
3,529,509 |
|
|
|
3,529,509 |
|
Deposits and other assets |
|
|
1,869,548 |
|
|
|
1,595,015 |
|
TOTAL
ASSETS |
|
$ |
189,976,043 |
|
|
$ |
127,090,725 |
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
7,979,772 |
|
|
$ |
9,174,591 |
|
Accrued expenses and other current liabilities |
|
|
8,074,989 |
|
|
|
4,481,395 |
|
Current portion of deferred revenue |
|
|
142,834 |
|
|
|
142,834 |
|
Current portion of lease obligations |
|
|
275,988 |
|
|
|
229,073 |
|
Total current liabilities |
|
|
16,473,583 |
|
|
|
14,027,893 |
|
Senior notes payable, net of
discount |
|
|
82,108,633 |
|
|
|
68,291,163 |
|
Deferred revenue, net of
current portion |
|
|
2,154,407 |
|
|
|
2,261,532 |
|
Subordinated note payable, net
of discount |
|
|
14,934,926 |
|
|
|
14,908,053 |
|
Lease obligations, net of
current portion |
|
|
2,860,732 |
|
|
|
1,302,361 |
|
Other non-current
liabilities |
|
|
67,808 |
|
|
|
106,574 |
|
TOTAL
LIABILITIES |
|
|
118,600,089 |
|
|
|
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, $0.0001 par
value, 150,000,000 shares authorized, 89,616,176 and 59,318,355
shares issued and outstanding |
|
|
8,960 |
|
|
|
5,932 |
|
Additional paid-in
capital |
|
|
392,424,323 |
|
|
|
290,903,772 |
|
Accumulated deficit |
|
|
(321,057,329 |
) |
|
|
(264,716,555 |
) |
TOTAL STOCKHOLDERS'
EQUITY |
|
|
71,375,954 |
|
|
|
26,193,149 |
|
TOTAL LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
$ |
189,976,043 |
|
|
$ |
127,090,725 |
|
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