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ADMA Biologics Reports 2012 Year End Financial and Operational Results



  ADMA Biologics Reports 2012 Year End Financial and Operational Results

Business Wire

HACKENSACK, N.J. -- March 6, 2013

ADMA Biologics, Inc. (ADMA), a specialty immune globulin company that
develops, manufactures and intends to market plasma-based biologics for the
treatment and prevention of certain infectious diseases, today reported
financial and operational results for the year ended December 31, 2012.
Year-end and subsequent highlights include:

  * Secured $6 million term loan to advance Phase III study
  * Executed long-term manufacturing, supply and license agreement for RI-002
  * Out-licensed RI-002 to Biotest AG, to market and sell in selected
    countries outside of the United States
  * Generated $1.1 million in revenues from ADMA BioCenters during 2012
  * Appointed key members to management team and Board of Directors
  * Commenced pivotal Phase III clinical trial for RI-002

“2012 was a solid year for ADMA during which we made significant progress with
our lead product candidate and achieved a number of key milestones,” stated
Adam Grossman, President and Chief Executive Officer of ADMA. “Looking ahead,
we expect 2013 to be a year of continued execution as we advance RI-002
through our pivotal Phase III study.”

Year-end Business Review

Revenue

For the year ended December 31, 2012, revenues increased 37.5% to $1.1 million
compared to the same period in 2011. The increase was primarily a result of
the sale of normal source plasma under our June 2012 supply agreement. The
normal source plasma material is collected at ADMA’s wholly-owned subsidiary,
ADMA BioCenters, an FDA-licensed plasma collection facility. ADMA has
generated revenues of $1.9 million since inception through December 31, 2012
from the sale of normal source human plasma collected at ADMA BioCenters.

Cost of Revenues

Cost of revenues for the year ended December 31, 2012 was $0.7 million,
compared to $0.2 million for the same period in 2011. The increase was a
result of higher costs associated with the sale of normal source plasma
through a supply agreement entered into in June 2012.

Operating Expenses

Research and development expenses for the year ended December 31, 2012 were
$3.5 million, compared to $0.7 million for the same period in 2011. Research
and development expenses increased primarily as a result of higher
manufacturing, testing and regulatory costs for ADMA’s lead product candidate,
RI-002, along with costs for the initiation of its Phase III clinical study,
as well as increased wages and benefits for new hires during 2012, which
include the July 2012 appointment of a Chief Scientific Officer/Chief Medical
Officer.

Plasma center operating expenses for the year ended December 31, 2012 were
$1.8 million, compared to $1.2 million for the same period in 2011. Plasma
center operating expenses increased following the U.S. Food and Drug
Administration licensing of ADMA BioCenters in August 2011, of which increases
include additional facility expenses, supplies and increased headcount during
2012.

General and administrative expenses for the year ended December 31, 2012 were
$3.1 million, compared to $1.4 million for the same period in 2011. General
and administrative expenses increased as a result of increased stock-based
compensation charges, increased professional and filing fees associated with
becoming a public company during the first quarter of 2012, as well as
increased wages and benefits for new hires during 2012, which includes the May
2012 appointment of our Chief Financial Officer.

Net Loss

For the year ended December 31, 2012, ADMA’s net loss was $7.3 million, or
$(1.76) per share, compared to a net loss of $5.9 million, or $(16.72) per
share, in the same period of 2011. The increase in net loss is attributable to
an increase in research and development expenses relating to the
manufacturing, testing and regulatory costs of ADMA’s lead product candidate,
costs for the initiation of its Phase III clinical study of RI-002, in
addition to increased general and administrative expenses relating to higher
stock-based compensation charges, professional filing fees as a result of
becoming a public reporting company during the first quarter of 2012, offset
by increased revenues. The increase in the number of shares outstanding
resulted from the conversion of preferred stock and notes payable into common
stock and the issuance of common stock in connection with the merger and
financing in February 2012.

Cash Position

As of December 31, 2012, the Company had cash and cash equivalents of $12.5
million.

About ADMA Biologics, Inc.

ADMA is a specialty immune globulin company that develops, manufactures and
intends to market plasma-based biologics for the treatment and prevention of
certain infectious diseases. ADMA’s mission is to develop and commercialize
plasma-derived, human immune globulins targeted to niche patient populations
for the treatment and prevention of certain infectious diseases. The target
patient populations include immune-compromised individuals who suffer from an
underlying immune deficiency disease or who may be immune-compromised for
medical reasons. ADMA also operates ADMA Bio Centers, which is an FDA-licensed
source plasma collection facility located in Norcross, Georgia, which provides
us with a portion of our blood plasma for the manufacture of RI-002. For more
information please visit the Company’s website at: www.admabiologics.com.

About ADMA’s lead product candidate RI-002

ADMA’s lead product candidate, RI-002 is a specialty plasma-derived,
polyclonal, Intravenous Immune Globulin, or IGIV, derived from human plasma
containing naturally occurring polyclonal antibodies (eg. streptococcus
pneumoniae, H. influenza type B, CMV, measles, tetanus etc.) as well as high
levels of antibodies targeted to respiratory syncytial virus, or RSV. ADMA is
pursuing an indication for the use of this specialty IGIV product for
treatment of patients diagnosed with primary immune deficiency diseases, or
PIDD. Polyclonal antibodies are the primary component of IGIV products.
Polyclonal antibodies are proteins produced by B-cells that are used by the
body’s immune system to neutralize microbes such as bacteria and viruses. The
polyclonal antibodies that are present in RI-002 are expected to prevent
infections in immune-compromised patients.

About Primary Immune Deficiency Disease (PIDD)

PIDD is a class of inherited genetic disorders that causes an individual to
have a deficient or absent immune system due to either a lack of necessary
antibodies or a failure of these antibodies to function properly. PIDD
patients are more vulnerable to infections and more likely to suffer
complications from these infections. According to the World Health
Organization, there are over 150 different presentations of PIDD. As patients
suffering from PIDD lack a properly functioning immune system, they typically
receive monthly, outpatient infusions of IGIV therapy. Without this exogenous
antibody immune support, these patients would be susceptible to a wide variety
of infectious diseases. PIDD has an estimated prevalence of 1:1,200 in the
United States, or approximately 250,000 people.

Cautionary Statement Regarding Forward-Looking Information

This press release contains “forward looking statements.” Forward-looking
statements include, without limitation, any statement that may predict,
forecast, indicate, or imply future results, performance or achievements, and
may contain the words “estimate,” “project,” “intend,” “forecast,”
“anticipate,” “plan,” “planning,” “expect,” “believe,” “will,” “will likely,”
“should,” “could,” “would,” “may” or, in each case, their negative, or words
or expressions of similar meaning. These forward-looking statements include,
but are not limited to, statements concerning the timing, progress and results
of the clinical development, regulatory processes, potential clinical trial
initiations, potential investigational new product applications, biologics
license applications, and commercialization efforts of the Company's product
candidate(s). Forward-looking statements are subject to many risks and
uncertainties that could cause our actual results to differ materially from
any future results expressed or implied by the forward-looking statements,
including, but not limited to, the risks listed under the heading “Risk
Factors” in our Annual Report on Form 10-K for the year ended December 31,
2012. Therefore, 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. In light of the significant
uncertainties inherent to the forward-looking statements included herein, the
inclusion of such information should not be regarded as a representation or
warranty by ADMA or any other person that the objectives and plans of ADMA
will be achieved in any specified time frame, if at all. 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.

 
ADMA BIOLOGICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
Years Ended December 31, 2012 and 2011

 
 
                                     For the Year Ended     For the Year Ended
                                     December 31, 2012      December 31, 2011
                                                             
REVENUES                           $ 1,118,118            $ 761,042
                                                             
Cost of sales                        669,056                207,570
                                                             
Gross profit                         449,062                553,472
                                                             
OPERATING EXPENSES
                                                             
Research and development             3,469,078              646,756
expenses
                                                             
Loss on sale of inventory            -                      1,934,630
                                                             
Plasma center operating              1,746,864              1,163,148
expenses
                                                             
General and administrative           3,142,289              1,431,894
expenses
                                                             
TOTAL OPERATING                      8,358,231              5,176,428
EXPENSES
                                                             
LOSS FROM OPERATIONS                 (7,909,169)            (4,622,956)
                                                             
Interest income                      20,924                 1,689
                                                             
Interest expense                     (30,683)               (1,602,958)
                                                             
LOSS BEFORE INCOME TAXES             (7,918,928)            (6,224,225)
                                                             
State income tax benefit             617,615                320,765
NET LOSS                           $ (7,301,313)          $ (5,903,460)
                                                             
NET LOSS PER SHARE – BASIC         $ (1.76)               $ (16.72)
AND DILUTED
                                                             
WEIGHTED AVERAGE
SHARES OUTSTANDING –                 4,146,276              353,098
BASIC AND DILUTED
                                                             

 
CONDENSED BALANCE SHEET INFORMATION:
 
                                           *December 31,       *December 31,
                                           2012                2011
Assets
Cash and cash equivalents                  $ 12,535,672        $ 87,771
Total Assets                               $ 15,555,419        $ 2,925,909
                                                                
Deficit accumulated during the             $ (37,109,328 )     $ (29,808,015 )
development stage
Total Stockholders’ Equity                 $ 9,423,746         $ 385,816
 
*Condensed from audited financial statements
 

Contact:

ADMA Biologics, Inc.
Brian Lenz, CPA, 201-478-5552
Vice President & Chief Financial Officer
www.admabiologics.com
info@admabio.com
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