Full Press Release Details
ADMA Biologics Provides Corporate Timeline
and Activities Update to Stockholders
RAMSEY, N.J. and BOCA RATON, FL. - June 27, 2017 - ADMA Biologics,
Inc. (NASDAQ:ADMA), a late-stage biopharmaceutical company that develops, manufactures and commercializes specialty plasma-based
biologics for the proposed treatment of immune deficiencies and prevention of certain infectious diseases, announced today that
is has provided a corporate timeline and activities update to Stockholders. The communication is provided below:
On behalf of the Board of Directors, management team and all
employees of ADMA Biologics, Inc. ("we," "us," or the "Company"), I would like to thank you
for your support with respect to our recent asset acquisition from Biotest Pharmaceuticals Corporation (the "Transaction").
We believe this Transaction is transformative because having ownership of a vertically integrated biologics production plant is
a rarity in our industry.
There are only a handful of these highly-specialized plasma
fractionation plants in the world with approvals to market products in the U.S. and we believe that we are the only American-owned,
headquartered and domiciled company with fractionation capacity. We have seen that the M&A activity in the plasma products
space, for both large and small vertically integrated facilities, has continued to yield attractive valuations. Based on industry
reports and the rising global demand for plasma and plasma derived biologics, we expect this trend to continue. With the closing
of the Transaction, we believe that our Company has a number of value creating milestones and inflection points in the near-term,
Now that we have control over our drug substance manufacturing,
and with that the ability to have a direct communication with the U.S. Food and Drug Administration (the "FDA") as
an approved manufacturer of immune globulins, we believe ADMA Biologics is a more attractive Company than we were just a year ago.
We realize that many of you have questions regarding our Company's
near- and long-term goals and objectives. Our goal is to evolve ADMA Biologics into a leading vertically integrated human protein
plasma products and immune globulin manufacturer with an innovative and differentiated product portfolio that will address the
unmet medical needs of patients with various forms of immune deficiencies. We now have many of the assets in place to achieve this
goal. We believe a significant amount of value exists in this business model, and we have a clear strategic plan in place to unlock
Our top priority is to remediate the outstanding compliance
issues identified at our acquired manufacturing facility and ensure that the status of the previously issued FDA Warning Letter
is lifted and the objectionable status is eliminated.
As part of the Company's preparations for closing the
Transaction, we initiated discussions with the FDA's Office of Compliance and Biologics Quality under the Center for Biologics
Evaluation and Research with respect to our plans for achieving a successful remediation program. In order to quickly and efficiently
complete this objective, we have engaged a leading consulting firm with extensive experience in remediating compliance and inspection
issues related to quality management systems, that manages a robust team of subject matter experts in plasma derived products and
biologic drugs. These consultants have been and continue to work side-by-side with our talented staff to develop and implement
specific remediation strategies for each quality system in order to bring the facility into compliance with current Good Manufacturing
Practices ("cGMP "). Over the past four months (prior to closing of the Transaction), we worked with our advisors to
identify all of the quality system functions within our manufacturing facility which required modifications, amendments and improvements.
We are now focused on implementing the appropriate changes and our consultants will assist, train and provide oversight of our
plant manufacturing and testing activities as we advance towards GMP compliance. Our goal with respect to this remediation project
is to be "inspection ready" in approximately 6 months. While we cannot control the FDA's inspection
and meeting schedule, we are hopeful and optimistic that through our ongoing transparent dialogue with the FDA, we can achieve
these target timelines.
Additionally, we remain committed to addressing the Complete
Response Letter ("CRL") received from the FDA for our patented lead product, RI-002. As previously disclosed, we received
the CRL because of existing compliance issues with certain of our vendors. With our continuing focus on remediation on all aspects
of our manufacturing and of our vendors activities, we believe that these vendors have addressed their specific issues directly
with the FDA. Now following the closing of the Transaction, and our team having operational control of the drug substance manufacturing,
we anticipate that we will be in a position to refile the Biologics License Application ("BLA") for RI-002 in the middle of 2018.
Concurrently, we are focused on relaunching Bivigam (Immune
Globulin Intravenous, Human), and renewing sales and marketing efforts for Nabi-HB (Hepatitis B Immune Globulin,
Human) which are products we acquired in the Transaction. As reported in our proxy statement filed in connection with the Transaction,
revenues of $76.5M were reported for calendar year 2016 from the Boca Facility, of which Bivigam represented approximately
$50M of revenues during the same period. However, as previously disclosed, the production of Bivigam was voluntarily halted
by the prior ownership in order to conduct appropriate facility upgrades, renovations and improvements. We are pleased to report
that these upgrades have now been completed and that we are in the process of final qualification with respect to these improvements.
With our continuing path towards compliance, we anticipate that our facility will be ready to begin manufacturing certain products
for our Company and our clients in approximately 8 weeks.
While relaunch is important to our near-term success, we remain
committed to maximizing our Company's long-term success to becoming competitive in the market of specialty immune globulins.
To that end, over the past several months, we have been working with our consultant experts to optimize the manufacturing process
for immune globulin products. As you may recall, the previously issued Warning Letter for our manufacturing facility cited filter
clogging during the manufacturing process for BIVIGAM . We are pleased to report that we have identified a number of possible
sources for filter clogging and we are diligently working to prioritize and resolve these various possibilities. Our preliminary
data suggests that optimization of the process has produced significant improvements in the filterability of the product. We are
hopeful that the institution of newly identified process controls, the setting of specific parameters for these processes during
manufacturing combined with the tightening of our production specifications will bring our facility in line with FDA's manufacturing
expectations. We believe that this is an important step in the overall remediation process to lift the FDA Warning Letter status.
We continue to grow revenue through the sale of source plasma
to third party customers, as well as through the sale of our newly acquired hyperimmune globulin product for Hepatitis B, Nabi-HB .
There is a broad population of patients who remain susceptible to potential Hepatitis B infection and ADMA is committed to increasing
awareness and utilization of its Nabi-HB product to provide patients with the protection they need, as well as assist
those patients who have failed conventional antiviral therapies and for whom the hyperimmune globulin may be the only available
Along with expending efforts to generate revenues for the business,
ADMA management is exploring various financing options, which include potentially, refinancing its current senior debt facility,
which if achieved on favorable terms, would be expected to allow ADMA to extend its current cash runway from the first quarter
2018, well into the second half of 2018 and perhaps further, depending on the timing and structuring of the loan facility.
Management is committed to the success of this acquisition and
integration process. Although there can be no assurances that we can achieve our goals on the timelines described, if at all, or
that our current assumptions are accurate and do not require updating, we believe that hands-on oversight and operational management
will be the single most important aspect to effect the corporate cultural changes at the Boca facility that are necessary to improve
operational efficiency, accountability and redefine the focus of ADMA Biologics personnel on becoming a highly valuable company.
To this end, I will be moving to Boca Raton with my family in August 2017.
ADMA is committed to all of these activities because ultimately,
there are patients who are counting on our Company and our products to improve medical outcomes and potentially save their lives.
All of this is possible because of our Stockholders. We are grateful to you, for your continued patience and support while we work
on integrating business operations and work to remediate the quality systems of our manufacturing facility. You have the ability
to make a difference in the lives of so many people by investing in ADMA Biologics, and for this we deeply thank you for your confidence
President, CEO and Founder
About ADMA Biologics, Inc. (ADMA)
ADMA Biologics is a fully-integrated biopharmaceutical and specialty
immunoglobulin manufacturing company that currently markets and develops specialty plasma-based biologics for the proposed treatment
of immune deficiencies 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 has received U.S. Patent 9,107,906 relating to certain aspects of its product
candidate. ADMA has recently announced the closing of its acquisition of certain assets from Biotest Pharmaceuticals Corporation.
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. Forward-looking statements include,