Full Press Release Details
C O R P O R A T E P A R
Jeremy Feffer, Managing Director,
LifeSci Advisors, LLC
Adam Grossman, President and Chief
C O N F E R E N C E C A
L L P A R T I C I P A N T S
Jason McCarthy, Maxim Group
Leland Gershel, Oppenheimer and
Edward Marks, H.C. Wainwright
Yale Jen, Laidlaw & Co.
Ren Benjamin, Raymond James
Good day and welcome to the conference
call to discuss recent regulatory updates on Bivigam PAS submission. Today's conference is being recorded. At this time I
would like to turn the conference over to Jeremy Feffer. Please go ahead.
Thank you, Kim, and good morning. This
conference call contains forward-looking statements pursuant to the Safe Harbor provisions of the Private Securities Litigation
Reform Act of 1995, about ADMA Biologics Incorporated, we, our or the Company.
These forward-looking statements include
without limitation any statement that may predict, forecast, indicate or imply future results, performance or achievements concerning
our plans to develop, manufacture, market, launch and expand our commercial infrastructure, the expected timing of and our ability
to obtain and maintain regulatory approvals of our CARD (phon) products and product candidates, and our expectations for future
capital requirements. Actual events or results may differ materially from those described in this conference call due to a number
of important factors. There can be no assurances that the forward-looking statements included 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 and 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
ViaVid has made considerable efforts to provide an accurate
transcription, there may be material errors, omissions, or inaccuracies in the reporting of the substance of the conference call.
This transcript is being made available for information purposes only.
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With that, I would like to turn the call
to Adam Grossman, ADMA's President and Chief Executive Officer. Adam?
Thanks, Jeremy. Good morning everybody.
Thank you to our shareholders, analysts and other interested constituents in our growing company ADMA Biologics. I am Adam Grossman,
the co-Founder, Director, President and CEO of the company, and I sincerely appreciate your time and attention today as we provide
some further updates and details on the status of our much needed IVIG product Bivigam and its FDA review for approval.
I'd like to start today by reporting
that it's been approximately 18 months since closing our acquisition on the manufacturing plant and drug product assets from
Biotest Pharmaceuticals, and we have made significant and tremendous progress accomplishing tasks and objectives which the prior
owners could not achieve. We are truly pleased with our progress in turning the plant and assets around as we continue to execute
on our goals and corporate objectives.
We would like to specifically point out
that under our leadership and guidance, the compliance status of the facility has improved from OAI, standing for Office Action
Indicated, to VAI meaning Voluntary Action Indicated. This again is something the previous owners could not accomplish in four
years. This improved compliance status is a necessary step in order to receive any new FDA approval under the previous compliance
status which was OAI. No approvals were issued for new applications at the site during the time period that that status was in
place with the previous ownership.
Subsequent to our April 2018 FDA Compliance
Inspection at our Boca Raton manufacturing facility, the agency accepted our responses and plans for addressing the inspectional
observations and issued the Company what's known as an Establishment Inspection Report, or EIR, which indicated that we were
found to be operating within compliance. Again, this is the first time that this site has been operating in compliance and received
Today, ADMA operates as a commercial biologics
manufacturer and marketing and sales organization. We continue to produce and release commercial drug into the U.S market with
Nabi-HB, our specialty hyperimmune globulin for use in patients at risk or infected with hepatitis B. We also continue to produce
and release batches of rabies immune globulin paste for our contract client customer. With this as our backdrop, I'd like
to turn the topic over to the topic of the day which is the receipt of a Complete Response Letter, or CRL, in regard to selected
topics included in Bivigam's drug substance Prior Approval Supplement to amend it's already approved BLA.
As we reported previously, ADMA successfully
produced three conformance batches of Bivigam earlier in 2018 using what we call our new, optimized IVIG manufacturing process.
These conformance batches were produced after we conducted extensive evaluation and study of the old Bivigam process in our small-scale
production model in which the old process frequently exhibited filter clogging and contained other undesirable impurities in its
production. We then executed a comparability protocol to compare the old process to the new ADMA optimized Bivigam process. We
believe these manufacturing evaluations were completed appropriately, successfully and were well documented in accordance with
ViaVid has made considerable efforts to provide an accurate
transcription, there may be material errors, omissions, or inaccuracies in the reporting of the substance of the conference call.
This transcript is being made available for information purposes only.
1-888-562-0262 1-604-929-1352 www.viavid.com
The CRL ADMA received for Bivigam is mainly
asking for additional clarification with regard to these topics for Bivigam. These requests and the CRL received are for Bivigam
only and we want to make it clear that they do not directly affect anything for our other ongoing interactions including RI-002's
ongoing FDA BLA review and potential approval.
As you may expect, ADMA provided thousands
of pages of documents, data, explanations and information to the FDA in our initial PAS submission, which we made in June 2018.
During the FDA's review cycle, the Company responded to multiple routine information requests from our regulatory project
manager at FDA, which also included additional thousands of pages of documents and data. The data and submissions which ADMA prepared
are robust and full of complex information and details. The point I'm trying to make is we gave the FDA a lot of information
to review. As we previously reported, FDA extended the Bivigam PAS PDUFA Review Action Date by two months from October 2018 to
December 2018 due to the volume of our submission. We believe since receiving the CRL that FDA had a few remaining questions and
clarification requests and therefore they need a bit more time to complete their review of our extensive data package.
All of the questions and clarification
requests including in the recently received CRL for Bivigam drug substance PAS, we feel are fully resolvable and addressable in
the near term. We believe that none of the requests included in the CRL appear to require lengthy amounts of time to complete and
we believe that some of the additional data FDA is requesting is currently included in other sections of the PAS submission or
we have the data on file at the company, ready to go.
I want to emphasize that the questions
in the CRL are strictly related to specific CMC, chemistry manufacturing and controls-related topics, and the agency has not requested
any additional information for new clinical trials, data, anything to do with our compliance status. We believe there are no additional
manufacturing runs required or other lengthy processing or testing studies or information which could delay our ability to respond
to the CRL. Additionally, the CRL does not identify any issues with our third-party laboratories, vendors or suppliers.
It's important to note that while
Bivigam and RI-002 share the same plant, share certain equipment and relatively similar production processes, both products are
separate from each from a regulatory standpoint, which means they are two separate and standalone complete submissions. We continue
to work with the FDA review team assigned to RI-002's review and we are routinely receiving information requests with the
ongoing review of RI-002's BLA.
It's important today for me to point
out how encouraging it is that our drug product Prior Approval Supplement for Bivigam's BLA was approved. For clarification,
when ADMA submitted its PAS, we separated the submission into two parts. The first part is for what we do at our Boca Raton plant
to manufacture the actual immunoglobulin drug substance for Bivigam. The second part of the PAS submission was for the fill finish