SEC Comment Letter for ADMA BIOLOGICS, INC. (ADMA) (CIK 0001368514) (ADMA) — Mar 9, 2012
ADMA BIOLOGICS, INC. (ADMA) (CIK 0001368514)
Date: March 9, 2012 · CIK: 0001368514 · Accession: 0000000000-12-012443
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File numbers found in text: 000-52120
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March 9, 2012 Via E-mail
Adam S. Grossman Chief Executive Officer ADMA Biologics, Inc. 133 Summit Avenue, Suite 22 Summit, New Jersey 07901
Re: ADMA Biologics, Inc.
Form 8-K Filed February 13, 2012 File No. 000-52120
Dear Mr. Grossman:
We have reviewed your filing and have the following comments. In some of our
comments, we may ask you to provide us w ith information so we may better understand
your disclosure.
Please respond to this letter within ten business days by amending your filing, by
providing the requested information, or by advising us when you will provide the requested response. If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your filing and the information you provide in
response to these comments, we may have additional comments. Safe Harbor Statement Under the Private S ecurities Litigation Reform Act, page 2
1. Please remove reference to the safe har bors of the Private Securities Litigation
Reform Act of 1995 including Section 27A of the Securities Act and Section 21E
of the Exchange Act given that you appear to be a penny stock issuer, or tell us
why this is not necessary. Please refer to Section 27A(b)(1)(C) of the Securities
Act and 21E(b)(1)(C) of the Exchange Act.
Adam S. Grossman
ADMA Biologics, Inc. March 9, 2012 Page 2
Additional Information Required Pursuant to Form 10, page 10
Business of ADMA, page 10
General
2. Please revise to define industry specific terms when first used, such as “immune
globulins,” “polyclonal,” and “RSV,” on page 10 and “PIDD” on page 11.
Overview, page 10
3. Please balance the disclosure in the second paragraph to clarify, as indicated on
page 21, that the results of your Phase II c linical trials may not be indicative of
future results.
4. We note the statement in the second paragraph that ADMA is preparing to
conduct a Phase III clinical trial “in order to gain FDA approval” of RI-001.
Please revise to state that the FDA may require additional Phase III trials and
Phase IV trials after this planned Phase III trial. Additiona lly please revise to
clarify that it is possible that the FDA may not grant approval.
Business of ADMA, page 10
5. Please revise to discuss how you have developed RI-001. Explain whether you
developed it internally or ac quired it from another party.
Background of the Plasma Industry, page 11
6. Please refer to the second paragraph on pa ge 11. Please refrain from referring to
compound growth rates here and elsewher e as these repres ent two discrete
snapshots in time but do not show trends or events during the remaining period.
Otherwise, please revise to disclose the information in a manner that conveys the
interim trends or events and presents a more complete picture of the worldwide
revenue growth within the industry.
7. Please refer the second paragraph on page 11 regarding the $11.8 billion
worldwide market and $4.5 billion United St ates market for the plasma industry,
the third paragraph on page 11 regarding the $5.1 billion worl dwide IGIV market,
and the fourth paragraph on page 11 regarding the $900 million worldwide
hyperimmune products market. Please revise to state, if true, that RI-001, if
approved for treatment of PIDD by the FDA, would represent only a sub-segment of each of these markets. Additionally please balance references to worldwide markets by stating that you currently only have plans for gaining regulatory
acceptance in the United States.
Adam S. Grossman
ADMA Biologics, Inc. March 9, 2012 Page 3
Our Strategy, page 11
8. For each business initiative you list, please revise to provide a timeline including
milestones and the costs you will face at each step along the way. Discuss what
steps you have taken so far. Explain when you expect each ini tiative to generate
revenue. Additionally, please explain whic h initiatives will require you to raise
additional capital.
9. Please revise to address your strategy in the event the FDA requires additional
Phase III trials or Phase IV trials. Di scuss a timeline including costs and whether
additional capital would be needed.
10. You state here that ADMA BioCenters r eceived its FDA license in August 2011.
We also note on page F-6 of Exhibit 99.2 that you founded ADMA BioCenters
Georgia, Inc. on April 3, 2008. Please te ll us, with a view towards revised
disclosure, what operations were conducted by the facility prior to receiving the
FDA license and when the facility began collecting plasma.
Our Product Candidate, page 12
11. Please tell us, with a view towards re vised disclosure, why you believe RI-001
will be clearly differentiated from currently marketed IGIV products.
Manufacturing and Supply, page 13
12. We note that you have filed the manufacturing and supply agreements with
Biotest Pharmaceuticals Corporation as mate rial contracts. Please revise this
section to disclose the material terms of these agreements. Please also disclose
more specifically to what extent you in tend to rely on third parties for blood
plasma sourcing.
13. Please disclose the precautions your manufact urer is required to take to protect
your trade secrets.
Intellectual Property, page 14
14. Please revise to state, as indicated on page 22, that you do not own any issued
patents and do not have any pate nt applications in process.
Government Regulation and Product Approval, page 14
15. Please revise to address the regulati on and licensing of ADMA BioCenters.
Adam S. Grossman
ADMA Biologics, Inc. March 9, 2012 Page 4
Risk Factors, page 18
16. We note the reference to known “and unknow n” risks and the statement that
“[t]he risks described below are not th e only ones the Company will face.” All
material risks should be discu ssed in this section. If ri sks are not deemed material
they should not be mentioned. Please revise accordingly.
17. Please revise to include a ri sk factor discussing, if true , that your Chief Executive
Officer has no experience managing a public company.
To date, we have generated limited product revenues, page 18
18. Please revise to state, as indicated on page 34, that you estimate you will run out
of funds after the third quarter of 2013, but may run out sooner and require
additional capital sooner.
We do not own any issued patents, page 22
19. Please provide a separate risk factor addressing risks th at third parties may obtain
patents and that you would then be infringing on those patents unless you
negotiate appropriate licenses.
Management’s Discussion and Analysis or Plan of Operation, page 31
Results of Operations, page 31
20. Please consider including a tabular pres entation of period to period comparative
data for clarity in addition to your narrative discussion.
Liquidity and Capital Resources, page 34
21. You state here that you expect your exis ting cash will be sufficient to fund your
operations through the third quarter of 2013. You state on page 11, however, that
you anticipate potential FDA approval of RI-001 by year-end 2014 and you intend
to commercialize thereafter. Please address this potential funding shortfall more specifically, including your intended cour ses of action to remedy the deficiency.
22. Please revise your discussion here to speci fically state that the auditors’ report
expressed substantial doubt as to your ability to continue as a going concern
similar to the disclosure on page 18. Fili ngs with such accountants’ reports must
contain appropriate and prominent disclosu re of financial difficulties and viable
plans to overcome these difficulties. Refer to Section 607.02 of the Financial
Reporting Codification for guidance.
Adam S. Grossman
ADMA Biologics, Inc. March 9, 2012 Page 5
Summary Compensation Table, page 39
23. We note the statement on page 40 that Mr. Grossman received a bonus of $50,000
in connection with his 2011 performan ce. Please explain why you have not
included this amount in the Summary Co mpensation Table as 2011 compensation.
Certain Relationships and Related Transact ions, and Director I ndependence, page 41
24. Please revise to quantify the estimated amount of reimbursed legal fees, as
discussed in the first paragraph.
25. Please disclose the number of shares underlying the common stock purchase
warrants in the first paragra ph under “Note Financings.”
Other Related Party Transactions, page 42
26. Please revise to identify the “affiliate of the Placement Agent.” Additionally
please revise to identify the “bank of which Dr. Grossman serves as a director….”
Description of Registrant’s Secu rities to be Registered, page 43
27. You state that the summary of certain provisions of your capital stock is qualified
by the “provisions of applicable law.” Su ch a qualification is inappropriate unless
you file these provisions of applicable law as exhibits to the cu rrent report. Please
revise accordingly.
Note 2 – Summary of Significant Accounting Policies
Inventory, page F-6
28. We note your disclosure on page 31 of your Form 8-K that, during the nine
months ended September 30, 2011, you incurr ed a loss on sale of research and
development inventory of $1,934,630 because you disposed of your inventory of
high priced, high titer plasma that you had previously acquired to conduct
research and development for a second pr oduct that was subsequently abandoned.
Please revise your disclosures in the Form 8-K and in this note to indicate the
total amount of inventory sold at book va lue, proceeds received, and loss taken on
sale.
29. Further, we note your inventor y policy indicates inventor y is carried at the lower
of cost or market. Given the significan t loss on sale of plasma inventory taken
during the nine months ended Septembe r 30, 2011, it appears the market value of
remaining inventories may be significantly less than their carr ying value. Please
tell us how you have considered the remain ing plasma inventory for impairment.
Adam S. Grossman
ADMA Biologics, Inc. March 9, 2012 Page 6
30. As a related matter, we note your disclo sure on page 10 of your Form 8-K that
you own and operate ADMA BioCenters , an FDA-licensed source plasma
collection facility that collects source plasma that may be manufactured into
finished goods by third-party manufacturers or sold in the open market. Please
tell us why you have not recorded the sale of the plasma inventory as revenue and
the related cost of such plasma as cost of sales within operations on your
Condensed Consolidated Statements of Op erations on page F-3. Include in your
response whether ADMA BioCenters has sold plasma to third party manufacturers or in the open ma rket for any period presented.
Exhibit 10.10
31. Please refile this material contract in its entirety, in cluding Exhibit A.
We urge all persons who are responsible for the accuracy and adequacy of the
disclosure in the filing to be certain that the filing includes the information the Securities
Exchange Act of 1934 and all applicable Exch ange Act rules require. Since the company
and its management are in possession of all f acts relating to a company’s disclosure, they
are responsible for the accuracy and adequacy of the disclosures they have made.
In responding to our comments, please provide a written statement from the
company acknowledging that:
the company is responsible for the adequacy and accuracy of the disclosure in the
filing;
staff comments or changes to disclosure in response to staff comments do not
foreclose the Commission from taking any action with respect to the filing; and
the company may not assert staff comme nts as a defense in any proceeding
initiated by the Commission or any person under the federal secu rities laws of the
United States.
You may contact Amy Gedde s at (202) 551-3304 or Ma rgery Reich at (202) 551-
3347 if you have questions regarding comments on the financial statements and related
matters. Please contact John Dana Brown at (202) 551-3859 or the undersigned at (202)
551-3469 with any other questions.
S i n c e r e l y , / s / J u s t i n D o b b i e
Justin Dobbie Legal Branch Chief
Adam S. Grossman
ADMA Biologics, Inc. March 9, 2012 Page 7
cc: Roland S. Chase
SNR Denton US LLP