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ADMA BIOLOGICS, INC.
Awaiting Response
0 company response(s)
High
ADMA BIOLOGICS, INC.
Response Received
3 company response(s)
High - file number match
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Company responded
2025-07-23
ADMA BIOLOGICS, INC.
References: July 16, 2025
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2025-08-13
ADMA BIOLOGICS, INC.
References: July 16, 2025 | July 23, 2025 | July 30, 2025
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Company responded
2025-09-26
ADMA BIOLOGICS, INC.
References: August 13, 2025 | July 16, 2025 | July 23, 2025 | July 30, 2025 | September 16, 2025
ADMA BIOLOGICS, INC.
Awaiting Response
0 company response(s)
High
ADMA BIOLOGICS, INC.
Awaiting Response
0 company response(s)
High
ADMA BIOLOGICS, INC.
Response Received
1 company response(s)
Medium - date proximity
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ADMA BIOLOGICS, INC.
Response Received
1 company response(s)
High - file number match
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ADMA BIOLOGICS, INC.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
ADMA BIOLOGICS, INC.
Response Received
3 company response(s)
High - file number match
↓
Company responded
2017-10-23
ADMA BIOLOGICS, INC.
References: October 18, 2017
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Company responded
2017-11-06
ADMA BIOLOGICS, INC.
Summary
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2017-11-06
ADMA BIOLOGICS, INC.
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ADMA BIOLOGICS, INC.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2017-06-22
ADMA BIOLOGICS, INC.
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2017-06-26
ADMA BIOLOGICS, INC.
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ADMA BIOLOGICS, INC.
Response Received
8 company response(s)
High - file number match
SEC wrote to company
2013-02-12
ADMA BIOLOGICS, INC.
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2013-04-23
ADMA BIOLOGICS, INC.
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2013-04-23
ADMA BIOLOGICS, INC.
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2013-04-25
ADMA BIOLOGICS, INC.
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2013-04-30
ADMA BIOLOGICS, INC.
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2013-04-30
ADMA BIOLOGICS, INC.
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2013-05-01
ADMA BIOLOGICS, INC.
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2013-10-16
ADMA BIOLOGICS, INC.
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2013-10-16
ADMA BIOLOGICS, INC.
Summary
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ADMA BIOLOGICS, INC.
Response Received
4 company response(s)
High - file number match
SEC wrote to company
2012-04-25
ADMA BIOLOGICS, INC.
References: March 9, 2012
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Company responded
2012-05-08
ADMA BIOLOGICS, INC.
References: April 24, 2012 | March 9, 2012
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Company responded
2012-06-05
ADMA BIOLOGICS, INC.
References: May 22, 2012
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2012-07-03
ADMA BIOLOGICS, INC.
References: June 19, 2012
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2012-08-09
ADMA BIOLOGICS, INC.
Summary
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ADMA BIOLOGICS, INC.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2012-07-09
ADMA BIOLOGICS, INC.
Summary
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ADMA BIOLOGICS, INC.
Response Received
7 company response(s)
High - file number match
SEC wrote to company
2012-03-09
ADMA BIOLOGICS, INC.
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Company responded
2012-03-23
ADMA BIOLOGICS, INC.
References: March 9, 2012
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2012-03-29
ADMA BIOLOGICS, INC.
References: March 9, 2012
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2012-04-24
ADMA BIOLOGICS, INC.
References: April 12, 2012
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2012-05-23
ADMA BIOLOGICS, INC.
References: May 9, 2012
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2012-06-04
ADMA BIOLOGICS, INC.
References: May 9, 2012
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2012-06-15
ADMA BIOLOGICS, INC.
References: May 9, 2012
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2012-06-22
ADMA BIOLOGICS, INC.
References: May 9, 2012
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ADMA BIOLOGICS, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-06-19
ADMA BIOLOGICS, INC.
Summary
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ADMA BIOLOGICS, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-05-23
ADMA BIOLOGICS, INC.
References: April 24,
2012
Summary
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ADMA BIOLOGICS, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-05-09
ADMA BIOLOGICS, INC.
Summary
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ADMA BIOLOGICS, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-04-13
ADMA BIOLOGICS, INC.
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-29 | SEC Comment Letter | ADMA BIOLOGICS, INC. | DE | 001-36728 | Read Filing View |
| 2025-09-26 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2025-09-16 | SEC Comment Letter | ADMA BIOLOGICS, INC. | DE | 001-36728 | Read Filing View |
| 2025-08-13 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2025-07-30 | SEC Comment Letter | ADMA BIOLOGICS, INC. | DE | 001-36728 | Read Filing View |
| 2025-07-23 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2025-07-16 | SEC Comment Letter | ADMA BIOLOGICS, INC. | DE | 001-36728 | Read Filing View |
| 2021-07-30 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2021-06-03 | SEC Comment Letter | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2019-10-10 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2019-10-09 | SEC Comment Letter | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2018-05-29 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2017-11-06 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2017-11-06 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2017-10-23 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2017-10-19 | SEC Comment Letter | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2017-06-26 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2017-06-22 | SEC Comment Letter | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2013-10-16 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2013-10-16 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2013-05-01 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2013-04-30 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2013-04-30 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2013-04-25 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2013-04-23 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2013-04-23 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2013-02-12 | SEC Comment Letter | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-08-09 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-07-09 | SEC Comment Letter | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-07-03 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-06-22 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-06-19 | SEC Comment Letter | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-06-15 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-06-05 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-06-04 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-05-23 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-05-23 | SEC Comment Letter | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-05-09 | SEC Comment Letter | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-05-08 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-04-25 | SEC Comment Letter | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-04-24 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-04-13 | SEC Comment Letter | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-03-29 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-03-23 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-03-09 | SEC Comment Letter | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-29 | SEC Comment Letter | ADMA BIOLOGICS, INC. | DE | 001-36728 | Read Filing View |
| 2025-09-16 | SEC Comment Letter | ADMA BIOLOGICS, INC. | DE | 001-36728 | Read Filing View |
| 2025-07-30 | SEC Comment Letter | ADMA BIOLOGICS, INC. | DE | 001-36728 | Read Filing View |
| 2025-07-16 | SEC Comment Letter | ADMA BIOLOGICS, INC. | DE | 001-36728 | Read Filing View |
| 2021-06-03 | SEC Comment Letter | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2019-10-09 | SEC Comment Letter | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2017-10-19 | SEC Comment Letter | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2017-06-22 | SEC Comment Letter | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2013-02-12 | SEC Comment Letter | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-07-09 | SEC Comment Letter | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-06-19 | SEC Comment Letter | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-05-23 | SEC Comment Letter | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-05-09 | SEC Comment Letter | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-04-25 | SEC Comment Letter | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-04-13 | SEC Comment Letter | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-03-09 | SEC Comment Letter | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-26 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2025-08-13 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2025-07-23 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2021-07-30 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2019-10-10 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2018-05-29 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2017-11-06 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2017-11-06 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2017-10-23 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2017-06-26 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2013-10-16 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2013-10-16 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2013-05-01 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2013-04-30 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2013-04-30 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2013-04-25 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2013-04-23 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2013-04-23 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-08-09 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-07-03 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-06-22 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-06-15 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-06-05 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-06-04 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-05-23 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-05-08 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-04-24 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-03-29 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
| 2012-03-23 | Company Response | ADMA BIOLOGICS, INC. | DE | N/A | Read Filing View |
2025-09-29 - UPLOAD - ADMA BIOLOGICS, INC. File: 001-36728
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> September 29, 2025 Brad Tade Chief Financial Officer & Treasurer ADMA Biologics, Inc. 465 State Route 17 Ramsey, New Jersey 07446 Re: ADMA Biologics, Inc. Form 10-K for the fiscal year ended December 31, 2024 Filed March 18, 2025 File No. 001-36728 Dear Brad Tade: We have completed our review of your filing. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Sincerely, Division of Corporation Finance Office of Life Sciences </TEXT> </DOCUMENT>
2025-09-26 - CORRESP - ADMA BIOLOGICS, INC.
CORRESP 1 filename1.htm Brad Tade Chief Financial Officer & Treasurer ADMA Biologics, Inc. 465 State Route 17 Ramsey, New Jersey 07446 September 26, 2025 U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, D.C. 20549 Attention: Ms. Jenn Do and Mr. Kevin Vaughn Re: ADMA Biologics, Inc. Form 10-K for the fiscal year ended December 31, 2024 Filed March 18, 2025 File No. 001-36728 Dear Ms. Do and Mr. Vaughn: On behalf of ADMA Biologics, Inc. (the “ Company ”), we submit this supplemental letter in response to the comments received from the staff (the “ Staff ”) of the United States Securities and Exchange Commission (the “ Commission ”) in its letter dated September 16, 2025, with respect to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in connection with the Staff’s initial letter to the Company dated July 16, 2025, the Company’s response letter to the Staff dated July 23, 2025, the Staff’s letter to the Company dated July 30, 2025, and the Company’s response letter to the Staff dated August 13, 2025 (the “ August 13, 2025 Response Letter ”). For the Staff’s convenience, the Staff’s comment has been stated below in its entirety in bold, followed by the corresponding response from the Company. Form 10-K for the fiscal year ended December 31, 2024 Management's Discussion and Analysis of Financial Condition and Results of Operations, page 68 Results of Operations, page 70 1. We appreciate your response to prior comment one, including your concerns about the possibility that the proposed disclosure could be competitively harmful. However, we continue to believe such disclosure is required and would be useful to investors. Please revise your future filings accordingly. Response : The Company respectfully acknowledges the Staff’s comment and will revise future filings accordingly. Commencing with the Company’s Annual Report on Form 10-K for the fiscal year ending December 31, 2025, and continuing in Quarterly Reports on Form 10-Q beginning thereafter, the Company will expand its discussion of revenue performance by respective Immune Globulin products in the notes to the financial statements and in the Management’s Discussion and Analysis of Financial Condition and Results of Operations section of its Annual Reports on Form 10-K or Quarterly Reports on Form 10-Q, as applicable, to include a tabular breakdown of revenue, and the Company will also disclose product revenue on a blended basis, substantially in the respective example forms presented in the Company’s August 13, 2025 Response Letter. Securities and Exchange Commission September 22, 2025 Page 2 The Company thanks the Staff for its review of the foregoing. If you have any questions or comments, please feel free to contact our counsel, David C. Schwartz, Esq. at david.schwartz@morganlewis.com or by telephone at (609) 919-6680. Sincerely, ADMA Biologics, Inc. By: /s/ Brad Tade Name: Brad Tade Title: Chief Financial Officer and Treasurer cc: David C. Schwartz, Esq., Morgan, Lewis & Bockius LLP
2025-09-16 - UPLOAD - ADMA BIOLOGICS, INC. File: 001-36728
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> September 16, 2025 Brad Tade Chief Financial Officer & Treasurer ADMA Biologics, Inc. 465 State Route 17 Ramsey, New Jersey 07446 Re: ADMA Biologics, Inc. Form 10-K for the fiscal year ended December 31, 2024 Filed March 18, 2025 File No. 001-36728 Dear Brad Tade: We have reviewed your August 13, 2025 response to our comment letter and have the following comment. Please respond to this letter within ten business days by providing the requested information or advise us as soon as possible when you will respond. If you do not believe a comment applies to your facts and circumstances, please tell us why in your response. After reviewing your response to this letter, we may have additional comments. Unless we note otherwise, any references to prior comments are to comments in our July 30, 2025 letter. Form 10-K for the fiscal year ended December 31, 2024 Management's Discussion and Analysis of Financial Condition and Results of Operations, page 68 Results of Operations, page 70 1. We appreciate your response to prior comment one, including your concerns about the possibility that the proposed disclosure could be competitively harmful. However, we continue to believe such disclosure is required and would be useful to investors. Please revise your future filings accordingly. Please contact Jenn Do at 202-551-3743 or Kevin Vaughn at 202-551-3494 if you have questions regarding comments on the financial statements and related matters. September 16, 2025 Page 2 Sincerely, Division of Corporation Finance Office of Life Sciences </TEXT> </DOCUMENT>
2025-08-13 - CORRESP - ADMA BIOLOGICS, INC.
CORRESP 1 filename1.htm FOIA CONFIDENTIAL TREATMENT REQUESTED PURSUANT TO 17 C.F.R. § 200.83 The entity requesting confidential treatment is: ADMA Biologics, Inc. 465 State Route 17 Ramsey, New Jersey 07446 Telephone: 561-989-5800 CERTAIN PORTIONS OF THIS LETTER HAVE BEEN OMITTED FROM THE VERSION FILED VIA EDGAR. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. INFORMATION THAT WAS OMITTED IN THE EDGAR VERSION HAS BEEN NOTED IN THIS LETTER WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[***].” Brad Tade Chief Financial Officer & Treasurer ADMA Biologics, Inc. 465 State Route 17 Ramsey, New Jersey 07446 August 13, 2025 U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, D.C. 20549 Attention: Ms. Jenn Do and Mr. Kevin Vaughn Re: ADMA Biologics, Inc. Form 10-K for the fiscal year ended December 31, 2024 Filed March 18, 2025 File No. 001-36728 Dear Ms. Do and Mr. Vaughn: On behalf of ADMA Biologics, Inc. (the “ Company ”), we submit this supplemental letter in response to the comments received from the staff (the “ Staff ”) of the United States Securities and Exchange Commission (the “ Commission ”) in its letter dated July 30, 2025, with respect to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in connection with the Staff’s initial letter to the Company dated July 16, 2025, and the Company’s response letter to the Staff dated July 23, 2025. Because of the commercially sensitive nature of the information contained herein, this submission is accompanied by the Company’s request for confidential treatment for selected portions of this letter. The Company has filed a separate letter with the Office of Freedom of Information and Privacy Act Operations in connection with the confidential treatment request, pursuant to Rule 83 of the Commission’s Rules on Information and Requests, 17 C.F.R. § 200.83. We have enclosed for the Staff’s reference a copy of the Company’s letter to the Office of Freedom of Information and Privacy Act Operations, as well as a copy of this correspondence, marked to show the portions redacted from the version filed via EDGAR and for which the Company is requesting confidential treatment. For the Staff’s convenience, the Staff’s comment has been stated below in its entirety in bold, followed by the corresponding responses from the Company. CONFIDENTIAL TREATMENT REQUESTED BY ADMA BIOLOGICS, INC. Form 10-K for the fiscal year ended December 31, 2024 Management's Discussion and Analysis of Financial Condition and Results of Operations, page 68 Results of Operations, page 70 1. Please address the following regarding your response to comment one. From your recent earnings calls, it appears there has been a shift in the mix of your three Immune Globulin (IG) products over the last eight quarters. During these investor calls, you have been able to provide quantification of the shift between these respective IG products, the shift of which appears to be of significant interest to the investing community, especially leading up to and since the yield enhancement. As you noted in your response, for the years ended December 31, 2024, 2023 and 2022, the three IG Products represented 94%, 92% and 89%, respectively, of your total revenue. Accordingly, a breakout that presents all three IG products as a single unit, may not be as informative as one that separately quantifies each of them. • Tell us how you specifically considered the guidance in Item 303(b)(2)(i) and (ii) of Regulation S-K in your analysis, since your IG products as a whole constitute substantially all of your revenue and there may be sales trends for each IG product within that group that warrant disclosure as seem to be referenced in your earnings calls. Response: The Company respectfully acknowledges the Staff’s comment. The Company has reviewed Item 303(b)(2)(i) and (ii) of Regulation S-K and ASC 280-10-50-40. The Company advises the Staff that it considers and follows the provisions of ASC 280-10-50-40, “Information about Products and Services” (“ ASC 280-10-50-40 ”), when preparing its financial statements. ASC 280-10-50-40 states that a public entity shall report the revenues from external customers for each product and service or each group of similar products and services unless it is impracticable to do so. The Company discloses revenues from its ADMA BioManufacturing operating segment, whose business activities consist of the manufacturing and sales of the Company’s Immune Globulin (IG) products. The Company respectfully submits that the products and services produced and sold by this operating segment, including the products noted in the Staff’s comment, in all material respects constitute groups of similar products, and that further disaggregation of revenues within these groups is therefore not required by ASC 280-10-50-40. The Company appreciates the Staff’s noting recent discussion among investors on the Company’s earnings calls, including investment community interest in various trends in our product revenues. In considering the Staff’s comments, the Company has determined that providing further dissection of our revenues amongst the similar IG products within the BioManufacturing operating segment would be competitively harmful to the Company. The Company believes that disclosing a detailed breakdown of revenue by product would be competitively harmful for several reasons. The Company anticipates that its competitors would use this information to strategically and actively target the relatively small pool of patients who benefit from particular IG products in the Company’s portfolio and seek to usurp market share of those products. In addition, the Company’s competitors or those seeking to research and develop new or competing products may use such disaggregated revenue details to develop their own product pipelines, based on perceived demand or supply for such particular products. Additionally, disclosing such information could potentially weaken our ability to negotiate commercial arrangements with external third parties, such as suppliers or vendors, as such third parties could leverage this sensitive information to our disadvantage, which could impact our ability to secure agreements on optimal terms and even make certain proposed arrangements commercially prohibitive to the Company. Any of the foregoing scenarios could adversely affect the Company’s market share, which in turn, would negatively harm the Company’s stockholders. Furthermore, the Company has reviewed SEC filings by certain of the Company’s competitors, including certain of the listed foreign competitors as discussed within our Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on March 18, 2025, under “Item 1. Business—Competition”, and has noted that these competitors do not appear to be disclosing disaggregated revenue of their respective immune globulin products in their public filings. As a result, if the Company were required to disclose such detailed, disaggregated revenue of each of its IG products within a single operating segment, such disclosure would put the Company at a significant competitive disadvantage given the imbalance of information among competitors. CONFIDENTIAL TREATMENT REQUESTED BY ADMA BIOLOGICS, INC. The Company believes that it must remain mindful that the requested disclosure could potentially affect its competitive position. Accordingly, the Company respectfully prefers to continue reporting its financials in the manner it has historically, which the Company believes provides transparency while preserving important competitive considerations. Notwithstanding the foregoing, the Company remains committed to working collaboratively with the Staff and would welcome the opportunity to further discuss these considerations. Should the Staff ultimately take a different view, the Company proposes the following approach to address the Staff’s comments constructively. Albeit competitively harmful, if the Staff determines such an approach is necessary, then beginning with the Company’s Annual Report on Form 10-K for the year ending December 31, 2025 (the “ 2025 Form 10-K ”), and continuing in Quarterly Reports on Form 10-Q beginning thereafter, the Company will expand its discussion of revenue performance by respective products in the notes to the financial statements and in the Management’s Discussion and Analysis of Financial Condition and Results of Operations (“ MD&A ”) section of the Annual Report on Form 10-K or Quarterly Report on Form 10-Q, as applicable, to include a tabular breakdown of revenue, and the Company will also disclose product margins on a blended basis, as shown below. Solely as an example, the Company presents on Exhibit A attached hereto a sample of how such disclosure would appear for the years ended December 31, 2025 and 2024, respectively. Please note the Company’s proposed discussion of revenue performance by its respective products in MD&A of its 2025 Form 10-K: Revenues We recorded total revenues of $XXX million for the year ended December 31, 2025, as compared to $426.5 million for the year ended December 31, 2024, an [increase/decrease] of $XXX million, or XX%. This [increase/decrease] is primarily related to [increased/decreased] sales of ASCENIV and BIVIGAM, which collectively represented XX% of our total IG product portfolio sales in the current period, as we continue to experience [increased/decreased] physician, payer and patient acceptance and utilization and [increased/decreased] volume of sales of these products. In addition, we experienced [higher/lower] sales of our other IG products and [an increase / a decrease] in sales of normal source plasma (“NSP”) and hyperimmune Hepatitis B plasma by our Plasma Collection Centers business segment in the amount of $XX million. • Further, in applying the guidance of ASC 280-10-50-40, an enterprise with a relatively narrow product line may not consider two products to be similar, while an enterprise with a broad product line may consider those same two products to be similar. Please amplify your discussion of your application of ASC ###-##-#### to explain how you considered whether the concentration of substantially all your revenues being from only three IG products would warrant further disaggregation. CONFIDENTIAL TREATMENT REQUESTED BY ADMA BIOLOGICS, INC. Response: The Company respectfully acknowledges the Staff’s comment. The Company has reviewed ASC 280-10-50-40 and, as noted above, if the Staff so requires, would plan to revise and update its discussion of revenue performance by its respective products in the notes to the financial statements and in the MD&A section of the 2025 Form 10-K. • As part of your response, please provide us with a sample breakdown of revenue from the three IG products for recent periods. Response : The Company respectfully acknowledges the Staff’s comment and, as described above, if the Staff so requires, proposes to present a breakdown of revenue from its IG products as illustrated on Exhibit A attached hereto. In response to the Staff’s verbal comment regarding the Company’s voluntary withdrawal during the three months ended March 31, 2025, the Company provided additional disclosure and information in the MD&A section in its Form 10-Q for the three months ended June 30, 2025 filed with the Commission on August 6, 2025 (“ Q2 2025 Form 10-Q ”). The Company also updated disclosure in a related risk factor to address this matter in the Q2 2025 Form 10-Q. The additional disclosure in the MD&A is referenced below, for the Staff’s convenience: Q2 2025 Form 10-Q, page 26 “During the three months ended June 30, 2025, and as previously disclosed in our Form 10-Q for the three months ended March 31, 2025, that was filed with the Securities and Exchange Commission (the “SEC”) on May 7, 2025 (the "2025 1Q 10-Q"), we voluntarily withdrew three lots of BIVIGAM (such a withdrawal, hereinafter referred to as the “Voluntary Withdrawal”) as a precautionary measure. This resulted in a reduction in revenue of $0.2 million for credits issued to customers that were impacted by this Voluntary Withdrawal during the current period. This action was proactively initiated, and we believe this matter to be resolved.” Q2 2025 Form 10-Q, page 28 “During the six months ended June 30, 2025, and as previously disclosed in the 2025 1Q 10-Q, we effected the Voluntary Withdrawal as a precautionary measure. This resulted in a reduction in revenue of $4.0 million for credits issued to customers that were impacted by this Voluntary Withdrawal during the current period. This action was proactively initiated, and we believe this matter to be resolved.” The Company thanks the Staff for its review of the foregoing. If you have any questions or comments, please feel free to contact our counsel, David C. Schwartz, Esq. at david.schwartz@morganlewis.com or by telephone at (609) 919-6680. Sincerely, ADMA Biologics, Inc. By: /s/ Brad Tade Name: Brad Tade Title: Chief Financial Officer and Treasurer cc: David C. Schwartz, Esq., Morgan, Lewis & Bockius LLP CONFIDENTIAL TREATMENT REQUESTED BY ADMA BIOLOGICS, INC. EXHIBIT A Proposed Sample Disclosure For purposes of the table set forth below, information that is not yet available as of the date of this Response Letter is denoted by “XXX”, and information that is Confidential Material is denoted in brackets, with bold, underlined font in the example format shown here: [sample text] . Rule 83 Confidential Treatment Request by ADMA Biologics, Inc. Request #1 Year Ended December 31, (in thousands) 2025 2024 Increase/ (Decrease) Increase/ (Decrease) % [***] $ XXX $ [*** ] $ XXX XXX % [***] XXX [ *** ] $ XXX XXX % [***] XXX [*** ] $ XXX XXX % ADMA BioManufacturing XXX 415,806 $ XXX XXX % Plasma Collection Centers XXX 10,505 $ XXX XXX % Total Revenues $ XXX $ 426,311 $ XXX XXX % [***] The Company respectfully requests that the information contained in Request #1 be treated as confidential information and that the Commission provide timely notice to Brad Tade, Chief Financial Officer & Treasurer, ADMA Biologics, Inc., 465 State Route 17, Ramsey, New Jersey 07446, telephone 561-989-5800, before it permits any disclosure of the bracketed information contained in this Request #1. CONFIDENTIAL TREATMENT REQUESTED BY ADMA BIOLOGICS, INC. (ADMA-2025-1)
2025-07-30 - UPLOAD - ADMA BIOLOGICS, INC. File: 001-36728
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> July 30, 2025 Brad Tade Chief Financial Officer & Treasurer ADMA Biologics, Inc. 465 State Route 17 Ramsey, New Jersey 07446 Re: ADMA Biologics, Inc. Form 10-K for the fiscal year ended December 31, 2024 Filed March 18, 2025 File No. 001-36728 Dear Brad Tade: We have reviewed your July 23, 2025 response to our comment letter and have the following comment. Please respond to this letter within ten business days by providing the requested information or advise us as soon as possible when you will respond. If you do not believe our comment applies to your facts and circumstances, please tell us why in your response. After reviewing your response to this letter, we may have additional comments. Unless we note otherwise, any references to prior comments are to comments in our July 23, 2025 letter. Form 10-K for the fiscal year ended December 31, 2024 Management's Discussion and Analysis of Financial Condition and Results of Operations, page 68 Results of Operations, page 70 1. Please address the following regarding your response to comment one. From your recent earnings calls, it appears there has been a shift in the mix of your three Immune Globulin (IG) products over the last eight quarters. During these investor calls, you have been able to provide quantification of the shift between these respective IG products, the shift of which appears to be of significant interest to the investing community, especially leading up to and since the yield enhancement. As you noted in your response, for the years ended December 31, 2024, 2023 and 2022, the three IG Products represented 94%, 92% and 89%, respectively, of your total revenue. Accordingly, a breakout that presents all three IG products as a single unit, may not be July 30, 2025 Page 2 as informative as one that separately quantifies each of them. Tell us how you specifically considered the guidance in Item 303(b)(2)(i) and (ii) of Regulation S-K in your analysis, since your IG products as a whole constitute substantially all of your revenue and there may be sales trends for each IG product within that group that warrant disclosure as seem to be referenced in your earnings calls. Further, in applying the guidance of ASC 280-10-50-40, an enterprise with a relatively narrow product line may not consider two products to be similar, while an enterprise with a broad product line may consider those same two products to be similar. Please amplify your discussion of your application of ASC 280-10-50- 40 to explain how you considered whether the concentration of substantially all your revenues being from only three IG products would warrant further disaggregation. As part of your response, please provide us with a sample breakdown of revenue from the three IG products for recent periods. Please contact Jenn Do at 202-551-3743 or Kevin Vaughn at 202-551-3494 if you have questions regarding comments on the financial statements and related matters. Sincerely, Division of Corporation Finance Office of Life Sciences </TEXT> </DOCUMENT>
2025-07-23 - CORRESP - ADMA BIOLOGICS, INC.
CORRESP 1 filename1.htm Brad Tade Chief Financial Officer & Treasurer ADMA Biologics, Inc. 465 State Route 17 Ramsey, New Jersey 07446 July 23, 2025 U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, D.C. 20549 Attention: Ms. Jenn Do and Mr. Kevin Vaughn Re: ADMA Biologics, Inc. Form 10-K for the fiscal year ended December 31, 2024 Filed March 18, 2025 File No. 001-36728 Dear Ms. Do and Mr. Vaughn: On behalf of ADMA Biologics, Inc. (the “ Company ”), we submit this letter in response to the comment letter received from the staff (the “ Staff ”) of the United States Securities and Exchange Commission contained in its letter dated July 16, 2025, with respect to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (the “ Form 10-K ”). For the Staff’s convenience, the Staff’s comment has been stated below in its entirety in bold, followed by the corresponding responses from the Company. Form 10-K for the fiscal year ended December 31, 2024 Management’s Discussion and Analysis of Financial Condition and Results of Operations, page 68 Results of Operations, page 70 1. We note your analysis of revenues for the periods presented on pages 73 and 75, including the 65% increase in revenue in 2024 and improved operating results which contributed to net income on a GAAP basis for the first time, and your expectation of increased physician, payer and patient acceptance and utilization of ASCENIV, as well as sales increases for some of your other IG products. Please address the following: ● Please revise your future filings to provide a breakout of revenue by product. Refer to Item 303(b)(2)(ii) of Regulation S-K and ASC 280-10-50-40. Response: The Company acknowledges the Staff’s comment. ASC 280-10-50-40 requires a public entity to “report the revenues from external customers for each product and service or each group of similar products and services unless it is impracticable to do so.” The Company has analyzed its products and services under both Item 303(b)(2)(ii) of Regulation S-K and ASC 280-10-50-40, and determined that its products should be grouped as follows: ◾ Immune Globulin (IG) Products: Consists of revenue from sales of ASCENIV, BIVIGAM and Nabi-HB, all FDA-approved for treatment of Primary Immunodeficiency, manufactured in the same manner, all utilizing human source plasma as the starting raw material and distributed to similar customers through a shared sales infrastructure. U.S. Securities and Exchange Commission July 23, 2025 Page 2 ◾ Plasma, Intermediates and Other: Consists of the following: (i) sales of human source plasma to third parties, (ii) sales of intermediates, which consist of sales of partially processed biologics, not intended for final therapeutic use and sold to third-party manufacturers or testing organizations, rather than to end users as a therapeutic, and (iii) other miscellaneous revenue. For the years ended December 31, 2024, 2023 and 2022, IG Products represented 94%, 92% and 89%, respectively, of our total revenue. Accordingly, in future filings, the Company will provide a narrative breakout of revenue, per the above proposed product groups, within the Management’s Discussion and Analysis of Financial Condition and Results of Operations to address the requirements of Item 303(b)(2)(ii) of Regulation S-K. ● In light of the Voluntary Withdrawal in the first quarter of 2025, please revise your future filings to disclose your methodology for how you account for product returns and how the Voluntary Withdrawal had an impact on your ability to make estimates of variable consideration vis a vis the gradual increase in charges to the inventory valuation allowance over the last three years as shown in your Schedule II. Response: The Company acknowledges the Staff’s comment and respectfully advises the Staff that the change to the Company’s inventory valuation allowance over the last three years as shown in Schedule II is attributed to normal manufacturing activities, mainly related to the Company’s expiring materials. The Company’s recorded inventory return charges over the last three years were less than $0.5 million in the aggregate. Therefore, the charges to the inventory valuation allowance over the last three years were not related to product returns. Accordingly, the Company evaluates the need for inventory valuation allowance with consideration of its experience with product returns, and believes its disclosures are appropriate based on the historically infrequent and immaterial nature of the same. During the first quarter of 2025, we voluntarily withdrew certain products. We have not had instances of any withdrawals, voluntary or otherwise, prior to 2025. While it is possible we may have a product withdrawal in the future, any such withdrawal is unlikely and not expected to be common or recurring in nature. Therefore, based on our historical experience as well as our expectation, no material reserves for product withdrawals (whether voluntary or involuntary) are necessary. We will continue monitoring and consider establishing an allowance for product withdrawals, should we experience any withdrawals in the future. U.S. Securities and Exchange Commission July 23, 2025 Page 3 ● Consider providing a tabular rollforward of significant adjustments to revenue such as product returns for the periods presented. Response: The Company acknowledges the Staff’s comment and respectfully advises that Staff that significant adjustments to revenue are infrequent, and historically, the Company provided detailed narrative disclosures in its Management’s Discussion and Analysis of Financial Condition and Results of Operations regarding nature, timing and impact with respect to such adjustments, if deemed material. The Company will continue to monitor the frequency, materiality and nature of such adjustments going forward and will consider providing a tabular roll forward to the extent such a presentation would provide additional clarity and insight. The Company thanks the Staff for its review of the foregoing. If you have any questions or comments, please feel free to contact our counsel, David C. Schwartz, Esq. at david.schwartz@morganlewis.com or by telephone at (609) 919-6680. Sincerely, ADMA Biologics, Inc. By: /s/ Brad Tade Name: Brad Tade Title: Chief Financial Officer and Treasurer cc: David C. Schwartz, Esq., Morgan, Lewis & Bockius LLP
2025-07-16 - UPLOAD - ADMA BIOLOGICS, INC. File: 001-36728
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> July 16, 2025 Brad Tade Chief Financial Officer & Treasurer ADMA Biologics, Inc. 465 State Route 17 Ramsey, New Jersey 07446 Re: ADMA Biologics, Inc. Form 10-K for the fiscal year ended December 31, 2024 Filed March 18, 2025 File No. 001-36728 Dear Brad Tade: We have limited our review of your filing to the financial statements and related disclosures and have the following comment. Please respond to this letter within ten business days by providing the requested information or advise us as soon as possible when you will respond. If you do not believe the comment applies to your facts and circumstances, please tell us why in your response. After reviewing your response to this letter, we may have additional comments. Form 10-K for the fiscal year ended December 31, 2024 Management's Discussion and Analysis of Financial Condition and Results of Operations, page 68 Results of Operations, page 70 1. We note your analysis of revenues for the periods presented on pages 73 and 75, including the 65% increase in revenue in 2024 and improved operating results which contributed to net income on a GAAP basis for the first time, and your expectation of increased physician, payer and patient acceptance and utilization of ASCENIV, as well as sales increases for some of your other IG products. Please address the following: Please revise your future filings to provide a breakout of revenue by product. Refer to Item 303(b)(2)(ii) of Regulation S-K and ASC 280-10-50-40. In light of the Voluntary Withdrawal in the first quarter of 2025, please revise your future filings to disclose your methodology for how you account for product returns and how the Voluntary Withdrawal had an impact on your ability to make July 16, 2025 Page 2 estimates of variable consideration vis a vis the gradual increase in charges to the inventory valuation allowance over the last three years as shown in your Schedule II. Consider providing a tabular rollforward of significant adjustments to revenue such as product returns for the periods presented. In closing, we remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Jenn Do at 202-551-3743 or Kevin Vaughn at 202-551-3494 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences </TEXT> </DOCUMENT>
2021-07-30 - CORRESP - ADMA BIOLOGICS, INC.
CORRESP
1
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ADMA Biologics, Inc.
465 State Route 17 South
Ramsey, New Jersey 07446
(201) 478-5552
July 30, 2021
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Deanna Virginio
Re:
ADMA Biologics, Inc.
Registration Statement on Form S-3
Filed May 28, 2021
File No. 333-256643
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act of 1933, as amended, ADMA Biologics, Inc. hereby requests acceleration of the effective date of the
above referenced registration statement so that such registration statement may become effective at 4:00 P.M. (Washington, D.C. time) on August 2, 2021, or as soon as practicable thereafter.
ADMA Biologics, Inc.
By:
/s/ ADAM S. GROSSMAN
Name:
Adam S. Grossman
Title:
President and Chief Executive Officer
2021-06-03 - UPLOAD - ADMA BIOLOGICS, INC.
United States securities and exchange commission logo
June 3, 2021
Adam S. Grossman
President and Chief Executive Officer
ADMA Biologics, Inc.
465 State Route 17 South
Ramsey, NJ 07446
Re:ADMA Biologics, Inc.
Registration Statement on Form S-3
Filed May 28, 2021
File No. 333-25664
Dear Mr. Grossman:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Deanna Virginio at 202-551-4530 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David C. Schwartz, Esq.
2019-10-10 - CORRESP - ADMA BIOLOGICS, INC.
CORRESP
1
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Brian Lenz
Executive Vice President and Chief Financial Officer
ADMA Biologics, Inc.
465 State Route 17
Ramsey, NJ 07446
October 10, 2019
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attention: Ada D. Sarmento
Re: ADMA Biologics, Inc.
Registration Statement on Form S-3
File No. 333-234107
Dear Ms. Sarmento:
In accordance with Rule 461 under the Securities
Act of 1933, as amended, we hereby request acceleration of the effective date of the above-referenced registration statement on
Form S-3 (the “Registration Statement”) of ADMA Biologics, Inc. (the “Company”). We respectfully request
that the Registration Statement become effective as of 4:00 p.m., Eastern Time, on October 15, 2019, or as soon as practicable
thereafter. Once the Registration Statement has been declared effective, please confirm that event with our counsel, Morgan, Lewis
& Bockius LLP, by calling David C. Schwartz, Esq. at 609.919.6680.
Very truly yours,
ADMA Biologics,
Inc.
By:
/s/ Brian Lenz
Brian Lenz
Executive Vice President and Chief Financial Officer
CC: David C. Schwartz, Esq., Morgan, Lewis & Bockius LLP
2019-10-09 - UPLOAD - ADMA BIOLOGICS, INC.
October 9, 2019
Adam S. Grossman
Chief Executive Officer
ADMA Biologics, Inc.
465 State Route 17
Ramsey, NJ 07446
Re:ADMA Biologics, Inc.
Registration Statement on Form S-3
Filed October 4, 2019
File No. 333-234107
Dear Mr. Grossman:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Ada D. Sarmento at 202-551-3798 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David C. Schwartz, Esq.
2018-05-29 - CORRESP - ADMA BIOLOGICS, INC.
CORRESP
1
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ADMA Biologics, Inc.
465 State Route 17
Ramsey, New Jersey 07446
May 29, 2018
Via EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549-4561
Attn: Mary Beth Breslin
Re: ADMA Biologics, Inc. (the “Company”)Registration
Statement on Form S-3
Filed May 18,
2018, as amended
File No. 333-225048
Dear Ms. Breslin:
The Company hereby
requests that the effective date for the Registration Statement referred to above be accelerated so that it will be declared effective
at 4:00 p.m. (EST) on May 31, 2018, or as soon as practicable thereafter, pursuant to Rule 461 of the Securities Act of 1933, as
amended.
The Company acknowledges
that (i) should the Securities and Exchange Commission (the “Commission”) or the staff of the Commission, acting pursuant
to delegated authority, declare the filing effective, such declaration does not foreclose the Commission from taking any action
with respect to the filing; (ii) the action of the Commission or the staff of the Commission, acting pursuant to delegated authority,
in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the
disclosure in the filing; and (iii) the Company may not assert staff comments and the declaration of effectiveness as a defense
in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
Please contact David
C. Schwartz, Esq. of DLA Piper LLP (US) with any questions or comments at (973) 520-2555. Thank you for your assistance with this
filing.
ADMA BIOLOGICS, INC.
By:
/s/ Adam S. Grossman
Name:
Adam S. Grossman
Title:
President and Chief Executive Officer
2017-11-06 - CORRESP - ADMA BIOLOGICS, INC.
CORRESP
1
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RAYMOND JAMES & ASSOCIATES, INC.
880 Carillon Parkway
St. Petersburg, Florida 33716
November 6, 2017
VIA EDGAR
U.S. Securities and Exchange Commission
100 F St., NE
Washington D.C. 20549
Attention:
Irene J. Paik, Attorney Adviser
Re:
ADMA Biologics, Inc.
Registration Statement on Form S-1 (File No. 333-220910)
Ladies and Gentlemen:
Pursuant to Rule 461 of the General Rules
and Regulations of the U.S. Securities and Exchange Commission under the Securities Act of 1933, as amended, Raymond James &
Associates Inc., as representative of the underwriters, hereby requests acceleration of the effective date of the above-referenced
Registration Statement so that it will become effective at 4:30 p.m. Eastern Time on November 8, 2017, or as soon thereafter
as practicable.
Pursuant to Rule 460 under the Securities
Act, please be advised that there will be distributed to each underwriter, who is reasonably anticipated to be invited to participate
in the distribution of the security, as many copies of the proposed form of preliminary prospectus as appears to be reasonable
to secure adequate distribution of the preliminary prospectus.
The undersigned confirms that it has complied
with and will continue to comply with, and it has been informed or will be informed by participating dealers that they have complied
with, or will comply with, Rule 15c2-8 promulgated under the Securities Exchange Act of 1934, as amended, in connection with the
above-referenced issue.
Very truly yours,
RAYMOND JAMES & ASSOCIATES, INC.
By:
/s/ Ed Newman
2017-11-06 - CORRESP - ADMA BIOLOGICS, INC.
CORRESP
1
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ADMA Biologics, Inc.
465 State Route 17
Ramsey, New Jersey 07446
November 6, 2017
Via EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549-4561
Attn:
Irene J. Paik, Attorney Adviser
Re:
ADMA Biologics, Inc. (the
“Company”)
Registration
Statement on Form S-1
Filed October
11, 2017, as amended
File No. 333-220910
Dear Ms. Paik:
The Company hereby
requests that the effective date for the Registration Statement referred to above be accelerated so that it will be declared effective
at 4:30 p.m. (EST) on November 8, 2017, or as soon as practicable thereafter, pursuant to Rule 461 of the Securities Act of 1933,
as amended.
The Company acknowledges
that (i) should the Securities and Exchange Commission (the “Commission”) or the staff of the Commission, acting pursuant
to delegated authority, declare the filing effective, such declaration does not foreclose the Commission from taking any action
with respect to the filing; (ii) the action of the Commission or the staff of the Commission, acting pursuant to delegated authority,
in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the
disclosure in the filing; and (iii) the Company may not assert staff comments and the declaration of effectiveness as a defense
in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
Please contact David
C. Schwartz, Esq. of DLA Piper LLP (US) with any questions or comments at (973) 520-2555. Thank you for your assistance with this
filing.
ADMA BIOLOGICS, INC.
By:
/s/ Adam S. Grossman
Name:
Adam
S. Grossman
Title:
President
and Chief Executive Officer
2017-10-23 - CORRESP - ADMA BIOLOGICS, INC.
CORRESP
1
filename1.htm
DLA Piper LLP (US)
51 John F. Kennedy Parkway, Suite 120
Short Hills, New Jersey 07078-2704
www.dlapiper.com
David C. Schwartz
david.schwartz@dlapiper.com
T 973.520.2555
F 973.520.2575
Partners Responsible for Short Hills Office:
Andrew P. Gilbert
Michael E. Helmer
October 23, 2017
Via UPS Overnight
Office of the Secretary
Room 10915
Mail Stop 1090
Securities and Exchange Commission
100 F Street, NE
Washington, DC 20549-1090
Re:
ADMA Biologics, Inc.
Registration Statement on Form S-1
Filed October 11, 2017
File No. 333-220910
Dear Ms. Paik and Ms. Breslin:
On behalf of ADMA Biologics,
Inc., a Delaware corporation (the “Company”), we respectfully submit this letter in response to the comments
issued by the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”)
in a letter dated October 18, 2017 (the “Letter”) regarding the Company’s Registration Statement
on Form S-1 filed on October 11, 2017 (the “Registration Statement”).
Concurrently with this
letter, the Company is publicly filing with the Commission Amendment No. 1 to the publicly filed Registration Statement (“Amendment
No. 1”). A marked copy of Amendment No. 1 indicating changes from the Registration Statement is enclosed.
The numbering of the
paragraph below corresponds to the numbering of the Staff’s comment set forth in the Letter, which, for the Staff’s
convenience, has been incorporated into this response letter, marked with italicized text. Page references in this letter are to
page numbers in Amendment No. 1.
Registration Statement on Form S-1 filed
October 11, 2017
Underwriting, page 81
1. Based on your disclosure on the cover page and in this section, it appears you are registering
a firm commitment underwritten offering of your common stock at a fixed price on a non-delayed and non-continuous basis. Given
this, please explain your disclosure, "After the initial offering of the shares of Common Stock, the offering price and other
selling terms may be changed by the underwriters."
Securities and Exchange Commission
October 23, 2017
Page Two
Response: The Company acknowledges the Staff’s comment and
has revised page 81 of Amendment No. 1 to clarify the terms of the Company’s
proposed fixed price, non-delayed, non-continuous offering.
The Company appreciates
the Staff's attention to the review of the Registration Statement. Please contact the undersigned at (973) 520-2555 if you have
any questions regarding the foregoing.
Very truly yours,
DLA Piper LLP (US)
By:
/s/ David C. Schwartz, Esq.
David C. Schwartz, Esq.
cc: Adam S. Grossman
President and Chief Executive Officer, ADMA Biologics, Inc.
2017-10-19 - UPLOAD - ADMA BIOLOGICS, INC.
October 18, 2017
Adam S. Grossman
President and Chief Executive Officer
ADMA Biologics, Inc.
465 State Route 17
Ramsey, New Jersey 07446
Re:ADMA Biologics, Inc.
Registration Statement on Form S-1
Filed October 11, 2017
File No. 333-220910
Dear Mr. Grossman:
We have limited our review of your registration statement to those issues we have
addressed in our comment.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comment applies 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 registration statement and the information you
provide in response to this comment, we may have additional comments.
Registration Statement on Form S-1 filed October 11, 2017
Underwriting, page 81
1.Based on your disclosure on the cover page and in this section, it appears you are
registering a firm commitment underwritten offering of your common stock at a fixed
price on a non-delayed and non-continuous basis. Given this, please explain your
disclosure, "After the initial offering of the shares of Common Stock, the offering price
and other selling terms may be changed by the underwriters."
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
FirstName LastNameAdam S. Grossman
Comapany NameADMA Biologics, Inc.
June 16, 2017 Page 2
FirstName LastName
Adam S. Grossman
ADMA Biologics, Inc.
October 18, 2017
Page 2
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
Please contact Irene Paik at 202-551-6553 or Mary Beth Breslin at 202-551-3625 with
any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: David C. Schwartz, Esq. - DLA Piper LLP
2017-06-26 - CORRESP - ADMA BIOLOGICS, INC.
CORRESP
1
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ADMA Biologics, Inc.
465 State Route 17
Ramsey, New Jersey 07446
June 26, 2017
Via EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549-4561
Attn: Ada D. Sarmento
Re: ADMA Biologics, Inc. (the
“Company”)
Registration Statement on Form
S-3
Filed June 16, 2017
File No. 333-218802
Dear Ms. Sarmento:
The Company hereby
requests that the effective date for the Registration Statement referred to above be accelerated so that it will be declared effective
at 4:00 p.m. (EST) on June 28, 2017, or as soon as practicable thereafter, pursuant to Rule 461 of the Securities Act of 1933,
as amended.
The Company acknowledges
that (i) should the Securities and Exchange Commission (the “Commission”) or the staff of the Commission, acting pursuant
to delegated authority, declare the filing effective, such declaration does not foreclose the Commission from taking any action
with respect to the filing; (ii) the action of the Commission or the staff of the Commission, acting pursuant to delegated authority,
in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the
disclosure in the filing; and (iii) the Company may not assert staff comments and the declaration of effectiveness as a defense
in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
Please contact David
C. Schwartz, Esq. of DLA Piper LLP (US) with any questions or comments at (973) 520-2555. Thank you for your assistance with this
filing.
ADMA BIOLOGICS, INC.
By:
/s/
Adam S. Grossman
Name:
Adam S. Grossman
Title:
President and Chief Executive Officer
2017-06-22 - UPLOAD - ADMA BIOLOGICS, INC.
June 21, 2017
Adam S. Grossman
Chief Executive Officer
ADMA Biologics, Inc.
465 State Route 17
Ramsey, NJ 07446
ADMA Biologics, Inc.
Registration Statement on Form S-3
Filed June 16, 2017
File No. 333-218802Re:
Dear Mr. Grossman:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Ada D. Sarmento at (202) 551-3798 with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: David C. Schwartz, Esq.
2013-10-16 - CORRESP - ADMA BIOLOGICS, INC.
CORRESP
1
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Unassociated Document
[ADMA Biologics Letterhead]
October 16, 2013
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re:
ADMA Biologics, Inc. (the “Company”)
Registration Statement on Form S-1, as amended
File No. 333-186579
Ladies and Gentlemen:
Pursuant to Rule 461 of Regulation C promulgated under the Securities Act of 1933, as amended, the Company hereby requests that the effectiveness of the above-captioned Registration Statement be accelerated to 3:00 pm Eastern Time on October 16, 2013, or as soon thereafter as is practicable.
In connection with this letter, the Company acknowledges that:
· should the Securities and Exchange Commission (the “Commission”) or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing;
· the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and
· the Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
Very truly yours,
ADMA BIOLOGICS, INC.
/s/ Brian Lenz
Brian Lenz
Vice President and Chief Financial Officer
2013-10-16 - CORRESP - ADMA BIOLOGICS, INC.
CORRESP
1
filename1.htm
Unassociated Document
October 16, 2013
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re:
ADMA Biologics, Inc.
Registration Statement on Form S-1, as amended
File No. 333-186579
Ladies and Gentlemen:
In connection with the above-captioned Registration Statement, we wish to advise that between October 4, 2013 and the date of this letter, 1,570 copies of the Preliminary Prospectus dated October 4, 2013 were distributed as follows: approximately 0 to prospective underwriters; 265 to institutional investors; 5 to prospective dealers; and 1,300 to individuals.
We have been informed by the participating underwriters that they will comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.
We hereby join in the request of the registrant that the effectiveness of the above-referenced Registration Statement, as amended, be accelerated to 3:00 p.m. Eastern time on October 16, 2013 or as soon thereafter as practicable.
Very truly yours,
Oppenheimer & Co. Inc.
As Representative of the several Underwriters
Oppenheimer & Co. Inc.
By:
/s/ Douglas Cameron
Name: Douglas Cameron
Title: Head of Equity Capital Markets
2013-05-01 - CORRESP - ADMA BIOLOGICS, INC.
CORRESP
1
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Unassociated Document
[ADMA Biologics, Inc. Letterhead]
May 1, 2013
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re:
ADMA Biologics, Inc. (the “Company”)
Registration Statement on Form S-1, as amended
File No. 333-186579
Ladies and Gentlemen:
Reference is made to the acceleration request letter (the “Acceleration Request”) filed on April 30, 2013 with the Securities and Exchange Commission by the Company with respect to the acceleration of the effective date of the above referenced Registration Statement. The Company hereby withdraws the Acceleration Request. The Company expects to file a new acceleration request in the future with a future requested effective date for the Registration Statement.
If you have any questions or comments, please do not hesitate to contact the undersigned or our counsel, Jeffrey A. Baumel or Roland S. Chase at (973) 912-7100.
Very truly yours,
ADMA BIOLOGICS, INC.
/s/ Brian Lenz
Brian Lenz
Vice President and Chief Financial Officer
2013-04-30 - CORRESP - ADMA BIOLOGICS, INC.
CORRESP
1
filename1.htm
Unassociated Document
[ADMA Biologics Letterhead]
April 30, 2013
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re:
ADMA Biologics, Inc. (the “Company”)
Registration Statement on Form S-1, as amended
File No. 333-186579
Ladies and Gentlemen:
Pursuant to Rule 461 of Regulation C promulgated under the Securities Act of 1933, as amended, the Company hereby requests that the effectiveness of the above-captioned Registration Statement be accelerated to 4:00 p.m. Eastern Time on April 30, 2013, or as soon thereafter as is practicable.
In connection with this letter, the Company acknowledges that:
· should the Securities and Exchange Commission (the “Commission”) or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing;
· the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and
· the Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
Very truly yours,
ADMA BIOLOGICS, INC.
/s/ Brian Lenz
Brian Lenz
Vice President and Chief Financial Officer
2013-04-30 - CORRESP - ADMA BIOLOGICS, INC.
CORRESP
1
filename1.htm
Unassociated Document
April 30, 2013
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re:
ADMA Biologics, Inc.
Registration Statement on Form S-1, as amended
File No. 333-186579
Ladies and Gentlemen:
In connection with the above-captioned Registration Statement, we wish to advise you that as of the date hereof, approximately 1,300 copies of the Preliminary Prospectus dated April 30, 2013 were distributed as follows: approximately 0 to prospective underwriters; approximately 300 to institutional investors; approximately 0 to prospective dealers; and approximately 1,000 to individuals.
We have been informed by the participating underwriters that they will comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended, to the extent applicable.
We hereby join in the request of the registrant that the effectiveness of the above-referenced Registration Statement, as amended, be accelerated to 4:00 pm Eastern time on April 30, 2013 or as soon thereafter as practicable.
Very truly yours,
Oppenheimer & Co. Inc.
BMO Capital Markets Corp.
As Representatives of the severalUnderwriters
Oppenheimer & Co. Inc.
By:
/s/ Douglas Cameron
Name: Douglas Cameron
Title: Managing Director
BMO Capital Markets Corp.
By:
/s/ Lori A. Begley
Name: Lori A. Begley
Title: Managing Director
2013-04-25 - CORRESP - ADMA BIOLOGICS, INC.
CORRESP
1
filename1.htm
Unassociated Document
[ADMA Biologics Letterhead]
April 25, 2013
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re:
ADMA Biologics, Inc. (the “Company”)
Registration Statement on Form S-1, as amended
File No. 333-186579
Ladies and Gentlemen:
Reference is made to the acceleration request letter (the “Initial Request”) filed on April 23, 2012 with the Securities and Exchange Commission by the Company with respect to the acceleration of the effective date of the above referenced Registration Statement. The Company hereby withdraws the Initial Request. The Company expects to file a new acceleration request in the future with a future requested effective date for the Registration Statement.
If you have any questions or comments, please do not hesitate to contact the undersigned or our counsel, Jeffrey A. Baumel or Roland S. Chase at (973) 912-7100.
Very truly yours,
ADMA BIOLOGICS, INC.
/s/ Brian Lenz
Brian Lenz
Vice President and Chief Financial Officer
2013-04-23 - CORRESP - ADMA BIOLOGICS, INC.
CORRESP
1
filename1.htm
Unassociated Document
April 23, 2013
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re:
ADMA Biologics, Inc.
Registration Statement on Form S-1, as amended
File No. 333-186579
Ladies and Gentlemen:
In connection with the above-captioned Registration Statement, we wish to advise that between April 22, 2013 and the date hereof, approximately 1,300 copies of the Preliminary Prospectus dated April 22, 2013 were distributed as follows: approximately 0 to prospective underwriters; approximately 300 to institutional investors; approximately 0 to prospective dealers; and approximately 1,000 to individuals.
We have been informed by the participating underwriters that they will comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.
We hereby join in the request of the registrant that the effectiveness of the above-referenced Registration Statement, as amended, be accelerated to 4:00 pm Eastern time on April 24, 2013 or as soon thereafter as practicable.
Very truly yours,
Oppenheimer & Co. Inc.
BMO Capital Markets Corp.
As Representatives of the several
Underwriters
Oppenheimer & Co. Inc.
By:
/s/ Douglas Cameron
Name: Douglas Cameron
Title: Managing Director
BMO Capital Markets Corp.
By:
/s/ Lori A. Begley
Name: Lori A. Begley
Title: Managing Director
2013-04-23 - CORRESP - ADMA BIOLOGICS, INC.
CORRESP
1
filename1.htm
Unassociated Document
[ADMA Biologics Letterhead]
April 23, 2013
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re:
ADMA Biologics, Inc. (the “Company”)
Registration Statement on Form S-1, as amended
File No. 333-186579
Ladies and Gentlemen:
Pursuant to Rule 461 of Regulation C promulgated under the Securities Act of 1933, as amended, the Company hereby requests that the effectiveness of the above-captioned Registration Statement be accelerated to 4:00 pm Eastern Time on April 24, 2013, or as soon thereafter as is practicable.
In connection with this letter, the Company acknowledges that:
· should the Securities and Exchange Commission (the “Commission”) or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing;
· the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and
· the Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
Very truly yours,
ADMA BIOLOGICS, INC.
/s/ Brian Lenz
Brian Lenz
Vice President and Chief Financial Officer
2013-02-12 - UPLOAD - ADMA BIOLOGICS, INC.
February 12, 2013 Via E -mail Adam S. Grossman Chief Executive Officer ADMA Biologics, Inc. 65 Commerce Way Hackensack, New Jersey 07601 Re: ADMA Biologics, Inc. Registration Statement on Form S-1 Filed February 11, 2013 File No. 333-186579 Dear Mr. Grossman : We have limited our review of your registration statement to the resolution of your pending confidential treatment request and to the issue we have addressed in our comment . Please respond to this letter by amending your registration statement and providing the requested information . Where you do not believe our comment applies to your facts and circumstances or do not believe an amendment is approp riate, please tell us why in your response. After reviewing any amendment to your registration statement and the information you provide in response to our comment , we may have additional comments. 1. Please file the legal opinion of SNR Denton as exhibit 5.1 to your registration statement. We may have further comments based on our review of the opinion. 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 Act of 193 3 and all applicable Securities Act rules require . Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. Notwithstanding our comment , in the event you request accele ration of the effective date of the pending registration statement please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does no t foreclose the Commission from taking any action with respect to the filing; Adam S. Grossman ADMA Biologics, Inc. February 12, 2013 Page 2 the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act o f 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. Please co ntact Johnny Gharib at (202) 551 -3170, Daniel Greenspan at (202) 551 -3623 or me at (202) 551 -3715 with any questions. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedler Assistant Director Via E -mail Jeffrey A. Baumel, Esq. SNR Denton US LLP 1221 Avenue of the Americas New York, New York 10020
2012-08-09 - CORRESP - ADMA BIOLOGICS, INC.
CORRESP
1
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Unassociated Document
[ADMA Biologics Letterhead]
August 9, 2012
Justin Dobbie
John Dana Brown
Division of Corporation Finance
Securities and Exchange Commission
100 F. Street, N.E.
Washington, D.C. 20549-3010
Re:
ADMA Biologics, Inc. (the “Company”)
Registration Statement on Form S-1, as amended
File No. 333-180449
Dear Messrs. Dobbie and Brown:
Pursuant to Rule 461 of Regulation C promulgated under the Securities Act of 1933, as amended, the Company hereby requests that the effectiveness of the Company’s Registration Statement on Form S-1, as amended, File No. 333-180449, be accelerated to 4:00 pm (Washington, D.C. time), on Monday, August 13, 2012, or as soon thereafter as is practicable.
In connection with this letter, the Company acknowledges that:
· should the Securities and Exchange Commission (the “Commission”) or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing;
· the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and
· the Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
Very truly yours,
ADMA BIOLOGICS, INC.
/s/ Brian Lenz
Brian Lenz
Vice President and Chief Financial Officer
2012-07-09 - UPLOAD - ADMA BIOLOGICS, INC.
July 9, 2012 Via E -mail Adam S. Grossman Chief Executive Officer ADMA Biologics, Inc. 65 Commerce Way Hackensack, New Jersey 07601 Re: ADMA Biologics, Inc. Form 8 -K Filed February 13 , 2012 File No. 000 -52120 Dear Mr. Grossman: We have completed our review of your filing . We remind you that our comments or changes to disclosure in response to our comments do not foreclose the Commission from taking any action with respect to the company or the filing and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing include the information the Securities Exchange Act of 1934 and all applicable rules require. Sincerely, /s/ Justin Dobbie Justin Dobbie Legal Branch Chief cc: Jeffrey Baumel SNR Denton US LLP
2012-07-03 - CORRESP - ADMA BIOLOGICS, INC.
CORRESP
1
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Unassociated Document
SNR Denton US LLP
101 JFK Parkway
Short Hills, NJ 07078-2708 USA
Jeffrey A. Baumel
Partner
jeffrey.baumel@snrdenton.com
D +1 973 912 7189
T +1 973 912 7100
F +1 973 912 7199
snrdenton.com
July 3, 2012
Justin Dobbie
John Dana Brown
Division of Corporation Finance
Securities and Exchange Commission
100 F. Street, N.E.
Washington, D.C. 20549-3010
Re:
ADMA Biologics, Inc.
Amendment No. 2 to
Registration Statement on Form S-1
Filed June 5, 2012
File No. 333-180449
Dear Messrs. Dobbie and Brown:
By letter dated June 19, 2012 (the “SEC Letter”), the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) provided comments on Amendment No. 2 to the Registration Statement on Form S-1 ( the “Registration Statement”) filed by ADMA Biologics, Inc. (the “Company”). The Company has revised the Registration Statement to reflect its responses to the SEC Letter in Amendment No. 3 to the Registration Statement (the “Amendment”), which is filed with the Commission concurrently herewith. Capitalized terms used but not defined herein have the meaning ascribed to such terms in the Amendment.
In order to facilitate your review, this letter responds, on behalf of the Company, to each of the comments set forth in the SEC Letter on a point-by-point basis. The numbered paragraphs set forth below respond to the Staff’s comments and correspond to the numbered paragraphs in the SEC Letter. Unless otherwise noted, page numbers refer to the marked copy of the Amendment.
Outside Cover Page of Prospectus
1.
We note your response to our prior comment 3. We note on page 75 that you issued shares in the 2012 Financing at $9.60 per share to Burrill, Aisling, and the Grossman Group and that these selling shareholders are initially offering your securities at $9.60 per share. Please explain how $9.60 per share constitutes a bona fide estimate of the maximum price per share. Your explanation should address the fact, as appropriate, that the $9.60 per share price was the original price paid by certain of the selling shareholders and that this prohibits them from making any profit on sales unless and until there is an active trading market. This particular fact suggests that $9.60 per share is not a bona fide estimate of the maximum offering price. Alternatively, increase the fixed price to a bona fide estimate and pay any additional filing fee.
U.S. Securities and Exchange Commission
July 3, 2012
Page
RESPONSE: As discussed with Mr. Brown, the Company has revised its disclosure to indicate that until such time as its shares are quoted on the OTCBB, the selling stockholders will sell the shares covered by the prospectus at a range of $9.60 to $11.50 per share. The Company has paid an additional filing fee with respect to the difference between $11.50 and $9.60 per share.
The Company believes that the range of $9.60 to $11.50 establishes a reasonable bona fide estimate of a valid range for a sales price of the shares covered by the prospectus at times prior to quotation of the shares on the OTCBB. First, with respect to the low end of the range, the Company believes that $9.60 represents an arms-length, independent stock price valuation between the investors, the Company and the Company’s financial advisors Rodman & Renshaw and is a reasonable estimate of the low end of the range as it represents a break-even point for the selling stockholders. To the extent that the Company believes that the period of time between the effective date of the registration statement and the date the shares are quoted on the OTCBB will be very limited, were issues to arise for a selling stockholder, that the Company cannot predict, selling stockholders could seek to recover their investment. In that regard, the Company believes that selling stockholders would expect to receive a sales price equal to no less than their purchase price of $9.60 per share.
With regard to the high end of the range, the Company again looks to the short period of time that is anticipated between the effective date of this registration statement and the date that the shares are listed on the OTCBB. The Company cannot predict whether any events might occur during such short period of time that would trigger dramatic increases in the price per share of common stock. Accordingly, the Company believes that it is reasonable to expect that selling stockholders would seek an increase in valuation of no greater than approximately 20% per share, which would equal approximately $11.50.
The Company therefore believes that the range of $9.60 to $11.50 per share represents a bona fide estimate of an offering price by the selling stockholders during the period of time prior to the shares being quoted on the OTCBB.
Determination of Offering Price, page 39
2.
We note your response to our prior comment 3. Please revise your disclosure here to be consistent with your disclosure on the outside cover page of the prospectus indicating that until your shares are quoted on the OTCBB, the selling stockholders will sell the shares covered by this prospectus at a fixed price.
RESPONSE: As discussed with Mr. Brown, the Company has revised its disclosure to indicate that until such time as its shares are quoted on the OTCBB, the selling stockholders will sell the shares covered by the prospectus at a range of $9.60 to $11.50 per share.
If you have any questions, or if we may be of any assistance, please do not hesitate to contact the undersigned at (973) 912-7189 or Roland S. Chase at (973) 912-7179.
Sincerely,
/s/ Jeffrey A. Baumel
Jeffrey A. Baumel
Enclosures
2012-06-22 - CORRESP - ADMA BIOLOGICS, INC.
CORRESP
1
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Unassociated Document
SNR Denton US LLP
101 JFK Parkway
Short Hills, NJ 07078-2708 USA
Roland S. Chase
Partner
roland.chase@snrdenton.com
D +1 973 912 7179
T +1 973 912 7100
F +1 973 912 7199
snrdenton.com
June 22, 2012
VIA EDGAR
Justin Dobbie
John Dana Brown
Division of Corporation Finance
Securities and Exchange Commission
100 F. Street, N.E.
Washington, D.C. 20549-3010
Re:
ADMA Biologics, Inc.
Amendment No. 2 to Form 8-K
Filed April 24, 2012
File No. 000-52120
Dear Messrs. Dobbie and Brown:
By letter dated May 9, 2012 (the “SEC Letter”), the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) provided comments on Amendment No. 2 to Form 8-K (as so amended, the “Form 8-K”) filed by our client, ADMA Biologics, Inc. (the “Company”). The Company has revised the Form 8-K to reflect its responses to the SEC Letter in an amendment (the “Amendment”), which is filed with the Commission concurrently herewith.
In order to facilitate your review, this letter responds, on behalf of the Company, to each of the comments set forth in the SEC Letter on a point-by-point basis. The numbered paragraphs set forth below respond to the Staff’s comments and correspond to the numbered paragraphs in the SEC Letter. Unless otherwise noted, page numbers refer to the marked copy of the Amendment.
General
1.
Please refer to comment 1 of our letter to you dated April 24, 2012 regarding your registration statement on Form S-1. Please make similar changes to this current report on Form 8-K. In addition, both here and in the Form S-1, consider describing the extent to which any of the emerging growth company exemptions are available to you as a smaller reporting company.
Response: The Company has added the requested disclosure to the Amendment.
U.S. Securities and Exchange Commission
June 22, 2012
Page 2
Manufacturing and Supply, page 18
2.
We note your response to our prior comment 5. As exhibits to your next amendment please file your agreements with contract laboratories that conduct and run your laboratory testing, including your proprietary assay, or explain to us why this is not required by Item 601(b)(10) of Regulation S-K.
Response: The Company respectfully advises the Staff that, with one exception, its business is not substantially dependent on any agreement it has in place with contract laboratories. The exception is an agreement for laboratory testing services, which agreement had not yet been entered into on February 13, 2012, the date on which the Form 8-K was originally filed. The Company expects to file this agreement as an exhibit to the next amendment to its registration statement on Form S-1 (File No. 333-180449). The Company furthermore expects to file an Application for Confidential Treatment with respect to certain information contained in such agreement.
3.
Please revise to reconcile the statement in the first sentence of the last paragraph of this section that your “contract laboratories do not have access to [y]our trade secrets” with the third sentence in that paragraph stating that your “contract laboratories have informed [you] that they take all commercially reasonable steps to ensure the confidentiality of ADMA’s assay process, procedures, reagents, and other confidential information” and the statement in the first paragraph of this section that “ADMA relies on contract laboratories to conduct and run its laboratory testing, including its proprietary assay.” These statements statements appear to suggest that your contract laboratories may have access to your trade secrets such as your proprietary assay.
Response: The Company has revised the disclosure on page 18 of the Amendment to clarify that the contract laboratories do not have access to its trade secrets relating to donor selection and lot formulation during the manufacturing and testing of RI-001, that the contract laboratories do not assist with the determination of whether a donor is suitable for ADMA’s program and that the donor selection criteria and formulas employed with designing the manufacturing plasma pool are not shared with any third party, including the Company’s contract laboratories.
If you have any questions, or if we may be of any assistance, please do not hesitate to contact the undersigned at (973) 912-7179 or Jeffrey A. Baumel at (973) 912-7189.
Sincerely,
/s/ Roland S. Chase
Roland S. Chase
- 2 -
2012-06-19 - UPLOAD - ADMA BIOLOGICS, INC.
June 19, 2012
Via E -mail
Adam S. Grossman
Chief Executive Officer
ADMA Biologics, Inc.
65 Commerce Way
Hackensack, New Jersey 07601
Re: ADMA Biologics, Inc.
Amendment No. 2 to
Registration Statement on Form S-1
Filed June 5 , 2012
File No. 333-180449
Dear Mr. Grossman:
We have reviewed your responses to the comments in our letter dated May 22 ,
2012 and have the following additional comments.
Outside Cover Page of Prospectus
1. We note your response to our prior comment 3. We not e on page 75 that you
issued shares in the 2012 Financing at $9.60 per share to Burrill, Aisling, and the
Grossman Group and that the se selling shareholders are initially offering your
securities at $ 9.60 per share. Please explain how $ 9.60 per share cons titutes a
bona fide estimate of the maximum price per share. Your explanation should
address the fact, as appropriate, that the $ 9.60 per share price was the original
price paid by certain of the selling shareholders and that this prohibits them from
maki ng any profit on sales unless and until there is an active trading market. This
particular fact suggests that $ 9.60 per share is not a bona fide estimate of the
maximum offering price. Alternatively, increase the fixed price to a bona fide
estimate and pay any additional filing fee.
Determination of Offering Price, page 39
2. We no te your response to our prior comment 3. Please revise your disclosure
here to be consistent with your disclosure on the outside cover page of the
prospectus indicating that until your shares are quoted on the OTCBB, the selling
stockholders will sell the shares covered by this prospectus at a fixed pr ice.
Adam S. Grossman
ADMA Biologics, Inc.
June 19, 2012
Page 2
You may contact Amy Geddes at (202) 551 -3304 or Margery 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 me at (202) 551 -3469
with a ny other questions.
Sincerely,
/s/ Justin Dobbie
Justin Dobbie
Legal Branch Chief
cc: Roland S. Chase
SNR Denton US LLP
2012-06-15 - CORRESP - ADMA BIOLOGICS, INC.
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1
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Unassociated Document
[ADMA LETTERHEAD]
June 15, 2012
VIA EDGAR
Mr. Justin Dobbie
Mr. John Dana Brown
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Re:
ADMA Biologics, Inc.
Amendment No. 2 to Form 8-K
Filed April 24, 2012
File No. 000-52120
Dear Messrs. Dobbie and Brown:
By letter dated May 9, 2012, you provided comments on the above-referenced filing of ADMA Biologics, Inc. (the “Company”). As discussed between Mr. Brown and Roland Chase, of our counsel SNR Denton US LLP, the Company currently expects to submit its response letter via EDGAR, along with an amendment to the above-referenced filing, on or before June 22, 2012.
If you have any questions, or if we may be of any assistance, please do not hesitate to contact the undersigned at (201) 478-5552 or Jeffrey Baumel or Roland Chase at SNR Denton US LLP at (973) 912-7100.
Sincerely,
/s/ Brian Lenz
Brian Lenz
Chief Financial Officer
Cc:
Adam S. Grossman
President and Chief Executive Officer
2012-06-05 - CORRESP - ADMA BIOLOGICS, INC.
CORRESP
1
filename1.htm
Unassociated Document
SNR Denton US LLP
101 JFK Parkway
Short Hills, NJ 07078-2708 USA
Roland S. Chase
Partner
roland.chase@snrdenton.com
D +1 973 912 7179
T +1 973 912 7100
F +1 973 912 7199
snrdenton.com
John L. Cleary, II
Resident Managing Partner
June 5, 2012
Justin Dobbie
John Dana Brown
Division of Corporation Finance
Securities and Exchange Commission
100 F. Street, N.E.
Washington, D.C. 20549-3010
Re:
ADMA Biologics, Inc.
Amendment No. 1 to
Registration Statement on Form S-1
Filed May 8, 2012
File No. 333-180449
Dear Messrs. Dobbie and Brown:
By letter dated May 22, 2012 (the “SEC Letter”), the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) provided comments on Amendment No. 1 to the Registration Statement on Form S-1 ( the “Registration Statement”) filed by ADMA Biologics, Inc. (the “Company”). The Company has revised the Registration Statement to reflect its responses to the SEC Letter in Amendment No. 2 to the Registration Statement (the “Amendment”), which is filed with the Commission concurrently herewith. Capitalized terms used but not defined herein have the meaning ascribed to such terms in the Amendment.
In order to facilitate your review, this letter responds, on behalf of the Company, to each of the comments set forth in the SEC Letter on a point-by-point basis. The numbered paragraphs set forth below respond to the Staff’s comments and correspond to the numbered paragraphs in the SEC Letter. Unless otherwise noted, page numbers refer to the marked copy of the Amendment.
General
1.
We note your response to our prior comment 1. Please refer to the first paragraph of the risk factor beginning “We are an ‘emerging growth company’” on page 32. Please revise the reference to the “transitional period” in this paragraph to explain that this means that the reduced disclosure requirements discussed will be available as long as you are an emerging growth company.
RESPONSE: The Company has made the requested revision on page 32 of the Amendment.
U.S. Securities and Exchange Commission
June 5, 2012
Page 2
2.
We note your response to our prior comment 4. We note the statement in your response that all of the selling stockholders represented to the company that they were not acquiring their securities with a view to distribution or resale of the securities “except in full compliance with all applicable provisions of the Securities Act.” Please tell us whether any of the selling stockholders acquired their securities with a view to distribution, even if they intended to comply with the Securities Act.
RESPONSE: By virtue of conversations between representatives of the Company and the selling stockholders, the Company understands that none of the selling stockholders acquired their securities with a view to distribution of the securities, but rather acquired them for investment.
Outside Cover Page of Prospectus
3.
We note your response to our prior comment 5. Please revise to name a fixed price per share at which the selling stockholders will sell their shares until your shares are quoted on the OTCBB.
RESPONSE: The Company has added the requested disclosure on the outside cover page of the prospectus as well as on page 77 of the Amendment. The fixed price per share of $9.60 is based on the price per share in the 2012 Financing.
Risks Relating to Our Securities, page 30
4.
Refer to your disclosure that you are an “emerging growth company” on page 32. Please expand the second paragraph under this heading to also provide a cross reference to the Critical Accounting Policies section of Management’s Discussion and Analysis for a further discussion of the extended transition period for complying with new or revised accounting standards.
RESPONSE: The Company has added the requested disclosure on page 32 of the Amendment.
Critical Accounting Policies and Estimates, page 61
5.
Please expand your disclosures to more fully describe the implications of the extended transition period provided by the JOBS Act. Specifically, please clarify that you may take advantage of the extended transition period provided in Securities Act Section 7(a) (2)(B) until the first to occur of the date you (i) are no longer an “emerging growth company” or (ii) affirmatively and irrevocably opt out of the extended transition period provided in Securities Act Section 7(a)(2)(B). Accordingly, until the date you are no longer an “emerging growth company” or affirmatively and irrevocably opt out of the exemption provided by Securities Act Section 7(a)(2)(b), upon issuance of a new or revised accounting standard that applies to your financial statements and has a different effective date for public and private companies, you will disclose the date on which adoption is required for non-emerging growth companies and the date on which you will adopt the recently issued accounting standard.
U.S. Securities and Exchange Commission
June 5, 2012
Page 3
RESPONSE: The Company has added the requested disclosure on page 65 of the Amendment.
If you have any questions, or if we may be of any assistance, please do not hesitate to contact the undersigned at (973) 912-7179 or Jeffrey A. Baumel at (973) 912-7189.
Sincerely,
/s/ Roland S. Chase
Roland S. Chase
Enclosures
2012-06-04 - CORRESP - ADMA BIOLOGICS, INC.
CORRESP
1
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Unassociated Document
[ADMA LETTERHEAD]
June 4, 2012
VIA EDGAR
Mr. Justin Dobbie
Mr. John Dana Brown
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Re:
ADMA Biologics, Inc.
Amendment No. 2 to Form 8-K
Filed April 24, 2012
File No. 000-52120
Dear Messrs. Dobbie and Brown:
By letter dated May 9, 2012, you provided comments on the above-referenced filing of ADMA Biologics, Inc. (the “Company”). The Company currently expects to submit its response letter via EDGAR, along with an amendment to the above-referenced filing, on or before June 15, 2012.
If you have any questions, or if we may be of any assistance, please do not hesitate to contact the undersigned at (201) 478-5552 or Jeffrey Baumel or Roland Chase at our outside counsel, SNR Denton US LLP, at (973) 912-7100.
Sincerely,
/s/ Adam S. Grossman
Adam S. Grossman
President and Chief Executive Officer
2012-05-23 - CORRESP - ADMA BIOLOGICS, INC.
CORRESP
1
filename1.htm
Unassociated Document
[ADMA LETTERHEAD]
May 23, 2012
VIA EDGAR
Mr. Justin Dobbie
Legal Branch Chief
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Re:
ADMA Biologics, Inc.
Amendment No. 2 to Form 8-K
Filed April 24, 2012
File No. 000-52120
Dear Mr. Dobbie:
By letter dated May 9, 2012, you provided comments on the above-referenced filing of ADMA Biologics, Inc. (the “Company”). The Company currently expects to submit its response letter via EDGAR, along with an amendment to the above-referenced filing, on or before June 4, 2012.
If you have any questions, or if we may be of any assistance, please do not hesitate to contact the undersigned at (201) 478-5552 or Jeffrey Baumel or Roland Chase at our outside counsel, SNR Denton US LLP, at (973) 912-7100.
Sincerely,
/s/ Adam S. Grossman
Adam S. Grossman
President and Chief Executive Officer
2012-05-23 - UPLOAD - ADMA BIOLOGICS, INC.
May 22, 2012
Via E -mail
Adam S. Grossman
Chief Executive Officer
ADMA Biologics, Inc.
65 Commerce Way
Hackensack, New Jersey 07601
Re: ADMA Biologics, Inc.
Amendment No. 1 to
Registration Statement on Form S-1
Filed M ay 8, 2012
File No. 333-180449
Dear Mr. Grossman:
We have reviewed your responses to the comments in our letter dated April 24,
2012 and have the following additional comments.
General
1. We note your response to our prior comment 1. Please refer to the first paragraph
of the risk factor beginning “We are an „emerging growth company‟” on page 32.
Please revise the reference to the “transitional period ” in this paragraph to explain
that this means that the reduced disclosure requirements discussed will be
available as long as you are an emerging growth company.
2. We note your response to our prior comment 4. We note the statement in your
response that all of the selling stockholders represented to the company that they
were not acquiring their securities with a view to dist ribution or resale of the
securities “except in full compliance with all applicable provisions of the
Securities Act.” Please tell us whether any of the selling stockholders acquired
their securities with a view to distribution, even if they intended to c omply with
the Securities Act.
Outside Cover Page of Prospectus
3. We note your response to our prior comment 5. Please revise to name a fixed
price per share at which the selling stockholders will sell their shares until your
shares are quoted on the OTCB B.
Adam S. Grossman
ADMA Biologics, Inc.
May 22, 2012
Page 2
Risks Relating to Our Securities, page 30
4. Refer to your disclosure that you are an “emerging growth company” on page 32.
Please expand the second paragraph under this heading to also provide a cross
reference to the Critical Accounting Policies section of Management‟s Discussion
and Analysis for a further discussion of the extended transition period for
complying with new or revised accounting standards.
Critical Accounting Policies and Estimates, page 61
5. Please expand your disclosures to more fully describe the implications of the
extended transition period provided by the JOBS Act. Specifically, please clarify
that you may take advantage of the extended transition period provided in
Securities Act Section 7(a) (2)(B) until the first to occur of the date you (i) are no
longer an “emerging growth company” or (ii) affirmatively and irrevocably opt
out of the extended transition period provided in Securities Act Section
7(a)(2)(B). Accordingly, until the date you are no longer an “emerging growth
company” or affirmatively and irrevocably opt out of the exemption provided by
Securities Act Section 7(a)(2)(b), upon issuance of a new or revised accounting
standard that applies to your financial statements and has a different effective date
for public and private companies, you will disclose the date on which adoption is
required for non -emerging growth companies and the date on which you will
adopt the recently issued accounting standard.
You may contact Amy Geddes at (202) 551 -3304 or Margery 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 me at (202) 551 -3469
with any other questions.
Sincerely,
/s/ Justin Dobbie
Justin Dobbie
Lega l Branch Chief
cc: Roland S. Chase
SNR Denton US LLP
2012-05-09 - UPLOAD - ADMA BIOLOGICS, INC.
May 9, 2012 Via E-mail
Adam S. Grossman Chief Executive Officer ADMA Biologics, Inc. 65 Commerce Way Hackensack, New Jersey 07601
Re: ADMA Biologics, Inc.
Amendment No. 2 to Form 8-K Filed April 24, 2012 File No. 000-52120
Dear Mr. Grossman:
We have reviewed your response dated April 24, 2012 and have the following
comments. In some of our comments, we may ask you to provide us with 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. General
1. Please refer to comment 1 of our letter to you dated April 24, 2012 regarding your
registration statement on Form S-1. Please make similar changes to this current
report on Form 8-K. In addition, both here and in the Form S-1, consider
describing the extent to which any of the emerging growth company exemptions
are available to you as a smaller reporting company.
Manufacturing and Supply, page 18
2. We note your response to our prior comme nt 5. As exhibits to your next
amendment please file your agreements w ith contract laboratories that conduct
Adam S. Grossman
ADMA Biologics, Inc. May 9, 2012 Page 2
and run your laboratory testi ng, including your proprietary assay, or explain to us
why this is not required by Item 601(b)(10) of Regulation S-K.
3. Please revise to reconcile the statement in the first sentence of the last paragraph
of this section that your “c ontract laboratories do not ha ve access to [y]our trade
secrets” with the third sentence in that paragraph stating that your “contract
laboratories have informed [you] that they take all commercially reasonable steps
to ensure the confidentiality of ADMA’s assay process, procedures, reagents, and
other confidential information” and the statement in the first paragraph of this section that “ADMA relies on contract laboratories to conduct and run its
laboratory testing, including its proprietary assay.” These statements statements
appear to suggest that your contract laboratories may have access to your trade
secrets such as your pr oprietary assay.
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
cc: Jeffrey Baumel SNR Denton US LLP
2012-05-08 - CORRESP - ADMA BIOLOGICS, INC.
CORRESP
1
filename1.htm
Unassociated Document
SNR Denton US LLP
101 JFK Parkway
Short Hills, NJ 07078-2708 USA
Roland S. Chase
Partner
roland.chase@snrdenton.com
D +1 973 912 7179
T +1 973 912 7100
F +1 973 912 7199
snrdenton.com
May 8, 2012
Justin Dobbie, Esq.
Legal Branch Chief
Division of Corporation Finance
Securities and Exchange Commission
100 F. Street, N.E.
Washington, D.C. 20549-3010
Re:
ADMA Biologics, Inc.
Registration Statement on Form S-1
Filed March 29, 2012
File No. 333-180449
Dear Mr. Dobbie:
By letter dated April 24, 2012 (the “SEC Letter”), the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) provided comments on the registration statement on Form S-1 ( the “Original Filing”) filed by ADMA Biologics, Inc. (the “Company”). The Company has revised the Original Filing to reflect its responses to the SEC Letter in an amendment to the Original Filing (the “Amendment”), which is filed with the Commission concurrently herewith. Capitalized terms used but not defined herein have the meaning ascribed to such terms in the Amendment.
In order to facilitate your review, this letter responds, on behalf of the Company, to each of the comments set forth in the SEC Letter on a point-by-point basis. The numbered paragraphs set forth below respond to the Staff’s comments and correspond to the numbered paragraphs in the SEC Letter. Unless otherwise noted, page numbers refer to the marked copy of the Amendment.
General
1.
Since you appear to qualify as an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act (“the Act”), please disclose on your prospectus cover page that you are an emerging growth company, and revise your prospectus to provide the following additional disclosures:
·
Describe how and when a company may lose emerging growth company status;
·
A brief description of the various exemptions that are available to you, such as exemptions from Section 404(b) of the Sarbanes-Oxley Act of 2002 and Section 14A(a) and (b) of the Securities Exchange Act of 1934; and
·
Your election under Section 107(b) of the Act:
U.S. Securities and Exchange
Commission
May 8, 2012
Page 2
o
If you have elected to opt out of the extended transition period for complying with new or revised accounting standards pursuant to Section 107(b) of the Act, include a statement that the election is irrevocable; or
o
If you have elected to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(2)(B) of the Act, provide a risk factor explaining that this election allows you to delay the adoption of new or revised accounting standards that have different effective dates for public and private companies until those standards apply to private companies. Please state in your risk factor that, as a result of this election, your financial statements may not be comparable to companies that comply with public company effective dates. Include a similar statement in your critical accounting policy disclosures in MD&A.
RESPONSE: The Company has added the requested disclosure to the prospectus cover page, as well as to pages 4, 32 and 61 of the Amendment.
2.
We note the comment letters from the staff dated March 9, 2012 and April 12, 2012 regarding your Form 8-K filed on February 13, 2012, as amended. Please be advised that your outstanding comments concerning the Form 8-K must be resolved prior to the effectiveness of this Form S-1 registration statement. Additionally, to the extent you amend the Form 8-K, in response to comments or otherwise, please revise to make any applicable conforming changes to this Form S-1.
RESPONSE: The Company acknowledges the Staff’s comments and will, to the extent it amends the Form 8-K, revise the registration statement on Form S-1 to make any applicable conforming changes. It has also revised the registration statement on Form S-1 to include applicable changes made in Amendment No. 2 to Form 8-K filed on April 24, 2012.
3.
We note your pending confidential treatment request related to Exhibits 10.8 and 10.9 incorporated by reference to your Form 8-K filed on February 13, 2012. Please note that the staff must act on this confidential treatment request before the acceleration of effectiveness of this Form S-1.
RESPONSE: The Company acknowledges the Staff’s comment.
4.
It appears that the offering by the selling stockholders may be an indirect primary offering rather than a secondary offering. Please revise to name each of the selling stockholders as underwriters and to conduct the offering at a fixed price or provide detailed legal analyses explaining why this is not necessary.
RESPONSE: Rule 415 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), provides that “(a) Securities may be registered for an offering to be made on a continuous or delayed basis in the future, provided, that: (1) The registration statement pertains only to: (i) Securities which are to be offered or sold solely by or on behalf of a person or persons other than the registrant, a subsidiary of the registrant, or a person of which the registrant is a subsidiary….”
U.S. Securities and Exchange
Commission
May 8, 2012
Page 3
In the event that an offering registered in reliance on Rule 415(a)(1)(i) is deemed to be an offering that is “by or on behalf of the registrant” as specified in Rule 415(a)(1)(x), Rule 415 contains additional limitations. Rule 415(a)(4) provides that:
“In the case of a registration statement pertaining to an at the market offering of equity securities by or on behalf of the registrant, the offering must come within paragraph (a)(1)(x) of this section. As used in this paragraph, the term ‘at the market offering’ means an offering of equity securities into an existing trading market for outstanding shares of the same class at other than a fixed price.”
As a result, if an offering which purports to be a secondary offering is recharacterized as an offering “by or on behalf of the registrant,” Rule 415 is only available to register an “at the market offering” if the registrant is eligible to use Form S-3 or Form F-3 to register a primary offering. The Company is currently not eligible to use Form S-3 to effect a primary offering. Therefore, it cannot use Rule 415 to register a primary offering “at the market.”
In the event that the offering covered by the registration statement is recharacterized as a primary offering on behalf of the Company, (i) the offering would have to be made on a fixed price basis (in other words, the selling stockholders would not be able to sell their securities at prevailing market prices), (ii) the selling stockholders would be deemed to be “underwriters” (with the attendant liabilities under Section 11 of the Securities Act) and (iii) in accordance with the Staff’s long-standing interpretive position, Rule 144 would never be available to them to effect resales of their securities.
Because of the requirements of Rule 415, the Staff’s interpretation that the resale of the securities covered by the registration statement (the “Registrable Shares”) appears to be a primary offering would have a dramatic impact on the ability of a selling stockholder to effect the resale of its shares. Because such a recharacterization would have such a dramatic impact, and a mischaracterization could have a chilling effect on the ability of smaller public companies, like the Company, to raise capital, the Staff should only recharacterize a secondary offering as being made on behalf of a registrant after careful and complete review of the relevant facts and circumstances.
In Compliance and Disclosure Interpretation 612.09 (“CDI 612.09”) with respect to the rules under the Securities Act, the Staff acknowledged that:
[i]t is important to identify whether a purported secondary offering is really a primary offering, i.e., the selling shareholders are actually underwriters selling on behalf of an issuer. Underwriter status may involve additional disclosure, including an acknowledgment of the seller’s prospectus delivery requirements. In an offering involving Rule 415 or Form S-3, if the offering is deemed to be on behalf of the issuer, the Rule and Form in some cases will be unavailable (e.g., because of the Form S-3 “public float” test for a primary offering, or because Rule 415(a)(1)(i) is available for secondary offerings, but primary offerings must meet the requirements of one of the other subsections of Rule 415). The question of whether an offering styled a secondary one is really on behalf of the issuer is a difficult factual one, not merely a question of who receives the proceeds. Consideration should be given to how long the selling shareholders have held the shares, the circumstances under which they received them, their relationship to the issuer, the amount of shares involved, whether the sellers are in the business of underwriting securities, and finally, whether under all the circumstances it appears that the seller is acting as a conduit for the issuer. (emphasis added)
U.S. Securities and Exchange
Commission
May 8, 2012
Page 4
After consideration of all of the factors listed in CDI 612.09, which are discussed in detail below in the context of the registration statement, it is the Company’s view that the offering of the Registrable Shares is a valid secondary offering and is eligible to be made under Rule 415(a)(1)(i) under the Securities Act as contemplated by the registration statement.
The date on which and the circumstances in which each selling stockholder received the shares and/or the overlying securities
1,828,128 of the 1,969,026 Registrable Shares were acquired by selling stockholders in the reverse merger in exchange for shares received in the 2012 Financing effected in connection with such reverse merger on February 13, 2012. 53,044 of the Registrable Shares were acquired by selling stockholders in exchange for shares received in connection with the organization of ParentCo in 2006. Furthermore, 87,865 of the Registrable Shares are issuable upon exercise of warrants acquired by the placement agent in exchange for warrants issued to the placement agent in the 2012 Financing.
In any event, however, the length of time for which the selling stockholders will have held their Registrable Shares or overlying securities prior to resale pursuant to the registration statement is only one factor cited in CDI 612.09, to be considered alongside the other factors listed therein in arriving at a conclusion, after careful and complete review of the relevant facts and circumstances, of whether the transaction at issue is in fact a primary offering.
Also relevant to the analysis are the circumstances under which the selling stockholders received the Registrable Shares and/or the overlying securities. In the case at hand, the selling stockholders received the Registrable Securities and/or the overlying securities in the reverse merger in exchange for securities received either in the 2012 Financing or at the organization of ParentCo. In both cases, the issuances were valid private placements under Section 4(2) of the Securities Act and Regulation D promulgated thereunder.
All of the selling stockholders acquired their Registrable Shares, or in the case of the Placement Agent Warrants, such warrants, for investment and specifically represented to the Company that they were not acquiring their securities with a view to distribution or resale of the securities except in full compliance with all applicable provisions of the Securities Act. There is no evidence to suggest that those representations are false. The mere fact that the Registrable Shares are now being registered for resale is no evidence that the selling stockholders desire to effect an immediate distribution. In fact, there are a number of reasons why investors want shares registered other than to effect an immediate sale. Many private investment funds, for example, some of which are among the selling stockholders, are required to mark their portfolios to market. If portfolio securities are not registered, such investors are required to mark down the book value of those securities to reflect an illiquidity discount. That portfolio valuation does not depend on whether the selling stockholders intend to dispose of their shares or to hold them for an indefinite period. In addition, many investors are fiduciaries of other people’s money and have a common law duty to act prudently. It would be irresponsible for those investors not to have their shares registered. Not registering the shares would prevent them from taking advantage of market opportunities or from liquidating their investment if there is a fundamental shift in their investment judgment about the Company. Finally, registered shares of many issuers are eligible to be used as margin collateral under the Federal Reserve’s margin regulations. Restricted securities cannot be “margin stock.” The potential diminution of value of holding unregistered securities relative to holding registered securities explains why the selling stockholders negotiated for registration rights during the negotiations that preceded the 2012 Financing.
U.S. Securities and Exchange
Commission
May 8, 2012
Page 5
There is also no evidence that the selling stockholders are acting in concert to effect a distribution of the Registrable Shares. There are 16 persons or entities for whom the sale of securities is being registered in the registration statement. There is no evidence that the selling stockholders have any plan to act in concert with respect to their Registrable Shares. Under the Exchange Act of 1934, as amended (the “Exchange Act”), such a plan would make such investors a “group” under Section 13(d) of the Exchange Act. In similar circumstances, courts have found that investors who merely sign the same investment documents do not constitute a “group” for 13(d) purposes. See, e.g., Litzler v. CC Investments, 411 F.Supp. 2d 411 (S.D.N.Y. 2006) (investors participating in the same financing and signing the same investment documents prepared by one counsel are not a “group”). Accordingly, there does not appear to be any valid basis to impute to the selling stockholders any intent to act in concert.
Furthermore, under the Commission’s own rules, a “distribution” requires special selling efforts. Rule 100(b) of Regulation M defines a “distribution” as
“an offering of securities, whether or not subject to registration under the Securities Act, that is distinguished from ordinary trading transactions by the magnitude of the offering and the presence of special selling efforts and selling methods.” (Emphasis added)
There is no evidence in this case that any special selling efforts or selling methods have taken place or would take place if the sale of all of the Registrable Shares were registered. Again, it is unlikely that the selling stockholders in the 2012 Financing will band together to distribute their shares. Nor is there any evidence that any of the selling stockholders have conducted any road shows or taken any other actions to condition or “prime” the market for their shares. To do so would violate the detailed representations made by them in documents executed in connection with the 2012 Financing and the reverse merger.
Further reducing the probability of a distribution intent is the fact that approximately 74% of the Registrable Shares were issued to parties who are now affiliates of the Company (“Affiliates”) although certain of such parties were not Affiliates prior to the 2012 Financing. Under Section 16(b) under the Exchange Act and Rule 16b-6 thereunder, Affiliates would be subject to short-swing profit liability if they sold any of the Registrable Shares within six months of the 2012 Financing.
Finally, for practical purpose
2012-04-25 - UPLOAD - ADMA BIOLOGICS, INC.
April 24, 2012 Via E-mail
Adam S. Grossman Chief Executive Officer ADMA Biologics, Inc. 65 Commerce Way Hackensack, New Jersey 07601
Re: ADMA Biologics, Inc.
Registration Statement on Form S-1 Filed March 29, 2012 File No. 333-180449
Dear Mr. Grossman:
We have limited our review of your registra tion statement to those issues we have
addressed in our comments. In some of our comments, we may ask you to provide us
with information so we may be tter understand your disclosure.
Please respond to this letter by am ending your registration statement and
providing the requested information. Where you do not believe our comments apply to
your facts and circumstances or do not believ e an amendment is appropriate, please tell
us why in your response.
After reviewing any amendment to your registration statement and the
information you provide in response to th ese comments, we may have additional
comments. General
1. Since you appear to qualify as an “emerging growth company,” as defined in the
Jumpstart Our Business Startups Act (“the Act”), please disclose on your
prospectus cover page that you are an emerging growth company, and revise your
prospectus to provide the fo llowing additional disclosures:
Describe how and when a company may lose emerging growth company
status;
Adam S. Grossman
ADMA Biologics, Inc. April 24, 2012 Page 2
A brief description of the various exemptions that ar e available to you, such as
exemptions from Section 404(b) of the Sarbanes-Oxley Act of 2002 and
Section 14A(a) and (b) of the Securities Exchange Act of 1934; and
Your election under Secti on 107(b) of the Act:
o If you have elected to opt out
of the extended transition period for
complying with new or revised accounting standards pursuant to Section
107(b) of the Act, include a statement that the election is irrevocable; or
o If you have elected to use the extend ed transition period for complying
with new or revised accounting stan dards under Section 102(b)(2)(B) of
the Act, provide a risk factor explai ning that this election allows you to
delay the adoption of new or revi sed accounting standards that have
different effective dates for public and private companies until those
standards apply to private companies. Please state in your risk factor that,
as a result of this election, your financial statements may not be comparable to companies that comply with public company effective dates. Include a similar statemen t in your critical accounting policy
disclosures in MD&A.
2. We note the comment letters from the staff dated March 9, 2012 and April 12,
2012 regarding your Form 8-K filed on February 13, 2012, as amended. Please be advised that your outs tanding comments concerning the Form 8-K must be
resolved prior to the effectiveness of this Form S-1 registration statement. Additionally, to the extent you amend the Form 8-K, in response to comments or
otherwise, please revise to make any app licable conforming changes to this Form
S-1.
3. We note your pending confidential treatment request related to Exhibits 10.8 and
10.9 incorporated by reference to your Form 8-K filed on February 13, 2012.
Please note that the staff must act on this confidential treatment request before the
acceleration of effectivene ss of this Form S-1.
4. It appears that the offering by the selling stockholders ma y be an indirect primary
offering rather than a secondary offering. Please revise to name each of the selling
stockholders as underwriters and to conduct the offering at a fixed price or provide
detailed legal analyses explaining why this is not necessary.
Outside Cover Page of Prospectus
5. We note on page 39 and elsewhere that your common stock is not traded on any
national securities exchange but that you will seek to have the common stock quoted
on the OTCBB. Notwithstanding our comment 4 above, please revise here to state
that the selling stockholders will sell their shares at a fixed price per share until your
shares are quoted on the OTCBB and thereafter at prevailing market prices or
privately negotiated prices.
Adam S. Grossman
ADMA Biologics, Inc. April 24, 2012 Page 3
Signatures
6. Please revise so that the second half of the signature block is signed by persons
with the indicated capacity of principa l financial officer and either principal
accounting officer or controller.
Exhibit 5.1
7. Please delete the second sentence in the first full paragraph on page 2. Such a
limitation on the scope of documents examined is not appropriate. In addition this
appears inconsistent with th e first sentence on page 2.
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 Act of 1933 and all applicable Securities Act rules require. Since the company and its
management are in possession of all facts relating to a company’s disclosure, they are
responsible for the accuracy and adequacy of the disclosures they have made.
Notwithstanding our comments, in the event you request acceleration of the effective
date of the pending registration statement please provide a written statement from the
company acknowledging that:
should the Commission or the staff, acting pursuant to delegated authority,
declare the filing effective, it does not foreclose the Commission from taking any
action with respect to the filing;
the action of the Commission or the staff, acting pursuant to delegated authority,
in declaring the filing effective, does not relieve the company from its full
responsibility for the adequacy and accuracy of the disclosure in the filing; and
the company may not assert staff comments and the declaration of effectiveness
as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
Please refer to Rules 460 and 461 regarding requests for acceleration. We will
consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective
responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as
they relate to the proposed public offering of the securities specified in the above registration
statement. Please allow adequate time for us to review any amendment prior to the requested
effective date of the registration statement.
Adam S. Grossman
ADMA Biologics, Inc. April 24, 2012 Page 4
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 Brow n at (202) 551-3859 or me 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
cc: Roland S. Chase SNR Denton US LLP
2012-04-24 - CORRESP - ADMA BIOLOGICS, INC.
CORRESP
1
filename1.htm
Unassociated Document
SNR Denton US LLP
101 JFK Parkway
Short Hills, NJ 07078-2708 USA
Roland S. Chase
Partner
roland.chase@snrdenton.com
D +1 973 912 7179
T +1 973 912 7100
F +1 973 912 7199
snrdenton.com
April 24, 2012
Justin Dobbie, Esq.
Legal Branch Chief
Division of Corporation Finance
Securities and Exchange Commission
100 F. Street, N.E.
Washington, D.C. 20549-3010
Re:
ADMA Biologics, Inc.
Amendment No. 1 to
Form 8-K
Filed March 29, 2012
File No. 000-52120
Dear Mr. Dobbie:
By letter dated April 12, 2012 (the “SEC Letter”), the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) provided comments on Amendment No. 1 to Form 8-K (as so amended, the “Form 8-K”) filed by our client, ADMA Biologics, Inc. (the “Company”). The Company has revised the Form 8-K to reflect its responses to the SEC Letter in an amendment (the “Amendment”), which is filed with the Commission concurrently herewith.
In order to facilitate your review, this letter responds, on behalf of the Company, to each of the comments set forth in the SEC Letter on a point-by-point basis. The numbered paragraphs set forth below respond to the Staff’s comments and correspond to the numbered paragraphs in the SEC Letter.
Our Strategy, page 14
1.
We note your response to our prior comment 8. Please revise the bulleted discussion “Develop and commercialize RI-001 as a treatment for PIDD” to state when you expect to generate revenue from the commercialization of RI-001 as a treatment for PIDD.
RESPONSE: The Company respectfully advises the Staff that it is unable to predict with reasonable certainty when it will generate revenues from the commercialization of RI-001. It has revised the disclosure on pages 15, 48 and F-7 of the Amendment to include such statement along with disclosure on the uncertainty surrounding the amount of additional financing required prior to revenue generation.
U.S. Securities and Exchange
Commission
April 24, 2012
Page 2
2.
Please revise the statement on page 15 that “ADMA plans to sell normal source plasma to buyers in the open market” to state, if true, that you are already selling normal source plasma. We note on page 45 that you recorded revenue during the most recently completed fiscal year “from the sale of blood plasma collected in [your] Georgia-based blood plasma collection center.”
RESPONSE: The Company has revised the disclosure on page 15 of the Amendment to provide the requested statement.
3.
Please revise the discussion on the bottom of page 15 to clarify whether additional FDA licensing, local approvals, and federal and state inspections will be required to open new ADMA BioCenters locations.
RESPONSE: The Company has revised the disclosure on page 15 of the Amendment to provide the requested statement.
Our Product Candidate, page 16
4.
We note your response to our prior comment 11. We note the statement that you believe RI-001 will be clearly differentiated from currently marketed IGIV products in part because of “the manufacturing processes [the company] intends to employ.” We also note the statement on page 18 that “Biotest does not have access to [y]our trade secrets during the manufacturing of RI-001.” In light of this please revise to clarify how the manufacturing process will differentiate RI-001. To the extent the manufacturing process to which you refer is Biotest’s rather than yours, please revise accordingly.
RESPONSE: The Company has revised the disclosure on page 16 of the Amendment to provide the requested clarification.
Manufacturing and Supply, page 18
5.
Please refer to the second-to-last paragraph on page 18. Please revise to clarify what you are referring to by “ADMA’s contract laboratories.” Revise to clarify, if true, that this is not a reference to Biotest.
RESPONSE: The Company has revised the disclosure on page 18 of the Amendment to provide the requested clarification.
Certain Relationships and Related Party Transactions, page 59
6.
Please revise to clarify the reference to “Item 404(c)(iii)” on page 61 as it is unclear to us to what you are referring.
RESPONSE: The Company has revised the disclosure on page 61 of the Amendment to provide the requested clarification.
U.S. Securities and Exchange
Commission
April 24, 2012
Page 3
Exhibit 99.1 to Form 8-K/A filed March 29, 2012
7.
Refer to our previous comment 22. Please tell us how your auditor was able to come to the conclusion that a going concern paragraph was not necessary in their opinion issued on your December 31, 2011 audited financial statements. Specifically address, in expanded detail, your history of losses from operations, your cash flow burn rate, your disclosure on page F-7 that you have experienced net losses and negative cash flows from operations since inception and the fact that you expect these conditions to continue for the foreseeable future. In addition, address the fact that you will not be able to generate revenues from RI-001 until after FDA approval which may not occur, and that you will need to secure additional funding prior to the third quarter of 2013 to continue development and operations.
RESPONSE: The Company respectfully advises the Staff that its private placement of securities in February 2012 provided the Company with approximately $15.2 million in net cash proceeds. As discussed in Note 1 (page F-7) to the Company’s 2011 consolidated financial statements, the Company expects such proceeds, along with its projected revenue, to provide sufficient cash flow to fund its operations through the third quarter of 2013. Its cash used in operating activities was $4.8 million in 2010 and $1.4 million in 2011; accordingly, the Company believes that, based on historical cash flows and its projections, it will have adequate cash flow beyond one year from the date of the financial statements.
8.
In this regard, consideration should be given to including an explanatory paragraph that discloses the substantive reasons why the going-concern explanatory paragraph has been eliminated from the reissued report for December 31, 2010 by analogy to AU Section 508.69.
RESPONSE: The Company respectfully advises the Staff that in Note 1 to the Company’s 2011 consolidated financial statements, it discloses the following matters relating to its liquidity:
•
The Company has incurred net losses and negative cash flows from operations since inception - conditions that are expected to continue for the foreseeable future.
•
The Company has needed to raise capital to sustain operations.
•
The Company’s cash balances at December 31, 2011 were minimal.
•
In February 2012, the Company raised gross proceeds of $17.5 million in a private placement of securities (discussed in detail in Note 12 (page F-20)).
•
The Company expects to be able to fund operations into the third quarter of 2013.
•
If estimates about revenues and expenses prove to be wrong, the Company may have to raise additional capital sooner than anticipated and no assurance can be given that additional financing will be available to the Company.
The Company believes that the disclosure in Note 1 to the consolidated financial statements is robust, clearly discloses the Company’s current financial position, and explains by reference to the proceeds from the private placement why the 2010 “going concern” explanatory paragraph was not repeated in the March 29, 2011 audit report. The Company respectfully advises the Staff that it does not believe it would be appropriate for management to disclose why it believes the auditors removed the “going concern” explanatory paragraph, as per your suggestion to analogize to AU Section 508.69.
U.S. Securities and Exchange
Commission
April 24, 2012
Page 4
Summary of Significant Accounting Policies
Inventories, page F-7, and
Revenue Recognition, page F-8
9.
Please revise both of these policies to distinguish between your treatment of the different types of plasma inventories you hold and sell as part of operations, and those you hold for use in research and development. Ensure consistency with your responses to our previous comments 29 and 30.
RESPONSE: The Company has added the requested disclosure to pages F-7 and F-8 of the Amendment.
10.
As a related matter, please revise your discussion of research and development expenses on page 46 of the Form 8-K to specifically state, if true, that the plasma sold is not plasma collected at the Plasma center.
RESPONSE: The Company has added the requested disclosure to page 46 of the Amendment.
If you have any questions, or if we may be of any assistance, please do not hesitate to contact the undersigned at (973) 912-7179 or Jeffrey A. Baumel at (973) 912-7189.
Sincerely,
/s/ Roland S. Chase
Roland S. Chase
Enclosures
2012-04-13 - UPLOAD - ADMA BIOLOGICS, INC.
April 12, 2012 Via E-mail
Adam S. Grossman Chief Executive Officer ADMA Biologics, Inc. 65 Commerce Way Hackensack, New Jersey 07601
Re: ADMA Biologics, Inc.
Amendment No. 1 to Form 8-K Filed March 29, 2012 File No. 000-52120
Dear Mr. Grossman:
We have reviewed your response date d March 29, 2012 and have the following
comments. In some of our comments, we may ask you to provide us with 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. Our Strategy, page 14
1. We note your response to our prior co mment 8. Please revise the bulleted
discussion “Develop and commercialize RI- 001 as a treatment for PIDD” to state
when you expect to generate revenue fr om the commercialization of RI-001 as a
treatment for PIDD.
2. Please revise the statement on page 15 th at “ADMA plans to sell normal source
plasma to buyers in the open market” to st ate, if true, that you are already selling
normal source plasma. We note on page 45 that you recorded revenue during the
Adam S. Grossman
ADMA Biologics, Inc. April 12, 2012 Page 2
most recently completed fiscal year “fro m the sale of blood plasma collected in
[your] Georgia-based blood plasma collection center.”
3. Please revise the discussion on the bottom of page 15 to clarify whether additional
FDA licensing, local approvals, and federal and state inspections will be required
to open new ADMA BioCenters locations.
Our Product Candidate, page 16
4. We note your response to our prior comme nt 11. We note the statement that you
believe RI-001 will be clearly differen tiated from currently marketed IGIV
products in part because of “the manuf acturing processes [the company] intends
to employ.” We also note the statement on page 18 that “Biotest does not have
access to [y]our trade secrets during the ma nufacturing of RI-001.” In light of
this please revise to clarify how the ma nufacturing process will differentiate RI-
001. To the extent the manufacturing pr ocess to which you refer is Biotest’s
rather than yours, please revise accordingly.
Manufacturing and Supply, page 18
5. Please refer to the second-to-last paragra ph on page 18. Please revise to clarify
what you are referring to by “ADMA’s contra ct laboratories.” Revise to clarify,
if true, that this is not a reference to Biotest.
Certain Relationships and Relate d Party Transactions, page 59
6. Please revise to clarify the reference to “Item 404(c)(iii)” on page 61 as it is
unclear to us to what you are referring.
Exhibit 99.1 to Form 8-K/A filed March 29, 2012
7. Refer to our previous comment 22. Please tell us how your auditor was able to
come to the conclusion that a going concer n paragraph was not necessary in their
opinion issued on your December 31, 2011 audited financial statements.
Specifically address, in expanded detail, your history of losses from operations,
your cash flow burn rate, your disclosure on page F-7 that you have experienced
net losses and negative cash flows from operations since ince ption and the fact
that you expect these conditions to continue for the foreseeable future. In addition, address the fact that you will not be able to generate revenues from RI-
001 until after FDA approval which may not occur, and that you will need to
secure additional funding prior to th e third quarter of 2013 to continue
development and operations.
8. In this regard, consideration should be given to includi ng an explanatory
paragraph that discloses the substa ntive reasons why the going-concern
Adam S. Grossman
ADMA Biologics, Inc. April 12, 2012 Page 3
explanatory paragraph has been eliminated from the reissued report for December
31, 2010 by analogy to AU Section 508.69.
Summary of Significan t Accounting Policies
Inventories, page F-7, and
Revenue Recognition, page F-8
9. Please revise both of these policies to di stinguish between your treatment of the
different types of plasma inventories you hold and sell as part of operations, and
those you hold for use in research and de velopment. Ensure consistency with
your responses to our previous comments 29 and 30.
10. As a related matter, please revise your discussion of research and development
expenses on page 46 of the Form 8-K to speci fically state, if true, that the plasma
sold is not plasma collected at the Plasma center.
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
cc: Roland S. Chase SNR Denton US LLP
2012-03-29 - CORRESP - ADMA BIOLOGICS, INC.
CORRESP
1
filename1.htm
Unassociated Document
SNR Denton US LLP
101 JFK Parkway
Short Hills, NJ 07078-2708 USA
Jeffrey A. Baumel
Partner
jeffrey.baumel@snrdenton.com
D +1 973 912 7189
T +1 973 912 7100
F +1 973 912 7199
snrdenton.com
March 29, 2012
Justin Dobbie, Esq.
Legal Branch Chief
Division of Corporation Finance
Securities and Exchange Commission
100 F. Street, N.E.
Washington, D.C. 20549-3010
Re:
ADMA Biologics, Inc.
Form 8-K
Filed February 13, 2012
File No. 000-52120
Dear Mr. Dobbie:
By letter dated March 9, 2012 (the “SEC Letter”), the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) provided comments on the Form 8-K (the “Form 8-K”) filed by our client, ADMA Biologics, Inc. (the “Company”). The Company has revised the Form 8-K to reflect its responses to the SEC Letter in an amendment (the “Amendment”), which is filed with the Commission concurrently herewith.
In order to facilitate your review, this letter responds, on behalf of the Company, to each of the comments set forth in the SEC Letter on a point-by-point basis. The numbered paragraphs set forth below respond to the Staff’s comments and correspond to the numbered paragraphs in the SEC Letter. Unless otherwise noted, page numbers refer to the Amendment.
Safe Harbor Statement Under the Private Securities Litigation Reform Act, page 2
1.
Please remove reference to the safe harbors 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.
RESPONSE: The Company has revised the disclosure on page 2 of the Amendment to eliminate the reference to the safe harbors of the Private Securities Litigation Reform Act of 1995.
U.S. Securities and Exchange Commission
March 29, 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.
RESPONSE: The Company has revised the disclosure on page 12 of the Amendment to define industry specific terms upon first use.
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 clinical trials may not be indicative of future results.
RESPONSE: The Company has revised the disclosure on page 12 of the Amendment in response to the Staff’s comment.
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. Additionally please revise to clarify that it is possible that the FDA may not grant approval.
RESPONSE: The Company has revised the disclosure on page 12 of the Amendment in response to the Staff’s comment.
Business of ADMA, page 10
5.
Please revise to discuss how you have developed RI-001. Explain whether you developed it internally or acquired it from another party.
RESPONSE: The Company has revised the disclosure on page 12 of the Amendment in response to the Staff’s comment.
Background of the Plasma Industry, page 11
6.
Please refer to the second paragraph on page 11. Please refrain from referring to compound growth rates here and elsewhere as these represent 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.
RESPONSE: The Company has revised the disclosure on page 13 of the Amendment to eliminate the reference to compound growth rates.
7.
Please refer the second paragraph on page 11 regarding the $11.8 billion worldwide market and $4.5 billion United States market for the plasma industry, the third paragraph on page 11 regarding the $5.1 billion worldwide 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.
U.S. Securities and Exchange Commission
March 29, 2012
Page 3
RESPONSE: The Company has revised the disclosure on page 14 of the Amendment by eliminating the references described in the Staff’s comment and has added disclosure to the risk factor on page 28 that it currently only has plans for gaining regulatory approval in the United States.
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 initiative to generate revenue. Additionally, please explain which initiatives will require you to raise additional capital.
RESPONSE: The Company has revised the disclosure on pages 14-15 of the Amendment in response to the Staff’s comment.
9.
Please revise to address your strategy in the event the FDA requires additional Phase III trials or Phase IV trials. Discuss a timeline including costs and whether additional capital would be needed.
RESPONSE: The Company has revised the disclosure on page 12 of the Amendment in response to the Staff’s comment. Since the Company’s strategy in the scenario described in the Staff’s comment would depend on the specific requirements imposed by the FDA, and since a timeline and corresponding costs are difficult to predict, the Company has added language on page 12 highlighting the risk of additional Phase III trials or Phase IV trials.
10.
You state here that ADMA BioCenters received 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 tell 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.
RESPONSE: The Company has revised the disclosure on page 15 of the Amendment to clarify that prior to receiving its FDA license, the work at the Georgia facility consisted of obtaining local approvals, undergoing federal and state inspections, validating plasma collection systems, implementing quality programs for plasma collection, entering into vendor agreements, training and hiring staff and responding to FDA request letters. Further, the Company began to collect plasma in February 2009, as the FDA required a minimum of three months of fully documented quality assurance records to be completed prior to a submission for FDA licensure.
Our Product Candidate, page 12
11.
Please tell us, with a view towards revised disclosure, why you believe RI-001 will be clearly differentiated from currently marketed IGIV products.
RESPONSE: The Company has revised the disclosure on page 16 of the Amendment in response to the Staff’s comment to clarify that RI-001 will be differentiated from currently marketed IGIV products because of the Company’s proprietary methods of selecting and screening plasma donors and the manufacturing processes it intends to employ.
U.S. Securities and Exchange Commission
March 29, 2012
Page 4
Manufacturing and Supply, page 13
12.
We note that you have filed the manufacturing and supply agreements with Biotest Pharmaceuticals Corporation as material contracts. Please revise this section to disclose the material terms of these agreements. Please also disclose more specifically to what extent you intend to rely on third parties for blood plasma sourcing.
RESPONSE: The Company has revised the disclosure on page 18 of the Amendment in response to the Staff’s comments.
13.
Please disclose the precautions your manufacturer is required to take to protect your trade secrets.
RESPONSE: The Company has revised the disclosure on page 18 of the Amendment in response to the Staff’s comment.
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 patent applications in process.
RESPONSE: The Company has revised the disclosure on page 19 of the Amendment in response to the Staff’s comment.
Government Regulation and Product Approval, page 14
15.
Please revise to address the regulation and licensing of ADMA BioCenters.
RESPONSE: The Company has revised the disclosure on page 20 of the Amendment in response to the Staff’s comment.
Risk Factors, page 18
16.
We note the reference to known “and unknown” risks and the statement that “[t]he risks described below are not the only ones the Company will face.” All material risks should be discussed in this section. If risks are not deemed material they should not be mentioned. Please revise accordingly.
RESPONSE: The Company respectfully submits that the Risk Factors in the Amendment disclose all material risks known to be faced by the Company and has revised the preamble to the Risk Factors on page 25 accordingly.
17.
Please revise to include a risk factor discussing, if true, that your Chief Executive Officer has no experience managing a public company.
RESPONSE: The Company has revised the disclosure on page 33 of the Amendment to add the requested risk factor.
U.S. Securities and Exchange Commission
March 29, 2012
Page 5
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.
RESPONSE: The Company has revised the disclosure on page 25 of the Amendment in response to the Staff’s comment.
We do not own any issued patents, page 22
19.
Please provide a separate risk factor addressing risks that third parties may obtain patents and that you would then be infringing on those patents unless you negotiate appropriate licenses.
RESPONSE: The Company has revised the disclosure on page 32 of the Amendment to add the appropriate risk factor.
Management’s Discussion and Analysis or Plan of Operation, page 31 Results of Operations, page 31
20.
Please consider including a tabular presentation of period to period comparative data for clarity in addition to your narrative discussion.
RESPONSE: The Company has revised the disclosure on page 45 of the Amendment to add the requested table.
Liquidity and Capital Resources, page 34
21.
You state here that you expect your existing 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 courses of action to remedy the deficiency.
RESPONSE: The Company has revised the disclosure on page 48 of the Amendment in response to the Staff’s comment.
22.
Please revise your discussion here to specifically 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. Filings with such accountants’ reports must contain appropriate and prominent disclosure of financial difficulties and viable plans to overcome these difficulties. Refer to Section 607.02 of the Financial Reporting Codification for guidance.
RESPONSE: The Company respectfully submits that the auditor’s report accompanying the audited financial statements for the year ended December 31, 2011, which are being filed as exhibits to the Amendment, do not contain a “going concern” explanatory paragraph.
U.S. Securities and Exchange Commission
March 29, 2012
Page 6
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 performance. Please explain why you have not included this amount in the Summary Compensation Table as 2011 compensation.
RESPONSE: The Company has revised the disclosure on page 56 of the Amendment to include such bonus in response to the Staff’s comment.
Certain Relationships and Related Transactions, and Director Independence, page 41
24.
Please revise to quantify the estimated amount of reimbursed legal fees, as discussed in the first paragraph.
RESPONSE: The Company has revised the disclosure on page 59 of the Amendment in response to the Staff’s comment.
25.
Please disclose the number of shares underlying the common stock purchase warrants in the first paragraph under “Note Financings.”
RESPONSE: The Company has revised the disclosure on page 60 of the Amendment in response to the Staff’s comment.
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....”
RESPONSE: The Company has revised the disclosure on pages 60-61 of the Amendment to clarify that it is Rodman & Renshaw, LLC as Placement Agent, and not its affiliate, who will continue to hold an equity interest in the Company. The Company has also revised the disclosure to identify the bank as Pascack Bankcorp in response to the Staff’s comment.
Description of Registrant’s Securities 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.” Such a qualification is inappropriate unless you file these provisions of applicable law as exhibits to the current report. Please revise accordingly.
RESPONSE: The Company has revised the disclosure on page 63 of the Amendment to eliminate such reference.
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 incurred 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 product 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 value, proceeds received, and loss taken on sale.
U.S. Securities and Exchange Commission
March 29, 2012
Page 7
RESPONSE: The Company has revised the disclosure on page F-6 of the Amendment in response to the Staff’s comment to disclose the total amount of inventory sold at book value ($2,439,487), proceeds received ($504,857) and loss recorded on the sales ($1,934,630).
29.
Further, we note your inventory policy indicates inventory is carried at the lower of cost or market. Given the significant loss on sale of plasma inventory taken during the nine months ended September 30, 2011, it appears the market value of remaining inventories may be significantly less than their carrying value. Please tell us how you have considered the remaining plasma inventory for impairment.
RESPONSE: The Company respectfully submits that the inventory sold during the nine months ended September 30, 2011 was older plasma with a relatively short remaining shelf life. This plasma was intended for use in the clinical t
2012-03-23 - CORRESP - ADMA BIOLOGICS, INC.
CORRESP
1
filename1.htm
Unassociated Document
[ADMA LETTERHEAD]
March 23, 2012
VIA EDGAR
Mr. Justin Dobbie
Legal Branch Chief
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Re:
ADMA Biologics, Inc.
Form 8-K
Filed February 13, 2012
File No. 000-52120
Dear Mr. Dobbie:
By letter dated March 9, 2012, you provided comments on the above-referenced filing of ADMA Biologics, Inc. (the “Company”). The Company currently expects that the audit of the consolidated financial statements as of and for the periods ended December 31, 2011 and 2010 will be completed during the week of March 26, 2012. It therefore expects to submit its response letter via EDGAR, along with an amendment to the above-referenced filing containing such financial statements, on or before March 30, 2012.
If you have any questions, or if we may be of any assistance, please do not hesitate to contact the undersigned at (201) 478-5552 or Jeffrey Baumel or Roland Chase at our outside counsel, SNR Denton US LLP, at (973) 912-7100.
Sincerely,
/s/ Adam S. Grossman
Adam S. Grossman
President and Chief Executive Officer
2012-03-09 - UPLOAD - ADMA BIOLOGICS, INC.
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