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Biofrontera Inc.
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1 company response(s)
Low - unmatched response
Biofrontera Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2025-01-22
Biofrontera Inc.
Summary
Generating summary...
↓
Company responded
2025-01-24
Biofrontera Inc.
Summary
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Biofrontera Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-05-08
Biofrontera Inc.
Summary
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Company responded
2024-05-08
Biofrontera Inc.
Summary
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Biofrontera Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-03-18
Biofrontera Inc.
Summary
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Company responded
2024-04-22
Biofrontera Inc.
Summary
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Biofrontera Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2023-10-11
Biofrontera Inc.
Summary
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Company responded
2023-10-13
Biofrontera Inc.
Summary
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Company responded
2023-10-27
Biofrontera Inc.
Summary
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Biofrontera Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2022-11-03
Biofrontera Inc.
Summary
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Biofrontera Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2022-08-30
Biofrontera Inc.
Summary
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Biofrontera Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2022-06-01
Biofrontera Inc.
Summary
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Company responded
2022-06-07
Biofrontera Inc.
Summary
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Biofrontera Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2021-12-16
Biofrontera Inc.
Summary
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Company responded
2021-12-21
Biofrontera Inc.
Summary
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Biofrontera Inc.
Response Received
17 company response(s)
High - file number match
SEC wrote to company
2021-07-19
Biofrontera Inc.
Summary
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Company responded
2021-07-23
Biofrontera Inc.
Summary
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Company responded
2021-08-11
Biofrontera Inc.
Summary
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Company responded
2021-08-30
Biofrontera Inc.
Summary
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Company responded
2021-09-15
Biofrontera Inc.
Summary
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Company responded
2021-10-08
Biofrontera Inc.
Summary
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Company responded
2021-10-08
Biofrontera Inc.
Summary
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Company responded
2021-10-08
Biofrontera Inc.
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Company responded
2021-10-13
Biofrontera Inc.
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Company responded
2021-10-13
Biofrontera Inc.
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Company responded
2021-10-13
Biofrontera Inc.
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Company responded
2021-10-14
Biofrontera Inc.
Summary
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Company responded
2021-10-18
Biofrontera Inc.
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Company responded
2021-10-18
Biofrontera Inc.
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Company responded
2021-10-20
Biofrontera Inc.
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Company responded
2021-10-20
Biofrontera Inc.
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Company responded
2021-10-27
Biofrontera Inc.
Summary
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Company responded
2021-10-27
Biofrontera Inc.
Summary
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Biofrontera Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2021-10-14
Biofrontera Inc.
Summary
Generating summary...
Biofrontera Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2021-10-12
Biofrontera Inc.
Summary
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Biofrontera Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2021-10-07
Biofrontera Inc.
Summary
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Biofrontera Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2021-09-09
Biofrontera Inc.
Summary
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Biofrontera Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2021-08-20
Biofrontera Inc.
Summary
Generating summary...
Biofrontera Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2021-08-02
Biofrontera Inc.
Summary
Generating summary...
Biofrontera Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2021-07-01
Biofrontera Inc.
Summary
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↓
Company responded
2021-07-06
Biofrontera Inc.
Summary
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Biofrontera Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2021-06-10
Biofrontera Inc.
Summary
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-15 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2025-01-24 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2025-01-22 | SEC Comment Letter | Biofrontera Inc. | DE | 333-284371 | Read Filing View |
| 2024-05-08 | SEC Comment Letter | Biofrontera Inc. | DE | 333-279090 | Read Filing View |
| 2024-05-08 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2024-04-22 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2024-03-18 | SEC Comment Letter | Biofrontera Inc. | DE | 333-277811 | Read Filing View |
| 2023-10-27 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2023-10-13 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2023-10-11 | SEC Comment Letter | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2022-11-03 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2022-08-30 | SEC Comment Letter | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2022-06-07 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2022-06-01 | SEC Comment Letter | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-12-21 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-12-16 | SEC Comment Letter | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-10-27 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-10-27 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-10-20 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-10-20 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-10-18 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-10-18 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-10-14 | SEC Comment Letter | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-10-14 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-10-13 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-10-13 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-10-13 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-10-12 | SEC Comment Letter | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-10-08 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-10-08 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-10-08 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-10-07 | SEC Comment Letter | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-09-15 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-09-09 | SEC Comment Letter | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-08-30 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-08-20 | SEC Comment Letter | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-08-11 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-08-02 | SEC Comment Letter | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-07-23 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-07-19 | SEC Comment Letter | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-07-06 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-07-01 | SEC Comment Letter | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-06-10 | SEC Comment Letter | Biofrontera Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-01-22 | SEC Comment Letter | Biofrontera Inc. | DE | 333-284371 | Read Filing View |
| 2024-05-08 | SEC Comment Letter | Biofrontera Inc. | DE | 333-279090 | Read Filing View |
| 2024-03-18 | SEC Comment Letter | Biofrontera Inc. | DE | 333-277811 | Read Filing View |
| 2023-10-11 | SEC Comment Letter | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2022-08-30 | SEC Comment Letter | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2022-06-01 | SEC Comment Letter | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-12-16 | SEC Comment Letter | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-10-14 | SEC Comment Letter | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-10-12 | SEC Comment Letter | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-10-07 | SEC Comment Letter | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-09-09 | SEC Comment Letter | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-08-20 | SEC Comment Letter | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-08-02 | SEC Comment Letter | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-07-19 | SEC Comment Letter | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-07-01 | SEC Comment Letter | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-06-10 | SEC Comment Letter | Biofrontera Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-15 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2025-01-24 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2024-05-08 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2024-04-22 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2023-10-27 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2023-10-13 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2022-11-03 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2022-06-07 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-12-21 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-10-27 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-10-27 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-10-20 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-10-20 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-10-18 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-10-18 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-10-14 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-10-13 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-10-13 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-10-13 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-10-08 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-10-08 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-10-08 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-09-15 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-08-30 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-08-11 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-07-23 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
| 2021-07-06 | Company Response | Biofrontera Inc. | DE | N/A | Read Filing View |
2025-08-15 - CORRESP - Biofrontera Inc.
CORRESP 1 filename1.htm Biofrontera Inc. · 120 Presidential Way, Suite 330 · Woburn, MA 01801 · USA VIA EDGAR August 15, 2025 Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Re: Biofrontera Inc. Registration Statement on Form S-1 (File No. 333-288717) Request for Acceleration of Effective Date Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Biofrontera Inc. (the " Registrant ") hereby requests that the Securities and Exchange Commission (the " Commission ") accelerate the effective date of the above-referenced Registration Statement on Form S-1 (as amended, the " Registration Statement ") so that the Registration Statement will be declared effective as of 4:30 p.m. Eastern time, on August 19, 2025, or as soon thereafter as practicable. The Registrant hereby also authorizes Stephen Older and Andrew Terjesen of McGuireWoods LLP to orally modify or withdraw this request for acceleration. Once the Registration Statement has been declared effective, please orally confirm that event with Stephen Older of McGuireWoods LLP at (212) 548-2122, or in his absence, Andrew Terjesen at (704) 343-2024. Thank you for your assistance in this matter. Very truly yours, Biofrontera Inc. /s/ E. Fred Leffler, III Name: E. Fred Leffler, III Title: Chief Financial Officer cc: Hermann Luebbert Biofrontera Inc. Stephen Older McGuireWoods LLP Biofrontera Inc. . 120 Presidential Way, Suite 330 . Woburn, MA 01801 . USA Contact Phone +1 781 245 1325 . E-Mail info-us@biofrontera.com . www.biofrontera-us.com
2025-01-24 - CORRESP - Biofrontera Inc.
CORRESP
1
filename1.htm
Biofrontera
Inc. 120 Presidential Way, Suite 330 Woburn, MA 01801 USA
VIA
EDGAR
January
24, 2025
Securities
and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Biofrontera
Inc.
Registration
Statement on Form S-1 (File No. 333-284371)
Request
for Acceleration of Effective Date
Ladies
and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Biofrontera Inc. (the “Registrant”) hereby requests that
the Securities and Exchange Commission (the “Commission”) accelerate the effective date of the above-referenced Registration
Statement on Form S-1 (as amended, the “Registration Statement”) so that the Registration Statement will be declared
effective as of 4:30 p.m. Eastern time, on January 28, 2025, or as soon thereafter as practicable. The
Registrant hereby also authorizes Stephen Older and Andrew Terjesen of McGuireWoods LLP to orally modify or withdraw this request for
acceleration.
Once
the Registration Statement has been declared effective, please orally confirm that event with Stephen Older of McGuireWoods LLP at (212)
548-2122, or in his absence, Andrew Terjesen at (704) 343-2024.
Thank
you for your assistance in this matter.
Very
truly yours,
Biofrontera
Inc.
/s/
E. Fred Leffler, III
Name:
E.
Fred Leffler, III
Title:
Chief
Financial Officer
cc:
Hermann
Luebbert
Biofrontera
Inc.
Stephen
Older
McGuireWoods
LLP
Biofrontera
Inc. . 120 Presidential Way, Suite 330 . Woburn, MA 01801 . USA
Contact
Phone +1 781 245 1325 . E-Mail info-us@biofrontera.com . www.biofrontera-us.com
2025-01-22 - UPLOAD - Biofrontera Inc. File: 333-284371
January 22, 2025
Prof. Hermann Luebbert, Ph.D.
Chairman and Chief Executive Officer
Biofrontera Inc.
120 Presidential Way, Suite 330
Woburn, MA 01801
Re:Biofrontera Inc.
Registration Statement on Form S-1
Filed January 17, 2025
File No. 333-284371
Dear Prof. Hermann Luebbert Ph.D.:
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 Tim Buchmiller at 202-551-3635 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Stephen E. Older, Esq.
2024-05-08 - UPLOAD - Biofrontera Inc. File: 333-279090
United States securities and exchange commission logo
May 8, 2024
Hermann Luebbert, Ph.D.
Chairman and Chief Executive Officer
Biofrontera Inc.
120 Presidential Way, Suite 330
Woburn, MA 01801
Re:Biofrontera Inc.
Registration Statement on Form S-1
Filed May 3, 2024
File No. 333-279090
Dear Hermann Luebbert:
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 Daniel Crawford at 202-551-7767 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Andrew Terjesen, Esq.
2024-05-08 - CORRESP - Biofrontera Inc.
CORRESP
1
filename1.htm
Biofrontera
Inc. · 120 Presidential Way, Suite 330 · Woburn, MA 01801 · USA
VIA
EDGAR
May
8, 2024
Securities
and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Biofrontera
Inc.
Registration
Statement on Form S-1 (File No. 333-279090)
Request
for Acceleration of Effective Date
Ladies
and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Biofrontera Inc. (the “Registrant”) hereby requests that
the Securities and Exchange Commission (the “Commission”) accelerate the effective date of the above-referenced Registration
Statement on Form S-1 (as amended, the “Registration Statement”) so that the Registration Statement will be declared
effective as of 4:30 p.m. Eastern time, on May 9, 2024, or as soon thereafter as practicable. The
Registrant hereby also authorizes Stephen Older and Andrew Terjesen of McGuireWoods LLP to orally modify or withdraw this request for
acceleration.
Once
the Registration Statement has been declared effective, please orally confirm that event with Stephen Older of McGuireWoods LLP at (212)
548-2122, or in his absence, Andrew Terjesen at (704) 343-2024.
Thank
you for your assistance in this matter.
Very truly yours,
Biofrontera Inc.
/s/ E. Fred Leffler, III
Name:
E. Fred Leffler, III
Title:
Chief Financial Officer
cc:
Hermann
Luebbert
Biofrontera
Inc.
Stephen
Older
McGuireWoods
LLP
Biofrontera
Inc. . 120 Presidential Way, Suite 330 . Woburn, MA 01801 . USA
Contact
Phone +1 781 245 1325 . E-Mail info-us@biofrontera.com . www.biofrontera-us.com
2024-04-22 - CORRESP - Biofrontera Inc.
CORRESP
1
filename1.htm
Biofrontera
Inc. · 120 Presidential Way, Suite 330 · Woburn, MA 01801 · USA
VIA
EDGAR
April
22, 2024
Securities
and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Biofrontera
Inc.
Registration
Statement on Form S-1 (File No. 333-277811)
Request
for Acceleration of Effective Date
Ladies
and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Biofrontera Inc. (the “Registrant”) hereby requests that
the Securities and Exchange Commission (the “Commission”) accelerate the effective date of the above-referenced Registration
Statement on Form S-1 (as amended, the “Registration Statement”) so that the Registration Statement will be declared
effective as of 4:30 p.m. Eastern time, on April 22, 2024, or as soon thereafter as practicable. The
Registrant hereby also authorizes Stephen Older and Andrew Terjesen of McGuireWoods LLP to orally modify or withdraw this request for
acceleration.
Once
the Registration Statement has been declared effective, please orally confirm that event with Stephen Older of McGuireWoods LLP at (212)
548-2122, or in his absence, Andrew Terjesen at (704) 343-2024.
Thank
you for your assistance in this matter.
Very
truly yours,
Biofrontera
Inc.
/s/
Hermann Luebbert
Name:
Hermann
Luebbert
Title:
Chief
Executive Officer and Chairman
cc:
E.
Fred Leffler, III
Biofrontera
Inc.
Stephen
Older
McGuireWoods
LLP
Biofrontera
Inc. . 120 Presidential Way, Suite 330 . Woburn, MA 01801 . USA
Contact
Phone +1 781 245 1325 . E-Mail info-us@biofrontera.com . www.biofrontera-us.com
2024-03-18 - UPLOAD - Biofrontera Inc. File: 333-277811
United States securities and exchange commission logo
March 18, 2024
Dr. Hermann Luebbert
Chairman and Chief Executive Officer
Biofrontera Inc.
120 Presidential Way, Suite 330
Woburn, MA 01801
Re:Biofrontera Inc.
Registration Statement on Form S-1
Filed March 11, 2024
File No. 333-277811
Dear Dr. Hermann Luebbert:
Our initial review of your registration statement indicates that it fails in numerous
material respects to comply with the requirements of the Securities Act of 1933, the rules and
regulations thereunder and the requirements of the form. More specifically, it does not appear
that financial statements complying with the updating requirements of Rule 8-08 of Regulation
S-X are presented in your registration statement.
We will provide more detailed comments relating to your registration statement
following our review of a substantive amendment that addresses these deficiencies.
Please contact Cindy Polynice at 202-551-8707 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Andrew J. Terjesen, Esq.
2023-10-27 - CORRESP - Biofrontera Inc.
CORRESP
1
filename1.htm
Biofrontera
Inc. · 120 Presidential Way, Suite 330 · Woburn, MA 01801 · USA
VIA
EDGAR
October
27, 2023
Securities
and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Biofrontera
Inc.
Registration
Statement on Form S-1 (File No. 333-274871)
Request
for Acceleration of Effective Date
Ladies
and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Biofrontera Inc. (the “Registrant”) hereby requests that
the Securities and Exchange Commission (the “Commission”) accelerate the effective date of the above-referenced Registration
Statement on Form S-1 (as amended, the “Registration Statement”) so that the Registration Statement will be declared
effective as of 4:30 p.m. Eastern time, on October 30, 2023, or as soon thereafter as practicable. The
Registrant hereby also authorizes Stephen Older, Elizabeth Jones and Lawton Way of McGuireWoods LLP to orally modify or withdraw this
request for acceleration.
Once
the Registration Statement has been declared effective, please orally confirm that event with Stephen Older of McGuireWoods LLP at (212)
548-2122, or in his absence, Elizabeth Jones at (704) 373-8847 or Lawton Way at (804) 775-4711.
Thank
you for your assistance in this matter.
Very truly yours,
Biofrontera Inc.
/s/
E. Fred Leffler, III
Name:
E.
Fred Leffler, III
Title:
Chief
Financial Officer
cc:
Hermann
Luebbert
Biofrontera
Inc.
Stephen
Older
McGuireWoods
LLP
Biofrontera
Inc. . 120 Presidential Way, Suite 330 . Woburn, MA 01801 . USA
Contact
Phone +1 781 245 1325 . E-Mail info-us@biofrontera.com . www.biofrontera-us.com
2023-10-13 - CORRESP - Biofrontera Inc.
CORRESP
1
filename1.htm
VIA
EDGAR AND EMAIL
October
13, 2023
Securities
and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549
Attn:
Tyler
Howes
Re:
Biofrontera
Inc.
Registration
Statement on Form S-1
Filed
October 5, 2023
File
No. 333-274871
We
are submitting this letter on behalf of our client Biofrontera Inc. (the “Company”) in response to the comment letter,
dated October 11, 2023, of the staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange
Commission (the “Commission”) with respect to the above-referenced filing. This letter and our Amendment No. 1 to
the Registration Statement on Form S-1 (the “Amendment”) are being filed with the Commission electronically today.
In addition to the electronic filing, we are delivering via email a copy of this letter, along with a courtesy copy of the Amendment
No. 1 marked to indicate changes from the Company’s Registration Statement filed on October 5, 2023. Our response is set forth
in ordinary type beneath the Staff comment, which is set out in bold type.
Registration
Statement on Form S-1 filed on October 5, 2023
Cover
Page
1.
Please
revise your cover page to disclose the date the offering will end. Refer to Item 501(b)(8)(iii) of Regulation S-K for guidance.
Response:
We
acknowledge the Staff’s comment and respectfully advise the Staff that the cover page of the Amendment has been revised to disclose
the date the offering will terminate.
If
you have any questions regarding this letter or the Registration Statement, please contact the undersigned at solder@mcguirewoods.com
or (212) 548-2122.
Sincerely,
/s/
Stephen Older
McGuireWoods
LLP
cc:
Hermann
Luebbert, Biofrontera Inc.
Fred
Leffler, Biofrontera Inc.
Jonathan
Zimmerman, Faegre Drinker Biddle & Reath LLP
2023-10-11 - UPLOAD - Biofrontera Inc.
United States securities and exchange commission logo
October 11, 2023
Hermann Luebbert
Chief Executive Officer
Biofrontera Inc.
120 Presidential Way, Suite 330
Woburn, MA 01801
Re:Biofrontera Inc.
Registration Statement on Form S-1
Filed October 5, 2023
File No. 333-274871
Dear Hermann Luebbert:
We have conducted a limited review of your registration statement and have the
following comment.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe a 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 letter, we may have additional comments.
Registration Statement on Form S-1 filed October 5, 2023
Cover Page
1.Please revise your cover page to disclose the date the offering will end. Refer to
Item 501(b)(8)(iii) of Regulation S-K for guidance.
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.
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.
FirstName LastNameHermann Luebbert
Comapany NameBiofrontera Inc.
October 11, 2023 Page 2
FirstName LastName
Hermann Luebbert
Biofrontera Inc.
October 11, 2023
Page 2
Please contact Tyler Howes at 202-551-3370 or Laura Crotty at 202-551-7614 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Andrew J. Terjesen, Esq.
2022-11-03 - CORRESP - Biofrontera Inc.
CORRESP
1
filename1.htm
Biofrontera
Inc. · 120 Presidential Way, Suite 330 · Woburn, MA 01801 · USA
VIA
EDGAR
November
3, 2022
Securities
and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Biofrontera
Inc.
Registration
Statement on Form S-1 (File No. 333-268124)
Request
for Acceleration of Effective Date
Ladies
and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Biofrontera Inc. (the “Registrant”) hereby requests that
the Securities and Exchange Commission (the “Commission”) accelerate the effective date of the above-referenced Registration
Statement on Form S-1 (as amended, the “Registration Statement”) so that the Registration Statement will be declared
effective as of 4:30 p.m. Eastern time, on November 7, 2022, or as soon thereafter as practicable. The
Registrant hereby also authorizes Stephen Older and Andrew Terjesen of McGuireWoods LLP to orally modify or withdraw this request for
acceleration.
Once
the Registration Statement has been declared effective, please orally confirm that event with Stephen Older of McGuireWoods LLP at (212)
548-2122, or in his absence, Andrew Terjesen at (704) 343-2024.
Thank
you for your assistance in this matter.
Very
truly yours,
Biofrontera
Inc.
/s/ Erica L. Monaco
Name:
Erica
L. Monaco
Title:
Chief
Executive Officer
cc:
Hermann
Luebbert
Biofrontera
Inc.
Stephen
Older
McGuireWoods
LLP
Biofrontera
Inc. . 120 Presidential Way, Suite 330 . Woburn, MA 01801 . USA
Contact
Phone +1 781 245 1325 . E-Mail info-us@biofrontera.com . www.biofrontera-us.com
2022-08-30 - UPLOAD - Biofrontera Inc.
United States securities and exchange commission logo
August 30, 2022
Erica Monaco
Chief Executive Officer
Biofrontera Inc.
120 Presidential Way, Suite 330
Woburn, MA 01801
Re:Biofrontera Inc.
Draft Registration Statement on Form S-1
Submitted August 29, 2022
CIK No. 0001858685
Dear Ms. Monaco:
This is to advise you that we do not intend to review your registration statement.
We request that you publicly file your registration statement no later than 48 hours prior
to the requested effective date and time. 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 Dillon Hagius at 202-551-7967 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Andrew J. Terjesen
2022-06-07 - CORRESP - Biofrontera Inc.
CORRESP
1
filename1.htm
Biofrontera
Inc. · 120 Presidential Way, Suite 330 · Woburn, MA 01801 · USA
VIA
EDGAR
June
7, 2022
Securities
and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Biofrontera
Inc.
Registration
Statement on Form S-1 (File No. 333-265467)
Request
for Acceleration of Effective Date
Ladies
and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Biofrontera Inc. (the “Registrant”) hereby requests that
the Securities and Exchange Commission (the “Commission”) accelerate the effective date of the above-referenced Registration
Statement on Form S-1 (as amended, the “Registration Statement”) so that the Registration Statement will be declared
effective as of 4:30 p.m. Eastern time, on June 9, 2022, or as soon thereafter as practicable. The
Registrant hereby also authorizes Stephen Older and Andrew Terjesen of McGuireWoods LLP to orally modify or withdraw this request for
acceleration.
Once
the Registration Statement has been declared effective, please orally confirm that event with Stephen Older of McGuireWoods LLP at (212)
548-2122, or in his absence, Andrew Terjesen at (704) 343-2024.
Thank
you for your assistance in this matter.
Very
truly yours,
Biofrontera
Inc.
/s/
Erica L. Monaco
Name:
Erica
L. Monaco
Title:
Chief
Executive Officer
cc:
Hermann
Luebbert
Biofrontera
Inc.
Stephen
Older
McGuireWoods
LLP
Biofrontera
Inc. . 120 Presidential Way, Suite 330 . Woburn, MA 01801 . USA
Contact
Phone +1 781 245 1325 . E-Mail info-us@biofrontera.com . www.biofrontera-us.com
2022-06-01 - UPLOAD - Biofrontera Inc.
United States securities and exchange commission logo
June 1, 2022
Erica Monaco
Chief Executive Officer
Biofrontera Inc.
120 Presidential Way, Suite 330
Woburn, MA 01801
Re:Biofrontera Inc.
Draft Registration Statement on Form S-1
Submitted May 27, 2022
CIK No. 0001858685
Dear Ms. Monaco:
This is to advise you that we do not intend to review your registration statement.
We request that you publicly file your registration statement no later than 48 hours prior
to the requested effective date and time. 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 Michael Davis at 202-551-4385 or Celeste Murphy at 202-551-3257 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Stephen Older
2021-12-21 - CORRESP - Biofrontera Inc.
CORRESP
1
filename1.htm
Biofrontera
Inc
120
Presidential Way, Suite 330
Woburn,
MA 01801 USA
VIA EDGAR
December
21, 2021
Securities
and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Biofrontera
Inc.
Registration
Statement on Form S-1 (File No. 333-261812)
Request
for Acceleration of Effective Date
Ladies
and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Biofrontera Inc. (the “Registrant”) hereby requests that
the Securities and Exchange Commission (the “Commission”) accelerate the effective date of the above-referenced Registration
Statement on Form S-1 (as amended, the “Registration Statement”) so that the Registration Statement will be declared
effective as of 5:00 p.m. Eastern time, on December 23, 2021, or as soon thereafter as practicable. The
Registrant hereby also authorizes Stephen Older and Andrew Terjesen of McGuireWoods LLP to orally modify or withdraw this request for
acceleration.
Once
the Registration Statement has been declared effective, please orally confirm that event with Stephen Older of McGuireWoods LLP at (212)
548-2122, or in his absence, Andrew Terjesen at (704) 343-2024.
Thank
you for your assistance in this matter.
Very
truly yours,
Biofrontera
Inc.
/s/
Erica Monaco
Name:
Erica
Monaco
Title:
Chief
Executive Officer
cc:
Hermann
Luebbert
Biofrontera
Inc.
Stephen
Older
McGuireWoods
LLP
Biofrontera
Inc. 120 Presidential Way, Suite 330 Woburn, MA 01801 USA
Contact
Phone +1 781 245 1325 Email info-us@biofrontera.com www.biofrontera-us.com
Page 1 of 1
2021-12-16 - UPLOAD - Biofrontera Inc.
United States securities and exchange commission logo
December 16, 2021
Erica Monaco
Chief Executive Officer
Biofrontera Inc.
120 Presidential Way, Suite 330
Woburn, MA 01801
Re:Biofrontera Inc.
Draft Registration Statement on Form S-1
Submitted December 14, 2021
CIK No. 0001858685
Dear Ms. Monaco:
This is to advise you that we do not intend to review your registration statement.
We request that you publicly file your registration statement no later than 48 hours prior
to the requested effective date and time. 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 Margaret Schwartz at 202-551-7153 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Stephen Older, Esq.
2021-10-27 - CORRESP - Biofrontera Inc.
CORRESP
1
filename1.htm
October
27, 2021
VIA
EDGAR
U.S.
Securities and Exchange Commission Division of Corporation Finance
100
F Street, N.E. Washington, D.C. 20549
Re:
Biofrontera
Inc.
Registration
Statement on Form S-1, as amended (File No. 333-257722)
Request
for Acceleration of Effective Date
Ladies
and Gentlemen:
In
accordance with Rule 461 under the Securities Act of 1933, as amended (the “Act”), Roth Capital Partners, LLC and The Benchmark
Company, LLC, as representatives of several underwriters, hereby join Biofrontera Inc. (the “Company”) in requesting that
the Securities and Exchange Commission take appropriate action to cause the Registration Statement on Form S-1 (File No. 333-257722)
(the “Registration Statement”) to become effective on Thursday, October 28, 2021, at 4:30 p.m., Eastern Time,
or as soon thereafter as practicable, or at such other time as the Company or its outside counsel, McGuireWoods LLP, request by telephone
that such Registration Statement be declared effective.
Pursuant
to Rule 460 of the General Rules and Regulations of the Securities and Exchange Commission under the Act, we wish to advise you that
copies of the Company’s Preliminary Prospectus, dated October 26, 2021, were furnished to several prospective underwriters and
distributed by the underwriters approximately as follows through the date hereof: 500 copies to institutional investors and 100
copies to others.
The
undersigned advise that they have complied and will continue to comply with, and that they have been informed by the participating underwriters
and dealers that they have complied with and will continue to comply with, the requirements of Rule 15c2-8 under the Securities Exchange
Act of 1934, as amended.
Very
truly yours,
Roth
Capital Partners, LLC
By:
/s/
Aaron M. Gurewitz
Name:
Aaron
M. Gurewitz
Title:
Head
of Equity Capital Markets
The
Benchmark Company, LLC
By:
/s/
Michael S. Jacobs
Name:
Michael
S. Jacobs
Title:
Head
of Equity Capital Markets
2021-10-27 - CORRESP - Biofrontera Inc.
CORRESP
1
filename1.htm
Biofrontera
Inc. · 120 Presidential Way, Suite 330 · Woburn, MA 01801 · USA
VIA
EDGAR
October
27, 2021
Securities
and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549
Attn:
Abby
Adams
Suzanne
Hayes
Tara
Harkins
Brian
Cascio
Re:
Biofrontera
Inc.
Registration
Statement on Form S-1, as amended (File No. 333-257722)
Request
for Acceleration of Effective Date
Ladies
and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Biofrontera Inc. (the “Company”) hereby requests that the
Securities and Exchange Commission (the “Commission”) accelerate the effective date of the above-referenced Registration
Statement on Form S-1 (as amended, the “Registration Statement”) so that the Registration Statement will be declared
effective as of 4:30 p.m. Eastern time, on October 28, 2021, or as soon thereafter as practicable.
Once
the Registration Statement has been declared effective, please orally confirm that event with Erica Monaco of the Company at (781) 486-1502,
or in her absence, Stephen Older of McGuireWoods LLP at (212) 548-2122.
We
understand that the staff of the Commission will consider this request as confirmation by the Company that it is aware of its responsibilities
under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement. If you have
any questions regarding the foregoing, please contact Stephen Older of McGuireWoods LLP at the number set forth above.
Under
separate cover, you will receive today a letter from the underwriters of the proposed offering joining in the Company’s request
for acceleration of the effectiveness of the Registration Statement.
Thank
you for your assistance in this matter.
[Signature
page follows]
Very
truly yours,
Biofrontera
Inc.
/s/
Erica Monaco
Name:
Erica
Monaco
Title:
Chief
Financial Officer and Chief Operating Officer
cc:
Hermann
Luebbert
Biofrontera
Inc.
Stephen
Older
McGuireWoods
LLP
Biofrontera
Inc. . 120 Presidential Way, Suite 330 . Woburn, MA 01801 . USA
Page
2 of 2
Contact
Phone +1 781 245 1325 . E-Mail info-us@biofrontera.com . www.biofrontera-us.com
Board
of Directors Prof. Dr. Hermann Luebbert (CEO & Chair) . Erica Monaco (CFO & COO)
2021-10-20 - CORRESP - Biofrontera Inc.
CORRESP
1
filename1.htm
Biofrontera
Inc. · 120 Presidential Way, Suite 330 · Woburn, MA 01801 · USA
VIA
EDGAR
October
20, 2021
Securities
and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549
Attn:
Abby
Adams
Suzanne
Hayes
Tara
Harkins
Brian
Cascio
Re:
Biofrontera
Inc.
Registration
Statement on Form S-1, as amended (File No. 333-257722)
Withdrawal
of Prior Acceleration Request
Ladies
and Gentlemen:
Reference
is made to our letter, filed as correspondence with the U.S. Securities and Exchange Commission via EDGAR on October 18, 2021, in which
we requested the acceleration of the effective date of the above-captioned Registration Statement, as amended, to 4:30 p.m., Eastern
time, on October 19, 2021. We are no longer requesting that the Registration Statement be declared effective at that date and time, and
we hereby formally withdraw our prior request for acceleration of the effective date of the above-captioned Registration Statement, as
amended.
Very
truly yours,
Biofrontera
Inc.
/s/
Erica Monaco
Name:
Erica
Monaco
Title:
Chief
Financial Officer and Chief Operating Officer
cc:
Hermann
Luebbert
Biofrontera
Inc.
Stephen
Older
McGuireWoods
LLP
Biofrontera
Inc. . 120 Presidential Way, Suite 330 . Woburn, MA 01801 . USA
Contact
Phone +1 781 245 1325 . E-Mail info-us@biofrontera.com .
www.biofrontera.us.com
Board
of Directors Prof. Dr. Hermann Luebbert (CEO & Chair) . Erica Monaco (CFO & COO)
2021-10-20 - CORRESP - Biofrontera Inc.
CORRESP
1
filename1.htm
October
20, 2021
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Biofrontera
Inc.
Registration
Statement on Form S-1, as amended (File No. 333-257722)
Withdrawal
of Prior Acceleration Request
Ladies
and Gentlemen:
Reference
is made to our letter, filed as correspondence with the U.S. Securities and Exchange Commission via EDGAR on October 18, 2021, in which
we requested the acceleration of the effective date of the above-captioned Registration Statement, as amended, to 4:30 p.m., Eastern
Time, on October 19, 2021. We are no longer requesting that the Registration Statement be declared effective at that date and time, and
we hereby formally withdraw our prior request for acceleration of the effective date of the above-captioned Registration Statement, as
amended.
Very
truly yours,
Roth
Capital Partners, LLC
By:
/s/
Aaron M. Gurewitz
Name:
Aaron
M. Gurewitz
Title:
Head
of Equity Capital Markets
The
Benchmark Company, LLC
By:
/s/
Michael S. Jacobs
Name:
Michael
S. Jacobs
Title:
Head
of Equity Capital Markets
2021-10-18 - CORRESP - Biofrontera Inc.
CORRESP
1
filename1.htm
Biofrontera
Inc. · 120 Presidential Way, Suite 330 · Woburn, MA 01801 · USA
VIA
EDGAR
October
18, 2021
Securities
and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549
Attn:
Abby
Adams
Suzanne
Hayes
Tara
Harkins
Brian
Cascio
Re:
Biofrontera
Inc.
Registration
Statement on Form S-1, as amended (File No. 333-257722)
Request
for Acceleration of Effective Date
Ladies
and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Biofrontera Inc. (the “Company”) hereby requests that the
Securities and Exchange Commission (the “Commission”) accelerate the effective date of the above-referenced Registration
Statement on Form S-1 (as amended, the “Registration Statement”) so that the Registration Statement will be declared
effective as of 4:30 p.m. Eastern time, on October 19, 2021, or as soon thereafter as practicable.
Once
the Registration Statement has been declared effective, please orally confirm that event with Erica Monaco of the Company at (781) 486-1502,
or in her absence, Stephen Older of McGuireWoods LLP at (212) 548-2122.
We
understand that the staff of the Commission will consider this request as confirmation by the Company that it is aware of its responsibilities
under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement. If you have
any questions regarding the foregoing, please contact Stephen Older of McGuireWoods LLP at the number set forth above.
Under
separate cover, you will receive today a letter from the underwriters of the proposed offering joining in the Company’s request
for acceleration of the effectiveness of the Registration Statement.
Thank
you for your assistance in this matter.
[Signature
page follows]
Very
truly yours,
Biofrontera
Inc.
/s/
Erica Monaco
Name:
Erica
Monaco
Title:
Chief
Financial Officer and Chief Operating Officer
cc:
Hermann
Luebbert
Biofrontera
Inc.
Stephen
Older
McGuireWoods
LLP
Biofrontera
Inc. . 120 Presidential Way, Suite 330 . Woburn, MA 01801 . USA
Page
2 of 2
Contact
Phone +1 781 245 1325 . E-Mail info-us@biofrontera.com . www.biofrontera-us.com
Board
of Directors Prof. Dr. Hermann Luebbert (CEO & Chair) . Erica Monaco (CFO & COO)
2021-10-18 - CORRESP - Biofrontera Inc.
CORRESP
1
filename1.htm
October
18, 2021
VIA
EDGAR
U.S.
Securities and Exchange Commission Division of Corporation Finance
100
F Street, N.E. Washington, D.C. 20549
Re:
Biofrontera
Inc.
Registration
Statement on Form S-1, as amended (File No. 333-257722)
Request
for Acceleration of Effective Date
Ladies
and Gentlemen:
In
accordance with Rule 461 under the Securities Act of 1933, as amended (the “Act”), Roth Capital Partners, LLC and The Benchmark
Company, LLC, as representatives of several underwriters, hereby join Biofrontera Inc. (the “Company”) in requesting that
the Securities and Exchange Commission take appropriate action to cause the Registration Statement on Form S-1 (File No. 333-257722)
(the “Registration Statement”) to become effective on Tuesday, October 19, 2021, at 4:30 p.m., Eastern Time, or as
soon thereafter as practicable, or at such other time as the Company or its outside counsel, McGuireWoods LLP, request by telephone that
such Registration Statement be declared effective.
Pursuant
to Rule 460 of the General Rules and Regulations of the Securities and Exchange Commission under the Act, we wish to advise you that
copies of the Company’s Preliminary Prospectus, dated October 14, 2021, were furnished to several prospective underwriters
and distributed by the underwriters approximately as follows through the date hereof: 1,600 copies to institutional investors
and 25 copies to others.
The
undersigned advise that they have complied and will continue to comply with, and that they have been informed by the participating underwriters
and dealers that they have complied with and will continue to comply with, the requirements of Rule 15c2-8 under the Securities Exchange
Act of 1934, as amended.
Very
truly yours,
Roth
Capital Partners, LLC
By:
/s/
Aaron M. Gurewitz
Name:
Aaron
M. Gurewitz
Title:
Head
of Equity Capital Markets
The
Benchmark Company, LLC
By:
/s/
Michael S. Jacobs
Name:
Michael
S. Jacobs
Title:
Head
of Equity Capital Markets
2021-10-14 - UPLOAD - Biofrontera Inc.
United States securities and exchange commission logo
October 14, 2021
Hermann Lubbert, Ph.D.
Chief Executive Officer
Biofrontera Inc.
120 Presidential Way, Suite 330
Woburn, MA 01801
Re:Biofrontera Inc.
Amendment No. 8 to Registration Statement on Form S-1
Filed October 14, 2021
File No. 333-257722
Dear Dr. Lubbert:
We have reviewed your amended registration statement and have the following
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 these comments, we may have additional comments.
Amendment No. 8 to Registration Statement on Form S-1
Summary, page 1
1.We reissue our oral comment as further discussed this morning. As discussed, as Ameluz
has not been submitted to the FDA for an IND for all indications included in the product
table, including those indicated as "Phase III," revise the product development table to
depict the products in a traditional pipeline format, indicating the current FDA status of all
indications. For those indications for which an IND has not been submitted, remove them
from the pipeline table to the extent they are not material. To the extent indications for
which an IND has not been submitted are material, indicate the expected IND submission
date, to the extent known.
FirstName LastNameHermann Lubbert, Ph.D.
Comapany NameBiofrontera Inc.
October 14, 2021 Page 2
FirstName LastName
Hermann Lubbert, Ph.D.
Biofrontera Inc.
October 14, 2021
Page 2
You may contact Tara Harkins at (202) 551-3639 or Brian Cascio at (202) 551-3676 if
you have questions regarding the financial statements and related matters. Please contact Abby
Adams at (202) 551-6902 or Celeste Murphy at (202) 551-3257 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Stephen E. Older, Esq.
2021-10-14 - CORRESP - Biofrontera Inc.
CORRESP
1
filename1.htm
Biofrontera
Inc · 120 Presidential Way, Suite 330 · Woburn, MA 01801 · USA
VIA
EDGAR AND EMAIL
October
14, 2021
Securities
and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549
Attn:
Abby
Adams
Suzanne
Hayes
Tara
Harkins
Brian
Cascio
Re:
Biofrontera
Inc.
Amendment
No. 8 to Registration Statement on Form S-1
Filed
October 14, 2021
File
No. 333-257722
We
are submitting this letter in response to the comment letter, dated October 14, 2021, of the staff of the Division of Corporation Finance
(the “Staff”) of the Securities and Exchange Commission (the “Commission”) with respect to the
above-referenced filing. This letter and our Amendment No. 9 to the Registration Statement on Form S-1 (the “Amendment No. 9”)
are being filed with the Commission electronically today. In addition to the electronic filing, we are delivering via email a copy of
this letter, along with a courtesy copy of the Amendment No. 9 marked to indicate changes from our Amendment No. 8 to the Registration
Statement filed on October 14, 2021. Our response is set forth in ordinary type beneath the Staff comment, which is set out in bold type.
The page references in our response are to the pages in the clean version of our Amendment No. 9.
Amendment
No. 8 to Registration Statement on Form S-1 filed on October 14, 2021
Summary,
page 1
1.
We
reissue our oral comment as further discussed this morning. As discussed, as Ameluz has not been submitted to the FDA for an IND
for all indications included in the product table, including those indicated as “Phase III,” revise the product development
table to depict the products in a traditional pipeline format, indicating the current FDA status of all indications. For those indications
for which an IND has not been submitted, remove them from the pipeline table to the extent they are not material. To the extent indications
for which an IND has not been submitted are material, indicate the expected IND submission date, to the extent known.
Response:
We
acknowledge the Staff’s comment and respectfully advise the Staff that we have revised the disclosure on pages 2 and 64 to replace
the tables included in Amendment No. 8 to the Registration Statement with a revised product development table, identical to the table
shared with the Staff earlier today, in a traditional pipeline format for clinical studies we have presented to the FDA and with
more detail about the status of these clinical studies. We respectfully inform the Staff, as indicated in our revised disclosure, that
we have been able to conduct these studies under the original IND application for Ameluz® that was submitted to the FDA
in 2017 for the development of Ameluz®/BF-RhodoLED® to treat superficial basal cell carcinoma, and
later amended to include the BF-RhodoLED® XL lamp, as the FDA has a policy to allow multiple indications to be
conducted under the same IND as long as the formulation is the same and it is submitted to the same FDA reviewing division.
If
you have any questions regarding this letter or the Registration Statement, please contact the undersigned at e.monaco@biofrontera.com
or (781) 486-1502.
Very
truly yours,
Biofrontera
Inc.
/s/
Erica Monaco
Name:
Erica
Monaco
Title:
Chief
Financial Officer and Chief Operating Officer
cc:
Hermann
Luebbert
Biofrontera
Inc.
Stephen
Older
McGuireWoods
LLP
Ralph
De Martino
Schiff
Hardin LLP
Biofrontera
Inc. · 120 Presidential Way, Suite 330 · Woburn, MA 01801 · USA
Page
2 of 2
Contact
Phone +1 781 245 1325 · E-Mail info-us@biofrontera.com ·
www.biofrontera.us.com
Board
of Directors Prof. Dr. Hermann Luebbert (CEO & Chair) · Erica Monaco (CFO & COO)
2021-10-13 - CORRESP - Biofrontera Inc.
CORRESP
1
filename1.htm
Biofrontera
Inc · 120 Presidential Way, Suite 330 · Woburn, MA 01801 · USA
VIA
EDGAR AND EMAIL
October
13, 2021
Securities
and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549
Attn:
Abby
Adams
Suzanne
Hayes
Tara
Harkins
Brian
Cascio
Re:
Biofrontera
Inc.
Amendment
No. 6 to Registration Statement on Form S-1
Filed
October 8, 2021
File
No. 333-257722
We
are submitting this letter in response to the comment letter, dated October 12, 2021, of the staff of the Division of Corporation Finance
(the “Staff”) of the Securities and Exchange Commission (the “Commission”) with respect to the
above-referenced filing. This letter and our Amendment No. 7 to the Registration Statement on Form S-1 (the “Amendment No. 7”)
are being filed with the Commission electronically today. In addition to the electronic filing, we are delivering via email a copy of
this letter, along with a courtesy copy of the Amendment No. 7 marked to indicate changes from our Amendment No. 6 to the Registration
Statement filed on October 8, 2021. Our response is set forth in ordinary type beneath the Staff comment, which is set out in bold type.
The page references in our response are to the pages in the clean version of our Amendment No. 7.
Amendment
No. 6 to Registration Statement on Form S-1 filed on October 8, 2021
Summary,
page 1
1.
Revise
the document to reflect the material changes to your license agreement for Ameluz throughout. We note in particular that it appears
Biofrontera Inc. no longer “has the authority under the Ameluz LSA in certain circumstances to take over clinical development,
regulatory work and manufacturing from the Biofrontera Group if they are unable or unwilling to perform [clinical development and
other] functions appropriately” as disclosed in the fourth full summary risk factor on page 8 and the risk factor on page 18,
where you also note you are “entitled to take over clinical trial and regulatory work under certain circumstances and subtract
the cost of the trials from the transfer price of Ameluz.” if Biofrontera affiliates determine not to go forward with development.
We note similar disclosure in the second paragraph under the Ameluz product development timeline table on page 65. Revise the summary
on page 1, the summary risk factors, the risk factor on page 18 and throughout the document to reflect this change. Include this
disclosure with both Ameluz development tables. In addition, clarify how Biofrontera Inc. intends to seek development of products
not currently in the pipeline and thus covered by the Ameluz LSA, or if they do not intend to pursue the product line further, or
whether Biofrontera AG may grant those rights to another affiliate.
Response:
We
acknowledge the Staff’s comment and respectfully advise the Staff that the Amendment to the Amended and Restated License and Supply
Agreement dated October 8, 2021 that was filed as Exhibit 10.17 to Amendment No. 6 to the Registration Statement did not reflect
the intent of the negotiations between us and Biofrontera AG with respect to the revisions of Section 7.1(c) of the Ameluz LSA. An understanding
had been reached that we would not be able to take control of trials for future indications, but it was not the intent of the parties
to remove our ability to exert control over clinical development with respect to indications that are currently being pursued
by Biofrontera AG which are listed in the product development timeline table on pages 2 and 64. To rectify this error in drafting,
we have entered into a Corrected Amendment to the Ameluz LSA, effective as of October 8, 2021, which clarifies that we retain the ability
to exert control over clinical development with respect to those indications.
In
addition, we have revised the disclosure on pages 1, 2, 3, 8, 18, 47, 64, 65, 72, 76 and F-27 to increase the prominence of the disclosure
regarding the Ameluz LSA, as amended, as well as to clarify how indications that are not currently in development will be treated.
We
respectfully advise the staff that we have filed the Corrected Amendment to the Amended and Restated License and Supply Agreement as
Exhibit 10.17 to Amendment No. 7.
If
you have any questions regarding this letter or the Registration Statement, please contact the undersigned at e.monaco@biofrontera.com
or (781) 486-1502.
Very
truly yours,
Biofrontera
Inc.
/s/
Erica Monaco
Name:
Erica
Monaco
Title:
Chief
Financial Officer and Chief Operating Officer
cc:
Hermann
Luebbert
Biofrontera
Inc.
Stephen
Older
McGuireWoods
LLP
Ralph
De Martino
Schiff
Hardin LLP
Biofrontera
Inc. · 120 Presidential Way, Suite 330 · Woburn, MA 01801 · USA
Page
2 of 2
Contact Phone +1 781 245 1325 · E-Mail info-us@biofrontera.com ·
www.biofrontera.us.com
Board
of Directors Prof. Dr. Hermann Luebbert (CEO & Chair) · Erica Monaco (CFO & COO)
2021-10-13 - CORRESP - Biofrontera Inc.
CORRESP
1
filename1.htm
Biofrontera
Inc. · 120 Presidential Way, Suite 330 · Woburn, MA 01801 · USA
VIA
EDGAR
October
13, 2021
Securities
and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549
Attn:
Abby
Adams
Suzanne
Hayes
Tara
Harkins
Brian
Cascio
Re:
Biofrontera
Inc.
Registration
Statement on Form S-1, as amended (File No. 333-257722)
Withdrawal
of Prior Acceleration Request
Ladies
and Gentlemen:
Reference
is made to our letter, filed as correspondence with the U.S. Securities and Exchange Commission via EDGAR on October 8, 2021, in which
we requested the acceleration of the effective date of the above-captioned Registration Statement, as amended, to 4:30 p.m., Eastern
time, on October 12, 2021. We are no longer requesting that the Registration Statement be declared effective at that date and time, and
we hereby formally withdraw our prior request for acceleration of the effective date of the above-captioned Registration Statement, as
amended.
Very
truly yours,
Biofrontera
Inc.
/s/ Erica Monaco
Name:
Erica
Monaco
Title:
Chief
Financial Officer and Chief Operating Officer
cc:
Hermann
Luebbert
Biofrontera
Inc.
Stephen
Older
McGuireWoods
LLP
Biofrontera
Inc. . 120 Presidential Way, Suite 330 . Woburn, MA 01801 . USA
Contact Phone +1 781 245 1325 . E-Mail info-us@biofrontera.com .
www.biofrontera.us.com
Board of Directors Prof. Dr. Hermann Luebbert (CEO & Chair) . Erica Monaco (CFO &
COO)
2021-10-13 - CORRESP - Biofrontera Inc.
CORRESP
1
filename1.htm
October
13, 2021
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Biofrontera
Inc.
Registration
Statement on Form S-1, as amended (File No. 333-257722)
Withdrawal
of Prior Acceleration Request
Ladies
and Gentlemen:
Reference
is made to our letter, filed as correspondence with the U.S. Securities and Exchange Commission via EDGAR on October 8, 2021, in which
we requested the acceleration of the effective date of the above-captioned Registration Statement, as amended, to 4:30 p.m., Eastern
Time, on October 12, 2021. We are no longer requesting that the Registration Statement be declared effective at that date and time, and
we hereby formally withdraw our prior request for acceleration of the effective date of the above-captioned Registration Statement, as
amended.
Very truly yours,
Roth
Capital Partners, LLC
By:
/s/
Aaron M. Gurewitz
Name:
Aaron
M. Gurewitz
Title:
Head
of Equity Capital Markets
The
Benchmark Company, LLC
By:
/s/
Michael S. Jacobs
Name:
Michael
S. Jacobs
Title:
Head
of Equity Capital Markets
2021-10-12 - UPLOAD - Biofrontera Inc.
United States securities and exchange commission logo
October 12, 2021
Hermann Lubbert, Ph.D.
Chief Executive Officer
Biofrontera Inc.
120 Presidential Way, Suite 330
Woburn, MA 01801
Re:Biofrontera Inc.
Amendment No. 6 to Registration Statement on Form S-1
Filed October 8, 2021
File No. 333-257722
Dear Dr. Lubbert:
We have reviewed your amended registration statement and have the following
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 our comment, we may have additional comments.
Amendment No. 6 to Registration Statement on Form S-1
Summary, page 1
1.Revise the document to reflect the material changes to your license agreement for Ameluz
throughout. We note in particular that it appears Biofrontera Inc. no longer "has the
authority under the Ameluz LSA in certain circumstances to take over clinical
development, regulatory work and manufacturing from the Biofrontera Group if they are
unable or unwilling to perform [clinical development and other] functions appropriately"
as disclosed in the fourth full summary risk factor on page 8 and the risk factor on page
18, where you also note you are "entitled to take over clinical trial and regulatory work
under certain circumstances and subtract the cost of the trials from the transfer price of
Ameluz." if Biofrontera affiliates determine not to go forward with development. We
note similar disclosure in the second paragraph under the Ameluz product development
timeline table on page 65. Revise the summary on page 1, the summary risk factors, the
risk factor on page 18 and throughout the document to reflect this change. Include this
disclosure with both Ameluz development tables. In addition, clarify how Biofrontera
FirstName LastNameHermann Lubbert, Ph.D.
Comapany NameBiofrontera Inc.
October 12, 2021 Page 2
FirstName LastName
Hermann Lubbert, Ph.D.
Biofrontera Inc.
October 12, 2021
Page 2
Inc. intends to seek development of products not currently in the pipeline and thus covered
by the Ameluz LSA, or if they do not intend to pursue the product line further, or whether
Biofrontera AG may grant those rights to another affiliate.
You may contact Tara Harkins at (202) 551-3639 or Brian Cascio at (202) 551-3676 if
you have questions regarding comments on the financial statements and related matters. Please
contact Abby Adams at (202) 551-6902 or Celeste Murphy at (202) 551-3257 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Stephen E. Older, Esq.
2021-10-08 - CORRESP - Biofrontera Inc.
CORRESP
1
filename1.htm
Biofrontera
Inc · 120 Presidential Way, Suite 330 · Woburn, MA 01801 · USA
VIA
EDGAR AND EMAIL
October
8, 2021
Securities
and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549
Attn:
Abby
Adams
Suzanne
Hayes
Tara
Harkins
Brian
Cascio
Re:
Biofrontera
Inc.
Amendment
No. 5 to Registration Statement on Form S-1
Filed
October 1, 2021
File
No. 333-257722
We
are submitting this letter in response to the comment letter, dated October 7, 2021, of the staff of the Division of Corporation Finance
(the “Staff”) of the Securities and Exchange Commission (the “Commission”) with respect to the
above-referenced filing. This letter and our Amendment No. 6 to the Registration Statement on Form S-1 (the “Amendment No. 6”)
are being filed with the Commission electronically today. In addition to the electronic filing, we are delivering via email a copy of
this letter, along with a courtesy copy of the Amendment No. 6 marked to indicate changes from the Amendment No. 5 to the Registration
Statement filed on October 1, 2021. In addition to addressing the comment raised by the Staff in its letter, we have revised the Amendment
No. 6 to update other disclosures. Our response is set forth in ordinary type beneath the Staff comment, which is set out in bold type.
The page references in our response is to the pages in the clean version of the Amendment No. 6.
Amendment
No. 5 to Registration Statement on Form S-1 filed on October 1, 2021
Recent
Developments, page 4
1.
Please
revise your presentation of financial results for the quarter and nine months ended September 30, 2021 to also disclose your estimated
expenses and net income/loss for the period in addition to the presentation of estimated revenues.
Response:
We
acknowledge the Staff’s comment and respectfully advise the Staff that we have revised the disclosure on page 4 to disclose the
estimated expenses and net income/loss for the quarter and nine months ended September 30, 2021.
If
you have any questions regarding this letter or the Registration Statement, please contact the undersigned at e.monaco@biofrontera.com
or (781) 486-1502.
Very
truly yours,
Biofrontera
Inc.
/s/
Erica Monaco
Name:
Erica
Monaco
Title:
Chief
Financial Officer and Chief Operating Officer
cc:
Hermann
Luebbert
Biofrontera
Inc.
Stephen
Older
McGuireWoods
LLP
Ralph
De Martino
Schiff
Hardin LLP
Biofrontera
Inc. · 120 Presidential Way, Suite 330 · Woburn, MA 01801 · USA
Page
2 of 2
Contact
Phone +1 781 245 1325 · E-Mail info-us@biofrontera.com · www.biofrontera.us.com
Board
of Directors Prof. Dr. Hermann Luebbert (CEO & Chair) · Erica Monaco (CFO & COO)
2021-10-08 - CORRESP - Biofrontera Inc.
CORRESP
1
filename1.htm
Biofrontera
Inc. · 120 Presidential Way, Suite 330 · Woburn, MA 01801 · USA
VIA
EDGAR AND EMAIL
October
8, 2021
Securities
and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549
Attn:
Abby
Adams
Suzanne
Hayes
Tara
Harkins
Brian
Cascio
Re:
Biofrontera
Inc.
Registration
Statement on Form S-1, as amended (File No. 333-257722)
Request
for Acceleration of Effective Date
Ladies
and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Biofrontera Inc. (the “Company”) hereby requests that the
Securities and Exchange Commission (the “Commission”) accelerate the effective date of the above-referenced Registration
Statement on Form S-1 (as amended, the “Registration Statement”) so that the Registration Statement will be declared
effective as of 4:30 p.m. Eastern time, on October 12, 2021, or as soon thereafter as practicable.
Once
the Registration Statement has been declared effective, please orally confirm that event with Erica Monaco of the Company at (781) 486-1502,
or in her absence, Stephen Older of McGuireWoods LLP at (212) 548-2122.
We
understand that the staff of the Commission will consider this request as confirmation by the Company that it is aware of its responsibilities
under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement. If you have
any questions regarding the foregoing, please contact Stephen Older of McGuireWoods LLP at the number set forth above.
Under
separate cover, you will receive today a letter from the underwriters of the proposed offering joining in the Company’s request
for acceleration of the effectiveness of the Registration Statement.
Thank
you for your assistance in this matter.
[Signature
page follows]
Very
truly yours,
Biofrontera
Inc.
/s/
Erica Monaco
Name:
Erica
Monaco
Title:
Chief
Financial Officer and Chief Operating Officer
cc:
Hermann
Luebbert
Biofrontera
Inc.
Stephen
Older
McGuireWoods
LLP
Biofrontera Inc. . 120 Presidential Way, Suite 330 . Woburn, MA 01801 . USA Page
2 of
2
Contact Phone +1 781 245 1325 . E-Mail info-us@biofrontera.com . www.biofrontera.us.com
Board of Directors Prof. Dr. Hermann Luebbert (CEO & Chair) . Erica Monaco (CFO & COO)
2021-10-08 - CORRESP - Biofrontera Inc.
CORRESP
1
filename1.htm
October
8, 2021
VIA
EDGAR
U.S.
Securities and Exchange Commission Division of Corporation Finance
100
F Street, N.E. Washington, D.C. 20549
Re:
Biofrontera
Inc.
Registration
Statement on Form S-1, as amended (File No. 333-257722)
Request
for Acceleration of Effective Date
Ladies
and Gentlemen:
In
accordance with Rule 461 under the Securities Act of 1933, as amended (the “Act”), Roth Capital Partners, LLC and The Benchmark
Company, LLC, as representatives of several underwriters, hereby join Biofrontera Inc. (the “Company”) in requesting that
the Securities and Exchange Commission take appropriate action to cause the Registration Statement on Form S-1 (File No. 333-257722)
(the “Registration Statement”) to become effective on Tuesday, October 12, 2021, at 4:30 p.m., Eastern Time, or as soon thereafter
as practicable, or at such other time as the Company or its outside counsel, McGuireWoods LLP, request by telephone that such Registration
Statement be declared effective.
Pursuant
to Rule 460 of the General Rules and Regulations of the Securities and Exchange Commission under the Act, we wish to advise you that
copies of the Company’s Preliminary Prospectus, dated October 1, 2021, were furnished to several prospective underwriters and distributed
by the underwriters approximately as follows through the date hereof: 1,500 copies to institutional investors and 17 copies to others.
The
undersigned advise that they have complied and will continue to comply with, and that they have been informed by the participating underwriters
and dealers that they have complied with and will continue to comply with, the requirements of Rule 15c2-8 under the Securities Exchange
Act of 1934, as amended.
Very
truly yours,
Roth
Capital Partners, LLC
By:
/s/
Aaron M. Gurewitz
Name:
Aaron
M. Gurewitz
Title:
Head
of Equity Capital Markets
The
Benchmark Company, LLC
By:
/s/
Michael S. Jacobs
Name:
Michael
S. Jacobs
Title:
Head
of Equity Capital Markets
2021-10-07 - UPLOAD - Biofrontera Inc.
United States securities and exchange commission logo
October 7, 2021
Hermann Lubbert, Ph.D.
Chief Executive Officer
Biofrontera Inc.
120 Presidential Way, Suite 330
Woburn, MA 01801
Re:Biofrontera Inc.
Amendment No. 5 to Registration Statement on Form S-1
Filed October 1, 2021
File No. 333-257722
Dear Dr. Lubbert:
We have reviewed your amended registration statement and have the following
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.
Amendment 5 to Form S-1 filed on October 1, 2021
Recent Developments, page 4
1.Please revise your presentation of financial results for the quarter and nine months ended
September 30, 2021 to also disclose your estimated expenses and net income/loss for the
period in addition to the presentation of estimated revenues.
You may contact Tara Harkins at (202) 551-3639 or Brian Cascio at (202) 551-3676 if
you have questions regarding the financial statements and related matters. Please contact Abby
Adams at (202) 551-6902 or Suzanne Hayes at (202) 551-3675 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Stephen E. Older, Esq.
2021-09-15 - CORRESP - Biofrontera Inc.
CORRESP
1
filename1.htm
Biofrontera
Inc · 120 Presidential Way, Suite 330 · Woburn, MA 01801 · USA
VIA
EDGAR AND EMAIL
September
15, 2021
Securities
and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549
Attn:
Abby
Adams
Suzanne
Hayes
Tara
Harkins
Brian
Cascio
Re:
Biofrontera
Inc.
Amendment
No. 3 to Registration Statement on Form S-1
Filed
August 31, 2021
File
No. 333-257722
We
are submitting this letter in response to the comment letter, dated September 9, 2021, of the staff of the Division of Corporation Finance
(the “Staff”) of the Securities and Exchange Commission (the “Commission”) with respect to the
above-referenced filing. This letter and our Amendment No. 4 to the Registration Statement on Form S-1 (the “Amendment No. 4”)
are being filed with the Commission electronically today. In addition to the electronic filing, we are delivering via email a copy of
this letter, along with a courtesy copy of the Amendment No. 4 marked to indicate changes from the Amendment No. 3 to the Registration
Statement filed on August 31, 2021. In addition to addressing the comments raised by the Staff in its letter, we have revised the Amendment
No. 4 to update other disclosures. Each of our responses is set forth in ordinary type beneath the corresponding Staff comment, which
is set out in bold type. The page references in our responses are to the pages in the clean version of the Amendment No. 4.
Amendment
No. 3 to Registration Statement on Form S-1 filed on August 31, 2021
Management’s
Discussion and Analysis of Financial Condition and Results of Operations
Results
of Operations
Comparison
of the Years Ended December 31, 2019 and December 31, 2020, page 53
1. Please
revise your MD&A to explain why your cost of revenues, related party is so significant
in comparison to your related party revenues while your cost of revenues, other is so minimal
compared to your product revenues, net for each reporting period, including your comparison
of the results of operations for the six months ended June 30, 2021 compared to June 30,
2020.
Response:
We
acknowledge the Staff’s comment and respectfully advise the Staff that we have revised the disclosure on pages 51, 53 and 55
to clarify that our “Product Revenue, net” encompasses all third-party sales of our licensed products, while “Related
Party Revenues” includes only those revenues related to sales of our licensed products and associated services to affiliates of
Biofrontera AG. However, our “Cost of Revenues, Related Party” includes all purchase costs for all sales of the products
we license from Biofrontera AG and its affiliates (i.e., Ameluz® and BF-RhodoLED® lamps), and so it is
related to revenue streams that might be classified under either “Product Revenues, net” or “Related Party Revenues”
depending on whether the products are sold to third parties (which are the majority of our sales) or affiliates of Biofrontera, respectively.
On the other hand, our “Costs of Revenues, Other” represents the purchase costs of Xepi®, which has not comprised
a large portion of our sales revenue and therefore only correlates with a small portion of our Product Revenues, net. We respectfully
point out to the Staff that these items are not meant to be correlated in the manner indicated in comment 1, as the use of “related
party” with respect to revenue is intended to categorize the revenues we receive from related parties (which are not significant),
while “related party” with respect to costs is intended to categorize the amounts we pay to related parties, which is fairly
significant because our most popular products are supplied by related parties.
Business
Our Strategy, page 65
2.
We
reissue comment 1. Your revised disclosure on page 65 does not address control in the sense of the extent to which you would be able
to control Biofrontera AG if you own at least 50% of their shares, where, as discussed, German minority shareholders have significant
rights in certain situations. Furthermore, in light of Dr. Lubbert’s positions as CEO of Biofrontera Inc., Chairman of the
management board and CEO of Biofrontera AG, and managing director of all subsidiaries of Biofron[t]era AG, please clarify the extent
to which he has been involved in any discussions/negotiations regarding the control of Biofrontera AG. Also, expand your statement
that “Biofrontera AG has informed” you that it would abstain from a stockholder vote to approve the issuance of shares
needed for an exchange offer of Biofrontera AG stock, to clarify whether that notice came from the management board, Dr. Lubbert,
or some other authority at Biofrontera AG. In addition, revise your disclosure here and in your background and elsewhere in the document
to clarify Dr. Lubbert’s involvement in Biofrontera AG and its subsidiaries going forward. Include a risk factor discussing
the potential conflicts of interest related to Dr. Lubbert’s multiple roles.
Response:
We
acknowledge the Staff’s comment and respectfully advise the Staff that we have revised the disclosure on page 65 to clarify that,
as is the case with U.S. companies, owning 50% or more of the shares of Biofrontera AG would enable us to control major shareholder decisions,
including the election of the members of the supervisory board who are the equivalent of a board of directors in the United States. In
a call with the Staff on September 14, 2021 regarding this comment, we noted to the Staff that although German law provides rights to
minority shareholders that are not found under Delaware law, these rights would not limit the ability of a shareholder with more than
50% ownership to control major shareholder decisions.
In
addition, we respectfully inform the staff that we have added a risk factor on page 34 discussing potential conflicts related to Prof.
Dr. Lübbert’s multiple roles at Biofrontera AG and Biofrontera Inc. and have revised the disclosure on pages 2, 65, 88,
93, 94 and 101 regarding his multiple roles following the offering and involvement in Biofrontera AG going forward as well as to
provide further details of his compensation arrangements with us and Biofrontera AG.
Biofrontera Inc. · 120 Presidential Way, Suite 330 · Woburn, MA 01801 · USA Page 2 of 4
Contact Phone +1 781 245 1325 · E-Mail info-us@biofrontera.com · www.biofrontera.us.com
Board of Directors Prof. Dr. Hermann Luebbert (CEO & Chair) · Erica Monaco (CFO & COO)
Legal
Proceedings, page 77
3.
We
note your response to comment 2. Revise to clearly state that there is no binding agreement with Biofrontera AG based on percentage
of ownership or any other factor and provide a risk factor that also clearly states the risk that Biofrontera Inc. could incur some
or all of the litigation expenses, including any and all of an adverse judgment and/or legal fees related to the DUSA litigation.
Response:
We
acknowledge the Staff’s comment and respectfully advise the Staff that we have revised the disclosure on page 77 and added risk
factor disclosure on page 15 to clearly state that there is no binding agreement with Biofrontera AG regarding the percentage of legal
costs, and that we may incur some or all of the litigation expenses, including any and all of an adverse judgment, in each case related
to the DUSA litigation.
Executive
Compensation, page 93
4.
Revise
Executive Compensation to disclose Dr. Lubbert’s compensation at Biofrontera AG, or provide us your analysis why you believe
it is not required to be disclosed, with appropriate notes as applicable, where Dr. Lubbert’s salary is paid by the parent
company which continues to own 100% of Biofrontera Inc. Refer to Item 402(n) of Regulation SK.
Response:
We
acknowledge the Staff’s comment and respectfully advise the Staff that we have revised the disclosure on pages 93 and 94 to
further clarify the sources of Prof. Dr. Lübbert’s compensation before and after the offering related to this registration
statement. As noted in the revised disclosure, Prof. Dr. Lübbert’s services to Biofrontera Inc. have been rendered as part
of his role as Chief Executive Officer of Biofrontera AG and all compensation was paid directly to him by Biofrontera AG. Furthermore,
Biofrontera AG did not allocate a portion of his compensation to Biofrontera Inc. or seek reimbursement from Biofrontera Inc. for the
payments to him. We have not disclosed his compensation for 2019 and 2020 in the Summary Compensation Table or accompanying narrative
disclosure pursuant to Regulation S-K Compliance & Disclosure Interpretation 217.03, since Biofrontera Inc. is a subsidiary of a
public company that is going public and the compensation was previously awarded by our parent, Biofrontera AG. However, we have included
information regarding the compensation Prof. Dr. Lübbert has and will receive from our parent corporation as part of our disclosure
of executive compensation arrangements, which is also cross-referenced in our related party disclosure, in the interest of full disclosure
regarding potential conflicts of interest.
Biofrontera Inc. · 120 Presidential Way, Suite 330 · Woburn, MA 01801 · USA Page 3 of 4
Contact Phone +1 781 245 1325 · E-Mail info-us@biofrontera.com · www.biofrontera.us.com
Board of Directors Prof. Dr. Hermann Luebbert (CEO & Chair) · Erica Monaco (CFO & COO)
Certain
Relationships and Related Party Transactions
Related
Party Agreements in Effect Prior to this Offering
Service
Agreements, page 101
5.
Please
file the 2021 Services Agreement and any subsequent statements of work. To the extent you continue to rely on provisions of the 2016
Services Agreement, please also file this as an agreement.
Response:
We
acknowledge the Staff’s comment and respectfully advise the Staff that we have filed the form of the 2021 Services Agreement
as well as the 2016 Services Agreement as Exhibits 10.8 and 10.10, respectively.
If
you have any questions regarding this letter or the Registration Statement, please contact the undersigned at e.monaco@biofrontera.com
or (781) 486-1502.
Very truly yours,
Biofrontera Inc.
/s/
Erica Monaco
Name:
Erica
Monaco
Title:
Chief
Financial Officer and Chief Operating Officer
cc:
Hermann
Luebbert
Biofrontera
Inc.
Stephen
Older
McGuireWoods
LLP
Ralph
De Martino
Schiff
Hardin LLP
Biofrontera Inc. · 120 Presidential Way, Suite 330 · Woburn, MA 01801 · USA Page 4 of 4
Contact Phone +1 781 245 1325 · E-Mail info-us@biofrontera.com · www.biofrontera.us.com
Board of Directors Prof. Dr. Hermann Luebbert (CEO & Chair) · Erica Monaco (CFO & COO)
2021-09-09 - UPLOAD - Biofrontera Inc.
United States securities and exchange commission logo
September 9, 2021
Hermann Lubbert, Ph.D.
Chief Executive Officer
Biofrontera Inc.
120 Presidential Way
Suite 330
Woburn, MA 01801
Re:Biofrontera Inc.
Amendment No. 3 to Registration Statement on Form S-1
Filed August 31, 2021
File No. 333-257722
Dear Dr. Lubbert:
We have reviewed your amended registration statement 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 by amending your registration statement and providing the
requested information. 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 registration statement and the information you
provide in response to these comments, we may have additional comments. Unless we note
otherwise, our references to prior comments are to comments in our August 20, 2021 letter.
Amendment 3 to Form S-1 filed on August 31, 2021
Management's Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations
Comparison of the Years Ended December 31, 2019 and December 31, 2020, page 53
1.Please revise your MD&A to explain why your cost of revenues, related party is so
significant in comparison to your related party revenues while your cost of revenues, other
is so minimal compared to your product revenues, net for each reporting period, including
your comparison of the results of operations for the six months ended June 30, 2021
compared to June 30, 2020.
FirstName LastNameHermann Lubbert, Ph.D.
Comapany NameBiofrontera Inc.
September 9, 2021 Page 2
FirstName LastName
Hermann Lubbert, Ph.D.
Biofrontera Inc.
September 9, 2021
Page 2
Business
Our Strategy, page 65
2.We reissue comment 1. Your revised disclosure on page 65 does not address control in
the sense of the extent to which you would be able to control Biofrontera AG if you own
at least 50% of their shares, where, as discussed, German minority shareholders have
significant rights in certain situations. Furthermore, in light of Dr. Lubbert's positions as
CEO of Biofrontera Inc., Chairman of the management board and CEO of Biofrontera
AG, and managing director of all subsidiaries of Biofronera AG, please clarify the extent
to which he has been involved in any discussions/negotiations regarding the control of
Biofrontera AG. Also, expand your statement that "Biofrontera AG has informed" you
that it would abstain from a stockholder vote to approve the issuance of shares needed for
an exchange offer of Biofrontera AG stock, to clarify whether that notice came from the
management board, Dr. Lubbert, or some other authority at Biofrontera AG. In addition,
revise your disclosure here and in your background and elsewhere in the document to
clarify Dr. Lubbert's involvement in Biofrontera AG and its subsidiaries going forward.
Include a risk factor discussing the potential conflicts of interest related to Dr. Lubbert's
multiple roles.
Legal Proceedings, page 77
3.We note your response to comment 2. Revise to clearly state that there is no binding
agreement with Biofrontera AG based on percentage of ownership or any other factor and
provide a risk factor that also clearly states the risk that Biofrontera Inc. could incur some
or all of the litigation expenses, including any and all of an adverse judgment and/or legal
fees related to the DUSA litigation.
Executive Compensation , page 93
4.Revise Executive Compensation to disclose Dr. Lubbert's compensation at Biofrontera
AG, or provide us your analysis why you believe it is not required to be disclosed, with
appropriate notes as applicable, where Dr. Lubbert's salary is paid by the parent company
which continues to own 100% of Biofrontera Inc. Refer to Item 402(n) of Regulation S-
K.
Certain Relationships and Related Party Transactions
Related Party Agreements in Effect Prior to this Offering
Service Agreements, page 101
5.Please file the 2021 Services Agreement and any subsequent statements of work. To the
extent you continue to rely on provisions of the 2016 Services Agreement, please also file
this as an agreement.
FirstName LastNameHermann Lubbert, Ph.D.
Comapany NameBiofrontera Inc.
September 9, 2021 Page 3
FirstName LastName
Hermann Lubbert, Ph.D.
Biofrontera Inc.
September 9, 2021
Page 3
You may contact Tara Harkins at (202) 551-3639 or Brian Cascio at (202) 551-3676 if
you have questions regarding comments on the financial statements and related matters. Please
contact Abby Adams at (202) 551-6902 or Suzanne Hayes at (202) 551-3675 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Stephen E. Older, Esq.
2021-08-30 - CORRESP - Biofrontera Inc.
CORRESP
1
filename1.htm
Biofrontera
Inc · 120 Presidential Way, Suite 330 · Woburn, MA 01801 · USA
VIA
EDGAR AND EMAIL
August
30, 2021
Securities
and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549
Attn:
Abby Adams
Suzanne Hayes
Tara Harkins
Brian Cascio
Re:
Biofrontera
Inc.
Amendment
No. 2 to Registration Statement on Form S-1
Filed
August 12, 2021
File
No. 333-257722
We
are submitting this letter in response to the comment letter, dated August 20, 2021, of the staff of the Division of Corporation Finance
(the “Staff”) of the Securities and Exchange Commission (the “Commission”) with respect to the
above-referenced filing. This letter and our Amendment No. 3 to the Registration Statement on Form S-1 (the “Amendment No. 3”)
are being filed with the Commission electronically today. In addition to the electronic filing, we are delivering via email a copy of
this letter, along with a courtesy copy of the Amendment No. 3 marked to indicate changes from the Amendment No. 2 to the Registration
Statement filed on August 12, 2021. In addition to addressing the comments raised by the Staff in its letter, we have revised the Amendment
No. 3 to update other disclosures, including updating the financials for the six month periods ended June 30, 2021 and 2020. Each
of our responses is set forth in ordinary type beneath the corresponding Staff comment, which is set out in bold type. The page references
in our responses are to the pages in the clean version of the Amendment No. 3.
Amendment
No. 2 to Registration Statement on Form S-1 filed on August 12, 2021
Business
Our
Strategy, page 65
1. We
note your response to comment 3. In your revised disclosure you changed the future interest
from an attempt to acquire a controlling interest in your parent company to simply “shares”
of your parent company, with the same goal, “to strengthen [y]our U.S. market position
through control of future pipeline development.” Revise to disclose under German law
what percentage of ownership of Biofrontera AG you would need to own to control the company,
and thus your future pipeline development. In addition, we note the disclosure that there
have been no negotiations with Biofrontera AG shareholders. Revise to also address Biofrontera
AG control persons.
Response:
We
acknowledge the Staff’s comment and respectfully advise the Staff that we have revised page 65 to include disclosure regarding
the percentage of ownership that we would need to be deemed to control Biofrontera AG. As is the case for companies incorporated under
Delaware law, if we were able to acquire more than 50% of the voting control of Biofrontera AG, we would clearly be in control of Biofrontera
AG. Even if we controlled less than 50% of the voting control of Biofrontera AG, we would still in practice be able to control Biofrontera
AG so long as we held the voting control of the majority of shares present and entitled to vote at a shareholder meeting. Below 50% of
the outstanding shares, there is no bright line under German law, which determines whether a significant shareholder has such de facto
control of a company. Instead whether a company is controlled by a shareholder depends on the facts and circumstances of each meeting
and may vary from meeting to meeting. We had revised the previous disclosure to remove the reference to acquiring a “controlling
interest” because, as already noted in the disclosure for that section, we cannot be sure at this time whether it
is possible for us to acquire a clear controlling interest in Biofrontera AG. However, if the circumstances are favorable, we might
seek to acquire shares in order to obtain de facto control at shareholder meetings, if not outright “control” as defined
under German law.
We
have also revised the disclosure on page 65 to indicate that there have been no negotiations with any person or entity deemed to control
Biofrontera AG and that there is no current agreement, arrangement or understanding between us and Biofrontera AG with respect to any
possible acquisition other than the Biofrontera AG’s intent to abstain from voting any of our shares if shareholder approval is
required for the issuance of any of our shares in connection with such a possible acquisition, as previously disclosed on page 65.
Legal
Proceedings, page 77
2.
We
reissue comment 4 to the extent it is unclear where you have addressed the allocation of legal costs and liability when you cease
to be a wholly owned subsidiary.
Response:
We
acknowledge the Staff’s comment and respectfully advise the Staff that we have revised the disclosure on page 77 to add
disclosure regarding the agreement we plan to enter into with Biofrontera AG upon the consummation of the offering to allocate costs
of the DUSA litigation between the two companies based on a percentage to be determined following the consummation of this
offering based on Biofrontera AG’s ownership of Biofrontera Inc. at that time. We respectfully inform the Staff that we
also have included disclosure that any agreement to allocate liability will be negotiated once the outcome of the DUSA litigation is
known.
If
you have any questions regarding this letter or the Registration Statement, please contact the undersigned at e.monaco@biofrontera.com
or (781) 486-1502.
Very
truly yours,
Biofrontera
Inc.
/s/
Erica Monaco
Name:
Erica
Monaco
Title:
Chief Financial Officer and Chief
Operating Officer
cc:
Hermann
Luebbert
Biofrontera
Inc.
Stephen
Older
McGuireWoods
LLP
Ralph
De Martino
Schiff
Hardin LLP
Biofrontera
Inc. · 120 Presidential Way, Suite 330 · Woburn, MA 01801 · USA
Contact
Phone +1 781 245 1325 · E-Mail info-us@biofrontera.com · www.biofrontera.us.com
Board
of Directors Prof. Dr. Hermann Luebbert (CEO & Chair) · Erica Monaco (CFO & COO)
Page 2 of 2
2021-08-20 - UPLOAD - Biofrontera Inc.
United States securities and exchange commission logo
August 20, 2021
Hermann Lubbert
Chief Executive Officer
Biofrontera Inc.
120 Presidential Way
Suite 330
Woburn, MA 01801
Re:Biofrontera Inc.
Amendment No. 2 to Registration Statement on Form S-1
Filed August 12, 2021
File No. 333-257722
Dear Dr. Lubbert:
We have reviewed your amended registration statement 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 by amending your registration statement and providing the
requested information. 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 registration statement and the information you
provide in response to these comments, we may have additional comments. Unless we note
otherwise, our references to prior comments are to comments in our [Month day, year] letter.
Amendment No. 2 to Registration Statement on Form S-1
Business
Our Strategy, page 65
1.We note your response to comment 3. In your revised disclosure you changed the future
interest from an attempt to acquire a controlling interest in your parent company to simply
"shares" of your parent company, with the same goal, "to strengthen [y]our U.S. market
position through control of future pipeline development." Revise to disclose under
German law what percentage of ownership of Biofrontera AG you would need to own to
control the company, and thus your future pipeline development. In addition, we note the
disclosure that there have been no negotiations with Biofrontera AG shareholders. Revise
FirstName LastNameHermann Lubbert
Comapany NameBiofrontera Inc.
August 20, 2021 Page 2
FirstName LastName
Hermann Lubbert
Biofrontera Inc.
August 20, 2021
Page 2
to also address Biofrontera AG control persons.
Legal Proceedings, page 77
2.We reissue comment 4 to the extent it is unclear where you have addressed the allocation
of legal costs and liability when you cease to be a wholly owned subsidiary.
You may contact Tara Harkins at 202-551-3639 or Brian Cascio at 202-551-3676 if you
have questions regarding comments on the financial statements and related matters. Please
contact Abby Adams at 202-551-6902 or Suzanne Hayes at 202-551-3675 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Stephen E. Older, Esq.
2021-08-11 - CORRESP - Biofrontera Inc.
CORRESP
1
filename1.htm
Biofrontera
Inc · 120 Presidential Way, Suite 330 · Woburn, MA 01801 · USA
VIA
EDGAR AND EMAIL
August
11, 2021
Securities
and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549
Attn:
Abby
Adams
Suzanne
Hayes
Tara
Harkins
Brian
Cascio
Re:
Biofrontera
Inc.
Amendment
No. 1 to Registration Statement on Form S-1
Filed
July 26, 2021
File
No. 333-257722
We
are submitting this letter in response to the comment letter, dated August 2, 2021, of the staff of the Division of Corporation Finance
(the “Staff”) of the Securities and Exchange Commission (the “Commission”) with respect to the
above-referenced filing. This letter and our Amendment No. 2 to the Registration Statement on Form S-1 (the “Amendment No. 2”)
are being filed with the Commission electronically today. In addition to the electronic filing, we are delivering via email a copy of
this letter, along with a courtesy copy of the Amendment No. 2 marked to indicate changes from the Amendment No. 1 to the Registration
Statement filed on July 26, 2021. In addition to addressing the comments raised by the Staff in its letter, we have revised the Amendment
No. 2 to update other disclosures. Each of our responses is set forth in ordinary type beneath the corresponding Staff comment, which
is set out in bold type. The page references in our responses are to the pages in the marked version of the Amendment No. 2.
Amendment
No. 1 to Registration Statement on Form S-1 filed on July 26, 2021
Summary
Overview,
page 1
1.
With
this amendment you removed explanatory information such as the column headings from the chart on page 2, which was a form of pipeline
table, and also appears in your business section. Revise to clarify what the information here represents, as the introduction to
this chart is not clear. For example, explain what “Start anticipated 2022” for Ameluz for “AK: Trunk & extremities”
refers to where column three indicates “Phase III in preparation.” Also clarify why you removed the territory information.
Response:
We
acknowledge the Staff’s comment and respectfully advise the Staff that we have revised pages 2 and 64 of Amendment No. 2 to
provide an updated chart as well as to clarify the information presented in the table. Our intent is to simplify the prior presentation
to present the information that is most pertinent to an investment in a company that commercializes, but does not clinically develop,
pharmaceutical products solely in the United States. The updated chart includes which indications are currently being, or will be, sought
in the United States, the type of study that will be undertaken for each indication, the status of ongoing or future trials related to
those indications and when it is anticipated that patient recruitment will begin for each such trial. Since we only have a license to
market these products in the United States, we removed the territory information as superfluous.
Management’s
Discussion and Analysis of Financial Conditions and Results of Operations Overview
Selling,
General and Administrative Expenses, page 51
2.
Refer
to comment 1. Revise to clarify on what basis you have determined that “Biofrontera AG and its wholly owned subsidiaries will
continue to provide these services following the consummation of the Offering with the same terms for reimbursement and allocation
of expenses,” which is the cost plus 6% “accounting consolidation, IT support, and pharmacovigilance” services
“based on costs incurred plus 6% in accordance with the Intercompany Services Agreement with Biofrontera AG dated January 1,
2016.” The Master Services Agreement does not appear to provide for those terms and you state that the prior agreement is no
longer in force and is not carried forward with the new agreement, although the recitals appear to contemplate the terms would be
carried forward. The new agreement appears to require each new service be agreed with a new statement of work. To the extent the
companies have agreed to follow the terms of the previous Master Service Agreement, and it provides the material terms of the new
agreement, file it as an exhibit. If not, revise the disclosure here and throughout to clarify how you will account for intercompany
services.
Response:
We
acknowledge the Staff’s comment and respectfully advise the Staff that we have revised the disclosure on pages 51 and 101 to
reflect that the reimbursement and allocation of expenses will be based on the terms of the prior intercompany services agreement until
such time as a statement of work with provisions for the reimbursement and allocation of expenses is executed under our Services Agreement
(as defined below). Prior to the consummation of the offering, we will enter into an amended and restated Master Contract Services Agreement
(the “Services Agreement”) which will clarify that the parties have agreed to follow the terms of the prior intercompany
services agreement until such time as a statement of work is executed under the Services Agreement whose terms supersede the prior intercompany
services agreement.
As
requested by the Staff, we will file by amendment prior to the effectiveness of the Registration Statement the prior intercompany services
agreement. We respectfully advise the Staff that we will file by amendment prior to the effectiveness of the Registration Statement the
Services Agreement as amended as Exhibit 10.8 and have updated the description of the Services Agreement on pages 2, 51, 75 and
101 accordingly.
Biofrontera Inc. · 120 Presidential Way, Suite 330 · Woburn, MA 01801 · USA Page 2 of 4
Contact Phone +1 781 245 1325 · E-Mail info-us@biofrontera.com · www.biofrontera.us.com
Board of Directors Prof. Dr. Hermann Luebbert (CEO & Chair) · Erica Monaco (CFO & COO)
Business
Our
Strategy, page 65
3.
As
discussed, we note your potential exchange offer for your parent addressed here, as well as the disclosure remaining in the document
that you will be a controlled company under Nasdaq listing standards after the consummation of this offer. Tell us whether you have
determined your potential exchange offer for your parent is reasonably feasible. And if it is feasible, if it would, in fact, enable
you to control your pipeline and revenues given the nature of German corporate law. Tell us what consideration you have given to
revising this document to provide more detailed disclosure regarding the nature of your plans, even though they may be tentative,
including additional material risk factor disclosure.
Response:
We
acknowledge the Staff’s comment and respectfully advise the Staff that we have revised the disclosure on page 65 to provide
more detail regarding the conditions under which a potential exchange offer for our parent would be possible, including the restrictions
on holding shares of our parent under German law, the requirements for the offer under German law and the need for approval from our
shareholders to issue more than 20% of our shares in the exchange offer. As the Staff has noted, we expect to be a controlled company
under Nasdaq listing standards following the consummation of the offering based on the anticipated offering size. Under German law, we
are not permitted to acquire shares of our parent as long as we are still controlled by our parent. If we are a controlled company under
Nasdaq listing standards, then we would be controlled by our parent under German Law as well. If we cease to be a controlled company
under Nasdaq listing standards, we could still be deemed to be controlled by our parent if in a shareholder meeting Biofrontera AG holds
the majority of shares present and entitled to vote (even if that is less than 50% of our total outstanding shares). Consequently, in
order to launch a potential exchange offer for shares of Biofrontera AG, Biofrontera AG’s holdings would need to be reduced substantially
below 50% of our total outstanding shares.
At
this time, we are not able to estimate how much further Biofrontera AG’s holdings would need to be reduced following the offering
in order for us to no longer be considered a company controlled by Biofrontera AG under German law. Moreover, even if we had an estimate
of the amount to be reduced, we do not know if the means will be available to reduce Biofrontera AG’s holdings by such an amount.
The most common ways to reduce Biofrontera AG’s holdings would be either for us to issue more shares to investors (other than Biofrontera
AG or its affiliates) or for Biofrontera AG to sell some of the shares it currently holds. However, we are not sure whether there will
be sufficient demand for our shares to support a follow-on offering or sales into the secondary market. If there are other means by which
Biofrontera AG could reduce its holdings in our company, we will not be able to explore them prior to the consummation of the offering.
In addition, we would need the consent of the underwriters to issue any shares in a follow-on offering or other transaction that occurred
within 180 days of this Offering. Because of the uncertainties surrounding a reduction of Biofrontera AG’s holdings, we are
not able at this time to determine if it would be feasible for us to go forward with a potential exchange offer, although it remains
a possible option for our future development.
Biofrontera Inc. · 120 Presidential Way, Suite 330 · Woburn, MA 01801 · USA Page 3 of 4
Contact Phone +1 781 245 1325 · E-Mail info-us@biofrontera.com · www.biofrontera.us.com
Board of Directors Prof. Dr. Hermann Luebbert (CEO & Chair) · Erica Monaco (CFO & COO)
Legal
Proceedings, page 77
4.
We
note the disclosure added here with respect to the jury trial to begin November 29, 2021. Revise this section to address all legal
proceedings required to be disclosed pursuant to Item 103 of Regulation S-K, including any additional claims referenced in the risks
factors on pages 14-15 or elsewhere in the document, or explain why no additional disclosure is required. Revise this or another
appropriate section of the document to explain how legal costs and liability are distributed pursuant to the separation agreements.
Revise the risk factor on page 15 to describe the factual basis alleged to underlie the proceedings and provide more information
regarding the relief sought. Refer to Item 103(a) of Regulation S-K.
Response:
We
acknowledge the Staff’s comment and respectfully advise the Staff that we have revised the disclosure on page 77 to indicate
that the litigation involving DUSA is the only proceeding required to be disclosed pursuant to Item 103 of Regulation S-K as all the
specific claims referenced on page 15 are part of the same proceeding. We respectfully advise the Staff that we have also revised
the disclosure on page 15 to describe the factual bases alleged to underlie the claims in the proceeding, provide more information
regarding the relief sought and to explain how we and Biofrontera AG have agreed to allocate the legal costs and any liability in connection
with the proceeding.
Directors,
page 89
5.
Please
file the consent of each director nominee as an exhibit to your registration statement. See Securities Act Rule 438.
Response:
We
acknowledge the Staff’s comment and respectfully advise the Staff that we have filed as Exhibits 99.1, 99.2 and 99.3
to Amendment No. 2 the consent for each director nominee in accordance with Rule 438 of the Securities Act.
If
you have any questions regarding this letter or the Registration Statement, please contact the undersigned at e.monaco@biofrontera.com
or (781) 486-1502.
Very
truly yours,
Biofrontera
Inc.
/s/ Erica
Monaco
Name:
Erica
Monaco
Title:
Chief
Financial Officer and Chief Operating Officer
cc:
Hermann
Luebbert
Biofrontera
Inc.
Stephen
Older
McGuireWoods
LLP
Ralph
De Martino
Schiff
Hardin LLP
Biofrontera Inc. · 120 Presidential Way, Suite 330 · Woburn, MA 01801 · USA Page 4 of 4
Contact Phone +1 781 245 1325 · E-Mail info-us@biofrontera.com · www.biofrontera.us.com
Board of Directors Prof. Dr. Hermann Luebbert (CEO & Chair) · Erica Monaco (CFO & COO)
2021-08-02 - UPLOAD - Biofrontera Inc.
United States securities and exchange commission logo
August 2, 2021
Hermann Lubbert
Chief Executive Officer
Biofrontera Inc.
120 Presidential Way
Suite 330
Woburn, MA 01801
Re:Biofrontera Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed July 26, 2021
File No. 333-257722
Dear Dr. Lubbert:
We have reviewed your amended registration statement 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 by amending your registration statement and providing the
requested information. 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 registration statement and the information you
provide in response to these comments, we may have additional comments. Unless we note
otherwise, our references to prior comments are to comments in our July 19, 2021 letter.
Amendment No. 1 to Registration Statement on Form S-1
Summary
Overview, page 1
1.With this amendment you removed explanatory information such as the column headings
from the chart on page 2, which was a form of pipeline table, and also appears in your
business section. Revise to clarify what the information here represents, as the
introduction to this chart is not clear. For example, explain what "Start anticipated 2022"
for Ameluz for "AK: Trunk & extremities" refers to where column three indicates "Phase
III in preparation." Also clarify why you removed the territory information.
FirstName LastNameHermann Lubbert
Comapany NameBiofrontera Inc.
August 2, 2021 Page 2
FirstName LastNameHermann Lubbert
Biofrontera Inc.
August 2, 2021
Page 2
Management's Discussion and Analysis of Financial Condition and Results of Operations
Overview
Selling, General and Administrative Expenses, page 51
2.Refer to comment 1. Revise to clarify on what basis you have determined
that "Biofrontera AG and its wholly owned subsidiaries will continue to provide these
services following the consummation of the Offering with the same terms for
reimbursement and allocation of expenses," which is the cost plus 6% "accounting
consolidation, IT support, and pharmacovigilance" services "based on costs incurred plus
6% in accordance with the Intercompany Services Agreement with Biofrontera AG dated
January 1, 2016." The Master Services Agreement does not appear to provide for those
terms and you state that the prior agreement is no longer in force and is not carried
forward with the new agreement, although the recitals appear to contemplate the terms
would be carried forward. The new agreement appears to require each new service be
agreed with a new statement of work. To the extent the companies have agreed to follow
the terms of the previous Master Service Agreement, and it provides the material terms of
the new agreement, file it as an exhibit. If not, revise the disclosure here and throughout
to clarify how you will account for intercompany services.
Business
Our Strategy, page 65
3.As discussed, we note your potential exchange offer for your parent addressed here, as
well as the disclosure remaining in the document that you will be a controlled company
under Nasdaq listing standards after the consummation of this offer. Tell us whether you
have determined your potential exchange offer for your parent is reasonably feasible. And
if it is feasible, if it would, in fact, enable you to control your pipeline and revenues given
the nature of German corporate law. Tell us what consideration you have given to
revising this document to provide more detailed disclosure regarding the nature of your
plans, even though they may be tentative, including additional material risk factor
disclosure.
Legal Proceedings, page 77
4.We note the disclosure added here with respect to the jury trial to begin November 29,
2021. Revise this section to address all legal proceedings required to be disclosed
pursuant to Item 103 of Regulation S-K, including any additional claims referenced in the
risks factors on pages 14-15 or elsewhere in the document, or explain why no additional
disclosure is required. Revise this or another appropriate section of the document to
explain how legal costs and liability are distributed pursuant to the separation agreements.
Revise the risk factor on page 15 to describe the factual basis alleged to underlie the
proceedings and provide more information regarding the relief sought. Refer to Item
103(a) of Regulation S-K.
FirstName LastNameHermann Lubbert
Comapany NameBiofrontera Inc.
August 2, 2021 Page 3
FirstName LastName
Hermann Lubbert
Biofrontera Inc.
August 2, 2021
Page 3
Directors, page 89
5.Please file the consent of each director nominee as an exhibit to your registration
statement. See Securities Act Rule 438.
You may contact Tara Harkins at (202) 551-3639 or Brian Cascio at (202) 551-3676 if
you have questions regarding the financial statements and related matters. Please contact Abby
Adams at (202) 551-6902 or Tim Buchmiller at (202) 551-3635 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Stephen E. Older, Esq.
2021-07-23 - CORRESP - Biofrontera Inc.
CORRESP
1
filename1.htm
Biofrontera
Inc · 120 Presidential Way, Suite 330 · Woburn, MA 01801 · USA
VIA
EDGAR AND EMAIL
July
23, 2021
Securities
and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549
Attn:
Abby
Adams
Suzanne
Hayes
Tara
Harkins
Brian
Cascio
Re:
Biofrontera
Inc.
Registration
Statement on Form S-1
Filed
July 6, 2021
File
No. 333-257722
We
are submitting this letter in response to the comment letter, dated July 19, 2021, of the staff of the Division of Corporation Finance
(the “Staff”) of the Securities and Exchange Commission (the “Commission”) with respect to the
above-referenced filing. This letter and our Amendment No. 1 to the Registration Statement on Form S-1 (the “Amendment No. 1”)
are being filed with the Commission electronically today. In addition to the electronic filing, we are delivering via email a copy of
this letter, along with a courtesy copy of the Amendment No. 1 marked to indicate changes from the Registration Statement filed on July
6, 2021. In addition to addressing the comments raised by the Staff in its letter, we have revised the Amendment No. 1 to update other
disclosures. Each of our responses is set forth in ordinary type beneath the corresponding Staff comment, which is set out in bold type.
The page references in our responses are to the pages in the marked version of the Amendment No. 1.
Registration
Statement on Form S-1 filed on July 6, 2021
Management’s
Discussion and Analysis of Financial Discussion and Results of Operations Selling, General and Administrative Expenses, Related Party,
page 51
1.
Refer
to comment 9 of our June 6, 2021, letter. We note you filed the Master Contract Services Agreement dated July 2, 2021 by and among
the Company, Biofrontera AG, Biofrontera Pharma GmbH and Biofrontera Bioscience GmbH as Exhibit 10.8. Please revise the disclosure
on page 51 and elsewhere, as applicable, to clarify this agreement extends the Intercompany Services Agreement and the Quality Assurance
Agreement, both of which have expired by their terms, but appear to have been followed in practice and revived in this agreement,
as reflected in paragraph 9.5 of this agreement. File both agreements as exhibits to the registration statement. If the agreements,
in fact, do not apply, revise page 51 to clarify whether Biofrontera AG continues to provide your accounting consolidation, IT support
and pharmacovigilance services, and if so, how those expenses are charged to you and under what agreement. This agreement appears
to defer all allocations of expenses to be determined for at the time of each proposed statement of work.
Response:
We
acknowledge the Staff’s comment and respectfully advise the Staff that we have revised the disclosure on pages 2, 51, 75 and 101
of Amendment No. 1 to clarify the relationship between the Master Contract Services Agreement and the other intercompany agreements
we have entered into with the Biofrontera Group. We respectfully inform the Staff that the Master Contract Services Agreement does not
extend either the prior Intercompany Services Agreement or the Quality Assurance Agreement. The Master Contract Services Agreement is
meant to supersede the existing Intercompany Services Agreement as is indicated in the second paragraph of Section 9.5 of the Master
Contract Services Agreement. Section 9.5 of the Master Contract Services Agreement also states that the agreement is intended to be consistent
with the Amended and Restated License and Supply Agreement and the Quality Assurance Agreement and that to the extent there is any conflict
with those agreements, the terms of the Amended and Restated License and Supply Agreement, as applicable, should prevail. Since the Amended
and Restated License and Supply Agreement was recently entered into, it has not yet lapsed and, therefore, does not need to be extended
by the Master Contract Services Agreement. The Quality Assurance Agreement is by its terms intended to be a living document that evolves
with the Company’s development and is tied to the Amended and Restated License and Supply Agreement. As a result, the Quality Assurance
Agreement relies on the Amended and Restated License and Supply Agreement to maintain its force, and it does not need to be extended
by the Master Contract Services Agreement.
Since
the Intercompany Services Agreement has been superseded by the Master Contract Services Agreement, we have not filed it as an exhibit
to Amendment No. 1. As requested by the Staff, we have filed the Quality Assurance Agreement as Exhibit 10.9 to Amendment No. 1, since
it will remain in effect following the initial public offering.
Business
Our
Strategy, page 64
2.
We
note your response to comment 3. Clarify, for example, why this proposed transaction is more beneficial than, for example, structuring
the spinoff differently, to provide the company more control of the future pipeline development than in the June 16, 2021 Ameluz
LSA.
Response:
We
acknowledge the Staff’s comment and respectfully advise the Staff that we have revised the disclosure on page 65 to further elucidate
why a potential acquisition of a controlling interest in Biofrontera AG would be more beneficial to the Company than structuring the
spinoff differently. As discussed in greater detail on a call with the Staff on July 20, 2021, the post-IPO arrangements between the
Company and Biofrontera AG were the result of arm’s-length negotiations with Biofrontera AG and reflect that Biofrontera AG would
not cede control of the product pipeline. However, we believe that, should the opportunity present itself, acquiring a controlling interest
of Biofrontera AG through a tender or exchange offer would provide benefits to shareholders of both companies. Nevertheless, such a potential
transaction would be subject to a number of conditions and the further actions that would need to be taken to satisfy those conditions
cannot be undertaken prior to the IPO and we will not be able to assess the feasibility of satisfying those conditions until after the
consummation of the initial public offering.
Biofrontera Inc. · 120 Presidential Way, Suite 330 · Woburn, MA 01801
· USA
Contact Phone +1 781 245 1325 · E-Mail info-us@biofrontera.com · www.biofrontera.us.com
Board of Directors Prof. Dr. Hermann Luebbert (CEO & Chair) · Erica Monaco (CFO & COO)
Page
2 of 3
If
you have any questions regarding this letter or the Registration Statement, please contact the undersigned at e.monaco@biofrontera.com
or (781) 486-1502.
Very
truly yours,
Biofrontera
Inc.
/s/ Erica Monaco
Name:
Erica
Monaco
Title:
Chief
Financial Officer and Chief Operating Officer
cc:
Hermann
Luebbert
Biofrontera
Inc.
Stephen
Older
McGuireWoods
LLP
Ralph
De Martino
Schiff
Hardin LLP
Biofrontera Inc. · 120 Presidential Way, Suite 330 · Woburn, MA 01801
· USA
Contact Phone +1 781 245 1325 · E-Mail info-us@biofrontera.com · www.biofrontera.us.com
Board of Directors Prof. Dr. Hermann Luebbert (CEO & Chair) · Erica Monaco (CFO & COO)
Page
3 of 3
2021-07-19 - UPLOAD - Biofrontera Inc.
United States securities and exchange commission logo
July 19, 2021
Hermann Lubbert
Chief Executive Officer
Biofrontera Inc.
120 Presidential Way
Suite 330
Woburn, MA 01801
Re:Biofrontera Inc.
Registration Statement on Form S-1
Filed July 6, 2021
File No. 333-257722
Dear Dr. Lubbert:
We have reviewed your registration statement and have the following comments. Please
respond to this letter by amending your registration statement and providing the requested
information. 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 registration statement and the information you
provide in response to our comments, we may have additional comments.
Registration Statement on Form S-1
Management's Discussion and Analysis of Financial Discussion and Results of Operations
Selling, General and Administrative Expenses, Related Party, page 51
1.Refer to comment 9 of our June 6, 2021, letter. We note you filed the Master Contract
Services Agreement dated July 2, 2021 by and among the Company, Biofrontera AG,
Biofrontera Pharma GmbH and Biofrontera Bioscience GmbH as Exhibit 10.8. Please
revise the disclosure on page 51 and elsewhere, as applicable, to clarify this agreement
extends the Intercompany Services Agreement and the Quality Assurance Agreement,
both of which have expired by their terms, but appear to have been followed in practice
and revived in this agreement, as reflected in paragraph 9.5 of this agreement. File both
agreements as exhibits to the registration statement. If the agreements, in fact, do not
apply, revise page 51 to clarify whether Biofrontera AG continues to provide your
accounting consolidation, IT support and pharmacovigilance services, and if so, how those
expenses are charged to you and under what agreement. This agreement appears to
defer all allocations of expenses to be determined for at the time of each proposed
FirstName LastNameHermann Lubbert
Comapany NameBiofrontera Inc.
July 19, 2021 Page 2
FirstName LastName
Hermann Lubbert
Biofrontera Inc.
July 19, 2021
Page 2
statement of work.
Business
Our Strategy, page 64
2.We note your response to comment 3. Clarify, for example, why this proposed transaction
is more beneficial than, for example, structuring the spinoff differently, to provide the
company more control of the future pipeline development than in the June 16,
2021 Ameluz LSA.
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.
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.
You may contact Tara Harkins at (202) 551-3639 or Brian Cascio at (202) 551-3676 if
you have questions regarding the financial statements and related matters. Please contact Abby
Adams at (202) 551-6902 or Tim Buchmiller at (202) 551-3635 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Stephen E. Older, Esq.
2021-07-06 - CORRESP - Biofrontera Inc.
CORRESP
1
filename1.htm
Biofrontera
Inc · 120 Presidential Way, Suite 330 · Woburn, MA 01801 · USA
VIA
EDGAR AND EMAIL
July
6, 2021
Securities
and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549
Attn:
Abby
Adams
Suzanne
Hayes
Tara
Harkins
Brian
Cascio
Re:
Biofrontera
Inc.
Amendment
Draft Registration Statement on Form S-1
Filed
June 22, 2021
CIK
No. 0001858685
We
are submitting this letter in response to the comment letter, dated July 1, 2021, of the staff of the Division of Corporation Finance
(the “Staff”) of the Securities and Exchange Commission (the “Commission”) with respect to the
above-referenced filing. This letter and our Registration Statement on Form S-1 (the “Registration Statement”) are
being filed with the Commission electronically today. In addition to the electronic filing, we are delivering via email a copy of this
letter, along with a courtesy copy of the Registration Statement marked to indicate changes from Amendment No. 2 to the Draft Registration
Statement filed on June 22, 2021. In addition to addressing the comments raised by the Staff in its letter, we have revised the Registration
Statement to update other disclosures. Each of our responses is set forth in ordinary type beneath the corresponding Staff comment, which
is set out in bold type. The page references in our responses are to the pages in the marked version of the Registration Statement.
Amendment
No. 2 to Draft Registration Statement on Form S-1 filed on June 22, 2021
Risk
Factors
The
Biofrontera Group currently depends on a single unaffiliated . . ., page 11
1.
We
note your response to comment 5. Item 101(h)(4)(v) seeks disclosure of the business of Biofrontera, including its “sources
and availability of raw materials and the names of principal suppliers” to the extent material. We disagree with your analysis
that disclosing the Biofrontera affiliate that adds one layer to the chain between Biofrontera and the true sole source supplier
satisfies this requirement.
Response:
We
acknowledge the Staff’s comment and respectfully advise the Staff that we have revised the disclosure on page 11 of the Registration
Statement to add the names of Biofrontera Pharma GmbH’s principal suppliers as well as to update for the fact that Biofrontera
Pharma GmbH has signed an agreement with a second supplier for the product.
Business
Our
Strategy, page 65
2.
We
note the added disclosure on page 65 that you “may attempt to acquire a controlling interest of our parent company, Biofrontera
AG,” through what sounds like an exchange offer for stock and cash. Clarify how acquiring control of your parent furthers your
goals and which goals it furthers.
Response:
We
acknowledge the Staff’s comment and respectfully advise the Staff that we have revised the disclosure on page 65 of the Registration
Statement to clarify how acquiring control of our parent could further our goals by supporting one of the key elements in our strategy
for increasing sales of our licensed products: leveraging the potential for future approvals and label extensions of our licensed portfolio
products. If, following the consummation of the initial public offering, the opportunity arises to acquire a controlling interest in
our parent, that would enable us to strengthen our position in the U.S. market as it would enable us to control future pipeline development
directly. Ensuring that the manufacturing process related to our licensed products supports our sales of the licensed products is important
enough that we have negotiated provisions in our license and supply agreement with Biofrontera AG that give us the right to step into
the shoes of Biofrontera AG in its commercial relationships with its contract manufacturers if BiofronteraAG does not fulfill its supply
obligations under the license and supply agreement.
Commercial
Partners and Agreements, page 76
3.
We
reissue comment 13. Please quantify the percentage discount of your “anticipated net price per unit” you pay Biofrontera
Pharma for Ameluz.
Response:
We
acknowledge the Staff’s comment and respectfully advise the Staff that we have revised the disclosure on pages 76 of Registration
Statement to quantify the percentage discount as requested by the Staff.
Management,
page 88
4.
Revise
the disclosure of the background of your three new directors on page 89 to provide the business experience of each for the past five
years, as required by Item 401(e) of Regulation S-K.
Biofrontera
Inc. · 120 Presidential Way, Suite 330 · Woburn, MA 01801 · USA
Contact
Phone +1 781 245 1325 . E-Mail info-us@biofrontera.com · www.biofrontera.us.com
Board
of Directors Prof. Dr. Hermann Luebbert (CEO & Chair) · Erica Monaco (CFO & COO)
Page
2 of 3
Response:
We
acknowledge the Staff’s comment and respectfully advise the Staff that we have revised the disclosure on page 89 of the Registration
Statement to provide the business experience of each new director who will be appointed upon the consummation of the initial public offering.
If
you have any questions regarding this letter or the Registration Statement, please contact the undersigned at e.monaco@biofrontera.com
or (781) 486-1502.
Very truly yours,
Biofrontera Inc.
/s/ Erica L. Monaco
Name:
Erica
Monaco
Title:
Chief
Financial Officer and Chief Operating Officer
cc:
Hermann
Lübbert
Biofrontera
Inc.
Stephen
Older
McGuireWoods
LLP
Ralph
De Martino
Schiff
Hardin LLP
Biofrontera
Inc. · 120 Presidential Way, Suite 330 · Woburn, MA 01801 ·
USA
Contact
Phone +1 781 245 1325 . E-Mail info-us@biofrontera.com · www.biofrontera.us.com
Board
of Directors Prof. Dr. Hermann Luebbert (CEO & Chair) · Erica Monaco (CFO & COO)
Page
3 of 3
2021-07-01 - UPLOAD - Biofrontera Inc.
United States securities and exchange commission logo
July 1, 2021
Hermann Lubbert
Chief Executive Officer
Biofrontera Inc.
120 Presidential Way
Suite 330
Woburn, MA 01801
Re:Biofrontera Inc.
Amended Draft Registration Statement on Form S-1
Filed June 22, 2021
CIK No. 000185685
Dear Dr. Lubbert:
We have reviewed your amended registration statement 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 by amending your registration statement and providing the
requested information. 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 registration statement and the information you
provide in response to these comments, we may have additional comments. Unless we note
otherwise, our references to prior comments are to comments in our June 10, 2021 letter.
Amendment No. 2 to Draft Registration Statement on Form S-1
Risk Factors
The Biofrontera Group currently depends on a single unaffiliated . . ., page 11
1.We note your response to comment 5. Item 101(h)(4)(v) seeks disclosure of the business
of Biofrontera, including its "sources and availability of raw materials and the names of
principal suppliers" to the extent material. We disagree with your analysis that disclosing
the Biofrontera affiliate that adds one layer to the chain between Biofrontera and the true
sole source supplier satisfies this requirement.
FirstName LastNameHermann Lubbert
Comapany NameBiofrontera Inc.
July 1, 2021 Page 2
FirstName LastName
Hermann Lubbert
Biofrontera Inc.
July 1, 2021
Page 2
Business
Our Strategy, page 65
2.We note the added disclosure on page 65 that you "may attempt to acquire a controlling
interest of our parent company, Biofrontera AG," through what sounds like an exchange
offer for stock and cash. Clarify how acquiring control of your parent furthers your goals
and which goals it furthers.
Commercial Partners and Agreements, page 76
3.We reissue comment 13. Please quantify the percentage discount of your "anticipated net
price per unit" you pay Biofrontera Pharma for Ameluz.
Management, page 88
4.Revise the disclosure of the background of your three new directors on page 89 to provide
the business experience of each for the past five years, as required by Item 401(e) of
Regulation S-K.
You may contact Tara Harkins at (202) 551-3639 or Brian Cascio at (202) 551-3676 if
you have questions regarding the financial statements and related matters. Please contact Abby
Adams at (202) 551-6902 or Suzanne Hayes at (202) 551-3675 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Stephen E. Older, Esq.
2021-06-10 - UPLOAD - Biofrontera Inc.
United States securities and exchange commission logo
June 10, 2021
Hermann Lubbert
Chief Executive Officer
Biofrontera Inc.
120 Presidential Way
Suite 330
Woburn, MA 01801
Re:Biofrontera Inc.
Amended Draft Registration Statement on Form S-1
Filed May 11, 2021
CIK No. 000185685
Dear Dr. Lubbert:
We have reviewed your draft registration statement 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 by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. 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 the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Amendment No. 1 to Draft Registration Statement on Form S-1
Summary, page 1
1.Please clarify the relationships between Biofrontera AG, Biofrontera Inc., Biofrontera
Pharma and any other subsidiaries of Biofrontera AG with which you do business. Also
consider including an organizational chart depicting these relationships.
2.We note your disclosure on page 51 indicating that you generate revenues through sales of
licensed products, including BF-RhodoLED lamps, please clarify that you also have a
license to sell these products. .
3.Please clarify whether your exclusive license to sell Ameluz and the BF-RhodeoLED
FirstName LastNameHermann Lubbert
Comapany NameBiofrontera Inc.
June 10, 2021 Page 2
FirstName LastNameHermann Lubbert
Biofrontera Inc.
June 10, 2021
Page 2
lamp is for all approved indications in the United States or all approved indications in the
United States as of the date of the agreement.
Risk Factors, page 8
4.From the risk factors on pages 12-15 and disclosure elsewhere, it appears you are not
obligated or tasked with the duty to defend your intellectual property, have control over
your source of products or the quantity you must purchase, or have the ability to
determine the future products you will seek to commercialize. Add a risk factor
addressing the risks associated with the lack of control your management and board will
have over your company and its direction given the current structure, the degree of control
related entities have over your business currently through licensing and intellectual
property agreements, in addition to their significant share ownership.
The Biofrontera Group depends on a single unaffiliated manufacturer to manufacture Ameluz...,
page 11
5.We note your reliance on a single unaffiliated contract manufacturer to manufacture
Ameluz. Disclose the name of that supplier as required by Item 101(h)(4)(v) of
Regulation S-K. As you disclose your business could be materially harmed if you fail to
maintain your relationship with this supplier, file your supply agreement as required by
Item 601(b)(10)(ii)(B) of Regulation S-K or tell us why you believe you are not
substantially dependent upon it.
Our amended and restated certificate of incorporation will become effective..., page 40
6.Please revise the discussion to disclose that investors cannot waive compliance with the
federal securities laws and the rules and regulations thereunder and that there is also a risk
that your forum selection provisions may result in increased costs for investors to bring a
claim.
Use of Proceeds, page 43
7.Your use of proceeds states your expenditures may vary based on factors including “the
timing and success of any clinical trials and preclinical studies [you] may commence in
the future, [and] the timing of regulatory submissions.” As you state you specialize in
commercialization and it does not appear that your company develops drugs, but only in-
licenses drugs once they receive regulatory approval, please clarify. We note the
statement on page 72 that “in the future, [you] may conduct your own clinical trials to
better the market positioning of [your] in-licensed products;” however, we see no
disclosure of specific plans. To the extent you intend to use the proceeds to implement
your strategy, such as growing your dedicated sales and marketing infrastructure, please
update your to quantify the amounts intended to be used for each purpose. Alternatively if
you have no specific plan for your use of proceeds, revise your disclosure to discuss the
principal reasons for the offering and add a risk factor concerning the lack of a specific
FirstName LastNameHermann Lubbert
Comapany NameBiofrontera Inc.
June 10, 2021 Page 3
FirstName LastNameHermann Lubbert
Biofrontera Inc.
June 10, 2021
Page 3
plan. Please refer to Item 504 of Regulation S-K.
Management's Discussion and Analysis of Financial Condition and Results of Operations, page
47
8.We note your disclosure of the impact of the COVID-19 pandemic on your company, and
also the seasonality of your main product, Ameluz. We also note the patent protection for
Ameluz expired in early 2019. Revise your disclosure related to the impact of the
pandemic to provide additional insight as to why you believe your product sales declines
related to the pandemic rather than other factors, such as increased competition from
generic products. For example, clarify whether sales increased in the fourth quarter of
2020 and first quarter of 2021, as the pandemic restrictions eased in some areas.
Components of Our Results of Operations, page 51
9.File the Intercompany Services Agreement with Biofrontera AG dated January 1, 2016,
referenced on page 51 as an exhibit to the registration statement. Refer to Item
601(b)(10)(i)(A) and (ii) of Regulation S-K.
Business, page 64
10.Please revise the discussion of your parent company's research activities to clarify to what
degree you control the progress of these studies, whether the products will be
commercialized and the terms of any potential licensing agreement.
Intellectual Property, page 75
11.Please revise your discussion of the patent family related to nanoemulsions held by
Biofrontera Bioscience to provide the following additional information:
•the jurisdiction where the patents were issued;
•the products dependent on the patents;
•when such patents expire
•any licenses or similar agreements providing you with rights or protections related to
the patents.
To the extent you are party to any agreements providing you with rights or protections
related to the patents, file them as exhibits pursuant to Item 601(b)(10) of Regulation S-K
or tell us why you believe they are not required to be filed.
12.Please revise your intellectual property disclosure to clearly describe the type of patent
protection granted for Xepi by each patent family, the expiration year of each patent held,
and the jurisdiction of each patent.
Commercial Partners and Agreements, page 76
13.We note your disclosure on page 10 indicating your license agreements impose regulatory
and commercial diligence obligations and payment of milestones and royalties. Please
FirstName LastNameHermann Lubbert
Comapany NameBiofrontera Inc.
June 10, 2021 Page 4
FirstName LastName
Hermann Lubbert
Biofrontera Inc.
June 10, 2021
Page 4
revise he descriptions of your agreements with Biofrontera Pharma and Ferrer to describe
the regulatory and diligence obligations; clarify whether the milestone obligations are
development or sales based milestones; quantify the maximum potential milestone
payments for each type of milestone obligation; and quantify the royalty rate or provide a
reasonable range not exceeding 10 percentage points, and disclose when the royalty
provisions expire. Clarify who controls the pricing of your supply of Ameluz and lamps.
General
14.Please provide us with copies of all written communications, as defined in Rule 405 under
the Securities Act, that you, or anyone authorized to do so on your behalf, present to
potential investors in reliance on Section 5(d) of the Securities Act, whether or not they
retain copies of the communications.
You may contact Tara Harkins at 202-551-3639 or Brian Cascio at 202-551-3676 if you
have questions regarding comments on the financial statements and related matters. Please
contact Abby Adams at 202-551-6902 or Suzanne Hayes at 202-551-3675 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences