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.
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
FirstName LastNameHermann Lubbert, Ph.D.
5. Please file the 2021 Services Agreement and any subsequent statements of
work. To the
Comapany NameBiofrontera
extent you continue to Inc.
rely on provisions of the 2016 Services
Agreement, please also file
this as an agreement.
September 9, 2021 Page 2
FirstName LastName
Hermann Lubbert, Ph.D.
FirstName
BiofronteraLastNameHermann Lubbert, Ph.D.
Inc.
Comapany 9,
September NameBiofrontera
2021 Inc.
September
Page 3 9, 2021 Page 3
FirstName LastName
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.