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
Hermann Lubbert
FirstName
BiofronteraLastNameHermann Lubbert
Inc.
Comapany
June NameBiofrontera Inc.
10, 2021
June 10,
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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
Hermann Lubbert
FirstName
BiofronteraLastNameHermann Lubbert
Inc.
Comapany
June NameBiofrontera Inc.
10, 2021
June 10,
Page 3 2021 Page 3
FirstName LastName
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
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.
FirstName LastNameHermann Lubbert Sincerely,
Comapany NameBiofrontera Inc.
Division of
Corporation Finance
June 10, 2021 Page 4 Office of Life
Sciences
FirstName LastName