View:
July 16, 2019
Prof. Ugur Sahin, M.D.
Chief Executive Officer
BioNTech SE
An der Goldgrube 12
D-55131 Mainz
Germany
Re: BioNTech SE
Draft Registration Statement on Form F-1
Submitted June 19, 2019
CIK No. 0001776985
Dear Dr. Sahin:
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.
Draft Registration Statement on Form F-1
Prospectus Summary
Overview, page 1
1. Please provide us with support for your characterization of your
immunotherapeutic
platforms and product candidates as first-in-class. Please also balance
your summary
disclosure by disclosing that no mRNA immunotherapy has been approved in
your new
category of therapeutics as well as the risks and costs associated with
some of your
product candidates being classified as gene therapies.
Prof. Ugur Sahin, M.D.
FirstName SE
BioNTech LastNameProf. Ugur Sahin, M.D.
Comapany NameBioNTech SE
July 16, 2019
July 16, 2019 Page 2
Page 2
FirstName LastName
Our Pipeline, page 3
2. Please revise your pipeline table here and in other sections of the
prospectus to mark
clearly what phase each product candidate is currently in. We note
that there is no clear
separation in the pipeline table between Phase 1, Phase 2 and Phase 3
and it is not clear to
which clinical phase the arrows point. Please also ensure that the
graphical depiction of
status in the table corresponds with the disclosure in the prospectus
regarding how far
along each candidate is in the development process.
3. Please tell us why you believe it is material to investors to include
the product candidates
identified merely as "to be selected" or left blank in several places
in your pipeline table.
We also note that you do not provide specific targets/indications for
these product
candidates. In this regard, we note that it appears that all of these
product candidates are
in preliminary stages of development.
Implications of Being an Emerging Growth Company and a Foreign Private Issuer,
page 7
4. 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.
Use of Proceeds, page 95
5. We note your disclosure that you intend to use the proceeds of this
offering to advance
your clinical programs, advance additional product candidates into
clinical trials, advance
additional preclinical product candidates, develop additional product
candidates and
expand your manufacturing and laboratory capacity. Please specify how
far in the
development of each of your pipeline projects you expect to reach with
the proceeds of the
offering. If any material amounts of other funds are necessary to
accomplish the specified
purposes, state the amounts and sources of other funds needed for each
specified purpose
and the sources. Refer to Instruction 3 to Item 504 of Regulation S-K.
Critical Accounting Policies and Use of Estimates
Stock-Based Compensation, page 116
6. Once you have an estimated offering price or range, please explain to
us how you
determined the fair value of the common stock underlying your equity
issuances and the
reasons for any differences between the recent valuations of your
common stock leading
up to the IPO and the estimated offering price. This information will
help facilitate our
review of your accounting for equity issuances including stock
compensation and
beneficial conversion features.
Prof. Ugur Sahin, M.D.
FirstName SE
BioNTech LastNameProf. Ugur Sahin, M.D.
Comapany NameBioNTech SE
July 16, 2019
July 16, 2019 Page 3
Page 3
FirstName LastName
Business
Our MVT-5873 (BNT321) Trials, page 182
7. To the extent material to understanding the status of the product
candidate discussed in
this section, please disclose why the trial is currently paused.
XIV. Third-Party Collaborations, page 186
8. We note that for some of your collaboration agreements you have not
disclosed all of the
material terms of the agreements, such as aggregate milestone payments
and royalty
ranges or royalties rates. Please disclose the following:
the aggregate future potential milestone payments and the royalty
rates or a royalty
range under the Genentech agreement described on page 187;
the sales milestone payments and royalties under the Genmab
next-generation
immunomodulator collaboration agreement on page 189;
the running royalties under the LSU license agreement on page 225;
and
the aggregate future potential milestone payments and royalties
under the Cellscript
and mRNA Ribotherapeutics license agreement on page 225.
In addition, if any other collaboration or license agreements contain
milestone and royalty
provisions that have not been disclosed in this section, please
disclose such information
about these provisions.
Sanofi -- Intratumoral Therapy Collaboration, page 188
9. We note your references to "low double digits" royalties on pages 189
and 192. Please
revise your disclosure on each of the referenced pages to narrow the
royalty range to no
more than ten percentage points (for example, between twenty and
thirty percent).
Related Party Transactions, page 241
10. We note your disclosure on page F-56 that "purchases of various goods
an services
controlled by key management personnel" accounted for approximately
11.16 million in
2018 and 6.55 in 2017. Please disclose these transactions in your
related party
transactions section or otherwise clarify which disclosure includes
these transactions.
4 Revenue from contracts with customers, page F-31
11. Please expand your disclosures to include the amounts of the upfront
payments received
from Genentech and Sanofi, how you determined the amount to recognize
in the periods
presented and the amounts that have been included in deferred revenue.
Part II
Item 7. Recent Sales of Unregistered Securities, page II-1
12. For each of the transactions listed in this section please disclose
the consideration
Prof. Ugur Sahin, M.D.
BioNTech SE
July 16, 2019
Page 4
received. As to any securities sold otherwise than for cash, state the
nature of the
transaction and the nature and aggregate amount of consideration received
by the
registrant. Refer to Item 701 of Regulation S-K.
Exhibits
13. We note your reference to the two secured credit facilities with Deutsche
Bank AG on
page 111. Please file these facilities as exhibits to your registration
statement and describe
all of their material terms or tell us why you believe they are not
required to be filed.
General
14. Please revise throughout to remove any references regarding regulatory
approval or safety
and efficacy of your product candidates. We note, by way of example, the
statement that
you "have tested [your] lead mRNA product candidates in over 250 patients
and have
already demonstrated signs of single-agent clinical efficacy in [your]
two lead programs"
on page 5, that four of your therapeutic platforms "generated promising
early evidence of
clinical efficacy in several cancer types" on page 126, and that you
"observed efficacy for
22 patients who received BNT111 as a monotherapy" on page 167.
You may contact Vanessa Robertson at (202) 551-3649 or Lisa Vanjoske at
(202) 551-
3614 if you have questions regarding comments on the financial statements and
related
matters. Please contact Tonya K. Aldave at (202) 551-3601 or Justin Dobbie,
Legal Branch
Chief, at (202) 551-3469 with any other questions.
Sincerely,
FirstName LastNameProf. Ugur Sahin, M.D.
Division of
Corporation Finance
Comapany NameBioNTech SE
Office of
Healthcare & Insurance
July 16, 2019 Page 4
cc: Eric Blanchard, Esq.
FirstName LastName