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United States securities and exchange commission logo
May 28, 2020
Ingmar Hoerr
Chief Executive Officer
CureVac B.V.
Friedrich-Miescher-Strasse 15
72076
Tubingen
Germany
Re: CureVac B.V.
Draft Registration
Statement on Form F-1
Submitted April 29,
2020
CIK No. 0001809122
Dear Dr. Hoerr:
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 submitted April 29, 2020
Our Company, page 1
1. The prospectus summary
should include a balanced presentation of your business,
including your
competitive position in the industry. In the presentation of your business,
you state that you are
"a leading global clinical-stage biopharmaceutical company" and
that you have a
"differentiated technology platform." Please tell us the basis for these
claims. We note that
your most advanced is currently in a Phase 1 clincal trial and that no
mRNA products have been
approved by any regulatory agency and that you have not yet
obtained regulatory
approval for any product. Please balance your summary presentation
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FirstName LastNameIngmar Hoerr
CureVac B.V.
Comapany NameCureVac B.V.
May 28, 2020
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as well as presentations of your business elsewhere in the document by
providing equally
prominent disclosure about the competitive and regulatory challenges
you face.
2. We note your disclosure that your lead clinical programs have
"generated promising early
efficacy and safety results" or "shown potential" in clinical trials.
Safety and efficacy are
determinations that are solely within the authority of the FDA or
similar foreign
regulators. You may present clinical trial end points and objective
data resulting from
trials without concluding efficacy and you may state that your product
candidates have
been well tolerated, if accurate. Please revise these statements here
and throughout the
document.
3. We note your disclosure that mRNA-based medicines "represent a
foundational class of
medicine" and that they have "inherent advantages." Please provide the
source for this
statement and clarify your disclosure to explain why mRNA-based
medicines are
foundational and potentially provide an advantage compared to other
treatments.
4. Recent news coverage indicates that you are focused on developing a
vaccine for SARS-
CoV-2. A news release posted on your website on March 15, 2020 stated
that "internal
efforts are focused on the development of a coronavirus vaccine" and
an interview with
one of your executives stated that "[your] key focus is [your]
SARS-CoV-2 vaccine." An
additional article summarizing an interview with Dr. Hoerr stated that
Dr. Hoerr
acknowledged that your search for a vaccine has "all but consumed"
your
company. Please revise the summary section and other relevant portions
throughout the
document to disclose the impact that your focus on a potential
SARS-CoV-2 vaccine has
had, and will continue to have, on the rest of your business,
including preclinical and
clinical development of your other product candidates.
5. We note you count your in house manufacturing infrastructure as a
strength yet on page
17 , you state that you rely on CMOs to manufacture and supply your
product candidates.
Please clarify the disclosure throughout the document to explain the
the apparent
discrepancy.
6. Please revise the description of your programs to eliminate the
reliance on overly
technical language so investors can understand the nature of your
product candidates. For
example, please explain the significance of "activation of the toll
like receptors 7, or
TLR7, TLR8, and retonic acid-inducible Gene-I, or RIG-I pathways."
7. We note that you intend to initiate the first Phase 1/2a clincical
trial for COVID-19 in
____. Please clarify whether you have submitted an NDA or when you
expect to submit
an NDA.
Our Product Portfolio, page 3
8. Please revise your pipeline table to include a column for Phase 3,
include all indications
that the identified product candidates/programs are designed to treat
and remove programs
that are not material to your operations. To the extent that you have
licensed a
Ingmar Hoerr
FirstName LastNameIngmar Hoerr
CureVac B.V.
Comapany NameCureVac B.V.
May 28, 2020
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program/product candidate to another party, please clarify your
continued involvement in
the program and why it is appropriate to consider it as part of your
product development
pipeline. Your response should address your indications that
collaborative partners
exercise full control over development and commercialization.
We note your inclusion of references to collaborators such as Yale,
Harvard Medical
School and SERI without describing your collaborative agreements. To
the extent the
collaborations are material, please disclose the material terms of
these agreement. If they
are not material, remove the collaborative partner and the program
from your pipeline
table.
Additionally, we note your statement that you are advancing multiple
undisclosed
programs in preclinical studies across liver and rare diseases, eye
disorders, lung disease
and delivering theraputic antibodies and you have included them in
your pipeline table. It
is not appropriate to highlight programs that are not material.
Similarly, it is not
appropriate to omit disclosures relating to material programs.
Implications of Being an Emerging Growth Company, page 6
9. Please supplementally 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.
We depend on strategic partnerships..., page 15
10. We note that in certain cases your collaborative partners exercise
full control over further
development and potential commercialization and that collaborators can
independently
develop product that compete with the collaborative product candidate.
Additionally, we
note that you are subject to diligence requirements. Please clarify
whether your
collaborative partners are also subject to diligence requirements and
whether you have
contractual rights to information about clinical trial developments
and results.
We may face business disruption and related risks..., page 21
11. We note your disclosure about potential disruptions due to the
COVID-19 pandemic. To
the extent you have experienced delays in clinical trials,
difficulties enrolling new
participants, participants terminating their participation, or any
other disruptions, please
revise the discussion to describe the events and their potential
impact.
If we are unable to obtain, maintain and enforce intellectual property
protection for our
products..., page 37
12. Please identify all your product candidates that are subject to march
in rights.
Ingmar Hoerr
FirstName LastNameIngmar Hoerr
CureVac B.V.
Comapany NameCureVac B.V.
May 28, 2020
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Use of Proceeds, page 78
13. We note your disclosure that you intend to use the proceeds of this
offering to advance
your preclinical and clinical programs, invest in your mRNA technology
platform and
fund expansion of your manufacturing capabilities. Please also what
amounts will be
allocated to each of your programs and 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 Item 3.C.1 of Form 20-F.
Our Collaborations and License Agreements, page 86
14. Please revise the descriptions of each of your agreements to disclose:
each parties' rights and obligations under the agreement;
quantify all payment made to date;
disclose separately the aggregate amount of all potential
development, regulatory and
commercial milestone payments;
disclose the amount of option fees for additional targets;
quantify the royalty rate, or a range no greater than 10 percentage
points per tier;
disclose when royalty provisions expire, if the expiration is based
on a number of
years following commercialization, disclose the number of years;
disclose the expiration date; and
describe any termination provisions.
Please note disclosures such as "mid-nine figure amount" and "low
seven figure amount"
are not sufficent.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Results of Operations
Year Ended December 31, 2018 Compared to Year Ended December 31, 2019
Research and development expenses, page 90
15. You have two clinical stage programs and a COVID-19 program which you
identify as
key programs. We acknowledge your breakout of research and development
costs by type
of expenditure. To the extent known, please further disaggregate your
costs by each key
program. Costs related to insignificant product candidates may be
aggregated into one
line item with any unallocated costs on a separate line item to
reconcile the total costs to
the total on the Statement of Operations.
Contractual Obligations, page 93
16. Please provide narrative disclosure quantifying the total aggregate
amount of potential
future milestone payments under your collaboration and licensing
agreements.
Ingmar Hoerr
FirstName LastNameIngmar Hoerr
CureVac B.V.
Comapany NameCureVac B.V.
May 28, 2020
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Business, page 99
17. We note that your disclosures throughout this section reference to
"progressive disease,"
"stable disease," "complete response," and "partial response." Please
revise your document
to define these terms and disclose how responses were measured. Please
also revise your
document to provide definitions for Grade 1, Grade 2 and Grade 3 or
higher adverse
events.
Overview, page 100
18. We note your disclosure on page 100 that you have "made rapid advances
in de-risking
[your] RNAoptimizer platform through rational disease selection."
Please clarify to
explain how your disease selection process has de-risked your
RNAoptimizer platform
and to explain the significance of de-risking your platform.
Overview, page 101
19. We note your disclosure on page 100 that your "protein therapy
platform has the potential
to be used as a treatment against infectious diseases and toxins and
to be applied in many
disease indications including cancer, cardiovascular diseases, and
autoimmune diseases."
Please clarify whether your protein therapy platform is separate from
the RNAoptimizer
platform.
Our Strengths, page 103
20. Please explain the basis for your beliefs that mRNA-based medicines
have advantages
over existing treatment modalities and mRNA vaccines offer advantages
over existing
vaccine technologies.
21. Please balance your claim that you have a broad portfolio of
mRNA-based medicines by
clarifying that you are still developing your product candidates and
that to date you have
only conducted preclinical studies and initiated Phase 1 trials of
those product candidates.
Management, page 188
22. Please file the consulting agreement with Dr. Winterhalter as an
exhibit to your
registration statement.
Management
Equity Incentive Plans, page 198
23. 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.
Ingmar Hoerr
FirstName LastNameIngmar Hoerr
CureVac B.V.
Comapany NameCureVac B.V.
May 28, 2020
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Description of Share Capital and Articles of Association, page 206
24. On page F-29 of the document, you state that your Series B and Series
C shares include
preference rights in the case of a defined exit event. Please update
this section to discuss
any outstanding shares of preferred stock or whether the preferred
stock will convert to
common stock in the reorganization. See Item 10.A of Form 20-F.
3.1 Revenue from contract with customers, page F-22
25. Please include disclosure of your collaboration agreement with Eli
Lilly and Company, or
identify which of your disclosed agreements generated the revenues
attributed to Eli Lilly
and Company in the tables on page F-22.
26. You recorded EUR 17,416,000 of revenue in 2019 of which EUR 8,617,000
was from
product sales and EUR 5,777,000 was from revenue recognized from
upfront payments.
Please clarify the nature of the remaining revenue recognized and the
accounting policy.
Clarify in Management's Discussion and Analysis the reason for the
increase in the
revenue from the prior year.
27. You state on page F-8 that you generally concluded that you act as a
principal in sales
transactions as you customarily have control over the goods or
services before transferring
control to the customer. Please clarify the following:
the circumstances in which you would or would not act as a principal
in sales
transactions,
what you mean by "customarily has control over the goods or services
before
transferring control to the customer",
how your accounting policy for recording product sales as a
principal or agent is
consistent with B34-B38 of IFRS 15, and
if the product sales relate to sales to the collaborative partner
and if so, where the
performance obligations relating to those sales are disclosed for
each significant
agreement
3.2 Cost of Sales, page F-23
28. You disclose that your revenues have been recognized pursuant to
license and
collaboration agreements. Please explain to us what differentiates
expenses recorded as
cost of sales from those recorded as research and development
expenses. In addition,
please clarify in Management's Discussion and Analysis the reasons why
each component
of cost of sales increased, why quantitatively the cost of sales
increased more than the
increase in revenue, and why the percentage increase in cost of sales
was higher than the
percentage increase in revenue.
Notes to the Consolidated Financial Statements
12. Convertible loans, page F-35
29. Please disclose the conversion rate of the convertible loans.
Ingmar Hoerr
CureVac B.V.
May 28, 2020
Page 7
You may contact Rolf Sundwall at 202-551-3105 or Mary Mast at
202-551-3613 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Alan Cambell at 202-551-4224 or Suzanne Hayes at 202-551-3675 with any
other
questions.
FirstName LastNameIngmar Hoerr Sincerely,
Comapany NameCureVac B.V.
Division of Corporation
Finance
May 28, 2020 Page 7 Office of Life Sciences
FirstName LastName