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February 28, 2019
David Eatwell
Chief Financial Officer
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V, Denmark
Re: Genmab A/S
Draft Registration Statement on Form F-1
Submitted on February 5, 2019
CIK No. 0001434265
Dear Mr. Eatwell:
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, page 1
1. We note your references to "low double digit royalties," "royalties [in]
low double-digits,"
and "royalties with rates in the double-digits" on pages 5, 97, 139,
150, and 152. Please
revise your disclosure throughout the prospectus to narrow the royalty
range to no more
than ten percentage points (for example between twenty and thirty
percent).
2. Please define "stringent complete response" and explain how it differs
from complete
response. In addition, please explain what you mean by "blockbuster
status."
David Eatwell
FirstName LastNameDavid Eatwell
Genmab A/S
Comapany NameGenmab A/S
February 28, 2019
February 28, 2019 Page 2
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Implications of Being an Emerging Growth Company and a Foreign Private Issuer,
page 10
3. 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.
Risk Factors, page 16
4. Please add risk factor disclosure addressing the risks to investors
posed by the arbitration,
exclusive forum and jury trial waiver provisions contained in your
deposit agreement.
Use of Proceeds, page 70
5. Please disclose the principal reasons for the offering, as you do not
disclose any specific
plans for the proceeds. Please refer to Item 4.A of Form F-1 and Item
3.C of Form 20-F.
Key Components of Our Results and Related Trends , page 78
6. Regarding your expectations for Arzerra net sales in the near future,
as set forth in the
third full paragraph on page 79, please disclose whether you expect
them to decrease. In
this regard, we note your disclosure about Novartis' ongoing
transition of Arzerra to
limited availability in most jurisdictions. Please also update your
disclosure in the
prospectus summary as necessary.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Research and Development Expenses, page 83
7. We note that your table on page 84 shows third-party costs incurred
for research, contract
manufacturing of your product candidates and clinical and regulatory
services, which also
presents other costs and overhead consisting of third-party costs for
your pre-clinical stage
programs, personnel, facilities and other indirect costs not directly
charged to
development programs. Please disclose your research and development
expenses incurred
to date similar to the presentation in this table.
Business
Griffin (MMY2004), page 118
8. Please disclose what were the adverse and serious adverse events
referenced in the "safety
data" subsection on page 119. In addition, please disclose all adverse
events in the
MIRROR study on page 131.
MIRROR, page 131
9. We note your reference here that "[i]maging showed that all subQ
ofatumumab doses
demonstrated efficacy." As currently drafted, this statement could
imply that the FDA has
David Eatwell
FirstName LastNameDavid Eatwell
Genmab A/S
Comapany NameGenmab A/S
February 28, 2019
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FirstName LastName
approved, or will more easily approve, your product candidates. Please
revise throughout
the prospectus to remove any implication that your product candidates
are more likely
than others to receive FDA approval or explain to us why such
statements are appropriate
given the stage of your product candidates.
Collaboration with Novartis, page 132
10. We note your references to "decreasing global demand for Arzerra" on
page 133 and
Novartis' decision to transition the commercial availability of the
drug to limited
availability through manged access programs. Please disclose the
reasons for decreased
global demand of the drug, if known.
Collaborations and Other Agreements for our Partnered Product Candidates, page
151
11. Regarding the descriptions of the Immatics Research Collaboration and
Novo Nordisk
DuoBody Collaboration on page 153, please disclose what the "tiered
royalties on net
sales," or their ranges, are under the Immantics Research
Collaboration. Also, please
disclose the maximum aggregate milestone payments under the Nordisk
DuoBody
Collaboration.
Other Enabling Technologies
Medarex UltiMAb System License, page 154
12. Please file the license agreement with Medarex as an exhibit to your
registration statement
or tell us why you believe it is not required to be filed. In
addition, please disclose the
aggregate milestone and royalty payments under this agreement.
Management
Compensation, page 185
13. Please update the aggregate compensation for your officers and
directors for the fiscal
year ended December 31, 2018.
Certain Senior Management Agreements , page 187
14. Please either tell us why you believe you are not required to file the
senior management
agreements as exhibits to the registration statement or file them as
exhibits. Please refer
to Item 8.A of Form F-1 and Item 601(b)(10) of regulation S-K.
Jury Trial Waiver, page 219
15. Please disclose here that the waiver of the right to a jury trial
contained in the deposit
agreement is not intended to be deemed a waiver by any holder or
beneficial owner of
ADSs of the company's or the depositary's compliance with the U.S.
federal securities
laws and the rules and regulations promulgated thereunder. In
addition, please ensure that
the filed deposit agreement provides that no disclaimer of liability
under the Securities Act
David Eatwell
FirstName LastNameDavid Eatwell
Genmab A/S
Comapany NameGenmab A/S
February 28, 2019
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February 28, 2019 Page 4
FirstName LastName
or the Exchange Act is intended by any provision of the deposit
agreement. Finally,
please ensure that the arbitration provision in the deposit agreement
provides that the
provision does not preclude holders and beneficial owners from
pursuing claims under the
Securities Act or the Exchange Act in federal courts.
Notes to the Consolidated Financial Statements
1.2 New Accounting Policies and Disclosures, page F-12
16. With respect to your adoption of IFRS 15, you disclose that you will
recognize sales-
based royalties and commercial sales-based milestones in the period to
which the sales
relate based on estimates provided by collaborations partners, which
is consistent with
your current accounting policies. However, on page F-14, you disclose
that your current
accounting policy is to recognize revenue when third-party results are
available and are
deemed to be reliable. Please tell us why you believe it is
appropriate to delay recognition
until the sales information is received under paragraph B63 of IFRS
15.
Part II
Exhibit Index, page II-3
17. Please either file the following agreements as exhibits to your
registration statement or tell
us why you believe they are not required to be filed:
agreement with BioNTech, which is discussed on page 78;
collaboration agreement with Roche, which is discussed on page 152;
agreement with Lundbeck, which is discussed on page 152; and
direct license from Immunex Corporation, which is discussed on page
152.
18. Please file a list of your subsidiaries as an exhibit to your
registration statement. Please
refer to Item 601(b)(21) of Regulation S-K.
Signatures, page II-4
19. Please revise the introductory language to the registrant's signature
block to add the
certification required by Form F-1 that the registrant has reasonable
grounds to believe it
meets all of the requirements for filing Form F-1.
David Eatwell
Genmab A/S
February 28, 2019
Page 5
You may contact Isaac Esquivel at (202) 551-3395 or Kate Tillan at (202)
551-3604 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Tonya K. Aldave at (202) 551-3601 or Dietrich King at (202) 551-8071
with any other
questions.
Sincerely,
FirstName LastNameDavid Eatwell
Division of
Corporation Finance
Comapany NameGenmab A/S
Office of Healthcare
& Insurance
February 28, 2019 Page 5
cc: Harald Halbhuber
FirstName LastName