July 25, 2019
Christopher Martin
Chief Executive Officer
ADC Therapeutics SA
Biop le, Route de la Corniche 3B
1066 Epalinges
Switzerland
Re: ADC Therapeutics SA
Draft Registration Statement on Form F-1
Submitted June 28, 2019
CIK No. 0001771910
Dear Dr. Martin:
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
Our Pipeline, page 2
1. Please include columns for Phase 2 and Phase 3 in your product pipeline
table here, as
well as on pages 98, 106 and 127, in lieu of the column labeled
"Pivotal," which appears
to combine the aforementioned phases.
Risks Associated with Our Business, page 4
2. Please clarify in the fourth bullet that you have previously been
subject to clinical holds.
Christopher Martin
ADC Therapeutics SA
July 25, 2019
Page 2
Implications of Being an Emerging Growth Company, page 5
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
Our product candidates may cause undesirable side effects, page 19
4. We note your discussion of the clinical hold the FDA placed on your
Phase 1 clinical trial
of ADCT-301. You also state that in October 2018 the FDA made certain
recommendations, which were implemented. Please disclose here and on
page 121 the
recommendations the FDA made relating to the clinical hold.
Use of Proceeds, page 75
5. We note your disclosure that you intend to use net proceeds to fund
the ongoing trials of
ADCT-402, ADCT-301, ADCT-602, and fund research and development of
your
preclinical product candidates and preclinical pipeline. Please
specify how far in the
development of each of the listed clinical trials 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.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Policies and Significant Judgments and Estimates
Employee Benefits
Share-Based Compensation Expense, page 93
6. Once you have an estimated offering price range, please explain to us
the reasons for any
differences between recent valuations of your common shares leading up
to the planned
offering and the midpoint of your estimated offering price range. This
information will
help facilitate our review of your accounting for equity issuances,
including stock
compensation.
Business
Synaffix Commercial License Agreement, page 137
FirstName LastNameChristopher Martin
7. Please disclose the upfront payments, aggregate milestone payments, and
the royalty rates
Comapanyroyalty range) you are required to pay under the Synaffix Commercial
License
(or NameADC Therapeutics SA
agreement.
July 25, 2019 Page 2
FirstName LastName
Christopher Martin
FirstName LastNameChristopher Martin
ADC Therapeutics SA
Comapany NameADC Therapeutics SA
July 25, 2019
Page 3
July 25, 2019 Page 3
FirstName LastName
Bergenbio License Agreement, page 138
8. Please disclose the upfront fee paid and the aggregate milestone
payments to be
paid under the Bergenbio License Agreement.
Notes to the Consolidated Financial Statements
Summary of significant accounting policies
2.11 Revenue recognition, page F-16
9. Please expand your disclosure to describe and quantify the key terms
governing the 2013
license and joint collaboration agreement with Genmab, your accounting
treatment for
payments under this agreement and key assumptions underlying the
associated revenue
recognition. Refer us to the technical guidance upon which you relied
and revise your
disclosure accordingly.
6. Research and development expenses, page F-23
10. Please expand your disclosure to describe and quantify the key terms
governing the
license agreements with Spirogen Ltd. in 2011, Bergenbio AS in 2014
and Synaffix in
2016 and your accounting treatment for payments under these
agreements. Refer us to the
technical guidance upon which you relied and revise your disclosure
accordingly.
13. Intangible assets, page F-27
11. Please revise the disclosure to explain why no amortization expense of
licenses was
recognized in 2017 or 2018.
Part II
Exhibit Index, page II-3
12. Please file the following agreements as exhibits to your registration
statement or tell us
why you believe they are not required to be filed:
2019 Equity Incentive Plan on page 167; and
employment agreements with your executive officers disclosed on page
167.
Christopher Martin
FirstName LastNameChristopher Martin
ADC Therapeutics SA
Comapany NameADC Therapeutics SA
July 25, 2019
Page 4
July 25, 2019 Page 4
FirstName LastName
You may contact Franklin Wyman at (202) 551-3660 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 Dietrich King at
(202) 551-
8071 with any other questions.
Sincerely,
Division of
Corporation Finance
Office of Healthcare &
Insurance
cc: Deanna Kirkpatrick, Esq.