March 17, 2020
Joseph A. Wiley
Chief Executive Officer
Amryt Pharma plc
Dept 920a 196 High Road, Wood Green
London, United Kingdom N22 8HH
Re: Amryt Pharma plc
Draft Registration Statement on Form F-1
Submitted February 19, 2020
CIK No. 0001783010
Dear Dr. Wiley:
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
Cover page
1. We note your disclosure on the prospectus cover page that the last
reported sale price of
your ordinary shares on the London AIM market was ___ per ordinary
share, equivalent
to $ ___ per ADS. You may use the most recent home market trading price,
converted to
U.S. dollars at the most recent exchange rate, assuming the U.S. IPO
price will be
substantially similar to the home market trading price. If you expect
that the U.S. IPO
price will not be substantially similar as the home market trading
price, please disclose on
the prospectus cover page a bona fide price range of the offered
securities. If you intend to
price the securities based on the London AIM market price, you may
disclose a percentage
range based on that price (for example, 10% of the home market price)
within which you
Joseph A. Wiley
FirstName LastNameJoseph A. Wiley
Amryt Pharma plc
Comapany2020
March 17, NameAmryt Pharma plc
March 17, 2020 Page 2
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FirstName LastName
intend to price the securities. Please refer to the instructions to
Item 501(b)(3) of
Regulation S-K which require bona fide pricing information for
offerings by companies
not subject to the reporting requirements of Section 13(a) or 15(d) of
the Exchange Act.
Prospectus Summary
Overview, page 3
2. We note your disclosure in footnote four to your program chart that
AP101 was approved
in 2016 by the European Medicines Agency (EMA) for the treatment of
partial thickness
wounds in adults, but has not been commercially launched. We note also
your discussion
in the Business section beginning on page 84 of three Phase 3 clinical
trials of AP101 for
the treatment of other partial thickness wounds and statement that you
do not intend to
pursue this indication but focus your development of AP101 on the
treatment
of Epidermolysis Bullosa (EB). Please tell us whether you have been
permitted to rely on,
or anticipate being permitted to rely on, data from such clinical
trials for the treatment of
partial thickness wounds for purposes of securing marketing approval
for the treatment of
EB and if that is not the case, please tell us why you believe such
disclosure is
appropriate. Please address as part of your response your presentation
of pooled data.
Implications of Being an Emerging Growth Company, page 5
3. 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.
Risks Associated with our Business, page 5
4. Please add a bullet point that includes your amount of outstanding
debt as of December
31, 2019 and highlights the risk of your debt obligations.
Risk Factors
Risks Related to Our Business, Financial Condition and Capital Resources
Restrictive covenants in certain of the agreements and instruments governing
our indebtedness...,
page 15
5. Please expand your risk factor to disclose provisions in your debt
agreements that provide
for cross-default with other of your debt agreements, as referenced on
pages 135 to 136.
Use of Proceeds, page 57
6. Please revise the discussion to disclose the estimated net amount of
the proceeds
broken down into each principal intended use. If the anticipated
proceeds will not be
sufficient to fund all the proposed purposes, please disclose the
order of priority of such
purposes. To the extent material amounts of other funds are necessary
to accomplish the
Joseph A. Wiley
FirstName LastNameJoseph A. Wiley
Amryt Pharma plc
Comapany2020
March 17, NameAmryt Pharma plc
March 17, 2020 Page 3
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FirstName LastName
specified purposes, state the amounts and sources of such other funds
needed for each
specified purpose. Refer to Item 3.C.1 of Form 20-F.
Management's Discussion and Analysis and Results of Operations
Research and Development Expenses, page 69
7. Please revise your disclosure to quantify the research and development
expenses by
product candidate. To the extent that you do not track expenses by
product candidate,
please disclose as such and disclose the costs incurred by the types
of costs classified
as research and development for each period presented.
Intellectual Property, page 90
8. Please revise this section to clearly disclose the patents that relate
to each of your
commercialized products and development stage products, including the
type of patent
protection, whether the patent is issued or pending, the expiry date
and relevant
jurisdiction. In this regard, as examples only, we note the following:
disclosure indicating your lomitapide patent portfolio includes
patents that provide
protection into "2027 in the United States and into 2025 in the
European Union with
supplementary protection granted to extend patent protection in
major EU countries
into 2028" and that granted patents "expire between 2019 and 2030
and pending
patent applications (if granted) would expire at the latest in
2039, or later."
reference to patents that provide orphan exclusivity for
metreleptin for a specified
period; and
reference to global intellectual property coverage.
Please also revise your discussion of orphan drug exclusivity to
clearly distinguish
among granted designations, designations you plan to seek and
designations that have
expired.
University College Dublin In-License Agreement, page 91
9. Please revise your disclosure of the termination provisions under the
agreement to provide
the anticipated expiry of patents licensed under the agreement, the
period of orphan drug
exclusivity and the circumstances under which University College
Dublin may terminate
the agreement. Please revise to provide similar disclosure throughout
this section where
you reference patent expiry and/or data or market exclusivity with
respect to termination
rights. Please also revise to clarify whether the "Completion Date"
for purposes of
the Japan Lomitapide License Agreement has occurred.
University of Pennsylvania Lomitapide License Agreement, page 92
10. We note your discosure that if the indication is not homozygous
familial
hypercholesterolemia (HoFH) or severe refractory hypercholesterolemia,
then additional
Joseph A. Wiley
Amryt Pharma plc
March 17, 2020
Page 4
payments are required to be made upon the occurence certain milestone
events. If
applicable to your development of lomitapide for the treatment of
familial
chylomicronemia syndrome (FCS), please revise your disclosure provide
your potential
payment obligations.
Amgen License Agreement, page 93
11. Please revise your disclosure of the royalty term under the agreement to
provide the
anticipated patent expiry and referenced data exclusivity period.
Additionally, please
expand your disclosure of the terms of the National Institutes of Health
( NIH ) License
Agreement to include the circumstances under which NIH may terminate the
agreement.
You may contact Gary Newberry at 202-551-3761 or Kevin Kuhar at
202-551-3662 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Christine Westbrook at 202-551-5019 or Suzanne Hayes at 202-551-3675
with any other
questions.
Sincerely,
FirstName LastNameJoseph A. Wiley
Division of
Corporation Finance
Comapany NameAmryt Pharma plc
Office of Life
Sciences
March 17, 2020 Page 4
cc: Boris Dolgonos, Esq.
FirstName LastName