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September 28, 2018
Mark Rothera
President, Chief Executive Officer and Director
Orchard Rx Ltd
108 Cannon Street
London EC4N 6EU
United Kingdom
Re: Orchard Rx Ltd
Amended Draft Registration Statement on Form F-1
Submitted September 14, 2018
CIK No. 0001748907
Dear Mr. Rothera:
We have reviewed your amended 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.
Amendment No. 1 to Draft Registration Statement on Form F-1 submitted September
14, 2018
Prospectus Summary
Overview, page 1
1. We note your response to our prior comment 5. We also note your
disclosure on pages
158, 162 and 165 that your discussions with relevant regulatory
authorities are ongoing
and that you do not yet have definitive feedback on the scope or
adequacy of the requisite
data necessary to justify approval and that you may be unable to
demonstrate
comparability between drug product manufactured using HSCs derived from
mobilized
Mark Rothera
FirstName LastNameMark Rothera
Orchard Rx Ltd
Comapany 28, 2018
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peripheral blood and HSCs derived from bone marrow and/or
comparability between drug
product that has been cryopreserved and fresh drug product. Please
expand your
disclosure in the Prospectus Summary to clarify that your table was
prepared based on
your hopes that the regulatory authorities will consider your trials
to be sufficient and
explain the consequences if they do not..
OTL-101 Program Safety, page 156
2. We note your revision in response to our prior comment 25 that there
was one SAE, a
product contamination, that was deemed by the investigator as being
possibly related to
protocol treatment or procedures. Please revise your disclosure
toidentify the SAE To the
extent known, explain the circumstances related to the contamination
and consider
whether the circumstances warrant risk factor disclosure.
UCLB/UCLA License Agreement, page 179
3. We note you are obligated to pay a non-refundable "low-double digit"
royalty percentage
to UCL on net sales of product candidates subject to the UCLB/UCLA
Agreement. Please
revise the royalty range to reflect no more than a 10% range.
Competition, page 180
4. We note that G n thon is sponsoring clinical trials with autologous ex
vivo lentiviral gene
therapy for WAS and for X-CGD in France, to which you have certain
rights. We also
note that you are party to a license agreement with G n thon with
respect to OTL-102.
Please provide a description of the rights and obligations of each
party under this
agreement, and clarify whether G n thon could be a competitor for the
treatment of WAS
and X-CGD.
Notes to Financial Statements
7. Shares-based compensation, page F-50
5. Please tell us why your expected volatility decreased from 80.00% in
2017 to 66.51% -
68.17% in 2018. Please provide us with the names and volatility of
each of the peer
companies you used to estimate expected volatility for 2018 and
explain why you believe
each company was similar to you. In your response, at a minimum,
specifically tell us
whether these peer companies have any product revenues, the number of
product
candidates in the pipeline, the general therapeutic area of these
product candidates and the
phase of development for these product candidates.
8. License and research arrangements
GSK asset purchase and license agreement, page F-52
Mark Rothera
FirstName LastNameMark Rothera
Orchard Rx Ltd
Comapany 28, 2018
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6. You disclose that you allocated $100.7 million of the total
consideration to IPR&D based
on the fair value of the underlying programs in development, and $92.4
million to
indefinite-life intangible assets related to the PRVs based on the
fair value at the date of
acquisition. Please tell us how your allocation complies with ASC
805-50-30-3 which
requires the cost of the acquisition to be allocated on a relative
fair value basis.
7. Please tell us how you applied the guidance in ASC 805-50-30 related
to the contingent
PRV liabilities and your basis for recording these amounts prior to
when the contingency
is resolved or becomes payable. In this regard, we note that your
obligations to GSK,
including transferring the first PRV to GSK and selling the subsequent
PRVs to GSK or
sharing with GSK the proceeds from the sale of the subsequent PRVs to
third parties, are
contingent on various uncertain factors including your ability to
obtain the PRVs from the
FDA.
8. With regard to the GSK acquisition, we note your disclosure of the
total consideration of
$193.0 million as of the date of acquisition. Please tell us and
disclose clearly all elements
of your purchase consideration that reconcile to the total
consideration amount.
9. You disclose on page F-45 that the indefinite-lived intangible assets
you recorded on the
balance sheets represent the acquired rights to receive a PRV. Please
tell us why the rights
are deemed indefinite-lived and explain the basis for assigning value
to such rights. In this
regard, we note that you have to use commercially reasonable efforts
to obtain a PRV
from the FDA and you will only be eligible for a PRV upon the approval
of a BLA for
OTL-101, OTL-200 and OTL-103 which are not expected to be submitted
until 2020 and
2021. In addition, your disclosure on page 32 indicates that the PRV
program, which has
been subject to criticism including by the FDA, may no longer be in
effect at the time
when and if you qualify for such a PRV and that you may not be able to
realize the
benefits of such PRV.
Notes to Unaudited Condensed Consolidated Financial Statements
13. Subsequent events, page F-60
10. We note from your disclosure on page 138 that you granted stock
options subsequent to
June 30, 2018. Please disclose these grants and the total compensation
expense attributed
to them in your subsequent events note, and discuss in MD&A the
anticipated impact on
results of operations of this apparent known trend in share-based
compensation.
You may contact Sisi Cheng at 202-551-5004 or Sharon Blume at
202-551-3474 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Irene Paik at 202-551-6553 or Suzanne Hayes at 202-551-3675 with any
other questions.
Sincerely,
Mark Rothera
Orchard Rx Ltd
September 28, 2018
FirstName LastNameMark Rothera
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Comapany NameOrchard Rx Ltd
Division of Corporation Finance
September 28, 2018 Page 4 Office of Healthcare & Insurance
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