United States securities and exchange commission logo
January 30, 2023
Ryan Preblick
Chief Financial Officer
Indivior PLC
234 Bath Road, Slough, Berks, SL1 4EE
United Kingdom
Re: Indivior PLC
Amendment No. 2 to
Draft Registration Statement on Form 20-F
Submitted January
18, 2023
CIK No. 0001625297
Dear Ryan Preblick:
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. 2 to Draft Registration Statement on Form 20-F submitted
on January 18, 2023
Item 4.B. Business Overview
Long Term Pipeline, page 80
1. We note your response
to prior comment 15. Please revise the footnotes below the
pipeline table to
correspond to the product candidates shown in the table. For example,
the first row lists
AEF0117 but the corresponding footnote lists Addex Therapeutics.
Additionally, please
revise the heading Brand/Product Name so that it does not imply
that your product
candidates are likely to be approved.
2. We note your response
to prior comment 17, which we reissue in part. You continue to
state on page 81 that
the Phase 1 study of INDV-2000 demonstrated good safety.
Ryan Preblick
Indivior PLC
January 30, 2023
Page 2
Please revise this statement and any similar statements that imply that
your product
candidates are safe as such determinations are made solely by the FDA and
comparable
foreign regulators.
Cannabis Use Disorder, AEF0117 Synthetic CB1 Specific Signaling Inhibitor, page
81
3. We note your response to prior comment 14 and reference to your
"double-digit" royalty
obligation. In order to provide investors with material information
concerning your
agreement with Aelis Farma, please revise your disclosure to specify the
royalty rate or
range not to exceed ten percent (for example, low-teen or
high-teen ).
We also note your response to prior comment 18, which we reissue. You
state here that
you are developing AEF0117 as part of a strategic collaboration with
Aelis Farma.
Disclose here the upfront payment and any other payments made to date.
You also state
that you are developing INDV-2000 in partnership with C4X Discovery
and INDV-
1000 in "partnership" with Addex Therapeutics. Disclose here the material
terms of your
agreements with C4X and Addex Therapeutics, including upfront payments
and any other
payments made to date, milestone payments segregated by development and
commercial
milestones, term and termination provisions. Please file the agreements
with C4X and
Addex Therapeutics as exhibits to your registration statement or tell us
why you believe
such filing is not required.
Exhibits
4. Please file as exhibits the service agreements between the company and
the executive
directors or, alternatively, explain why such filing is not required.
Please see Item
601(b)(10)(ii)(A) for guidance.
You may contact Eric Atallah at 202-551-3663 or Angela Connell at
202-551-3426 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Joshua Gorsky at 202-551-7836 or Christine Westbrook at 202-551-5019
with any other
questions.
Sincerely,
FirstName LastNameRyan Preblick
Division of
Corporation Finance
Comapany NameIndivior PLC
Office of Life
Sciences
January 30, 2023 Page 2
cc: Michael Levitt, Esq.
FirstName LastName