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United States securities and exchange commission logo
December 16, 2022
Ryan Preblick
Chief Financial Officer
Indivior PLC
234 Bath Road, Slough, Berks, SL1 4EE
United Kingdom
Re:Indivior PLC
Amendment No. 1 to Draft Registration Statement on Form 20-F
Submitted November 22, 2022
CIK No. 0001625297
Dear Ryan Preblick:
            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.
Amendment No. 1 to Draft Registration Statement on Form 20-F, submitted November 22, 2022
Glossary, page 1
1.We note your disclosure here and on page 29 that AEF0117 is a "first-in-class synthetic
CB1 specific signaling inhibitor[.]"  Please remove the references throughout your
registration statement to "first-in-class" product candidates as these descriptions imply an
expectation of regulatory approval and are inappropriate given the length of time and
uncertainty with respect to securing marketing approval.
About This Registration Statement, page 4
2.We note your disclosure that your registration statement "contains information regarding
[y]our business and the industry in which [you] operate and compete, which [you] have

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obtained from various third-party sources."  Your disclosure also provides that you have
"not independently verified and do not guarantee the accuracy and completeness of []
information [obtained from industry publications and surveys and from third-party
sources.]"  Please note that you are responsible for the entire content of the registration
statement.  It is not appropriate to directly or indirectly disclaim liability for statements in
your registration statement.  Please revise or specifically state that you take liability for
these statements.
Item 3. Key Information
B. Capitalization and Indebtedness , page 8
3.Please remove “Cash and cash equivalents” from your “Total capitalization”, as cash and
cash equivalents are not a component of capitalization.  Consider also including a double
underline under "Cash and cash equivalents" to clarify that the amount is not included in
total capitalization.
Item 3.D. Risk Factors
Risks Related to our Group and Its Business
Compliance with the terms and conditions of our Corporate Integrity Agreement..., page 11
4.We note your disclosure that in 2020, you entered into a Corporate Integrity Agreement
with the U.S. Department of Health and Human Services Office of the Inspector General.
Please disclose here and in other relevant sections, such as your "Legal proceedings" and
"Material Contracts" sections, the allegations related to the criminal and civil charges that
led to the execution of the Corporate Integrity Agreement.
We are currently, in the past have been, and in the future may be, subject to substantial litigation
and ongoing litigation..., page 14
5.We note your disclosure that in 2019, the U.S. Attorney's Office for the Western District
of Virginia brought an indictment against the Group in connection with your "marketing
and promotional practices related to SUBOXONE Film and SUBOXONE Tablet[.]"  We
also note your disclosure that Indivior PLC entered into the Resolution Agreement in 2020
and "pleaded guilty to a single count of making a false statement relating to healthcare
matters in 2012."  Please provide further details regarding the factual allegations
underlying the indictment brought against the Group in 2019.
6.We note your disclosure that in January 2022, the Group settled a securities law class
action brought by holders of your Level 1 American Depository Receipts related to
"alleged misstatements regarding the marketing of SUBOXONE Film in the U.S. for
approximately $2 million."  Please provide further details about the nature of the alleged
misstatements at issue in that case and please disclose whether the parties entered into a
written settlement agreement.
7.We note your disclosure that civil antitrust claims have been filed against you.  Please

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disclose the status of these claims, the venue in which these claims are being litigated, and
the relevant parties associated with this matter.
We are subject to risks related to the manufacture and distribution of our products..., page 18
8.We note your disclosure that "[y]our manufacturing facilities also maintain high direct and
indirect labor costs due to the complexity of [y]our manufacturing processes, often
requiring specialized personnel."  We also note your disclosure on page 11 that you rely
"almost exclusively on third parties, including contract manufacturing organizations, to
manufacture, package, test, and distribute [y]our products."  Please revise your disclosure
here to note whether you are referring to manufacturing facilities that you own and
operate or facilities operated by third parties and whether the labor costs you are referring
to are borne by you or your third party partners.
Item 4. Information on the Company
Merger Agreement, page 63
9.Please expand your disclosure to include the aggregate merger consideration for the
acquisition of Opiant.
CVR Agreement, page 65
10.We note your disclosure that Indivior Inc. will have to pay certain milestone payments in
relation to the CVR Agreement and that those payments are linked to "the period
beginning with the first commercial sale of certain of Opiant's products."  Please revise to
specify which of Opiant's products would trigger the milestone payment period.
11.We note your disclosure that you estimate that total potential payments related to the CVR
Agreement include an additional $68 million over a period of up to 7 years from the date
of the first commercial sales of a new "Olive product."  Please explain your reference to
an "Olive product."
Opioid use disorder ("OUD"), page 67
12.We note your disclosure that "[r]ecent data indicates that sustained high-plasma
concentrations of buprenorphine . . . significantly reduced fentanyl-induced respiratory
depression in opioid-tolerant participants."  Please provide the basis for this statement.
Products of the Indivior Group
SUBLOCADE Long-acting injectable (buprenorphine) extended-release injection, page 73
13.We note your reference to your "RECOVER extension study."  Please revise your
disclosure to include the details of that study, including but not limited to, the selection
criteria for participants, where the study was conducted, study parameters and whether
there were any serious adverse events and if applicable, the number of participants who
experienced them.

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Cannabis Use Disorder, AEF0117 Synthetic CB1 Specific Signaling Inhibitor, page 78
14.We note your disclosure that upon commercialization of AEF0017, you would have to pay
Aelis Farma a "double-digit tiered royalty" on net sales.  Please revise your disclosure to
specify a royalty rate or range not to exceed ten percentage points per tier.
Long term pipeline, page 78
15.Please revise your table with respect to Treatment for Cannabis Use Disorder
(AEF0117) and Treatment for Substance Use Disorder (INDV-1000) to ensure that your
bars do not appear to depict that Phase 2 has been completed for AEF0117 and pre-
clinical work has been completed for INDV-1000.  While AEF0117 is currently in a Phase
2B clinical trial it is not appropriate for the table to indicate that Phase 2 trials have been
completed.  Similarly, while INDV-1000 is still in the pre-clinical development phase, it
is not appropriate for the table to indicate that pre-clinical development has been
completed.
16.We note your disclosure that AEF0117 is currently in a Phase 2B clinical trial in
treatment-seeking subjects with moderate to severe CUD.  Please revise your disclosure to
provide further details about this trial, including but not limited to, the selection criteria
for participants, where the trial is being conducted, endpoints and whether there have been
any serious adverse events to date and if applicable, the number of participants who
experienced them.
Opioid Use Disorder, page 79
17.We note your disclosure that a "Phase 1, Single Ascending Dose study was completed and
demonstrated good safety."  Please revise your disclosure indicating or implying that your
product is, or will be determined to be, safe and effective.  Safety and efficacy
determinations are solely within the authority of the FDA or similar regulators.

Additionally, please revise your disclosure to provide further details about the Single
Ascending Dose study, including but not limited to, the selection criteria for participants,
where the study was conducted, study parameters and whether there were any
serious adverse events and if applicable, the number of participants who experienced
them.
Intellectual Property , page 85
18.We note your disclosure that you own or license several patents and patent rights.  You
also state that you license or assign certain intellectual property rights to third parties.
Revise your disclosure to specify whether the patents are owned or licensed.  To the
extent you have not done so, please add disclosure, where appropriate, of the material
terms of your license agreements, including any upfront fees paid or received, aggregate
potential milestone payments segregated by development and commercial milestones,
royalty rate or range not to exceed ten percentage points, term and termination provisions.

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Please also file such agreements as exhibits to your registration statement or tell us why
you believe such filing is not required.
Item 5. Operating and Financial Review and Prospects
Results of operations, page 108
19.With respect to changes in net revenues for each period presented, please enhance your
discussion to disclose the degree to which such changes were impacted by price changes
as opposed to volume/market share.
Liquidity and Capital Resources
The Term Loan, page 120
20.Please disclose the names of the parties, including the lenders, to the Term Loan.
Item 7. Major Shareholders and Related Party Transactions
Major Shareholders, page 149
21.Please revise to identify the natural persons who have voting and/or investment control
of the shares held by Scopia Capital Management LP and Two Seas Capital LP.
Item 9.C. Material Contracts, page 174
22.Please expand your disclosure to include the termination provisions under each of your
Copacker Supply Agreement, Commercial Exploitation Agreement, Master
Manufacturing Services Agreement and Master Development and Supply Agreement.
Item 18. Financial Statements
Consolidated Cash Flow Statement, page F-25
23.We note your reconciliation of operating cash flows begins with operating profit/(loss)
instead of net income/(loss) for the year.  Per paragraph 20 of IAS 7, cash flows from
operating activities are determined by adjusting profit or loss.  Paragraph 7 of IAS 1
defines profit or loss as the total of income less expenses, excluding the components of
other comprehensive income.  Please revise your presentation accordingly, or tell us why
you believe no modification is necessary.
Note 27. Post Balance Sheet Subsequent Events
Opiant Pharmaceuticals Acquisition, page F-62
24.We note that you entered into a definitive agreement in November 2022 to acquire Opiant
Pharmaceuticals and that you expect this transaction to close in the first quarter of 2023.
Please revise to provide pro forma financial information in accordance with Article 11 of
Regulation S-X as it relates to this acquisition or tell us why you believe it is not required.
Please also explain your consideration of Rule 3-05 of Regulation S-X.

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Ryan Preblick
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            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,
Division of Corporation Finance
Office of Life Sciences
cc:       Michael Levitt, Esq.