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
Ryan Preblick
FirstName LastNameRyan Preblick
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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
Ryan Preblick
FirstName LastNameRyan Preblick
Indivior PLC
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2022 PLC
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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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2022 PLC
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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.
Ryan Preblick
Indivior PLC
December 16, 2022
Page 5
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.
FirstName LastNameRyan Preblick
Please revise to provide pro forma financial information in accordance
with Article 11 of
Comapany NameIndivior
Regulation PLC
S-X as it relates to this acquisition or tell us why you
believe it is not required.
Please
December 16,also
2022explain
Page 5your consideration of Rule 3-05 of Regulation S-X.
FirstName LastName
Ryan Preblick
FirstName LastNameRyan Preblick
Indivior PLC
Comapany16,
December NameIndivior
2022 PLC
December
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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.