Indivior Pharmaceuticals, Inc 6-K, filed Oct 23, 2023
Indivior Pharmaceuticals, Inc. (INDV)
6-K
2023-10-23
For: 2023-10-23
View Original
Added on
April 10, 2026
About this 6-K
Indivior Pharmaceuticals, Inc filed this 6-K on October 23, 2023.
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
________________________
Washington, D.C. 20549
_____________________
FORM 6-K
_____________________
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
under the Securities Exchange Act of 1934
Date: October 23, 2023
Commission File Number: 001-37835
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Indivior PLC
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10710 Midlothian Turnpike, Suite 125
North Chesterfield, Virginia 23235
(Address of principal executive office)
_______________________________
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F
Form
20-F ☒ Form 40-F ☐
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ☐
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EXHIBIT INDEX
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Exhibit
No.
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Description
of Exhibit
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99.1
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SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
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Indivior PLC
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Date: October 23,
2023
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/s/
Kathryn Hudson
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Name:
Kathryn Hudson
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Title:
Company Secretary
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Exhibit
99.1
FOR IMMEDIATE RELEASE
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF
ARTICLE 7 OF THE MARKET ABUSE REGULATION (EU) 596/2014 (AS IT FORMS
PART OF DOMESTIC LAW IN THE UK BY VIRTUE OF THE EUROPEAN UNION
(WITHDRAWAL) ACT 2018).
Indivior Reaches Agreement with Direct Purchasers to Resolve
Antitrust Multi-District Litigation; Provides Preliminary Q3 and
YTD 2023 Results
Richmond, VA, October 23, 2023 - Indivior PLC (LSE/NASDAQ:
INDV), a leading addiction
treatment company, announced that its subsidiary, Indivior Inc.
(the "Company"), has reached an agreement to resolve the claims
brought by the direct purchasers (the "Claimants") in
the In
re Suboxone Antitrust Litigation multi-district litigation ("the
MDL").
Indivior previously announced settlement agreements with two other
groups of plaintiffs in the MDL, a class of End Payors (the "EPs")
and various State Attorneys General (the "States"). The agreement
with the direct purchasers will mark the conclusion of the MDL,
once the settlements for the Claimants and EPs are approved by the
United States District Court for the Eastern District of
Pennsylvania (the "Court"). The trial, which was scheduled to begin
on October 30, 2023, will be canceled.
As part of the Agreement with the Claimants, Indivior will pay $385
million and will take a charge of $228 million in the third
quarter, which will be excluded from adjusted earnings. This charge
represents the additional amount above the current remaining
provision of $157 million for the Antitrust MDL, which reflects the
previously announced settlement agreements with the States and End
Payors. The Agreement will become final once approved by the Court.
Payment of the $385 million is expected to be made in November 2023
and funded from Indivior's existing cash.
"We are pleased to achieve this settlement to conclude this legacy
multi-district antitrust matter," said Indivior Chief Executive
Officer Mark Crossley. "The resolution of this litigation, which
was filed over a decade ago, provides greater certainty for all
Indivior stakeholders and allows us to continue focusing on our
important work for patients suffering from opioid use disorder and
mental health illnesses around the world."
Indivior expects that Court approval of the Agreement will remove
the previously disclosed material uncertainty related to
Indivior's going concern basis of accounting.
Preliminary Q3 and YTD
2023 Results:
Based on management's current view, the below preliminary unaudited
results are expected:
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$-in millions
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Q3 2023
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YTD 2023
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Net revenue
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$268m to $273m
(+17% vs. Q3 2022 at the mid-point)
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$797m to $802m
(+21% vs. Q3 YTD 2022 at the mid-point)
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SUBLOCADE net revenue
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$165m to $170m
(+55% vs. Q3 2022 at the mid-point)
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$452m to $457
(+57% vs. Q3 YTD 2022 at the mid-point)
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Reported operating profit
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($178m) to ($188m)
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($60m) to ($70m)
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Adjusted operating profit
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$55m to $65m
(+3% vs. Q3 2022 at the mid-point)
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$197m to $207m
(+17% vs. Q3 YTD 2022 at the mid-point)
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Indivior will report Q3 and YTD 2023 results on November
9th.
Important Cautionary Note Regarding Forward-Looking
Statements
This news release contains certain statements that are
forward-looking. Forward-looking statements include, among other
things, statements regarding expected court approval of the
settlement, expectations that Indivior will be able to remove the
material uncertainty following Court approval, the expected timing
of settlement payments, that Indivior has sufficient liquidity to
continue to invest in the business and the pipeline and that
Indivior has the financial flexibility to meet its other
stakeholder obligations; and other statements containing the words
"believe", "anticipate", "plan", "expect", "intend", "estimate",
"forecast," "strategy," "target," "guidance," "outlook,"
"potential", "project", "priority," "may", "will", "should",
"would", "could", "can", "outlook," "guidance", the negatives
thereof, and variations thereon and similar expressions. By their
nature, forward-looking statements involve risks and uncertainties
as they relate to events or circumstances that may or may not occur
in the future.
Actual results may differ materially from those expressed or
implied in such statements because they relate to future events.
Various factors may cause differences between Indivior's
expectations and actual results, including, among others, the
material risks described in the most recent Indivior PLC Annual
Report and in subsequent releases; whether the Court approves the
Agreement; events that may occur or facts of which the Company
becomes aware subsequent to the date of this news release which
affect the current accounting period; the potential removal of the
previously disclosed material uncertainty related to Indivior's
going concern basis of accounting; timing of payment of the $385
million settlement with the direct purchasers; Indivior's belief
that it has sufficient liquidity and future cash generation to
continue investing in its business and pipeline for long-term
growth, and to maintain financial capacity to meet its other
stakeholder obligations; the substantial litigation and ongoing
investigations to which we are or may become a party; our reliance
on third parties to manufacture commercial supplies of most of our
products, conduct our clinical trials and at times to collaborate
on products in our pipeline; our ability to comply with legal and
regulatory settlements, healthcare laws and regulations,
requirements imposed by regulatory agencies and payment and
reporting obligations under government pricing programs; risks
related to the manufacture and distribution of our products, some
of which are controlled substances; market acceptance of our
products as well as our ability to commercialize our products and
compete with other market participants; the uncertainties related
to the development of new products, including through acquisitions,
and the related regulatory approval process; our dependence on a
small number of significant customers; our ability to retain key
personnel or attract new personnel; our dependence on third-party
payors for the reimbursement of our products and the increasing
focus on pricing and competition in our industry; unintended side
effects caused by the clinical study or commercial use of our
products; our use of hazardous materials in our manufacturing
facilities; our import, manufacturing and distribution of
controlled substances; our ability to successfully execute
acquisitions, partnerships, joint ventures, dispositions or other
strategic acquisitions; our ability to protect our intellectual
property rights and the substantial cost of litigation or other
proceedings related to intellectual property rights; the risks
related to product liability claims or product recalls; the
significant amount of laws and regulations that we are subject to,
including due to the international nature of our business;
macroeconomic trends and other global developments such as the
COVID-19 pandemic; the terms of our debt instruments, changes in
our credit ratings and our ability to service our indebtedness and
other obligations as they come due; changes in applicable tax rate
or tax rules, regulations or interpretations; and our ability to
realize our deferred tax assets.
Forward-looking statements speak only as of the date that they are
made and should be regarded solely as our current plans, estimates
and beliefs. Except as required by law, we do not undertake and
specifically decline any obligation to update, republish or revise
forward-looking statements to reflect future events or
circumstances or to reflect the occurrences of unanticipated
events.
About Indivior
Indivior is a global pharmaceutical company working to help change
patients' lives by developing medicines to treat addiction and
serious mental illnesses. Our vision is that all patients around
the world will have access to evidence-based treatment for the
chronic conditions and co-occurring disorders of substance use
disorder (SUD). Indivior is dedicated to transforming SUD from a
global human crisis to a recognized and treated chronic disease.
Building on its global portfolio of OUD treatments, Indivior has a
pipeline of product candidates designed to both expand on its
heritage in this category and potentially address other chronic
conditions and co-occurring disorders of SUD, including alcohol use
disorder and cannabis use disorder. Headquartered in the
United States in Richmond, VA, Indivior employs more
than 1,000 individuals globally and its portfolio of products is
available in 39 countries worldwide.
Visit www.indivior.com to learn more. Connect with
Indivior on LinkedIn by
visiting www.linkedin.com/company/indivior.
This release is being made by Kathryn Hudson, Company Secretary
Indivior PLC.
Media
Contacts:
US Media:
Cassie France-Kelly
Vice President, Communications
Indivior PLC
Tel: 804-724-0327
UK Media:
Teneo
Tel: +44 207-353-4200
Investors
and Analysts:
Jason Thompson
Vice President, Investor Relations
Indivior PLC
Tel: 804-402-7123
Tim Owens
Director, Investor Relations
Indivior PLC
Tel: 804-263-3978
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