REG - Indivior PLC - Indivior settles Antitrust MDL with DPs

IndiviorAnnouncement

23/10/2023 07:15

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20231023:nRSW9231Qa&default-theme=true

RNS Number : 9231Q  Indivior PLC  23 October 2023

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:

 

 $-in millions              Q3 2023                               YTD 2023
 Net revenue                $268m to $273m                        $797m to $802m

                            (+17% vs. Q3 2022 at the mid-point)   (+21% vs. Q3 YTD 2022 at the mid-point)
 SUBLOCADE net revenue      $165m to $170m                        $452m to $457

                            (+55% vs. Q3 2022 at the mid-point)   (+57% vs. Q3 YTD 2022 at the mid-point)
 Reported operating profit  ($178m) to ($188m)                    ($60m) to ($70m)
 Adjusted operating profit  $55m to $65m                          $197m to $207m

                            (+3% vs. Q3 2022 at the mid-point)    (+17% vs. Q3 YTD 2022 at the mid-point

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

 

 

-ends-

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCUUUUROAURUUA