Indivior Pharmaceuticals, Inc 6-K, filed May 23, 2024
Indivior Pharmaceuticals, Inc. (INDV)
6-K
2024-05-23
For: 2024-05-23
View Original
Added on
July 07, 2026
About this 6-K
Indivior Pharmaceuticals, Inc filed this 6-K on May 23, 2024.
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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
For the month of May 2024
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 ☐
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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: May 23,
2024
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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
Indivior to Host Analyst Teach-in Event in New York City;
Reconfirms Full Year 2024 Guidance
Richmond, VA, May 23, 2024 - Indivior PLC (LSE: INDV; Nasdaq:
INDV), a
leading addiction treatment company, announced that
in anticipation of the expected
primary listing of the Company's shares on Nasdaq, members of
Indivior's senior leadership team will be hosting an analyst
teach-in event today in New York City. The event, which will be
webcast (see details below), is intended to provide an in-depth
overview of Indivior's growth and value creation path. During the
event, the Company will reconfirm its unchanged FY 2024 guidance as
set forth below.
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FY 2024
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Net Revenue (NR)1
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$1,240m to $1,330m
(+18% at midpoint vs. FY 2023)
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SUBLOCADE NR
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$820m to $880m
(+35% at midpoint vs. FY 2023)
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OPVEE® NR
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$15m to $25m1
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PERSERIS NR
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$55m to $65m
(+43% at midpoint vs. FY 2023)
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SUBOXONE Film Market Share
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Assumes historic rate of share decline in FY 2024 of 1 to 2
percentage points and the potential impact from a fourth
buprenorphine/naloxone sublingual film generic in the U.S.
market
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Adjusted Gross Margin
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Low to mid-80s range
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Adjusted SG&A
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($575m) to ($590m)
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R&D
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($120m) to ($130m)
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Adjusted Operating Profit
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$330m to $380m
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1 The OPVEE NR guidance for FY 2024 includes approximately $8m as
part of a multi-year agreement with the U.S. Biomedical Advancement
Research and Development Authority (BARDA).
Link to today's analyst teach-in event
Webinar Registration - Zoom
About Indivior
Indivior is a global pharmaceutical company working to help change
patients' lives by developing medicines to treat substance use
disorders (SUD) 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
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 over 1,100 individuals globally and
its portfolio of products is available in 37 countries worldwide.
Visit www.indivior.com to
learn more. Connect with Indivior on LinkedIn by
visiting https://www.linkedin.com/company/indivior.
Important Cautionary Note Regarding Forward-Looking
Statements
This announcement contains
certain statements that are forward-looking. Forward-looking
statements include, among other things, statements regarding: the
Indivior Group's financial guidance including operating and profit
margins for 2024 and its medium- and long-term growth outlook;
assumptions regarding expected changes in share and expectations
regarding the extent and impact of competition; assumptions
regarding future exchange rates; strategic priorities, strategies
for value creation, and operational goals; expected future growth
and expectations for sales levels for particular products, and
expectations regarding the future impact of factors that have
affected sales in the past; expected growth rates, growing
normalization of medically assisted treatment for opioid use
disorder, and expanded access to treatment; our product development
pipeline and potential future products, expectations regarding
regulatory approval of such product candidates, the timing of such
approvals, and the timing of commercial launch of such products or
product candidates, and eventual annual revenues of such future
products; expectations regarding future production at the Group's
Raleigh, North Carolina manufacturing facility; our intention to
seek shareholder approval in May 2024 to facilitate a primary
listing in the U.S. while maintaining a secondary listing in the
U.K., and the expected timing and potential benefits of such
listing; 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; 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, most
of which contain controlled substances; market acceptance of our
products as well as our ability to commercialize our products and
compete with other market participants; competition; the
uncertainties related to the development of new products, including
through acquisitions, and the related regulatory approval process;
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 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 armed
conflicts and pandemics; 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; and volatility in our share
price due to factors unrelated to our operating performance or that
may result from the potential move of our primary listing to the
U.S.
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.
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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