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 October 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 ☐
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 10, 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
Indivior Provides Preliminary Q3 2024 Results; Updates FY 2024
Guidance; Group Continues to Expect
SUBLOCADE Peak Net Revenue of >$1.5 Billion
Conference Call Today at 8:00 AM US Eastern
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).
Richmond, VA, October 10, 2024 - Indivior PLC (Nasdaq/LSE: INDV) today
announced preliminary Q3 2024 financial results and provided
updated FY 2024 guidance.
●
Group now sees lower than expected Q3 2024 and FY 2024 SUBLOCADE
net revenue (NR) from a combination of faster initial adoption
among treatment providers of the competing long-acting injectable
(LAI), variability in the timing of funding among certain Criminal
Justice System (CJS) accounts and incremental lower trade
stocking.
o Preliminary
Q3 2024 SUBLOCADE NR: $187m to $192m
o Revised
FY 2024 SUBLOCADE NR: $725m to $745m (+17% at the midpoint vs. FY
2023)
●
Expected peak SUBLOCADE NR of >$1.5 billion is unchanged,
however the Group no longer expects a SUBLOCADE NR run rate of $1
billion exiting 2025.
●
The Group is actively seeking efficiencies to fuel SUBLOCADE growth
and support margins.
Comment by Mark Crossley, CEO of Indivior PLC
"We are seeing faster than expected initial adoption of the
competitive product to SUBLOCADE. This dynamic, together with
greater variability in the timing of funding among Criminal Justice
System customers, as well as incremental trade stocking pressure,
has resulted in net revenue below our expectations set out in July.
We are reducing our FY 2024 guidance to reflect these impacts. In
addition, looking to the year ahead, as the US market adjusts
to two LAI products, pressure on SUBLOCADE volume growth is
expected from continued initial competitor adoption. Therefore, we
no longer expect that SUBLOCADE will exit 2025 at a $1 billion net
revenue run rate.
We remain firm in our conviction that SUBLOCADE has a
differentiated and optimal profile for opioid use disorder (OUD)
patients, including our belief that it will best meet the
increasing challenges that synthetic opioids are presenting to OUD
patients and treatment providers. Additionally, we expect
SUBLOCADE's profile to be further enhanced with important label
updates in February 2025 that, if approved by the FDA, are expected
to improve both the patient and healthcare provider experience. We
also are actively evaluating actions to fuel SUBLOCADE's growth and
to support margins.
Further, we have been tracking multiple market cohorts since the
competitor's launch a year ago and, while we have seen faster than
expected initial adoption, recent market data is consistently
showing that SUBLOCADE's share is stabilizing at levels
demonstrating its leading position in the clinic. Coupled with the
continued expected growth of the wider LAI market, we believe this
evidence validates the significant market opportunity we see for
SUBLOCADE and we believe it confirms our unchanged peak annual
SUBLOCADE NR expectation of greater than $1.5
billion."
Preliminary Q3 Net Revenue Expectations:
The Group is providing the below preliminary expectations for key
NR drivers for Q3 2024.
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October 10,
2024
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Net Revenue (NR)
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$302m to $309m (+13% vs. Q3 2023 at the
mid-point)
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SUBLOCADE NR
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$187m to $192m (+14% vs. Q3 2023 at the
mid-point)
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OPVEE
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~$15m
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●
Competition: Initial adoption among treatment providers
for the competing LAI has been faster than expected. In particular,
the Group has seen accelerated trial among Criminal Justice System
(CJS) accounts. While this dynamic is adversely impacting SUBLOCADE
NR in the near-term, the Group is seeing SUBLOCADE's market share
stabilizing in multiple early competitive cohorts at levels in line
with the Group's expectations of maintaining its leading position
in the clinic.
●
CJS: New CJS activations continued to grow in the
third quarter. However, CJS NR is expected to decline versus the
previous quarter due to greater variability in funding timing
across certain CJS accounts in the near-term as well as from
continued competitive pressure. The Group continues to see
significant growth in interest and intention to treat with
SUBLOCADE among its CJS accounts and therefore expects strong
contribution to SUBLOCADE growth from this
channel.
●
Stocking: Stocking levels were lower than expected in
the third quarter, as days of SUBLOCADE inventory on-hand were
further reduced from the historically low levels seen in the first
half of 2024. The Group believes its specialty pharmacy and
specialty distributors have made permanent inventory adjustments to
take advantage of shortened lead times associated with supply chain
efficiencies to organized health system and CJS customers and have
adjusted accordingly.
●
OPVEE: OPVEE NR in the third quarter is estimated
to be approximately $15 million driven by an additional product
order from Biomedical Advanced Research and Development Authority
(BARDA) for approximately $8 million in late September.
Updated FY 2024
Guidance1:
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Updated October 10, 2024
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July 25, 2024
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Net Revenue (NR)
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$1,125m to
$1,165m
(+5% at mid-point vs. FY 2023)
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$1,150m to $1,215m
(+8% at mid-point vs. FY 2023)
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SUBLOCADE NR
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$725m to $745m
(+17% at mid-point vs. FY 2023)
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$765m to $805m
(+25% at mid-point vs. FY 2023)
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OPVEE NR
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Approx. $15m
Predominantly from two optioned product deliveries as part of the
10-year BARDA2 contract
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$9m to $14m
Predominantly expected to come from fulfilling first delivery as
part of 10-year BARDA2 contract
(~$8m)
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PERSERIS NR
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$32m to $37m
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$27m to $33m
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SUBOXONE Film Market Share3
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No change
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Assumes historic rate of share decline 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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No change
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Low to mid 80% range
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Adjusted SG&A
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($555m) to ($560m)
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($550m) to ($560m)
Reflecting discontinuation of the sales and marketing of
PERSERIS
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R&D
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($115m) to ($120m)
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($120m) to ($130m)
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Adjusted Operating Profit
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$260m to $280m
(mid-point flat vs. FY 2023)
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$285m to $320m
(approx. 100 bps of margin expansion vs. FY 2023)
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1
Guidance assumes no material change in exchange rates for key
currencies compared with FY 2023 average rates, notably USD/GBP and
USD/EUR
2
Biomedical Advanced Research and Development Authority
3
Reflecting underlying share erosion at a similar rate to the last
two years (approximately 2 share points p.a.)
Conference Call Information:
Indivior will host a presentation via live webcast at 1:00 p.m.
London time (8:00 a.m. U.S. Eastern) today. The webcast event can
be accessed on the "Investors" section of the Group's website
at www.indivior.com before
the event begins.
Participants may access the event telephonically to ask a question
by registering with the following link:
https://register.vevent.com/register/BI1645f2be3a89406283143f50502ce9b8
(Registrants will have an
option to be called back directly immediately prior to the call or
be provided a call-in # with a unique pin code following their
registration)
The webcast link is: https://edge.media-server.com/mmc/p/n9euz3cz
Important Cautionary Note Regarding Forward-looking
Statements
This press release contains certain statements that are
forward-looking. Forward-looking statements include, among other
things, express and implied statements regarding: financial
guidance for Q3 and full year 2024, including sales expectations
for SUBLOCADE, PERSERIS, and OPVEE, and other financial metrics
such as market share, adjusted gross margin, adjusted SG&A,
research and development expenses, and adjusted operating profit;
peak net revenue goals for SUBLOCADE; our present intention to take
actions to fund and accelerate SUBLOCADE Net Revenue growth,
including resource reallocation and investment prioritization for
additional SUBLOCADE growth initiatives, and whether those will be
successful; expectations for SUBLOCADE growth in the near, medium,
and long-term, including that it will hit a peak net revenue goal
of >1.5 billion; and other statements containing the words
"believe," "anticipate," "plan," "expect," "expectation," "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, such 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 these forward-looking statements due to a number of
factors, including: lower than expected future sales of our
products; increased impacts from competition; failure to achieve
market acceptance of OPVEE; unanticipated costs; whether we are
able to identify and fund additional investments that we expect to
generate increased revenues, and the timing of such actions; and
our belief that SUBLOCADE will meet the challenges that synthetic
opioids present to patients and treatment providers. For
information about some of the risks and important factors that
could affect our future results and financial condition, see "Risk
Factors" in Indivior's Annual Report on Form 20-F for the fiscal
year 2023 and its other filings with the U.S. Securities and
Exchange Commission.
We have based the forward-looking statements in this press release
on our current expectations and beliefs concerning future events.
Forward-looking statements contained in this press release apply
only at the date of this press release, and except as required by
law we undertake no obligation publicly to update or revise any
forward-looking statement, whether due to new information, future
developments or otherwise.
About Indivior
Indivior is a global pharmaceutical company working to help change
patients' lives by developing medicines to treat substance use
disorders (SUD), overdose 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 1,000 individuals globally and its portfolio of
products is available in over 30 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.
Investor
Contacts:
Jason Thompson
Vice President, Investor Relations
Tel: 804-402-7123 or jason.thompson@indivior.com
Tim Owens
Director, Investor Relations
Tel: 804-263-3978 or timothy.owens@indivior.com
Media
Contacts:
Jonathan Sibun
Teneo
Office: +44 20 7427 1588
Mobile:
+44 7779 999683
E-mail: jonathan.sibun@teneo.com
Will Palfreyman
Teneo
Office: +44 20 7427 5413
Mobile: +44 7796 016191
E-mail: will.palfreryman@teneo.com
###
Grafico Azioni Indivior (NASDAQ:INDV)
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Da Dic 2024 a Gen 2025
Grafico Azioni Indivior (NASDAQ:INDV)
Storico
Da Gen 2024 a Gen 2025
