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.
|
|
October
10,
2024
|
|
Net
Revenue (NR)
|
$302m to
$309m
(+13% vs. Q3 2023 at the mid-point)
|
|
SUBLOCADE NR
|
$187m to
$192m
(+14% vs. Q3 2023 at the
mid-point)
|
|
OPVEE
|
~$15m
|
·
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:
|
|
Updated October 10,
2024
|
July 25,
2024
|
|
Net
Revenue (NR)
|
$1,125m to $1,165m
(+5% at
mid-point vs. FY 2023)
|
$1,150m
to $1,215m
(+8% at
mid-point vs. FY 2023)
|
|
SUBLOCADE NR
|
$725m to $745m
(+17% at
mid-point vs. FY 2023)
|
$765m to
$805m
(+25% at
mid-point vs. FY 2023)
|
|
OPVEE NR
|
Approx.
$15m
Predominantly from two optioned product deliveries as part of
the 10-year BARDA2 contract
|
$9m to
$14m
Predominantly expected to come from fulfilling first delivery
as part of 10-year BARDA2 contract (~$8m)
|
|
PERSERIS NR
|
$32m to
$37m
|
$27m to
$33m
|
|
SUBOXONE Film Market Share3
|
No
change
|
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
|
|
Adjusted Gross Margin
|
No
change
|
Low to
mid 80% range
|
|
Adjusted SG&A
|
($555m)
to ($560m)
|
($550m)
to ($560m)
Reflecting discontinuation of the sales and marketing of
PERSERIS
|
|
R&D
|
($115m)
to ($120m)
|
($120m)
to ($130m)
|
|
Adjusted Operating Profit
|
$260m to
$280m
(mid-point flat vs. FY 2023)
|
$285m to
$320m
(approx.
100 bps of margin expansion vs. FY 2023)
|
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
###