REG - Indivior PLC - Preliminary Q3 Results & Updated FY 2024 Guidance

IndiviorAnnouncement

10/10/2024 12:00

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RNS Number : 7317H  Indivior PLC  10 October 2024

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 Guidance(1):

                                Updated October 10, 2024                                                    July 25, 2024
 Net Revenue (NR)                $1,125m to $1,165m                                                         $1,150m to $1,215m

                                (+5% at mid-point vs. FY 2023)                                              (+8% at mid-point vs. FY 2023)
 SUBLOCADE NR                    $725m to $745m                                                             $765m to $805m

                                (+17% at mid-point vs. FY 2023)                                             (+25% at mid-point vs. FY 2023)
 OPVEE NR                       Approx. $15m                                                                $9m to $14m

                                Predominantly from two optioned product deliveries as part of the 10-year   Predominantly expected to come from fulfilling first delivery as part of
                                BARDA(2) contract                                                           10-year BARDA(2) contract (~$8m)
 PERSERIS NR                    $32m to $37m                                                                $27m to $33m
 SUBOXONE Film Market Share(3)  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                                                              $285m to $320m

                                (mid-point flat vs. FY 2023)                                                (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
(http://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
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(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
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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
(https://nam12.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.indivior.com%2F&data=05%7C02%7Ctimothy.owens%40Indivior.com%7C2ee94fc9c2d64161a77008dcbc7a4776%7Cbed52191489442999db948e4fb29646e%7C1%7C0%7C638592480580845033%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=4Mbg93AWrUoMpnYZHhLx6zIpk4UxNX%2FwHchEJzCnyQk%3D&reserved=0)
to learn more. Connect with Indivior on LinkedIn by visiting
www.linkedin.com/company/indivior
(https://nam12.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.linkedin.com%2Fcompany%2Findivior&data=05%7C02%7Ctimothy.owens%40Indivior.com%7C2ee94fc9c2d64161a77008dcbc7a4776%7Cbed52191489442999db948e4fb29646e%7C1%7C0%7C638592480580860049%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=2ZCnZz793XRzFBKi%2BLrnxdo36oM6ncN5M14bQzMeK%2B8%3D&reserved=0)
.

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
(mailto:jason.thompson@indivior.com)

 

Tim Owens

Director, Investor Relations

Tel: 804-263-3978 or timothy.owens@indivior.com
(mailto: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

 

 

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