Press Release: Indivior Provides Business Update; Conference Call at 8:00 AM U.S. EDT

Dow Jones
09 Jul 2024
-------------------------  -------------------------  ------------------------ 
                                                      $55m to $65m  (+43% vs. 
                                                        at mid-point vs. FY 
PERSERIS NR                      $27m to $33m                  2023) 
-------------------------  -------------------------  ------------------------ 
                                                      Assumes historic rate of 
                                                      share decline of 1 to 2 
                                                       percentage points and 
                                                        the potential impact 
                                                           from a fourth 
                                                       buprenorphine/naloxone 
SUBOXONE Film Market                                  sublingual film generic 
Share(3)                           No change             in the U.S. market 
-------------------------  -------------------------  ------------------------ 
Adjusted Gross Margin              No change            Low to mid 80% range 
-------------------------  -------------------------  ------------------------ 
                              ($550m) to ($560m) 
                                   Reflecting 
                             discontinuation of the 
                             sales and marketing of 
Adjusted SG&A                       PERSERIS             ($575m) to ($590m) 
-------------------------  -------------------------  ------------------------ 
R&D                                No change             ($120m) to ($130m) 
-------------------------  -------------------------  ------------------------ 
                            $285m to $320m (approx. 
                               100 bps of margin 
Adjusted Operating Profit    expansion vs. FY 2023)        $330m to $380m 
-------------------------  -------------------------  ------------------------ 
 
 
 
(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.) 
 
 

Long-term Net Revenue Targets Remain Unchanged:

The Group remains confident that given the scale of the U.S. opioid epidemic, which is now being driven by misuse of fentanyl and other synthetic opioids, its opportunity to help patients and deliver value for shareholders remains intact. The unique profile of SUBLOCADE's paradigm-shifting treatment gives the Group confidence in delivering on its stated NR targets for SUBLOCADE: exiting 2025 at a $1 billion NR run-rate and achieving greater than $1.5 billion in peak annual NR.

Settlement with Certain End Payors:

On July 8, 2024, Indivior Inc. and Indivior Solutions Inc. reached an agreement via mediation with Blue Cross Blue Shield of Massachusetts, Inc., Health Care Service Corp., Blue Cross and Blue Shield of Florida, Inc., Molina Healthcare, Inc., Aetna, Inc., and certain of their affiliates (collectively, the "Plaintiffs") to resolve consolidated antitrust litigation proceedings in Roanoke County Circuit Court. These actions had been pending since 2020. The agreement will terminate the trial that was scheduled to begin on July 15, 2024.

As part of the agreement with the plaintiffs, Indivior will pay $85 million and will take a charge of $85 million in the second quarter, which will be excluded from adjusted earnings. Payment will be funded from Indivior's existing cash balance.

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/BI07a0798620a745bca417b4b9d15d9fe2

(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/nga7b6nn

Important Cautionary Note Regarding Forward-looking Statements

This press release contains certain statements that are forward-looking. Forward-looking statements include, among other things, statements regarding financial guidance for 2024, including sales expectations for SUBLOCADE, PERSERIS, and OPVEE, expected growth in adjusted operating income and expected margin expansion; expected medium term margin expansion and cash flow generation; peak net revenue goals for SUBLOCADE and OPVEE, and a $1 billion net revenue run rate for SUBLOCADE by the end of 2025; our expectation that we will continue to grow and increase shareholder value; our expectation that cessation of PERSERIS marketing efforts will not impact sales of our other products; expected costs and timing of costs, and related expense savings, from no longer marketing PERSERIS; our expectation that the Court will approve the settlement with the end payors; 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, 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 other products; increased impacts from competition; failure to achieve market acceptance of OPVEE; the possibility that the Court will not approve the settlement, the possibility that the Court will require changes to the settlement prior to approving it, potential delays in obtaining Court approval of the settlement; and those factors described 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 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 $(SUD.AU)$ 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 more than 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 www.linkedin.com/company/indivior.

This release is being made by Kathryn Hudson, Company Secretary Indivior PLC.

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SOURCE Indivior PLC

/CONTACT: 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

 
 

(END) Dow Jones Newswires

July 09, 2024 02:00 ET (06:00 GMT)

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