Trading Update Release

Slough, UK, 18 December 2018 – Indivior PLC (the “Company”) with today’s announcement and accompanying supplement published on its website (http://www.indivior.com) is:

• Providing an update on legal matters relating to the Court of Appeals for the Federal Circuit (CAFC) vacating the preliminary injunction (PI) against Dr. Reddy’s Laboratories (DRL), including next steps and estimated timelines;
• Confirming that the Company expects to meet its overall FY 2018 net revenue and net income guidance, including exceeding FY 2018 SUBLOCADE™ net revenue guidance;
• Providing an update on SUBLOCADE™ KPIs;
• Confirming the launch of PERSERIS™; and,
• Confirming key elements of its contingency plan, should a generic buprenorphine/naloxone sublingual film product enter the U.S. market.

This announcement and the accompanying supplement substitutes for the Capital Markets Day that was originally scheduled for December 5th and will now be postponed until after the Company’s FY 2018 financial results on February 14th, 2019. A date will be confirmed later.

CAFC / DRL Update:

On November 20th, the CAFC vacated the preliminary injunction (PI) granted by the U.S. District Court of New Jersey, which enjoined DRL from entering the U.S. market. However, the exact timing for DRL’s potential “at-risk” market re-entry in the U.S. is unknown, as the PI remains in effect until the issuance of a mandate by the CAFC. The “mandate” is a formal filing by the CAFC that returns the case to the District Court for actions consistent with the CAFC’s ruling.

On December 11th, the CAFC denied DRL’s motion (filed on November 20th) to issue the mandate immediately or, alternatively, stay the PI pending issuance of the mandate. Consequently, the PI will remain in place and DRL will remain enjoined from resuming the “at-risk” launch in the U.S. market of its generic buprenorphine/naloxone sublingual film until after the mandate issues. Indivior will file a petition for a rehearing by the original panel of judges as well as a rehearing en banc by December 20th. The CAFC must rule on Indivior’s petition for the rehearings before the mandate can be issued.

Even if the CAFC issues the mandate and the PI is vacated, any DRL generic product sales in the U.S. would be on an “at-risk” basis, subject to the outcome of the appeal of the non-infringement judgments related to U.S. Patent Nos. 8,603,514 and 8,017,150 – as well as ongoing litigation against DRL in the District of New Jersey asserting recently-granted Orange Book-listed patents (U.S. Patent Nos. 9,931,305 and 9,687,454).

Indivior has made it clear that it intends to continue its vigorous assertion and protection of its intellectual property with respect to SUBOXONE® Film and will seek redress and damages from any “at-risk” launch following success in any of these cases.

Trading Update & Financial Guidance for FY 2018:

Assuming no generic buprenorphine/naloxone sublingual film entry in the U.S. before the beginning of FY 2019, Indivior confirms that it expects to meet its FY 2018 financial guidance of net revenue of $990 to $1,020 million and net income of $230 to $255 million.

Indivior also confirms that SUBLOCADE™ net revenues for FY 2018 will exceed the top end of its previous guidance range of $8 to $10 million by approximately $2 million.

The Company expects to give financial guidance for FY 2019 with its FY 2018 results on February 14th, 2019, when the Company anticipates having greater clarity on U.S. market conditions.

SUBLOCADE™ KPIs Update:

Prescription Journey KPIs have reached or are progressing toward their target range:

• As of 11/30/18 formulary access stood at 83% (versus 82% at 9/30/18).
• As of 10/31/18 (latest available data) the Prescription Journey timeline of 16 to 23 days was generally in the Company’s target range (versus 16 to 22 days at 9/30/18).
• As of 10/31/18 (latest available data) the Dispense Conversion Rate improved modestly to 37% (versus 36% at 9/30/18) and continues towards the Company’s target of 50%.

HCP trial and adoption KPIs as of November 30th, 2018:

• HCPs Initiating a Prescription Journey increased to 2,270 (versus 1,870 at 9/30/18).
• HCPs Administered SUBLOCADE™ increased to 1,195 (versus 824 at 9/30/18).
• HCPs Administered SUBLOCADE™ to 5-plus patients increased to 199 (versus 108 at 9/30/18).

Indivior remains confident in its peak net revenue goal for SUBLOCADE™ of $1 billion-plus.

PERSERIS™ Update:

Indivior is confirming today that the Company is moving ahead with the launch of PERSERIS™ in the U.S. with a sales force consisting of approximately 50 representatives. While PERSERIS™ has been available in the U.S. since November 19th, the commercial launch is scheduled to take place in February 2019. The PERSERIS™ team is currently engaged in creating payor access, growing prescriber awareness and interest, as well as establishing its INSUPPORT™ patient hub. Indivior remains confident in its peak net revenue goal for PERSERIS™ of $200 to $300 million.

Contingency Planning:

Indivior has updated its contingency plan to reflect current market conditions and future outlook. The key event which may adversely impact consolidated near-term net revenue and cash flow is the potential launch of generic buprenorphine/naloxone film in the U.S. market. Until the timing of potential generic film entry is certain, the full financial impact cannot be assessed.

The objective of the contingency plan is to provide for the commercial success of SUBLOCADE™ and PERSERIS™ while ensuring a minimum cash balance of $250 million to remain in compliance with the Company’s debt covenants. At the end of November 2018, the Company had a cash balance of approximately $910 million.

The contingency plan is expected to cover the transition period of net revenue loss due to potential generic erosion of the Company’s SUBOXONE® Film franchise until combined net revenue growth from SUBLOCADE™ and PERSERIS™ gathers sufficient momentum to return the Company to profitable growth. 

Indivior’s actions to meet the Company’s objective of maintaining a $250 million minimum cash balance include:

• Launching an Authorized Generic of SUBOXONE® Film upon entry by a generic buprenorphine/naloxone film by an ANDA competitor. The launch is expected to capture some share of the generic segment and generate a small amount of net revenue in the range of tens of $ millions;
• Optimizing the profitability of the base U.S. and Rest of World businesses; and,
• Streamlining actions to materially reduce Indivior’s cost base to a level appropriate to the expected level of net revenue in such changed U.S. market conditions, the detail of which will depend on the exact timing of any generic entry. These savings would be derived primarily from SG&A and R&D, and would be incremental to the previously-announced targeted annual savings of $135 to $155 million versus the Company’s planned operating and R&D expense base for FY 2018.

Summary:

“As the leading provider of buprenorphine-based medication-assisted treatment for opioid dependence, Indivior has a responsibility to sustain our work on behalf of patients suffering from this condition” said Shaun Thaxter, CEO of Indivior. “With SUBLOCADE™ we believe we have a potentially transformational treatment for opioid dependence. The setbacks we have experienced this year will not impede our relentless search for better treatment outcomes for patients and better options for healthcare professionals. However, given the potential for a dramatically altered market, we are prepared to take the difficult but necessary steps to ensure the viability of the business and, above all else, our ability to deliver the potential of SUBLOCADE™ through a period of challenge.

“We also remain excited about the potential of PERSERIS™ and currently are looking forward to commercial launch in February 2019. This differentiated treatment for schizophrenia provides us another attractive growth avenue in a complex disease space that often is a co-occurring disorder of substance use disorders. We look forward to sharing more of our go-to-market plans and performance updates for both SUBLOCADE™ and PERSERIS™ at our Capital Markets Day next year.”

About Indivior
Indivior is a global specialty pharmaceutical company with a 20-year legacy of leadership in patient advocacy and health policy while providing education on evidence-based treatment models that have revolutionized modern addiction treatment. The name is the fusion of the words individual and endeavour, and the tagline “Focus on you” makes the Company’s commitment clear. Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of opioid dependence treatments, Indivior has a strong pipeline of product candidates designed to both expand on its heritage in this category and address other chronic conditions and cooccurring disorders of addiction, including alcohol use disorder and schizophrenia. Headquartered in the United States in Richmond, VA, Indivior employs more than 800 individuals globally and its portfolio of products is available in over 40 countries worldwide. Visit www.indivior.com to learn more.

Forward-Looking Statements 
This announcement contains certain statements that are forward-looking and which should be considered, amongst other statutory provisions, in light of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. By their nature, forward-looking statements involve risk and uncertainty 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. Forward-looking statements include, among other things, statements regarding the Indivior Group’s financial guidance for 2018 and its medium- and long-term growth outlook, its operational goals, its product development pipeline and statements regarding ongoing litigation. 

Various factors may cause differences between Indivior's expectations and actual results, including: factors affecting sales of Indivior Group’s products; the outcome of research and development activities; decisions by regulatory authorities regarding the Indivior Group’s drug applications; the speed with which regulatory authorizations, pricing approvals and product launches may be achieved; the outcome of post-approval clinical trials; competitive developments; difficulties or delays in manufacturing; the impact of existing and future legislation and regulatory provisions on product exclusivity; trends toward managed care and healthcare cost containment; legislation or regulatory action affecting pharmaceutical product pricing, reimbursement or access; claims and concerns that may arise regarding the safety or efficacy of the Indivior Group’s products and product candidates; risks related to legal proceedings, including the ongoing investigative and antitrust litigation matters; the Indivior Group’s ability to protect its patents and other intellectual property; the outcome of patent infringement litigation relating to Indivior Group’s products, including the ongoing ANDA lawsuits; changes in governmental laws and regulations; issues related to the outsourcing of certain operational and staff functions to third parties; uncertainties related to general economic, political, business, industry, regulatory and market conditions; and the impact of acquisitions, divestitures, restructurings, internal reorganizations, product recalls and withdrawals and other unusual items.
 

Media Contacts

US
IndiviorMediaContacts@indivior.com
+1 804-594-0836

UK
Tulchan Communications
+44 207-353-4200

Investor Contact
Jason Thompson
Indivior Vice President, Investor Relations
+1 804-402-7123
Jason.Thompson@indivior.com