Court of Appeals for the Federal Circuit (CAFC) Denies Motion for Rehearing or Rehearing En Banc Following the CAFC’s Ruling Vacating the Preliminary Injunction Granted against Dr. Reddy’s Laboratories

Slough, UK and Richmond, VA – February 5, 2019 – Indivior PLC (LON: INDV) (“Indivior” or the “Company”) today announced that the U.S. Court of Appeals for the Federal Circuit (“CAFC”) has denied Indivior’s motion for rehearing and rehearing en banc following the CAFC’s ruling vacating the preliminary injunction (“PI”) granted against Dr. Reddy’s Laboratories (“DRL”) based on U.S. Patent No. 9,931,305. The CAFC also stated its mandate is currently set to issue on February 11, 2019.

Indivior intends to file an emergency motion with the CAFC to stay issuance of the mandate pending resolution of Indivior’s appeal of the District of Delaware’s decision finding DRL does not infringe U.S. Patent No. 8,603,514 (“the ’514 patent”), and pending Indivior’s forthcoming petition for a writ of certiorari to the Supreme Court of the United States in the PI matter. The mandate is a formal order by the CAFC that returns the case to the District Court for actions consistent with the CAFC’s ruling. After the mandate issues, DRL will no longer be prevented from selling, offering to sell, or importing its generic buprenorphine/naloxone sublingual film product in the U.S.

Indivior assumes that DRL will resume the launch of its generic buprenorphine/naloxone sublingual film product in the U.S. once the CAFC issues the mandate. Indivior also assumes that Alvogen Pine Brook LLC (“Alvogen”) will also launch its generic in the U.S. once the CAFC issues the mandate, pursuant to a January 31, 2019 agreement between Alvogen and Indivior. Industry analogs1 suggest that a launch in the U.S. of a generic product that can be directly substituted by a pharmacist for the branded product without consultation with the patient would result in the branded incumbent (in this case, SUBOXONE® Film) losing up to 80% of its market share within a matter of months.

Any generic product sales in the U.S. by DRL and/or Alvogen would be on an “at-risk” basis, subject to the outcome of the appeal of the non-infringement judgments related to the ’514 patent (as well as U.S. Patent No. 8,017,150 in the case of DRL), and ongoing litigation against DRL and Alvogen in the District of New Jersey asserting other Orange Book-listed patents (including U.S. Patent No. 9,931,305).

Shaun Thaxter, CEO of Indivior, Commented:
“We are disappointed that the CAFC has denied Indivior’s motion for rehearing,” said Shaun Thaxter, CEO of Indivior. “While we ultimately believe in the strength of our patent portfolio, we acknowledge that the Company faces major disruption in the immediate future from a potential material and rapid loss of market share by our SUBOXONE® film product to generic buprenorphine/naloxone sublingual film competition. We have been taking prudent steps toward this eventuality with our contingency plan, including reducing debt and certain operating expenses, while preserving a strong cash balance. We will continue to vigorously pursue our infringement cases against DRL to protect our SUBOXONE® (buprenorphine and naloxone) Sublingual Film patent portfolio, including continuing to pursue the appeals of the District of Delaware’s non-infringement decisions related to the ’514 and ’150 Patents, as well as litigating our more recently listed Orange Book patents for SUBOXONE® Film.”

Contingency Plan Implementation:

Indivior has implemented initial elements of the contingency plan shared on December 18, 2018. As outlined, these plans were developed with the objective of providing for the commercial success of SUBLOCADE™ and PERSERIS™ and ensuring a minimum cash balance of $250m to remain in compliance with the Company’s debt covenants. Specifically, the initial actions taken to date are:

• Reducing outstanding principal on the Term Loan by $235m during FY 2018 to $243m;
• Cash conservation through FY 2018 leading to cash and equivalents of approximately $920m at the end of FY 2018; and,
• Headcount reductions as of this release and other previously committed savings.

In the event of a generic buprenorphine/naloxone sublingual film product launch in the U.S. by DRL and/or Alvogen, further parts of Indivior’s contingency plan would be triggered, including:
 

• Launching an Authorized Generic of SUBOXONE® Film to capture some share of the generic segment and to generate a modest amount of net revenue in the range of tens of $ millions; and,
• Further initiatives reducing structural costs, including delaying and/or cancelling R&D projects. As a result of these cost initiatives, the FY 2019 operating expense base (SG&A and R&D) is expected to be reduced to $440m to $460m. Indivior will announce its FY 2018 results on February 14 at 7:00 a.m. GMT (2:00 a.m. Eastern U.S.) on the RNS.

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 thinking statements 
This press release 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 6 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 2019 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.

This press release does not constitute an offer to sell or the solicitation of an offer to subscribe for or otherwise acquire or dispose of shares in the Company to any person in any jurisdiction to whom it is unlawful to make such offer or solicitation.

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