Indivior Raises FY 2019 Net Revenue and Net Income Guidance

Slough, UK, and Richmond, VA, 15 October 2019 – Indivior PLC (LON: INDV) (the “Group”) today announced revised expectations for FY 2019 net revenue and net income following stronger-than-expected net revenue performance. FY 2019 Group net revenue is now expected to be in the range of $750m to $790m (previously $670m to $720m) and net income in the range of $160m to $190m (previously $80m to $130m), excluding exceptional items and F/X. The primary driver is the expected continued market share performance through 2019 of branded SUBOXONE® (buprenorphine and naloxone) Film when compared with historic analogues (1) of branded pharmaceutical products facing generic competition. Cash at Q3 2019 is expected to be approximately $1,020m.

Additionally, Indivior is narrowing the FY 2019 net revenue guidance range for SUBLOCADE™ (buprenorphine extended-release) Injection to $60m to $70m (from $50m to $70m).

The revised FY 2019 net revenue guidance also includes an expected adverse net revenue impact from the recent passage of H.R. 4378 – Continuing Appropriations Act, 2020, and Health Extenders Act of 2019 (the “legislation”). The legislation, which came into effect on 1st October 2019, includes changes to the methodology for calculating the average manufacturer price (AMP) for branded drugs that now prohibits including authorized generics in AMP calculations, but does not affect the Group’s authorized generic offering as the “best price” for calculating mandatory rebates. As a consequence of this change, rebating in US government channels is increased. Based on the current business dynamics and material discounting already provided to US government accounts and managed Medicaid entities, this legislative change results in negative gross profit on SUBOXONE® Film in the majority of US government channels.

In order to mitigate the impact from the legislation in 2020 and beyond, Indivior has given notice to Sandoz Inc. of its intention to cease production of its authorized generic buprenorphine/naloxone sublingual film. This action will mitigate the “best price” implications used in calculating mandatory government rebates, which was set by Indivior’s authorized generic. With three other generic buprenorphine/naloxone sublingual film products available, Indivior does not expect this decision to affect patient choice of branded or generic buprenorphine/naloxone sublingual film, but it will protect the Group’s ability to invest in growing SUBLOCADE™, its once-monthly depot buprenorphine for moderate to severe opioid use disorder.

All other previously-stated key FY 2019 guidance elements are being maintained, including:

• Modest net revenue contribution from PERSERIS™ (risperidone) for extended-release injection;
• Authorized generic buprenorphine/naloxone film net revenue contribution in the tens of $-millions in 2019;
• Operating expense (SG&A and R&D combined) of $440m to $460m (before exceptional costs); and,
• A tax rate in the high-single to low double-digit range.

Comment by Shaun Thaxter, CEO of Indivior PLC
“We are raising FY 2019 guidance to reflect continued stronger-than-expected market share performance of SUBOXONE® Film. We cannot be certain how long this benefit will last and hence we continue to prudently manage the additional cash flow this is providing us to help transition our business towards our novel depot technologies, SUBLOCADE™ and PERSERIS™. Our decision to discontinue production of the authorized generic  buprenorphine/naloxone sublingual film in light of the newly passed legislation was not taken lightly. This action is, however, necessary for Indivior to meet its obligations to its stakeholders and to continue our relentless focus on combating the opioid crisis with SUBLOCADE®. We look forward to sharing more details on our progress with our Q3 results on 31st October.”
 

About Indivior
Indivior is a global pharmaceutical company working to help change patients’ lives by developing medicines to treat addiction 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 addiction. 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 pipeline of product candidates designed to both expand on its heritage in this category and address other chronic conditions and co-occurring disorders of addiction, including alcohol use disorder. 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. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior.

Forward-Looking 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 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 longterm 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.

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