A world leading addiction treatment company with enormous future potential. Jefferies Conference, London 18 th November 2015

Transcription

1 A world leading addiction treatment company with enormous future potential Jefferies Conference, London 18 th November 2015

2 Forward looking statements This presentation contains certain statements that are forward-looking and which should be considered, amongst other statutory provisions, in light of the safe harbour provisions of the United States Private Securities Litigation Reform Act of By their nature, forward-looking statements involve risk and uncertainty as they relate to events or circumstances that will or may 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 our financial guidance for 2015 and our medium- and long-term growth outlook, our operational goals, our 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 Suboxone Tablet, Suboxone Film, Subutex Tablet and any future 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; the Indivior Group s ability to protect its patents and other intellectual property; the outcome of the Suboxone Film patent litigation relating to 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 presentation 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. 2

3 OUR VISION That all patients around the world will have unrestricted access to high quality treatment services for the chronic relapsing conditions and co-morbidities of addiction

4 Dec-14 Jan-15 Feb-15 Mar-15 Apr-15 May-15 Jun-15 Jul-15 Aug-15 Sep-15 Oct-15 What a difference a year makes! 2014 Jefferies Conference 2015 Jefferies Conference INDV 230 (Incorporated under the Companies Act 2006 and registered in England and Wales with registered number ) Admission to the premium listing segment of the Official List and to trading on the main market of the London Stock Exchange Join Sponsor Deutsche Bank Financial Advisor Jefferies Joint Sponsor Morgan Stanley

5 So what has changed in a year? 1. Addiction remains a growing global epidemic Over 145m people worldwide are addicted to opioids, alcohol, cocaine, methamphetamine, cannabis Structurally growing market Increasing recognition that every $1 spent on treatment saves $12 in healthcare and societal costs* and is the focus of growing attention, particularly in the USA Obama administration announces public and private sector efforts to address prescription drug abuse and heroin use White House: 21/10/2015 Obama tells outdated opioid treatment industry it's time to change Huffington Post: 21/10/2015 *World Health Organization, Accessed June 20,

6 Addiction A growing global epidemic 230m people worldwide use illicit drugs 1 122m people worldwide dependent on alcohol (and under-reported) 2 23m people worldwide dependent on opioids (and under-reported) 3 39 Deaths per 100,000 population due to alcohol and drug use implies >2.5m global deaths a year 4 1.WHO World Drug Report 2012; 2. Global Dependency Trends, July 2014: Abuwala & Company LLC; 3. opioids, cocaine, cannabis, methamphetamine; NSDUH 2013, SAMSHA and RBP Trends data ; 4. WHO Atlas on Substance Use Source: United Nations Office on Drugs and Crime, World Drug Report 2015 (United Nations publication, Sales No. E.15.XI.6); European Monitoring Centre for Drugs and Drug Addiction (EMCDDA): European Drug Report 2015: Trends and Development, doi: /084165; ISBN:

7 Millions Certified physicians by year Cumulative Patients Treated But when authorities get it right, the market develops rapidly The market has grown beyond expectations US market size by mg Supported by a consistent growth in certified physicians Nearly 6mm patients have received treatment through Suboxone therapy (tablets & film) 2,500 35,000 6M 30,589 2,000 1,500 1, ,000 25,000 20,000 15,000 10,000 5,000 3,682 6,154 9,359 12,585 16,105 18,454 20,695 23,018 27,536 25,581 5M 4M 3M 2M 1M 0 0 M 7

8 So what has changed in a year? 1. Addiction remains a growing global epidemic Over 145m people worldwide are addicted to opioids, alcohol, cocaine, methamphetamine, cannabis Structurally growing market Increasing recognition that every $1 spent on treatment saves $12 in healthcare and societal costs* and is the focus of growing attention, particularly in the USA 2. Indivior has demonstrated the resilience of its SUBOXONE Film business US share retained at 59% in the face of multiple competition 4 Generic tablet competitors Branded competition from BUNAVAIL and ZUBSOLV 8

9 Jul-12 Sep-12 Nov-12 Jan-13 Mar-13 May-13 Jul-13 Sep-13 Nov-13 Jan-14 Mar-14 May-14 Jul-14 Sep-14 Nov-14 Jan-15 Mar-15 May-15 Jul-15 Sep-15 Generic bup / nal tablets launched Branded tablet launched CVS formulary loss United formulary loss and 3rd generic tablet approved Bunavail Launch Competition is intensifying, but film share has been resilient 80% 70% 60% 59.1% 50% 40% 30% 20% 10% 0% 19.5% 15.7% 5.1% SUBOXONE FILM SUBOXONE TABLET GENERIC BUP GENERIC BUP/NAL ZUBSOLV BUNAVAIL 9

10 So what has changed in a year? 1. Addiction remains a growing global epidemic Over 145m people worldwide are addicted to opioids, alcohol, cocaine, methamphetamine, cannabis Structurally growing market Increasing recognition that every $1 spent on treatment saves $12 in healthcare and societal costs* and is the focus of growing attention, particularly in the USA 2. Indivior has demonstrated the resilience of its SUBOXONE Film business US share retained at 59% in the face of multiple competition 4 Generic tablet competitors Branded competition from BUNAVAIL and ZUBSOLV 3. Indivior is protecting the IP of its Suboxone Film business Now 6 ANDA filers for FDA approval of generic films First trial v Actavis & Par split November / December 2015 Retain confidence in the strength of our IP multi-layered patent protection to

11 ANDA litigation update Trial in the lawsuits against Actavis and Par involving the Orange Book-listed patents for Suboxone Film commenced November 3rd, 2015, and will continue to November 4th, December 17th and December 18th. A decision in these lawsuits is still expected ahead of expiry of Actavis 30 month stay of FDA approval (expiring February 28th, 2016). Par s 30 month stay of FDA approval expires on September 25th, Trial against Actavis and Par in the lawsuits involving the two recently granted process patents (US Patent No. 8,906,277 and US Patent No. 8,900,497) scheduled for November Trial against Teva in the lawsuit involving the Orange Book-listed patents and process patents for Suboxone Film scheduled for November 2016, with Teva s 30- month stay of FDA approval on ANDA No Expiring April 17th, Indivior believes Teva s 30- month stay of FDA approval on ANDA No also expires on April 17th, 2017, however, Teva disputes the applicability of the stay to this ANDA. Trial against Alvogen in the lawsuit involving the range Book-listed patents and process patents for Suboxone Film scheduled for April 2017, with Alvogen s 30-month stay of FDA approval expiring October 28th, Indivior received Paragraph IV notifications from Mylan Technologies Inc. and Sandoz Inc. on September 24th, 2015 and October 2nd, 2015, respectively. Indivior intends to assert and enforce its intellectual property against both ANDA-filers, and will initiate a patent infringement lawsuit against both within 45 days of having received the Paragraph IV notification, which will trigger the automatic stay of FDA approval of their ANDAs pursuant to the Hatch Waxman statute.

12 So what has changed in a year? 1. Addiction remains a growing global epidemic 2. Indivior has demonstrated the resilience of its SUBOXONE Film business 3. Indivior is protecting the IP of its Suboxone Film business 4. Relentless progress with our innovative pipeline Label expansion for Suboxone Film (Buccal Indication) and new patents approved China FDA approved clinical trial application for Suboxone Film Nov 2015 French ATU for Nasal Naloxone approved Nov 2015 Nasal Naloxone NDA under FDA review Compelling Phase 3 efficacy data (end points met) on Risperidone Monthly Depot, safety extension in progress Monthly buprenorphine depot progressing well through phase 3 1 new Phase 2 trial started (Arbaclofen Placarbil) 1 new Phase 1 trial initiated (RBP 6300) 4 peer reviewed publications plus one approved for publication

13 Relentless progress on pipeline in 2015 Product Stage Status RBP-6000: Buprenorphine once monthly in Atrigel Phase 3 (US) On track with pivotal efficacy trial (RB-US ): First patient randomized February 20 th, 2015 Current status On track for last patient in by end 2015 RBP-6300: Buprenorphine Hemiadipate in ADF* Phase 1 First Patient In pivotal PK study in Man (RB-EU ) Sept RBP-7000: Risperidone once monthly in Atrigel Phase 3 (US) US: Phase 3 pivotal efficacy study (RB-US ) preliminary data published May5 th, Phase 3 (RB-US )safety study on track to complete December 31 st, Patents: US Application No 14/490,034 & 14/490,082 granted November 2015 and will be listable in the Orange Book Arbaclofen Placarbil Phase 2A (US) Pre-IND meeting with FDA January 29 th, 2015 IND submission June 26 th, 2015 First Patient screened In Phase IIA study (RB-US ) September 2015 * Abuse Deterrent Formulation Encap s Abusolve. Atrigel is a registered trade mark of Tolmar Therapeutics Inc. 13

14 An innovative pipeline designed to improve patient outcomes Stages of development and earliest approval dates* Buprenorphine Lifecycle Suboxone Tablet Suboxone Film Buprenorphine Monthly Depot Oral Swallowable Capsule Overdose Rescue Products Nasal Naloxone Cocaine Esterase Alcohol Use Disorders Arbaclofen Placarbil Adjacency - Schizophrenia Risperidone Monthly Depot Stage of Development Estimated Approval Dates Phase I Phase II Phase III NDA Can EU US China China EU * Dates are best estimates only and could be subject to change 14

15 Two projects with potential timeline changes Monthly depot of Buprenorphine (RBP 6000) for Europe Reflects recent meeting with EU Regulatory Agencies Require comparator data (vs US which requires placebo-controlled study) Full implications will become clear when Phase 3 data from US study become available Oral Swallowable Tablet of Buprenorphine Hemiadipate First Phase 1 Pharmacokinetics (PK) trial under way in September 2015 May require additional Phase 2 dose-ranging study (as new formulation) New development timelines will be defined in 2016 with output of PK trial. 15

16 Nasal Naloxone for opioid overdose rescue ~25 K deaths per year in the United States 1 ~69 K deaths per year globally 2 Approved by ANSM under a Temporary Use Authorization in France on November 6th, 2015 US PDUFA Date: Q4, 2015 Indivior to ensure broad access Retail list price set < $50 per dose with effective price significantly lower 1: National Institute on Drug Abuse 2. UNODC, WHO. Community Management of Opioid Overdose. Geneva: World Health Organization;

17 Indivior R&D day for investors December 9 th 2015 New York Jefferies Offices Invitations sent out last week Live webcast for those who cannot travel to New York 17

18 The Future

19 Agenda for 2015 Second half Date Activity Event Q3 Change of Name to Indivior in US, UK & other markets 1st July 2015 Indivior PLC Half Year Results 2015 Presentation in London: 29th July 2015 RBP-6300 Oral Swallowable capsule Buprenorphine First Patient in Phase I PK study Arbaclofen Placarbil for alcohol use disorder First Patient Screened in Phase 2A trial Morgan Stanley Conference New York: September 2015 Q4 Suboxone Film EU Final CSR pivotal PK study ANDA litigation (Actavis) & Par) Trial commenced 3rd 4th November 2015 Indivior PLC Q3 Results Conference call: 3rd November 2015 Jefferies Conference London: 18th November 2015 Nasal Naloxone for Opioid Overdose Rescue FDA Approval R&D Day with Christian Heidbreder New York: 9th December 2015 RBP-6000 Monthly Depot Buprenorphine Last patient in Phase 3 Efficacy trial ANDA Litigation (Actavis & Par) Trial continues 17th -18th December

20 Summary The leading global company in the growing epidemic of addiction 230m people worldwide abusing drugs, 122m dependent on alcohol * Indivior has the leading portfolio of existing and future treatments A sustainable franchise with existing products in face of growing competition Suboxone Film is demonstrating resilience in US market Confident that it will fund the business model pipeline, business development and M&A Consistent progress in developing the levers of future growth Pipeline of innovative products designed to improve patient outcomes Business Development and M&A to widen business coverage A management with the experience and capabilities necessary to deliver the future 1.WHO World Drug Report 2012; 2. Global Dependency Trends, July 2014: Abuwala & Company LLC 20

21 A World Leading Addiction Treatment Company with enormous future potential