A World Leading Addiction Treatment Company with enormous future potential. Jefferies Healthcare Conference 2014

Transcription

1 A World Leading Addiction Treatment Company with enormous future potential Jefferies Healthcare Conference 2014

2 Disclaimer. For the purposes of this disclaimer the "Presentation" shall mean and include these slides, the oral presentation of the slides, any document that follows, any oral briefing, the question and answer session that follows the oral briefing, and any material distributed at, or in connection with, the presentation. By attending or reading the Presentation, you will be deemed to have agreed to the obligations and restrictions set out below. The Presentation is strictly private and confidential and is intended solely for the information of analysts and/or investors in connection with the proposed demerger by Reckitt Benckiser Group plc of its pharmaceutical business (the Demerger ). It is not an offer or invitation to the public and should not be reproduced or circulated or used for any purpose other than assisting with the assessment of the Demerger. It should not be shared with or disclosed to any third party without the prior written permission of Reckitt Benckiser Group plc or Indivior PLC. Under no circumstances may any person contact the management or employees of Reckitt Benckiser Group plc or Indivior PLC, or its shareholders, or visit any sites used by the Reckitt Benckiser Group plc or Indivior PLC. The Presentation is not a prospectus. It does not constitute an offer of securities for sale or a solicitation of an offer to purchase securities in any jurisdiction. The shares of Indivior PLC have not been, and will not be, registered under the US Securities Act of 1933, and may not be offered or sold within the United States, except pursuant to an applicable exemption from, or in a transaction not subject to, the registration requirements of the US Securities Act of 1933 and in compliance with any applicable securities laws of any state or other jurisdiction of the US. There will be no public offering of the Indivior PLC shares in the US for the purposes of the US Securities Act of No representations or warranties, express or implied are given in, or in respect of, the Presentation or any further information supplied. In no circumstances, to the fullest extent permitted by law, will Reckitt Benckiser Group plc, Indivior PLC, or any of their respective subsidiaries, shareholders, affiliates, representatives, partners, directors, officers, employees, advisers or agents, or any other person be responsible or liable for any direct, indirect or consequential loss or loss of profit arising from the use of the Presentation, its contents (including the management presentations and details on the market), its omissions, reliance on the information contained herein, or on opinions communicated in relation thereto or otherwise arising in connection therewith. The Presentation is supplied as a guide only and does not purport to contain all the information that you may require. The Presentation is exempt from the general restriction (in section 21 of the Financial Services and Markets Act 2000) on the communication of invitations and inducements to engage in investment activity on the grounds that this presentation is being directed only at (a) persons outside the United Kingdom, (b) persons who have professional experience in matters relating to investments who fall within Article 19 of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the Order ) or (c) high net worth companies and other persons to whom it may be lawfully communicated, falling within Article 49 of the Order or otherwise. The information contained in the Presentation does not, and will not, form any part of a contract or offer for sale. The Presentation may contain forward-looking statements that are based on current expectations or beliefs, as well as assumptions about future events. Although we believe our expectations, beliefs and assumptions are reasonable, reliance should not be placed on any such statements because, by their very nature, they are subject to known and unknown risks and uncertainties and can be affected by other factors that could cause actual results, and our plans and objectives, to differ materially from those expressed or implied in the forward-looking statements. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. Neither Reckitt Benckiser Group plc nor Indivior PLC nor any other person undertakes any obligation to revise or update any forward-looking statement contained within this presentation, regardless of whether those statements are affected as a result of new information, further events or otherwise. Past performance is not an indicator of future performance. The Presentation, including this disclaimer, shall be governed by and construed in accordance with English law and any claims or disputes, whether contractual or non-contractual, arising out of, or in connection with, the Presentation, including this disclaimer, shall be subject to the exclusive jurisdiction of the English Courts.

3 Indivior PLC is the industry leader in treatment of addiction Global Leader in Opioid Addiction Treatment Structurally growing market Unrivalled experience and reputation Sustainable franchise with existing products Multi-layered IP protection to 2030 Several Levers for Future Growth Pipeline & business development Global expansion Strong, experience, stable management team Excellent track record Specialty pharmaceutical company focused on developing and commercialising products for the addiction and closely related markets Product portfolio includes Suboxone Film, Suboxone Tablets and Subutex Key product today is Suboxone Film (buprenorphine + naloxone) for treatment of Opioid Dependency Pipeline of lifecycle management and new drug candidates in addiction and CNS Presence in 45 countries globally $1,216m net revenue and $489m net income in 2013 Led by experienced management team with decades of experience in addiction

4 with an exciting pipeline of new opportunities Stages of development and earliest approval dates* Lifecycle management Suboxone film Depot Swallowable tablet Other areas of addiction Nasal Naloxone Cocaine Overdose Arbaclofen Placarbil Immediate Adjacencies Risperidone Stage of Development Estimated Approval Dates Phase I Phase II Phase III NDA USA LAUNCHED Can EU China EU * Dates are best estimates only and could be subject to change

5 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 In support of this, we will leverage our unique patient focused leadership model

6 The four stages of treatment development Drug Policy & Regulatory Environment 01 Illegal 02 Harm Reduction 03 Recognised Disease 04 Legitimised Disease Patient Physician Criminal Prevented from providing treatment or very tightly controlled Illegal drug user client Distribution of pharmaceuticals through drug clinics Broad access by legislation or regulation Stigmatised patient Mix of supervised dosing and take-homes Patient in treatment Focus on quality care with psycho-social support. Take-home standard Payor Driven by Government funded clinics trying to reduce crime and needle sharing Funding often limited or capped by Governments Insured patients in mainstream medicine Heroin Heroin & Prescription Opioids

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8 Realizing our vision 01 Attract and retain a highly dedicated team of people who are passionate about helping addicted patients 02 Have addiction recognized as a chronic relapsing disease among public health care officials, managed care and doctors 03 Train physicians, with the help of medical opinion leaders, how to provide high quality care including psychological support services 04 Build patient awareness of treatment availability and make treatment easily accessible to patients 05 Develop products with the aim of improving patient compliance Source: RBP investor & analyst presentation July 2011

9 Nov-04 May-05 Nov-05 May-06 Nov-06 May-07 Nov-07 May-08 Nov-08 May-09 Nov-09 May-10 Nov-10 May-11 Nov-11 May-12 Nov-12 May-13 Millions Certified physicians by year Cumulative patients treated Outstanding success in developing the market We grew the market beyond expectations US market size by mg 2,500 2,000 1,500 1,000 Supported by a consistent growth in certified physicians 30,000 25,000 20,000 15,000 10,000 9,359 12,585 16,105 18,454 20,695 23,018 25,581 27,536 5mm+ patients have received treatment through Suboxone therapy (tablets & film) 5mm 4mm 3mm 2mm 500 5,000 3,682 6,154 1mm 0 0 0mm Source: Source Healthcare Analytics Retail and Non-Retail Sales data; Internal modeling October 2014 Source: Healthcare Analytics Retail Sales Data; internal modelling; NTIS DEA Certification List

10 Rewarded by consistent revenue and profit delivery 1600 Net Revenue ($m) Operating Profit ($m) RBP R&D expenditure: 2012 $41m 2013 $76m

11 The future: 5 value drivers Sustainability versus current competition Pipeline Inorganic opportunities Sustainability versus future competition Opportunities to grow the market

12 Business update 2 Years Ago Film share 55% Tablet share 30% No generics Double digit market growth Early stage pipeline Today Film share 59% 4 generic + 1 branded tablet approved. Bunavail buccal film approved and launched in November Double digit market growth Good progress on pipeline and licensing opportunities

13 Generic bup/nal tablets launched Branded tablet approved CVS formulary loss United formulary loss and 3rd generic tablet approved Competition is intensifying, but Film share has been resilient 80% 70% 60% TRx MG share by week 50% 40% 30% 20% 10% 0% 29- Jun 27- Jul 24- Aug 21- Sep 19- Oct 16- Nov 14- Dec 11- Jan 08- Feb 08- Mar 05- Apr 03- May 31- May 28- Jun 26- Jul 23- Aug 20- Sep 18- Oct 15- Nov 13- Dec 10- Jan 07- Feb 07- Mar 04- Apr 02- May 30- May 27- Jun 25- Jul 22- Aug 19- Sep 17- Oct Source: Source Healthcare Analytics Retail PHAST Weekly Data Suboxone Film Suboxone Tablet Generic Bup Generic Bup-Nal Zubsolv - MG EQ

14 Suboxone film a sustainable platform Preferred product Unique physician & payor access Strong protection Patients Physicians Payors Over 25,000 registered physicians 91% formulary access Multi-layered IP in place up to 2030

15 Dynamics For 2015/16 Dynamics From 2017 Market continuing to grow volume low double digits Entry of third and fourth generic will lead to a rapid change in the dynamics of the US business Likely to lose the majority of share in the part of our business that is most price sensitive cash/managed medicaid = 25% - 30% Our value to patients, physicians and payors will ensure resilience in other market segments and enable us to continue to pursue our premium pricing Downward pressure on net revenue due to higher rebates to protect remaining market share Loss of share could be swift before new base is established. May last into 2016, although exact timing is uncertain; 3 generics already on market, 1 more approved European Government s continuing pressure on pricing and volume through generic first initiatives Growth off strong base in the core market in USA market growth estimated to be high single digits EU market opportunities from pipeline and focus on developing OPD market Global Pipeline launches for 2016/17 Nasal Naloxone Buprenorphine monthly depot Risperidone monthly depot Global expansion opportunities Global pipeline launches beyond 2018 Buprenorphine oral swallowable tablet Cocaine overdose Arbaclofen Placarbil

16 The future: 5 value drivers Sustainability versus future competition

17 Suboxone Film IP Formulation patents 3 orange book listed patents Providing protection up to non-orange book listed patent Further protection to 2024 Process patents 3 patents covering processes for manufacturing film Providing protection up to 2023 Further pending patents 3 process patent applications recently allowed by USPTO 7 additional process and 3 formulation patent applications in prosecution

18 The future: 5 value drivers Pipeline

19 Existing pipeline the Indivior approach De-risked product development Search & development Leverage the known Pay for progress Not a discovery house 76 compounds in addiction identified Action when the time is right Existing compounds and / or Existing technologies Small cash payment up front Further payments through clinical trials and commercialisation

20 Buprenorphine 1-month injectable a major development For patients From 365 decisions / year to 12 decisions / year For physicians Improved compliance Reduced potential for diversion Payors Strong pharmacoeconomic value Will attract existing patients and new patients

21 Buprenorphine Hemi-Adipate swallowable tablet The patients Normalises treatment Palatable medication - no issue with taste The physician Improved compliance - traditional medication format Enhanced abuse deterrence Payors Strong pharmacoeconomic value Opportunities in Europe Potential scheduling challenge in the US

22 Nasal Naloxone Opioid overdose Saving lives amidst a growing epidemic 45* people per day die from opioid overdose Easy to use first response product Leverage the known Existing compound Naloxone Pre-filled, unit dose delivery system Pay for progress Small cash payment up front Further payments through clinical trials and commercialisation * Centers for Disease Control and Prevention. Wide-ranging OnLine Data for Epidemiologic Research (WONDER) [online]. (2012) Available from URL: (

23 Cocaine Esterase for Cocaine intoxication Saving lives amidst a growing epidemic 500k people per year admitted to ER for cocaine overdose Simple injection eliminates cocaine in 5-10 minutes Improving patient and physician Speeds patient flow Prevents admissions to hospital Owned & patented Patent protected to 2029* Owned technology FDA granted Breakthrough Therapy Designation, October 2014 * Worldwide pending patents.

24 Arbaclofen Placarbil (AP) Alcohol use disorder Significant undertreated population 122m population No current mainstream treatment available Potential game-changer; does not require detoxification prior to treatment Leverage the known Existing compound passed phase 3 safety trials Pro-drug of Baclofen, found to be effective in observational studies Pay for progress Small cash payment up front Further payments through clinical trials and commercialisation

25 Risperidone 1-Month Depot in Atrigel Most commonly prescribed drug for Schizophrenia Existing 4-week depot is for different compound 2 week only depot for Risperidone Leverage the known Existing compound Risperidone Utilising existing Atrigel platform which is already on the market (for prostate cancer) Looking at best commercial model Extensive co-morbidity with addiction However not looking to enter mainstream marketplace

26 Pipeline Product Summary (2015 to 2020) Product Current Status Launch Year Factors to consider Market Size * Potential Peak NR ** Opioid Overdose Nasal Naloxone Phase k emergency room visits and 15k deaths a year. Potential to be required protocol in every public facility and ambulance. $500m $50m - $100m Buprenorphine Monthly Depot Phase Potential to increase compliance Additional cost savings to health care system $2,000m + $400m - $700m Risperidone Monthly Depot Phase $1.8bn global depot market with growth driven by improved dosing frequency $2,000m $100m -$200m Buprenorphine Oral tablet Phase Oral swallowable tablet helps shift mindset in disease treatment $2,000m + $400m - $700m Cocaine Overdose Cocaine esterase Alcohol Arbaclofen Placarbil Phase Phase k admissions a year 5k - 10k deaths a year $500m $50m -$100m 122m potential treatable population 3m deaths a year from alcohol abuse Does not require detoxification $2,000m + $500m - $900m * = Estimated Market Size on Gross Sales basis (Indivior Estimates based on current market size for Buprenorphine and estimated market size for other indications) ** = Estimated Indivior peak net revenue potential based on a sensible market share assumption 26

27 The future: 5 value drivers Opportunities for growth

28 Significant untapped market in the US Non Medical Use of Opioids 11.7m Opioids dependance prevalence 2.4m Untreated 1,124,000 Other 542,000 Methadone 280,000 Buprenorphine 450,000 Source: Trinity Market Research, October 2012, IMS data, Company data

29 Opioid Dependence is a Global Epidemic Implied size of opioid dependent populations US vs. ROW Millions of people Source: RBP Global Dependency Treatment Trends Study & RBP Estimates

30 But market development is at a much earlier stage Drug Policy & Regulatory Environment USA & Australia EU RoW 01 Illegal 02 Harm Reduction 03 Recognised Disease 04 Legitimised Disease Source: RBP investor & analyst presentation July 2011

31 The future: 5 value drivers Inorganic opportunities

32 Long term pipeline areas of interest Lifecycle management of buprenorphine franchise Licensing and clinical development of medical compounds which have demonstrated potential as a treatment in the addiction fields of: Alcohol Cannabis Cocaine Methamphetamine

33 Inorganic Growth - Business Development and M&A Focus first on developing our business organically Leverage our market development model for long term growth Addiction : alcohol, cannabis, cocaine, methamphetamines Closely related co-morbidities Closely related treatment areas where our model also applies Licensing / compound acquisition / technology acquisition for a de-risked approach to expanding our opportunities M&A where it makes sense to acquire companies (or part of companies) Management Team is already experienced in M&A execution and integration

34 Strong, experienced, long-serving management team Cary Claiborne Chief Financial Officer Tony Goodman Chief Business Development Officer Christian Heidbreder Chief Scientific Officer Shaun Thaxter Chief Executive Officer Richard Simkin Chief Commercial Officer Jon Fogle Chief Human Resources Officer Javier Rodriguez Chief Legal Officer Many years of industry experience And over 60 years experience at Indivior PLC Frank Stier Chief Supply Officer Tim Baxter Chief Medical Officer And backed by a powerful Board Mark Crossley Chief Strategic Planning Officer Debby Betz Chief Corporate Affairs & Communications Officer

35 We have created a long term sustainable business Global addiction treatment business Sustainable franchise in opioid addiction Pursuing future growth platforms Highly committed & experienced management team

36 Thank You