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

A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

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Page 1: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

A World Leading Addiction Treatment Company…with enormous future potential

Jefferies Healthcare Conference 2014

Page 2: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

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 1933.

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.

Page 3: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

Indivior PLC is the industry leader in treatment of addiction

Global Leader in Opioid Addiction Treatment• Structurally growing market• Unrivalled experience and reputation

Several Levers for Future Growth• Pipeline & business development• Global expansion

Sustainable franchise with existing products• Multi-layered IP protection to 2030

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

Page 4: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

…with an exciting pipeline of new opportunitiesStages of development and earliest approval dates*

* Dates are best estimates only and could be subject to change

Stage of Development Estimated Approval Dates

Phase I Phase II Phase III NDA 2014 2015 2016 2017 2018 2019 2020

Lifecycle management

Suboxone film

Depot

Swallowable tablet

Other areas of addiction

Nasal Naloxone

Cocaine Overdose

Arbaclofen Placarbil

Immediate Adjacencies

Risperidone

EU

Can EU ChinaUSA LAUNCHED

Page 5: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

OUR VISIONThat 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

Page 6: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

03 Recognised Disease

04Legitimised Disease

Stigmatised patient Patient in treatment

Mix of supervised dosing and take-homes

Focus on quality care with psycho-social support. Take-home standard

Funding often limited or capped by Governments

Insured patients in mainstream medicine

The four stages of treatment development

Drug Policy & Regulatory Environment

01Illegal

02Harm Reduction

Patient CriminalIllegal drug user client

PhysicianPrevented from providing treatment or very tightly

controlled

Distribution of pharmaceuticals through

“drug clinics”

Payor

Driven by Government funded clinics trying to

reduce crime and needle sharing

Heroin Heroin & Prescription Opioids

Broad accessby legislation or regulation

Page 7: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence
Page 8: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

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

Page 9: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

Outstanding success in developing the market

5mm+ patients have received treatment through Suboxone therapy (tablets & film)…

…Supported by a consistent growth in certified physicians

0mm

1mm

2mm

3mm

4mm

5mm

No

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ay-0

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3,682

6,154

9,359

12,585

16,105

18,454

20,695

23,018

25,581

27,536

0

5,000

10,000

15,000

20,000

25,000

30,000

20

04

20

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20

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We grew the market beyond expectationsUS market size by mg

Source: Healthcare Analytics Retail Sales Data; internal modelling; NTIS DEA Certification ListSource: Source Healthcare Analytics Retail and Non-Retail Sales data;Internal modeling October 2014

0

500

1,000

1,500

2,000

2,500

20

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10

20

11

20

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13

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Mill

ion

s

Page 10: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

426

628

934

1152

12541339

1216

0

200

400

600

800

1000

1200

1400

1600

2007 2008 2009 2010 2011 2012 2013

242

398

650

824872 884

695

0

100

200

300

400

500

600

700

800

900

1000

2007 2008 2009 2010 2011 2012 2013

Rewarded by consistent revenue and profit delivery

Net Revenue ($m) Operating Profit ($m)

RBP R&D expenditure: 2012 $41m 2013 $76m

Page 11: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

The future: 5 value drivers

Sustainability versus current competition

Sustainability versus future competition

Pipeline

Opportunities to grow the

market

Inorganic opportunities

Page 12: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

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

Page 13: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

Competition is intensifying, but Film share has been resilient

Source: Source Healthcare Analytics Retail PHAST Weekly Data

0%

10%

20%

30%

40%

50%

60%

70%

80%

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

Suboxone Film Suboxone Tablet Generic Bup Generic Bup-Nal Zubsolv - MG EQ

Bra

nd

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able

t ap

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rove

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Gen

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alta

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d

Page 14: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

Preferred product

Strong protection

Unique physician & payor access

Suboxone film – a sustainable platform

Multi-layered IP inplace up to 2030

Patients

Physicians

Payors

Over 25,000registered physicians

91% formulary access

Page 15: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

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

Page 16: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

The future: 5 value drivers

Sustainability versus future competition

Page 17: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

Suboxone Film IP

Formulation patents

3 orange book listed patents

Providing protection up to 2030

1 non-orange book listed patent

Further protection to 2024

Further pending patents

Process patents

3 patents covering processes for manufacturing film

Providing protection up to 2023

3 process patent applications recently allowed by USPTO

7 additional process and 3 formulation patent applications in prosecution

Page 18: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

The future: 5 value drivers

Pipeline

Page 19: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

De-risked product development

Existing pipeline – the Indivior approach

Search & development

Not a discovery house

76 compounds in addiction identified

Action when the time is right

Pay forprogress

Small cash paymentup front

Further paymentsthrough clinical trials and commercialisation

Leverage“the known”

Existing compounds

and / or

Existing technologies

Page 20: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

For patients PayorsFor physicians

Buprenorphine 1-month injectable – a major development…

Strong pharmaco-economic value

From

365 decisions / year…

Improved compliance

Reduced potential for diversion…to

12decisions / year

Will attract existing patients

andnew patients

Page 21: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

Buprenorphine Hemi-Adipate – swallowable tablet

The patients PayorsThe physician

Strong pharmaco-economic value

Normalises treatment

Palatable medication -no issue with taste

Improved compliance - traditional medication format

Enhanced abuse deterrence

Opportunitiesin Europe

Potential scheduling

challenge in the US

Page 22: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

Nasal Naloxone – Opioid overdose

Saving lives amidst a growing epidemic

45* people per day die from opioid overdose

Easy to use first response product

Pay forprogress

Small cash paymentup front

Further paymentsthrough clinical trials and commercialisation

Leverage“the known”

Existing compound– Naloxone

Pre-filled, unit dose delivery system

* Centers for Disease Control and Prevention. Wide-ranging OnLine Data for Epidemiologic Research (WONDER) [online]. (2012) Available from URL: (http://wonder.cdc.gov/mortsql.html).

Page 23: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

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

Owned & patented

Patent protected to 2029*

Owned technology

FDA granted “Breakthrough Therapy Designation, October 2014

Improving patient and physician

Speeds patient flow

Prevents admissionsto hospital

* Worldwide pending patents.

Page 24: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

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

Pay forprogress

Leverage“the known”

Existing compound passed phase 3 safety trials

Pro-drug of Baclofen, found to be effective in observational studies

Small cash paymentup front

Further paymentsthrough clinical trials and commercialisation

Page 25: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

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

Looking at best commercial model

Extensive co-morbidity with addiction

However not looking to enter mainstream marketplace

Leverage“the known”

Existing compound– Risperidone

Utilising existing Atrigel® platform which is already on the market (for prostate cancer)

Page 26: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

Pipeline Product Summary (2015 to 2020)

Product Current Status Launch Year Factors to considerMarket Size

*

Potential Peak NR

**

Opioid

OverdoseNasal Naloxone

Phase 3 2016

500k emergency room visits and 15k deaths a year. Potential to be required protocol in every public facility and ambulance.

$500m $50m - $100m

Buprenorphine

Monthly DepotPhase 3 2017

Potential to increase complianceAdditional cost savings to health care system

$2,000m + $400m - $700m

Risperidone

Monthly DepotPhase 3 2017

$1.8bn global depot market – with growth driven by improved dosing frequency

$2,000m $100m -$200m

Buprenorphine

Oral tabletPhase 2 2018

Oral swallowable tablet helps shift mindset in disease treatment

$2,000m + $400m - $700m

Cocaine OverdoseCocaine esterase

Phase 2 2018500k admissions a year5k - 10k deaths a year $500m $50m -$100m

AlcoholArbaclofen Placarbil

Phase 2 2020122m potential treatable population3m deaths a year from alcohol abuseDoes 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

Page 27: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

The future: 5 value drivers

Opportunities for growth

Page 28: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

Significant untapped market in the US…

Source: Trinity Market Research, October 2012, IMS data, Company data

Non Medical Use of Opioids

11.7mOpioids

dependance prevalence

2.4mUntreated1,124,000

Other542,000

Methadone280,000

Buprenorphine450,000

Page 29: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

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 2011-12 & RBP Estimates

Page 30: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

But market development is at a much earlier stage

Drug Policy & Regulatory Environment

01Illegal

02Harm

Reduction

03 Recognised

Disease

04Legitimised

Disease

USA & Australia

EU

RoW

Source: RBP investor & analyst presentation – July 2011

Page 31: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

The future: 5 value drivers

Inorganic opportunities

Page 32: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

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

Page 33: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

Inorganic Growth - Business Development and M&A

Management Team is already

experienced in M&A execution and

integration

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)

Page 34: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

Strong, experienced, long-serving management team

Many years of industry experience

And over

60 yearsexperience

at Indivior PLC

And backed by a powerful Board

Shaun Thaxter

Chief Executive Officer

Christian Heidbreder

Chief Scientific Officer

Frank Stier

Chief Supply Officer

Javier Rodriguez

Chief Legal Officer

Jon Fogle

Chief Human Resources

Officer

Richard Simkin

Chief Commercial Officer

Cary Claiborne

Chief Financial Officer

Tim Baxter

Chief Medical Officer

Tony Goodman

Chief Business

Development Officer

Debby Betz

Chief Corporate Affairs &

Communications Officer

Mark Crossley

Chief Strategic Planning

Officer

Page 35: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

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

Page 36: A World Leading Addiction Treatment Company …with enormous … 1040 2 Reckitt... · • Pipeline of lifecycle management and new drug candidates in addiction and CNS • Presence

Thank You