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A World Leading Addiction Treatment Company…with enormous future potential
Jefferies Healthcare Conference 2014
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.
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
…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
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
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
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
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
v-0
4M
ay-0
5N
ov-
05
May
-06
No
v-0
6M
ay-0
7N
ov-
07
May
-08
No
v-0
8M
ay-0
9N
ov-
09
May
-10
No
v-1
0M
ay-1
1N
ov-
11
May
-12
No
v-1
2M
ay-1
3
Cu
mu
lati
ve p
atie
nts
tre
ate
d
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
05
20
06
20
07
20
08
20
09
20
10
20
11
20
12
20
13
Ce
rtif
ied
ph
ysic
ian
s b
y ye
ar
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
03
20
04
20
05
20
06
20
07
20
08
20
09
20
10
20
11
20
12
20
13
20
14
Mill
ion
s
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
The future: 5 value drivers
Sustainability versus current competition
Sustainability versus future competition
Pipeline
Opportunities to grow the
market
Inorganic opportunities
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
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
ed t
able
t ap
pro
ved
CV
S fo
rmu
lary
loss
Un
ite
d f
orm
ula
ry lo
ss a
nd
3rd
ge
ne
ric
tab
let
app
rove
d
TRx MG share by week
Gen
eric
bu
p/n
alta
ble
ts la
un
che
d
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
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
The future: 5 value drivers
Sustainability versus future competition
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
The future: 5 value drivers
Pipeline
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
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
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
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).
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.
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
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)
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
The future: 5 value drivers
Opportunities for growth
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
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
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
The future: 5 value drivers
Inorganic opportunities
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
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)
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
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
Thank You