Professional Documents
Culture Documents
Electronics
Note: Reduced-Risk Products ("RRPs") is the term we use to refer to products that have the potential to reduce individual risk and population harm. The RRPs depicted are subject to ongoing
development and therefore the descriptions are illustrative and do not necessarily represent the latest stages of product development 2
Leadership in Reduced-Risk Products
Reduced-Risk Products ("RRPs")
Note: Reduced-Risk Products ("RRPs") is the term we use to refer to products that have the potential to reduce individual risk and population harm. The RRPs depicted are subject to ongoing
development and therefore the descriptions are illustrative and do not necessarily represent the latest stages of product development 3
Agenda
Note: Reduced-Risk Products ("RRPs") is the term we use to refer to products that have the potential to reduce individual risk and population harm 4
Best-In-Class R&D Capability in the Industry
Note: Reduced-Risk Products ("RRPs") is the term we use to refer to products that have the potential to reduce individual risk and population harm 5
PMI R&D Centers and Global Partnerships Network
● Devices:
- PMI’s technology developed with external partners
- Scale up and manufacturing by third-party
- Manufacturing for pilot launches commenced
Note: Reduced-Risk Products ("RRPs") is the term we use to refer to products that have the potential to reduce individual risk and population harm. Visual execution is for illustrative purposes only 7
Long-Term RRPs Pipeline
Note: Reduced-Risk Products ("RRPs") is the term we use to refer to products that have the potential to reduce individual risk and population harm 8
Developing Robust Evidence to Support a Claim of Reduced Risk
Note: Reduced-Risk Products ("RRPs") is the term we use to refer to products that have the potential to reduce individual risk and population harm 9
Agenda
Note: Reduced-Risk Products ("RRPs") is the term we use to refer to products that have the potential to reduce individual risk and population harm 10
RRPs: Our Product Platforms
Note: Reduced-Risk Products ("RRPs") is the term we use to refer to products that have the potential to reduce individual risk and population harm. The RRPs depicted are subject to ongoing
development and therefore the descriptions are illustrative and do not necessarily represent the latest stages of product development 11
Platform 1: Precisely Controlled Electrically-Heated
Tobacco System
Source: Baker R. R., 1975, High Temp. Sci., 7, 236-247 and PMI Research & Development 12
Platform 2: Heat-Not-Burn with Combustible Cigarette Ritual
Platform 2
13
E-Vapor Products
14
Platform 4: Innovative Technology
15
Platform 3: Effective Delivery of Nicotine Salt Aerosol
Platform 3
16
Agenda
17
Substantiating Reduced Risk
● Developing robust evidence packages based on state-of-the-art science and
best in class data
Post-Market Studies
& Surveillance Reduced Population Harm
Consumer Perception and
Behavior Assessment
Reduced Exposure & Risk
Clinical Trials
Systems Toxicology
Reduced Risk in Laboratory Models
Assessment
Standard Toxicology
Reduced Toxicity in Laboratory Models
Assessment
Aerosol Chemistry and
Physics
Reduced Formation of HPHCs
Product Design and
Control Principles
Note: HPHCs stands for Harmful or Potentially Harmful Constituents 18
Substantiating Reduced Risk
Post-Market Studies
& Surveillance Reduced Population Harm
Consumer Perception and
Behavior Assessment
Reduced Exposure & Risk
Clinical Trials
Systems Toxicology
Reduced Risk in Laboratory Models
Assessment
Standard Toxicology
Reduced Toxicity in Laboratory Models
Assessment
Aerosol Chemistry and
Physics
Reduced Formation of HPHCs
Product Design and
Control Principles
19
Substantiating Reduced Risk
Post-Market Studies
& Surveillance Reduced Population Harm
Consumer Perception and
Behavior Assessment
Reduced Exposure & Risk
Clinical Trials
Systems Toxicology
Reduced Risk in Laboratory Models
Assessment
Standard Toxicology
Reduced Toxicity in Laboratory Models
Assessment
Aerosol Chemistry and
Physics
Reduced Formation of HPHCs
Product Design and
Control Principles
20
Substantiating Reduced Risk
Post-Market Studies
& Surveillance Reduced Population Harm
Consumer Perception and
Behavior Assessment
Reduced Exposure & Risk
Clinical Trials
Systems Toxicology
Reduced Risk in Laboratory Models
Assessment
Standard Toxicology
Reduced Toxicity in Laboratory Models
Assessment
Aerosol Chemistry and
Physics
Reduced Formation of HPHCs
Product Design and
Control Principles
21
Substantiating Reduced Risk
Post-Market Studies
& Surveillance Reduced Population Harm
Consumer Perception and
Behavior Assessment
Reduced Exposure & Risk
Clinical Trials
Systems Toxicology
Reduced Risk in Laboratory Models
Assessment
Standard Toxicology
Reduced Toxicity in Laboratory Models
Assessment
Aerosol Chemistry and
Physics
Reduced Formation of HPHCs
Product Design and
Control Principles
22
Substantiating Reduced Risk
Post-Market Studies
& Surveillance Reduced Population Harm
Consumer Perception and
Behavior Assessment
Reduced Exposure & Risk
Clinical Trials
Systems Toxicology
Reduced Risk in Laboratory Models
Assessment
Standard Toxicology
Reduced Toxicity in Laboratory Models
Assessment
Aerosol Chemistry and
Physics
Reduced Formation of HPHCs
Product Design and
Control Principles
23
Substantiating Reduced Risk
Post-Market Studies
& Surveillance Reduced Population Harm
Consumer Perception and
Behavior Assessment
Reduced Exposure & Risk
Clinical Trials
Systems Toxicology
Reduced Risk in Laboratory Models
Assessment
Standard Toxicology
Reduced Toxicity in Laboratory Models
Assessment
Aerosol Chemistry and
Physics
Reduced Formation of HPHCs
Product Design and
Control Principles
24
Cessation: The "Gold Standard"
From
Point of
Epidemiology
Intervention
Disease Risk
Time
Note: Reduced-Risk Products ("RRPs") is the term we use to refer to products that have the potential to reduce individual risk and population harm. The descriptions in the chart are for illustrative
purposes only
Source: IOM (Institute of Medicine), 2012, Scientific Standards for Studies on Modified Risk Tobacco Products. Washington, DC: The National Academies Press 25
Investor Day – Reduced-Risk Products
Lausanne, June 26, 2014
Manuel Peitsch
Vice President, Biological Systems Research
Note: Reduced-Risk Products ("RRPs") is the term we use to refer to products that have the potential to reduce individual risk and population harm
Evidence Package
Post-Market Studies
& Surveillance Reduced Population Harm
Consumer Perception and
Behavior Assessment
Reduced Exposure & Risk
Clinical Trials
Systems Toxicology
Reduced Risk in Laboratory Models
Assessment
Standard Toxicology
Reduced Toxicity in Laboratory Models
Assessment
Aerosol Chemistry and
Physics
Reduced Formation of HPHCs
Product Design and
Control Principles
27
Reduction of HPHCs in Platform 1 and Platform 2 Aerosols
Aerosol Composition(a): Relative Amounts Reported on a Nicotine Basis Compared to a
3R4F Reference Cigarette (%) Laboratory Filter Pad
Combustible Cigarette
100 Combustible Reference Cigarette
90
80
70 Platform 1 Platform 2
60
50
40
30
20 Laboratory Filter Pad
10 Platform 1
0
(a) Aerosol collection with Intense Health Canada’s Smoking Regime (55 mL puff volume, 2 second puff duration, 30 second interval puff)
(b) < LOQ in Platform 1
(c) < LOQ in Platform 1 and Platform 2
(d) < LOQ in Platform
Note: These data alone do not represent a claim of reduced exposure or reduced risk. LOQ refers to the Limit of Quantification
Source: PMI Research and Development 28
Evidence Package
Post-Market Studies
& Surveillance Reduced Population Harm
Consumer Perception and
Behavior Assessment
Reduced Exposure & Risk
Clinical Trials
Systems Toxicology
Reduced Risk in Laboratory Models
Assessment
Standard Toxicology
Reduced Toxicity in Laboratory Models
Assessment
Aerosol Chemistry and
Physics
Reduced Formation of HPHCs
Product Design and
Control Principles
29
Reduction of Toxicity in Heat-Not-Burn Platforms
200
12.8 9.6 11.6
7.4
0% 0
3R4F Regular Menthol 0 1,000 2,000 3,000
Platform 1 TPM (µg/plate)
Note: These data alone do not represent a claim of reduced exposure or reduced risk. 3R4F reference cigarette. TPM refers to Total Particulate Matter. GVP refers to Gas Vapor Phase
Source: PMI Research and Development 30
Systems Toxicology-Based Risk Assessment
Cell
Inflammation Cell Stress DNA Damage Apoptosis Autophagy Necroptosis Senescense
Proliferation
Cigarette Smoke
Group Exposure
Combustible Cigarette CC
Cessation CC Air
Combustible Cigarette
Cessation
Platform 2 Use
Note: These data alone do not represent a claim of reduced exposure or reduced risk. Prototype of Platform 2
Source: PMI Research and Development 33
Compare Heat-not-Burn Platforms with Continued Smoking and
Cessation in Mouse Model: Impact on Disease Mechanisms
Time (months)
1 2 3 5 7
Combustible Cigarette
Cessation
Combustible Cigarette
Platform 2 Prototype (Switching)
Platform 2 Use
Note: These data alone do not represent a claim of reduced exposure or reduced risk. Prototype of Platform 2
Source: PMI Research and Development 34
Compare Heat-not-Burn Platforms with Continued Smoking and
Cessation in Mouse Model: Impact on Disease Mechanisms
Time (months)
1 2 3 5 7
Combustible Cigarette
Cessation
Combustible Cigarette
Platform 2 Prototype (Switching)
10
1
0 0
CC Cess. Switch. Air P2 CC Cess. Switch. Air P2 CC Cess. Switch. Air P2
Note: These data alone do not represent a claim of reduced exposure or reduced risk. Cess. is Cessation, Switch. is Switching and P2 is Platform 2 (Prototype)
Source: PMI Research and Development 36
Evidence Package
Post-Market Studies
& Surveillance Reduced Population Harm
Consumer Perception and
Behavior Assessment
Reduced Exposure & Risk
Clinical Trials
Systems Toxicology
Reduced Risk in Laboratory Models
Assessment
Standard Toxicology
Reduced Toxicity in Laboratory Models
Assessment
Aerosol Chemistry and
Physics
Reduced Formation of HPHCs
Product Design and
Control Principles
37
PMI’s Approach to Clinical Assessment
Clinical Assessment
1 2 3
Pharmacokinetics /
Reduced Exposure Exposure Response
Pharmacodynamics
1 week in a clinic
1 week in a clinic 6-12 months at home
3 months at home
38
Platform 1 Clinical Assessment: Pharmacokinetic
Preliminary Results
Platform 1 16
14
12
Nicotine (ng/mL)
10
8
6
4
2
0
0 10 20 30 40 50 60 70 80 90 100 110 120
Time (min)
Note: These data alone do not represent a claim of reduced exposure or reduced risk
Source: PMI Research & Development 39
Platform 1 Clinical Assessment: Reduced Exposure
Preliminary Results
Carbon Monoxide Benzene
6 4000
3500
S-phenylmercapturic acid
Carboxyhemoglobin (%)
5
3000
(pg/mg creat)
4
2500
3 2000
Continued smoking 2
1500
1000
1 500
0 0
Switched to Baseline Day 1 Day 2 Day 3 Day 4 Day 5 Baseline Day 1 Day 2 Day 3 Day 4 Day 5
Acrolein 1,3-Butadiene
Quit during study
Monohydroxybutenyl mercapturic
3500
3-hydroxypropylmercapturic acid
1200
1000 3000
800
2000
600
1500
400
1000
200 500
0 0
Baseline Day 1 Day 2 Day 3 Day 4 Day 5 Baseline Day 1 Day 2 Day 3 Day 4 Day 5
Post-Market Studies
& Surveillance Reduced Population Harm
Consumer Perception and
Behavior Assessment
Reduced Exposure & Risk
Clinical Trials
Systems Toxicology
Reduced Risk in Laboratory Models
Assessment
Standard Toxicology
Reduced Toxicity in Laboratory Models
Assessment
Aerosol Chemistry and
Physics
Reduced Formation of HPHCs
Product Design and
Control Principles
42
Consumer Perception and Behavior Assessment
Note: Reduced-Risk Products ("RRPs") is the term we use to refer to products that have the potential to reduce individual risk and population harm 43
PMI’s Post-Market Assessment
44
Evidence Package
Post-Market Studies
& Surveillance Reduced Population Harm
Consumer Perception and
Behavior Assessment
Reduced Exposure & Risk
Clinical Trials
Systems Toxicology
Reduced Risk in Laboratory Models
Assessment
Standard Toxicology
Reduced Toxicity in Laboratory Models
Assessment
Aerosol Chemistry and
Physics
Reduced Formation of HPHCs
Product Design and
Control Principles
45
Reduced-Risk Products: R&D
Note: Reduced-Risk Products ("RRPs") is the term we use to refer to products that have the potential to reduce individual risk and population harm 46
Reduced-Risk Products: Regulation
Reduced-Risk Products ("RRPs")
Note: Reduced-Risk Products ("RRPs") is the term we use to refer to products that have the potential to reduce individual risk and population harm. The RRPs depicted are subject to ongoing
development and therefore the descriptions are illustrative and do not necessarily represent the latest stages of product development 47
Reduced-Risk Products: Regulation
48
Reduced-Risk Products: Regulation
● US FDA:
- Statute and MRTP Draft Guidance
- "Deeming Regulations"
49
Reduced-Risk Products: R&D
RRPs Regulation
• Uncharted territory
• PMI well-positioned
Note: Reduced-Risk Products ("RRPs") is the term we use to refer to products that have the potential to reduce individual risk and population harm 50
Investor Day – Reduced-Risk Products
Lausanne, June 26, 2014
Frederic de Wilde
Senior Vice President, Marketing & Sales
Note: Reduced-Risk Products ("RRPs") is the term we use to refer to products that have the potential to reduce individual risk and population harm
Reduced-Risk Products: Commercialization
Reduced-Risk Products ("RRPs")
Note: Reduced-Risk Products ("RRPs") is the term we use to refer to products that have the potential to reduce individual risk and population harm. The RRPs depicted are subject to ongoing
development and therefore the descriptions are illustrative and do not necessarily represent the latest stages of product development 52
Commercialization of RRPs
Note: Reduced-Risk Products ("RRPs") is the term we use to refer to products that have the potential to reduce individual risk and population harm 53
Evolution of E-Vapor Products Market
Note: Reduced-Risk Products ("RRPs") is the term we use to refer to products that have the potential to reduce individual risk and population harm 54
Evolution of E-Vapor Products Market
55
Maturity Levels of E-Vapor Markets
● Mature markets:
- UK (7.8% adult smokers used an e-vapor in the past 7 days), Poland (4.9%), Italy (3.5%)
● Developing markets:
- France (11.9%), Spain (2.0%), Denmark (7.6%), Netherlands (3.8%)
● Low penetration markets:
- Germany (0.4%), Austria (1.2%)
Note: Reduced-Risk Products ("RRPs") is the term we use to refer to products that have the potential to reduce individual risk and population harm
Source: PMI RRP Market Research (% of adult smokers using e-vapor products in the past 7 days) 56
Italy: Adoption of E-Vapor Products
(% of adult smokers)
100 Awareness of
96
e-vapor products
79
70
40 Trial
39
(past 12 months)
13
10
16 Purchase
15
(past 12 months)
5
Usage
3
(past 7 days)
0
Oct Nov Dec Jan Feb Mar Apr May Jun Sept Oct Nov Dec
2012 2013
Note: n ~ 2,300 for each wave
Source: PMI RRP Market Research (3 months moving, no fieldwork in July and August) 57
E-Vapor Market: Conclusions
58
RRPs Commercialization
Note: Reduced-Risk Products ("RRPs") is the term we use to refer to products that have the potential to reduce individual risk and population harm 59
PMI’s RRPs Portfolio Addresses Adult Smokers Preferences and
Market Opportunities
Importance of satisfaction
P4 like
P1 like
P4 like
P1 like
P2 like
P4 like
P1 like
P3 like
P2 like
P4 like
9.1
8.7
100% 95%
3.3
36% 1.5
17% 0.4(a)
3%
Adult Awareness of Trial Purchase Usage
Smokers E-vapor Products (past 12 months) (past 12 months) (past 7 days)
(a) Includes all users of tobacco products in the past 7 days
Note: Number of adult smokers: Italy n ~ 2,300
Source: PMI RRP Market Research (3 months-moving average, February 2014 – April 2014) 64
Italy: Size of the Opportunity
# of Adult
Smokers
(millions)
No Tobacco
e-vapor product users 0.4 satisfaction
• Electronics
• Convenience, less smell, no ash
Note: The RRPs depicted are subject to ongoing development and therefore the descriptions are • Price advantage
illustrative and do not necessarily represent the latest stages of product development. Number of adult smokers: Italy n ~ 2300
Source: PMI RRP Market Research (3 months-moving average, February 2014 – April 2014) 65
Italy: Size of the Opportunity
# of Adult
Smokers
(millions)
Tobacco
Platform 1
• Taste satisfaction
• Convenience, less smell, no ash
• Electronics
No Tobacco
e-vapor product users 0.4 satisfaction
• Electronics
• Convenience, less smell, no ash
Note: The RRPs depicted are subject to ongoing development and therefore the descriptions are • Price advantage
illustrative and do not necessarily represent the latest stages of product development. Number of adult smokers: Italy n ~ 2300
Source: PMI RRP Market Research (3 months-moving average, February 2014 – April 2014) 66
Italy: Size of the Opportunity
# of Adult
Smokers
(millions)
Tobacco
try e-vapor products
Platform 1
• Taste satisfaction
• Convenience, less smell, no ash
• Electronics
No Tobacco
e-vapor product users 0.4 satisfaction
• Electronics
• Convenience, less smell, no ash
Note: The RRPs depicted are subject to ongoing development and therefore the descriptions are • Price advantage
illustrative and do not necessarily represent the latest stages of product development. Number of adult smokers: Italy n ~ 2300
Source: PMI RRP Market Research (3 months-moving average, February 2014 – April 2014) 67
Italy: Size of the Opportunity
# of Adult Platform 2
• Taste satisfaction
Smokers
• Convenience, less smell, no ash
(millions)
• Cigarette-like ritual
Aware of but did not
55.0% 5.4
Tobacco
try e-vapor products
Platform 1
• Taste satisfaction
• Convenience, less smell, no ash
• Electronics
No Tobacco
e-vapor product users 0.4 satisfaction
• Electronics
• Convenience, less smell, no ash
Note: The RRPs depicted are subject to ongoing development and therefore the descriptions are • Price advantage
illustrative and do not necessarily represent the latest stages of product development. Number of adult smokers: Italy n ~ 2300
Source: PMI RRP Market Research (3 months-moving average, February 2014 – April 2014) 68
Italy: Size of the Opportunity
Tobacco
Aware of but did not
55.0% 5.4
try e-vapor products Platform 1 • Taste satisfaction
• Convenience, less smell, no ash
• Electronics
No Tobacco
e-vapor products
Note: Reduced-Risk Products ("RRPs") is the term we use to refer to products that have the potential to reduce individual risk and population harm 70
Investor Day – Reduced-Risk Products
Lausanne, June 26, 2014
Video
Note: Reduced-Risk Products ("RRPs") is the term we use to refer to products that have the potential to reduce individual risk and population harm
Introducing The System
● campaign
● Leverage current infrastructure
● New capabilities and channels
80
Visual Not Shown
Visual Not Shown
Visual Not Shown
Visual Not Shown
Visual Not Shown
Communication and Commercialization
● campaign
● Leverage current infrastructure
● New capabilities and channels
86
Leverage Current Infrastructure
87
Visual Not Shown
Visual Not Shown
Visual Not Shown
New Capabilities and Channels
● Customer Care:
● Personalized, multi-channel customer support center
Mobile App
● Electronics:
● Logistic and distribution infrastructure
92
Platform 4
93
Platform 4: Commercialization Plan
94
Nicocigs: Company Information
Note: Reduced-Risk Products ("RRPs") is the term we use to refer to products that have the potential to reduce individual risk and population harm 96
Reduced-Risk Products: Conclusions
Reduced-Risk Products ("RRPs")
Note: Reduced-Risk Products ("RRPs") is the term we use to refer to products that have the potential to reduce individual risk and population harm. The RRPs depicted are subject to ongoing
development and therefore the descriptions are illustrative and do not necessarily represent the latest stages of product development 97
Investor Day – Reduced-Risk Products
Lausanne, June 26, 2014
Note: Reduced-Risk Products ("RRPs") is the term we use to refer to products that have the potential to reduce individual risk and population harm
Reconciliation of non-GAAP measures included in this presentation
to the most comparable GAAP measures are provided on our
website at: www.pmi.com/2014InvestorDay/RecSlides